Clearing the Fog: A Scoping Literature Review on the Ethical Issues Surrounding Artificial Intelligence-Based Medical Devices

Abstract

The use of AI in healthcare has sparked much debate among philosophers, ethicists, regulators and policymakers who raised concerns about the implications of such technologies. The presented scoping review captures the progression of the ethical and legal debate and the proposed ethical frameworks available concerning the use of AI-based medical technologies, capturing key themes across a wide range of medical contexts. The ethical dimensions are synthesised in order to produce a coherent ethical framework for AI-based medical technologies, highlighting how transparency, accountability, confidentiality, autonomy, trust and fairness are the top six recurrent ethical issues. The literature also highlighted how it is essential to increase ethical awareness through interdisciplinary research, such that researchers, AI developers and regulators have the necessary education/competence or networks and tools to ensure proper consideration of ethical matters in the conception and design of new AI technologies and their norms. Interdisciplinarity throughout research, regulation and implementation will help ensure AI-based medical devices are ethical, clinically effective and safe. Achieving these goals will facilitate successful translation of AI into healthcare systems, which currently is lagging behind other sectors, to ensure timely achievement of health benefits to patients and the public.

Keywords: artificial intelligence; ethics; healthcare; machine learning; medical devices; regulatory affairs.

Figure 1

PRISMA flow diagram for study screening and inclusion. * Refers to studies identified from the records retrieved from the database which were not held on the database searched.

Figure 2

Percentage of studies discussing different technological contexts. Multiple technologies were discussed in some studies.