Overview of DHT Landscape

DHTs are systems that use computing platforms, connectivity, software, and sensors for healthcare and related uses. They can be used in clinical development and throughout the care continuum. The Food and Drug Administration (FDA) has approved hundreds of medical devices that incorporate software, at least 10 wearable devices, and a number of prescription digital therapeutics (PDTs), with many more granted breakthrough designation. As development and use of DHTs increase, stakeholders will seek greater clarity on differentiating between types of DHTs, applicable regulatory frameworks, and integration of products in the broader healthcare market.

FDA Regulatory Considerations for DHTs

Approval Pathways

The classification of a DHT has an impact on the life cycle management of a product. First, sponsors need to determine whether a DHT is defined as a medical device, which will impact the approval pathways required to market the product. Notably, combination products can also fall under the medical device category should the product have a medical device and DHT-led component, as classified by the FDA. Some DHTs are explicitly excluded from the definition of a medical device. These exclusions are outlined in legislation under the 21st Century Cures Act and clarified under FDA guidance. Figure 1 below depicts the classification of DHTs for regulatory purposes and applicable FDA oversight for each category.

Clinical Trial Use

DHTs are also used to support clinical trial recruitment, participation, and data collection. They can promote health equity in clinical trials by making participation more accessible and diversifying patient recruitment. DHTs that will be used only in the clinical trial context, such as for continuous recording of physiological data (e.g., blood pressure), will be assessed on criteria distinct from medical device regulation—though some overlap can exist—that the FDA has recently outlined in a draft guidance. The draft guidance elaborates on some of the evidence required for sponsors to demonstrate that a DHT is fit for purpose in context of the clinical investigation. However, the FDA has not yet provided a robust framework specifying the type and granularity of data that will be required.

What’s Next? Near-Term Legislative and Regulatory Developments

Congress is considering several bills that address the DHT regulation or their use in clinical development.

• PREVENT Pandemics Act: Proposes to modernize clinical trials through appropriate use of validated DHTs and require s the FDA to publish additional guidance.
• Cures 2.0 Act: Proposes that the FDA create a plan for greater alignment across its divisions regarding DHT regulation, provide for grants for innovative trial designs that include DHT components, and require development of a report proposing payment and coverage pathways for “digital alternatives” to treatment and therapies.
• Prescription Drug User Fee Amendment (PDUFA VII): Proposes to establish a framework document to guide the use of DHT-derived data in regulatory decision making, a committee to support consistency of DHT regulation across centers, and issue-focused demonstration projects to inform methodologies for efficient DHT evaluation. PDUFA VII is considered must-pass legislation by September 30 for the continued functioning of the FDA and may thus be a vehicle for advancing DHT evidence generation and regulation. The first House committee hearing on PDUFA VII was held in February, with others expected in the near future.

Other DHT-focused programs expected from the FDA may be included in the Medical Device User Fee Amendment (MDUFA), though the FDA missed the deadline to submit the commitment letter to Congress. DHT stakeholders should monitor progress on these proposals as they may be modified.

Coding Advancements

Recent Centers for Medicare and Medicaid Services (CMS) actions have also improved pathways for covering and reimbursing PDTs. In February 2022, the CMS established a Healthcare Common Procedure Coding System level II code for PDTs, effective April 1, 2022. This code is a crucial first step in expanding coverage and reimbursement of PDTs, since a lack of established codes may contribute to payer hesitance to cover these products, and signals increasing access to PDTs.

Avalere’s Perspective

As the DHT market evolves, industry stakeholders must understand the statutory and regulatory classifications of DHTs and the applicable approval pathways in each case. More specifically, product sponsors should establish a reliable internal plan for evidence generation and work with the FDA early in clinical development to ensure they meet regulatory requirements. A well-conceived strategy will help create a smoother path to market and demonstrate value to payers and providers of DHT products cleared or approved by the FDA.

Product sponsors can leverage Avalere’s industry-leading expertise in US healthcare policy, FDA regulatory pathways, and payer dynamics to develop strategies for medical product development, review, and access. Connect with us to understand the DHT landscape and implications from clinical development to payer coverage.