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日英におけるデジタルヘルス法規制とビジネス創出 / UK-Japan Digital Health Regulatory Framework and Support for Innovation
English follows Japanese

オンライン診療やデジタル治療アプリ等、日本を含め、世界各国で医療・ヘルスケア市場でのデジタル技術の活用が始まっていますが、従来とは異なる評価方法が必要になる等、共通の課題もあります。英国では政府、NHSと企業が連携してデジタルヘルスの開発の指標、NICEによるevidence standards framework for digital health technologiesが2021年に改定されました。日英の現状について情報交換し、デジタルヘルスの開発を進める上での課題と今後の展望、日英連携での課題解決を模索します。

17:00 ご挨拶
英国大使館 貿易担当 参事官

17:05 講演1:デジタルヘルスのクラス分類とエビデンス要件
Ms Jeanette Kusel, Director for Scientific Advice
NICE (National Institute for Health and Clinical Excellence)

17:20 講演2:デジタルヘルスの保険適用について(仮題)
Dr Indra Joshi, Director of AI, NHSX

17:35 講演3:プログラム医療機器実用化促進パッケージ戦略 DASH for SaMD
医薬・生活衛生局 医療機器審査管理課
福田 悠平様

17:50 パネルディスカッション

株式会社デジタルガレージ DG Lab
深谷 李映

18:20 質疑応答

18:30 閉会

Digital health development is taking place in an increasing pace and it can be an answer to many of the challenges in global healthcare. Regulatory framework also needs to evolve to accommodate the new technology development for smooth adaptation of new innovations both in the UK and in Japan. In this webinar, we invite NICE, NHSX from the UK and MHLW from Japan to discuss opportunities and challenges we face in the digital health.

9:00 GMT Opening Remarks
Marie-Claire Joyce, Counsellor, Head of Trade
British Embassy Tokyo

9:05 Digital health technology classification and evidence requirements
Ms Jeanette Kusel, Director for Scientific Advice
NICE (National Institute for Health and Clinical Excellence)

9:20 Foreseeability of reimbursement (applicability, price) (tentative)
Dr Indra Joshi, Director of AI, NHSX

9:35 DX Action Strategies in Healthcare for SaMD (DASH for SaMD)
Mr Yuhei FUKUTA, Deputy Director, Office of Software as a Medical Device Evaluation, Medical Device Evaluation Division,
Pharmaceutical Safety and Environmental Health Bureau
Ministry of Health Labour and Welfare

9:50 Panel Discussion
Ms Rie FUKAYA, Head, Global Clinical Regulatory Strategy, DG Lab, Digital Garage, Inc.

10:20 Q&A

10:30 Closing

Oct 6, 2021 05:00 PM in Osaka, Sapporo, Tokyo

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