The Clinical Decision Support Coalition comprises healthcare industry stakeholders – software developers, patient advocacy groups, clinical societies, providers and healthcare payers – working to develop policy positions on CDS technology that safeguard patient safety while also encouraging innovation free from overregulation.

"The Coalition’s focus is to proactively develop a proposal for how to draw the line between regulated and unregulated CDS software," according to its mission statement. "The Coalition will develop answers to two basic questions: What types of CDS software should be regulated? And for those types of CDS software that are regulated, to what level should they be regulated?"

[Also: Clinical decision support: no longer just a nice-to-have]

This past week, the group released its "Voluntary Industry Guidelines for the Design
of Medium Risk Clinical Decision Support Software to Assure the Central Role of Healthcare Professionals in Clinical Decision-Making."

The 21st Century Cures Act removes certain CDS software from the scope of FDA regulation. While FDA governs high-risk software, according to CDSC, medium-risk tools are those that use patient-specific information and organized clinical knowledge; perform some analysis using that information and knowledge (rather than just displaying or transmitting the data); produces a particular actionable recommendation (with or without additional recommendations) for the diagnosis, treatment or management of a disease or condition for a particular patient; and is not an accessory to a medical device.

"Separately, over the last several years, many companies developing CDS software have been sorting through the various design options for empowering the user to take control of the decision-making," according to the CDSC. "In this quest, some companies have been looking for guidelines on the proper approach to user engagement.

The need for some guidance is especially acute as more and more companies innovative with the use of "machine learning and other forms of artificial intelligence to power CDS software," said CDSC officials.

For those technologies not regulated by the FDA, CDSC recommends self-regulating through voluntary design guidelines, in order to provide a unified approach to software development and "a basic level of transparency."

Essentially, the guidelines are meant "to give software developers a framework for discerning whether additional validation – beyond that which they would ordinarily do – is required as a consequence of the software taking over decision-making from healthcare professionals," according to the group. "These guidelines reflect the view that taking over, in any substantial way, the healthcare decision-making carries with it heightened responsibility for validation."

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