Vendors and developers of mobile health apps and connected devices (“health apps”) that track or collect fitness or other health information that contain individually identifiable health information created or received by health care providers (“personal health records” or “PHR”) and their service providers (“collectively “PHR Vendors””) should verify their data security and breach notification policies and processes comply with applicable federal data breach rules in light of a September 15, 2021 Federal Trade Commission (“FTC”) policy statement cautioning health app vendors and their service providers that that app providers are responsible for complying with the FTC Health Breach Notification Rule; Final Rule, 16 C.F.R. Part 318 (“Health Breach Rule”) unless the breach is covered by and addressed in accordance with the Health Insurance Portability & Accountability Act (“HIPAA”) Breach Notification for Unsecured Protected Health Information, 45 CFR Parts 160 and 164 (“HIPAA Breach Rule”) applicable to health plans, health care providers, health care clearinghouses and their service provider business associates (“HIPAA Entities”) experiencing breaches of protected health information (“PHI”).
The HIPAA Breach Notification Rule and the Health Breach Rule implement enhanced health information data security and breach notification requirements added to federal law by the Health Information Technology for Economic and Clinical Health Act (HITECH) enacted by Congress as part of the American Recovery and Reinvestment Act (ARRA) of 2009. Widely recognized, the HIPAA Breach Rule adopted and enforced by the Department of Health & Human Services Office of Civil Rights (“OCR”) implements breach notification and other requirements for the protection of electronic PHI applicable to HIPAA Covered Entity. In contrast, the FTC Health Breach Rule implements the HITECH Act’s requirements for breaches not subject to the HIPAA Breach Rule of individually identifiable consumer health information in “personal health records” and falls under the FTC’s jurisdiction to investigate and enforce.
Awareness of the HIIPAA Breach Rule is much more widespread, largely due to OCR’s long and ever-growing list of settlements and prosecutions of violations of its HIPAA Breach Rules. See e.g., Pennsylvania OCR Settlement Warns Others Against Disability Or Other Civil Rights Discrimination In COVID-19 Resource Allocation & Other Response; Gastroenterology Practices Pays $100K For HIPAA Noncompliance; OCR Warns HIPAA Entities To “Get Serious” About HIPAA Compliance In Announcing Latest Settlement Against Ambulance Company; $1.6M HIPAA Penalty Mostly Due To Inadequate Security Assessment & Oversight. However the FTC’s lack of enforcement or other meaningful action of the Health Breach Rules since its adoption has fostered both a lack of awareness and concern about compliance with its requirements regarding reporting of breaches of PHR.
FTC Health Breach Rule For PHR Breaches
The FTC Health Breach Rule applies to breaches of electronic PHR. For purposes of the Health Breach Rule, “personal health record” or “PHR” generally means an electronic record any information, collected from an individual, that:
- Is not subject to the HIPAA Breach Notification rules applicable to HIPAA Entities when a breach of electronic PHI happens;
- Is created or received by a health care provider, health plan, employer, or health care clearinghouse;
- Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual; and
- Either identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual; and
- Is managed, shared, and controlled by or primarily for the individual.
Where applicable, the Health Breach Notification Rule requires that the Health App vendors or related entities notify consumers, the FTC, and, in some cases, the media when that data in a Personal Health Record is disclosed or acquired without the consumers’ authorization. In addition, a third party service provider of such vendors or entities that experiences a breach must notify such vendors or entities of the breach, so that they can in turn notify their customers. Beyond requiring notification of breaches of Personal Health Records, the Health Breach Rule also contains specific requirements governing the timing, method, and contents of the breach notice to consumers. In general, it requires entities to provide breach notices by first class mail, or if specified as a preference by the individual, via e-mail “without unreasonable delay,” and in no case later than 60 calendar days after discovering a breach. Substitute notice, through the media or a web posting, also may be required when there is insufficient contact information for ten or more individuals.
Violations of the Health Breach Rule can be costly. The HITECH Act authorizes the FTC to seek civil penalties for violations. Companies that fail to comply with the rule could be subject to monetary penalties of up to $43,792 per violation per day.
FTC Signals Health Rule Enforcement Impending
The FTC Commission’s adoption of a Statement of the Commission on Breaches by Health Apps and Other Connected Devices (the”Statement”) at its September 15, 2021 meeting signals the FTC is preparing to begin enforcing the Health Breach Rule after taking no enforcement action in the decade since its adoption.
Responding to the explosive growth Health Apps and their use, the Statement notes that Health Apps such as wearable fitness tracking devices that collect consumers’ health information are covered by the Health Breach Notification Rule if they can draw data from multiple sources, and are not covered by the HIPAA Breach Rule. The Statement warns PHR Vendors not covered by HIPAA are responsible for protecting PHRs from unauthorized access and face civil monetary penalties of up to $43,792 per violation per day for failing to provide breach notification in accordance with the Health Breach Notification Rule when their PHRs experience a “breach of security” of PHRs on a Health App.
The Statement also urges PHR Vendors, health app developers, and others involved with the creation, provision or use of mobile devices collecting or accessing fitness or other individually identifiable health information to examine their obligation and recommends using the Developing a Mobile Health Act Tool (the “Tool”) to help determine what laws apply. For example, the Statement states a Health App would be covered under the FTC’s Health Breach Rule if it collects health information from a consumer and has the technical capacity to draw information through an API that enables synching with a consumer’s fitness tracker, but cites to cross references to the HIPAA Breach Rule in the Health Breach Rule to explain that a Health App developer is a “health care provider” subject to the HIPAA Breach Rule because it “furnish[es] health care services or supplies.”
Comments made by FTC Commissioner Lina M. Khan regarding the need for the Statement add weight to the credibility of concerns about impending enforcement. While noting the Health Breach Rule “imposes some measure of accountability on tech firms that abuse our personal information, Ms. Khan identified “the commodification of sensitive health information, where companies can use this data to feed behavioral ads or power user analytics” as an even “more fundamental problem.” She also stated “Given the growing prevalence of surveillance-based advertising, the Commission should be scrutinizing what data is being collected in the first place and whether particular types of business models create incentives that necessarily place users at risk.”
ALL HEALTH APP VENDERS & PROVIDERS SHOULD VERIFY COMPLIANCE WITH APPLICABLE BREACH REQUIREMENTS
In the face of OCR’s ongoing enforcement of HIPAA and the Statement’s signal of the FTC’s new commitment to the Health Breach Rule enforcement PHR Vendors, HIPAA Covered Entitles, and others involved with the development, provision, use or management of mobile apps or other devices that collect or access individually identifiable health information should take documented steps to evaluate their responsibilities and risks and address potential compliance exposures promptly. As PHI Vendors also could face exposure from service providers, this review should include assessment of those compliance risks and exposures. PHR Vendors also may wish to consider reviewing and strengthening contractual requirements for compliance, notification, audit and other vendor safeguarads. Given the potential of enforcement based on current or past practices or events and the likely need for candid discussion of issues and concerns associated with past and present noncompliance risks, HIPAA Covered Entities, PHR Vendors and others dealing with health apps or connected devices also should consider engaging legal counsel familiar with the various rules to help guide this evaluation within the scope of attorney-client privilege.
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.
Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; 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 actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, 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 and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, 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, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
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