$300,000+ Settlement Warns Health Plans, Other Covered Entities To Ensure Proper PHI Disposal

August 29, 2022

Health plans and insurers, health care providers, health care clearinghouses (“Covered Entities”), their business associate service providers, leaders and insurers should re-confirm their own organizations’ for handling and disposing of records and systems containing protected health information (“PHI”) comply with the Health Care Portability & Accountability Act (“HIPAA”) following the Department of Health & Human Services Office for Civil Rights (OCR) announcement yet another HIPAA enforcement action and settlement arising from improper PHI disposal.

OCR’s $300,000 plus settlement with New England Dermatology P.C., d/b/a New England Dermatology and Laser Center (“NDELC”) announced last week resolves OCR charges that NDELC violated the HIPAA Privacy Rules when it placed specimen containers with patient identifying PHI in its parking lot garbage bin.

OCR Long Enforced HIPAA PHI Disposal Responsibilities

OCR has long interpreted and enforced HIPAA as requiring Covered Entities and business associates to ensure appropriate processes are used to protect PHI when that safeguards are in place when disposing of patient information to keep it from being accessible by the public. ”Improper disposal of protected health information creates an unnecessary risk to patient privacy,” said Acting OCR Director Melanie Fontes Rainer.

The NEDLC enforcement action and NEDLC Resolution Agreement follow prior OCR settlements and warnings to Covered Entities and business associates about their responsibility to protect PHI through proper disposal during their ongoing operations as well as when closing operations.

Past OCR enforcement actions and settlements demonstrated OCR’s readiness to hold Covered Entities and their business associates accountable for properly disposing of records and materials containing PHI, In 2015, for instance, Cornell Prescription Pharmacy paid OCR $125,000 and implemented a correction action plan to correct alleged HIPAA violations after an OCR investigation of a local news report confirmed unsecured paper documents containing PHI of more than 1600 patients were disposed of in an unlocked, open container on Cornell’s premises. The documents were not shredded and contained identifiable information regarding specific patients. See Cornell Prescription Pharmacy Resolution Agreement. See also $800,000 HIPAA Settlement in Medical Records Dumping Case.

Other OCR enforcement actions highlighted the responsibility of Covered Entities and business associates to protect PHI when disposing of computer or other devices. For instance, OCR collected $1,215,780.00 from Affinity Health to settle potential HIPAA Civil Monetary Sanctions after OCR found it exposed the PHI of up to 344,579 individuals by returning photocopiers to a leasing agent without erasing the data contained on the copier hard drives. Affinity Health Plan, Inc. Resolution Agreement.

The OCR guidance and enforcement actions also make clear that the obligation for proper protection and disposal continues through termination of the business or operations through which a Covered Entity or business associate possessed or retained PHI. Thus, in the FileFax Resolution Agreement, for instance the receiver appointed to liquidate the assets of FileFax, Inc. paid $100,000 out of the receivership estate to OCR to settle potential HIPAA violations after Filefax shut its doors during the course of OCR’s investigation into alleged HIPAA violations.

New $300,000+ NEDLC Settlement Agreement

The NEDLC investigation and resulting settlement reflect OCR’s continued concern about ensuring appropriate protection of PHI through disposal. On May 11, 2021, NEDLC filed a breach report with OCR that reported empty specimen containers with the PHI on labels were placed in a garbage bin in their parking lot. The containers’ labels included patient names and dates of birth, dates of sample collection, and name of the provider who took the specimen. On March 31, 2021, a third-party security guard found one specimen container bearing a label containing patient names, dates of birth, dates of sample collection, and name of the provider who took the specimen. During the investigation, NEDLC stated that from February 4, 2011 until March 31, 2021, it regularly discarded specimen containers with an attached label that contained PHI as regular waste, bagged and placed in an exterior dumpster accessible via the parking lot, without alteration to the PHI containing label.

OCR’s New England Regional Office found the practice of disposing of specimen containers with their labels containing PHI violated the HIPAA Privacy Rule including the impermissible use and disclosure of PHI and failure to maintain appropriate safeguards to protect the privacy of PHI.

Under the NEDLC Resolution Agreement, NEDLC paid $300,640 to OCR and agreed to implement a “robust” corrective action plan that includes two years of OCR monitoring to settle OCR’s charges that it breached HIPAA by failing to appropriately secure and protect PHI through disposal. Among other things, the corrective action plan requires NEDLC to:

Within 60 days, develop, maintain, and revise, as needed and present for OCR review its written policies and procedures to comply with the physical safeguard and disposal of PHI created, received or maintained by or on behalf of NEDLC and all other HIPAA Privacy, Security and Breach Notification and training protocols to ensure workforce member compliance with these policies; and sanctions for workforce members violating these requirements;
Implement the updated policies and procedures within 30 days of receipt of HHS approval;
Distribute the policies to existing members of its workforce within 30 days of receipt of HHS approval of the policies and subsequently to new members of the workforce within 30 days of their beginning of service and obtain a signed written or electronic initial compliance certification from all members of the workforce and relevant business associates stating that the workforce members have read, understand, and shall abide by such policies and procedures;
Assess, update, and revise, as necessary, the policies and procedures at least annually or as needed, provide the revised policies and procedures to HHS for review and approval, and redistribute to and obtained new compliance certifications from workforce members and business associates within 30 days of HHS approval;
If it receives information during the Compliance Term that a workforce member or business associate may have failed to comply with its policies and procedures for safeguarding PHI, promptly investigate and it the investigation finds a violation, notify HHS within 30 days of the violation and corrective action taken;
Comply with specified breach investigation and notification requirements;
Provide reports certified by a designated leader of the organization its implementation of the corrective action plan, annually and upon the occurrence of certain other events during the two-year monitoring period.

Take Aways From NEDLC And Other OCR Improper Disposal Enforcement

As the NEDLC and other settlements make clear, Covered Entities and business associates are accountable for recognizing and protecting all PHI in the various phases of its lifecycle in the organization including when it is being disposed or migrating through various systems. Existing OCR enforcement actions like the NECLC Settlement Agreement highlight the need for other Covered Entities and their business associates to ensure all necessary steps are taken to protect PHI when disposing of any items, devices and data containing PHI from patient labeled items including identification bracelets, medication containers and labels, meal trays, folders, tags, storage containers, computers, copiers, jump drives and other electronic storage or other devices and plethora of other items. The announcement of the NEDLC settlement signals the advisability for Covered Entities and their business associates to reassess and reconfirm the adequacy of their own disposal processes and documentation.

Security and disposal practices and procedures are among the elements of HIPAA compliance that OCR expects Covered Entities to address in the documented risk assessments the regulations require Covered Entities to prepare and maintain. See $750,000 HIPAA Settlement Underscores the Need for Organization Wide Risk Analysis. As with other HIPAA compliance responsibilities, OCR regulations require that Covered Entities include their documented assessment and decision-making about the adequacy and reasonableness of their PHI protection and destruction practices under HIPAA as part of their overall HIPAA risk assessment plan and practices. The documented risk assessment requirements make it ill-advised for Covered Entities or business associates to assume their disposal or other HIPAA compliance obligations are satisfied by their past or current adoption of a standard set of policies and procedures obtained from a third-party.

When reviewing the adequacy of their organizations’ PHI disposal practices, Covered Entities and business associates should keep in mind OCR’s HIPAA regulations require them to document risk assessments, analysis, findings and actions as well as recurrently update this analysis periodically and at other times when warranted by events or developments putting the organizations on notice of potential concerns. These risk assessment requirements expect Covered Entities and business associates to conduct documented reviews and risk assessments “of their own circumstances to determine what steps are reasonable to safeguard PHI through disposal and develop and implement policies and procedures to carry out those steps” considering such issues as the form, type, and amount of PHI to be disposed. Covered entities are responsible for conducting and documenting their analysis as well as their adoption, implementation and enforcement of the resulting policies and procedures. HIPAA’s six-year record retention requirements extend to creation and preservation of the risk assessment documentation by a Covered Entity or business associate and OCR commonly asks for these assessment when initiating an audit or investigation. Accordingly, while organizations should consider examples discussed in OCR’s PHI destruction guidance when conducting their own risk announcement, each Covered Entity or business associate should resist the temptation of assuming reliance upon those examples is an adequate substitute for conducting and documenting their own specific risk assessment and analysis.

Best practices require tracking of all elements of PHI created, used, accessed, disclosed, or disposed of all times through documented, appropriate destruction. Ensuring proper fulfillment of these requirements necessitates that these policies and practices cover both disposition or destruction as part of continuing operations as well as required safeguards for disposal or destruction when a Covered Entity or business associate shuts down, sells or otherwise terminates operations that possess or have had access to PHI.

Of course, Covered Entities, business associates, their leaders and liability insurers also should remain mindful that their likely responsibilities and potential liability for mishandling PHI generally also runs concurrent with other contractual, statutory, regulatory or common law exposures. For instance, as HIPAA compliance is part of the Conditions of Participation that Medicare participating Covered Entities and Medicare Advantage Plans must meet to qualify for program participation, noncompliance could trigger program exclusion, False Claims Act or related exposures. Deficiencies in security or destruction of credit card, banking or other PHI that also qualifies as personal financial information could trigger exposure under Federal Trade Commission, state identity theft and privacy or other laws. Public companies and their leaders also may need to evaluate if deficiencies in their security or destruction protocols trigger investor disclosure obligations under Securities and Exchange Commission rules or other federal or state laws. Considering these and other exposures, documented, compliance and defensibility of PHI and other sensitive information use, protection, disclosure and destruction should rank high among the priorities of all Covered Entities and their leaders.

Since these evaluations could uncover or involve discussions of past or ongoing known or potential compliance concerns, Covered Entities and business associates should consider engaging legal counsel experienced with compliance and risk management under HIPAA and other implicated legal risks to advise and aid the Covered Entity to structure, conduct, evaluate findings and determine and implement any corrective actions that the review reveals as required or advisable within the scope of attorney client privilege. If circumstances come to light that indicate a breach of the standards in the course of the disposal compliance assessment or otherwise, Covered Entities also promptly should work with legal counsel timely to investigate, determine and provide any required notifications or other corrective action and document their actions to meet applicable HIPAA and other legal obligations and mitigate liability.

More Information

We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.

Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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Posted by Cynthia Marcotte Stamer

New $2.15M OCR Penalty Shows Health Plans Risks Of HIPAA Violations

October 23, 2019

Health plans and insurers and their service providers should heed as a warning of the potential perils they could face for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules the just-announced $2.15 million plus civil monetary penalty that Jackson Health System (JHS) paid the Department of Health & Human Services Office of Civil Rights (OCR).

While the HIPAA-covered entity that paid the $2,154,000 civil monetary penalty, JHS, is a Florida-based nonprofit academic medical system, rather than a health plan, the $1,500,000 HIPAA resolution payment OCR previously collected from Blue Cross Blue Shield of Tennessee (BCBST) in 2012 for its breaches of HIPAA make clear that health plans and insurers risk similar penalties for HIPAA violations. Consequently, health plans, health insurers and other health care providers and their business associates should construe the JHS civil monetary penalty as evidence of the need to re-verify and remain constantly vigilant about maintaining compliance with HIPAA’s privacy, security and breach notification rules currently and on an ongoing basis.

JHS HIPAA Breaches Found By OCR

The $2.1 million plus payment was required to satisfy a civil monetary penalty assessment OCR imposed in a Notice of Proposed Determination and Notice of Final Determination made public by OCR on October 23, 2019 in response to findings from a series of investigations of HIPAA breach and compliance concerns raised between 2013 and 2016 raised by various HIPAA-mandated breach reports and media reports that raised concerns about improper access disclosure and use of patient PHI between 2013 and 2016. When JHS did not challenge the findings or determination became final. OCR reports JHS has paid the specified $2.154,000 civil monetary penalty.

JHS operates six major hospitals, a network of urgent care centers, multiple primary care and specialty care centers, long-term care nursing facilities, and corrections health services clinics, provides health services to approximately 650,000 patients annually, and employs about 12,000 individuals.

On August 22, 2013, JHS submitted a breach report to OCR stating that its Health Information Management Department lost paper records containing the protected health information (PHI) of 756 patients in January 2013. JHS’s internal investigation determined that an additional three boxes of patient records also were lost in December 2012; however, JHS did not report the additional loss or the increased number of individuals affected to 1,436, until June 7, 2016.

In July 2015, OCR initiated an investigation following a media report that disclosed the PHI of a JHS patient. A reporter had shared a photograph of a JHS operating room screen containing the patient’s medical information on social media. JHS subsequently determined that two employees had accessed this patient’s electronic medical record without a job-related purpose.

On February 19, 2016, JHS submitted a breach report to OCR reporting that an employee had been selling patient PHI. The employee had accessed inappropriately over 24,000 patients’ records since 2011.

According to OCR Director Roger Severino, “OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years. …This hospital system’s compliance program failed to detect and stop an employee who stole and sold thousands of patient records; lost patient files without notifying OCR as required by law; and failed to properly secure PHI that was leaked to the media.”

These and other findings led to the OCR determination in the Notice of Proposed Determination and Notice of Final Determination that JHS failed to provide timely and accurate breach notification to the Secretary of HHS, conduct enterprise-wide risk analyses, manage identified risks to a reasonable and appropriate level, regularly review information system activity records, and restrict authorization of its workforce members’ access to patient ePHI to the minimum necessary to accomplish their job duties. OCR assessed the $2.1 million civil monetary penalty based on these determinations.

The JHS civil monetary penalty is The latest in a growing series of OCR enforcement and regulatory actions that drive home the perils HIPAA-covered health care providers, health plans and insurers, healthcare clearinghouses and business associates risk by failing to responsibly and effectively manage their HIPAA compliance including the one against mega-health plan and business associate, BCBST, that resulted in its payment of a $1,500,000 resolution payment. For details of the BCBS Resolution Agreement and Settlement payment, see here.

OCR enforcement data documents a steady rise in OCR investigation and enforcement activity. OCR set all-time records for HIPAA Enforcement in 2018. Heavy enforcement activity has continued in 2019. Before its October 23, 2019 announcement of the JHS civil monetary penalties, OCR already had announced:

A $10,000 resolution agreement with a dental practice for improperly disclosing patient PHI on social media at the beginning of October;
Its first HIPAA right of access resolution agreement against a health care provider for violating HIPAA’s right of access rules on September 9, 2019 as part of its recently announced HIPAA access rule enforcement initiative;
A $100,000 resolution payment from an Indiana Medical Records Service resulting from a breach of electronic protected health information at a business associate;
The collection of a $3 million resolution payment collected from a Tennessee diagnostic medical imaging services company to settle HIPAA civil monetary penalty exposures arising from a breach that exposed the protected health information of more than 300,000 patients; and
A multitude of other audits and enforcement activities resolved through corrective action without collection of any resolution payment or civil monetary penalties.

Given these and other previously announced enforcement initiatives and actions, all HIPAA covered entities and their business associates are urged to maintain hypervigilance about their own HIPAA compliance with long standing as well as emerging HIPAA requirements taking into account old, recent, and emerging guidance and enforcement activities of OCR. Of course health plans and other covered entities also need to additionally weigh their exposure under various other state and federal law likely to arise from such breaches and the investigation, mitigation and public and customer trust consequences that almost always accompany and frequently exceed the actual HIPAA liability imposed. Considered together, these and other consequences of HIPAA vioations or other sloppy dealings with protected health inforamtion or ther sensitive health care or financial information make a clear case for investing appropriately in HIPAA and related compliance.

For More Information

We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of management focused employment, employee benefit and insurance, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employers and other workforce management organizations; employer, union, association, government and other insured and self-insured health and other employee benefit plan sponsors, benefit plans, fiduciaries, administrators, and other plan vendors; domestic and international public and private health care, education and other community service and care organizations; managed care organizations; insurers, third-party administrative services organizations and other payer organizations; and other private and government organizations and their management leaders. As part of this work, she has worked extensively on employee benefit communication and other employee benefit plan legislative and regulatory policy, design, compliance and enforcement including testifying to the EBSA Advisory Council on Employee Welfare and Pension Benefit Plans in on the effectiveness of employee benefit plan disclosures during 2017 hearings on on reducing the burdens and increasing the effectiveness of ERISA mandated disclosures.

Throughout her 30 plus year career, Ms. Stamer has continuously worked with these and other management clients to design, implement, document, administer and defend hiring, performance management, compensation, promotion, demotion, discipline, reduction in force and other workforce, employee benefit, insurance and risk management, health and safety, and other programs, products and solutions, and practices; establish and administer compliance and risk management policies; manage labor-management relations, comply with requirements, investigate and respond to government, accreditation and quality organizations, regulatory and contractual audits, private litigation and other federal and state reviews, investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; prepare and present training and discipline; handle workforce and related change management associated with mergers, acquisitions, reductions in force, re-engineering, and other change management; and a host of other workforce related concerns. Ms. Stamer’s experience in these matters includes supporting these organizations and their leaders on both a real-time, “on demand” basis with crisis preparedness, intervention and response as well as consulting and representing clients on ongoing compliance and risk management; plan and program design; vendor and employee credentialing, selection, contracting, performance management and other dealings; strategic planning; policy, program, product and services development and innovation; mergers, acquisitions, bankruptcy and other crisis and change management; management, and other opportunities and challenges arising in the course of workforce and other operations management to improve performance while managing workforce, compensation and benefits and other legal and operational liability and performance.

A Fellow in the American College of Employee Benefit Counsel and Past Chair of both the ABA Managed Care & Insurance Interest Group and it’s RPTE Employee Benefits and Other Compensation Group, Ms. Stamer also has leading edge experience in health benefit, health care, health, financial and other plan, program and process design, administration, documentation, contracting, risk management, compliance and related process and systems development, policy and operations; training; legislative and regulatory affairs, and other legal and operational concerns.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career. Her public policy and regulatory affairs experience encompasses advising and representing domestic and multinational private sector health, insurance, employee benefit, employer, staffing and other outsourced service providers, and other clients in dealings with Congress, state legislatures, and federal, state and local regulators and government entities, as well as providing advice and input to U.S. and foreign government leaders on these and other policy concerns.

Author of leading works on a multitude of labor and employment, compensation and benefits, internal controls and compliance, and risk management matters and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; an ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission and its content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion.otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2019 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication or the topic of this article, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

$2.4M HIPAA Settlement Message Warns Health Plans & Providers Against Sharing Medical Info With Media, Others

May 10, 2017

Healthcare providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) can’t disclose the name or other protected health care information about a patient in press releases or other announcements without prior authorization from the patient. That’s the clear lesson Covered Entities should learn from the $2.4 million payment to the U.S. Department of Health and Human Services (HHS) that the largest not-for-profit health system in Southeast Texas, Memorial Hermann Health System (MHHS) is paying to settle charges it violated the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule by issuing a press release with the name and other protected health information (PHI) about a patient without the patient’s prior HIPAA-compliant authorization under a Resolution Agreement and Corrective Action Plan (Resolution Agreement) announced May 10, 2017 by HHS Office of Civil Rights (OCR).

