Lines of Thought / Topic

Medical devices: the line so far

6 developments and 19 rules, in date order. Built automatically from everything tagged with this topic.

  1. Rule · In forceIN
    ICMR AI health ethics guidelines
  2. Rule · ProposedID
    Draft AI Perpres
  3. Rule · In forceUS-UT
    Utah AI Policy Act
  4. Rule · SupersededUS-CO
    Colorado AI Act (SB 24-205)

    Also on Washington vs the states on AI rules, Can an algorithm deny your care?, Who audits the hiring algorithm?

  5. Rule · Partly in forceEU
    EU AI Act

    Also on Project Meridian and the race to govern military AI, Transparency, not licensing, Who decides if a medical AI is safe?

  6. Rule · In forceUS
    FDA PCCP guidance

    Also on Who decides if a medical AI is safe?

  7. Rule · In forceUS-UT
    Utah mental-health chatbot law
  8. Rule · In forceKE
    Kenya National AI Strategy
  9. Rule · In forceUS-TX
    TRAIGA
  10. Rule · In forceUS-IL
    Illinois AI therapy ban (WOPR Act)
  11. Rule · Partly in forceUS-CA
    CCPA ADMT regulations

    Also on Can an algorithm deny your care?, Who audits the hiring algorithm?

  12. Rule · In forceIT
    Italian AI Law
  13. Rule · In forceUS-CA
    SB 243

    Also on Children, companions and deepfakes

  14. Rule · In forceUS-NY
    NY AI companion law
  15. Rule changeHealthUS
    FDA loosens oversight of AI decision-support software and health wearables

    More AI tools used by clinicians and consumers can reach market without FDA clearance, shifting safety assurance to developers and health systems.

    Also on Who decides if a medical AI is safe?

  16. ResearchHealthSE
    MASAI trial: AI-supported mammography screening cuts interval cancers by 12%

    It is the first randomised evidence that AI in population screening improves a hard clinical outcome, strengthening the case for national programmes to adopt it.

  17. Rule · ProposedKE
    Kenya AI Bill
  18. PolicyHealthGB
    NHS England updates AI scribe guidance and launches supplier registry

    It turns AI scribes from local experiments into a regulated NHS product category with a minimum compliance bar for suppliers.

    Also on Who decides if a medical AI is safe?

  19. Rule changeHealthEU
    EU deal keeps AI medical devices under AI Act high-risk rules, delayed to 2028

    Medtech makers selling AI devices in Europe must plan for dual MDR and AI Act conformity, with one extra year to prepare.

    Also on Who decides if a medical AI is safe?

  20. Rule · Enacted, not yet in forceUS-CO
    SB 26-189 (Colorado ADMT law)
  21. Rule · In consultationEU
    High-risk classification guidelines (draft)
  22. Rule · In forceEU
    Digital Omnibus on AI
  23. PolicyHealthUS
    FDA proposes a risk framework for generative AI medical devices

    It is the first concrete sign of how FDA might clear LLM-based clinical tools, and comments will shape whether chatbots and scribes need premarket review.

    Also on Who decides if a medical AI is safe?

  24. Rule · Enacted, not yet in forceUS-CA
    SB 1119 / Adam's Law
  25. PolicyHealthGB
    UK accepts all 44 recommendations of doctor-led commission on regulating health AI

    Medical-AI makers selling in the UK should expect ongoing monitoring duties after approval, not a one-off clearance, bringing the UK closer to the FDA's lifecycle approach.