Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market. 

“The resulting overregulation would be to the detriment of patient care,” CDS Coalition Leader Bradley Merrill Thompson wrote in the comment that he penned on behalf of the organization.

The Clinical Decision Support Coalition is a recently-founded organization dedicated to ensuring clincial decision making software doesn't become overregulated, while ensuring patient safety.

In December the FDA finally released the new CDS draft guidance, which outlined forms of CDS which won't be regulated based on the degree of human involvement instead of based on risk. The draft says CDS software won’t be regulated if the physician can independently review and understand the basis of the software’s decision. 

The coalition's letter outlines three changes that it recommends to the CDS draft. First, it says the FDA should exempt low risk CDS software from FDA oversight and use the international criteria for stratifying risk of CDS software. Secondly, the organization urged the FDA to modify the draft to follow the Cures Act, which “allows for unregulated software that provides unique insights that the healthcare professional might not have come up with on his or her own, as long as the user has access to the factual basis for the insights.” Lastly, the organization said the FDA should include more examples of what is and isn’t going to be regulated.

The coalition says that as the draft is currently written it does not take a risk-based approach and would force many existing CDS software companies to remove their products from the market, until undergoing the FDA regulatory process. 

“[T]he Draft Guidance fails to take an approach that is risk-based, and would sweep within the scope of FDA regulation software that, for example, guides a physician on how to treat an occasional headache, if the software is not transparent enough to be exempt under the 21st Century Cures Act (“Cures Act”),” Thompson wrote in the letter. “Just four years ago, FDA worked with the International Medical Device Regulators Forum (“IMDRF”) to develop a risk-based model for software as a medical device, including CDS. In that context, FDA and other regulators from around the world identified the two key factors that drive risk based on the intended use of software. Those two factors were the nature of the disease and the role of the software. Yet now, in proposing the U.S. policy for this topic, the Agency inexplicably abandons that international consensus.” 

The letter goes on to say that the new draft guidance would also expand the scope of FDA regulation. For example, products would now have to go through the FDA process because they offer insights based on machine learning. The new regulations only exempt an item if a physician is able to make the same recommendation without primarily relying on the software, according to the letter. 

“FDA’s approach would basically extend regulation to any software that offers insights that the user might not be expected to come up with on his or her own,” Thompson wrote in the letter.  “FDA would thus end up regulating any software that does not simply do mundane calculations that users could do themselves.” 

But the letter did note there were some helpful policies that the draft outlined. Notably, the letter applauded the way the guidance addresses software used by patients and non-healthcare professional caregivers. The comment also said the inclusion of the Center for Drug Evaluation and Research’s signatures and the fact that the guidances refrained from being overly prescriptive with how CDS content is displayed are also helpful. 

However, the letter goes on to continue to criticize key components of the draft, specifically criticizing the transparency requirements. Now all CDS software is required to go through FDA regulatory requirements unless the software is transparent. However, many companies may not want their software to be transparent because of a proprietary algorithm, which competitors could steal or because transparency could make the interface more complicated, according to Thompson. 

The comment also expresses concern that the draft guidance will unnecessarily cloud the future of CDS software based on machine learning. 

“Much of the CDS software of the future will be based on machine learning and other similar technologies,” Thompson wrote. “However, the Draft Guidance seems to preclude any CDS software that uses machine learning from falling outside of FDA’s regulatory purview. In this respect, the Draft Guidance appears to go beyond the Cures Act and extends FDA regulation to certain software that should be exempt under the statute.” 

Thompson concluded by recommending that the FDA revise the draft and re-issuing the guidance in a draft format once revised.