The Resolution Agreement resolves OCR charges the operator of 13 hospitals, eight Cancer Centers, three Heart & Vascular Institutes, and 27 sports medicine and rehabilitation centers violated the Privacy Rule that resulted from an OCR compliance review of MHHS triggered by multiple media reports suggesting that MHHS improperly disclosed the name and other details about a patient arrested and charged with presenting an allegedly fraudulent identification card to office staff at an MHHS’s clinic after MHHS clinic staff alerted law enforcement of suspicions the patient was presenting false identification to the clinic. According to OCR, after law enforcement investigated and arrested the patient, MHHS published a press release concerning the incident in which MHHS senior management approved the impermissible disclosure of the patient’s PHI by adding the patient’s name in the title of the press release without securing prior authorization of the patient.

While OCR concluded the report to law enforcement allowable under the Privacy Rule, OCR found MHHS violated the Privacy Rule by issuing the press release disclosing the patient’s name and other PHI without authorization from the patient and also by failing to timely document the sanctioning of its workforce members for impermissibly disclosing the patient’s information.

To resolve and avoid the potential Civil Monetary Penalties that HIPAA could authorize OCR to impose for the alleged Privacy Rule violation, MHHS agrees in the Resolution Agreement to pay OCR a $2.4 million monetary settlement and implement a corrective action plan that obligates MHHS to update and train its workforce on its policies and procedures on safeguarding PHI from impermissible uses and disclosures including specific instructions and procedures to:

Address (a) Uses and disclosures for which an authorization is required, including to the media, to public officials, and on the internet; (b) Disclosures for law enforcement purposes; and (c) Uses and disclosures for health oversight activities;
Identify MHHS personnel or representatives whom workforce members, agents, or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities;
Internal reporting procedures requiring all workforce members to report to the designated person or office at the earliest possible time any potential violations of the Privacy, Security or Breach Notification Rules or of MHHS’ privacy and security policies and procedures and MHHS promptly to investigate and address all received reports in a timely manner; and
Application and documentation of appropriate sanctions (which may include retraining or other instructive corrective action, depending on the circumstances) against members of MHHS’ workforce, including senior level management, who fail to comply with the Privacy, Security or Breach Notification Rules or MHHS’ privacy and security policies and procedures, including a description of the sanctions; a timeframe in which MHHS will apply and document sanctions for violations of the HIPAA Rules or of MHHS’ privacy, security or breach policies or procedures; the manner in which MHHS will document the sanctions; and where MHHS will store or retain such documentation (e.g., personnel file).

The corrective action plan in the Resolution Agreement also requires all MHHS facilities to attest to their understanding of permissible uses and disclosures of PHI, including disclosures to the media and others.

Covered entities should keep in mind the MHHS Resolution Agreement is the latest in a series of OCR enforcement actions and resolution agreements highlighting the need for Covered Entities to adopt and use appropriate policies and procedures to prevent wrongful disclosures of PHI to the media or public. For instance, in June, 2013, OCR required Shasta Regional Medical Center (SRMC) to pay a $275,000 settlement payment and implement a comprehensive corrective action plan to resolve OCR charges stemming from SRMC’s disclosure of PHI about a patient to members of the media and its workforce in an effort to respond to accusations the patient made that SRMC engaged in fraud and other misconduct. See HIPAA Sanctions Triggered From Covered Entity Statements To Media, Workforce. In contrast, the $2.2 million resolution agreement that OCR required New York Presbyterian Hospital for improperly allowing a film crew to film hospital patients in violation of HIPAA was almost 10 times greater than the SRMC penalty and was accompanied by OCR’s publication OCR of specific additional guidance warning Covered Entities against improper disclosures to the media. See $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use.

Following on the heels of this previous guidance and prior enforcement actions warning Covered Entities against wrongful disclosure to the media, the MHHS Resolution Agreement sends a strong message to Covered Entities that they should expect little sympathy if their organizations improperly share PHI with the media. OCR’s announcement of the MHHS Resolution Agreement, for instance quotes OCR Director Roger Severino with stating that “Senior management should have known that disclosing a patient’s name on the title of a press release was a clear HIPAA Privacy violation that would induce a swift OCR response.” The announcement goes on to quote Director Severino further as stating, “This case reminds us that organizations can readily cooperate with law enforcement without violating HIPAA, but that they must nevertheless continue to protect patient privacy when making statements to the public and elsewhere.”

Conduct Entity-Wide Risk Assessment & Review & Tighten Media Relations Policies, Processes & Training ASAP

Covered entities should heed the warning by conducting a risk assessment of their organization’s susceptibility to potential improper disclosures to media or others and reviewing and implementing necessary written policies, procedures and training to prevent the improper disclosure of patient PHI to media or others unless the Covered Entity either secures prior HIPAA-compliant authorization from the patient or can prove the disclosure falls squarely under an exception to the Privacy Rule’s prohibition against disclosure of PHI without authorization except as allowed by the Privacy Rule.

Taking these and other needed steps to evaluate, and strengthen and enforce as needed, risk assessments, policies, procedures, and training to prevent wrongful use, access or disclosure of PHI to the media or others is particularly critical in light of the ongoing tightening of expectations, and rising enforcement and sanctions for HIPAA violations since Congress amended HIPAA in 2009. See OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

Based on experiences reported in the MHHS and other similar resolution agreements, Covered Entities also generally will want to ensure that their policies, procedures and training extend to all potential sources of communications that could involve patient information and make clear that the Privacy Rule restrictions must be followed even if the circumstances involve allegations of misconduct, special performance by healthcare providers or others that it would benefit the organization or certain individuals to have known to the public, or other circumstances likely to be of interest to the media or other parties.

As part of this process, covered entities should ensure they look outside the four corners of their Privacy Policies to ensure that appropriate training and clarification is provided to address media, practice transition, workforce communication and other policies and practices that may be covered by pre-existing or other policies of other departments or operational elements not typically under the direct oversight and management of the Privacy Officer such as media relations. Media relations, physician and patients affairs, outside legal counsel, media relations, marketing and other internal and external departments and consultants dealing with the media, the public or other inquiries or disputes should carefully include and coordinate with the privacy officer both to ensure appropriate policies and procedures are followed and proper documentation created and retained to show authorization, account, or meet other requirements.

In conducting this analysis and risk assessment, it will be important that Covered Entities include, but also look beyond the four corners of their Privacy Policies to ensure that their review and risk assessment identifies and assesses and addresses compliance risks on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer. For this reason, Covered Entities also generally will not only to adopt and implement specific policies, processes and training in these other departments to prohibit and prevent inappropriate disclosures of PHI in the course of those departments operations. It also may be advisable to pre-established processes for reviewing media or other communications for potential PHI content and require prior review of any proposed public relations and other internal or external communications containing patient PHI or other information by the privacy officer, legal counsel or another suitably qualified party.

Because of the high risk that the preparation or review of media or other public communications reports will involve the use and disclosure of PHI, Covered Entities also generally should verify that all outside media or public relations, legal, or other outside service providers participating in the investigation, response or preparation or review of communications to the media or others both are covered by signed business associate agreements that fulfill the Privacy Rule and other requirements of HIPAA as well as possess detailed knowledge and understanding of the Privacy and Security Rules suitable to participate in and help safeguard the Covered Entity against violations of these and other Privacy Rules. See e.g., Latest HIPAA Resolution Agreement Drives Home Importance Of Maintaining Current, Signed Business Associate Agreements.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to manage and defend compliance, public policy, regulatory, staffing and other operations and risk management concerns. A core focus of this work includes work to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; dealings with JCHO and other accreditation and quality organizations; investigation and defense of private litigation and other federal and state health care industry investigations and enforcement; insurance or other liability management and allocation; process and product development; managed care, physician and other staffing, business associate and other contracting; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other data security, privacy and breach laws. Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly regarded works and training programs on trade secret, HIPAA and other medical, consumer, insurance, tax, and other privacy and data security, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns.

In connection with this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.

Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

The American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health plans, health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other “nonpar,” insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; an ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional organizations.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.

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Posted by Cynthia Marcotte Stamer

Learn Key Lessons From $3.2M+ Children’s HIPAA CMP

February 2, 2017

A just-announced $3.2 million Health Insurance Portability & Accountability Act (HIPAA) Civil Monetary Penalty (CMP) paid by Children’s Medical Center of Dallas (Children’s) for failing to adequately secure electronic protected health information (ePHI) and correct other HIPAA compliance deficiencies teaches many key lessons for employer and other health plans and insurers, healthcare clearinghouses, healthcare providers and their business associates (“Covered Entities”) about mistakes to avoid in managing not only ePHI on laptops and mobile devices, as well as their overall HIPAA compliance and risk management.

The Department of Health & Human Services (HHS) Office of Civil Rights (OCR) imposed the $3,217,000.00 Civil Monetary Penalty (CMP) under a January 18, 2017 Final Determination based upon findings that Children’s for years knowingly violated HIPAA by failing to encrypt or otherwise properly secure ePHI on laptops and other mobile devices and failing to comply with many other HIPAA requirements. OCR originally notified Children’s of its intention to impose the CMP based on findings of widespread violations by Children’s of HIPAA in a September 30, 2016 Notice of Proposed Determination (Proposed Determination) that OCR sent to Children’s President of System Clinical Operations, David Berry. Although the Proposed Determination included instructions for requesting a hearing on the Proposed Determination, Children’s paid the CMP rather than exercising these hearing rights.

Evidence Children’s Ignored Repeated Notices of Violations For Years

According to the Proposed Determination, OCR uncovered widespread HIPAA violations by Children’s while investigating the HIPAA compliance of the Dallas-based pediatric health and hospital system in response to two separate notices of large breaches of ePHI that Children’s filed with OCR in response to the HIPAA Breach Notification Rule. Under the Breach Notification Rule, Covered Entities generally must provide notice of any breach of unsecured ePHI involving more than 500 individuals with OCR, subjects of the breached ePHI and the media within 60 days of receiving notice of the breach. In contrast, for breaches of unsecured ePHI involving fewer than 500 individuals, Covered Entities generally must notify subjects of the breached ePHI within 60 days, but can delay notification to OCR until filing a consolidated annual report of small breaches of ePHI.

The two breach notifications that triggered the OCR investigation leading to the CMP both involved losses of mobile devices containing ePHI that Children’s filed with OCR.

The first breach report, filed on January 18, 2010, notified OCR of the loss at the Dallas/Fort Worth International Airport on November 19, 2009 of an unencrypted, non-password protected BlackBerry device containing the ePHI of approximately 3,800 individuals.

The second reported breach report filed on July 5, 2013, reported the theft of an unencrypted laptop with the ePHI of 2,462 individuals from its premises sometime between April 4 and April 9, 2013. The OCR investigation found that although Children’s implemented some physical safeguards to the operating room storage area (e.g., badge access was required, and a security camera was present at one of the entrances), it also provided access to the area to staff who were not authorized to access ePHI. Children’s janitorial staff had unrestricted access to the area where the laptop was stored but did not provide encryption to protect the ePHI on the laptop from access by such unauthorized persons. Children’s internal investigation concluded that the laptop was probably stolen by a member of the janitorial staff.

In the course of investigating these two reported breaches, OCR took note that Children’s previously reported a small breach of unsecured ePHI on an unencrypted mobile device. In a letter dated August 22, 2011, from Children’s Vice President of Compliance and Internal Audit and Chief Compliance Officer Ron Skillens to OCR Equal Opportunity Specialist Jamie Sorley, Mr. Skillens stated that a Children’s workforce member (an unidentified medical resident) lost an iPod device in December 2010. The iPod had been synched to the resident’s Children’s email account, which resulted in the ePHI of at least 22 individuals being placed on the device. The ePHI on the iPod was not encrypted. The loss of the iPod resulted in the impermissible disclosure of ePHI by the medical resident. OCR concluded the ePHI of 22 individuals was impermissibly disclosed, because the workforce member and agent of Children’s provided access to any unauthorized person who discovered the device.

OCR found that the breaches resulted from Children’s violation of the HIPAA Security Rule by failing to encrypt laptops and other mobile devices or and implement other appropriate safeguards for the protection of ePHI on mobile devices;
Failing to appropriately document its decision to not implement encryption on mobile devices and any applicable rationale behind a decision to use alternative security measures to encryption; and
Failing to implement security measures that were an equivalent alternative to the security protection available from encryption solutions.

The Proposed Determination also reports that the OCR ’s investigation revealed that Children repeatedly over several years knowingly failed to implement and administer proper encryption and other safeguards on laptops and other mobile devices containing ePHI despite actual knowledge of the unaddressed risks to unencrypted ePHI in violation of the HIPAA Security Rule dating back to at least 2007. The Proposed Determination notes, for instance, that:

A Security Gap Analysis and Assessment conducted for Children’s December 2006-February 2007 by Strategic Management Systems, Inc. (SMS) (SMS Gap Analysis) identified the absence of risk management as a major finding and recommended that Children’s implement encryption to avoid loss of PHI on stolen or lost laptops.
A separate PricewaterhouseCoopers (PwC) analysis of threats and vulnerabilities to certain ePHI (PwC Analysis) conducted in August, 2008 for Children’s determined that encryption was necessary and appropriate. The PwC Analysis also determined that a mechanism was not in place to protect data on a laptop, workstation, mobile device, or USB thumb drive if the device was lost or stolen and identified the loss of data at rest through unsecured mobile devices as being “high” risk. PwC identified data encryption as a “high priority” item and recommended that Children’s implement data encryption in the fourth quarter of 2008.
Furthermore, in September 2012, the HHS Office of the Inspector General (OIG) issued the findings from its audit of Children’s that focused on information technology controls for devices such as smartphones and USB drives. Among other things, the report, entitled “Universal Serial Bus Control Weaknesses Found at Children’s Medical Center,” found that Children’s had insufficient controls to prevent data from being written onto unauthorized and unencrypted USB devices and that “without sufficient USB controls, there was a risk that ePHI could have been written onto an unauthorized/unencrypted USB device and taken out of the hospital, resulting in a data breach.” A copy of this report was provided to Mr. Skillens.
Despite the prior breach notifications and warnings from the SMS Gap Analysis, the PwC Analysis and the OIG audit report, Children’s failed to take the necessary steps to encrypt and otherwise safeguard its ePHI on mobile devices. Children’s still had not implemented encryption on all devices as of April 9, 2013 even though appropriate commercial encryption products were available to achieve encryption of laptops, workstations, mobile devices, and USB thumb drives in use by Children’s staff by, at least, the time of the PwC Analysis in 2008. Furthermore, while leaving these deficiencies unresolved, the Proposed Determination notes that Children’s issued unencrypted BlackBerry devices to nurses beginning in 2007 and allowed its workforce members to continue using unencrypted laptops and other mobile devices until at least April 9, 2013 despite the findings of SMS and PwC and Children’s actual knowledge about the risk of maintaining unencrypted ePHI on its devices.

Based on this evidence, OCR concluded that Children’s had “actual knowledge” of the unaddressed threats to ePHI as early as March 2007 and at least one year prior to the reported security incidents. Furthermore, OCR also found that Children’s additionally violated HIPAA by failing to implement sufficient policies and procedures governing the receipt and removal of hardware and electronic media that contain ePHI into and out of its facility, and the movement of these items within the facility prior to at least November 9, 2012. Prior to November 2012, Children’s information technology (IT) assets were inventoried and managed separately from the inventory of devices used within its Biomedical Department. Children’s IT asset policies did not apply to devices that accessed or stored ePHI that were managed by the Biomedical Department. Consequently, Children’s was unable to identify all devices to which the device and media control policy should apply prior to completing a full-scope inventory to identify all information systems containing ePHI in November 9, 2012. As Children’s did not conduct a complete inventory to identify all devices to which its IT asset policies apply to ensure that all devices were covered by its device and media control policies, the Proposed Determination concluded Children’s was out of compliance with the Security Rule at 45 C.P.R. § 164.310(d)(l).

After OCR’s investigation indicated widespread Privacy and Security Rule noncompliance by Children’s, the Proposed Determination states that OCR attempted to negotiate a resolution with Children’s through its informal resolution agreement process from approximately November 6, 2015, to August 30, 2016. When these efforts failed, OCR issued a May 10,2016 Letter of Opportunity that formally informed Children’s that since OCR had been unable to resolve its findings that Children’s violated the Privacy and Security Rules by informal means, OCR was informing Children’s of the preliminary indications of non-compliance and providing Children’s with an opportunity to submit written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 45 C.F.R. § 160.410 for OCR’s consideration in making a determination of a CMP pursuant to 45 C.F.R. § 160.404. The letter stated that Children’s could also submit written evidence to support a waiver of a CMP for the indicated areas of non-compliance. Each of Children’s indicated acts of noncompliance and the potential CMP for them were described in the letter. The letter was delivered to Children’s and received by Children’s agent on May 12, 2016.

Children’s responded to OCR’s letter on or about June 9, 2016. The Proposed Determination states that OCR determined that the information and arguments submitted by Children’s in its June 9, 2016 letter did not support an affirmative defense pursuant to 45 C.F.R. § 160.410 or a waiver of the CMP pursuant to 45 C.F.R. § 160.412. Accordingly, OCR notified Children’s in its September 30, 2016 Proposed Determination of OCR’s intent to implement the $3,217,000.00 CMP and procedures for appealing this planned CMP assessment. When Children’s did not file an appeal, OCR issued the Final Determination assessing the CMP. OCR reports that Children now has paid the $3,217,000.00 CMP.

Important Lessons For Other Covered Entities

The Children’s CMP and underlying circumstances provide many key lessons for other Covered Entities. Obviously, the Final Decision drives home the importance of:

Proper encryption and other security and access controls of devices and systems containing ePHI; and
Proper documentation of risk assessments, audits, breach investigations and other events, compliance analysis and conclusions taken in response, and corrective actions selected and implemented in response to these events.

Beyond the importance of documented compliance with encryption and other requirements, the Children’s CMP and its associated Proposed Determination and Final Determinations also illustrate the importance of proper behavior in response to a known or suspected breach. The Proposed Determination and Final Determination make clear that beyond the breaches uncovered in the course of the investigation, OCR’s decision to implement the CMP was influenced by, among other things:

OCR investigates all large breach reports;
Small breach reports can count too;
The recurrent disregard and failure by Children to act to address the HIPAA security violations over a period of years despite both repeated notifications of its noncompliance and actual breaches resulting from these compliance deficiencies; and
The failure of Children’s to cooperate with OCR to reach a voluntary resolution agreement which might have allowed Children to resolve its liability for the breaches OCR found by paying a potentially smaller settlement payment and implementing corrective actions to OCR’s satisfaction.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 28 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps these and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s includes nearly 30 years’ of work with a diverse range of health industry clients on an extensive range of matters.

