The “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. http://www.healthit.gov/sites/default/files/fdasia_healthitreport_final.pdf

The Agencies’ proposed strategy identifies three categories of health IT: 1) administrative health IT functions, 2) health management health IT functions, and 3) medical device health IT functions.

The controversial part is the section on health management health IT functions. “Health management functionalities include, but are not limited to, health information and data exchange, data capture and encounter documentation, electronic access to clinical results, most clinical decision support, medication management, electronic communication and coordination, provider order entry, knowledge management, and patient identification and matching.”  “As such, if a product with health management health IT functionality meets the statutory definition of a medical device, FDA does not intend to focus its oversight on it.

If you want to make comments, you have until July 7, 2014. Here is the link: http://www.regulations.gov/#!submitComment;D=FDA-2014-N-0339-0001http://www.regulations.gov/#!home