August 21, 2020 Results of Call for Public Comments on Draft Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information and Release of the Finished Guidelines

From March 6 (Fri.) to April 6 (Mon.), 2020, the Ministry of Internal Affairs and Communications (MIC) and the Ministry of Economy, Trade and Industry (METI) opened a call for wide-ranging public comments on the “Draft Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information”.
As a result of the call, the ministries received comments from 17 individuals and organizations and then compiled these submitted comments and the ministries’ approaches thereto. Accordingly, the ministries hereby publish the compiled public comments as well as the final guidelines.

1. Overview

In August 2019, MIC and METI jointly inaugurated a Committee on Revision of the Guidelines for Safety Management of Medical Information by Information Processing Businesses Entrusted with Medical Information (for members, see Appendix 1) in order to revise the “Guidelines for Safety Management of Medical Information by Cloud Service Providers (first version)” and the “Guidelines for Safety Management of Medical Information by Information Processing Businesses Entrusted with Medical Information (second version)” and to consolidate these two sets of guidelines into one. Since then, the committee has been holding discussions for these purposes.
Based on the results of the discussions by the committee and other information, MIC and METI opened a call for public comments on the “Draft Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information” from March 6 (Fri.) to April 6 (Mon.), 2020, and as a result, received comments from 17 individuals and organizations.
In response, MIC and METI compiled the submitted comments and the ministries’ approaches thereto and they formulated the “Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information (first version).” They hereby publish the comments and the final guidelines. In addition, MIC and METI compiled basic stances on the guidelines into “FAQ on the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information” for the purpose of enhancing public understanding of the guidelines. They hereby publish it as well.

2. Results of the call and other information

For the public comments submitted to MIC and METI from 17 individuals and organizations and the ministries’ approaches thereto, see Appendix 2. In addition, for the final guidelines as an outcome of revising the draft guidelines based on the submitted comments, see Appendix 3. Furthermore, for the FAQ on the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information, see Appendix 4.

3. List of the materials

  • Appendix 1: Members of the Study Group on Revision of the Guidelines for Safety Management of Medical Information by Information Processing Businesses Entrusted with Medical Information
  • Appendix 2: List of submitted comments
  • Appendix 3: Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information
    • Appendix 3-1: Collection of References Concerning Statement of Disclosure on Satisfaction of Service Specifications and Written Service-Level Agreements (SLA) under the Guidelines
    • Appendix 3-2: Concordance List between the List of Measures for Safety Management under the Former Guidelines and the Security Guidelines for Medical Information Systems by Ministry of Health, Labour and Welfare
  • Appendix 4: FAQ on Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information

4. References

  • Reference 1: Call for Public Comments on “Draft Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information”
  • Reference 2: Summary of the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information
  • *
    The published material is in Japanese only.

Contact

For further information about this press release, please fill in the inquiry form and submit it to MIC on the website
https://www.soumu.go.jp/common/english_opinions.html

International Policy Division, Global Strategy Bureau, MIC

TEL: +81 3 5253 5920

FAX: +81 3 5253 5924