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Challenges and opportunities in software-driven medical devices

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.


  1. Fu K. in Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report (ed. Wizemann, T.) Appendix D (Nat. Acad. Press, 2011).

  2. Software as a Medical Device Working Group. Software as a Medical Device (SAMD): Clinical Evaluation (IMDRF, 2017).

  3. CDRH. Digital Health Innovation Action Plan (FDA, 2019).

  4. Shuren, J., Patel, B. & Gottlieb, S. JAMA 320, 337–338 (2018).

    Article  Google Scholar 

  5. Directive 2007/47/EC of the European Parliament and of the Council (Official Journal of the European Union, 2007).

  6. Software as a Medical Device Working Group. Software as a Medical Device (SAMD): Key Definitions (IMDRF, 2013).

  7. Developing a Software Precertification Program: A Working Model (v.1 - April 2018) (FDA, 2018).

  8. Digital Health Criteria (FDA, 2018);

  9. H. R.34 - 21st Century Cures Act (114th US Congress, 2015–2016).

  10. Precertification (Pre-Cert) Pilot Program: Frequently Asked Questions (FDA, 2019);

  11. McHugh, M. et al. in Software Process Improvement and Capability Determination (eds Woronowicz T. et al.) 199–210 (Springer, 2013).

  12. McHugh, M., Cawley, O., McCaffery, F., Richardson, I. & Wang, X. In Proc. 5th International Workshop on Software Engineering in Health Care (eds Knight, J. & Kuziemsky, C.) 12–19 (IEEE Press, 2013).

  13. McHugh, M., McCaffery, F. & Casey, V. in Software Process Improvement and Capability Determination (eds Mas, A. et al.) 141–147 (Springer, 2012).

  14. IEC 62304:2006 Medical device software -- Software life cycle processes (International Organization for Standardization, 2006).

  15. Program - International Workshop on Software Engineering in Healthcare Systems (Lero, 2018).

  16. International Conference on Healthcare Informatics (IEEE, 2019);

  17. Medical Device Recalls: K150910 (FDA, accessed 18 July 2018;

  18. Class 2 Device Recall AccuChek Connect Diabetes Management App (FDA, accessed 18 July 2018);

  19. Ronquillo, J. G. & Zuckerman, D. M. Milbank Q 95, 535–553 (2017).

    Article  Google Scholar 

  20. Hospira Symbiq Infusion System Vulnerability Advisory ICSA-15-174-0 (ICS-CERT, 2018).

  21. Liu, V., Musen, M. A. & Chou, T. JAMA 313, 1471–1473 (2015).

    Article  CAS  Google Scholar 

  22. Microsoft Security Bulletin MS17-010 - Critical (Microsoft, 2017).

  23. Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (FDA, 2017).

  24. Schaeffer, N. E., Parks, L. J., Verhoef, E. T., Morgan, C. A. & Stal, M. J. Diabetes Sci. Technol. 10, 453–456 (2015).

    Article  Google Scholar 

  25. Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (FDA, 2018).

  26. Wimmer, N. J. et al. J. Health Care Finance 2016 Summer2016 (Spec Features, 2017).

  27. Bates, D. W., Saria, S., Ohno-Machado, L., Shah, A. & Escobar, G. Health Aff. 33, 1123–1131 (2014).

    Article  Google Scholar 

  28. Ghassemi, M., Celi, L. A. & Stone, D. J. Crit. Care 19, 118 (2015).

    Article  Google Scholar 

  29. Parikh, R. B., Kakad, M. & Bates, D. W. JAMA 315, 651–652 (2016).

    Article  CAS  Google Scholar 

  30. Henry, K. E., Hager, D. N., Pronovost, P. J. & Saria, S. Sci. Transl Med. 7, 299ra122 (2015).

    Article  Google Scholar 

  31. Ram, S., Zhang, W., Williams, M. & Pengetnze, Y. IEEE J. Biomed. Health Inform. 19, 1216–1223 (2015).

    Article  Google Scholar 

  32. Chen, J. H. & Asch, S. M. N. Engl. J. Med. 376, 2507–2509 (2017).

    Article  Google Scholar 

  33. Jiang, F. et al. Stroke Vasc. Neurol. 2, 230–243 (2017).

    Article  Google Scholar 

  34. Resnic, F. S. & Matheny, M. E. N. Engl. J. Med. 378, 595–597 (2018).

    Article  Google Scholar 

  35. Sherman, R. E. et al. N. Engl. J. Med. 375, 2293–2297 (2016).

    Article  Google Scholar 

  36. Budrionis, A. & Bellika, J. G. J. Biomed. Inform. 64, 87–92 (2016).

    Article  Google Scholar 

  37. Apple announces effortless solution bringing health records to iPhone (Apple, 2018).

  38. CMS & HHS. Fed. Regist. 80, 62761–62955 (2015)..

  39. Access of individuals to protected health information 45 CFR § 164.524 (HSS, 2016).

  40. Lee, T. T. & Kesselheim, A. S. Ann. Intern. Med. 168, 730–732 (2018).

    Article  Google Scholar 

  41. FDA’s Sentinel Initiative (FDA, 2018).

  42. National Evaluation System for Health Technology (NEST) (FDA, 2019).

  43. Anand, S. S. et al. JAMA Cardiol. 1, 601–606 (2016).

    Article  Google Scholar 

  44. Chan, Y.-F. Y. et al. Nat. Biotechnol. 35, 354–362 (2017).

    Article  CAS  Google Scholar 

  45. Semigran, H. L., Linder, J. A., Gidengil, C. & Mehrotra, A. BMJ 351, h3480 (2015).

    Article  Google Scholar 

  46. Redfern, J. et al. BMJ 4, e004523 (2014).

    Google Scholar 

  47. Sepah, S. C., Jiang, L. & Peters, A. L. J. Med. Internet. Res. 17, e92 (2015).

    Article  Google Scholar 

  48. Firth, J. et al. World Psych. 16, 287–298 (2017).

    Article  Google Scholar 

  49. Gottlieb, S. Twitter (11 April 2018);

  50. Comstock, J. MobiHealthNews (23 March 2016);

  51. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. FDA (13 November 2017).

  52. Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap (FDA, 2018).

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

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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).

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