FDA Under Pressure To Deliver Clinical Decision Support Guidelines

The world of clinical decision support technologies may change soon, as the FDA may soon be releasing guidelines on how it will regulate such technology. According to a new report in Politico, the agency has been working on such guidelines since 2011, but it’s not clear what standards it will use to establish these rules.

Software vendors in the CDS business are getting antsy. Early this year, a broad-based group known as the Clinical Decision Support Coalition made headlines when it challenged the agency to clarify the scope of CDS software it will regulate, as well as what it will require from any software that does fall under its authority.

At the time, the group released a survey which found that one-third of CDS developers were abandoning CDS product development due to uncertainty around FDA regulations. Of CDS developers that were moving ahead despite the uncertainty, the only two-thirds were seeing significant delays in development, and 20% of that group were seeing delays of greater than one year.

The delay has caught the attention of Congress, where Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) have filed the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, legislation designed to resolve open questions around CDS software, but the problem still remains.

The FDA has had a research project in place since late 2014 which is creating and evaluating a CDS system for safe and appropriate use of antibiotics. The researcher-developed system generates alerts when a provider prescribes an antibiotic that poses a risk of serious cardiac adverse events for specific patients. Two of the 26 hospitals in the Banner Health network are participating in the study, one of which will use the system and the other which will not. The results aren’t due until April of next year.

It’s hard to say what’s holding the FDA up in this case, particularly given that the agency itself has put CDS guidance on his list of priority projects. But it could be a simple case of too much work and too few staff members to get the job done. As of late last year, the agency was planning to fill three new senior health scientist positions focused on digital health, a move which could at least help it keep up with the flood of new health technologies flooding in from all sides, but how many hours can they work?

The truth is, I’d submit, that health IT may be moving too quickly for the FDA to keep up with it. While it can throw new staff members at the problem, it could be that it needs an entirely new regulatory process to deal with emerging technology such as digital health and mobile device-based tools; after all, it seems to be challenged by dealing with CDS, which is hardly a new idea.

About the author

Anne Zieger

Anne Zieger

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.