Flatiron Predictive DSI Intervention Risk Management Practices

This document is a technical report detailing Flatiron's practices regarding the risk management of externally developed predictive DSI (pDSI) functionality. It outlines the requirements for vendors supplying pDSI to Flatiron's Certified Health IT product, OncoEMR. The report describes how Flatiron collects necessary risk analysis and governance documentation from these vendors, ensuring their responses meet Flatiron's Quality Management System (QMS) standards. The document explains the risk analysis process that assesses validity, reliability, robustness, fairness, intelligibility, safety, security, and privacy of pDSI. It also details the risk mitigation strategies required from vendors, including design controls, informational controls, testing and validation, and incident response protocols. Furthermore, the report emphasizes the importance of governance policies and oversight mechanisms that vendors must adhere to for the development and deployment of their algorithms. Only vendors meeting these stringent criteria are approved for integration into OncoEMR.