HIMSS Electronic Health Record Association, a national trade association of EHR developers that includes 30 member companies, sent a letter to the U.S. Food and Drug Administration this week outlining concerns about the The ultimate regulatory authority guide to clinical decision support software.
WHY IT IMPORTANT
The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to exclude certain functions of medical software, including certain decision support software, from the device definition.
The EHR Association wrote in its December 6 letter that, although its members had already provided comments on the draft guidance in September 2019 and had long awaited final guidance, but they are concerned about five key areas based on members’ experience in assisting healthcare providers in their use of EHRs and other healthcare information technology.
EHR vendors say CDS is tightly coupled with EHR technology, but can be obtained from a number of places, making compliance responsibilities ambiguous.
“FDA guidance does not properly reflect the fact that decision alerts are typically created and configured by provider organizations, and that for many health IT solutions, developers claim little or no control over the decision-making process.” CDS configuration control,” the EHR Association said in the letter.
“It is not clear who is ultimately obligated to enforce compliance when a vendor is using a solution to deliver CDS that they have developed themselves or purchased and deployed directly from a third party.”
A second concern for the EHR Consortium is that the expanded functionality existing in the EHR, “apparently directly or in part against the new FDA guidance,” has been used throughout the market.
“Clinical decision support has been part of the [Office of the National Coordinator for Health Information] EHR certification has been required since 2011 and is widely implemented,” the group’s letter said. Clinicians rely on to maximize both their ability to use EHRs, as well as to help them sift through the massive amounts of patient data they’ve gathered when making decisions about a diagnostic plan and treatment.”
To address this concern, the providers then asked the following questions:
- FDA plans to address the long list of CDS tools that are already on the market and actively used by hospitals and providers, which FDA has now classified as a device CDS through this guidance as: how?
- Is FDA saying that CDS function needs to be removed from EHR, is it allowed to stay in EHR if it is divided or segregated somehow in a way that does not affect other EHR function or tissue- module can stay that way as long as it’s managed as a CDS?
- Does the FDA count on an expected effective date or a transition period?
In the letter, the EHR Consortium discussed the difference between CDS and clinical decision making. It says the guideline is incorporating artificial intelligence-based decisions without input, assessment or interaction from the point-of-care clinician with CDS, where clinicians always have a choice choose whether or not to follow a decision support outcome with a single proposition.
“The approach suggested in the CDS guidelines, where warnings should always include options, would greatly reduce the usefulness of clinical decision support alerts that significantly aid decision-making. nowadays.”
In addition, the EHR Association says the guidance is “arbitrary in discriminatory” identifying elements of a device’s CDS, such as not categorizing drug/allergy warnings and requiring modifications.
Finally, vendors take issue with what they say is how to interpret many common scenarios such as automation trends in CDS.
“The fact that an alert has been successfully designed to be easy to understand appears to be an unreasonable criterion for identifying it as an automation trend,” said the EHR Association.
While they acknowledge that AI-powered CDS is an important concern, EHR vendors suggest handling this separately, in specific AI guidance. They asked the FDA to reconsider the matter.
TREND TO BIGGER WOMAN
The FDA has been trying to draw the line between controlled devices and uncontrolled functionality for some time.
Previously, the American Health Informatics Association weighed in on the FDA’s decision support rules, claiming that the draft guidance left “persistent confusion among developers and clinicians.” is trying to determine if a particular decision support software should be considered a device.”
ON PROFILE
We are very concerned that this guidance could lead to disruption in providing the solutions that clinicians rely on to maximize both their EHR use and help them screen the vast amount of patient data they have collected when making decisions about diagnosis and treatment plans.
Andrea Fox is the senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS.
