healthtech-hipaa

HIPAA compliance requires AES-256 encryption for PHI at rest and AES-GCM authenticated encryption in transit, combined with role-based access control (RBAC) using unique user IDs. Implement administrative, physical, and technical safeguards across Privacy Rule and Security Rule requirements, then audit access via 6-year retention logs.

The Privacy Rule governs PHI use, disclosure, and patient rights; the Security Rule mandates technical and administrative safeguards for electronic PHI (ePHI). Both apply to covered entities and business associates, with Security Rule specifying encryption, access controls, audit logging, and risk assessments as enforceable standards.

HIPAA requires covered entities to execute BAAs with vendors handling PHI. Use templated BAA frameworks to define responsibilities, safeguards, and breach notification obligations. Pair with breach playbooks covering risk assessment, notice timelines (60 days), notification channels, and regulatory reporting to HHS and media.

Yes. HL7 v2 and FHIR R4 interoperability standards must embed HIPAA security controls: PHI encryption, audit logging, access controls, and breach risk assessments. Conduct security audits on data mappings, transmission protocols, and stored FHIR resources to ensure Privacy Rule and Security Rule compliance.

A breach occurs when unauthorized access, use, or disclosure of PHI compromises confidentiality, integrity, or availability. Under HITECH enforcement, notify affected individuals within 60 days, report to HHS and media if 500+ individuals affected, and document the breach risk assessment and mitigation steps.

Risk analysis identifies threats and vulnerabilities to ePHI across systems, networks, and facilities. Document likelihood and impact, prioritize by severity, then implement mitigations (encryption, access controls, monitoring). Maintain records demonstrating Security Rule compliance and update analysis annually or after significant system changes.