Ms. Stamer has worked closely with health industry, managed care and insurance and other businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of staffing, human resources and workforce performance management, internal controls and regulatory compliance, change management and other performance and operations management and compliance. She supports her clients both on a real-time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others, and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns including policy design, drafting, administration and training; business associate and other contracting; risk assessments, audits and other risk prevention and mitigation; investigation, reporting, mitigation and resolution of known or suspected breaches, violations or other incidents; and defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others. Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy and governmental and regulatory affairs experience, Ms. Stamer also is widely recognized for regulatory and policy work, advocacy and outreach on healthcare, education, aging, disability, savings and retirement, workforce, ethics, and other policies. Throughout her adult life and career, Ms. Stamer has provided thought leadership; policy and program design, statutory and regulatory development design and analysis; drafted legislation, proposed regulations and other guidance, position statements and briefs, comments and other critical policy documents; advised, assisted and represented health care providers, health plans and insurers, employers, professional. and trade associations, community and government leaders and others on health care, health, pension and retirement, workers’ compensation, Social Security and other benefit, insurance and financial services, tax, workforce, aging and disability, immigration, privacy and data security and a host of other international and domestic federal, state and local public policy and regulatory reforms through her involvement and participation in numerous client engagements, founder and Executive Director of the Coalition for Responsible Health Policy and its PROJECT COPE: the Coalition on Patient Empowerment, adviser to the National Physicians Congress for Healthcare Policy, leadership involvement with the US-Mexico Chamber of Commerce, the Texas Association of Business, the ABA JCEB, Health Law, RPTE, Tax, Labor, TIPS, International Life Sciences, and other Sections and Committees, SHRM Governmental Affairs Committee and a host of other involvements and activities.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

Beyond her extensive involvement advising and representing clients on privacy and data security concerns and other health industry matters, Ms. Stamer also has served for several years as a scrivener for the ABA JCEB’s meeting with OCR, the Chair of the Southern California ISSA Health Care Privacy & Security Summit, and an editorial advisory board member, author, program chair or steering committee member, and faculties for a multitude of other programs and publications regarding privacy, data security, technology and other compliance, risk management and operational concerns in the health care, health and other insurance, employee benefits and human resources, retail, financial services and other arenas.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

Learn Latest HIPAA Health Plan Rules In 3/30 SLP Webex

March 9, 2016

Solutions Law Press, Inc. ™ Invites You To A Special WebEx Briefing

HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments

Wednesday, March 30, 2016

1:00 P.M.-2:00 P.M. Eastern | 12:00 P.M.-1:00 P.M. Central 11:00 A.M-12:00 P.M. Mountain | 10:00 A.M-11:00 A.M. Pacific

Health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) face new imperatives to review and tighten their practices to ensure their practices comply with recently released guidance from the U.S. Department of Health & Human Services Office of Civil Rights (OCR)) emphasizing and clarifying the responsibilities of health care providers, health plans and the healthcare clearinghouses under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) to provide access to individuals that are the subject of protected health information or “PHI” to access or copies of their PHI in accordance with HIPAA’s rules and other recent HIPAA guidance and enforcement. With OCR’s recent release of added guidance and OCR enforcement statistics continuing to show HIPAA access rule violations among the most common HIPAA violations and OCR stepping up HIPAA enforcement, health care providers, health plans, healthcare clearinghouses can expect heightened scrutiny and enforcement of these requirements. Additionally, Covered Entities also should evaluate the adequacy of their other practices in light of other recent OCR guidance and enforcement actions.

Solutions Law Press, Inc.™ invites to catch up on the latest guidance on HIPAA’s requirements to provide access to patients to PHI by registering here to participate in the Solutions Law Press, Inc.™ “HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments” WebEx briefing from Cynthia Marcotte Stamer on Friday, March 18, 2016. During the Briefing, Ms. Stamer will provide participants with:

√ An update on OCR enforcement actiions and guidance over past 12 months

√ A detailed discussion of OCR’s new guidance about when Covered Entities must provide PHI access or copies to patients

√ Discuss rules and best practices for verifying the identity and credentials of an individual requesting PHI as a patient or personal representative of a patient

√ Share tips for contracting and dealing with business associates to facilitate administration of patient PHI access and security compliance activities

√ Share other practical considerations & best practices for compliance and risk management

√ Respond to participant questions on a time permitting basis

√ More

ABOUT THE SPEAKER

Recognized as “Legal Leader™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” and an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble, singled out as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine;, Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her more than 28 years extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care, health plan and employee benefits, workforce and related regulatory and other compliance, performance management, risk management, product and process development, public policy and other key operational concerns.

As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, the Co-Managing Member of Stamer Chadwick Soefje PLLC, Ms. Stamer has worked extensively throughout her nearly 30 year career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance including extensive involvement with HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others. Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health, employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with the US Congress, Departments of Labor, Treasury, Health & Human Services, Federal Trade Commission, HUD and Justice, as well as a state legislatures attorneys general, insurance, labor, worker’s compensation, and other agencies and regulators as well supports clients in defending litigation as lead strategy counsel, special counsel and as an expert witness.

Beyond her extensive involvement advising and defending clients on these matters, Ms. Stamer also has served as the scrivener for the ABA JCEB’s meeting with OCR on HIPAA for many years. She returns as Chair of the Southern California ISSA Health Care Privacy & Security Summit for the third year in 2016, as well as speaks and serves on the steering committee of a multitude of other programs.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE; Coalition on Patient Empowerment, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Counsel, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clients, serves on the faculty and planning committee of many workshops, seminars, and symposia, and on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or the Stamer│Chadwick │Soefje PLLC or contact Ms. Stamer via email to here or via telephone to (469) 767-8872.

REGISTRATION & PROGRAM DETAILS

Registration Fee per course is $75.00 per person. Registration Fee Discounts available for groups of three or more participants from the same organization. Limited opportunities for participation. Registration accommodated on a first come basis. Completed registration and payment required via website registration 48 hours in advance of the program. No checks or cash accepted. Persons not registered with completed payment at least 48 hours in advance will only participate subject to availability and completed registration and payment. Payment only accepted via website PayPal. Register Here!

The Webex will be conducted over the internet. Participants will receive access code and instructions for sign on to participate in the Webex and/or dial in to participate in the program via telephone after processing of completed registration. Participants must have access to a computer with internet access and to telephone access to dial in via telephone to participate in the program. Solutions Law Press, Inc. is not responsible for any interruption or interference in participation resulting from limitations in the internet connectivity, computer, telephone or other equipment used by the participant to access and participate in the program.

ABOUT SOLUTIONS LAW PRESS, INC.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders better anticipate legal and operational issues impacting their organization’s performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives. Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs. For additional information about upcoming programs, to inquire about becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com. These programs, publications and other resources are provided only for general informational and educational purposes, the applicability of which to any particular circumstances may be impacted by legal changes, the specific facts and circumstances or other factors. Consequently, neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are not intended to or shall not be construed as establishing an attorney-client relationship, to constitute legal advice or a substitute for legal advice, or otherwise provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties that any participant or any other party can rely upon the information or any statements presented herein. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com. If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net. CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request. ©2016 Solutions Law Press, Inc.

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Posted by Cynthia Marcotte Stamer

Health Plans, Sponsoring Employers & Others Urged To Act Immediately In Response To Premera, Anthem Blue Cross Breaches

March 17, 2015

Today’s report by Premera Blue Cross of a massive data breach affecting as many as 11 million customers’ personal health and financial information on the heels of the large-scale data breach announcement by fellow Blue Cross Association, Anthem, is another reminder that employers and other health plan sponsors, fiduciaries, insurers specifically, and U.S. businesses generally should immediately assess and tighten up their privacy, data security and data breach compliance and risk management to fulfill applicable legal mandates and to strengthen defenses against resulting liabilities and member backlash likely to arise from these or future breaches.

Notice of the Premera and Anthem breaches are likely to trigger obligations for health plans and their sponsoring employers or unions, administrators, insurers, and other vendors and service providers to take immediate steps to conduct documented investigations, take corrective action and provide breach notifications the Privacy, Security and Breach Notification rules of the Health Insurance Portability & Accountability Act require health plans and their business associates to provide in response to notice of a breach. Depending on the scope and nature of data affected and their involvement with the affected plans, employer or other plan sponsors, fiduciaries, administrators and service providers also may be subject additional responsibilities under applicable contracts and policies, the fiduciary responsibility requirements of the Employee Retirement Income Security Act of 1974 (ERISA), the Internal Revenue Code, and a host of other laws. Insurance industry or other vendors providing services to these plans also may face specific responsibilities under applicable insurance, health care, federal or state identity theft, privacy or data security, or other federal or state laws. See, e.g., Restated HIPAA Regulations Require Health Plans To Tighten Privacy Policies And Practices; Cybercrime and Identity Theft: Health Information Security Beyond; HIPAA Compliance & Breach Data Shares Helpful Lessons For Health Plans, Providers and Business Associates.

The need for prompt assessment and action is not necessarily limited to health plans and organizations sponsoring, administering or doing business with the plans involved in the Premera or Anthem breaches. The occurrence of these breaches arguably raises the questions about the adequacy of the safeguards, practices and policies of other health plans and insurers, their sponsors and fiduciaries, insurers, administrators and other vendors. places other health plans. Health plans, their sponsors, fiduciaries, administrators, insurers and other vendors generally will want to make prudent documented inquiries about the adequacy of their health plan’s data security and privacy safeguards in anticipation of potential future breaches, audits or other scrutiny.

Beyond the specific health plan related concerns, most businesses also will want to consider the adequacy and defensibility of the data collection, use, disclosure, security and other practices affecting sensitive data within or on behalf of their organization. The report of these and other health plan breaches, as well recent reports of identity theft and other fraud impacting federal tax returns and other large data breach reports involving retailers and other prominent businesses are spurring recognition of the large risks and need for greater scrutiny and accountability to business collection, use, and protection of sensitive personal and other data.

Of course, as in the case of health plans, the risk is exploding largely in response to the continued evolution of electronic payment and other business operating systems coupled with the emergence of data harvesting and other capabilities. These new technologies and practices are fueling a host of new mandates, opportunities and risks for virtually every U.S. business. Cyber criminals seem to always be one step ahead of business and government in leveraging these emerging opportunities for their criminal purposes.

With everyone from the Internal Revenue Service and other federal and state government agencies to private business partners pushing to leverage the efficiencies and other opportunity of electronic transactions and data, businesses in the US and around the world increasing are encouraged if not required to conduct more and more transactions containing sensitive business and individual tax information, personal financial information, personal health information, trade secrets and other confidential business and personal information electronically. Meanwhile big data and other business and marketing gurus also encourage business to leverage their own opportunities to use data collected for these business mandates and expanding technology also to collect, use and repurpose customer, prospect or other business information collected in the course of business to benefit their business’ marketing, transactional and other opportunities.

As these practices take hold and expand, data breaches and other cyber crime events, the legal requirements and risks of collection and use of data also are growing. Privacy, identity theft and other cyber crime and other concerns have led federal and state lawmakers to enact an ever-growing list of notice, consent, disclosure, security and other laws and regulations including but not limited to the Fair & Accurate Credit Transaction Act (FACTA),the Gramm-Leach-Bliley Act, the HIPAA Privacy & Security Rules, state identity theft, data security and data breach and other electronic privacy and security laws and an ever-growing plethora of others.

As the cyber crime epidemic continues to grow and notorious breeches and schemes involving the Internal Revenue Service, Veterans Administration, retail giants like Target, Home Depot, and others, insurance giants like Anthem and Premera and others, government and private enforcement is rising and the judgments, penalties and other costs soaring even as federal and state regulators are looking at the need for expanded rules and penalties. See Cybercrime Enforcement Statistics; DOJ Enforcement Priorities & Statistics. In addition, widening data privacy and security concerns from these massive data breach reports also are prompting Congress and State regulatorsto consider the need for added reforms, see, McCaul to Hold Hearing on President’s Cybersecurity. In deed, even before news of the Premera breach broke, he Federal Trade Commission today announced plans to host a workshop on Nov. 16, 2015, to look at the privacy issues around the tracking of consumers’ activities across their different devices for advertising and marketing purposes.

While these and other legal and enforcement developments promise new liabilities and expenses, the business losses and customer and business partner implications experienced by Target, Anthem and other businesses already affected illustrate the severe business consequences that inevitably result if a business appears to have failed to take customer privacy or other data security concerns seriously.

The now notorious Target hacking data breach event is illustrative. Target reported in late 2013 that credit and debit card thieves stole the name, address, email address and phone number from the credit and debit card records of around 70 million Target shoppers between November 27 and December 15, 2013. After announcing the breach, Target reported a 46% drop in profits in the fourth quarter of 2013, compared with the year before despite having announced plans to invest $100 million upgrading their payment terminals to support Chip-and-PIN enabled cards and millions of dollars more in rectification efforts. See The Target Breach, By the Numbers. Subsequently, Target’s losses have continued to mount even as it now faces lawsuits and other enforcement actions as a result of the breach. See Banks’ Lawsuits Against Target for Losses Related to Hacking Can Continue. Meanwhile, the enforcement and other fallout continues to evolve.

While businesses generally need to tighten their defenses and compliance, health plans, their sponsors, fiduciaries, administrators and vendors have specific obligations that require immediate, well-documented action when an actual or potential breach happens. The Privacy, Security and Breach Notification requirements of HIPAA require that health plans adopt specific policies and maintain and administer specific safeguards to prevent and respond to breaches of protected health information. In the event of a breach, these rules require that the health plan, usually acting through its fiduciaries, and affected service providers that qualify as business associates both investigate and redress the breach, as well as provide specific notification as soon as possible and usually no later than 30 days after the health plan knows or has reason to know of the breach. Significant civil and even criminal penalties can apply if a health plan, health insurer or its business associate fails to fulfill these obligations.

Beyond the specific requirements of HIPAA, employers and other plan sponsors and others involved in the maintenance and administration of the health plan or the selection and oversight of its vendors often may have other less-realized responsibilities. As health plan data often includes payroll and other tax data, employers, the health plans and other parties involved also may have specific responsibilities under the Internal Revenue Code or other laws. To the extent that the plan sponsor or another party is named as the plan administrator or otherwise exercises discretion and control over the selection of the insurer or other plan vendor or other plan operations, the fiduciary obligations of ERISA also may require a prudent investigation and other action to meet fiduciary obligations of ERISA. Brokers, insurers, third party administrators, preferred provider organizations or other managed care providers and others doing business with the health plan also may have specific responsibilities under state insurance, health care, data breach and identity theft or other laws. Under the provisions of most of these laws, leaving it to the insurer or other vendor involved in the breach generally will not suffice to fulfill applicable legal responsibilities, much less allay the fears of plan members, employees, health care providers and others involved with the health plan.

In the face of these developments, health plans and their sponsors, fiduciaries and others working with them must take immediate action in response to the breaches reported. Along with these specific health plan related responses, businesses also should the adequacy and defensibility of their current overall data collection, use and security practices while remaining ever vigilant for new requirements, as well as weaknesses in their own practices. Health plans specifically and businesses generally need to build their defenses in anticipation of these events both to withstand government and private litigation and enforcement, and to survive the harsh judgment of public opinion.

For Help With Risk Management, Compliance & Other Management Concerns

If you need assistance in responding to a health plan breach concern or with auditing or assessing, updating or defending your organization’s compliance, risk management or other internal controls practices or actions, please contact the author of this update, attorney Cynthia Marcotte Stamer here or at (469) 767-8872.

Scribe for the ABA JCEB Annual Agency Meeting with the Office of Civil Rights, a faculty and steering committee for the Southern California ISSA-HIMSS Health Care Privacy Program, Board Certified in Labor & Employment Law, a Fellow in the American College of Employee Benefits Counsel recognized as a “Top 100” lawyer in labor and employment, employee benefits and health care law, Ms. Stamer is nationally recognized for her work, publications, public speaking and education and other leadership on privacy and data security and other risk management and compliance.

A management attorney who works with businesses and government to manage and redress people, process and risk, Ms. Stamer has worked extensively on data and other privacy risk management and compliance, Throughout her career, she has conducted investigations and advised, and assisted health care, insurance, retail and a broad range of other public and private organizations with privacy and data security audit and risk management, contracting, investigation, defense and remediation throughout her more than 25 year career.

Past Chair and of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Committee, a Council Representative on the ABA Joint Committee on Employee Benefits, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, current Co-Chair of the RPTE Welfare Benefit Committee and Vice Chair of the ABA TIPS Employee Benefits Committee, Ms. Stamer works, publishes and speaks extensively on cyber crime and other privacy, management, reengineering, investigations, human resources and workforce, employee benefits, compensation, internal controls and risk management, federal sentencing guideline and other enforcement resolution actions, and related matters. She also is recognized for her publications, industry leadership, workshops and presentations on these and other concerns and regularly speaks and conducts training on these matters.Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the ABA, Insurance Thought Leadership, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications.

As part of her extensive involvements in privacy and data security concerns, Ms. Stamer will be among the panelists discussing “Fiduciary Obligations In the Context of a Data Breach” conference call to be hosted on April 2, 2015 by Fiduciary Responsibility Committee of the American Bar Association (ABA) Real Property Probate and Estate Section Employee Benefits & Other Compensation Group. During the program, Ms. Stamer and other panelists will discuss the quagmire of fiduciary legal and operational challenges that data breach announcements by health plan vendors and insurers present for employer and union-sponsored health plan fiduciaries and health plans. She also will serves as the scribe for the upcoming ABA Joint Committee On Employee Benefits Annual Agency Meeting with the Federal agency that enforces HIPAA, the Office of Civil Rights, and 2014 Conference Chair and steering committee and faculty member of the Southern California ISSA/HIMSS Healthcare Privacy & Security Summit scheduled for June 4, 2015 in Los Angeles.

For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see here or contact Ms. Stamer directly. For information about participation in the April 2 Conference Call or joining the Committee, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources at www.solutionslawpress.com.

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1 Comment | Claims Administration, Data Security, Employers, ERISA, Fiduciary Responsibility, Health Plans, HIPAA, Insurance, Internal Controls, Internal Investigations, Reporting & Disclosure | Tagged: Anthem, Data Breach, HIPAA, Personal Health Information, PHI, Premera | Permalink
Posted by Cynthia Marcotte Stamer

Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements

April 27, 2014

“Encrypt your laptops and other mobile devices” is only one of the key lessons leaders of health plans, health care providers, health care clearinghouses (“Covered Entities”) and their business associates should take away from the Department of Health and Human Services Office for Civil Rights (OCR)’s April 22 announcement that Concentra Health Services (Concentra) and QCA Health Plan, Inc. of Arkansas (QCA) collectively are paying $1,975,220 under separate Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rule resolution agreements resulting from thefts of unencrypted laptops. Along with the importance of encryption, however, these Resolution Agreements also contain equally significant, more broadly applicable lessons to Covered Entities, business associates and their leaders about some of the specific processes, actions and documentation that OCR them to implement and be prepared to defend the adequacy of their HIPAA “culture of compliance” if they file a breach report or otherwise face a HIPAA audit or investigation from OCR.

Consequently, while confirming the adequacy of their organization’s existing encryption of laptops and mobile devices, Covered Entities and their leaders should also consider using these and other Resolution Agreements as a road map for reviewing and tightening their management oversight and other HIPAA compliance documentation and practices generally.

