Medical Device Cybersecurity Standards: Raising the Bar for Patient Safety

Authors

  • Naomi Schwartz Vice President, Regulatory Strategy, Medcrypt
  • Elizabeth Baker, PhD Professor of Information Systems at Virginia Commonwealth University, and THMT Academic & Research Integrity Oversight
  • Maria Palombini Director, Healthcare & Life Sciences Global Practice Lead, IEEE Standards Association

DOI:

https://doi.org/10.30953/thmt.v11.696

Keywords:

Cybersecurity, cybersecurity standards, designing medical devices, digital health, medical device cybersecurity, patient safety and security, quality management systems for medical devices

Abstract

As healthcare becomes increasingly connected, medical device cybersecurity is no longer an IT issue — it is a patient safety imperative. In this expert discussion, three leaders at the intersection of regulation, standards, and innovation explore why cybersecurity must be embedded into the DNA of medical device design from day one.

Topics include:

  • Standards and Innovation — Raising the Bar
  • Purpose Driven Functionality & Protecting Patients
  • Predictability & Security in Procurement
  • Designing with Standards from the Start
  • Medical Devices in Patient Care Settings
  • FDA’s VEX Data & Quality Management Systems
  • Cybersecurity = Patient Safety
  • Be Proactive. Participate. Lead.

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Published

2026-03-31

How to Cite

Schwartz, N., Baker, PhD, E., & Palombini, M. (2026). Medical Device Cybersecurity Standards: Raising the Bar for Patient Safety. Telehealth and Medicine Today, 11(1). https://doi.org/10.30953/thmt.v11.696

Issue

Vol. 11 No. 1 (2026): Telehealth and Medicine Today

Section

Podcast

License

Copyright (c) 2026 Naomi Schwartz, Elizabeth Baker, PhD, Maria Palombini

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Authors retain copyright of their work, with first publication rights granted to  Telehealth and Medicine Today (THMT).

THMT is published under a Creative Commons Attribution-NonCommercial 4.0 International License.