AIMC Topic: Government Regulation
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Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.
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...
Congress Must Update FDA Regulations for Medical AI.
JAMA health forum
Jul 5, 2024
Continual learning in medical devices: FDA's action plan and beyond.
The Lancet. Digital health
Apr 28, 2021
Precision Regulation Approach: A COVID-19 Triggered Regulatory Drive in South Korea.
Frontiers in public health
Feb 1, 2021
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...
Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.
The Lancet. Digital health
Jan 18, 2021
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...
Artificial Intelligence in Health Care: Current Applications and Issues.
Journal of Korean medical science
Nov 2, 2020
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...
Psychiatry and Fitness to Fly After Germanwings.
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...
Transforming health policy through machine learning.
PLoS medicine
Nov 13, 2018
In their Perspective, Ara Darzi and Hutan Ashrafian give us a tour of the future policymaker's machine learning toolkit.
Artificial Intelligence and the 'Good Society': the US, EU, and UK approach.
Science and engineering ethics
Mar 28, 2017
In October 2016, the White House, the European Parliament, and the UK House of Commons each issued a report outlining their visions on how to prepare society for the widespread use of artificial intelligence (AI). In this article, we provide a compar...
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Regulating Innovation: Addressing the Challenges of Canada's Health-Tech Sector.
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...
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