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

Committee:
Medical Equipment
status:
Good progress
Published:
A new Japanese version of DiGA was approved in two stages and insurance was institutionalised. The evaluation and medical treatment system was also adopted at the initial phase, and the policy to control the barrier to entry of the start-up enterprises and to support the popularisation of the innovation was decided.

Recommendations

  • The EBC recommends continuing to propose the use of the “Selected Medical Care” system (Sentaku Ryōyō) as a second-step option within the two-step approval and reimbursement framework. The EBC also recommends highlighting functions that contribute to workstyle reform as a key discussion point in these proposals.