US Regulatory Considerations Applicable to Digital Health Providers and Suppliers – Part II: HIPAA (Continued) & Additional Important Privacy Considerations

Lexology October 18, 2021
K&L Gates LLP

Primary Regulatory Regimes Relevant to mHealth

In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application developers, as well as examine additional privacy issues and considerations that non-US companies should keep in mind.

HIPAA (Continued): Application of HIPAA to mHealth application developers

General

If a Covered Entity is the developer of a mobile application (“app”) and the app uses Protected Health Information (PHI), HIPAA will apply and will govern the creation, receipt, maintenance and transmission of PHI by the app (unless the PHI was acquired pursuant to a HIPAA-compliant patient authorization specifically releasing the data...

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