Over the last 3 years, many AI healthcare products have been approved in the West. However, this has not been the case in Japan. AI healthcare approvals in Japan have been difficult to obtain and experienced a very slow approval process. Given this, Japan’s PDMA is now further discussing the use of AI in healthcare products. Accordingly, the PMDA has set up a special committee on how to evaluate and regulate AI healthcare products.
Recent PMDA discussions include topics like – how to evaluate AI products that can be updated after approval, how to use machine learning to construct accurate clinical information, whether using AI data presents problems for patient privacy, etc. The PMDA is now closely studying how the US FDA is regulating AI products too.