About 60 health information technology ("health IT") industry groups recently joined to ask Congress to provide more clarity in health IT laws by codifying a risk-based regulatory framework proposed in April 2014 by FDA, the Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission. The framework was prompted by the 2012 FDA Safety and Innovation Act, which required the three agencies to collaborate on a regulatory scheme that would promote innovation while protecting patients. The framework attempts to balance device function against risks to the patient, regardless of the particular technology platform. In their letter, the health IT groups told Congress they want "statutory clarity and a stable foundation for continued innovation in health IT." Other health IT groups have cautioned that the framework is not ready for adoption, urging FDA to issue guidance to clarify several complex issues, such as the scope of medical device accessories and the difference between wellness and disease.
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