Hospitals, vendors team to influence FDA, HHS on decision support

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Responding to a recent focus on clinical decision support systems by the U.S. Food and Drug Administration and the Department of Health & Human Services, an industry coalition is forming to influence their efforts.

Called the CDS Coalition, the group will be made up of hospital execs, clinicians, software vendors, payers, medical device makers, and trade groups, according to a coalition overview provided to FierceMobileHealthcare by one of its creators, FDA expert and attorney Bradley Thompson of Washington, D.C.-based Epstein Becker Green.

The goal is to provide industry guidance to the FDA, HHS and other agencies as they work to regulate clinical decision-support systems. One particular focus will be on the mobile connectivity that has become so integral to CDS today.

Thompson gives the example of a smartphone or cell phone app for diabetics. The users may enter information on their diet, exercise, sleep and other metrics, and receive recommendation on when to take insulin, and possibly how much to take, he explains. The algorithms and decision-making software are functions that regulators are uncertain how to regulate just yet, but certainly are causing them concern.

It's one of the crucial mobile issues the coalition likely will tackle--what devices and apps should be regulated, depending on their use and purpose in a CDS system.

As in the above example, when the mobile device actively calculates or is involved in clinical decision-making or recommendations, it "would be mobile decision support software," he explains. However, if the smartphone is "merely a conduit for decision support software, facilitating either data entry or delivery of the final analysis...it's the software that resides on a server somewhere that would be regulated, not the communication device/cell phone."

That won't likely be the first item on the coalition's agenda, however. Front and center right now is the FDA's draft policy guidance issued earlier this year, and the issues regulators raised about the safety of CDS software.

"My guess is they will first focus on developing a cohesive policy approach that can be shared with FDA for the agency's consideration as it develops a guidance document on this topic," Thompson says.

Other issues the coalition is certain to take on are electronic health records and security, although Thompson points out the true agenda won't be mapped out for a few months yet. Right now, he's putting out the call for industry members to join up in a Nov. 15 "introductory call," followed by an in-person meeting in Washington, D.C. on Dec. 7. He hopes to have the group ready to start work by Jan. 4, 2011.

To learn more:
- check out the CDS Coalition overview (.pdf)

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