The ethics of advancing artificial intelligence in healthcare: analyzing ethical considerations for Japan's innovative AI hospital system.

Public and private investments into developing digital health technologies-including artificial intelligence (AI)-are intensifying globally. Japan is a key case study given major governmental investments, in part through a Cross-Ministerial Strategic Innovation Promotion Program (SIP) for an "Innovative AI Hospital System." Yet, there has been little critical examination of the SIP Research Plan, particularly from an ethics approach. This paper reports on an analysis of the Plan to identify the extent to which it addressed ethical considerations set out in the World Health Organization's 2021 Guidance on the Ethics and Governance of Artificial Intelligence for Health. A coding framework was created based on the six ethical principles proposed in the Guidance and was used as the basis for a content analysis. 101 references to aspects of the framework were identified in the Plan, but attention to the ethical principles was found to be uneven, ranging from the strongest focus on the potential benefits of AI to healthcare professionals and patients ( = 44; Principle 2), to no consideration of the need for responsive or sustainable AI ( = 0; Principle 6). Ultimately, the findings show that the Plan reflects insufficient consideration of the ethical issues that arise from developing and implementing AI for healthcare purposes. This case study is used to argue that, given the ethical complexity of the use of digital health technologies, consideration of the full range of ethical concerns put forward by the WHO must urgently be made visible in future plans for AI in healthcare.