Definition of 'function' differs among health IT stakeholders

Despite agreement from many attendees at a meeting Tuesday on proposed federal health IT regulations unveiled last month that such regulation should focus on functionality instead of platform, developing a singular definition for that functionality is proving to be a challenge, according to attorney Brad Thompson of Epstein Becker Green.

Thompson, who serves as general counsel for both the mHealth Regulatory Coalition and the CDS Coalition, told FierceHealthIT via email that while some health IT stakeholders at the meeting thought that function needed to focus on "mechanical aspects" of what software can do, others thought of intended uses and users as more important.

The meeting, which took place at the National Institute of Standards and Technology in Gaithersburg, Maryland, was the first of three running through May 15.

Disagreements also arose between attendees when it came to categories created to sort such tools. In the proposed strategy, health IT is divided into one of three buckets: administrative functionality, health management functionality and medical device functionality. Attendees, however, wondered if that second category needed further division.

"Health management software really includes two very different types of software: software for data management and software for data analytics," Thompson told FierceHealthIT. Those two buckets really raise different questions and both potentially spill over into medical device territory."

The biggest challenge to using such a limited number of categories, Thompson added, was connectedness; how software is used, he said, varies depending on the system.

"A simple router is not worthy of regulation when it is simply used to transmit health-related email, but might very well merit regulation if used to transmit pacemaker data [in] real-time," he said.

In a conference call with reporters last month following the unveiling of the report--published jointly by the Office of the National Coordinator for Health IT, the U.S. Food and Drug Administration and the Federal Communications Commission--Jeffrey Shuren, director of the FDA's center for devices and radiological health, said that efforts to assure the safety of products in the health management functionality category would be led by ONC.


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