Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled "Definition of 'Function' Differs Among Health IT Stakeholders."
Following is an excerpt:
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. ?...
"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.
