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Article | BMJ Open

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

by Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

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Abstract

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. 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. Design:
We 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. Setting:
The 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. Results:
Among 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%. Conclusions:
To ensure the safest possible health care 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.

Keywords: digital; medicine; FDA; cybersecurity; Health Care and Treatment; Software; Safety; Medical Devices and Supplies Industry;

Format: Print Read Now

Citation:

Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).

About the Author

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Ariel D. Stern
Poronui Associate Professor of Business Administration
Technology and Operations Management

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More from the Author

  • Article | NEJM Catalyst | October 14, 2019

    How Artificial Intelligence Is Changing Health Care Delivery

    Samantha F. Sanders, Mats Terwiesch, William J. Gordon and Ariel Dora Stern

    The development of intelligent machines holds great promise for making health care delivery more accurate, efficient, and accessible, but challenges remain for incorporating AI into clinical and administrative settings.

    Keywords: artificial intelligence; Health Care and Treatment; Service Delivery; Technological Innovation;

    Citation:

    Sanders, Samantha F., Mats Terwiesch, William J. Gordon, and Ariel Dora Stern. "How Artificial Intelligence Is Changing Health Care Delivery." NEJM Catalyst (October 17, 2019).  View Details
    CiteView Details Read Now Related
  • Case | HBS Case Collection | September 2019

    Adaptive Platform Trials: The Clinical Trial of the Future? (B)

    Ariel D. Stern and Sarah Mehta

    This case provides an update to the (A) case, which introduces students to adaptive platform trials, an ambitious, more efficient type of clinical trial that increases access to therapies. The A case centers on Dr. Brian Alexander’s efforts to launch an adaptive platform trial for studying potential therapies for glioblastoma (GBM), an aggressive form of brain cancer. The (B) case provides an update and explores the strategies that Alexander is considering for sustainably financing this trial.

    Keywords: clinical trials; Drug Trials; Drug Testing; Cancer Trials; glioblastoma; platform trials; adaptive trials; adaptive platform trials; Health Testing and Trials; Health Care and Treatment; Business Strategy; Health Industry; United States;

    Citation:

    Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Case 620-001, September 2019.  View Details
    CiteView DetailsEducators Related
  • Article | Journal of Law, Medicine & Ethics

    Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.

    Ariel Dora Stern

    The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated—a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and policy-driven incentives.

    Keywords: biomarkers; Information Management; Health Care and Treatment; Motivation and Incentives;

    Citation:

    Stern, Ariel Dora. "Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures." Journal of Law, Medicine & Ethics 47, no. 3 (September 2019): 396–397.  View Details
    CiteView DetailsFind at Harvard Read Now Related
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