The goal of the proposed framework is to improve the federal government's regulation of healthcare IT applications by promoting product innovation while maintaining patient protection and avoiding regulatory duplication. The report was developed by the U.S. Food and Drug Administration (FDA), in collaboration with the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC).
The report proposes a regulatory framework that would divide healthcare IT software into three categories, based on functionality and risk:
- Low-risk software that performs administrative healthcare IT functions, such as applications for billing and claims processing, scheduling, and practice and inventory management.
- Medium-risk software with health management IT functions, such as software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results, and clinical decision support.
- Higher-risk software that could pose a greater risk to patients if it does not function as intended. Applications in this category include computer-aided detection (CAD) software, applications for bedside monitor alarms, and radiation treatment software.
The draft report proposes that the products in the first two categories are of sufficiently low risk that the FDA will not focus on regulating them; instead, it will shift oversight to ONC as well as private-sector activities. For software in the higher-risk category, the report proposes that the FDA continue regulating these products.
The report also calls for ONC to create a public-private Health IT Safety Center, which would develop best practices and provide a forum for exchanging ideas and information centered on patient safety.
The FDA, ONC, and FCC will announce a public meeting to collect comments on the draft report and gather feedback.
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