The Health and Global Policy Institute (HGPI) has published a discussion paper titled 'Key Points for the Era of AI Diagnostic Support' in conjunction with Rare Disease Day (May 23).
This paper organizes the issues that should be discussed across the sectors of citizens/patients, government, academia, and industry to accelerate the social implementation of AI diagnostic support, including Software as a Medical Device (SaMD).
Currently, the Japanese government plans to revise the 'Medical Device Basic Plan' to its third phase in April 2027, with an interim report released in March 2026. Following an expert meeting on April 17, 2026, and individual interviews, HGPI compiled this paper from an independent standpoint.
The points are organized into the following six areas: 1. Evidence construction 2. PMDA review systems and pharmaceutical affairs regulations 3. Post-market operations 4. Fostering understanding and trust among citizens and patients 5. The 'valley' of insurance reimbursement and economic incentives 6. Data utilization infrastructure and promoting development in the rare disease field
This paper is intended to serve as a material for policy discussions.
FACT BOX
- Source: PR TIMES
- Category: Survey