$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 RisksHIPAA 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 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.

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.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, 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, Inc.™ resources here.

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©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.

 


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

February 2, 2017

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.

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.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, 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, Inc.™ resources here such as:

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 your profile here.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™  All other rights reserved.


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.

 

 

 


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 ContinueMeanwhile, 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.

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 at here or e-mailing this information here.

©2015 Cynthia Marcotte Stamer.  Non-exclusive right to republish granted to Solutions Law Press.  All other rights reserved.


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:

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.


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

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 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.

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 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.


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

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 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.

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 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.