Concentra Resolution Agreement

Under the Concentra Resolution Agreement, Concentra agrees to pay OCR a monetary settlement of $1,725,220 and adopt a corrective action plan to settle potential violations of the HIPAA Privacy and Security Rules and evidence their remediation of OCR’s findings.

OCR opened a compliance review of Concentra after receiving a breach report that an unencrypted laptop was stolen from its the Springfield Missouri Physical Therapy Center on November 30, 2011. OCR’s investigation concluded that Concentra previously had recognized in multiple risk analyses that a lack of encryption on its laptops, desktop computers, medical equipment, tablets and other devices containing electronic protected health information (ePHI) was a critical risk. While steps were taken to begin encryption, Concentra’s efforts were incomplete and inconsistent over time leaving patient PHI vulnerable throughout the organization. OCR’s investigation further found Concentra had insufficient security management processes in place to safeguard patient information.

In particular, the Resolution Agreement states that HHS’ investigation found that the following conduct occurred (Covered Conduct):

Concentra failed to adequately remediate and manage its identified lack of encryption or, alternatively, document why encryption was not reasonable and appropriate and implement an equivalent alternative measure to encryption, if reasonable and appropriate, from October 27, 2008, until June 22, 2012 (date on which a complete inventory assessment was completed and Concentra immediately took action to begin encrypting all unencrypted devices) (see 45 C.F.R. § 164.312(a)(2)(iv))

Concentra did not sufficiently implement policies and procedures to prevent, detect, contain, and correct security violations under the security management process standard when it failed to adequately execute risk management measures to reduce its identified lack of encryption to a reasonable and appropriate level from October 27, 2008, (date of Concentra’s last project report indicating that 434 out of 597 laptops were encrypted) until June 22, 2012 (date on which a complete inventory assessment was completed and Concentra immediately took action to begin encrypting all unencrypted devices) (see 45 C.F.R. § 164.308(a)(1)(i)). 3.

In the Resolution Agreement, Concentra has agreed to pay OCR $1,725,220 to settle potential violations and will adopt a corrective action plan to evidence their remediation of these findings.

QCA Resolution Agreement

QCA’s much smaller $250,000 monetary penalty under the QCA Resolution Agreement also resulted from a breach notification of the theft of an unencrypted laptop and also requires corrective actions in addition to a monetary settlement. OCR opened its investigation after QCA reported in February 2012 that an unencrypted laptop computer containing the ePHI of 148 individuals was stolen from a workforce member’s car. OCR’s investigation revealed that while QCA encrypted their devices following discovery of the breach, QCA failed to comply with multiple requirements of the HIPAA Privacy and Security Rules, beginning from the compliance date of the Security Rule in April 2005 and ending in June 2012.

To resolve OCR’s charges it violated HIPAA, QCA agreed to a $250,000 monetary settlement and is required to provide HHS with an updated risk analysis and corresponding risk management plan that includes specific security measures substantially similar to those imposed on the Concentra Resolution Agreement to reduce the risks to and vulnerabilities of its ePHI. QCA is also required to retrain its workforce and document its ongoing compliance efforts.

Corrective Action Plan Lessons For Other Covered Entities & Business Associates

Unquestionably, laptop and other mobile device encryption is a key take away of the two separate resolution agreements against Concentra and QCA. OCR Deputy Director of Health Information Privacy Susan McAndrew made this point clear in the announcement of the Concentra and QCA Resolution Agreements, stating “Covered entities and business associates must understand that mobile device security is their obligation,” and “Our message to these organizations is simple: encryption is your best defense against these incidents.”

As important as this encryption warning is, however, leaders of Covered Entities and business associates must not overlook the more subtle but equally important messages in these Resolution Agreements share about the management oversight and other specific actions, documentation and other evidence that OCR may expect their organizations and its leadership to produce if OCR investigates or audits its HIPAA compliance.

OCR officials have stated that Covered Entities and their business associates should use the corrective action plans in resolution agreements to help guide their own compliance efforts. While the message to encrypt mobile device is important, it is not the only lesson that leaders should learn. The Concentra and QCA Resolution Agreements, as well as their predecessors also contain detailed information about various other processes and procedures that OCR views as necessary or helpful to the compliance efforts of Covered Entities and their business associates. Privacy officers and other leaders of Covered Entities and business associates should avoid the mistake of allowing the Resolution Agreement’s clear messaging about mobile device encryption to lure them or their organization into overlooking broader and more generalized messages the corrective action plans included in the Concentra, QCA and other Resolution Agreements share about the compliance processes and analysis, management review and oversight, training and other compliance practices and documentation that OCR may expect their organizations to create and produce.

The requirement of officer attestation that his organization completed the detailed corrective actions required by OCR and that the reports submitted to OCR are accuratein the Concentra and QCA Resolution Agreements Corrective Action Plans, for instance, reflects OCR’s expectation that senior management take ownership of ensuring the adequacy of their organization’s HIPAA compliance. In this respect, leaders of Covered Entities and business associates particularly should note that both the Concentra and QCA Resolution Agreements, as well as the Skagit County Resolution Agreement announced in March, 2014 require specific attestations from an “officer” of the entity that the officer reviewed the reports, made reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful. These attestation requirements, like those required by OCR in the Skagit County Resolution Agreement OCR announced in March send a clear message that OCR views leaders as responsible for taking appropriate steps to require and confirm adequate HIPAA compliance in the same manner as typically applies to other Federal Sentencing Guideline compliance efforts. See HIPAA Covered Entities Should Review & Correct HIPAA Policies In Response To New County Hospital Resolution Agreement, Other Developments. These attestation requirements send a strong message that OCR expects the leadership of Covered Entities, business associates to take ownership of and keep tabs on their organization’s HIPAA compliance. In light of this, leadership of all Covered Entities and their business associates should evaluate the adequacy of their current HIPAA management oversight and documentation in proving the “culture of compliance” expected by HIPAA.

Viewed from this perspective, the corrective action steps and reporting requirements imposed by the Concentra, QCA and other Resolution Agreements are valuable road maps to both privacy officers and other management of Covered Entities and business associates about the processes, steps and documentation that management should consider requiring as part of its direction and oversight of their organizations’ Privacy, Security and Breach Notification compliance.

In this respect, management should note that both Resolution Agreements require that Concentra and QCA conduct, document, and report to OCR on a series of specific steps toward compliance. In both cases, for instance, OCR requires Concentra and QCA among other things, to conduct a ‘thorough risk assessment’ of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all ePHI, then develop and implement a ‘detailed risk management plan’ that addresses the identified compliance concerns, the plan and timeline for their redress and steps for monitoring and verifying those actions are taken.

From the Resolution Agreements’ discussion, leaders should expect that the documentation and evidence that OCR may require their organizations to produce will include:

A detailed risk management plan that documents and explains its strategy for implementing security measures sufficient to reduce the risks and vulnerabilities identified in the risk analysis to a reasonable and appropriate level based on the organization’s circumstances;
With the risk management plan, include material evidence of all implemented and all planned remediation actions associated with the risk management plan along with specific timelines for their expected completion and identify the compensating controls that will be in place in the interim to safeguard Concentra ePHI;
Requires for any changes to its information technology (IT) infrastructure, software or other components, an updated risk analysis in association with any changes or updates to its organizational IT infrastructure (security environment) that affect the risks and vulnerabilities to ePHI received or maintained by Concentra containing all of these elements;
Require that their team track and document the encryption status of mobile and other devices and PHI that both shows that the organization both requires and tracks compliance with requirements to encrypt devices containing ePHI and that the organization requires specific review and documentation that ePHI will not be used on computer or other devices that are unencrypted.
Not only that required workforce training is completed but also whether existing and future documentation requires and retains the documentation that would enable the organization to demonstrate to OCR that the leadership of the organization requires monitoring and documentation that all workforce members have completed the required training, the training materials used for the training, the topics covered, the length of the session(s), when training session(s) were held, and the attestations or other documentation from individual workforce members that the organization requires to verify participation, understanding and affirmation of the individual of the need to comply with HIPAA.

Accordingly, management of Covered Entities and business associates should consider verifying that these organizations have, or take the steps necessary, to be able to provide this documentation and other evidence.

The reporting requirements that OCR imposes under the Resolution Agreements also may be helpful to leaders of Covered Entities or their business associates about the importance of requiring periodic detailed and documented reporting from the Privacy Officer on their organization’s compliance with HIPAA, and some of the types of information that they should expect to receive in these reports. In this regard, leaders may wish to take note that the Resolution Agreements in Concentra, QCA, and Skagit each required that their organizations prepare and provide reports, accompanied by the required officer attestations containing among other things:

A summary of the organization’s security management process and the security measures taken during the Reporting Period, including, if applicable, any documentation of training related to those measures;
A summary of the organization’s encryption efforts taken during the Reporting Period; and
A summary of the organization’s security awareness training efforts taken during the Reporting Period.

In light of these requirements, leaders of Covered Entities or business associates also should consider establishing policies that both require periodic reporting to management and management review of reports on their organization’s ePHI and other Privacy and Security compliance that will produce documentation of similar periodic management oversight as an ongoing process within their organizations.

Since the Concentra and QCA Resolutions are only two of several existing Resolution Agreements, and likely will be supplemented by others in the future, management also should ensure that past and future Resolution Agreements as well as other guidance and developments under HIPAA are systematically reviewed and responded to in a similar, well documented manner.

Learn More At Upcoming Workshops and Teleconferences

Leaders, privacy officers, internet security officers, technology professionals and others concerned about HIPAA and other privacy and security management for Covered Entities, business associates and others can learn more about HIPAA Privacy, Security and Data Breach compliance and risk management by participating in one of the following upcoming HIPAA educational events that the author of this update, Cynthia Marcotte Stamer, will be a featured presenter:

HIPAA Compliance: Are You Ready If A Breach Occurs? Privacy, Security, HITECH, Record Retention Teleconference presented by the American Bar Association Joint Committee on Employee Benefits on April 29, 2014;and
ISSA-LA and HIMSS Southern California 2nd Annual Healthcare Privacy and Security Summit scheduled for May 15-16 at the Universal City Hilton, Universal City, California.

For Representation, Training & Other Resources

If you need assistance monitoring these and other regulatory policy, enforcement, litigation or other developments, or to review or respond to these or other workforce, benefits and compensation, performance and risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Board Certified in Labor & Employment Law, Past Chair of the ABA RPTE Employee Benefit & Other Compensation Arrangements Group, Co-Chair and Past Chair of the ABA RPTE Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Plans Committee, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years’ experience advising health plan and employee benefit, insurance, financial services, employer and health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the ABA JCEB Annual Agency Meeting with the Office of Civil Rights (OCR) for the past several years who has worked on medical and other privacy concerns throughout her career, she regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others, defends covered entities and business associates against OCR, FTC and other privacy and data security investigations, serves as special counsel in litigation arising from these concerns and is the author of several highly regarded publications on HIPAA and other privacy and security concerns.

Ms. Stamer also regularly works with OCR, FTC, USSS, FBI and state and local law enforcement on privacy, data security, health care, benefits and insurance and other matters, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here.

You can review other recent human resources, employee benefits and internal controls publications and resources and additional information about the employment, employee benefits and other experience of the Cynthia Marcotte Stamer, PC here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile www.cynthiastamer.com or by registering to participate in the distribution of these and other updates on our HR & Employee Benefits Update distributions here including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here. For important information about this communication click here. ©2014 Cynthia Marcotte Stamer. Limited, non-exclusive right to republished granted to Solutions Law Press, Inc. All other rights reserved.

Comments Off on Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements | Employers, ERISA, Health Plans, HIPAA, Human Resources, Insurance | Tagged: "Encrypt your laptops and other mobile devices" is only one of the key lessons leaders of health plans, 220 under separate Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rule resolution agreements resulting from thefts of unencrypted laptops. Along with the importance o, 975, actions and documentation that OCR them to implement and be prepared to defend the adequacy of their HIPAA "culture of compliance" if they file a breach report or otherwise face a HIPAA audit or inves, business associates and their leaders about some of the specific processes, Covered Entities, Health Care, health care clearinghouses ("Covered Entities") and their business associates should take away from the Department of Health and Human Services Office for Civil Rights (OCR)'s April 22 announcement th, health care providers, Health Plans, HIPAA OCR, however, Inc. of Arkansas (QCA) collectively are paying $1, more broadly applicable lessons to Covered Entities, PHI, Privacy, these Resolution Agreements also contain equally significant | Permalink
Posted by Cynthia Marcotte Stamer

ONC HIPAA Security Risk Assessment Tool Intended To Help Covered Entities Assess Compliance

March 31, 2014

Health care providers, health plans, health care clearinghouses and their business associates Health Insurance Portability and Accountability Act (HIPAA) should check out the new Security Risk Assessment (SRA) Tool (Tool) application from the Office of the National Coordinator for Health IT (ONC). ONC says the Tool will help users take a self-directed tour of and assess compliance with the HIPAA Security Rule more understandable and security risk assessments easier. The Tool includes:

Context sections to help understand potential threats, vulnerabilities, and impacts
Examples of safeguards that could be instituted
Ability to export the report as an Excel or pdf document to share or analyze the information in a convenient format.

Download the Windows version of the tool at http://www.HealthIT.gov/security-risk-assessment or the iOS iPad version from the Apple App Store (search under “HHS SRA Tool”).

Public comments on the SRA Tool will be accepted at http://www.HealthIT.gov/security-risk-assessment until June 2. ONC says it will use comments to improve the SRA Tool in future update cycles.

For Representation, Training & Other Resources

Ms. Stamer also regularly works with OCR, FTC, USSS, FBI and state and local law enforcement on privacy, data security, health care, benefits and insurance and other matters, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here. For important information concerning this communication click here. ©2014 Cynthia Marcotte Stamer. Limited, non-exclusive right to republished granted to Solutions Law Press, Inc. All other rights reserved.

Comments Off on ONC HIPAA Security Risk Assessment Tool Intended To Help Covered Entities Assess Compliance | Employers, ERISA, Health Plans, HIPAA, Human Resources, Insurance | Tagged: Covered Entities, Health Care, Health Plans, HIPAA OCR, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

HHS Extends Health Plan Certification of Compliance Comment Period

March 18, 2014

The Department of Health and Human Services (HHS) has extended the comment period for the proposed rule, “Administrative Simplification: Health Plan Certification of Compliance” to April 3, 2014 in hopes of receiving additional input from third party administrators (TPAs) and self-insured plans.

HHS is now accepting public comments on the proposed rule through April 3, 2014.

The Certification of Compliance for Health Plans proposed rule is different from previous Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification regulations because it affects more and different types of entities.

For example, many third party administrators, self-funded health plans, and group health plans that have not been impacted by previous HIPAA Administrative Simplification requirements will be affected by this rule, even if they do not directly conduct HIPAA covered transactions.

The proposed rule would require controlling health plans to submit documentation on or before December 31, 2015. It would also establish penalty fees for a controlling health plan that fails to comply with the Certification of Compliance requirements.

HHS says the goal of the extension of the comment period is to provide self-insured health plans and their TPAs time to understand and offer feedback on the business impacts of the Certification of Compliance proposed rule. HHS encourages these entities to submit feedback so that their comments and suggestions can be considered during the policy-making process.

The proposed rules will require self-insured health plans and their TPAs to incur financial and operational expense to implement the necessary technology, data collection and other arrangements to come into compliance with the proposed rules. To help minimize these burdens to the extent possible, these and other concerned parties should review the rules and share their concerns and input as soon as possible. Accordingly, self-insured health plans, their sponsors, TPAs and advisors should review the proposed rules and provide relevant input as soon as possible and no later than the extended April 3, 2014 due date.

For Representation, Training & Other Resources

Ms. Stamer also regularly works with OCR, FTC, USSS, FBI and state and local law enforcement on privacy, data security, health care, benefits and insurance and other matters, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here. For important information concerning this communication click here. ©2014 Cynthia Marcotte Stamer. Limited, non-exclusive right to republished granted to Solutions Law Press, Inc. All other rights reserved.

Comments Off on HHS Extends Health Plan Certification of Compliance Comment Period | Employers, ERISA, Health Plans, HIPAA, Human Resources, Insurance | Tagged: Covered Entities, Health Care, Health Plans, HIPAA OCR, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

HIPAA Covered Entities Should Review & Correct HIPAA Policies In Response To New County Hospital Resolution Agreement, Other Developments

March 16, 2014

Health Department HIPAA Violations Cost County $250,000, Requires Sweeping HIPAA Reforms

Hear Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting

Skagit County, Washington will pay a $215,000 monetary settlement and work closely with the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) to correct deficiencies in its HIPAA compliance program to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules by the Skagit County Public Health Department (Health Department) under a Resolution Agreement announced by OCR on March 7, 2014. The Resolution Agreement makes clear the need for health care providers, health plans, health care clearinghouses and their business associates to update and maintain their policies and practices in compliance with the constantly evolving OCR guidance and resolution agreements, as well as to timely investigate and report breaches. Interested persons are invited to hear a briefing on a series of new developments including this latest Resolution Agreement at the March 18, 2014 North Texas Healthcare Professionals Association Meeting.

OCR investigated the Health Department after receiving a breach report that unknown parties accessed money receipts with electronic protected health information (ePHI) of seven individuals after the ePHI had been inadvertently moved to a publicly accessible server maintained by the County.

OCR reports its investigation revealed a broader exposure of protected health information involved in the incident, which included the ePHI of 1,581 individuals. Many of the accessible files involved sensitive information, including protected health information about the testing and treatment of infectious diseases.

OCR’s investigation further uncovered general and widespread non-compliance by Skagit County with the HIPAA Privacy, Security, and Breach Notification Rules.

Specifically, the Resolution Agreement between OCR and the Health Department states that OCR found the following conduct occurred (“Covered Conduct”).

From approximately September 14, 2011 until September 28, 2011, Skagit County disclosed the ePHI of 1,581 individuals in violation of the Privacy Rule by providing access to ePHI on its public web server;
From November 28, 2011 until present, Skagit County failed to provide notification as required by the Breach Notification Rule to all of the individuals for whom it knew or should have known that the privacy or security of the individual’s ePHI had been compromised as a result of the breach incident;
From April 20, 2005 until present, Skagit County failed to implement sufficient policies and procedures to prevent, detect, contain, and correct security violations;
From April 20, 2005 until June 1, 2012, Skagit County failed to implement and maintain in written or electronic form policies and procedures reasonably designed to ensure compliance with the Security Rule; and
From April 20, 2005 until present, Skagit County failed to provide security awareness and training to all workforce members, including its Information Security staff members, as necessary and appropriate for the workforce members to carry out their functions within Skagit County.

