Will FDA make revisions to Clinical Decision Support Software Guidance as asked by EHR Vendors?
HIMSS EHR Association layout distress and ask for clarifications around problems like automation discrimination.
It also raises concerns about how the industry is going to cope with the transition away from legacy technologies that clash with the guidance.
What is HIMSS Electronic Health Record Association?
The HIMSS EHR Association is a national trade association of EHR developers including 30 member companies. A letter regarding the concerns has been sent by them to the US Food and Drug Administration by early December 2022.
Why do the concerns matter?
The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to eliminate some medical software functions, like certain decision support software from the definition of a device.
In its December letter, EHRA wrote, in September 2019, while its members had contributed input on the draft guidelines, and waited for the final guidance for a long time, they are worried about 5 key areas. These 5 key areas depended on the members’ experiences assisting providers in their EHR usage and other health information technology.
The EHR vendors state CDS is very much entwined with EHR technology. But it can be sourced from various places making compliance gloomy.
What does FDA’s guidance say?
It does not completely consider that decision alerts are constantly created and Configured by provider organizations. For many health IT solutions, the developer maintains little to no control over CDS configuration.
- The first concern EHR Association has is that it is obscure who has the final obligation to impose compliance when a provider is utilizing the solution to dispatch CDS they have developed by themselves or buy and implement directly from a third party.
- The second is the large-scale functionality of the EHRs consist. It seems like it directly or partially increases against the FDA’s new guidance which is already in use.
CDS is a part of EHR certification requirements (Office of the National Coordinator for Health Information) since 2011 and is widely used across healthcare systems.
The Association says, that this guidance could lead to disturbances in the availability of solutions that clinicians depend upon to optimize their EHR usability and filter through the abundant amount of data they have collected for making clinical decisions.
The Questions asked by Vendors to address these Concerns
- 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?
- 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?
- Is there an expected effective date, or a transition period the FDA has in mind?
After much debate, the EHR vendors concluded that after considering common interpretations, the automation is biased towards CDS.
The FDA for some time has been trying to put a line between regulated devices and unregulated functionality.
The American Medical Informatics Association previously observed the FDA’s decision support rules, voicing that the draft guidance resulted in persistent confusion among developers and clinicians trying to decide whether specific decision support software is or isn’t considered a device.
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