Regulatory Issues and Medical Device Certification

Articles published in this theme: 10 (scroll down to load remaining articles)

2026

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Privacy Policy Compliance of Mobile Sports and Health Apps in China: Scale Development, Data Analysis, and Prospects for Regulatory Reform

Rengui Guo, Fanhong Chen

JMIR Mhealth Uhealth 2026 (Feb 11); 14:e73651

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Conceptual Model for the Integration of Marketing Strategies and Biomedical Innovation in Patient-Centered Care: Mixed Methods Study

Atantra Das Gupta, Yashpal Yadav

JMIR Biomed Eng 2026 (Jan 06); 11:e77115

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2025

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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study

Marlen Peseke, Ilja Michaelis, Ornella Tangila Kayembe, Majella Geraghty, Ali McDonnell, Franco Luigi Zurlo, Zoe Sophie Oftring, Nicolas Martelli, Tom Melvin, Sebastian Kuhn

J Med Internet Res 2025 (Oct 01); 27:e77982

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Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?

Alex Emilio Fischer, Samanta Tresha Lalla-Edward, Vinodh Edward, Musaed Abrahams, Luke Shankland, John de Wit

JMIR Mhealth Uhealth 2025 (Aug 22); 13:e60276

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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025 (Jul 11); 13:e67552

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2024

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Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Laura Maaß, Robert Hrynyschyn, Martin Lange, Alexandra Löwe, Kathrin Burdenski, Kaley Butten, Sebastian Vorberg, Mariam Hachem, Aldo Gorga, Vittorio Grieco, Vincenzo Restivo, Giuseppe Vella, Marlien Varnfield, Felix Holl

J Med Internet Res 2024 (Sep 30); 26:e54814

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Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device

Liga Svempe

JMIR Med Inform 2024 (Sep 05); 12:e58080

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2023

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Forecasting Artificial Intelligence Trends in Health Care: Systematic International Patent Analysis

Stan Benjamens, Pranavsingh Dhunnoo, Márton Görög, Bertalan Mesko

JMIR AI 2023 (May 26); 2:e47283

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2022

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Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device

Jane Elizabeth Carolan, John McGonigle, Andrea Dennis, Paula Lorgelly, Amitava Banerjee

JMIR Med Inform 2022 (Jan 27); 10(1):e34038

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2021

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Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis

Aaron Ceross, Jeroen Bergmann

JMIR Biomed Eng 2021 (Nov 03); 6(4):e20652

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