If your AI systems touch protected health information, make clinical decisions, or feed diagnostic models, you're governed by more than HIPAA alone. HITECH breach reporting, FDA SaMD classification, and ONC decision-support interoperability all overlap. This page lists what actually binds, sourced directly from Praxient's regulatory library.
HIPAA's Privacy Rule, Security Rule, and Breach Notification Rule predate the modern AI stack by a decade — they cover traditional data flows but say nothing about model training pipelines, inference-time PHI exposure, or the audit trail obligations that come with using AI in clinical decision-making. That gap is where regulated risk now lives.
The provisions below are drawn from Praxient's seeded regulatory library (HIPAA Privacy Rule, HIPAA Security Rule, HITECH breach-notification, FDA's Software-as-a-Medical-Device guidance, and ONC decision-support criteria). They are not a substitute for legal advice — they are a curated snapshot of the obligations a healthcare AI governance program has to address, rendered inline so you can see what binds before deciding whether to book the $500 strategy session.
In one focused $500 session, we will map your highest-risk AI workflows to the obligations that apply and identify the most practical next steps.
Sourced live from Praxient's seeded library of active regulations and provisions, scoped to the healthcare vertical.
The free scorecard tags your readiness by category. The $500 strategy session walks through which of these provisions apply to the AI you already have in production.