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.

An Algorithm engagement around HIPAA for Digital Health is a fixed-price commitment against named milestones. We do not bill discovery phases separately; we do not staff against a body-count target; we do not deliver assessment documents in place of working systems. The deliverable is a Digital Health-deployed system that satisfies HIPAA from the first commit, with the documentation regulators actually consume.

The cross-cutting findings we see when Digital Health clients engage us to remediate a prior vendor's HIPAA implementation: missing audit-trail records for the operations regulators specifically examine; access-control logic that authenticates correctly but authorizes against the wrong scope; encryption configured to meet the HIPAA label but not the specific cipher-suite or key-management requirements HIPAA actually mandates; incident-response runbooks documented but never exercised; and compliance evidence assembled retroactively rather than generated continuously.

Each of these is a remediation pattern we have shipped multiple times under HIPAA in Digital Health. Our engagements deliver systems where these findings do not arise — because the underlying architecture decisions are made correctly the first time, and HIPAA compliance is enforced mechanically through the deployment pipeline rather than relied on through developer discipline.

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.