Health Breach Notification Rule
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FTC Proposes Health Breach Notification Rule Amendments

At a recent open Commission meeting, the Federal Trade Commission (FTC) voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment aims to codify the HBNR’s application to digital health and mobile technologies. However, several aspects of the proposed amendment lack clarity and are likely to cause confusion unless further clarified through the ongoing rulemaking process.

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FTC Issues Policy Statement Expanding Interpretation of Health Breach Notification Rule’s Scope

On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach Notification Rule, 16 CFR Part 318 (the Rule). According to the policy statement, the Rule applies to health apps and connected devices that are not subject to the Health Insurance Portability and Accountability Act (HIPAA) but are capable of drawing information from multiple sources—for example, through a combination of consumer inputs and application programming interfaces (APIs).

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Protecting the Telehealth Consumer: FTC and State-Based Considerations

Telemedicine in the United States is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers instituted during the COVID-19 pandemic are likely to expire soon. As lawmakers and agency officials consider updated or expanded digital health rules, regulators are expected to intensify their scrutiny of providers.

In this webinar, McDermott partners Jiayan Chen and Brian J. Boyle explore consumer protections for telehealth consumers, including the following:

  • Privacy considerations beyond the Health Insurance Portability and Accountability Act of 1996, including Federal Trade Commission requirements;
  • How to prepare for the Health Breach Notification Rule;
  • The ins and outs of advertising telehealth, including claims, endorsements and social media;
  • Strategies for engaging with users in the digital environment; and
  • Increased fraud enforcement.

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