ArticleBMJ open2019
Cybersecurity features of digital medical devices: an analysis of FDA product summaries.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The trial behind it
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Who cites it
20 citing papers in PubMed.
- Developing a medical-device formulary for council of health insurance beneficiaries in Saudi Arabia: stakeholder challenges and policy recommendations.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Article
- Regulatory Approaches to Cybersecurity Risk Management for AI-Enabled Medical Device Software in Korea, the United States, and the European Union: Comparative Document Analysis.JMIR medical informatics · 2026Article
- Emerging Endorobotic and AI Technologies in Colorectal Cancer Screening: A Review of Design, Validation, and Translational Pathways.Diagnostics (Basel, Switzerland) · 2026Review
- Integrating digital therapeutics for patients with mental illness into clinical practice: perspectives for US healthcare professionals.Frontiers in public health · 2026Review
- Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.JMIR medical informatics · 2025Article
- A scoping review and expert consensus on digital determinants of health.Bulletin of the World Health Organization · 2025Article
- Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019-16 and FDA premarket cybersecurity guidance.Computational and structural biotechnology journal · 2025Article
- Understanding patient perspectives on digital therapeutics and its platform for insomnia: insights from focused group interviews.BMC health services research · 2024Article
- Innovation Process and Industrial System of US Food and Drug Administration-Approved Software as a Medical Device: Review and Content Analysis.Journal of medical Internet research · 2023Review
- Cybersecurity vulnerability analysis of medical devices purchased by national health services.Scientific reports · 2023Article
- Strengthening Cybersecurity for Patient Data Protection in Europe.Journal of medical Internet research · 2023Article
- Digital therapeutics in the clinic.Bioengineering & translational medicine · 2023Review
- Current challenges for evaluating mobile health applications.Journal of the American Medical Informatics Association : JAMIA · 2023Article
- Health app policy: international comparison of nine countries' approaches.NPJ digital medicine · 2022Article
- The inclusion of augmented intelligence in medicine: A framework for successful implementation.Cell reports. Medicine · 2022Review
- Hospital cybersecurity risks and gaps: Review (for the non-cyber professional).Frontiers in digital health · 2022Review
- Application of artificial intelligence in glioma researches: A bibliometric analysis.Frontiers in oncology · 2022Article
- The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2021Article
- Characteristics and challenges of the clinical pipeline of digital therapeutics.NPJ digital medicine · 2020Article
- Should Medical Devices Be Regulated as Rigorously as Drugs?The Canadian journal of hospital pharmacyArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices.
designWe analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information.
settingThe full set of regulated medical devices, approved over the years 2002-2016 included in the FDA's 510(k) and premarket approval databases. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas.
resultsAmong regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%.
conclusionsTo ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.