A practical guide to the implementation of AI in orthopaedic research—Part 7: Risks, limitations, safety and verification of medical AI systems
Review article, 2025
Artificial intelligence (AI) has been influencing healthcare and medical research for several years and will likely become indispensable in the near future. AI is intended to support healthcare professionals to make the healthcare system more efficient and ultimately improve patient outcomes. Despite the numerous benefits of AI systems, significant concerns remain. Errors in AI systems can pose serious risks to human health, underscoring the critical need for safety, as well as adherence to ethical and moral standards, before these technologies can be integrated into clinical practice. To address these challenges, the development, certification, and deployment of medical AI systems must adhere to strict and transparent regulations. The European Commission has already established a regulatory framework for AI systems by enacting the European Union Artificial Intelligence Act. This review article, part of an AI learning series, discusses key considerations for medical AI systems such as reliability, accuracy, trustworthiness, lawfulness and legal compliance, ethical and moral alignment, sustainability, and regulatory oversight. Level of Evidence: Level V.
standards
digitalization
safety
future
risk
AI
certification
healthcare
Author
Philipp W. Winkler
University of Gothenburg
Johannes Kepler University of Linz (JKU)
Sahlgrenska University Hospital
Bálint Zsidai
University of Gothenburg
Sahlgrenska University Hospital
Eric Hamrin Senorski
Sahlgrenska University Hospital
University of Gothenburg
James Pruneski
Tripler Army Medical Center
Michael T. Hirschmann
Canton Hospital Basel-Land
University of Basel
Christophe Ley
University of Luxembourg
Thomas Tischer
University of Rostock
Malteser Waldkrankenhaus Erlangen
Elmar Herbst
University of Münster
Ayoosh Pareek
Hospital for Special Surgery
Volker Musahl
University of Pittsburgh
Jacob F. Oeding
University of Gothenburg
Mayo Clinic
Felix C. Oettl
University of Zürich
Umile Giuseppe Longo
Campus Bio Medico University Hospital
Università Campus Bio-Medico di Roma
Kristian Samuelsson
Sahlgrenska University Hospital
University of Gothenburg
Robert Feldt
Chalmers, Computer Science and Engineering (Chalmers), Software Engineering (Chalmers)
Journal of Experimental Orthopaedics
2197-1153 (eISSN)
Vol. 12 2 e70247Subject Categories (SSIF 2025)
Health Care Service and Management, Health Policy and Services and Health Economy
Medical Ethics
DOI
10.1002/jeo2.70247
PubMed
40276496