专题：Healthcare Regulation

This cluster of papers covers a wide range of topics related to the regulation of healthcare products and practices, including the role of regulatory agencies, patient safety, infection control, drug resistance, epidemiology, and health policy. It also addresses specific issues such as nursing care, medical devices, and regulatory compliance.
最新文献
A Licensure Framework for Autonomous Clinical AI

article Full Text OpenAlex

Large language models in healthcare quality management: a European perspective on process automation and compliance

review Full Text OpenAlex

From bench to market: Regulatory and commercial challenges in clinical point-of-care biosensors

article Full Text OpenAlex

Regulating complexity in AI-enabled omics and multi-omics technologies for precision medicine

article Full Text OpenAlex

Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China

review Full Text OpenAlex

Vision 2035 – Medico-Pharmaceutical Law for Human Security

book Full Text OpenAlex

Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR–Guided Scoping Review of Global Guidance and Evidence (2017–2025)

article Full Text OpenAlex

The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects

review Full Text OpenAlex

Total product lifecycle regulatory considerations and recommendations for generative AI-enabled medical devices

article Full Text OpenAlex

A Critical Review of the FDA’s Draft Guidance on Artificial Intelligence in Drug and Biological Product Regulation

article Full Text OpenAlex

近5年高被引文献
FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine

review Full Text OpenAlex 331 FWCI7.6003

Global Regulatory Frameworks for the Use of Artificial Intelligence (AI) in the Healthcare Services Sector

review Full Text OpenAlex 300 FWCI92.1019

FDA-Approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An Updated Landscape

article Full Text OpenAlex 293 FWCI25.7481

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

review Full Text OpenAlex 286 FWCI36.908

The EU Artificial Intelligence Act (2024): Implications for healthcare

article Full Text OpenAlex 266 FWCI685.1164

ISO 10993: Biological Evaluation of Medical Devices

book-chapter Full Text OpenAlex 258 FWCI64.3577

Navigating the EU AI Act: implications for regulated digital medical products

article Full Text OpenAlex 225 FWCI579.5158

Real-World Evidence — Where Are We Now?

article Full Text OpenAlex 221 FWCI36.0186

Large language model AI chatbots require approval as medical devices

article Full Text OpenAlex 207 FWCI7.0936

Toxic or not toxic? The specifications of the standard ISO 10993-5 are not explicit enough to yield comparable results in the cytotoxicity assessment of an identical medical device

article Full Text OpenAlex 200 FWCI44.9163