Digital Health Task Force- Representative Meeting 2022 December 8, 2022
Shinichi Eda, Ph.DEBC, MEDICAL EQUIPMENT & DIAGNOSTICS COMMITTEE
Medical Affairs CPSTransforming clinical decision-making

Executive Summary1）Digital Health (DH) Task Force (TF) established in July 2021 continued andexpanded its efforts in 2022, aiming to- share and align DH related information/actions in Subcommittees- introduce overseas DH regulations and reimbursement systems toJapanese authorities and industry groups2) In 2022, the TF made following activities;- held TF Team meeting 10 times & exchanged the information and thoughts- held Webinar on DiGA, innovative reimbursement system for SaMD inGermany; 145 participants with positive feedback- made proposals to government bodies e.g., MHLW & METI
Page 229 April 2020 | page 2 | © 2020 RocheExecutive Summary4) In 2023, 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 discussion with authorities<Planned Actions>
To external stakeholders- make proposals in official meetings with e.g., MHLW and METI
- follow-up webinar of DiGA; 2nd half of 2023
To EBC internal members- hold educational lecture for EBC members

Page 329 April 2020 | page 3 | © 2020 RocheAgenda1）Scope2）Activities in 2022
‐Taskforce Meetings‐Introduction of overseas regulations:DiGA Webinar‐Involvement in the activities for making proposals to government
authorities
3）Action plans for 2023

Page 429 April 2020 | page 4 | © 2020 RocheScope1）Scope of EBC Digital Health Task Force (DHTF)‐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

Page 529 April 2020 | page 5 | © 2020 RocheActivities in 2022１）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 situation‐DiGA webinar held on November 7th （2nd webinar following 2021）
Details shown in the following slides３）Involved in policy discussion‐2 step approval process based on DiGA was proposed at Public-Private Discussion
held by MHLW on November 28 (see below)

Page 629 April 2020 | page 6 | © 2020 Roche
第3回革新的医療機器創出のための官民対話（2022/11/28）資料より抜粋

⌚ 2022年11月 7日（月）17:00 ～ 18:30

German DiGA Process – Update 2022ー ドイツにおけるプログラム医療機器に関する保険償還 Update 2022 ー

本日の内容:

講師:

1.

EBCからご挨拶

Dr. Philipp Kircher

2.

DiGAに関する講演（日本語通訳付き）

DiGA創設において、連邦保健省に助言を行った3.

Q＆A（日本語通訳付き）

ThinkTank HIH（Health Innovation Hub;現在は解体）のﾒﾝﾊﾞｰ。弁護士としてDiGAのケースに関わっている。

DiGA Webinar held on November 7, 2022
29 April 2020 | page 7 | © 2020 RocheSummary of DiGA Webinar -11) Contents- Greetings by Mr. Mori/Chair of EBC MD&IVD Committee- Lecture by Philipp Kircher- Q&A: 8 inquiries were discussed in webinar, 2 questions answered later
Webinar is video recorded, Slides shared2) Participants- 145 (ca. 140 till the end)
Up from 110 in 2021
- 59 responded post webinar questionnaire- 72% of respondents rated the webinar useful ~ quite usefulPage 829 April 2020 | page 8 | © 2020 RocheSummary of DiGA Webinar -２３）Overview & Remarks- Positive & negative aspects of DiGA were presented, based on the actual
cases after law enforcement in 2020＋:many cases (153 up to end Oct. 2022) applied due to the benefitsof the process
speedy introduction of SaMD with temporary reimbursement
defined by manufacturers
clinical usefulness verified with RWD during temporary approval period
ー:many cases (84 cases) withdrawn due to insufficient preparation
significant reduction of reimbursement after final approval- Feedback of participants

2 step approval process would be applicable to Japanese systemtemporary reimbursement point by manufacturers might not fit to Japan
Page 929 April 2020 | page 9 | © 2020 RocheAction plan for 2023
１）Involvement in the policy discussion with authorities- Contribution to regular meeting/discussion with MHLW
- Involvement in the working group organized by METI
２）Hold seminars＜to external stake holders＞‐ Follow-up webinar on DiGA:latter half of 2023
‐ Seminar by local experts
・Development of SaMD
・Personal information protection law and PHR＜internal seminar within EBC＞
‐ to be planned
Page 1029 April 2020 | page 10 | © 2020 RocheThank you for your kind support tothe activities of EBC in 2022

11Page 1129 April 2020 | page 11 | © 2020 Roche