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# Coalition Seeks Guidance on Clinical Decision-Support Software
- URL: https://www.fdaweb.com/coalition-seeks-guidance-on-clinical-decision-support-software/
- Published: 2016-10-10T12:00:00.000Z
- Updated: 2026-09-14T21:38:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137037

FDA needs to stop delaying a “a much-needed – and supposedly top priority – guidance” on clinical decision-support software, according to Clinical Decision Support Coalition counsel and Epstein Becker & Green partner **Bradley Merrill Thompson*.* The agency has been working on the guidance for five years, but it still hasn’t published anything, he says in a [*venturebeat.com*](http://venturebeat.com/2016/10/08/the-fdas-5-year-delay-on-automated-medicine-must-end/?ref=fdaweb.com) guest post.

The Coalition has suggested principles that FDA could adopt to “discern the difference between high- and low-risk software,” Thompson writes. “Some of those principles are derived from consensus guidelines developed by regulators worldwide. Others stem from the relatively common-sense proposition that the FDA should not regulate software designed to ensure that doctors can independently review the basis for the software’s recommendations and make their own decisions. The Coalition is focused on the complementary use of software with pharmaceutical products. Software now is used to inform many of the decisions around pharmaceutical care management, including drug selection and dosage. This is an area where FDA rules are very opaque, because the people at the FDA who regulate software and those who regulate drugs are in two entirely different Centers and it’s slowing innovation.”

In August, the group filed a [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2497-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) asking for public answers on three hypothetical case studies. “The Coalition’s proposal is for the FDA to move toward what we refer to as ‘case study guidance,’” Thompson says. “In this proposed model of regulating, the FDA would publish guidance not on broad topics where the scope is uncertain, but on specific real-world case studies. In this way, the FDA can give more timely and valuable guidance, without getting hung up on the need to anticipate every twist and turn the technology might take in the future.”