Press Release: HGPI Publishes 'Key Points for the Era of AI Diagnostic Support'
On May 23, designated as Rare Disease Day, the Health and Global Policy Institute (HGPI) released a discussion paper outlining key points for the social implementation of AI diagnostic support.
📋 Article Processing Timeline
- 📰 Published: May 26, 2026 at 03:00
- 🔍 Collected: May 25, 2026 at 18:31
- 🤖 AI Analyzed: May 25, 2026 at 18:39 (7 min after Collected)
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.
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.
FAQ
日本医療政策機構（HGPI）が「AIによる診断支援時代を見据えた論点」を公表した目的は何ですか？
SaMDをはじめとするAI診断支援の社会実装を加速させるため、市民・患者、行政、アカデミア、産業界の各セクターで議論されるべき論点を整理し、政策議論の場での素材として活用されることを目的としています。
本ペーパーで提示された6つの主要な論点領域は何ですか？
1. エビデンス構築、2. PMDA審査体制・薬事制度、3. 市販後運用、4. 市民・患者の理解と信頼の醸成、5. 保険償還と経済的インセンティブ、6. データ活用基盤と希少疾患領域での開発促進、の6点です。
AI診断支援ツールは医療の質向上にどう寄与すると整理されていますか？
「日常業務の効率化（医療従事者の負担軽減や診療効率向上）」と、「専門性の補完（プライマリケア段階での希少疾患の検出など）」の二つの方向性で医療の質向上に寄与すると位置づけています。
この論点抽出ペーパーはどのようなプロセスで作成されましたか？
厚生労働省から2026年3月に発表された中間とりまとめを受け、2026年4月17日に開催したチャタムハウスルールのもとでの専門家会合の議論、およびアドバイザリーボードメンバーへの個別ヒアリングを踏まえて作成されました。
本ペーパーが特に難病の日（5月23日）に合わせて公表された理由は？
AI診断支援が、特に難病・希少疾患領域での活用が期待されており、難病対策の重要性を考慮して同日に合わせて公表されました。