The CDS Alliance is asking the US Food and Drug Administration to withdraw its clinical decision support guidance to ensure that the agency better balances its regulatory oversight with the need healthcare industry innovation while adhering to the statutory language of 21st Century Cure Action.
‘Intuition’ disregards the law and the intentions of Congress
Alliance stakeholders – clinical decision support software developers, patient advocates, clinical societies, healthcare providers and healthcare payers – said FDA guidance exceeds Congress’ statutory definition of what counts as CDS and threatens to undermine lawmakers’ goals.
“The Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services strongly believe that CDS software will help improve quality of care, and that innovation must be encouraged in the this time,” the union said in a February 6 petition prepared by Epstein Becker & Green, PC
“Congress has expressed similar intentions to remove certain functions of CDS from FDA regulation as a medical device under the 21st Century Cures Act. FDA action in exporting CDS Guidelines contrary to these other federal policies and the intent of Congress.”
The union added that CMS has long made it clear that CDS includes diagnostic support. The formula for CDS, according to the 2014 CMS document, links the petition to specify the following structure:
- Appropriate information – including evidence-based guidance.
- The right people – the entire care team and the patient.
- On the right channels – EHR, patient portal, etc
- In the right format – dashboards, orders.
- At the right points in the clinical workflow – optimizing decision making or action.
Obligation to comply is unclear
In December, the HIMSS EHR Consortium sent a letter to the FDA that also expressed concern and focused on the closely linked nature of CDS with EHR technology.
“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 a letter to the FDA.
“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.”
The organization points out that with CDS sources from several places, compliance responsibilities are unclear and will become cumbersome, hindering innovation.
Unsustainable claim and harmful to public health
The CDS Alliance, formed in 2012 after the FDA announced its intention to develop CDS guidelines, argued that in the final guideline, the FDA was harming its own ability to enforce the law, harming human health. public health and will be overwhelmed with submissions.
The alliance shared a summary of the following key points:
- The FDA’s own filing regarding the CDS software shows no public health issues to be addressed.
- The FDA is harming rather than helping public health by preventing innovators from developing CDS software for the betterment of the community and imposing arbitrary rules on technology development that does not serve them. their intended purpose.
- The FDA is ending the process that Congress established for the agency to expand its regulatory oversight in the event the agency determines there is a need to do so.
- FDA is illegally entering US state jurisdiction over the practice of medicine and thereby violating the Constitution.
- The FDA violated federal law by publishing the CDS Guidelines without sufficient notice to give the public a legitimate opportunity to comment.
- The FDA violated federal law by ignoring the plain language of the Cures Act, and instead inventing its own interpretation that went against the intent of congress.
- FDA is taking on unsustainable liabilities.
“Among other things, the FDA should, among other things, make clear in the re-proposed guideline that CDS software can actually recommend a single diagnosis or treatment route,” the union said.
Andrea Fox is the senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
