This is the fourth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what data will be needed to substantiate the offering?
FDA Issues Updated Guidance on the Regulation of Digital Health Technologies
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure alignment with the new approaches being adopted by the Agency.
As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in the 21st Century Cures Act of 2016 (the “Cures Act”). Those guidance documents raised a number of issues that we discussed on this previous alert.
After receiving comments from stakeholders, the Agency responded by issuing: (i) a revised draft guidance document for clinical decision support (CDS) software (“Clinical and Patient Decision Support Software” or the “CDS Draft Guidance”) and (ii) a final guidance document for other software functions exempted by the Cures Act (“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” or the “Software Policies Guidance”).
Here are key takeaways on FDA’s newly-issued guidance:
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Top 10 Questions During Ideation of Digital Health Solutions
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested. Covington has created a Top 10 Questions for Ideation of Digital Health
Senators Introduce Legislation to Regulate Privacy and Security of Wearable Health Devices and Genetic Testing Kits
Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health
FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post.
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FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software
On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The AI Framework does not establish new requirements or an official policy, but rather was released by FDA to seek early input prior to the development of a draft guidance. FDA acknowledges that the approach “may require additional statutory authority to implement fully.”
In an accompanying press release, former FDA Commissioner Scott Gottlieb outlined the need for a “more tailored” regulatory paradigm for algorithms that learn and adapt in the real world. FDA’s medical device regulation scheme was not designed for dynamic machine learning algorithms, as the Agency traditionally encounters products that are static at the time of FDA review. The AI Framework is FDA’s attempt to develop “an appropriate framework that allows the software to evolve in ways to improve its performance while ensuring that changes meet [FDA’s] gold standard for safety and effectiveness throughout the product’s lifecycle.”
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Key Takeaways from FDA’s Framework for Real-World Evidence for Pharmaceuticals
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.” FDA opened a docket for public comments on the Framework through February 5, 2019.
The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness. The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications. The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs. This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team.
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Significant FDA Digital Health Policy Development for Prescription Drug Sponsors
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s prescription drug(s). Last spring, the Commissioner stated that FDA would be seeking input “on how to support the development of digital health tools that are included as part of approved drugs.” The goal in establishing the framework, Gottlieb stated, would be “to develop an efficient pathway for the review and approval of digital health tools as part of drug review, so that these tools reach their full potential to help us treat illness and disease, and encourage synergies between software and therapeutics that meet FDA’s gold standard for safety and effectiveness.”
This policy development is significant, not only because it is one of CDER’s first policy statements on digital health associated with pharmaceuticals (see a few of our earlier posts about pharma-related digital health here and here), but also because it implicates a broad range of information that could be made available by prescription drug sponsors through software used with their products. We encourage prescription drug sponsors with any interest in providing digital health solutions, including through collaborations, to review the Federal Register notice and consider submitting comments to FDA.
Here are a few key takeaways from FDA’s notice:
- Under the proposed framework, software with the same drug-related functionalities will be subject to different regulatory approaches by FDA, depending on the developer of the software. FDA will apply the proposed framework to prescription drug-user-related software developed by or on behalf of pharmaceutical manufacturers, and a different approach to drug-related software developed “independently” by third-party software developers and other entities that are not prescription drug sponsors.
- It is unclear from the notice how the proposed framework, including the evidentiary standards described in the Federal Register notice, will align with other FDA initiatives such as the use of real-world evidence for drug development and the pre-certification program (see our earlier post here).
- An important question for prescription drug sponsors in particular is whether the proposed framework will encourage continued digital health innovation, including through collaborations, or whether FDA’s proposal will create challenges that may discourage advances in this area.
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What physicians are reading about digital health
There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions. These papers serve as examples of the active dialogue taking place around the appropriate regulatory
Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar:
- Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company