The Implications of Open Source Technologies in Safety-critical Medical Device Platforms

Location: F151
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FDA regulated medical devices are considered safety-critical systems due to their ability to affect patient lives. Given the nature of scrutiny and the requirement to play it safe, most medical device vendors end up choosing proprietary or custom solutions for operating systems, databases, messaging platforms, alarm notification systems, and event logging.

This talk will uncover some of the common misconceptions around government regulations and how there are not inherent limitations around using FOSS in safety-critical systems so long as the requisite risk analysis and quality assurance work is conducted.

Shahid will present his recent work on modern medical device architectures, the challenges and opportunities associated with using open source software in medical devices, and real-world findings from use of open source answering questions such as:

  • Will the FDA accept open source in safety-critical systems?
  • Are open source systems safe enough for medical devices?
  • What kind of assessments are needed for open source software in medical devices?
Photo of Shahid Shah

Shahid Shah


Shahid N. Shah is an internationally recognized and influential government technology and healthcare IT thought leader and writer who is known as “The Healthcare IT Guy” across the Internet. He is a strategist for various federal agenices on IT matters and winner of Federal Computer Week’s coveted “Fed 100” award given to IT experts that have made a big impact in the government. Shahid has architected and built multiple clinical solutions over his almost 20 year career. He helped design and deploy the American Red Cross’s electronic health record solution across thousands of sites; he’s built two web-based EMRs now in use by hundreds of physicians; he’s designed large groupware and collaboration sites in use by thousands; and, as an ex-CTO for a billion dollar division of CardinalHealth he helped design advanced clinical interfaces for medical devices and hospitals. Shahid also serves as a senior technology strategy advisor to NIH’s SBIR/STTR program helping small businesses commercialize their healthcare applications.

Shahid runs three successful blogs. At he writes about architecture issues, at he provides valuable insights on how to apply technology in health care, at he advises senior federal technologists, and at he gives a glimpse of the health-care IT blogosphere as an aggregator.