Langate’s 2025 HIPAA checklist says any software that handles ePHI for covered entities or their business associates must meet Security/Privacy Rule safeguards. Key 2025 shifts: stronger cybersecurity (making all specs mandatory), alignment with 42 CFR Part 2, and tighter rules for reproductive-health PHI. Determine if your app involves PHI/covered entities; typical cases include EHR/EMR, telehealth, AI analytics, RPM/IoT, billing, and portals. Do annual risk, privacy, security, asset/device, and physical audits; maintain BAAs; enforce unique IDs, encryption at rest/in transit, logging/monitoring, incident response, and documented remediation; appoint trained privacy/security officers and train staff. Noncompliance risks fines up to $50k per violation (capped at $1.5M/year) and reputational harm.

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