Healthcare software operates under some of the most demanding regulatory requirements in any industry. Key frameworks include:
- HIPAA Security Rule: Requires technical safeguards to protect ePHI. HHS proposed significant rule updates in December 2024, with finalization expected in 2026.
- HITECH Act: Extends HIPAA requirements and strengthens breach notification and enforcement.
- FDA / SaMD guidance: Software that qualifies as a medical device is subject to FDA oversight under 21 CFR Part 11 and related guidance.
- SOC 2: Commonly required of healthcare SaaS companies that process patient or clinical data on behalf of covered entities.
- State-level requirements: California, Washington, and other states have enacted health data privacy laws that may apply alongside federal requirements.
A code audit tailored to healthcare maps your software against the specific controls each applicable framework requires.
Reference
Summary of the HIPAA Security Rule – HHS.gov – hhs.gov