Until the Food and Drug Administration provides further clarification on what types of applications would be viewed as clinical decision support, this software category will remain a regulatory gray area leaving developers unclear as to how to market these products. That is the consensus of stakeholders who met May 14 as part of a public meeting on a risk-based health IT regulatory framework proposed by federal agencies.

At Wednesday’s meeting, stakeholders discussed the possible factors used to determine whether CDS should be regulated. William Maisel from FDA's Center for Devices and Radiological Health said the draft framework that FDA, ONC and FCC released April 3 defines CDS as providing healthcare professionals and patients with “knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and healthcare.” However, stakeholders expressed their confusion regarding regulatory oversight of CDS software.

"In my opinion, what's necessary now is detail," said Bradley Merrill Thompson, general counsel for the CDS Coalition, a group of stakeholders consisting of software providers, IT infrastructure manufacturers, healthcare payers, hospitals and other providers, as well as medical device manufacturers and trade groups. "What we're looking for is FDA guidance and it needs to be written at a level of detail where an entrepreneur can sit down with what's written and figure out whether they are regulated or not." 

FDA's Maisel noted that the report provides some specific examples of CDS types that fall into three categories based on the risk presented by a product's functionality: administrative health IT, health management health IT, and medical device health IT. Under the HIT framework proposed by the federal agencies, most CDS software would fall into the health management health IT category which has medium risk. 

"This is the middle tier of risk but it could really hurt a patient by commission or omission and it's not to be taken lightly," argued David Hirschorn, M.D., of the American College of Radiology. "It is not a no-risk thing and actually can make the difference in the life and death of a patient."

Examples of health management functions include health information and data exchange and management, data capture and encounter documentation, electronic access to clinical results, medication management, electronic communication and coordination among providers and patients, provider order entry, knowledge management and patient identification and matching. FDA intends to defer to ONC and not focus regulatory oversight on these functionalities, even if a product in this category meets the technical definition of a medical device. 

"FDA doesn't regulate the practice of medicine. They regulate medical devices and this is on the edge of that," said Hirschorn. "Is CDS a device or is it an educational tool? Is it a practice of medicine thing? Well, it's kind of both." 

Joel White, executive director of the Health IT Now Coalition, made the case for Congress passing legislation rather than encouraging FDA to move swiftly to produce further guidance on CDS. White said his organization has endorsed the PROTECT Act, a bill sponsored by Senator Deb Fischer (R-Neb.), that would amend the Federal Food, Drug and Cosmetic Act and ensure that clinical software would not be subject to regulation. 

However, Thompson argued against passage of such a law. "Our fear is that another statute simply adds another high-level, hundred thousand foot thing to be interpreted, when really what we need is down here at the ten thousand foot level--specific guidance helping us understand what's in and what's out." Toward that end, he urged the FDA to complete the guidance development process the regulatory agency began in 2011, when it held a regulatory hearing on the topic of developing a CDS guidance document. 

Nevertheless, the consensus among stakeholders at the public meeting was that some software poses a higher risk to patients and therefore warrants FDA’s continued focus and oversight in regulating certain high-risk CDS.

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