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Industry Raises Concerns with FDA Draft Guidance on Clinical Decision Support Software

Posted 15 March 2018 | By Ana Mulero 

Industry Raises Concerns with FDA Draft Guidance on Clinical Decision Support Software

A draft guidance from the US Food and Drug Administration (FDA) on clinical and patient decision support software received a deluge of industry comments highlighting key issues and concerns.  

The draft document – issued December 2017 as part of the agency’s recently launched action plan to shift its regulatory approach on digital health products – provided initial interpretations on the scope of FDA oversight by identifying the types of functionalities that fall outside of the definition of a medical device, as amended by the 21st Century Cures Act, and are exempt from certain compliance requirements.

The Cures Act offered clarity for reducing regulatory involvement as FDA comes increasingly under pressure to reevaluate its use of resources. This prompted a need for new guidance, including a draft on changes to existing medical software policies and final guidance on software as a medical device (SaMD), but beginning with that of clinical decision support (CDS) software.


From vendors of electronic health record systems, such as Epic, Cerner, and athenahealth, to industry groups like AdvaMed and device maker GE Healthcare, the standard set forth in the draft versions with regards to data transparency is of major concern.

There is shared consensus that “the critical element is whether the software makes the information available to the user, not whether it is publicly available,” athenahealth argued. The issue with how the current approach is described is centered on how it may “limit the types of information that can be incorporated into CDS, which will in turn decrease the number of CDS tools on the market.”

According to AdvaMed, the concept of transparency in the context of the CDS guidance “should remain focused on the information underlying the recommendation within an artificial intelligence and/or machine learning process, rather than the algorithm itself.”

Health IT Now, a coalition that encourages wider use of health software, supported this argument, stating that Congress’ intention behind provisions of the Cures Act was for “the data be transparent to the user, not the algorithms into which the data are entered.”

Risk-based Approach

Another shared point in question relates to a lack of a risk-based framework to ensure clarity on FDA’s scope of software regulation and enforcement discretion.

The Clinical Decision Support Coalition said that if the draft guidance is implemented as is, there could be fewer CDS products on the market.

The coalition noted that about four years ago, FDA’s participation in the International Medical Device Regulators Forum contributed to the development of a SaMD risk-based approach using two intended use factors: the nature of the disease and the role of the software. “Yet now, in proposing the US policy for this topic, the agency inexplicably abandons that international consensus,” the coalition said.

GE Healthcare echoed the need for a risk-based model, arguing that the questions raised “regarding scope and extent of the proposed level of oversight” could cause an “unintended consequence of limiting innovation that may not fully correspond to the needs of protecting public health.”

Health IT Now, on the other hand, disagreed with these views. “We believe that the draft guidance is aligned with Congressional intent and appropriately adopts the risk-based framework called for in the law for clinical decision support software,” it said.

AdvaMed and the international nonprofit Healthcare Information and Management Systems Society (HIMSS) requested that FDA issue additional guidance to describe how it intends to regulate CDS subject to its rules and regulations.

HIMSS also called for a more specific definition of CDS that can ensure “a degree of flexibility moving forward” due to the certain situations in which changes made to a device can result in “an entirely new technology.”

Concerns over how accountability will be determined were expressed as well. HIMSS argued that “the drafted approach of requiring vendors to label and identify the CDS intended users is very challenging due to the expected need for, and reality of, end-user customization.”


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