To resolve OCR’s allegations of these breaches, Skagit County agrees under the Resolution Agreement to pay HHS $215,000.00 and to ensure that the Health Department implements a series of corrective actions. Among other things, the Resolution Agreement requires that the Health Department:

Provide substitute Breach Notification to individuals not previously notified of the breach of their ePHI in accordance with the Resolution Agreement
Revise to the satisfaction of OCR and adopt revised accounting for disclosure, hybrid entity designations, policies on safeguarding PHI, including its sample business associate agreements;
Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by the covered health care components of Skagit County as identified in its hybrid entity documentation approved by HHS and implement security measures sufficient to reduce the risks and vulnerabilities identified in the risk analysis to a reasonable and appropriate level.
Create and revise, as necessary, written policies and procedures for its covered health care components to comply with the Federal standards that govern the privacy, security, and breach notification of individually identifiable health information;
Comply with strict workforce training requirements;
Notify and OCR of the occurrence of some reported breaches, its investigation and corrective actions;
Provide a summary of the reported events and the status of any corrective and preventative action relating to all such Reportable Events; and
Provide OCR with an attestation signed by an officer of Skagit County attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.

In addition to bringing its policies and practices up to date with OCR regulations in effect at the time of the breach that resulted in the Resolution Agreement, the Health Department also will have to update its policies and practices to meet changes to OCR’s HIPAA rules that have taken effect since the breach under the revised rules published by OCR in its Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Final Rule) OCR published January 25, 2013 as well as a series of recently issued OCR rules such as the following:

HIPAA Privacy Rule and Sharing Information Related to Mental Health published on
Spanish Language Model Notices of Privacy Practices published on 2/13/14
CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports published on 2/3/14; and
Proposed Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS) published on 1/7/14
HIPAA Privacy Rule: Disclosures for Emergency Preparedness – A Decision Tool
The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual
Health Information of Deceased Individuals
Student Immunizations; and
Model Notices of Privacy Practices (English).With OCR stepping up both audits and enforcement and penalties for violations higher than ever since the HITECH Act amended HIPAA, Covered Entities and business associates should act quickly to review and update their policies, practices and training to implement any adjustments needed to maintain compliance and manage other risks under these ever-evolving HIPAA standards.

Covered Entities & Business Associates Should Review & Tighten Practices in Response To Resolution Agreement & Other New Guidance

Other covered entities and their business associates should carefully evaluate and tighten their existing practices in response to the Resolution Agreement and other recent guidance. In the past, OCR officials have stated it expects that other health care providers, health plans, health care clearinghouses and their business associates will review resolution agreements like this one along with other emerging OCR guidance and update their practices as necessary to address concerns within their own organization that might be similar to those reflected in the applicable resolution agreement. The Resolution Agreement documents this expectation by specifically incorporating this requirement as part of its terms.

When conducting these efforts, Covered Entities and business associates not only carefully watch for and react promptly to new OCR guidance and enforcement actions, but also document their commitment and ongoing compliance and risk management activities to help support their ability to show their organization maintains the necessary “culture of compliance” commitment needed to mitigate risks in the event of a breach or other HIPAA violation and take well-documented, reasonable steps to encourage their business associates to do the same. When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent.

Hear Stamer’s Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting

Scribe for the American Bar Association Annual Agency Meeting with OCR for the fourth year, attorney Cynthia Marcotte Stamer will overview these and other HIPAA developments when she presents “Tutoring On OCR’s Latest HIPAA Homework” at the North Texas Healthcare Professionals Association Study Group Luncheon on Tuesday, March 18, 2014 from 11:30 p.m. to 1:00 p.m. at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706. A complimentary luncheon will be served to guests to who register in advance. There is no charge to particulate but space is limited. RSVP here by Noon on March 17, 2014.

For Representation, Training & Other Resources

Ms. Stamer also regularly works with OCR, FTC, USSS, FBI and state and local law enforcement on privacy, data security, health care, benefits and insurance and other matters, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here. For important information concerning this communication click here. ©2014 Cynthia Marcotte Stamer. Limited, non-exclusive right to republished granted to Solutions Law Press, Inc. All other rights reserved.

Comments Off on HIPAA Covered Entities Should Review & Correct HIPAA Policies In Response To New County Hospital Resolution Agreement, Other Developments | Employers, ERISA, Health Plans, HIPAA, Human Resources, Insurance | Tagged: Covered Entities, Health Care, Health Plans, HIPAA OCR, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

HIPAA Sanctions Triggered From Covered Entity Statements To Media, Workforce

June 14, 2013

Health plans, health care providers, health care clearinghouses (covered entities) and their business associates should confirm their existing policies, practices and training for communicating with the media and others comply with the Privacy Rule requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in light of a Resolution Agreement with Shasta Regional Medical Center (SRMC) announced by the U.S. Department of Health and Human Services (HHS) Office of Civil Rights today (June 14, 2013).

Under the Resolution Agreement, SRMC agrees to pay $275,000 and implement a comprehensive corrective action plan (CAP) to settle an investigation that resulted when SRMC used and disclosed protected health information (PHI) of a patient to members of the media and its workforce while trying to do damage control against fraud or other allegations of misconduct involving individual patient information or circumstances. The Resolution Agreement shows how efforts to respond to press or media reports, patient or other complaints, physician or employee disputes, high profile accidents, or other events that may involve communications not typically run by privacy officers can create big exposures. While the Resolution Agreement targets a health care provider, the lessons are equally applicable to health plans and health care clearinghouses, who increasingly face their own pressure to communicate with the media and others about enforcement actions, workforce claims and other matters.

Talking Out Of Turn To Media & Others Violated HIPAA

OCR investigated SRMC after a January 4, 2012 Los Angeles Times article reported two SRMC senior leaders had met with media to discuss medical services provided to a patient. OCR’s investigation indicated that SRMC failed to safeguard the patient’s protected health information (PHI) from impermissible disclosure by intentionally disclosing PHI to multiple media outlets on at least three separate occasions, without a valid written authorization. OCR’s review also revealed senior management at SRMC impermissibly shared details about the patient’s medical condition, diagnosis and treatment in an email to the entire workforce. Further, SRMC failed to sanction its workforce members for impermissibly disclosing the patient’s records pursuant to its internal sanctions policy.

Among other things, the specific misconduct uncovered by HHS’s investigation indicated that from December 13 – 20, 2011, SRMC failed to safeguard the patient’s PHI from any impermissible intentional or unintentional disclosure on multiple occasions in connection with its response to media coverage arising from a Medicare fraud story including:

On December 13, 2011, for instance, OCR reports SRMC’s parent company sent a letter to California Watch, responding to a story about Medicare fraud. The letter described the patient’s medical treatment and provided specifics about her lab results even though SRMC did not have a written authorization from the patient to disclose this information to this news outlet.
On December 16, 2011, two of SRMC’s senior leaders also met with The Record Searchlight’s editor to discuss the patient’s medical record in detail even though SRMC did not have a written authorization from the patient to disclose this information to this newspaper.
On December 20, 2011, SRMC sent a letter to The Los Angeles Times, which contained detailed information about the treatment the patient received when, again, SRMC did not have a written authorization from the patient to disclose this information to this newspaper.

In addition, OCR found SRMC impermissibly used the affected party’s PHI when on December 20, 2011, SRMC sent an email to its entire workforce and medical staff, approximately 785-900 individuals, describing, in detail, the patient’s medical condition, diagnosis and treatment. SRMC did not have a written authorization from the patient to share this information with SRMC’s entire workforce and medical staff.

SRMC Must Correct & Pay $$275K Penalty

Under the Resolution Agreement, SRMC pays a $275,000 monetary settlement and agrees to comply with a CAP for the next year.

The CAP requires SRMC to update its policies and procedures on safeguarding PHI from impermissible uses and disclosures and to train its workforce members. The CAP also requires fifteen other hospitals or medical centers under the same ownership or operational control as SRMC to attest to their understanding of permissible uses and disclosures of PHI, including disclosures to the media.

The Resolution Agreement specifically requires that Shasta Regional Medical Center, among other things:

To update policies to include specific policies about sharing PHI with the media, members of the workforce not involved in an individual patient’s care and others to comply with HIPAA;.
To provide updated policies to OCR for approval;
To provide training documented with certification of all workforce members before allowing them to get access to PHI;

SRMC is one of several Prime Healthcare Services facilities under common ownership and control. The Resolution Agreement also requires corrective action at these commonly owned facilities including California-based Alvarado Hospital Medical Center in San Diego, Centinela Hospital Medical Center in Inglewood, Chino Valley Medical Center in Chino, Desert Valley Hospital in Victorville, Garden Grove Hospital Medical Center in Garden Grove, La Palma Intercommunity Hospital in La Palma, Paradise Valley Hospital in National City, San Dimas Community Hospital in San Dimas, Shasta Regional Medical Center in Redding, and West Anaheim Medical Center in Anaheim; Saint Mary’s Regional Medical Center in Reno, Nevada; Pennsylvania based Lower Bucks Hospital in Bristol and Roxborough Memorial Hospital in Philadelphia;and Texas-based Dallas Medical Center in Dallas, Harlingen Medical Center in Harlingen, Pampa Regional Medical Center in Pampa. Among other things, the Resolution Agreement requires that for each of these related facilities:

The CEO and Privacy Officer of each facility must give OCR a signed affidavit stating that they understand that the Privacy Rule protects an individual’s PHI is protected by Privacy Rule even if such information is already in the public domain or even though it has been disclosed by the individual; and that disclosures of PHI in response to media inquiries are only permissible pursuant to a signed HIPAA authorization; and
Ensure all members of their respective workforce are informed of this policy.

The Resolution Agreement highlights the difficulty that health care providers and other covered entities often face in properly recognizing and handling PHI in the case of fraud or other disputes. While health care providers have an understandable wish to defend themselves in the media and elsewhere in response to charges of misconduct, today’s settlement shows that improperly sharing PHI of each patient in the process will make matters much worse. It’s important to keep in mind that just omitting to mention the name or other common identifying information may not overcome this concern because information about a patient can be considered individually identifiable and to enjoy protection under HIPAA where the facts and circumstances would allow another person to know or determine who the individual is, even if the specific name, address or more common identifying information is not shared.

Furthermore, the settlement also makes clear that merely because the patient or some other party has shared the same information with the media or others does not excuse the health care provider or other covered entity or business associate from the obligation to keep confidential the PHI unless it gets proper consent or otherwise can show that an exception to HIPAA applies.

Finally, the Resolution Agreement also makes clear that OCR expects covered entities to connect their HIPAA compliance with other policies and operations and will hold covered entities and associates accountable for properly integrating, training workforce and enforcing compliance with these policies. While this means that covered entities and business associates may find themselves in the uncomfortable situation of facing unsavory reports and rumors without the ability to respond, the significant civil and even criminal penalties that can arise from violation of HIPAA make it critical that covered entities exercise discipline in responding to avoid sharing PHI improperly.

The 2013 Regulations Overview

Adding a review and update of HIPAA and other policies for communicating with the media and internally on matters that may involve use or discussions of PHI in unusual contexts outside the purview of typically HIPAA policies is a good idea while health plans and other covered entities and business associates are updating their existing policies and practices for compliance with updated Omnibus HIPAA Rules (2013 Regulations) implementing HITECH Act amendments to the Privacy and Security Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Rulemaking announced January 17, 2013 may be viewed here.

Since 2003, HIPAA generally has required that health care providers, health plans, health care clearinghouses and their business associates (“Covered Entities”) restrict and safeguard individually identifiable health care information (“PHI”) of individuals and afford other protections to individuals that are the subject of that information. The 2013 Regulations published today complete the implementation of changes to HIPAA that Congress enacted when it passed the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009 as well as make other changes to the prior regulations that OCR found desirable based on its experience administering and enforcing the law over the past decade.

Since passage of the HITECH Act, OCR officials have warned Covered Entities to expect an omnibus restatement of its original regulations. While OCR had issued certain regulations implementing some of the HITECH Act changes, it waited to publish certain regulations necessary to implement other HITECH Act changes until it could complete a more comprehensive restatement of its previously published HIPAA regulations to reflect both the HITECH Act amendments and other refinements to its HIPAA Rules. The 2013 Regulations published today fulfill that promise by restating OCR’s HIPAA Regulations to reflect the HITECH Act Amendments and other changes and clarifications to OCR’s interpretation and enforcement of HIPAA.

Among other things, the 2013 Regulations:

Revise OCR’s HIPAA regulations to reflect the HITECH Act’s amendment of HIPAA to add the contractors and subcontractors of health plans, health care providers and health care clearinghouses that qualify as business associates to the parties directly responsible for complying with and subject to HIPAA’s civil and criminal penalties for violating HIPAA’s Privacy, Security, and Breach Notification rules;
Update previous interim regulations implementing HITECH Act breach notification rules that require Covered Entities including business associates to give specific notifications to individuals whose PHI is breached, HHS and in some cases, the media when a breach of unsecured information happens;
Update interim enforcement guidance OCR previously published to implement increased penalties and other changes to HIPAA’s civil and criminal sanctions enacted by the HITECH Act;
Implement HITECH Act amendments to HIPAA that tighten the conditions under which Covered Entities are allowed to use or disclose PHI for marketing and fundraising purposes and prohibit Covered Entities from selling an individual’s health information without getting the individual’s authorization in the way required by the 2013 Regulations;
Update OCR’s rules about the rights that HIPAA requires that Covered Entities to afford to individuals who are the subject of PHI used or possessed by a Covered Entity to reflect tightened requirements enacted by the HITECH Act that allow individuals to order their health care provider not to share information about their treatment with health plans when the individual pays cash for the care and to clarify that individuals can require Covered Entities to provide electronic PHI in electronic form;
Revise the regulations to reflect amendments to HIPAA made as part of the Genetic Information Nondiscrimination Act of 2008 (GINA) which added genetic information to the definition of PHI protected under the HIPAA Privacy Rule and prohibits health plans from using or disclosing genetic information for underwriting purposes; and
Clarifies and revises other provisions to reflect other interpretations and information guidance that OCR has issued since HIPAA was passed and to make certain other changes that OCR found appropriate based on its experience administering and enforcing the rules.

Liability & Enforcement Risks Heighten Need To Act To Review & Update Policies & Practices

The new Resolution Agreement and the growing list of others like it, as well as restated rules in the 2013 Regulations make it imperative that Covered Entities review the revised rules carefully and updated their policies, practices, business associate agreements, training and documentation to comply with the updated requirements and other enforcement and liability risks. OCR even prior to the regulations has aggressively investigated and enforced the HIPAA requirements.

OCR increasingly is imposing sanctions against a covered entity for data breaches to show the potential risks of HIPAA violations are significant and growing. OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website; Providence To Pay $100000 & Implement Other Safeguards.

In response to the 2013 Regulations and these expanding exposures, all Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable. In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if tightening their policies, practices, documentation or training is necessary or advisable.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

The SRMC Resolution Agreement again shows the growing risk of enforcement that health care providers, health plans, health care clearinghouses and their business associates face as OCR continues its audits and enforcement, new Omnibus HIPAA Regulations implementing the HITECH Act amendments to HIPAA and state and federal liability grows.. See e.g., $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable.

For more information about HIPAA compliance and risk management tips, see here.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other human resources, employee benefit, or other compliance, risk management, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Nationally recognized for her extensive work, publications and leadership on HIPAA and other privacy and data security concerns, Ms. Stamer has extensive experience representing, advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical and other privacy and data security, employment, employee benefits, and to handle other compliance and risk management policies and practices; to investigate and respond to OCR and other enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

A Fellow in the American College of Employee Benefit Counsel, State Bar of Texas and American Bar Association, Vice President of the North Texas Health Care Compliance Professionals Association, the Former Chair of the ABA RPTE Employee Benefit & Compensation Group and current Co-Chair of its Welfare Benefit Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Council Representative, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer serves as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR. Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights on HIPAA and other data privacy and security concerns appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve in 2013 as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here.

In addition to this extensive HIPAA specific experience, Ms. Stamer also is recognized for her experience and skill aiding clients with a diverse range of other employment, employee benefits, health and safety, public policy, and other compliance and risk management concerns.

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, a member of the Editorial Advisory Board and expert panels of HR.com, Employee Benefit News, InsuranceThoughtLeadership.com, and Solutions Law Press, Inc., management attorney and consultant Ms. Stamer has 25 years of experience helping employers; employee benefit plans and their sponsors, administrators, fiduciaries; employee leasing, recruiting, staffing and other professional employment organizations; and others design, administer and defend innovative workforce, compensation, employee benefit and management policies and practices. Ms. Stamer often has worked, extensively on these and other workforce and performance related matters. In addition to her continuous day-to-day involvement helping businesses to manage employment and employee benefit plan concerns, she also has extensive public policy and regulatory experience with these and other matters domestically and internationally. A former member of the Executive Committee of the Texas Association of Business and past Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, Ms. Stamer served as a primary advisor to the Government of Bolivia on its pension privatization law, and has been intimately involved in federal, state, and international workforce, health care, pension and social security, tax, education, immigration, education and other legislative and regulatory reform in the US and abroad. She also is recognized for her publications, industry leadership, workshops and presentations on these and other human resources concerns and regularly speaks and conducts training on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications. For more information about Ms. Stamer and her experience or to get access to other publications by Ms. Stamer see here or contact Ms. Stamer directly.

For help with these or other compliance concerns, to ask about compliance audit or training, or for legal representation on these or other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested in exploring other Solutions Law Press, Inc. ™ tools, products, training and other resources here and reading some of our other Solutions Law Press, Inc.™ human resources news here including the following:

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Posted by Cynthia Marcotte Stamer

Group Health Plans &No-Fault & Worker’s Comp Ruled Primary Plans When Coordinating With Medicare Advantage Plans

May 9, 2013

Group health plans and liability, no-fault and worker’s compensation insurers should confirm they are properly coordinating benefits with Medicare Advantage organizations (MAOs) to avoid a private cause of action for double damages to recover amounts under the Medicare Secondary Payer Act (MSP Act) in light of the U.S. Supreme Court’s denial of certiorari on an appeal of the Third Circuit’s decision in In Re Avandia Marketing Sales Practices GlaxoSmithKline LLC v. Human Medical Plans, Inc. (Glaxo). The Supreme Court’s decision denying certiorari reported here lets stand a Third Circuit decision that the private right of action provision in the MSP Act, set forth at 42 U.S.C. 1395y(b)(3), gives Humana a private cause of action as a primary plan against GSK to recover the double damage award.

MSP Act Secondary Payor Rules Require Proper Coordination

The MSP Act contains specific rules about when and how group health plans, automobile and liability insurance, no fault insurance policies and amounts recovered from tort actions are coordinated with benefits under the Medicare Statute. The MSP Act’s Secondary Payor Rules require group health plans, automobile and liability insurance and no fault insurance policies to treat their coverage as the “primary plan” for purposes of coordinating their coverage with the benefits provided under the Medicare Statute under certain conditionsbenefits face double damage for improperly coordinating their benefits and coverage with those provided under the Medicare Statute. The MSP Act generally dictates the conditions under which these coverages are primary to benefits provided under the Medicare Statute and obligates primary plans and individuals receiving judgment or settlements that include payment for medical expenses for which benefits were received under the Medicare Statute to repay Medicare. Violation of these rules exposes the applicable plan to double damages and other costs of recovery.

