The HIMSS Electronic Health Record Association, a national trade association of EHR developers composed of 30 member companies, sent a letter to the U.S. Food and Drug Administration this week outlining concerns about the regulatory agency's final Guidance for clinical decision support software. 

WHY IT MATTERS

The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to exclude certain medical software functions, including certain decision support software, from the definition of device.

The EHR Association wrote in its December 6 letter that, while its members had contributed input on the draft guidelines in September 2019, and have long awaited the final guidance, they are concerned about five key areas based on the members' experiences supporting healthcare providers in their use of EHRs and other healthcare information technology.

The EHR vendors say CDS is highly intertwined with EHR technology, but can be sourced from a number of places, making compliance responsibility murky.

"The FDA’s guidance does not appropriately reflect the reality that decision alerts are frequently created and configured by provider organizations and that for many health IT solutions, the developer asserts little or no control over CDS configuration," the EHR Association said in the letter.

"It is unclear who ultimately has an obligation to enforce compliance when a provider is using the solution to deliver CDS they have developed themselves or purchased and implemented directly from a third party."

The second concern for the EHR Association is that extensive functionality existing within EHRs, "that seems to directly or in part bump up against the FDA’s new guidance," is already in use across the market.

"Clinical decision support has been part of [Office of the National Coordinator for Health Information] EHR certification requirements since 2011 and is widely deployed," the group's letter said. "We are highly concerned that this guidance could lead to disruption in the availability of solutions that clinicians rely upon to maximize both the usability of their EHRs, as well as to help them sift through the massive amounts of patient data they have gathered when making decisions about diagnosis and treatment plans."

To address this concern, the vendors then asked the following questions:

1. How does the FDA plan to address the long list of CDS tools already on the market and in active use by hospitals and providers that the FDA has now essentially classified as device CDS through this guidance? 
2. Does the FDA mean to say that the CDS functionality needs to be removed from the EHR, is it allowed to remain in the EHR if it is somehow divided or separated in such a way that it does not impact other EHR functionality, or can the module remain as is, as long as it is managed as CDS?
3. Is there an expected effective date, or a transition period the FDA has in mind?

In the letter, the EHR Association discussed the distinction between CDS and clinical decision-making. It says the guidance is conflating artificial intelligence-driven decisions without input, review or interaction from the clinician at the point of care with CDS, where clinicians always have a choice to follow or not follow a decision support result with a single recommendation.

"The approach suggested in the CDS guidance wherein alerts would always need to include options would significantly impair the helpfulness of clinical decision support alerts that significantly aid in decision-making today." 

Additionally, the EHR Association said the guidance is "arbitrary in making distinctions" that determine what constitutes device CDS, such as not categorizing medication/allergy alerts, and requested revisions.

Finally, the vendors took issue with what they say is an interpretation of many common scenarios as automation bias in CDS.

"The fact that an alert has been successfully designed to be easily interpreted seems an unreasonable criterion for identifying it as automation bias," the EHR Association said. 

While they acknowledge that artificial intelligence-enabled CDS is an important concern, the EHR vendors suggest dealing with it separately, in specific AI guidance. They recommend the FDA revisit the issue.

THE LARGER TREND

The FDA has been trying to draw a line between regulated devices and unregulated functionality for some time.

Previously, the American Medical Informatics Association weighed in on the FDA's decision support rules, stating that the draft guidance left "lingering confusion among developers and clinicians trying to determine whether specific decision support software is, or is not, considered a device."

ON THE RECORD

We are highly concerned that this guidance could lead to disruption in the availability of solutions that clinicians rely upon to maximize both the usability of their EHRs, as well as to help them sift through the massive amounts of patient data they have gathered when making decisions about diagnosis and treatment plans.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS publication.