Health plans, insurers and other health plan industry service providers widespread use and reliance on internet applications to access and share protected health information when performing online enrollment, claims administration and payment, reporting, member and provider communications and a host of other key health plan functions makes it particularly important for health plans, their employer or other sponsors, fiduciaries, insurers and other vendors and their management to respond quickly to a warning from Department of Health & Human Services (HHS) Office of Civil Rights (OCR) warning to ensure applications and systems properly safeguard protected health information (PHI) as required by the Health Insurance Portability & Accountability (HIPAA) Privacy, Security & Breach Notification Rules (HIPAA Rules) and other laws made in its July 10, 2015 announcement of its latest HIPAA settlement.
The new Resolution Agreement with the Massachusetts based hospital system, St. Elizabeth’s Medical Center (SEMC) settles charges OCR made that SEMC reached HIPAA by failing to protect the security of PHI when using internet applications to access and share PHI. The Resolution Agreement also shows how complaints filed with OCR by workforce members can create additional compliance headaches for Covered Entities or their business associates while the “robust corrective action plan” imposed under the Resolution Agreement shares examples of ladder reporting and management oversight and documentation Covered Entities and business associates can expect to need to prove their organizations maintains the “culture of compliance” with HIPAA OCR expects in the event of an OCR audit or investigation.
With recent reports on massive health plan HIPAA and other data breaches fueling widespread participant and regulatory concern over identity theft and other data security, Covered Entities and their business associates should prepare to defend the adequacy of their own HIPAA and other data security practices in the event of an OCR breach investigation or audit. Accordingly, health plans and their employer or other sponsors, health plan fiduciaries, health plan vendors acting as business associates and others dealing with health plans and their management should contact legal counsel experienced in these matters for advice within the scope of attorney-client privilege about how to respond to the OCR warning and other developments to manage their HIPAA and other privacy and data security legal and operational risks and liabilities.
SEMC Resolution Agreement Overview
The SEMC Resolution Agreement settles OCR charges that SEMC violated HIPAA stemming from an OCR investigation of a November 16, 2012 complaint by SEMC workforce members and a separate data breach report SEMC separately made to OCR of a breach of unsecured electronic PHI (ePHI) stored on a former SEMC workforce member’s personal laptop and USB flash drive affecting 595 individuals. In their complaint, SEMC workers complained SEMC violated HIPAA by allowing workforce members to use an internet-based document sharing application to share and store documents containing electronic protected health information (ePHI) of at least 498 individuals without adequately analyzing the risks. OCR says its investigation of the complaint and breach report revealed among other things that:
- SEMC improperly disclosed the PHI of at least 1,093 individuals;
- SEMC failed to implement sufficient security measures regarding the transmission of and storage of ePHI to reduce risks and vulnerabilities to a reasonable and appropriate level; and
- SEMC failed to timely identify and respond to a known security incident, mitigate the harmful effects of the security incident, and document the security incident and its outcome.
To resolve OCR’s charges, SMCS agreed to pay $218,400 to OCR and implement a “robust corrective action plan” to correct these alleged HIPAA violations. While the required settlement payment is relatively small, the Resolution Agreement’s focus security requirements for internet application and data use and sharing activities engaged in by virtually every Covered Entity and business associate make the Resolution Agreement merit the immediate attention of all Covered Entities, their business associates and their management.
SEMC HIPAA Specific Compliance Lessons For Health Plans & Business Associates
In announcing the Resolution Agreement, OCR Director Jocelyn Samuels sent a clear warning to all Covered Entities and their business associates “to pay particular attention to HIPAA’s requirements when using internet-based document sharing applications,” stating “In order to reduce potential risks and vulnerabilities, all workforce members must follow all policies and procedures, and entities must ensure that incidents are reported and mitigated in a timely manner.”
The Resolution Agreement makes clear that OCR expects health plans and other Covered Entities and their business associates to be able to show both their timely investigation of reported or suspected HIPAA susceptibilities or violations as well as to self-audit and spot test HIPAA compliance in their operations. The SEMC corrective action plan also indicates Covered Entities and business associates must be able to produce documentation and other evidence needed to show the top to bottom dedication to HIPAA compliance necessary to prove a “culture of compliance” with HIPAA permeates their organizations.
