Writing in the February 2023 edition of DIA’s Global Forum magazine, Yumi Wakabayashi of Janssen, Takahiro Horimatsu from the Institute for Advancement of Clinical and Translational Science at Kyoto University, Hiroshi Asai of Astellas, Yasuhiro Himeno from the Government of Japan’s Cabinet Office, and Hiroyuki Taruno of the Cancer Institute Hospital at the Japanese Foundation for Cancer Research take a look at the progress made since the publication of Japan’s Next-Generation Medical Infrastructure Law in 2017.
The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (commonly known as the “Next-Generation Medical Infrastructure Law” [hereafter, NGMIL]) is a law enacted in May 2017 in Japan. Its purpose is to achieve both protection of personal information and promotion of the use of medical information/data, aiming to develop economic society and improve public health. It came into force in May 2018. But progress has been slow, and more cooperation is needed among different stakeholders to implement it in full. The NGMIL Supplementary Rules state: “At the time when 5 years have passed after the enforcement of the Act, the implementation status shall be examined, and measures shall be taken as necessary.” A working group for this purpose has already been established and started, and 2023 is the opportune time to discuss NGMIL.