Work

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

Year: 2026

Type: article

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.

Source: EClinicalMedicine

DOI: 10.1016/j.eclinm.2026.103784

Authors: Antonis A. Armoundas, Joseph Loscalzo

Institutions: Broad Institute, Massachusetts General Hospital, Massachusetts Institute of Technology, Brigham and Women's Hospital, Harvard University

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDGs: Good health and well-being, Peace, justice, and strong institutions

Open Access status: gold

Estimated APC paid: $5,780