Health policy (Amsterdam, Netherlands)
Feb 1, 2025
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
COVID-19 has triggered various changes in our everyday lives and how we conceptualize the functions of governments. Some areas require stricter forms of regulation while others call for deregulation. The challenge for the regulatory authorities is to...
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governm...
In recent years, artificial intelligence (AI) technologies have greatly advanced and become a reality in many areas of our daily lives. In the health care field, numerous efforts are being made to implement the AI technology for practical medical tre...
The journal of the American Academy of Psychiatry and the Law
Nov 21, 2019
In March 2015, a co-pilot flying Germanwings Flight 9525 deliberately pointed his airplane into a descent, killing himself, five other crew members, and 144 passengers. Subsequent investigation and review teams examined the incident and considered po...
Studies in health technology and informatics
Feb 18, 2025
The Canadian health-tech sector faces regulatory challenges amidst rapid innovations in artificial intelligence (AI), digital health, biotechnology, and medical devices. This paper explores the regulatory landscape based on stakeholder interviews and...
Journal of the American Medical Informatics Association : JAMIA
Feb 1, 2025
OBJECTIVES: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...