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Challenges and opportunities in software-driven medical devices

Nature Biomedical Engineering volume 3, pages 493–497 (2019)Cite this article

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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.

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Fig. 1: Three examples of software-driven medical devices.

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Acknowledgements

The authors are grateful to F. Hillen, T. Wang, B. Eskofier and J. Kumar for helpful comments.

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Authors and Affiliations

  1. Division of General Internal Medicine, Brigham and Women’s Hospital, Harvard Medical School, and Partners HealthCare, Boston, MA, USA

    William J. Gordon

  2. Harvard Business School & the Harvard-MIT Center for Regulatory Science, Boston, MA, USA

    Ariel D. Stern

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Correspondence to William J. Gordon.

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Gordon, W.J., Stern, A.D. Challenges and opportunities in software-driven medical devices. Nat Biomed Eng 3, 493–497 (2019). https://doi.org/10.1038/s41551-019-0426-z

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