Digital Health Task Force- Representatives Meeting 2023 December 7, 2023
Shinichi Eda, Ph.DEBC, MEDICAL EQUIPMENT & DIAGNOSTICS COMMITTEE
Medical Affairs CPSTransforming clinical decision-making

Executive Summary1）EBC Digital Health Task Force (DHTF) continued its efforts in 2023 to- share and align DH related information/actions in Subcommittees- introduce overseas DH regulations/reimbursement & raise discussions
with local authorities and industry groups for establishing proper regulation/reimbursement systems in Japan2) As concrete actions, the TF made following activities;- held TF Team meeting 10 times & exchanged the information and thoughts- supported webinar on German healthcare system held by EBC (August 24)- joined discussions for and contributed to DASH for SaMD 2- made proposals to governmental bodies e.g., MHLW, METI, & PMDA

Page 229 April 2020 | page 2 | © 2020 RocheExecutive Summary4) In 2024, the TF will continue to work on- internal information sharing and alignment of opinions & actions- holding lectures internally as well as to external stakeholders- being involved in policy discussions with authorities<Planned Actions>- make proposals in official meetings with e.g., MHLW, PMDA & METI
- hold lecture(s) on cyber security & other relevant topics
As from January 2024, Tomohiko Matsukawa, AI Medical Service Inc. , will takeover the Leader role of Digital Health Task Force

Page 329 April 2020 | page 3 | © 2020 RocheAgenda1）Scope and Team Members2）Activities in 2023
‐Taskforce Meetings‐Introduction of overseas regulations:Support to EBC Committee Webinar‐Involvement in the discussion for DASH for SaMD 2‐Involvement in the activities for making proposals to government authorities
3）Action plans for 2024

Page 429 April 2020 | page 4 | © 2020 RocheScope & Team Members
1）Scope of EBC Digital Health Task

- Collect, analyze, and introduce overseas DH regulations and reimbursement
systems to Japanese authorities and industry groups- Share and align DH related information/actions between Subcommittees- Collaborate with local industry groups such as JFMDA and AMDD

2) Team members

Leader: Shinichi Eda (Vice Chair of the Committee)
Member: Miyo Nishimuta, Rie Fukaya, Yutaka Ikeuchi(Pharmaceutical Affairs Subcommittee)
Ryoichi Tanaka, Tomohiko Matsukawa(Reimbursement Subcommittee*)
Miwa Nishida, Kohei Yaegashi (IVD Subcommittee)
Shoji Toyofuku (EBC Medical Equipment & Diagnostics Committee)（as of Dec. 2023）*; Shegeyasu Mori, of Reimbursement Subcommittee contributed till Oct. 2023

Page 529 April 2020 | page 5 | © 2020 RocheActivities in 2023:TF Mtg & Webinar１）Taskforce Meeting‐Held 10 times on monthly basis, whereInformation of sub-committees and JFMDA Working Groups shared and discussed
Policy proposals for authorities discussed２）Introduction of overseas regulations‐Support to Webinar organized by EBC Med Equipment & IVD Committee on Aug. 24
Healthcare system in Germany, e.g., Update on DiGA (Dr. Keiko Yoshida)

8/24 EBC医療機器・IVD委員会主催講演会資料より
Page 629 April 2020 | page 6 | © 2020 RocheActivities in 2023:DASH for SaMD 2３）Involvement in the discussion for DASH for SaMD 2Joined the ‘Discussion on SaMD regulation & reimbursement’ organized by PMDA,
MHLW and METI (7 rounds from Dec. 2022 ~ Apr. 2023)
Outcome of the session: DASH for SaMD 2 (issued on Sep. 6, 2023)

Page 7

EBC's advocacy was incorporated, e.g., “the concept of two-step approval &reimbursement" and "English translation of review reports, etc".
29 April 2020 | page 7 | © 2020 RocheActivities in 2023:Proposals 1/5４）Proposals to Authorities‐43rd Regular Meeting between MHLW and medical device industry (2023/1/24)‐Lecture on DiGA in a meeting with authorities (2023/3/7）

Page 829 April 2020 | page 8 | © 2020 RocheActivities in 2023:Proposals2/5４）Proposals to Authorities‐3rd SaMD WG in Chuikyo（5/16）
Proposals were made on how SaMD should be reimbursed‐ 44th Regular meetings between MHLW and medical device industry（2023/7/12）
Page 929 April 2020 | page 9 | © 2020 RocheActivities in 2023:Proposals 3/5４）Proposals to Authorities‐121st Industry Opinion Statement Session（2023/8/30）
Media Coverage*＜SaMD effective in reforming physician work style,
manufacturers call for "additional evaluation," but
Chuikyo members object, saying they do notunderstand- Chuikyo, Materials Subcommittee><On 2 step approval/reimbursement, flexible
insurance coverage rules should be considered,including the use of the uninsured combined medicalcare cost system when obtaining Stage 1 approval,
and institutional support for reducing data collection
costs for Stage 2 approval.
＊: https://gemmed.ghc-j.com/?p=56043
Page 1029 April 2020 | page 10 | © 2020 RocheActivities in 2023:Proposals

4/5４）Proposals to Authorities‐Regular opinion exchange meeting on regulations (web meeting; 9/14/2023)＜Comments from Authorities＞
・They will consult with the industry groups on the use of 2-step approval and RWD evidence.
・There are actual cases of the use of RWDs, thus, handled on an individual case basis.
・Personal information needs to be well-considered as well

‐Government-Industry Dialogue（11/13）

Request from EBC: 2-step approval & reimbursement,utilization of evaluation treatment and selected treatment,utilization of Uninsured Combination Therapy＜Comment of MHLW Minister＞
Limitations of universal health insurance and consideration of the possibility of Uninsured Combination Therapy
were mentioned.
Page 1129 April 2020 | page 11 | © 2020 RocheActivities in 2023:Proposals

5/5４）Proposals to Authorities‐125th Industry Opinion Statement Session（2023/11/29）
・2 step approval & reimbursement
Agreed to continue the discussions on the use of the uninsured combination
therapy system after obtaining Step I approval.

・ SaMDs effective in reforming physician work: did not gain sufficient understanding of theevaluation of their contribution to work hour reduction as insurance points
Page 1229 April 2020 | page 12 | © 2020 RocheAction Plans for 2024１）Involvement in policy discussion with authorities- Contribution to Regular opinion exchange meetings on regulations, Regular meeting
between MHLW & industry on reimbursement, etc.
Implementation of DASH for SaMD 2 will be key topics- Collaboration with industry associations such as the JFMDA and AMDD２）Information sharing within EBC & seminars to external stakeholders‐ Cyber Security: global harmonization & local actions‐ AI Utilization Programs and SaMD trends３）Organizational Change of Taskforce
As from January 2024, Tomohiko Matsukawa, AI Medical Service Inc. , willtake over the Leader role of Digital Health Task Force

Page 1329 April 2020 | page 13 | © 2020 RocheThank you for your kind support tothe activities of EBC in 2023

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29 April 2020 | page 14 | © 2020 Roche