July 7, 2023 Results of Solicitation for Opinions on Draft Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 1.1 and publication of the Said Guidelines

The Ministry of Internal Affairs and Communications (MIC) and the Ministry of Economy, Trade and Industry (METI) solicited a wide range of opinions from Wednesday, April 19 through Thursday, May 18, 2023, on a draft of the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 1.1 and received 15 opinions.
Both ministries have now compiled their views on the submitted opinions and decided to release them alongside the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 1.1, which reflects these opinions.

1. Overview

The Ministry of Internal Affairs and Communications (MIC) and the Ministry of Economy, Trade and Industry (METI) considered the diversification and sophistication of cyberattacks in recent years, and the Guidelines for the Safety Management of Medical Information Systems Ver. 6.0 (issued by the Ministry of Health, Labor and Welfare (MHLW) in May 2023). MIC and METI then decided to review the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information (issued by MIC and METI in August 2020). To this end, the Expert Committee for Revision of Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information has been organized.
Based on the Expert Committee’s deliberations, both ministries drafted the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 1.1. Then, they solicited opinions on the draft from Wednesday, April 19 through Thursday, May 18, 2023. As a result, 15 comments were received.
Both ministries have compiled their views on the submitted opinions, and based on these views, they have finalized the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 1.1, which incorporates the feedback received. In addition, the Correspondence Table between the List of Countermeasures in the Pre-Integration Guidelines and the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information Ver. 6.0 and the Safety Management Guidelines for Providers of Information Systems and Services Handling Medical Information FAQ have also been revised and published.

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  The published materials are in Japanese only.