The public will get a chance to comment on a proposed risk-based regulatory framework for health information technology developed by the Food and Drug Administration in coordination with the Office of the National Coordinator for Health IT and Federal Communications Commission.
In an April 7 Federal Register notice, the FDA announced the availability of the draft report and website location where it can be downloaded as well as a docket where stakeholders may provide comments. The public has until July 7 to submit comments either electronically or in writing.
"FDA, ONC, and FCC invite interested persons to submit comments on this report," states Bakul Patel, senior policy advisor for the FDA's Center for Devices and Radiological Health, in the notice. "We have established a docket where comments may be submitted. We believe this docket is an important tool for receiving feedback on this report from interested parties and for sharing this information with the public."
The draft report, released April 3, has not been without its critics. Senator Deb Fischer (R-Neb.), co-sponsor of the PROTECT Act bill to amend the Federal Food, Drug and Cosmetic Act to ensure that clinical and health software is not subject to regulation, has taken issue with the proposed strategy. "Instead of providing a concrete framework that supports innovation and safety, the reports approach maintains the status quo under which the FDA retains unlimited discretion over regulation of low-risk health IT," including mobile wellness apps, scheduling software, and electronic health records, said Fischer in a written statement.
However, Patel challenges this criticism of the FDA and the draft report. "The unique aspect of health IT, that other people are raising, is exactly what we considered," he told Health Data Management. "Having a public-private partnership, we actually come out and say we think and believe that the regulatory approach is not the first step. We need to bring in the stakeholders creating a framework that's unique and applies to health management health IT."
According to the draft report, products with "health management heath IT" functions--including software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software--are of sufficiently low risk and, even if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.
"I don't know if that message is not coming across, but it's in the report very clearly written down," Patel added.
At an April 3 media briefing on the draft report, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said the regulatory agency's intention is to also hold a public meeting in May to solicit comments on the agencies' outlined strategy and approach.
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