Clinical AIACADEMY
The learning path

MODULE 6 / 8

AI Governance, Regulation & Institutional Policy

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Section 1 of 10

In this module

Topics to explore:

  • Define Software as a Medical Device (SaMD) and explain when an AI tool qualifies as one
  • Describe the FDA's key regulatory pathways for AI/ML-based SaMD and the significance of Predetermined Change Control Plans
  • Explain the EU AI Act's risk-based framework and how it interacts with the EU MDR for healthcare AI
  • Describe the role and responsibilities of a hospital AI governance committee
  • Identify the essential elements of a robust institutional AI policy
  • Articulate a clinician's responsibilities within the broader regulatory and governance ecosystem

Slide 1 – Why Regulation and Governance Matter to You

You may not think of yourself as a regulator. But AI governance is not just a job for lawyers and compliance officers.

Every time you use, recommend, or raise a concern about an AI tool, you are participating in governance.

Understanding the regulatory landscape helps you:

  • Ask the right questions when a new AI tool is proposed
  • Know when to raise a concern and to whom
  • Protect patients and protect yourself