Glaxo On MA Plan MSP Act Rights

In Glaxo, the Third Circuit ruled that MAOs can sue primary plans under the MSP Act for double damages when a primary plan fails to appropriately reimburse the MAO as a secondary payor.

In Glaxo, Humana Medical Plan Inc. and Humana Insurance Company (collectively, Humana) sued GlaxoSmithKline LLC and GlaxoSmithKline PLC (collectively, GSK) for reimbursement of expenses Humana incurred from injuries its MA members sustained from use of GSK’s type 2 diabetes drug, Avandia. GSK has paid more than $460 million to Avandia patients settle patient claims that Avandia patients sustained heart attacks, strokes or other injuries from taking the drug. In the settlement, GSK reserved monies to reimburse the Medicare Trust Fund for payments it made to cover the costs of treatment for the Medicare fee-for-service (FFS) enrollees’ Avandia-related injuries but did not set aside funds for reimbursement to MAOs. Humana sued GSK for reimbursement, claiming that GSK has a primary plan obligation under the MSP Act to reimburse Humana as a secondary payor.

The Supreme Court’s decision not to review the appeal from this Third Circuit decision means that in the Third Circuit (and perhaps other jurisdictions), MAOs can pursue an action for double damages under the Medicare Secondary Payor Act against a group health plan, no-fault carrier or worker’s compensation insurer that fails to fulfill its obligation as a primary plan to reimburse Medicare conditional payments paid by the MAO.

The Third Circuit’s decision in Glaxo is distinguishable from the Ninth Circuit’s position on a similar issue in Parra v. PacifiCare of Arizona, Inc. (PacifiCare), where the 9^th Circuit ruled PacifiCare did not have a private right of action under the MA statute or under 42 U.S.C. 1395y(b)(3)(A) against the surviving family members for amounts recovered in a wrongful death action since that provision of the MSP Act only applies in cases where a primary plan fails to reimburse an insurer as a secondary payor.

Proper identification and payment of claims and settlements in coordination with MAOs and their Plans is important because improper coordination may expose a group health plan or other primary payer to double damage liability, attorneys fees’ and other costs.

In light of Glaxo, group health plans and their administrators, and group health insurers, worker’s compensation insurers, and liability insurers should ask if asking Medicare beneficiares if they are or have been enrolled in a MA plan when paying or processing claims and if so, act proactively to ensure that payments under their programs are properly processed and paid to take into account responsibilities under the Medicare Secondary Payer rules. Determination and handling these types of payments and settlements likely will require special handling because the Medicare Secondary Payer system currently doesn’t distinguish MA Plans as primary plans. Accordingly, group health plans and the fiduciaries and administrators involved in their administration will want to take proper steps to identify claims that may involve individuals covered by MA Plans in a manner that allows the group health plan to track and distinguish the coverage provided by the MA Plan from other insurance coverage as needed to comply with the MSP Act.

For Help or More Information

If you need help with the MSP Act or with reviewing and updating, administering or defending your group health or other employee benefit, human resources, insurance, health care matters or related documents or practices, please contact the author of this update, Cynthia Marcotte Stamer.

A Fellow in the American College of Employee Benefit Council, immediate past Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Group and current Co-Chair of its Welfare Benefit Committee, Vice-Chair of the ABA TIPS Employee Benefits Committee, a council member of the ABA Joint Committee on Employee Benefits, and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer is recognized, internationally, nationally and locally for her more than 25 years of work, advocacy, education and publications on cutting edge health and managed care, employee benefit, human resources and related workforce, insurance and financial services, and health care matters including extensive experience on HIPAA and other privacy and data security issues.

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experienced with these and other employment, employee benefit and compensation matters, Ms. Stamer continuously advises and assists employers, employee benefit plans, their sponsoring employers, fiduciaries, insurers, administrators, service providers, insurers and others to monitor and respond to evolving legal and operational requirements and to design, administer, document and defend medical and other welfare benefit, qualified and non-qualified deferred compensation and retirement, severance and other employee benefit, compensation, and human resources, management and other programs and practices tailored to the client’s human resources, employee benefits or other management goals. A primary drafter of the Bolivian Social Security pension privatization law, Ms. Stamer also works extensively with management, service provider and other clients to monitor legislative and regulatory developments and to deal with Congressional and state legislators, regulators, and enforcement officials concerning regulatory, investigatory or enforcement concerns.

Extensively published and a popular speaker on HIPAA and other data security matters, Ms. Stamer works extensively with health care providers, health plans, employers, insurance and financial services, technology and other clients on privacy, data seurity and other privacy and cybercrime concerns. She also serves as the Scribe for the ABA JCEB Agency Techical Sessions Meetings with the Office of Civil Rights which occur each May in Washington, D.C.

Recognized in Who’s Who In American Professionals and both an American Bar Association (ABA) and a State Bar of Texas Fellow, Ms. Stamer serves on the Editorial Advisory Board of Employee Benefits News, the editor and publisher of Solutions Law Press HR & Benefits Update and other Solutions Law Press Publications, and active in a multitude of other employee benefits, human resources and other professional and civic organizations. She also is a widely published author and highly regarded speaker on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, Modern and many other national and local publications. You can learn more about Ms. Stamer and her experience, review some of her other training, speaking, publications and other resources, and register to receive future updates about developments on these and other concerns from Ms. Stamer here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

For important information about this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

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Posted by Cynthia Marcotte Stamer

Former White House Cybersecurity Coordinator Schmidt, Stamer & Others Share Key HIPAA & Other Privacy & Data Security Insights 5/21 In LA

May 3, 2013

Former White House Cybersecurity Coordinator Howard Schmidt and Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer are two of an impressive lineup of leaders scheduled to share key HIPAA & other privacy and data security compliance and risk management strategies at the Healthcare HITECH Privacy and Security Summit at the Fifth Annual Information Security Summit on May 21 in Los Angeles.

The Healthcare HITECH Privacy and Security Summit will bring together leaders in Privacy and Security within government and private industry for a day of collaboration, networking and presentations by leading Privacy and Security professionals sharing who HIPAA covered entities and business associates need to know to comply with new HITECH rules and OCR investigations.

Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer will help lay the foundation for the workshop by briefing participants on changes made to HIPAA rules by the new Omnibus HIPAA Rulemaking changes that the Office of Civil Rights (OCR) plans to start enforcing in September, 2013.

With the rapidly approaching and privacy and data breach penalties and enforcement rising, health care providers, health plans, health care clearinghouses and their business associates must get moving to update business associate contracts, policies and notices and processes to meet changing HIPAA rules while managing ongoing compliance and risks.

Stamer Speaks On Latest HIPAA Privacy, Security, Breach Notification & Enforcement Rules & Developments

Armed with the latest insights from serving as the scribe for the ABA JCEB annual agency meeting with the Office of Civil Rights (OCR), Ms. Stamer, a practicing attorney and widely published author and speaker, will discuss required changes and other recommended steps and strategies that covered entities and their business associates should take to maintain HIPAA compliance and manage HIPAA and other related risks in light of the Omnibus HIPAA Rulemaking changes, new OCR guidance for health care providers about disclosures to avert threats to health or safety, recent audit and enforcement activities and other changing risks and responsibilities including:

The latest on OCR’s regulatory guidance, audit and investigation and enforcement rules, actions and strategies and their implications on covered entities and business associates;
Changes to breach notification rules and their implications on covered entities and their business associates;
Practical implications of new rules on who is covered and their responsibilities;
Required and recommended updates to policies, business associate and other agreements, privacy notices and other HIPAA compliance arrangements;
Effective training and other risk management strategies;
Planning for, investigating and mitigating PHI privacy breaches and other compliance concerns under new rules other selected events; and
Other selected strategies for coordinating HIPAA and other privacy and data breach responsibilities and risk management; and
Participant questions.

For a complete agenda, to register, to get details on sponsorship or for other information, see here.

For Help or More Information

If you need help with the HIPAA, Affordable Care Act or other 2014 health plan compliance, risk management or defense, or with reviewing and updating, administering or defending your group health or other employee benefit, human resources, insurance, health care matters or related documents or practices, please contact the author of this update, Cynthia Marcotte Stamer.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

Comments Off on Former White House Cybersecurity Coordinator Schmidt, Stamer & Others Share Key HIPAA & Other Privacy & Data Security Insights 5/21 In LA | Employee Benefits, Employers, ERISA, Excise Tax, Health Plans, Human Resources, Insurance, Tax, Uncategorized | Tagged: Affordable Care Act, annual limits, Business Associate, Covered Entity, Employee Benefits, ERISA, Health Insurance, Health Plans, HIPAA, Isurance, Personal Health Information, PHI, Privacy, RE, SBC, Summary of Benefits and Communications | Permalink
Posted by Cynthia Marcotte Stamer

Strengthen Health Plan Privacy Compliance & Risk Management Using Lessons From New OCR Provider & Consumer Tools

April 30, 2013

Get More Key Information By Participating in 5/21 Workshop In LA

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has developed an array of new tools to educate consumers and health care providers about the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.

Many consumers are unfamiliar with their rights under the HIPAA Privacy Rule. With that in mind, OCR has posted a series of factsheets, also available in eight languages, to inform consumers about their rights under the HIPAA Privacy Rule. These materials are available on OCR’s website here.

The fact sheets compliment a set of seven consumer-facing videos released earlier this year on OCR’s YouTube channel. An additional video, The HIPAA Security Rule, has been designed for providers in small practices and offers an overview of how to establish basic safeguards to protect patient information and comply with the Security Rule’s requirements. The videos are available on the HHS OCR YouTube Channel at here.

OCR has also launched three modules for health care providers on compliance with various aspects of the HIPAA Privacy and Security Rules, available at Medscape.org:

Patient Privacy: A Guide for Providers at here;
HIPAA and You: Building a Culture of Compliance here; and
Examining Compliance with the HIPAA Privacy Rule here.

The Medscape modules offer free Continuing Medical Education (CME) credits for physicians and Continuing Education (CE) credits for health care professionals.

Although the materials are primarily consumer and provider focused, health plans and their sponsors, fiduciaries, administrators, business associates and others in the health plan workforce should review and incorporate the materials and principles contained in these materials as part of their own HIPAA compliance efforts. With the deadline to comply with recent amendments to the HIPAA rules in September, 2013 and enforcement and penalties rising, the insights and resources provided these rules can help strengthen compliance efforts.

Participate In 5/21 Workshop In LA To Get Other Key Information Needed To Update Compliance & Risk Management

With the September 23, 2013 enforcement date of the new Omnibus HIPAA Rulemaking changes rapidly approaching and privacy and data breach penalties and enforcement rising, health care providers, health plans, health care clearinghouses and their business associates must get moving to update business associate contracts, policies and notices and processes to meet changing HIPAA rules while managing ongoing compliance and risks.

Armed with the latest insights from serving as the scribe for the ABA JCEB annual agency meeting with the Office of Civil Rights (OCR), attorney and author Cynthia Marcotte Stamer will discuss required changes and other recommended steps and strategies that covered entities and their business associates should take to maintain HIPAA compliance and manage HIPAA and other related risks in light of the Omnibus HIPAA Rulemaking changes, new OCR guidance for health care providers about disclosures to avert threats to health or safety, recent audit and enforcement activities and other changing risks and responsibilities including:

The latest on OCR’s regulatory guidance, audit and investigation and enforcement rules, actions and strategies and their implications on covered entities and business associates;
Changes to breach notification rules and their implications on covered entities and their business associates;
Practical implications of new rules on who is covered and their responsibilities;
Required and recommended updates to policies, business associate and other agreements, privacy notices and other HIPAA compliance arrangements;
Effective training and other risk management strategies;
Planning for, investigating and mitigating PHI privacy breaches and other compliance concerns under new rules other selected events; and
Other selected strategies for coordinating HIPAA and other privacy and data breach responsibilities and risk management; and
Participant questions.

To register, review the agenda, get details on sponsorship or for other information, see here.

For Help or More Information

If you need help with the SBC or other 2014 health plan decision-making or preparation, or with reviewing and updating, administering or defending your group health or other employee benefit, human resources, insurance, health care matters or related documents or practices, please contact the author of this update, Cynthia Marcotte Stamer.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

Comments Off on Strengthen Health Plan Privacy Compliance & Risk Management Using Lessons From New OCR Provider & Consumer Tools | Employee Benefits, Employers, ERISA, Excise Tax, Health Plans, Human Resources, Insurance, Tax, Uncategorized | Tagged: Affordable Care Act, annual limits, Business Associate, Covered Entity, Employee Benefits, ERISA, Health Insurance, Health Plans, HIPAA, Isurance, Personal Health Information, PHI, Privacy, RE, SBC, Summary of Benefits and Communications | Permalink
Posted by Cynthia Marcotte Stamer

New OCR HIPAA De-Identification Guidance Among Developments Covered In 12/12 HIPAA Update Web Workshop

November 27, 2012

Get Up To Date On Details of New De-Identification Guidance & Other HIPAA Developments By Participating In 12/12 HIPAA Update Web Workshop

Health care providers, health plans, health care clearinghouses (covered entities) and their business associates and leadership should check and update their policies and practices for the de-identification of protected health information (PHI) in light of newly-released Guidance Regarding Methods for De-identification of Protected Health Information in Accordance With the Health Insurance Portability and Accountablity Act (HIPAA) Privacy Rule (Guidance) released by the Department of Health & Human Services (HHS) Office of Civil Rights yesterday (November 26, 2012).

Solutions Law Press, Inc. will host a one-hour, online HIPAA Update Workshop on the Guidance and other recent regulatory and enforcement developments under HIPAA for covered entities and their business associates on Wednesday, December 12 beginning at Noon Central Time. To register, see here.

PHI collected by health care providers, health plans, their management, sponsors, and vendors often includes a wealth of information valuable for use for functions unrelated to the HIPAA-covered functions and activities that leads covered entities or their business associates to collect or keep this data. While it might be tempting to repurpose this information for business planning and marketing purposes, covered entities and their business partners or associates frequently assume that covered entities and others that they deal with must take proper steps to that no PHI is used, accessed, disclosed or shared unless that action is allowed under the Privacy Rules, properly de-identified, or both.

When planning to rely upon the de-identification of PHI to engage in these activities, parties planning to rely upon HIPAA’s exception for de-identified PHI will want to consult new guidance just released by OCR about the de-identification requirements before moving forward. Existing Privacy Rules and the Guidance recognize two alternative methods that covered entities and their business can use to properly de-identify PHI for purposes of the HIPAA Privacy Rule.

OCR published the Guidance to help covered entities to understand what qualifies as de-identification, the general process by which de-identified information is created, and the options available for performing de-identification for purposes of the HIPAA Privacy Rule. The publication of this guidance was mandated as part of amendments to HIPAA enacted by Health Information Technology for Economic and Clinical Health (HITECH) Act included in the American Recovery and Reinvestment Act of 2009 (ARRA). Section 13424(c) of the HITECH Act requires the HHS to issue guidance on how best to implement the requirements for the de-identification of health information contained in the Privacy Rule.

De-identification & Its Rationale Under Privacy Rule

The Privacy Rule was designed to protect individually identifiable health information through permitting only certain uses and disclosures of PHI provided by the Rule, or as authorized by the individual subject of the information. However, in recognition of the potential utility of health information even when it is not individually identifiable, §164.502(d) of the Privacy Rule permits a covered entity or its business associate to create information that is not individually identifiable by following the de-identification standard and implementation specifications in Privacy Rule §164.514(a)-(b). These provisions allow the entity to use and disclose information that neither identifies nor provides a reasonable basis to identify an individual provided the Covered Entity can show that the PHI has been de-identified in accordance with either the Expert Determination Method or the Safe Harbor Method of the de-identification standard of the Privacy Rule and is not re-identified. Regardless of the method used to de-identify PHI, the Privacy Rule does not restrict the use or disclosure of de-identified health information, as it is no longer considered PHI and is not re-identified.

Privacy Rule De-Identification Implementation Standards Permit Alternative Methods of De-identification

Section 164.514(a) of the HIPAA Privacy Rule provides the standard for de-identification of protected health information. Under this standard, health information is not individually identifiable if it does not identify an individual and if the covered entity has no reasonable basis to believe it can be used to identify an individual. See Privacy Rule § 164.514.

Sections 164.514(b) and (c) of the Privacy Rule contain the implementation specifications that a covered entity must follow to meet the de-identification standard. As summarized in Figure 1, the Privacy Rule provides two methods by which health information can be designated as de-identified:

The formal determination by a qualified expert in accordance with the Privacy Rule (Expert Determination Method); or
The removal of specified individual identifiers as well as absence of actual knowledge by the covered entity that the remaining information could be used alone or in combination with other information to identify the individual (Safe Harbor Method).

In order for PHI to qualify as de-identified under the “Expert Determination Method, Privacy Rule § 164.514(b)(1) requires that a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable:

Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and
Documents the methods and results of the analysis that justify such determination.

Alternatively, Privacy Rule § 164.514(b)(2) provides that PHI will qualify as de-identified under the Safe Harbor Method if:

All of an extensive list of identifiers of the individual or of relatives, employers, or household members of the individual, are removed from the data; and
The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

As long as the data is not re-identified, the Guidance indicates that a covered entity may prove fulfillment of the de-identification standard of Privacy Rule §164.514(a) by showing satisfaction of all applicable requirements of either method. Under the Privacy Rule, de-identified health information created following these methods is no longer protected by the Privacy Rule because it does not fall within the definition of PHI. Of course, de-identification leads to information loss which may limit the usefulness of the resulting health information in certain circumstances. Consequently, covered entities may wish to select de-identification strategies that minimize such loss.

Both alternatives for de-identification under the Privacy Rule require that covered entities and their business associates decide whether and how to keep the option for re-identification of PHI slated for de-identification and where applicable, appropriately manage the re-identification opportunity and data to avoid violation of the Privacy Rule.

According to the Privacy Rule, if a covered entity or business associate successfully undertook an effort to identify the subject of de-identified information it maintained, the health information now related to a specific individual would again be protected by the Privacy Rule, as it would meet the definition of PHI. Disclosure of a code or other means of record identification designed to enable coded or otherwise de-identified information to be re-identified is also considered a disclosure of PHI. In this regard, Privacy Rule §164.514(c) specifies that if the covered entity assigns a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, themeans of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; it can’t use elements of the protected PHI as the re-identification key,must safeguard the key, and can’t use or disclose the key or other re-identification tool for any other purpose.

Preparing For, Guiding & Documenting The De-identification Process For Defensibility

The Guidance stresses that importance of documentation for which values in health data correspond to PHI, as well as the systems that manage PHI and its risk of identification or re-identification in the de-identification process cannot be overstated.

The Guidance provides guidance to help guide covered entities and their business associates through the steps and analysis of using the Expert Determination versus Safe Harbor Method. A review of this Guidance makes clear that the design and administration of the de-identification process under either method requires careful and well-documented planning, analysis and implementation to fulfill and to keep the documentation that a covered entity or business associate might need to defend its decision to treat and use PHI as de-identified under the Privacy Rule against a potential audit or enforcement inquiry. The Guidance also seeks to further illuminate the requirements for effective de-identification through a series of questions and answers, supplemented by work flow and other charts, examples and other illustrations and tips on the proper use of each alternative Method and managing risks and the process associated with that Method. A Glossary of Terms also is shared. The discussion in the Guidance makes clear that covered entities and their businesses associates using either Method to de-identify PHI should be prepared to make a number of judgments about which Method to use, whether and how to make arrangements for re-identification, and how to properly manage the process to meet the requirements of the implementation standard and manage re-identification or other risks.

