Trustworthy Medical Device Software

This report summarizes what the computing research community knows about the role of trustworthy software for safety and effectiveness of medical devices. Research shows that problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors. Recommendations to increase the trustworthiness of medical device software include (1) regulatory policies that specify outcome measures rather than technology, (2) collection of statistics on the role of software in medical devices, (3) establishment of open-research platforms for innovation, (4) clearer roles and responsibility for the shared burden of software, (5) clarification of the meaning of substantial equivalence for software, and (6) an increase in FDA’s access to outside experts in software. This report draws upon material from research in software engineering and trustworthy computing, public FDA data, and accident reports to provide a high-level understanding of the issues surrounding the risks and benefits of medical device software.