Agency wants to expand PHR breach reporting requirements to include entities not covered by HIPAA
The Federal Trade Commission (FTC) is asking for public input on changes it’s proposing to the Health Breach Notification Rule (HBNR) that include clarifying how the rule applies to health apps and similar technologies.
The rule requires vendors of personal health records (PHR) and related entities that are not covered by the Health Insurance Portability and Accountability Act (HIPAA) to notify individuals, the FTC, and, in some cases, the media of a breach of unsecured personally identifiable health data. It also requires third-party service providers to PHR vendors and PHR-related entities to notify such vendors and PHR-related entities when a breach is discovered.
The proposed changes come as business practices and technological developments increase both the amount of health data collected from consumers, and the incentive for companies to use or disclose that sensitive data for marketing and other purposes, Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a news release.
“We are witnessing an explosion of health apps and connected devices, many of which aren’t covered by HIPAA, collecting vast amounts of sensitive consumer health information,” Levine said. “When this information is breached, it is more vital than ever that mobile health app developers and others covered by the Health Breach Notification Rule provide consumers and the FTC with timely notice about what happened.”
On May 17, 2023 the FTC announced a proposed order settling allegations that the fertility app Premom violated the HBNR. In February 2023, the agency announced its first enforcement action under the HBNR against telehealth and prescription drug discount provider GoodRx Holdings Inc. It said GoodRx and Premom had each violated the rule by not notifying users about their unauthorized disclosure of users’ personally identifiable health information to third parties.
The proposed changes to the HBNR include:
The public has 60 days from May 18, the date the notice was published in the Federal Register, to submit comments on the proposed changes to the rule. Information on how to submit a comment can be found in the notice. Once processed, the comments will be posted to Regulations.gov.