FDA considers new FDASIA workgroup recommendations for regulating health IT
On 4 September 2013, a working group tasked with making recommendations for optimal regulation of health information technology (HIT) delivered its final report to the Food and Drug Administration (FDA or the agency), the Office of the National Co-ordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC).
The final report recommends only very low-level regulation for low-risk HIT products and requests that the FDA expedite the final guidance on medical mobile applications for smartphones and other mobile devices (medical mobile apps). FDA officials say that the agency is considering the recommendations and will work with other agencies to issue a report on overarching regulation of HIT by January 2014.
The FDASIA Workgroup was formed by the three government agencies in response to the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which called on these agencies to propose a comprehensive, risk-based regulatory framework for HIT by January 2014. The FDA, along with the FCC and ONC, created the Workgroup to make recommendations that will guide development of the framework…
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