Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We There Yet? A Response to the Recent Commentaries.
作者信息
Muylle Katoo M, Scharen Audrey Van, Shiwa Veronique, Cornu Pieter
机构信息
Research Group Clinical Pharmacology and Clinical Pharmacy (KFAR), Centre for Pharmaceutical Research (CePhar), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
Medical Ethics Committee, Universitair Ziekenhuis Brussel, Brussels, Belgium.
出版信息
Int J Health Policy Manag. 2024;13:8388. doi: 10.34172/ijhpm.2023.8388. Epub 2024 Jan 7.
Abstract
摘要
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本文引用的文献
1
Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".监管框架对医疗器械软件制造商的影响：指导文件是否支持实际实施？评“临床决策支持与医疗器械新监管框架：我们准备好了吗？——观点论文”。
Int J Health Policy Manag. 2023;12:7470. doi: 10.34172/ijhpm.2023.7470. Epub 2023 Jul 10.
2
The Challenges of Regulating Artificial Intelligence in Healthcare Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".规范医疗人工智能面临的挑战 述评“临床决策支持与医疗器械新监管框架：我们准备好了吗？——观点论文”。
Int J Health Policy Manag. 2023;12:7261. doi: 10.34172/ijhpm.2022.7261. Epub 2022 Sep 19.
3
Impact of Regulatory Changes on Innovations in the Medical Device Industry Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".监管变革对医疗器械行业创新的影响 述评“临床决策支持与医疗器械新监管框架：我们准备好了吗？——观点论文”。
Int J Health Policy Manag. 2023;12:7262. doi: 10.34172/ijhpm.2022.7262. Epub 2022 Jun 15.
4
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Int J Health Policy Manag. 2022 Dec 19;11(12):3159-3163. doi: 10.34172/ijhpm.2021.144. Epub 2021 Oct 18.
5
The case for an academic discipline of medical device science.医学设备科学学术学科的理由。
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