From: GovInfoSecurity
Three Agencies to Release Proposal in March
Federal regulators aim to release by the end of March a report that proposes a risk-based regulatory framework to help ensure that patient safety is maintained as the use of electronic health records, wireless medical devices, mobile applications and other health IT continues to expand. The report will address cybersecurity issues.
The Office the National Coordinator for Health IT, the Food and Drug Administration and the Federal Communications Commission are co-developing the risk-based regulatory framework for health IT based on recommendations made last summer by an HIT Policy Committee workgroup (see Advisers Tackle Health Safety IT Issues).
Industry speculation was that the framework report would be unveiled by regulators at a session during the 2014 HIMSS Conference. During that Feb. 25 session, however, leaders of ONC, FCC and FDA instead provided an overview of the effort, saying the report was under review by the Department of Health and Human Services and a number of other government agencies. Once the report is released in March, FDA, ONC and FCC will collaboratively seek comment from industry stakeholders before issuing a final version of the framework.
The effort to create a risk-based regulatory framework for health IT was mandated by Congress in the Food and Drug Administration Safety Innovation Act of 2012.
Draft Proposals
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