The "Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field" ("Next Generation Medical Infrastructure Act" or "Act") was enacted in Japan on April 28, 2017, and was promulgated on May 12, 2017. The Act establishes a system that certifies business operators that can properly and reliably anonymize medical data as certified medical data anonymization agencies ("certified agencies"), in order to promote advanced R&D and new business development relating to health and medical care through secure and proper use of anonymized medical data. For medical institutions, it will become possible to provide medical data to certified agencies if the medical institutions notify their patients in advance and their patients do not reject the provision of that medical data. This Act will come into force within one year from the date of promulgation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.