Decision support dangers: Who's responsible?

Identifying high-risk clinical decision support systems is easy, but deciding how to make them safer and determining who is responsible for doing so is more difficult, attorney Brad Thompson of Epstein Becker Green told FierceHealthIT in an email. 

Leaders and industry experts, including Thompson, gathered on Wednesday for day two of a three day event to discuss proposed health IT risk-based framework regulations.

Yesterday's focus was CDS and the potential dangers of systems that, for example, connect to automated medical devices, Thompson, who serves as general counsel for both the mHealth Regulatory Coalition and the CDS Coalition, told FierceHealthIT.

At Day 1 of the event, attendees struggled to develop a singular definition for functionality in terms of health IT tools. 

Some attendees, Thompson said, including Joel White of the Health IT Now Coalition, argued in favor of legislation to regulate CDS. Others, including Thompson himself, don't believe that it is the best course of action.

Thompson said he urged the U.S. Food and Drug Administration to complete the guidance development process that began back in 2011 when it held a regulatory hearing on the topic of developing a guidance document for CDS. "Basically, there is a trade-off between the permanence of a statue--recognizing that statutes can be changed but it takes an act of Congress to do so--against the need for clarity at a granular level so that a specific entrepreneur can know with reasonable clarity whether [his or her] particular software is FDA regulated," he said.

Clinical decision support reference tools lack the level of integration necessary to provide the strategic direction that providers need, according to a report published in January by Orem, Utah-based research firm KLAS. The report focuses on four groups of CDS tools: disease reference, drug reference, nursing reference and diagnostic decision support. Through interviews with providers, KLAS evaluated each for impact on patient care, usability, perceived value and workflow.

Additionally, research published in December concluded that there's little evidence to support the notion that CDS tools in electronic health records can reduce inpatient costs. That same month, U.S. Reps. Erik Paulsen (R-Minn.) and Jim Matheson (D-Utah) introduced a bill in Congress that mandated the use of CDS software by physicians receiving Medicare and Medicaid reimbursement.

A project announced by the Centers for Medicare & Medicaid Services in March will focus on harmonizing the standards for clinical decision support and electronic clinical quality measurement.

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