FTC Policy Statement: Mobile Health Apps Must Comply with Health Breach Notification Rule

Lexology January 20, 2022
Squire Patton Boggs

The FTC’s recent policy statement on the Health Breach Notification Rule (the “Rule”) substantially impacts the consumer-facing digital health industry by significantly expanding (a) the scope of entities subject to the Rule and (b) data practices that constitute a breach. Under the new guidance, any entity that collects health data from both a connected device and the consumer (excluding entities already subject to HIPAA) will be treated as a “vendor of Personal Health Records” (“PHR Vendor”) subject to the Rule. Moreover, PHR Vendors that share such information without the individual’s authorization will trigger the Rule’s breach notification requirements.

PHR Vendors Include Health Apps, Too

The Rule applies to PHR Vendors, PHR related entities, and their third party service providers that...

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