Register For 12/12 HIPAA Update Web Workshop To Catch Up On De-Identification Guidance & Other HIPAA & Texas HIPAA Regulatory & Enforcement Developments

Training and compliance mandates applicable to covered entities and their business associates under the newly strengthened Texas HIPAA law and HIPAA’s Privacy and Breach Notification Rules make it more important than ever that covered entities and their business associates get the timely training and other assistance needed to properly comply with requirements for the protection of PHI under the new Guidance and other HIPAA and Texas HIPAA mandates.

To aid in this process, Solutions Law Press, Inc. will host a 2012 HIPAA Update Web Workshop covering the new Guidance on de-identification and other regulatory and enforcement developments under HIPAA and the newly amended Texas HIPAA law on December 12, 2012 from 1:00 P.M.-2:00 P.M. Eastern | Noon – 1:00 P.M. Central | 11:00 A.M-Noon Mountain | 10:00A.M-11:00 A.M. Pacific Time.

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of PHI.

Complete HIPAA Training While You Catch Up On The Latest On HIPAA & Texas Medical Records Privacy Rules & Get Helpful Compliance And Risk Management Tips!

Health care providers, health plans, health care clearinghouses face new imperatives to strengthen their HIPAA and other procedures for handling protected health information and other sensitive information to manage expanding risks and responsibilities arising from evolving rules, expanding enforcement and oversight, and rising penalties and other liabilities.

The $4.3 million HIPAA Civil Monetary Penalty and growing list of $1 million plus resolution payments announced by the Office of Civil Rights coupled with its commitment to investigate all large breaches reported under the HITECH Act Breach Notification Rule and other stepped up enforcement and newly initiated audit activities send a clear signal that HIPAA-covered entities and their business associates face significant exposures for failing to appropriately manage their HIPAA and other responsibilities when handling protected health information. Meanwhile, Texas House Bill 300 has raised maximum state civil penalties for unlawful disclosures of Protected Health Information under the Texas Medical Records Privacy Act to from $5,000 to $1.5 million per year. Meanwhile HITECH Act amendments to HIPAA require covered entities provide notification of certain breaches while Texas House Bill 300 adds its own specific requirements to provide notice of certain breaches of computerized data containing sensitive personal information.

With Texas House Bill 300 expanding covered entities responsibilities and liabilities and OCR issuing new regulations and other guidance to implement amendments to the HIPAA Privacy & Security Standards and implement and enforce the HITECH Act Breach Notification Rule, health care providers, health plans and insurers, their brokers, third-party administrators, and other covered entities, as well as their business associates and employer and union clients must review and tighten their policies, practices, business associate and other contracts, and enforcement to manage HIPAA and other compliance and manage risks arising from the access, collection, use, protection and disclosure of PHI to meet expanding mandates and to guard against growing liability exposures under HIPAA and other federal and state laws.

Pre-approved for various types of continuing and professional education credit, the December 12, 2012 HIPAA Update Workshop will brief participants on the De-Identification Guidance as well as the latest on other regulatory and enforcement guidance under the HIPAA Privacy, Security and Breach Notification rules and guidance and share compliance and risk management lessons emerging from recent OCR enforcement and audit activities and other selected federal and state litigation and enforcement actions impacting the handling of protected health information. Among other things, the workshop will cover:

The De-Identification Guidance just released by OCR on November 26, 2012;
The latest HIPAA Privacy, Security & Breach Notification Guidance, Audits & Enforcement
Highlights Texas House Bill’s Amendments To Texas Medical Records Privacy Law That Took Effect September 1, 2012
Post HITECH Act Heightened Liability Risks: Audits, Civil Penalties, Criminal Penalties & State Lawsuits
Expansion of HIPAA Responsibilities & Liabilities To Business Associates & What Covered Entities & Business Associates Should Do In Response
HIPAA Data Breach Notification Requirements
Practical Challenges & Strategies For Managing These Responsibilities
Tips For Coordinating HIPAA & Other Federal & State Medical Privacy, Financial Information, Identity Theft & Date Security Compliance and Risk Management
Practical Strategies For Monitoring & Responding To New Requirements & Changing Rules
Participant Questions

About The Speaker

The workshop will be conducted by attorney Cynthia Marcotte Stamer. A Fellow in the American College of Employee Benefits Counsel, recognized in International Who’s Who, North Texas Health Care Compliance Professionals Association Vice-President and Board Certified in Labor & Employment Law, attorney Cynthia Marcotte Stamer has 25 years experience advising and representing private and public health care providers, employers, employer and union plan sponsors, employee benefit plans, associations, their fiduciaries, administrators, and vendors, group health, Medicare and Medicaid Advantage, and other insurers, governmental leaders and others on privacy and data security, health care, health and other employee benefit. employment, insurance and related matters. A well-known and prolific author and popular speaker, Ms. Stamer has worked extensively with heath care providers, health plans and other payers, health and insurance IT and data systems, and others on HIPAA and other privacy and data security concerns. She served as the scrivener for the ABA JCEB Agency Meetings with the Office of Civil Rights on HIPAA Privacy for the past two years. She presently serves as Co-Chair of the ABA RPTE Section Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Representative, an Editorial Advisory Board Member of the Institute of Human Resources (IHR/HR.com) and Employee Benefit News, and various other publications. A primary drafter of the Bolivian Social Security privatization law with extensive domestic and international regulatory and public policy experience, Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health, employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with OCR and other HHS agencies, as well as the Departments of Labor, Treasury, Federal Trade Commission, HUD and Justice, Congress and state legislatures, and various state attorneys general, insurance, labor, worker’s compensation, medical licensure and disciplinary and other agencies and regulators. A prolific author and popular speaker, Ms. Stamer regularly authors materials and conducts workshops and professional, management and other training on HIPAA and other privacy, health care, employee benefits, human resources, insurance and related topics for the ABA, Aspen Publishers, the Bureau of National Affairs (BNA), SHRM, World At Work, Government Institutes, Inc., the Society of Professional Benefits Administrators and many other organizations. Her insights on privacy and other matters are quoted in Modern Healthcare, HealthLeaders, Benefits, Caring for the Elderly, The Wall Street Journal and many other publications. She also regularly serves on the faculty and planning committees of a multitude of symposium and other educational programs. For more details about Ms. Stamer’s services, experience, presentations, publications, and other credentials or to ask about arranging counseling, training or presentations or other services by Ms. Stamer, see www.CynthiaStamer.com.

Registration

The Registration Fee is $125.00 per person. Registration Fee Discounts available for groups of three or more. Pre-payment required via website registration required via website PayPal. No checks or cash accepted. Persons not registered at least 48 hours in advance will only participate subject to system and space availability.

Continuing Education Credit

The HIPAA Update Workshop is approved to be offered for general certification credit by the State Bar of Texas, Texas Department of Insurance, HRCI and WorldAtWork education credit for the time period offered subject to fulfillment all applicable accrediting agency requirements, completion of required procedures. Note that the applicable credentialing agency retain the final authority to determine whether an individual qualifies to receive requested continuing education credit. Neither Solutions Law Press, Inc., the speaker or any of their related parties guarantees the approval of credit for any individual or has any liability for any denial of credit. Special fees or other conditions may apply. CANCELLATION & REFUND POLICY: In order to receive credit, cancellation (either fax or mail) must be received at least 48 hours in advance of the meeting and are subject to a $10.00 refund processing fee. Refunds will be made within 60 days of receipt of written cancellation notice.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives. Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs. For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com. If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net. CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

Comments Off on New OCR HIPAA De-Identification Guidance Among Developments Covered In 12/12 HIPAA Update Web Workshop | ADA, Civil Rights, Consumer Protection, Corporate Compliance, Data Security, Disease Management, Drug & Alcohol, Employers, ERISA, Fiduciary Responsibility, GINA, Health Plans, HIPAA, Human Resources, Insurance, Internal Controls, Medicare Part D, Prescription Drugs, Privacy, Wellness Programs | Tagged: compliance, Health Care, Heatlh Plans, HIPAA, PHI, Texas Medical Records Privacy | Permalink
Posted by Cynthia Marcotte Stamer

HIPAA & Texas Law Require HIPAA Training. Register Now For August 14 HIPAA Update Workshop!

August 8, 2012

Texas House Bill 300 Medical Records Privacy Act Amendments & HIPAA Regulations Require HIPAA Privacy Training!

Register Now!

HIPAA Update

August 14, 2012

12:30 P.M.-2:30 P.M. Eastern | 11:30 A.M.-1:30 P.M. Central | 10:30 A.M-12:30 P..M. Mountain | 9:30 A.M-11:30 A.M. Pacific

Texas Department Of Insurance Continuing Education Credit, HRCI and World At Work Education Credit Approved!

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of personal health information (“PHI”).

Complete HIPAA Training While You Catch Up On The Latest On HIPAA & Texas Medical Records Privacy Rules & Get Helpful Compliance And Risk Management Tips!

With Texas House Bill 300 expanding covered entities responsibilities and liabilities and OCR issuing new regulations and other guidance to implement amendments to the HIPAA Privacy & Security Standards and implement and enforce the HITECH Act Breach Notification Rule, health care providers, health plans and insurers, their brokers, third party administrators, and other covered entities, as well as their business associates and employer and union clients must review and tighten their policies, practices, business associate and other contracts, and enforcement to manage HIPAA and other compliance and manage risks arising from the access, collection, use, protection and disclosure of PHI to meet expanding mandates and to guard against growing liability exposures under HIPAA and other federal and state laws.

Solutions Law Press, Inc. invites you to catch up on the latest on these and other key HIPAA requirements and enforcement and learn tips for managing risks and liabilities by participating in the “HIPAA Update Workshop” on Tuesday, August 14, 2012. Participants may choose to attend the live briefing in Addison, Texas or participate via WebEx for a registration fee of $125.00. Texas Department of Insurance Continuing Education Credit and other professional certification credit may be requested by qualifying participant for an added charge.

Learn Latest On HIPAA & Texas House Bill 300 Privacy, Security & Breach Notification Guidance & Enforcement

The HIPAA Update Workshop will brief participants on the latest HIPAA Privacy, Security and Breach Notification rules and guidance and share compliance and risk management lessons emerging from recent OCR enforcement and audit activities and other selected federal and state litigation and enforcement actions impacting the handling of protected health information. Among other things, the workshop will cover:

√ Latest HIPAA Privacy, Security & Breach Notification Rules, Guidance & Enforcement

√Latest on Texas House Bill Amendments To Texas Medical Records Privacy Law Effective September 1, 2012

√Post HITECH Act Heightened Liability Risks: Audits, Civil Penalties, Criminal Penalties & State Lawsuits

√ Expansion of HIPAA Responsibilities & Liabilities To Business Associates & What Covered Entities & Business Associates Should Do In Response

√ HIPAA Data Breach Notification Requirements & Practical Challenges & Strategies For Managing These Responsibilities

√ HIPAA Compliance & Risk Management Coordination With Other Federal & State Medical Privacy, Financial Information, Identity Theft & Date Security Responsibilities

√ Breach Preparedness & Response Planning

√ Practical Steps & Best Practices For Compliance & Risk Management

√ Practical Strategies For Monitoring & Responding To New Requirements & Changing Rules

√ Participant Questions

√ More

About The Speaker

A Fellow in the American College of Employee Benefits Counsel, recognized in International Who’s Who, North Texas Health Care Compliance Professionals Association Vice-President and Board Certified in Labor & Employment Law, attorney Cynthia Marcotte Stamer has 25 years experience advising and representing private and public health care providers, employers, employer and union plan sponsors, employee benefit plans, associations, their fiduciaries, administrators, and vendors, group health, Medicare and Medicaid Advantage, and other insurers, governmental leaders and others on privacy and data security, health care, health and other employee benefit. employment, insurance and related matters. A well-known and prolific author and popular speaker, Ms. Stamer has served as the scrivener for the ABA JCEB Agency Meetings with the Office of Civil Rights on HIPAA Privacy for the past two years. She presently serves as Co-Chair of the ABA RPTE Section Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Representative, an Editorial Advisory Board Member of the Institute of Human Resources (IHR/HR.com) and Employee Benefit News, and various other publications. A primary drafter of the Bolivian Social Security privatization law with extensive domestic and international regulatory and public policy experience, Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health, employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with the US Congress, Departments of Labor, Treasury, Health & Human Services, Federal Trade Commission, HUD and Justice, as well as a state legislatures attorneys general, insurance, labor, worker’s compensation, and other agencies and regulators. A prolific author and popular speaker, Ms. Stamer regularly authors materials and conducts workshops and professional, management and other training on HIPAA and other privacy, health care, employee benefits, human resources, insurance and related topics for the ABA, Aspen Publishers, the Bureau of National Affairs (BNA), SHRM, World At Work, Government Institutes, Inc., the Society of Professional Benefits Administrators and many other organizations. Her insights on privacy and other matters are quoted in Modern Healthcare, HealthLeaders, Benefits, Caring for the Elderly, The Wall Street Journal and many other publications. She also regularly serves on the faculty and planning committees of a multitude of symposium and other educational programs. For more details about Ms. Stamer’s services, experience, presentations, publications, and other credentials or to inquire about arranging counseling, training or presentations or other services by Ms. Stamer, see http://www.CynthiaStamer.com.

Registration

Registration Fee per course is $125.00 per person (plus an additional $10 service fee for each individual seeking Texas Department of Insurance Continuing Education Credit). Registration Fee Discounts available for groups of three or more. Payment required via website registration required 48 hours in advance of the program to complete registration. Payment only accepted via website PayPal. No checks or cash accepted. Persons not registered at least 48 hours in advance will only participate subject to system and space availability.

*Tex. Dept. of Insurance, HRICI, WorldAtWork, CLE & Other Continuing Education Credit

These programs are approved to be offered for general certification credit by the Texas Department of Insurance, HRCI and WorldAtWork education credit for the time period offered subject to fulfillment all applicable accrediting agency requirements, completion of required procedures and payment of the additional service processing fee of $10.00. An application for State Bar of Texas continuing education legal education credit is pending. The Texas Department of Insurance has approved the HIPAA Update program is approved for 1.5 hours of General Credit and .5 Hours of Ethics Credit. The applicable credentialing agency retain the final authority to determine whether an individual qualifies to receive requested continuing education credit. Neither Solutions Law Press, Inc., the speaker or any of their related parties guarantees the approval of credit for any individual or has any liability for any denial of credit. Special fees or other conditions may apply. CANCELLATION & REFUND POLICY: In order to receive credit, cancellation (either fax or mail) must be received at least 48 hours in advance of the meeting and are subject to a $10.00 refund processing fee. Refunds will be made within 60 days of receipt of written cancellation notice.

Check Out Our Health Plan-U & Other Workshops Including:

HIPAA Update*

August 14, 2012

11:30 A.M.-1:00 P.M. Central

Health Plan Communications Update: SBCs, SPDs & Beyond*

August 28, 2012

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About Solutions Law Press, Inc.™

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Posted by Cynthia Marcotte Stamer

Health Plans & Business Associates Face 2/17 Deadline To Update Policies, Contracts & Procedures For HIPAA Privacy Rule Changes

February 15, 2010

Connecticut AG Lawsuit Highlights Expanding Civil Damage Exposure Risks Of Noncompliance

By Cynthia Marcotte Stamer

By Wednesday, February 17, 2010, employer and other health plans and health insurers (“covered entities”) and service providers performing functions on behalf of these entities (“business associates”) must begin complying with tighter federal requirements for the use, access, protection and disclosure of protected health information under Privacy & Security Standards of the Health Insurance Portability & Accountability Act (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act). The changes scheduled to take effect February 17, 2010 are likely to require that health plans and their business associates update their written policies, operational procedures, privacy notices and business associate agreements in several respects.

While the HITECH Act gave covered entities and business associates a year to complete the necessary arrangements to comply with these impending HITECH Act changes, many health plans and business associates have not completed the necessary arrangements despite expanding liability exposures that can result from noncompliance. To mitigate these exposures, covered entities and their business associates should act quickly both to update their services agreements, plans and policies, practices, and procedures, and to implement the training, oversight, and other management procedures necessary to comply with the HITECH Act changes and to mitigate other HIPAA risks.

2/17/10 Deadline To Comply With HITECH Act HIPAA Amendments

On February 17, 2010, health plans and other covered entities and their business associates will become subject to the latest to take effect in a series of amendments to the HIPAA enacted under the HITEC Act. The new rules are part of a broader series of changes to HIPAA made by the HITECH Act that collectively both significantly expand the obligations of covered entities and their business associates to regarding the use, protection and disclosure of protected health information and the liability exposures that can result when covered entities or business associates violate these requirements.

The changes scheduled to take effect February 17, 2010 are likely to require that health plans and their business associates update their written policies, operational procedures, privacy notices and business associate agreements in several respects. For instance, effective February 17, 2010, the HITECH Act generally requires that covered entities and their business associates revise their written privacy policies, privacy notices and operating procedures:

To meet expanded requirements to honor individual’s requests for special restrictions on uses and disclosures of protected health information to health plans for payment purposes
To restrict protected health information disclosures to the minimum necessary required to accomplish otherwise allowable purpose;
To comply with new rules that require that the covered entity and its business associates treat any use, access or disclosure of any protected health information made for purposes of making communications about products or services as made for marketing, rather than operational, purposes which are prohibited by HIPAA except where HIPAA’s requirements are met;
To comply with new restrictions on certain fundraising communications made for operational purposes including expanded obligations to allow recipients to opt out of further fundraising communications;
To prohibit covered entities or business associates from selling protected health information without meeting the amended requirements of HIPAA that a valid HIPAA authorization from the subject of the information and specific reassurances from the purchaser concerning its subsequent use of the protected health information except as otherwise permitted by HIPAA;
To take into account these tightened restrictions on the use, access or disclosure of protected health information for purposes of complying with new HITECH Act breach notification requirements that took effect in September, 2009, which apply when a covered entity or its business associate knows or should know a breach of “unsecured protected health information” has occurred and for purposes of making the necessary changes in written policies and business associate agreements, training and operational procedures necessary to comply with these rules;
To directly require business associates comply with HIPAA’s requirements in the same manner as other covered entities and make it necessary or advisable that that service provider agreements between health plans and business associates be updated to reflect these and other changes to HIPAA; and
To implement the necessary written policy changes, notification updates, business associate agreement amendments, training, management oversight and other procedural changes necessary to demonstrate fulfillment with these requirements.

Noncompliance with these and other HIPAA requirements subjects covered entities and business associates to civil penalties, criminal prosecution, civil damage awards under lawsuits brought by state attorneys general, and other legal remedies. In addition, timely update written policies, procedures, business associate agreements, training and documentation is imperative in order for covered entities and their business associates to fulfill their breach notification obligations under new rules enacted as part of the HITECH Act.

