|A corollary to HIPAA-regulations may get a rewrite to better regulate entities outside HHS’ jurisdiction that hold and use health information.|
As part of its regular review of its regulations, the Federal Trade Commission (FTC) has asked for input on its Health Breach Notification Rule (HBN Rule) that promulgated in 2010 per direction in the “American Recovery and Reinvestment Act” (ARRA) (P.L. 111-5). When enacted, Congress expected this regulation to be temporary as policymakers thought a national breach notification statute would shortly be enacted that would make the FTC’s regulations superfluous, but that has obviously not happened. And, hence the FTC continues to have regulations governing breach notification and security of some health information for entities not subject to the “Health Insurance Portability and Accountability Act” (HIPAA)/“Health Information Technology for Economic and Clinical Health Act” (HITECH Act) regulations, which are generally healthcare providers and their business associates. Incidentally, it is possible the FTC’s HBN Rule would govern breaches arising from breaches of vendors involved with COVID-19 contact tracing. In any event, the FTC wants comments by 20 August.
As explained in the current regulation, the HBN Rule “applies to foreign and domestic vendors of personal health records (PHR), PHR related entities, and third party service providers, irrespective of any jurisdictional tests in the Federal Trade Commission (FTC) Act, that maintain information of U.S. citizens or residents.” This rule, however, “does not apply to HIPAA-covered entities, or to any other entity to the extent that it engages in activities as a business associate of a HIPAA-covered entity.”
And yet, the FTC conceded it “has not had occasion to enforce its Rule because, as the PHR market has developed over the past decade, most PHR vendors, related entities, and service providers have been HIPAA-covered entities or “business associates” subject to the Department of Health and Human Services’ (HHS) rule.” The FTC foresees utility and need for the HBN Rule “as consumers turn towards direct-to-consumer technologies for health information and services (such as mobile health applications, virtual assistants, and platforms’ health tools), more companies may be covered by the FTC’s Rule.” Accordingly, the FTC “now requests comment on the HBN Rule, including the costs and benefits of the Rule, and whether particular sections should be retained, eliminated, or modified.”
In terms of how the HBN Rule functions, the FTC explained:
- The Recovery Act directed the FTC to issue a rule requiring these entities, and their third-party service providers, to provide notification of any breach of unsecured individually identifiable health information.
- Accordingly, the HBN Rule requires vendors of PHRs and PHR related entities to provide: (1) Notice to consumers whose unsecured individually identifiable health information has been breached; (2) notice to the media, in many cases; and (3) notice to the Commission.
- The Rule also requires third party service providers (i.e., those companies that provide services such as billing or data storage) to vendors of PHRs and PHR related entities to provide notification to such vendors and entities following the discovery of a breach.
- The Rule requires notice “without unreasonable delay and in no case later than 60 calendar days” after discovery of a data breach. If the breach affects 500 or more individuals, notice to the FTC must be provided “as soon as possible and in no case later than ten business days” after discovery of the breach. The FTC makes available a standard form for companies to use to notify the Commission of a breach. The FTC posts a list of breaches involving 500 or more individuals on its website. This list only includes two breaches, because the Commission has predominantly received notices about breaches affecting fewer than 500 individuals.
Moreover, per the current regulations, the FTC may treat breaches as violations of regulation on unfair or deceptive practices, permitting the FTC to seek and possibly levy civil fines of up to $43,000 per violation.
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