Do world-wide policy initiatives for regulating health care related artificial intelligence safeguard the declaration of Helsinki?

Abstract

Digital health technologies and artificial intelligence (AI), are transforming medical research, health care, and public health. The ever-increasing usage of algorithms in health care has challenged governments, regulatory agencies, health organizations, developers, and providers, and AI raises novel ethical challenges that extend beyond the jurisdiction of traditional borders and regulatory health-care processes and structures. While there is growing consensus in recognizing these ethical challenges, there is less agreement over the necessary AI guardrails. This Viewpoint offers a synthesis of representative AI-enabled health policy approaches across jurisdictions and advances practical recommendations for an adaptive, international AI policy and governance framework that will be responsible for monitoring and advancing its regulations in pace with the rapid growth of AI technologies. We use the Declaration of Helsinki as a normative reference point, to derive risk-proportionate safeguards for AI-enabled health across research and non-research settings.