Integrating Ethical Principles Into the Regulation of AI-Driven Medical Software

Abstract

In recent years, a sharp increase in artificial intelligence (AI)-based software as medical devices has been seen in the United States and the European Union. Despite the huge potential of these devices in alleviating suffering through rapid identification and early intervention, their adoption in clinical practice has remained relatively slow due to ethical questions surrounding their usage. Even though there is no universal framework for the approval of these devices, the guiding principles behind individual regulatory bodies almost stay the same, with some more focused on the technical aspect while others involving the ethical aspects as well. The International Medical Device Regulators Forum devised a SaMD Working Group to outline the essential controls guiding the approval of these devices, but there is a lack of a structured approach for the regulatory approval process. This article outlines the principles of medical ethics, such as autonomy, beneficence, and fair distribution of healthcare sources, and how they relate to the use of AI-based devices. The core regulatory guidelines are then viewed in light of these ethical principles. We recommend that a comprehensive regulatory framework with integration of principles of medical ethics be made public. Though no universally accepted framework is available, regulating quality management, risk assessment, and data privacy would help build trust to promote the adoption of AI in healthcare.

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