CDS Needs More Oversight to Have Impact on Radiology

Health care providers often juggle multiple pathways to treatment, including the use of medical imaging to diagnose injuries and conditions. At times, implementing clinical decision support systems can guide physicians to the option that yields the best possible outcome for patients.

However, these products have endured ambiguous regulation from the U.S. Food and Drug Administration, which oversees the approval of clinical software and other devices.

Providers want clarification on CDS
The FDA's Center for Device and Radiological Health has a lengthy agenda in 2015 as more products and systems are likely to be introduced in the coming year. Even electronic health record software continues to spring up in the industry, leading to more need for federal oversight than ever before.

According to Healthcare Informatics, the FDA has prioritized developing guidance for CDS software in the 2015 fiscal year, which is viewed by many as better late than never. So far, the agency has been noticeably ambiguous about what it plans to regulate for medical devices. It has taken a hands-off approach to approving mobile applications that guide decision-making while executives learn more about the burgeoning market.

However, the lack of specified oversight is tough on entrepreneurial developers who are looking for funding from interested venture capitalists. In 2014, legislation was introduced to U.S. Congress that aimed to establish three definitions of health-related platforms, but only one – medical software – would be subject to regulation by the FDA. As a result, the agency worked with the Office of the National Coordinator for Health IT and the Federal Communications Commission to publish a draft report that suggested risk-based framework for approving CDS and other clinical systems.

As these platforms become more integral to patient engagement and care management, the FDA is sure to issue official guidance on CDS software in 2015. In fact, a recent study showed that the platform can be used for ordering digital imaging for inpatients.

CDS can aid radiology departments
AuntMinnie.com reported that researchers from Henry Ford Health System, led by Andrew Moriarity, M.D., investigated the benefits of incorporating CDS into computerized physician order-entry software. They focused on a year-long period from Oct. 1, 2011 through Sept. 30, 2012, and assessed how providers at the care organization used CDS in the CPOE system to order CT and MR studies for adult patients.

Moriarity and his colleagues implemented the American College of Radiology's Appropriateness Criteria scores for the orders, with 1 to 3 considered "inappropriate", 3 to 4 deemed "uncertain" and 7 to 9 labeled "appropriate." While there was no statistically significant difference from the addition of CDS, it was enough improvement to purport that the software can be integral to decision-making.

Overall, the researchers found that physicians who had graduated in the most recent decade had the highest baseline AC scores. Yet the addition of CDS caused all other age cohorts to submit similar results and exceed initial reports.

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Ronny Bachrach

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Responsible for all marketing activities including, press, advertising, trade show coordination, website management, dealer and customer communications.