Algorithms used for clinical decision support, whether for diagnostic, or therapeutic use cases, have signiﬁcant implications for quality and safety. Despite this, regulation of these algorithms and models (what the FDA calls “Software as a Medical Device) is still in the early stages. In order to both foster a more responsible environment for clinical algorithm use and prepare for potential formal regulation, a new governance body called Algorithm-Based Clinical Decision Support (ABCDS) was formed at Duke. As the committee began putting in place a formal model registration & review process, ABCDS soon identified a need for a tool that would simplify the process for both researchers and review committee members.
Working closely with ABCDS stakeholders, Crucible has developed the Machine Intelligence Tracking Platform (MITRA) for algorithmic governance at Duke. MITRA leverages existing Duke systems to ensure the model registration process is intuitive and familiar for Duke researchers.