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FDA Urged to Clarify Clinical Decision Support Regulations

A coalition takes the FDA to task for not defining how it would govern CDS software, a key driver of mHealth innovation for healthcare providers.

By Eric Wicklund

- Among the biggest promises of mHealth is that it will enable clinical decision support in real time and at the point of care. But that won’t happen if federal officials can’t decide how to regulate the technology.

A broad-based coalition is taking the U.S. Food and Drug Administration to task for not clarifying its clinical decision support software guidelines, saying that inaction is hindering innovation. As proof, the coalition cites a recent survey it conducted in which one-third of the respondents said they’d abandoned plans to develop a CDS product because of that uncertainty.

“Prompt legislative and/or regulatory action is needed to clarify the scope of CDS software that will be subject to FDA regulation as well as the specific regulatory requirements that will apply to any software that is regulated,” the Clinical Decision Support Coalition says in a white paper released this week. “Until the regulatory playing field for CDS software is better defined, it is likely that powerful and potentially life-saving CDS tools will be kept out of clinicians’ and patients’ hands.”

Bradley Merrill Thompson, a Washington D.C.-based attorney and coalition member who’s long advocated for better FDA guidance on mHealth, says the coalition is working on a policy proposal and is looking for feedback from stakeholders.

“The government has to do something soon on CDS,” he said in a letter to “It breaks my heart to think of all the useful software that is currently being shelved simply because the developers don't know what the road ahead looks like in terms of cost or duration.”

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CDS software guidance was identified as a priority by the FDA in 2015, and it’s been a crucial part of the agency’s ongoing efforts to regulate mobile healthcare apps. But the mHealth industry has been frustrated in its quest to determine how CDS is defined in mobile apps and devices, and how the FDA – and any other agency – would monitor its development.

“(D)eveloping a regulatory framework for CDS software is no easy task, as (the) FDA must strike a delicate balance between ensuring patient safety and promoting innovation,” the coalition states in its white paper. “However, until a regulatory approach is defined, CDS innovators will be left in the dark with regard to the expected costs and timelines for CDS development. Such uncertainty has already contributed to delays in CDS products reaching the market and, worse yet, the abandonment of CDS development projects altogether.”

According to its survey of close to 50 CDS developers, almost evenly split between startups and large companies, the coalition reported that 65 percent of respondents “agreed that (the) FDA has not provided clarity with respect to the CDS products it will regulate.” As a result, 62 percent reported a delay in their development of a CDS product, and 20 percent said those delays lasted more than one year.

“With the enormous explosion in clinical information, and with the digitization of patient health records, CDS can help doctors dramatically improve the quality of care,” Michael Robinson, MD, a California-based endocrinologist, said in a press release issued by the coalition. “I am anxiously awaiting mobile apps that will allow me to better guide my patients … . There also are several areas of my practice where I would welcome new clinical decision support software to help me sort through my many options.”

Part of the problem is that CDS is broken down into several categories, depending on how the software or device would affect clinical outcomes. While lower-level solutions, such as BMI indicators or medication reminders, aren’t likely to face serious scrutiny, software or devices that, for instance, predict risk factors or assist clinicians in treatment would be regulated because they carry the potential to harm patients.

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CDS developers often run into problems deciding which category their products would fall under – or, as the coalition states, they may have their own ideas but can’t figure out how the FDA would react.

According to the coalition, the FDA has been discussing CDS guidance since 2011, but hasn’t come up with anything definitive yet. Likewise, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, introduced in 2014 and then amended in 2015 by co-sponsoring Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.), which would define which CDS products are subject to regulation, is slowly winding its way through Congress.

“It is also important to understand that in many ways risk and benefit go hand-in-hand,” the coalition said in its white paper. “CDS products might be higher risk precisely because they deal with more serious disease in a more significant way. And that makes the results of the survey all the more disturbing because it is these higher benefit software products that are being stymied by the lack of regulatory clarity.”


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