Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Medical Insurance Evaluation of Software as a Medical Device
Kazuhisa KOIKETakayuki UEKINobuhiko HORIOKA
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2022 Volume 12 Issue 3 Pages 301-306

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Abstract

Software as medical devices (SaMDs) are used in the current medical field. It is recognized as indispensable for the continuation of medical care. In 2020, SaMD that the patient directly operates to support treatment was put into practical use. It is expected that more and more SaMDs will be used in the medical field in the future. In the FY 2022 Medical fee revision, the ideal way of evaluating medical insurance for SaMDs was discussed. It is expected that not only medical device marketing approval holders but also pharmaceutical companies and start-ups will develop SaMDs. We hope that the developers of SaMDs will be able to think about insurance strategy for the products under development. This paper outlines the discussion on SaMDs in the FY 2022 Medical fee revision.

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© 2022 Society for Regulatory Science of Medical Products
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