Clinical Decision Support Regulation Legislation – 2015


By William A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University,
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Draft legislation in the House related to the regulation of Clinical Decision Support (CDS) software has been revived for 2015 as a component of the proposed Cures Act. Subtitle M, Sensible Oversight for Technology Which Advances Regulatory Efficiency (which has the acronym SOFTWARE) addresses a variety of healthcare software including CDS.

When I addressed the earlier version of this title in December 2013 I noted that it was proposed to exempt CDS from FDA regulation. The 2015 version does not propose a blanket exemption of CDS but instead allows for the Secretary of Health and Human Services to make a determination that a system potentially “poses a significant risk to patient safety”. This determination is to be based on:

  1. the likelihood and severity of patient harm if the product were to function improperly,
  2. the clinical significance of the information or recommendations supplied by the product,
  3. the extent to which the product is intended to replace the clinical judgment of a medical professional,
  4. whether a review of the means by which the analysis was performed by the product with respect to a particular disease or condition could be reasonably performed by a medical professional,
  5. whether there exists a means to independently evaluate and verify the accuracy of the analysis performed, and
  6. the intended use of the product, including the intended user and user environment.

Together these factors would allow for a consideration of whether the clinical user can in fact make an independent judgment using the same methodology as the CDS, and whether they are likely to do so. These questions are key to dealing with the claim by some that a CDS is effectively always subject to the judgment of the clinical user, ie the CDS is not to be relied on. This is particularly popular among CDS developers because it seeks to preemptively take them off the hook when there is an examination of the accuracy of the “advice” provided.

The proposed test also suggests a nice look at significance. If the CDS isn’t doing anything particularly important then maybe less or no regulation is appropriate whereas if the subject matter is important, more regulation may be required.

Overall the proposed provision builds in the “regulatory discretion” that FDA already says it follows in deciding what to regulate, and how strictly. In this regard the proposed legislation may not do anything new in this arena.

There is related draft legislation in the Senate which does exempt CDS from FDA regulation rather than create a possible exception by the Secretary, provided that the physician can “independently review the basis for each recommendation that the software presents such that it is not the intent that the health care professional rely solely on any specific recommendations or results provided by such software to make a clinical diagnosis or treatment decision. So the Senate draft is happy with the don’t-rely-on provision.

We will have to wait and see if either of these revised drafts have any traction, and whether Congress is inclined to actually much legislation.