The federal government has scheduled a public meeting and issued a request for information as it works to develop a risk-based regulatory framework for health information technology.
The goal of the framework, which likely will include deeming certain mobile apps as medical devices and subject to Food and Drug Administration regulation, is to promote innovation, protect patient safety and avoid regulatory duplication, according to a notice being published May 30 and now available here. The notice is a joint publication from FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission.
The recently formed Food and Drug Administration Safety Innovation Act Workgroup within the HIT Policy Committee that advises HHS will hold an in-person and Web cast meeting May 30-31 in Washington, which follows its introductory meeting on April 29. The group of stakeholders is tasked with developing a report on strategies and recommendations for the regulatory framework.
The request for information within the notice covers the types of health I.T. that should be addressed in the report, the patient risks posed by I.T. and the likelihood of such risks, approaches to promote innovation and safety, and current areas of regulatory overlap among FDA, ONC and/or FCC. Comments are encouraged before August 31.
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