In a risk-based regulatory framework for health IT released April 3 by federal agencies, clinical decision support software got major billing. In fact, an entire section of the draft report, developed by the Food and Drug Administration in coordination with the Office of the National Coordinator for Health IT and Federal Communications Commission, was devoted to CDS software. However, the level of detail in the report is lacking.    

"Frankly, just about everything in the CDS section was already known, except for maybe two or three of the examples that they gave of unregulated CDS. Basically there just wasn't much new there," Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues, told Health Data Management. 

The proposed FDA/ONC/FCC strategy divides health IT products into three categories--administrative health IT, health management heath IT, and medical device health IT--based on function and risk. Under the proposed framework, most clinical decision support software would fall into the health management heath IT category based on functions that "are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them." Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices. The draft report also proposes to rely on tools for testing, certification and accreditation of this category of products.

For the small subset of CDS software where medical device health IT functionality "present higher risks, and generally have been subject to active oversight by FDA, such active oversight should be continued," the draft report states. "FDA will work with federal and private stakeholders to clarify the types of medical device clinical decision support that should be the focus of FDA’s oversight." 

At a media briefing on the draft report, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said the regulatory agency's intention is to address these issues as part of a public meeting to be held in May to solicit public comments on the outlined strategy and approach. Another topic that industry is looking for clarification on is in the area of health and wellness. 

Shuren said the FDA will also provide greater clarity in the future on "general wellness versus disease-related claims" for medical devices. The FDASIA Workgroup, which provided input on the strategy and recommendations that are included in the draft report, recommended that the FDA provide additional clarity on CDS software, the distinction between wellness and disease-related medical device claims, as well as medical device accessories and medical device software modules.

"Many in industry have been waiting for years to find out more specifically the distinction between wellness and disease, exactly what constitutes medical device accessories, exactly what constitutes clinical decision support software that FDA would regulate, and parsing medical device software modules for regulation," said Thompson. "The report explicitly mentions all of those areas and says that they will be the subject of further clarity, and outside of the report obviously the agenda for 2014 for FDA includes those items. But I would like to have seen more in the report about where the agency plans to go with regard to those items." 

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