In light of OCR’s warning and expectations, Covered Entities and business associates should start by considering the advisability for their own organization to take one or more of the steps outlined in the “robust corrective action plan” included in the Resolution Agreement, starting with the specific steps the corrective action plan requires SEMC to address its internet application security concerns such as:
- Conducting self-audits and spot checks of workforce members’ familiarity and compliance with HIPAA policies and procedures on transmitting ePHI using unauthorized networks; storing ePHI on unauthorized information systems, including unsecured networks and devices; removal of ePHI from SEMC; prohibition on sharing accounts and passwords for ePHI access or storage; encryption of portable devices that access or store ePHI; security incident reporting related to ePHI; and
- Inspecting laptops, smartphones, storage media and other portable devices, workstations and other devices containing ePHI and other data devices and systems and their use; and
- Conducting other tests and audits of security and compliance with policies, processes and procedures; and
- Documenting results, findings, and corrective actions including appropriate up the ladder reporting and management oversight of these and other HIPAA compliance expectations, training and other efforts.
Broader HIPAA Compliance & Risk Management Lessons
Beyond the specific internet applications and other security of ePHI lessons in the Resolution Agreement, Covered Entities and their business associates also should be mindful of other more subtle, but equally important broader HIPAA compliance and risk management lessons provided in the Resolution Agreement and other recent OCR guidance about their overall HIPAA compliance responsibilities.
One of the most significant of these lessons is the need for proper workforce training, oversight and management. The Resolution Agreement sends an undeniable message that OCR expects Covered Entities, business associates and their leaders to be able to show their effective oversight and management of the operational compliance of their systems and members of their workforce with HIPAA policies. The SEMC corrective action plan should prompt Covered Entities and business associates to weigh the adequacy of their existing workforce training, reporting, investigation and other management processes and documentation. Meanwhile, OCR’s report that an OCR complaint made by SEMC insiders to OCR prompted its investigation also should sensitize Covered Entities and their business associates of the need to ensure that their workforce training and management processes are appropriate to position their organization both to show their processes encourage proper internal reporting and investigation of compliance concerns, as well as manage the inevitable HIPAA and other human resources retaliation and whistleblower exposures that can arise out of such reports.
The Resolution Agreement also provides insights to the internal corporate processes and documentation of compliance efforts that Covered Entities and business associates may need to show their organization has the required “culture of compliance” needed to mitigate consequences of breaches or other compliance glitches. Particularly notable are Resolution Agreement’s terms on the documentation and up the ladder reporting to management and OCR of SEMC’s self-audit and self-correction activities and management oversight and management of these activities. Like tips shared by HHS in the recently released Practical Guidance for Health Care Governing Boards on Compliance Oversight, these details in the Resolution Agreement provide invaluable tips to Boards and other leaders of Covered Entities and business associates about steps they can take to promote their ability to demonstrate their organizations have the necessary culture of HIPAA compliance OCR expects.
Health Plan HIPAA Compliance Risks & Responsibilities of Employers & Their Leaders
While HIPAA places the primary duty for complying with HIPAA on Covered Entities and business associates, health plan sponsors and their management still need to make HIPAA compliance a priority for many practical and legal reasons.
As employers forced to cope with the deluge of fears and questions of employees and other health plan members impacted by recent massive PHI breach reports shared by Blue Cross association health insurance plan giants, Anthem and Premera can attest, HIPAA data breach or other compliance reports often trigger significant financial, administrative, workforce satisfaction and other operational costs employer health plan sponsors. Inevitable employee concern about health plan data breaches undermines employee value and satisfaction of the health benefit plan as an employee benefit. These concerns also usually require employers to expend significant management and financial resources to respond to these concerns and address other employer fallout from the breach.
The costs of investigation and redress of a known or suspected HIPAA data or other breach typically far exceed the actual damages to participants resulting from the breach. While HIPAA technically does not make sponsoring employers directly responsible for these duties or the costs of their performance, as a practical matter sponsoring employers typically can expect to pay costs and other expenses that its health plan incurs to investigate and redress a HIPAA breach. For one thing, except in the all too rare circumstances where employers as plan sponsors have specifically negotiated more favorable indemnification and liability provisions in their vendor contracts, employer and other health plan sponsors usually agree in their health plan vendor contracts to pay the expenses and to indemnify health plan insurers, third party administrators, and other vendors for costs and liabilities arising from HIPAA breaches or other events arising in the course of the administration of the health plan. Since employers typically are obligated to pay health plan costs in excess of participant contributions, employers also typically would be required to provide the funding their health plan needs to cover these costs even in the absence of such indemnification agreements.
