RECORDED WEBINAR: UK-Japan Digital Health Regulatory Framework Webinar 2021

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, DIT Japan invites 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
Moderator:
Ms Rie FUKAYA, Head, Global Clinical Regulatory Strategy, DG Lab, Digital Garage, Inc.

10:20 Q&A

10:30 Closing


Mr Yuhei Fukuta’s presentation can be accessed here.