The ONC, the Federal Communications Commission and the Food and Drug Administration have released a proposed strategy and framework for the regulation of health IT products.
The proposed recommendations are the result of a provision of the FDA Safety and Innovation Act, signed into law in 2012, which requires the three agencies to work together to develop a regulatory strategy that promotes innovation while protecting patient safety. A workgroup was formed in early 2013 to formulate guidance on the issue; this report is the result of their efforts.
Below are six key takeaways from the proposed framework.
- The strategy is a risk-based approach, taking into consideration both the function of the health IT product and the risk to patient safety if the product fails to perform as intended. The framework is meant to be platform-agnostic to be able to adapt to fit apps, mobile health devices and other new and emerging technologies.
- The proposed regulatory strategy would divide health IT products into three categories: those used for more administrative functions, such as billing software; those used for health management, such as clinical decision support software; and those used as medical devices, such as computer-aided detection software.
- The first category, health IT products with administrative functions, would not receive additional oversight from any of the agencies.
- The second category, health management products, would be regulated by the ONC. This category includes the products the ONC already certifies as electronic health record technology.
- The third category, health IT with medical device functionality, would continue to be regulated by the FDA, as these products pose the greatest risk to patient safety if they fail to operate as intended.
- The framework also calls for the creation of the Health IT Safety Center, run by the ONC in conjunction with other government agencies, to convene stakeholders to discuss best practices and promote health IT safety.
"Given range of health IT functionalities, the proposed framework should be sufficiently agile to address future and evolving products as well as the evolution of the health systems and environments where they're used," said Jeffrey Shuren, MD, director of the center for devices and radiological health at the FDA, in a press briefing.
All of the agencies stressed the proposal was meant to be the start of a conversation rather than a definitive rule, and look forward to receiving stakeholder feedback.
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