Welcome to the first installment of Arnold & Porter's Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.
US News US News
FOOD AND DRUG ADMINISTRATION
FDA Issues Final Clinical Decision Support Software Guidance: On September 28, 2022, the Food and Drug Administration (FDA) issued a long-awaited final version of a guidance governing the regulation of clinical decision support (CDS) software as medical devices (Final CDS Guidance). As amended in 2016 by the 21st Century Cures Act (Cures Act), the statutory definition of a "device" excludes certain lower-risk software functions, including certain CDS software functions. FDA previously issued draft guidance explaining the agency's interpretation of the Cures Act criteria for exempt non-device CDS functions in 2017 and issued a revised draft guidance in 2019 (Draft CDS Guidance). The Final CDS Guidance issued differs in important ways from the Draft CDS Guidance, and suggests FDA intends to take a more expansive view of CDS software functions subject to agency oversight. Significantly, the Final CDS Guidance eliminates the enforcement discretion policy for certain low-risk patient and caregiver device CDS functions described in the Draft CDS Guidance. Although FDA interprets the Cures Act non-device CDS exemption as being limited to qualifying CDS functions intended for healthcare providers (HCPs), the Draft CDS Guidance articulated that the agency did not intend to enforce compliance with device requirements for certain device CDS functions for patients and caregivers for non-serious diseases or conditions under certain circumstances. The Final CDS Guidance does not include this enforcement discretion policy nor the enforcement discretion policy for low-risk device CDS functions for HCPs that fail to qualify as a non-device under the Cures Act criteria. In the Final CDS Guidance, FDA indicates that such CDS functions are considered medical device functions, but notes that certain such functions could fall within the scope of enforcement discretion policies described in other existing FDA digital health guidance.
In addition, the Final CDS Guidance includes important clarifications about each of the four Cures Act criteria that a CDS function must meet to be exempt from the device definition. For example, under the Final CDS Guidance, to meet Cures Act criterion 3, a non-device CDS software function's outputs or recommendations should not be directive or specific to a particular treatment or diagnosis. The Final CDS Guidance also provides more clarity around the information that should be included in a CDS software or its labeling to meet the Cures Act criterion 4 end-user transparency element, which often is the most difficult of the four mandatory exemption criteria for medical software developers to meet—particularly those using proprietary datasets, algorithms or artificial intelligence-driven analysis tools. The Final CDS Guidance also provides clearer examples of the types of CDS software functions that are and are not subject to regulation as medical devices.
Additional information about the Final CDS Guidance can be found in Arnold & Porters' October 17 Advisory.
FDA Holds Webinar on Final CDS Guidance: On October 18, 2022, FDA officials hosted a public webinar to discuss and answer questions about the Final CDS Guidance. Of note in the webinar, FDA emphasized that the Final CDS Guidance more clearly than ever before makes clear that even some of the most complex machine learning technologies can meet the Cures Act criteria for a non-device CDS, and that the Final CDS Guidance provides a roadmap for developers who choose to go that route. With respect to the enforcement discretion policies question, FDA officials confirmed that the Final CDS Guidance does not contain the enforcement discretion policies described in the Draft CDS Guidance and stated that the focus of the Final CDS Guidance is on statutory criteria for non-device CDS. However, FDA explained that enforcement discretion policies in other FDA guidance could apply to certain device CDS functions. For example, the agency suggested that certain CDS software tools could fall within the enforcement discretion policy for software functions that "help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions" described in FDA's Policy for Device Software Functions and Mobile Medical Applications.
Despite the Final CDS Guidance not including the two enforcement discretion policies described in the Draft CDS Guidance, FDA suggested that there are no products that previously were not devices that would now be considered devices due to the Final CDS Guidance. Rather, the agency expressed its view that the Final CDS Guidance is consistent with how FDA has been implementing the Cures Act since 2016. FDA recommended that developers with questions about the regulatory status of their CDS tools under the Final CDS Guidance contact the agency or consult FDA's Digital Health Policy Navigator resource (see below). Materials from the webinar, including links to the transcript and video, can be found under the "Specialty Technical Topics" tab of the CDRH Learn website.
FDA Updates Other Digital Health Guidance Documents: On the same day that FDA released the Final CDS Guidance, the agency also made updates to several other previously finalized digital health guidance, including FDA's Policy for Device Software Functions and Mobile Medical Applications (Software Functions and MMA Guidance), which specifies the types of software functions, including mobile medical application software functions, that FDA intends to actively regulate as devices. FDA revised the Software Functions and MMA Policy to ensure consistency with the Final CDS Guidance and last year's final rule, titled "Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act" (Device Classification Final Rule). That rule updated FDA device classification regulations to be in accordance with the Cures Act (e.g., removing statutorily exempt software functions from the classification regulations). Notably, in step with the Final CDS Guidance, the Software Functions and MMA Policy now specifies that software functions performing patient-specific analyses and providing patient-specific recommendations to users that are not HCPs are devices and revised examples of CDS software functions that are not devices to explicitly include certain non-device CDS criteria (e.g., enabling the HCP to independently review the basis for the information).
FDA also issued a revised Medical Device Data Systems, Medical Image Storage Devices and Medical Image Communications Devices Guidance (MMA Guidance). The guidance ensures consistency with the Device Classification Final Rule, as well as makes minor changes addressing submitted comments. FDA's policy for, and definitions of, non-device medical device data systems (MDDS) and device MDDS remains largely the same. Please refer to our October 17 advisory for additional information about the revised Software Functions and MMA Policy, the revised MDDS Guidance, and for a list of other digital health guidance updated by FDA.
FDA Makes Available Digital Health Policy Navigator and Other Digital Health Resources: In conjunction with release of the Final CDS Guidance and revisions to other digital health guidance, FDA also posted to its website various resources intended to assist developers understand whether their proposed digital health software products could be subject to regulation as medical devices. These resources include a new " Digital Health Policy Navigator" (Policy Navigator) which provides an interactive overview of the FDA digital health policies that might apply to a proposed software function. The Policy Navigator includes seven steps, with the answers to each question guiding users through the most relevant FDA medical device regulatory considerations. The webpage for the Policy Navigator cautions that the results of the Policy Navigator are not a formal device determination for a product. During the Q&A portion of the above-referenced October 18 Final CDS Guidance webinar, FDA referred individuals with questions about the regulatory status of certain CDS tools to this Policy Navigator. Another example of a new FDA digital health resource is a decision tree intended to help CDS developers analyze whether a proposed CDS software function is a medical device function available on the agency's website.
FDA Updates List of Devices That Incorporate Artificial Intelligence/Machine Learning: On October 5, 2022, FDA updated its "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices" webpage to include 178 additional AI/ML-based devices. First made available in September 2021, this webpage identifies FDA-cleared, approved or authorized medical devices that incorporate AI or ML marketed in the US. FDA assembled the list by searching FDA's publicly-facing information and other publicly available resources, and notes that the list is not intended to be an exhaustive or comprehensive resource of AL/ML-enabled devices. When FDA first released the list of AI/ML-enabled devices, the agency explained that it intended to update the list on a periodic basis. The October 5 update appears to potentially be the first update since FDA's initial issuance of the list in 2021. While the 178 newly added devices span therapeutic areas, the majority appear to be radiology devices. Of the 178 devices, 91 were cleared, approved or authorized in 2022.
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