Results of Call for Public Comments on Draft Guidelines and Final Guidelines compiled for Handling of Medical Information by Information Systems Providers

1. Overview

In August 2019, METI and MIC jointly inaugurated a Review 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, METI and MIC opened a call for public comments on the “Draft Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services” from March 6 (Fri.) to April 6 (Mon.), 2020, and as a result, received comments from 17 individuals and organizations.

In response, METI and MIC compiled the submitted comments and the ministries’ approaches thereto and they formulated the “Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information (first version).” They hereby publish the comments and the final guidelines. In addition, METI and MIC compiled basic stances on the guidelines into “FAQ on the Guidelines for Safety Management of Medical Information by 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 Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information, see Appendix 4.

3. List of the materials

• Appendix 1: Members of the Review Committee on Revision of the Guidelines for Safety Management of Medical Information by Information Processing Businesses Entrusted with Medical Information (in Japanese) (PDF:126KB)
• Appendix 2: List of submitted comments (in Japanese) (PDF:921KB)
• Appendix 3: Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information (in Japanese) (PDF:3,261KB)
• Appendix 3-1: Collection of References Concerning Statement of Disclosure on Satisfaction of Service Specifications and Written Service-Level Agreements (SLA) under the Guidelines (in Japanese) (PDF:865KB)
• Appendix 3-2: Concordance List between the List of Measures for Safety Management under the Former Guidelines and the New Guidelines for Safety Management of Medical Information (in Japanese) (PDF:854KB)
• Appendix 4: FAQ on Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information (in Japanese) (PDF:582KB)

4. References

• Reference 1: Call for Public Comments on “Draft Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information” (in Japanese)
• Reference 2: Summary of the Guidelines for Safety Management of Medical Information by Providers of Information Systems and Services Handling Medical Information (in Japanese) (PDF:1,398KB)

Division in Charge

• Healthcare Industries Division, Commerce and Service Industry Policy Group
• Software and Information Service Industry Strategy Office, IT Industry Division, Commerce and Information Policy Bureau