Almost 60 health IT industry groups have come together to ask Congress to pass a risk-based regulatory framework proposed by the ONC, the Federal Communications Commission and the Food and Drug Administration in April, providing clarity to developers and fostering innovation.
The proposed strategy and framework 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. The framework's risk-based approach takes 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.
In a letter to Congress, the stakeholder groups outline the potential of health IT to improve patient care quality and efficiency. However, they argue the current regulatory uncertainty discourages developers from trying to bring new products to market. Enacting the risk-based approach to regulation would both clarify oversight and help ensure an appropriate level of regulation was applied to each product.
"Before the end of the year, we urge Congress to provide much needed statutory clarity and a stable foundation for continued innovation in health IT," according to the letter. "This overdue action will allow the Administration to focus its limited resources, staff and expertise on ensuring the safety of new medical technologies that pose the highest potential risk to patients and will promote a new era of medical innovation that will improve care and lower costs."
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