Ministry of Economy, Trade and Industry
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Guidelines for Developing Health Software Formulated -For operating voluntary rules in collaboration with industry-

The Ministry of Economy, Trade and Industry (METI) compiled basic assumptions developers of health software for controlling and maintaining personal health should keep in mind when developing such software so as to provide users with increased security and safety, and formulated them into software development guidelines.

METI expects the industries related to such software will be further revitalized through the formulation and operation of specific standards based on the guidelines on a voluntary basis.

1. Background of formulating the guidelines

In November 2013, the Act for Partial Revision of the Pharmaceutical Affairs Law was promulgated (Act No. 84 of 2013; scheduled to be enforced in November 2014). Under the Act, independent computer programs (medical software) for diagnoses and other purposes will be regulated as medical equipment stipulated in the Pharmaceutical Affairs Law, the name of which will be revised to the Act for Securing Quality, Effectiveness and Safety of Medical Products and Equipment, or the Medical Products and Equipment Act (tentative English translation) after the enforcement.

To address the revision, in FY2012, METI created a Study Group for Medical Software, and held meetings to discuss ideal health software that the industry should develop based on considerations of the possible risks that users may bear when using such software.

Based on this background, METI established a Working Group for Discussing Issues in the Field of Medical Software as one of the efforts under the FY2013 METI budget project. The working group compiled the basic ideas upon which manufacturers should develop such software so as to provide users with increased security and safety into the software development guidelines. For details of the project, visit the following website:
URL: http://www.meti.go.jp/policy/mono_info_service/healthcare/report_iryou_fukushi.html (in Japanese)

Release Date

July 24, 2014

Division in Charge

Medical and Assistive Device Industries Office, Commerce and Information Policy Bureau

Ministry of Economy, Trade and Industry
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901, Japan Tel: +81-(0)3-3501-1511
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