Vertical Compliance Dossier
Healthcare, MedTech & Medical Devices (SaMD)
Governing regimes: FDA SaMD Guidance, EU MDR (2017/745), EU AI Act (Article 6 / Annex I), HIPAA Privacy Rule
Sector Risk Profile
Critical Safety & High Regulatory Risk
High Consequential Area
Primary Regulatory Regimes
Statutory Frameworks
FDA SaMD Guidance, EU MDR (2017/745), EU AI Act (Article 6 / Annex I), HIPAA Privacy Rule
Sector Penalty Exposure
Up to €15,000,000 + $50k/HIPAA violation + Medical Malpractice Damages
Includes federal agency civil penalties, state fines, and class actions.
Enforceable Regulations
3 Core Directives
Cross-jurisdictional compliance required for commercial deployments.
Codified Enactments & Directives
- • FDA Premarket Notification 510(k)
- • EU Medical Device Regulation (MDR 2017/745)
- • HIPAA Security Rule (45 CFR Part 160/164)
Sector AI Governance Checklist
Essential compliance milestones required before placing AI solutions into production in this sector:
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