FDA lays out plan for HIT oversight
by Kristen Fischer
, DOTmed News | April 10, 2014
Federal agencies are taking steps to determine which health IT advancements need regulation — and which do not.
This week, the U.S. Food and Drug Administration publicly sought comments for its new risk-based HIT guidelines, which were published the week before. The framework was required under the Safety and Innovation Act. The report was created with the Office of the National Coordinator (ONC) for HIT and the Federal Communications Commission (FCC).
In short, the FDA won't be regulating anything that it does not oversee already, but it has recognized new IT tools and established a position on the level that it will govern them.
"FDA is basically saying that they do not see any need to enlarge their responsibility over health information technology. I think most people agree with that," Bradley Merrill Thompson, a lawyer who counsels medical companies on FDA-related issues with Epstein Becker Green in Washington, D.C. told DOTmed News.
Instead, the federal government, and specifically the Department of Health and Human Services (DHHS) is proposing that the ONC play a leadership role in overseeing the safety of moderate risk health information technology, he said.
The report establishes three health IT categories centered on product function instead of its operating platform. So for instance, IT applications and tools aren't put into categories based on whether they exist on a mobile or cloud platform. Instead, they are categorized based on risk to the patient.
Category 1: Products with administrative health IT functions
The FDA will not regulate products with administrative health IT functions, such as billing, claims processing or inventory applications.
Category 2: Products with health management health IT functions
The second category includes software for health information, data management, provider order entry, medication management, knowledge management, electronic access to clinical results, and most clinical decision support tools. If these products meet the definition of a medical device, the FDA will not regulate them. The category also includes tools for testing, certification and accreditation.
The report suggests relying mostly on ONC-coordinated activities and private manufacturers to create quality products. The agencies will favor IT stakeholders to identify the essential elements of a quality product, instead of taking a formal regulatory approach.
Most clinical decision support software falls into this category, but not all. That's where Thompson would like to see more information.
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