HIPAA for Digital Health

Digital health companies — startups and established vendors building consumer and enterprise healthcare applications — face HIPAA compliance requirements that often exceed their initial assumptions. Any application that creates, receives, maintains, or transmits PHI on behalf of a HIPAA-covered entity is a Business Associate and must execute BAAs with those covered entities. Consumer-facing health apps that collect health information from users — not on behalf of a covered entity — may not be HIPAA-covered, but enterprise distribution through hospital systems requires HIPAA compliance regardless.

The ONC's 2020 interoperability rules create specific HIPAA-adjacent engineering requirements for digital health: patient access to their own health data through SMART on FHIR APIs, information blocking prohibitions that require making patient data available to authorized applications, and provider directory requirements. Digital health companies that want to distribute through hospital and payer channels must implement these requirements as part of their core architecture — not as a separate integration project at the point of enterprise sale.

We design digital health HIPAA compliance for enterprise distribution from the start. BAA structure is addressed in the architecture phase — selecting only cloud providers and third-party services with available BAAs. PHI handling in mobile applications follows secure session management patterns with automatic timeout and cryptographic session binding. SMART on FHIR implementation follows published HL7 implementation guides. ALICE validates every commit for PHI handling anti-patterns specific to mobile and web contexts.

Ready to build HIPAA compliance into your Digital Health system?

We build compliance architecture for Digital Health organizations — HIPAA and the full Digital Health compliance landscape — from the first infrastructure decision. Fixed price. Production delivery. No discovery phase.