Feds Schedule Meeting on HIT Regulation, Seek Comments

The federal government is confirming the dates and agenda for a three-day public meeting in May to get industry comment on a proposed strategy for regulating health information technology.

The meeting, hosted by the Food and Drug Administration, Office of the National Coordinator for Health IT and Federal Communications Commission, is scheduled for May 13-15 in Gaithersburg, Md. Registration is free and limited space is available on a first-come, first-served basis. The meeting will be available over the web with registration available through May 2 but also with limited connections.

The agencies released their proposed risk-based regulatory framework on April 3, which is light on regulation and heavy on stakeholder participation to self-police. A just-published notice gives more information on the public meeting and also includes a formal request for comments from stakeholders, with comments due by June 12.

The request for comments covers three categories of IT identified in the regulatory framework: administrative functions, health management functions and medical device functions. Government officials have 19 core questions (with follow-up questions for several) spanning five areas: Promoting use of quality management principles; Identifying, developing and adopting standards and best practices; Leveraging conformity assessment tools; Creating an environment of learning and continual improvement; and Clinical decision support.

The meeting notice and request for comments is available here.