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Dr. Ram KumarDiabetes & metabolic health

Medical AI · Track 9 of 10

Regulation, ethics & governance

How clinical AI is regulated and governed around the world: software as a medical device, the US, EU, UK and India, WHO guidance, liability and consent.

No code. Regulatory facts carry an 'as of' date and are re-checked at each review.

By the end of this track you should be able to

  • Decide whether a piece of software is likely to be a medical device
  • Compare the US, EU, UK and Indian approaches to AI in medical devices
  • Apply WHO ethics guidance to a real deployment decision
  • Identify liability and consent questions before a tool reaches patients

Lessons

  1. Software as a Medical Device (SaMD)

    Coming soon

  2. US FDA: AI-enabled devices and change-control plans

    Coming soon

  3. The EU AI Act and medical devices

    Coming soon

  4. UK MHRA: AI as a medical device

    Coming soon

  5. India: CDSCO and medical-device software

    Coming soon

  6. WHO guidance on AI ethics and large multimodal models

    Coming soon

  7. Liability and consent

    Coming soon

Lessons in this track are being written and reviewed. In the meantime, start with the Foundations track.

Next track: Applied case studies: diabetes & metabolic health

Educational content only. This material teaches methods; it is not clinical advice. Code, models and examples here are not validated medical devices and must not be used to make decisions about real patients without proper clinical validation, governance and any required regulatory approval. Examples use synthetic or openly licensed de-identified data only. Never paste identifiable patient information into public AI tools. Mentions of models, tools or vendors are for identification, not endorsement.