AI in Healthcare

Your AI diagnostics, treatment recommendations, and clinical decision support face FDA review, HIPAA obligations, and patient consent requirements.

The pain

Healthcare AI is regulated at the intersection of medical device law, data privacy, and clinical ethics. Getting it wrong means product seizure, criminal liability, and patient harm.

FDA SaMD HIPAA + AI GDPR Art. 22

Laws that likely apply to you

  • FDA AI/ML SaMD Guidance — premarket review, predetermined change control plans, post-market monitoring
  • HIPAA + AI — BAAs for AI vendors processing PHI, de-identification of training data
  • GDPR Art. 22 — right to human review of AI decisions affecting EU patients
  • California SB 942 — AI voice cloning disclosure in patient communications

What we do

We help healthcare AI companies build compliance programs that satisfy FDA, HHS, and state regulators — from pre-market documentation to post-market monitoring. If PHI is flowing into a third-party AI system with no controls, that's often an architectural fix, not just a policy one — see Temper Enclave.

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Informational only — not legal advice. Consult qualified counsel for binding guidance.