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FTC Health Breach Notification Rule

Amended United States (Federal) · In force Sep 24, 2009 · no upcoming deadlines

Official text
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Deadlines

Takes effectJul 29, 2024 · 2.2 years ago · Source
2024 amendments effectiveAmendments clarifying health app coverage, unauthorized disclosure as breach, email notice and FTC notice timing took effect.
ComplianceFeb 22, 2010 · 16.7 years ago · Source
Full compliance with original RuleFull compliance with the 2009 Health Breach Notification Rule was required.

Summaries for reference, not legal advice. Check the official text.

What it does

Requires vendors of personal health records (including health and wellness apps) and PHR related entities not covered by HIPAA to notify affected individuals, the FTC and, for 500+ residents of a state, prominent media, after a breach of unsecured PHR identifiable health information. The 2024 amendments confirm that unauthorized disclosures (not just hacks) are breaches, clarify coverage of health apps drawing data from multiple sources, allow email notice, and expand notice content.

Who it applies to
Vendors of personal health records, PHR related entities, and their third-party service providers that are not HIPAA covered entities or business associates. Notice to individuals within 60 calendar days of discovery; FTC notice for breaches of 500+ individuals contemporaneously with individual notice; smaller breaches logged and reported annually.
Penalties
Treated as violations of an FTC trade regulation rule: civil penalties up to $53,088 per violation (FTC Act 5(m)(1)(A) amount as adjusted January 2025, 90 FR 5580; adjusted annually for inflation).
Enforced by
Federal Trade Commission
Official name
FTC Health Breach Notification Rule (16 CFR Part 318), as amended 2024
Citation
16 CFR Part 318; 74 FR 42962 (2009); amendments 89 FR 47028 (May 30, 2024)
Topics
Health data, Privacy, Breach notification
Verified 2026-09-22 ecfr.gov federalregister.gov
Research notes

Prior FTC enforcement: GoodRx ($1.5 million civil penalty, 2023) and Easy Healthcare ($100,000, 2023), cited in the 2024 rule.

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Questions about FTC Health Breach Notification Rule
What are the FTC Health Breach Notification Rule compliance deadlines?
Feb 22, 2010: Full compliance with original Rule. Jul 29, 2024: 2024 amendments effective.
When does FTC Health Breach Notification Rule take effect?
FTC Health Breach Notification Rule took effect on Sep 24, 2009.
Who does FTC Health Breach Notification Rule apply to?
Vendors of personal health records, PHR related entities, and their third-party service providers that are not HIPAA covered entities or business associates. Notice to individuals within 60 calendar days of discovery; FTC notice for breaches of 500+ individuals contemporaneously with individual notice; smaller breaches logged and reported annually.
What are the penalties under FTC Health Breach Notification Rule?
Treated as violations of an FTC trade regulation rule: civil penalties up to $53,088 per violation (FTC Act 5(m)(1)(A) amount as adjusted January 2025, 90 FR 5580; adjusted annually for inflation).