Utilization of the system for combined insured and uninsured medical care and ensuring transparency

Committee:
Medical Equipment
status:
Some progress
Published:
Some progress was made on designating SaMD that failed to demonstrate sufficient utility in verification for second-stage approval as "selected medical care" (sentei ryoyo). On the other hand, there was no progress on the request to utilize the system for combined insured and uninsured medical care for specified insured medical materials.

Recommendations

  • Consider a framework for the use of AI, etc. at the patient's choice that ensures physician accountability, explanation and consent, and cost transparency.