Under the HITECH Act, health plans and other covered entities and their business associates have been obligated since September 23, 2009 to notify individuals who are the subject of protected health information, the Department of Health & Human Services and in some cases the media if and when a breach of “unsecured protected health information occurs. Failing to timely update written policies, procedures and training increases the likelihood that health plans, other covered entities or business associates will be obligated to provide breach notifications under these new rules, in addition to their otherwise applicable exposures under HIPAA.

HIPAA Enforcement & Liability Exposures Real and Rising

Health plans and other covered entities, their business associates and others involved in health plan design and operations generally should resist the temptation to underestimate their potential HIPAA exposure based on the limited enforcement of HIPAA by the Office of Civil Rights between 2003 and 2009 for a variety of reasons.

First, the changes taking effect on February 17, 2010 follow the implementation changes to HIPAA’s civil and criminal sanctions that took effect on February 17, 2009, when President Obama signed the HITECH Act into law and the new breach notification requirements added by the HITECH Act that took effect on September 23, 2009. The HITECH Act amendments to HIPAA’s remedies significantly increase the risk that health plans and other covered entities and their business associates will face civil lawsuits, civil or criminal penalties or other consequences for violating HIPAA.

The expanded risks stem in part from the HITECH Act’s amendments to HIPAA’s remedy provisions. Among other things, the HITECH Act amended HIPAA to:

Allow a State Attorney General to sue health plans or other covered entities, business associates or both that harm state citizens by committing HIPAA violations after February 16, 2009;
Expand the mandate by the Office of Civil Rights to investigate violations and audit compliance with HIPAA;
Require Office of Civil Rights to impose civil sanctions against health plans and other covered entities and their business associates involved in violations of HIPAA in accordance with tightened standards added to HIPAA by the HITECH Act;
Revise the criminal sanctions that the Department of Justice can seek against health plans and other covered entities, their business associates and others for violations of HIPAA;
Amend HIPAA to make clear that HIPAA’s criminal sanctions also can imposed on business associates, workforce members and other persons that improperly use, access and disclose protected health information in violation of HIPAA.

A HIPAA civil lawsuit filed on January 13, 2010 demonstrates the willingness of at least some states to exercise the new authority created by the HITECH Act on February 17, 2009 to sue covered entities and business associates that violate HIPAA for civil damages.

The HITECH Act empowers a state attorney general to sue covered entities or business associates engaging in HIPAA violations that harms citizens of the state for statutory damages equal to the sum of the number of violations multiplied by 100 up to a maximum of $25,000 per calendar year plus attorneys fees and costs

On January 13, 2010 Connecticut Attorney General Richard Blumenthal sued Health Net of Connecticut, Inc. (Health Net) for failing to secure private patient medical records and financial information involving 446,000 Connecticut enrollees and promptly notify consumers endangered by the security breach. The suit also names UnitedHealth Group Inc. and Oxford Health Plans LLC, who have acquired Health Net. The first attorney general enforcement action brought based on amendments made to HIPAA under the HITECH Act, Connecticut charges that Health Net violated HIPAA by failing to safeguard protected medical records and financial information on almost a half million Health Net enrollees in Connecticut then allowing this information to remain exposed for at least six months before notifying authorities and consumers.

Even before the HITECH Act amendments, however, the Office of Civil Rights and Department of Justice already were stepping up HIPAA investigation and enforcement. The Department of Justice has obtained a variety of criminal convictions against violators of HIPAA. See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health Information. Meanwhile, the Office of Civil Rights in February, 2009 announced that CVS Pharmacies, Inc. would pay $2.25 million to resolve HIPAA charges. This announcement followed the Office of Civil Rights announcement in July, 2008 that Providence Health Care would pay $100,000 to resolve HIPAA violation charges. While not resulting in the significant payments involved in CVS or Providence, the Office of Civil Rights also taken HIPAA enforcement actions against a broad range of other covered entities to redress HIPAA violations or other compliance concerns. To review examples of these other actions, see here.

Along side these governmental actions, state courts also increasingly are willing to allow individual plaintiffs to rely on violations of HIPAA as the basis for bringing state privacy, retaliation or other actions. While prior to the recent HITECH Act amendments, federal courts had ruled that private plaintiffs could not sue under HIPAA for damages they incurred from a covered entity’s violation of HIPAA, state courts have allowed private plaintiff’s to use the obligations imposed by HIPAA as the basis of a covered entity’s duty for purposes of certain state law lawsuits. In Sorensen v. Barbuto, 143 P.3d 295 (Utah Ct. App. 2006), for example, a Utah appeals court ruled a private plaintiff could use HIPAA standards to establish that a physician owed a duty of confidentiality to his patients for purposes of maintaining a state law damages claim. Similarly, the Court in Acosta v. Byrum, 638 S.E. 2d 246 (N.C. Ct. App. 2006) ruled that a plaintiff could use HIPAA to establish the “standard of care” in a negligence lawsuit. Meanwhile, private plaintiffs employed by covered entities also are increasingly pointing to HIPAA as the basis for their retaliation claims. See, e.g., Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim. Coupled with the HITECH Act changes, these and other enforcement actions signal growing potential hazards for covered entities and their business associates that fail to properly manage their HIPAA compliance obligations and risks.

Health Plans & Business Associates Should Take Timely Action To Comply & Manage Risks

As a consequence of these collective HITECH Act changes and growing HIPAA-related exposures, both health plans and business associates generally will find it necessary or advisable among other things to:

Conduct well-documented due diligence on each other’s practices and procedures to improve their ability to demonstrate both their commitment to compliance and their realistic efforts to ensure that these commitments are operationalized in performance;
Renegotiate their service provider agreements to detail the specific compliance obligations of each party relating to for auditing compliance, investigating potential breaches; providing required breach notifications; specify leadership and required cooperation in the event of a breach, charge, or other concern; indemnification and other liability allocations; and other related matters; and
Pursue appropriate liability and other protection as appropriate.

As part of these compliance and risk management efforts, most covered entities and their business associates will find it advisable to devote significant attention to the business associate relationship and its associated business associate agreements.

Proper management of the expanded compliance obligations and liability exposures created by the HITECH Act generally will necessitate that health plans and other covered entities and their business associates focus significant attention on the reworking of their operating and contractual relationships.

Even before the impending HIPAA changes scheduled to take effect on February 17, 2010, a strong need for more detailed contracting and planning of these relationships already existed. Since the enactment of HIPAA, the practice of many covered entities and their business associates of appending generic “business associate” representations onto existing services contracts without specific tailoring and planning has created undesirable ambiguities in these agreements.

Further updating and tailoring of these and other provisions of services agreements has become even more important over the past year in light of the new breach notification mandates that took effect under the HITECH Act in September, 2009, changes to HIPAA’s civil and criminal sanctions that took effect on February 17, 2009, and the impending extension by the HITECH Act to business associates of direct liability for compliance with HIPAA scheduled to occur on February 17, 2010.

Given these changes and the associated obligations and risks, both health plans and other covered entities and their business associates generally should act quickly to manage their own compliance and to minimize exposures that may result from the other’s compliance deficiencies. As part of these efforts, both covered entities and their business associates generally should review and tighten business associate and other service agreement provisions to provide for more specific and comprehensive HIPAA-related contractual assurances, as well as improved cooperation, coordination, management and oversight.

Curran Tomko Tarski LLP Can Help

If your organization need advice or assistance in reviewing, updating, administering or defending its HIPAA or other privacy policies, practices, business associate or other agreements, notices or other related activities, consider contacting Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer.

A widely published author and speaker on HIPAA and other related matter, Ms. Stamer has extensive experience advising health plans, their employer and other sponsors, health insurers, TPAs and other business associates and others about HIPAA and other health plan and privacy matters. Currently serving as both Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Group and as an ABA Joint Committee on Employee Benefits Council representative and Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer has more than 23 years experience assisting employers, insurers, plan administrators and fiduciaries and others to design, implement, draft and administer health and other employee benefit plans and to defend audits, litigation or other disputes by private parties, the IRS, Department of Labor, Office of Civil Rights, Medicare, state insurance regulators and other federal and state regulators. As part of this work, she regularly assists clients to review and update policies, practices, contracts, notices and procedures to comply with HIPAA and other requirements. A nationally recognized author and lecturer, Ms. Stamer also speaks and writes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see here or contact Ms. Stamer directly. For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi LLP team, see here.

Other Information & Resources

We hope that this information is useful to you. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here or e-mailing this information here or registering to participate in the distribution of our Solutions Law Press HR & Benefits Update distributions here. Examples of other recent updates that may be of interest include:

For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject here.

Comments Off on Health Plans & Business Associates Face 2/17 Deadline To Update Policies, Contracts & Procedures For HIPAA Privacy Rule Changes | ARRA, Employers, ERISA, Fiduciary Responsibility, GINA, Health Plans, HIPAA, Human Resources, Insurance, Internal Controls, Internal Investigations, Privacy, Protected Health Information, Risk Management, Stimulus Bill | Tagged: Breach Notice, Corporate Compliance, Data Breach, Employee Benefits, Employers, ERISA, GINA, Health Insurance, Health Plans, HIPAA, Human Resources, Insurance, Insurer, Internal Controls, Internal Investigations, Managed Care, Medical Coverage, PHI, Privacy, Privacy Rule, Risk Management, Security Rule | Permalink
Posted by Cynthia Marcotte Stamer

Rising Enforcement and Changing Rules Require Prompt Review & Update of Health Plan Privacy & Data Security Policies & Procedures

December 25, 2009

Health plans and their business associates should review and update their practices and policies concerning the use access and disclosure of protected health information in response to changing requirements and expanding enforcement exposures under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) Privacy and Security Rules.

A series of Office of Civil Rights (OCR) enforcement action against health plans highlights the need for group health plans and insurers to exercise care to comply with HIPAA’s Privacy & Security Rules. For example, OCR recently required a HMO to take a series of corrective actions based on findings from its investigation of a complaint that the HMO impermissibly disclosed a member’s protected health information by sending her entire medical record to a disability insurance company without her authorization. Based on its investigation, OCR found the HMO violated HIPAA by relying on a form to make the disclosure that failed to meet the Privacy Rule requirements to qualify as a valid authorization under the Privacy Rule. Based on these findings, OCR required the HMO among other things:

To create a new HIPAA-compliant authorization form that specifies what records and/or portions of the files will be disclosed, that the respective authorization will be kept in the patient’s record, together with the disclosed information and otherwise to meet the content requirements of the Privacy Rule for an authorization; and
To implement a new policy that directs staff to obtain patient signatures on these forms before responding to any disclosure requests, even if patients bring in their own “authorization” form.

Another action resulted after a national health maintenance organization sent explanation of benefits (EOB) by mail to a complainant’s unauthorized family member. OCR’s investigation determined that a flaw in the health plan’s computer system put the protected health information of approximately 2,000 families at risk of disclosure in violation of the Privacy Rule. To resolve this case, OCR required among other things that the insurer to correct the flaw in its computer system, review all transactions for a six month period and correct all corrupted patient information.

In yet another case, OCR found an employee of a major health insurer impermissibly disclosed the PHI of one of its members without following the insurer’s authorization and verification procedures. Among other corrective actions to resolve the specific issues in the case, OCR required the health insurer to train its staff on the applicable policies and procedures, to take action to mitigate the harm to the individual and to counsel and give a written warning to an employee who made the disclosure.

While OCR declined to impose any civil penalties in any of these three instances, violations of the Privacy Rules have resulted in both criminal prosecutions by the Department of Justice and the payment of large civil settlements to OCR. See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health Information HIPAA Risks Soar As CVS Agrees to Pay $2.25 Million To Resolve HIPAA Charges & Stimulus Bill Amends HIPAA. Furthermore, recent amendments to the Privacy Rules increase the likelihood that health plans and other covered entities violating the Privacy Rules will incur civil penalties. The American Recovery and Reinvestment Act of 2009 (ARRA) amended the Privacy Rules effective October, 2009 to increase the civil penalties for Privacy Rule violations and to include new breach notification requirements for covered entities. Additional ARRA amendments to HIPAA scheduled to take effect February 17, 2010 will further tighten the conditions under which covered entities may use, access or disclose PHI under the Privacy Rules, will expand the circumstances under which health plans and other covered entities will be required to account for dealings with PHI under HIPAA, and will extend the duty to comply with and liability for violations of the Privacy Rules to business associates. In the meanwhile, employees increasingly are alleging Privacy Rule violations as part of their whistleblower or other wrongful discharge claims. See, e.g. Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim.

In light of these changing rules and expanding liabilities, health plans and their business associates need to review and update their Privacy and Security practices, business associate agreements and privacy notices for compliance in light of the expanding enforcement activities of OCR and these evolving Privacy and Security Rules. These and other developments make it imperative that health plans and other covered entities and their business associates immediately review and update their HIPAA and other data security and privacy practices to guard against growing liability exposures under HIPAA and other federal and state laws.

If your organization needs assistance reviewing, updating, administering or defending privacy and data security practices under HIPAA, state data breach or other laws, Curran Tomko Tarski LLP can help. The author of this update, Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer has extensive experience advising and assisting health plans, health insurers, and other covered entities and business associates to review, update, document, enforce and defend their HIPAA and other privacy and data security policies and practices. The author of numerous publications on HIPAA and other privacy and data security rules, she also speaks and conducts training extensively on these concerns.

Ms. Stamer is experienced with assisting employers, insurers, administrators, and others to design and administer group health plans cost-effectively in accordance with HIPAA and other applicable federal regulations as well as well as advising and defending employers, health plans, insurers and others against privacy, tax, employment discrimination and other labor and employment, and other related audits, investigations and litigation, charges, audits, claims and investigations by the OCR, DOJ,IRS, Department of Labor and other federal and state regulators.. Chair of the American Bar Association RPTE Employee Benefits & Other Compensation Group, a representative to the ABA Joint Committee on Employee Benefits Council, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer has advised and represented employers on these and other labor and employment, compensation, employee benefit and other personnel and staffing matters for more than 22 years. Ms. Stamer also speaks and writes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see here or contact Ms. Stamer directly. For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi LLP team, see here.

Other Information & Resources

We hope that this information is useful to you. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here or e-mailing this information here or registering to participate in the distribution of our Solutions Law Press HR & Benefits Update distributions here. Some other recent updates that may be of interested include the following, which you can access by clicking on the article title:

For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject here.

Comments Off on Rising Enforcement and Changing Rules Require Prompt Review & Update of Health Plan Privacy & Data Security Policies & Procedures | Corporate Compliance, Data Security, Employee Benefits, Employers, ERISA, Health Plans, HIPAA, Human Resources, Insurance, Internal Controls, Privacy, Protected Health Information, Risk Management | Tagged: ARRA, Health Plans, HIPAA, OCR, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

Health Plans Must Comply with New HHS Interim Final Data Breach Rules Beginning September 24; Register to Participate In September 10th Briefing on New Rules In Person or Via Telephone

August 20, 2009

Employers and other health plan sponsors, fiduciaries, insurers and service providers need to move quickly to prepare to comply with “breach notification” regulations issued by the U.S. Department of Health and Human Services (HHS) yesterday (August 19, 2009). The new data breach regulations will require health plans, as well as health care providers, business associates and other covered entities (Covered Entities) under the personal health information privacy and security rules of the Health Insurance Portability & Accountability (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. Scheduled for publication in the Federal Register on August 24, 2009, the new breach notification regulations are part of a series of new rules that implement new electronic personal health information data security and data breach notification requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA). Covered entities must begin complying with the new rules no later than September 24, 2009.

Curran Tomko Tarski, LLP Health Practice leader Cynthia Marcotte Stamer will conduct a briefing on these new protected health information data security and data breach rules on Thursday, September 10, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201. For more information, e-mail here.

HITECH Act Data Breach and Unsecured PHI Rules

The new data breach notification rules are part of a series of recent HIPAA enacted under the HITECH Act to strengthen the federal rules requiring HIPAA covered entities to safeguard electronic and certain other protected health information. Enhanced data security and data breach rules added as part of these HITECH Act amendments obligate covered entities and business associates to provide certain notifications following a breach of “unsecured” “protected health information” within the meaning of HIPAA, as amended. “Unsecured protected health information” is defined as protected health information that is not secured through the use of a technology or methodology specified by the HHS Secretary.

The new data breach regulations implement the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach and the form, manner, and timing of that notification. For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the covered entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act. HHS and the Federal Trade Commission previously issued certain initial guidance concerning the HITECH Act standards for determining when electronic personal health information qualifies as secure. To help further define when electronic health information is treated as “unsecured” and therefore subject to the breach notification requirements, the data breach rules also update and clarify the previously issued existing HHS guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals published earlier this year by HHS to for purposes of determining when protected health information will be considered “unsecured” for purposes of the HITECH Act data breach rules. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information.

The HHS interim final regulations are effective September 24, 2009, which is the date 30 days after the date they will be published on the Federal Register and include a 60-day public comment period. To review the interim final data breach regulations, see here. To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

For More Information

The author of this article, Curran Tomko and Tarski LLP Labor and Employment and Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting employer and other health plan sponsors, insurers, managed care providers and other health and insurance industry clients about HIPAA and other privacy and data security matters, as well as a diverse range of health care, employment, and emplyee benefit policy, regulatory, compliance, risk management and operational concerns.

Current Chair of the American Bar Association (ABA) Real Property, Trusts & Estates Employee Benefit & Other Compensation Committee, an ABA Joint Committee on Employee Benefits Council member, past chair of the American Bar Association Health Law Section Managed Care & Insurance Section, Martindale Hubble AV-rated and recognized in International Who’s Who of Professionals, Ms. Stamer continuously advises health care providers, health care payers and administrators, employers, governments and others about health care, insurance, human resources, privacy and data security, technology, and other legal and operational concerns. A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer also writes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. She currently serves as the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010. Examples of her other works include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of others. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service Privacy Report, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a various other national and local publications. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

We hope that this information is useful to you. If you need assistance monitoring, evaluating or responding to these or other proposed health care or other regulatory reforms or with other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

We also encourage you and others to join the discussion about these and other health care reform proposals and concerns by joining the Coalition for Responsible Health Care Reform Group on Linkedin, registering to receive these updates here.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Solutions Law Press Health Care Update publication available here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

Comments Off on Health Plans Must Comply with New HHS Interim Final Data Breach Rules Beginning September 24; Register to Participate In September 10th Briefing on New Rules In Person or Via Telephone | Corporate Compliance, ERISA, GINA, Health Plans, HIPAA, Human Resources, Insurance, Internal Controls, Internal Investigations | Tagged: Corporate Compliance, Data Breach, Data Security, Date Security, Employee Benefits, Employers, ERISA, GINA, Health Plans, HIPAA, Human Resources, Insurance, Insurer, Internal Controls, Managed Care, PHI, Privacy, Privacy Rule, Protected Health Information, Security Rule | Permalink
Posted by Cynthia Marcotte Stamer

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