On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable provisions related to digital health.  This post highlights three items of potential interest for stakeholders in the space.

  1. Future FDA Digital Health Guidance

Section 502 of the discussion draft, titled “Modernizing Clinical Trials,” would require FDA to issue three draft guidances:

  • The appropriate use of digital health tools in clinical trials to help improve recruitment, participation, and data collection. This draft guidance also would include recommendations for “increasing access to, and the use of, [digital health tools] in clinical trials to facilitate the inclusion of diverse and underrepresented populations.”
  • Use of decentralized clinical trials to support the development of drugs and devices, improve trial participant engagement, and advance the use of flexible and novel clinical trial designs. Similar to the above, this FDA draft guidance would also include recommendations on how to encourage diversity among clinical trial participants.
  • Use of seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of applications for drugs and biological products.

FDA would have to issue all three drafts within one year after date of enactment of the Act.  Notably, if these guidance directives are enacted, FDA also would need to assess how the required guidance documents intersect with existing FDA guidance, such as the December 2021 draft guidance titled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

Watch this provision as it moves through the legislative process, as the topics and subtopics of the guidance directive could evolve and impact the content and timing of future FDA guidance relating to digital health technologies.

  1. Advancing Real-World Data and Real-World Evidence (RWD/E)

The last few months have seen increased FDA activity in the RWD/E front, with RWE playing a key role in notable regulatory decisions made by the Agency (see here and here).  Indeed, the Agency issued four new RWD/E guidance documents as part of the 21st Century Cures Act requirements, and made further RWD/E-related commitments as part of PDUFA VII for fiscal years 2023 through 2027.  The PREVENT Pandemics Act discussion draft makes clear that advancing RWD/E continues to be a topic of interest for Congress as well.  Section 505 of the discussion draft, titled “Facilitating the Use of Real World Evidence,” would require FDA to issue or revise guidance on the use of RWD/E to support regulatory decision making, including with respect to RWD/E from products authorized for emergency use (i.e., under an EUA pursuant to section 564 of the FDCA).  Not later than one year after enactment, FDA would have to issue or revise guidance that addresses the use of RWD/E to support the approval of a drug application (or clearance or classification of a device).  The guidance also would need to address considerations for the inclusion in such applications or submissions of RWD/E obtained as a result of the use of drugs or devices authorized by an EUA.

Watch for additional attention on advancing use of RWD/E.  In addition to the four recent draft guidances, CDER recently issued a 2022 guidance agenda that includes two new RWD/E draft guidances.

  1. Global Harmonization

Global harmonization continues to be a priority in the digital health space, with U.S., UK, and Canada regulators recently developing joint guiding principles for Good Machine Learning Practices.  Section 502 of the discussion draft requires FDA to continue its work with foreign regulators to facilitate international harmonization of regulation and use of decentralized clinical trials, digital health tools leveraged in clinical trials, and clinical trial designs.

Watch for more focus on the need for global coordination and potentially more joint recommendations from health authorities.  Also watch whether the new FDA Commissioner, Robert Califf, engages with his foreign regulatory counterparts on digital health and RWD/E.

Photo of Olivia Dworkin Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.

Photo of A.J. Carvalho A.J. Carvalho

A.J. Carvalho is an associate in the Washington office, where he practices in the Patent Litigation, False Claims Act, and White Collar Defense and Investigations Practice Groups, and also maintains an active pro bono practice.

Prior to attending law school, A.J. worked at…

A.J. Carvalho is an associate in the Washington office, where he practices in the Patent Litigation, False Claims Act, and White Collar Defense and Investigations Practice Groups, and also maintains an active pro bono practice.

Prior to attending law school, A.J. worked at Walter Reed National Military Medical Center coordinating exploratory clinical research studies related to blast injuries, particularly amputation, and concomitant conditions.

Photo of Christina Kuhn Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

Photo of Mingham Ji Mingham Ji

Mingham Ji is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Anti-Corruption practice groups. Ms. Ji advises food, dietary supplement, pharmaceutical, and biotechnology companies on regulatory and compliance issues.