Sponsoring employers and their management also should be aware the employer’s exception from direct liability for HIPAA Rule compliance does not fully insulate the employer or its management from legal risks in the event of a health plan data breach or other HIPAA violation.
While HIPAA generally limits direct responsibility for compliance with the HIPAA Rules to a health plan or other Covered Entity and their business associates, HIPAA hybrid entity and other organizational rules and criminal provisions of HIPAA, as well as various other federal laws arguably could create liability risks for the employer. See, e.g., Cyber Liability, Healthcare: Healthcare Breaches: How to Respond; Restated HIPAA Regulations Require Health Plans to Tighten Privacy Policies and Practices; Cybercrime and Identity Theft: Health Information Security Beyond. For example, hybrid entity and other organizational provisions in the HIPAA Rules generally require employers and their health plan to ensure that health plan operations are appropriately distinguished from other employer operations in order for otherwise non-covered human resources, accounting or other employer activities to avoid subjecting their otherwise non-covered employer operations and data to HIPAA Rules. To achieve this required designation and separation, the HIPAA rules typically also require that the health plan include specific HIPAA language and the employer and health plan take appropriate steps to designate and separate health plan records and data, workforces, and operations from the non-covered business operations and records of the sponsoring employer. Failure to fulfill these requirements could result in the unintended spread of HIPAA restrictions and liabilities to other aspects of the employer’s human resources or other operations. Sponsoring employers will want to confirm that health plan and other operations and workforces are properly designated, distinguished and separated to reduce this risk.
When putting these designations and separations in place, employers also generally will want to make arrangements to ensure that their health plan includes the necessary terms and the employer implements the policies necessary for the employer to provide the certifications to the health plan that HIPAA will require that the health plan receive before HIPAA will allow health plan PHI to disclosed to the employer or its representative for the limited underwriting and other specified plan administration purposes permitted by the HIPAA Rules.
Once these arrangements are in place, employers and their management also generally will want to take steps to minimize the risk that their organization or a member of the employer’s workforce honors these arrangements and does not improperly access or use health plan PHI, systems in violation of these conditions or other HIPAA Rules. This or other wrongful use or access of health plan PHI or systems could violate criminal provisions of HIPAA or other federal laws making it a crime for any person – including the employer or a member of its workforce – from wrongfully accessing health plan PHI, electronic records or systems. Since health plan PHI records also typically include personal tax, social security information that the Internal Revenue Code, the Social Security Act and other federal laws generally would require the employer to keep confidential and to protect against improper use, employers and their management also generally should be concern about potential exposures for their organization that could result from improper use or access of this information in violation of these other federal laws. Since HIPAA and some of these other laws under certain conditions make it a felony crime to violate these rules, employer and their management generally will want to treat compliance with these federal rules as critical elements of the employer’s Federal Sentencing Guideline and other compliance programs.
Beyond the already discussed concerns, employers or members of their management also may have an incentive to promote health plan compliance with HIPAA or other health plan privacy or data security requirements to many the exposure of the employer or management or other staff to statutory, regulatory, contractual or ethical liabilities arising under ERISA, Internal Revenue Code, the Fair & Accurate Credit Transaction Act (FACTA), trade secret, insurance, disability, identity theft, cybersecurity or other federal or state laws.
For instance, health plan sponsors and management involved in health plan decisions, administration or oversight could face personal fiduciary liability risks under ERISA for failing to act prudently to ensure that the health plan compliance with HIPAA and other federal privacy and data security requirements.. ERISA’s broad functional fiduciary definition encompasses both persons and entities appointed as “named” fiduciaries and others who functionally exercise discretion or control over a plan or its administration. Consequently, the sponsoring employer and certain members of its human resources or other executive management team who functionally possess or exercise responsibility or authority over the administration of the employer’s health plan or its data or other assets, the selection or oversight of plan fiduciaries, vendors, or other workforce members its administration, or other key health plan operations risk ERISA fiduciary liability for their own failures to act prudently in carrying out HIPAA compliance or other responsibilities or to take action when they know or should know that another fiduciary is or has breached these duties. This fiduciary status and risk can occur even if the entity or individual does not is not named a named fiduciary, expressly disclaims fiduciary responsibility or does not realize it bears fiduciary status or responsibility. Since fiduciaries generally bear personal liability for their own breaches of fiduciary duty as well as potential co-fiduciary liability for fiduciary breaches committed by others that they knew or prudently should have known, most employers and members of their management will make HIPAA health plan compliance a priority to avoid or minimize these potential ERISA fiduciary exposures.
