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  • July 2019
  • Article
  • Nature Biomedical Engineering

Challenges and Opportunities in Software-Driven Medical Devices

By: William J. Gordon and Ariel Dora Stern
  • Format:Print
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Abstract

The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device regulation and clinical care.

Keywords

Medical Devices; Healthcare; Health Care; Health Care and Treatment; Applications and Software; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

Citation

Gordon, William J., and Ariel Dora Stern. "Challenges and Opportunities in Software-Driven Medical Devices." Nature Biomedical Engineering 3, no. 7 (July 2019): 493–497.
  • Find it at Harvard

About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

More from the Authors

    • February 2023
    • Faculty Research

    The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation

    By: Ariel Dora Stern, Robert S. Huckman and Sarah Mehta
    • 2023
    • JAMA, the Journal of the American Medical Association

    Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

    By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
    • 2022
    • Faculty Research

    Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

    By: Alexander O. Everhart and Ariel D. Stern
More from the Authors
  • The Brigham and Women’s Hospital Innovation Hub: Driving Internal Innovation By: Ariel Dora Stern, Robert S. Huckman and Sarah Mehta
  • Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
  • Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data By: Alexander O. Everhart and Ariel D. Stern
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