Scope of application of programmes for medical devices including artificial intelligence and insurance coverage

Committee:
Medical Equipment
status:
Good progress
Published:
The previous revision clarified the direction of Insurance listing of the programme medical equipment, but the market-entry of products with no established clinical significance and the difficulty of Insurance listing continued. For this reason, we proposed a new Japanese version of DiGA with a two-stage approval and Insurance system, which is expected to be institutionalized in the next revision.

Recommendations

  • The first phase of the two-stage approval and Insurance system was introduced as the evaluation and medical treatment system, and a selection medical treatment system was proposed as the second stage option. In addition, the function that leads to the work style reform is also a point to be discussed and recommendation.