Furthermore, most employers and their management also will appreciate the desirability of taking reasonable steps to manage potential exposures that the employer or members of its management could face if their health plan or the employer violates the anti-retaliation rules of HIPAA or other laws through the adoption and administration of appropriate human resources, internal investigation and reporting, risk management policies and practices. See Employee & Other Whistleblower Complaints Common Source of HIPAA Privacy & Other Complaints.
Act To Manage HIPAA & Other Related Risks
OCR’s release of the Resolution Agreement on the heels of widespread publicity about massive health plan and other data breaches at Blue Cross health care giants, Anthem and Premera and other U.S. businesses and the potential legal and financial exposures that a HIPAA data breach or other violation could create, health plans and their sponsors, insurers, business associates, and leaders should appreciate the advisability of acting promptly to ensure that their health plans and business associates are taking appropriate steps to comply with the HIPAA Rules and manage other associated risks and liabilities. At minimum, health plans and their business associates should move quickly to conduct a documented assessment of the adequacy of their health plan internet applications and other HIPAA compliance in in light of the Resolution Agreement and other developments. Given the scope and diversity of the legal responsibilities, risks and exposures associated with this analysis, most health plan sponsors, fiduciaries, business associates and their management also will want to consider taking other steps to mitigate various other legal and operational risks that lax protection or use of health plan PHI or systems could create for their health plan, its sponsors, fiduciaries, business associates and their management. Health plan fiduciaries, sponsors and business associates and their leaders also generally will want to explore options to use indemnification agreements, liability insurance or other risk management tools as a stop gap against the costs of investigation or defense of a HIPAA security or other data breach.
For Legal or Consulting Advice, Legal Representation, Training Or More Information
If you need help responding to these new or other workforce, benefits and compensation, performance and risk management, compliance, enforcement or management concerns, help updating or defending your workforce or employee benefit policies or practices, or other related assistance, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.
A practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C., a member of Stamer│Chadwick │Soefje PLLC, Ms. Stamer’s more than 27 years’ of leading edge work as an practicing attorney, author, lecturer and industry and policy thought leader have resulted in her recognition as a “Top” attorney in employee benefits, labor and employment and health care law.
Board certified in labor and employment law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, past Chair and current Welfare Benefit Committee Co-Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, an ABA Joint Committee on Employee Benefits Council Representative and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer is recognized nationally and internationally for her practical and creative insights and leadership on HIPAA and other health and other employee benefit, human resources, and related insurance, health care, privacy and data security and tax matters and policy.
Ms. Stamer’s legal and management consulting work throughout her 27 plus year career has focused on helping organizations and their management use the law and process to manage people, process, 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 public and private, domestic and international businesses, governments, 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 workforce and other legal and operational crises large and small that arise in the course of operations.
Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce management operations 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.
Well known for her extensive work with health care, insurance and other highly regulated entities on corporate compliance, internal controls and risk management, her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.
As a key part of this work, Ms. Stamer uses her deep and highly specialized health, insurance, labor and employment and other knowledge and experience to help employers and other employee benefit plan sponsors; health, pension and other employee benefit plans, their fiduciaries, administrators and service providers, insurers, and others design legally compliant, effective compensation, health and other welfare benefit and insurance, severance, pension and deferred compensation, private exchanges, cafeteria plan and other employee benefit, fringe benefit, salary and hourly compensation, bonus and other incentive compensation and related programs, products and arrangements.
