Current Trends in AI Ethics for Software as a Medical Device (SaMD)

Abstract

Past scholarship has noted the growing concerns and complex challenges surrounding the emergent use of ubiquitous digital technologies in medicine and healthcare, including artificial intelligence (AI) and machine learning (ML). The scholarship has also noted the challenges that human research protection programs (HRPP) and institutional review boards (IRB) have faced in an evolving regulatory climate to review human subjects research involving AI and ML for medical devices. This chapter presents the results of a trends analysis of the current scholarship surrounding compliance trends for AI ethics specific to the use of protected health information (PHI) and compliance trends specifically surrounding AI ethics in software as a medical device (SaMD) for new investigators seeking IRB review for AI/ML research activities. The trends offered in the current scholarship also present many opportunities for policy implications needed to assure ethical oversight for the protection of human subjects in research involving AI/ML for IRBs and HRPPs to review this research.

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