The three federal agencies that last week proposed a risk-based regulatory framework for health information technology will hold a three-day public meeting in mid-May to get feedback from healthcare industry stakeholders on the draft report. While an official announcement of the dates and location has not yet been made, the meeting is tentatively slated for May 13-15.

"We will be hosting a public workshop in the middle of May and you should all be seeing an announcement in the next few days and a website for registration," said Bakul Patel, senior policy advisor for the Food and Drug Administration, during an April 10 eHealth Initiative webcast.  

Developed by the FDA in coordination with the Office of the National Coordinator for Health IT and Federal Communications Commission, the draft report to Congress was released on April 3. Mandated by the FDA Safety and Innovation Act, the report presents the agencies' strategies for defining categories of health IT and the level of regulatory oversight based on a product’s function and potential risk.

"This is a starting point and, as we've said in the past, this is a draft proposal for everybody in the community to react to and to help the agencies define further," said Patel.

The FDA opened a 90-day public comment period on the proposed regulatory framework on April 7.  A docket was established where stakeholders may provide comments. The public has until July 7 to submit comments either electronically or in writing.

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access