Evaluation on SaMD, considering healthcare professionals’ work-style reform, was suggested in the Japanese Regulatory Reform Promotion Council's report.
Source : "プログラム機器「働き方改革の視点」踏まえた評価を 規制改革推進会議が答申" issued on ME Journal June 07th.
In a report on the promotion of regulatory reform compiled by the Japanese government's Council for Promotion of Regulatory Reform on June 1, the policy got included that the government will "clarify the concept of evaluation for securing and improving the quality of medical care provided to patients, suggesting to reform healthcare professionals’ work-style " about the evaluation of SaMD (Software as a Medical Device) such as AI (Artificial Intelligence) in payment for medical services.
About subjects for medical devices, the report clearly states that the government should "facilitate the sale of used medical devices," "promote the reprocessing of Single-Use Device (SUD)," and "organize the system for the digital health market, including SaMD.”
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