Virtual and Digital Health Digest – Healthcare

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Welcome to the first installment of Arnold & Porter’s virtual and digital health digest. This inaugural edition includes highlights from September and October in the virtual and digital health space. This newsletter focuses on major virtual and digital health and telehealth related developments in the areas of healthcare, regulatory, privacy and corporate transactions in the United States, the United Kingdom and the European Union.

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 draft document governing the regulation of clinical decision support (CDS) software as medical devices (final CDS). released a long-awaited final version of the guidance. Advice). As amended by the 21st Century Cures Act (the Cures Act) in 2016, the statutory definition of a “device” excludes certain low-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 FDA previously issued draft guidance explaining the agency’s interpretation of the Cures Act criteria for exempt non-device CDS tasks in 2017 and issued a revised draft guidance in 2019 (Draft CDS Guidance). The final CDS guidance issued differs from the draft CDS guidance in important ways, and suggests that FDA seeks a more detailed consideration of CDS software functions subject to agency oversight. Notably, the final CDS guidance eliminates the enforcement discretionary policy for certain low-risk patient and caregiver device CDS actions described in the draft CDS guidance. Although the FDA Cures Act interprets the non-device CDS exemption as being limited to eligible CDS functions for healthcare providers (HCPs), the draft CDS guidance clarified that the agency may exempt device requirements for certain device CDS functions for patients. does not intend to enforce compliance. and caregivers for non-serious illnesses or conditions in certain circumstances. The final CDS guidance does not include this enforcement discretion policy nor does the enforcement discretion policy for low-risk device CDS actions for HCPs that fail to qualify as 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 some such functions may fall within enforcement discretion policies described in other existing FDA digital health guidance.

In addition, the final CDS Guidance contains important clarifications regarding each of the four Cures Act criteria that a CDS function must meet in order to be exempt from the device definition. For example, under final CDS guidance, to meet Cures Act Criterion 3, the outputs or recommendations of a non-device CDS software function must not be prescriptive or specific to a particular treatment or diagnosis. The final CDS guidance also provides more clarity about the information that must be included in CDS software or its labeling to meet the Cures Act Criterion 4 end-user transparency element, which is often one of the four mandatory exemption criteria for medical software. Most difficult of all. To meet developers – especially those using proprietary datasets, algorithms or artificial intelligence-powered analysis tools. The final CDS guidance also provides clear examples of the types of CDS software functions that are and are not subject to regulation as medical devices.

Additional details on the final CDS guidance can be found in Arnold & Porters’ advisory dated October 17.

FDA Hosts 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 is that the FDA emphasized that the final CDS guidance clarifies more clearly than ever that some of the most complex machine learning technologies can meet the Cures Act’s criteria for non-device CDS, And that final CDS guidance provides a roadmap for developers who choose to take that path. With respect to the question of enforcement discretion policies, FDA officials confirmed that the final CDS guidance does not include 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, the FDA clarified that enforcement discretion policies in other FDA guidance may apply to certain device CDS functions. For example, the agency suggested that some CDS software tools may fall under the Enforcement Discretion Policy for software functions that “enable patients (i.e., users) to self-manage their illness or conditions without providing specific treatments or treatment suggestions.” as described in the 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, the FDA suggested that there are no products that were not previously devices that would now be considered devices because of the final CDS guidance. Rather, the agency expressed its view that the final CDS guidance is consistent with how the FDA has been implementing the Cures Act since 2016. FDA recommends that developers with questions about the regulatory status of their CDS devices under the final CDS guidance contact or consult with the agency. FDA’s Digital Health Policy Navigator resource (see below). The contents of the webinar, including transcripts and links to videos, can be found under the “Featured Technical Topics” tab of the CDRH Learn website.

FDA Updates Other Digital Health Guidance Documents: On the same day that FDA issued the final CDS guidance, the agency also finalized several other previously issued guidelines, including FDA’s Policy for Device Software Functions and Mobile Medical Applications (Software Functions and MMA) Also updated the digital health guidelines prepared from guidance), which specifies the types of software functions, including mobile medical application software functions, that the 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 with the Medical Software Provisions in the 21st Century Cures Act” (Equipment Classification Final Rule). , That rule updated FDA device classification regulations in accordance with the Cures Act (for example, removing software functions that are statutorily exempt from classification regulations). Specifically, in step with the final CDS guidance, the Software Functions and MMA policy now specifies that software functions perform patient-specific analysis and provide patient-specific recommendations to users who are not HCPs and do not use CDS software functions. Modified examples that are not devices to explicitly incorporate some non-device CDS criteria (eg, enabling HCPs to independently review the information base).

The 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 making minor changes addressing submitted comments. The FDA’s policy and definitions for the non-device Medical Device Data System (MDDS) and the device MDDS are largely the same. Please see our October 17 advisory for additional information on the list of revised software functions and MMA policy, revised MDDS guidance, and other digital health guidance updated by FDA.

FDA Makes Digital Health Policy Navigator and Other Digital Health Resources Available: In conjunction with issuing final CDS guidance and revisions to other digital health guidance, FDA also posted various resources on its website to help 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) that provides an interactive overview of FDA digital health policies that may apply to the proposed software function. The Policy Navigator includes seven steps with 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 question-and-answer portion of the last CDS guidance webinar on October 18 referenced above, FDA referred individuals with questions about the regulatory status of certain CDS instruments 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 that is available on the agency’s website.

FDA Updates List of Devices to Include Artificial Intelligence/Machine Learning: On October 5, 2022, the FDA expanded its “Artificial Intelligence and Machine Learning (AI/ML)” list to include 178 additional AI/ML-based devices. -Enabled Medical Devices” webpage. First made available in September 2021, this webpage identifies FDA-approved, approved or authorized medical devices that incorporate AI or ML marketed in the US. FDA assembled the list by searching publicly available information and other publicly available resources, and notes that the list is not intended to be an exhaustive or comprehensive resource of AL/ML-capable devices. When the FDA first released the list of AI/ML-enabled devices, the agency made it clear that it intended to update the list from time to time. The October 5 update appears to be the first since the FDA released the list, potentially in 2021. While the 178 newly added devices span therapeutic areas, the majority appear to be radiology devices. Of the 178 devices, 91 were approved, approved or authorized in 2022.

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