She is particularly recognized for her leading edge work, thought leadership and knowledgeable advice and representation on the design, documentation, administration, regulation and defense of a diverse range of self-insured and insured health and welfare benefit plans including private exchange and other health benefit choices, health care reimbursement and other “defined contribution” limited benefit, 24-hour and other occupational and non-occupational injury and accident, ex-patriate and medical tourism, onsite medical, wellness and other medical plans and insurance benefit programs as well as a diverse range of other qualified and nonqualified retirement and deferred compensation, severance and other employee benefits and compensation, insurance and savings plans, programs, products, services and activities. In these and other engagements, Ms. Stamer works closely with employer and other plan sponsors, insurance and financial services companies, plan fiduciaries, administrators, and vendors and others to design, administer and defend effective legally defensible employee benefits and compensation practices, programs, products and technology. She also continuously helps employers, insurers, administrative and other service providers, their officers, directors and others to manage fiduciary and other risks of sponsorship or involvement with these and other benefit and compensation arrangements and to defend and mitigate liability and other risks from benefit and liability claims including fiduciary, benefit and other claims, audits, and litigation brought by the Labor Department, IRS, HHS, participants and beneficiaries, service providers, and others. She also assists debtors, creditors, bankruptcy trustees and others assess, manage and resolve labor and employment, employee benefits and insurance, payroll and other compensation related concerns arising from reductions in force or other terminations, mergers, acquisitions, bankruptcies and other business transactions including extensive experience with multiple, high-profile large scale bankruptcies resulting in ERISA, tax, corporate and securities and other litigation or enforcement actions.
In the course of this work, Ms. Stamer has accumulated an impressive resume of experience advising and representing clients on HIPAA and other privacy and data security concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights for several years, Ms. Stamer has worked extensively with health plans, health care providers, health care clearinghouses, their business associates, employer and other sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, 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 plans, health insurers, health care providers, banking, technology and other vendors, and others. Beyond advising these and other clients on privacy and data security compliance, risk management, investigations and data breach response and remediation, Ms. Stamer also advises and represents clients on OCR and other HHS, Department of Labor, IRS, FTC, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also is the author of numerous highly acclaimed publications, workshops and tools for HIPAA or other compliance including training programs 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.
Ms. Stamer also is deeply involved in helping to influence the Affordable Care Act and other health care, pension, social security, workforce, insurance and other policies critical to the workforce, benefits, and compensation practices and other key aspects of a broad range of businesses and their operations. She both helps her clients respond to and resolve emerging regulations and laws, government investigations and enforcement actions and helps them shape the rules through dealings with Congress and other legislatures, regulators and government officials domestically and internationally. A former lead consultant to the Government of Bolivia on its Social Security reform law and most recognized for her leadership on U.S. health and pension, wage and hour, tax, education and immigration policy reform, Ms. Stamer works with U.S. and foreign businesses, governments, trade associations, and others on workforce, social security and severance, health care, immigration, privacy and data security, tax, ethics and other laws and regulations. Founder and Executive Director of the Coalition for Responsible Healthcare Policy and its PROJECT COPE: the Coalition on Patient Empowerment and a Fellow in the American Bar Foundation and State Bar of Texas. She also works as a policy advisor and advocate to health plans, their sponsors, administrators, insurers and many other business, professional and civic organizations.
Author of the thousands of publications and workshops these and other employment, employee benefits, health care, insurance, workforce and other management matters, Ms. Stamer also is a highly sought out speaker and industry thought leader known for empowering audiences and readers. Ms. Stamer’s insights on employee benefits, insurance, health care and workforce matters in Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, Modern Healthcare, 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 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. Ms. Stamer also regularly serves on the faculty and planning committees for symposia of LexisNexis, the American Bar Association, ALIABA, the Society of Employee Benefits Administrators, the American Law Institute, ISSA, HIMMs, and many other prominent educational and training organizations and conducts training and speaks on these and other management, compliance and public policy concerns.
Ms. Stamer also is active in the leadership of a broad range of other professional and civic organizations. For instance, Ms. Stamer presently serves on an American Bar Association (ABA) Joint Committee on Employee Benefits Council representative; Vice President of the North Texas Healthcare Compliance Professionals Association; Immediate Past Chair of the ABA RPTE Employee Benefits & Other Compensation Committee, its current Welfare Benefit Plans Committee Co-Chair, on its Substantive Groups & Committee and its incoming Defined Contribution Plan Committee Chair and Practice Management Vice Chair; Past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and a current member of its Healthcare Coordinating Council; current Vice Chair of the ABA TIPS Employee Benefit Committee; the former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division; on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. She also previously served as a founding Board Member and President of the Alliance for Healthcare Excellence, as a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association. For additional information about Ms. Stamer, see www.cynthiastamer.com, or http://www.stamerchadwicksoefje.com the member of contact Ms. Stamer via email here or via telephone to (469) 767-8872.
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