Congress Urges FTC Crackdown on Heatlh Apps Via Break Notice Rule

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Congress Urges FTC Crackdown on Heatlh Apps Via Break Notice Rule

Congress broke what?

In this Health IT Security article, you'll learn about:
  • On March 4, 2019, the Office of the National Coordinator for Health Information Technology (ONC) issued proposed regulations to implement the Cures Act's provisions on interoperability, patient access, and information blocking. Epic, the largest vendor of certified EHRs, launched a nationwide public campaign proposing to delay the rule. The ONC's final regulation is now due any day, with an expected effective date in January 2022. The ONC's proposed regulations take a significant, indeed crucial step forward by requiring standardized, Fast Healthcare Interoperability Resource (FHIR)-based APIs for patient and population services. With all certified EHRs including the same standardized API, interoperability, care, and coordination, a learning health system will advance substantially.

  • The Cures Act requires API access to "all data elements of a patient's electronic health record," but the ONC proposed only to require access to a limited set of data elements. Physicians' and hospitals' refusal to give patients a copy of their protected health information (PHI) because the physician or hospital does not approve the patient's health app on privacy grounds. A consumer's apps might already collect or store health information while not being regulated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The ONC's proposed regulations change none of this. The ONC lacks legal authority to change the consumer protection rules that apply to consumer-facing health.

  • The ONC does have authority to require technical upgrades to EHRs that implement consumers' right to access their health data in a usable, computable format, but not to regulate consumer apps. Congress has the authority to improve consumer privacy protections and is well aware of the problem.
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