Digital health technologies (DHTs) use computing platforms, connectivity, software, and sensors for a wide range of diagnostic and therapeutic uses, including developing and studying medical products. DHTs can address various gaps in healthcare, ranging from specific conditions lacking existing therapies to facilitating remote access to clinical interventions. As with most emerging fields, regulators are actively collaborating with stakeholders to assess scientific, clinical, and utilization parameters and establish regulatory frameworks.

Gaining Approval for DHTs: FDA Authority and Regulation

One of the first challenges in launching DHTs is understanding if and to what extent the Food & Drug Administration (FDA) may regulate a product. Given the rapid advancement of DHTs, manufacturers may have questions about how much FDA oversight is required to market their tools. However, manufacturers familiar with digital health statutes and regulations can support compliance with the provisions most relevant to their innovations.

Engaging with the FDA’s Center for Devices and Radiological Health (CDRH) early in a product’s lifecycle can allow manufacturers to gain clarity on legal frameworks, minimize unforeseen delays, and expedite market entry. Manufacturers should consider their solution’s intended use and potential risks, which will inform the level of oversight that FDA may exert both before and after going to market. The agency’s Digital Health Policy Navigator is intended to help sponsors better understand how laws and regulations apply to the functionalities of a pipeline DHT. Additionally, through the FDA Digital Center of Excellence’s website, manufacturers can submit regulatory queries or request feedback on any previously submitted documentation.

Early engagement with CDRH is especially important for DHT sponsors given the variability of the non-clinical and clinical evidence necessary to obtain FDA clearance. The level and type of evidence can vary based on the FDA’s risk-classification assessment of the DHT. However, due to the evolving nature of the FDA’s digital health framework, forecasting this for cutting-edge technologies can pose challenges.

Linking Regulation, Evidence Generation, and Payer Dynamics

The challenges of determining the clinical evidence required for FDA clearance or approval are accompanied by a shifting payer landscape. Payers’ thresholds for the level of evidence required for coverage may differ from FDA’s threshold for clearance or approval (i.e., different endpoints for clinical efficacy and safety). Developing a robust evidence-generation strategy that addresses the needs of both FDA and payers can be complex.

Section 3630 of the Consolidated Appropriations Act of 2023 constitutes the erstwhile Pre-Approval Information Exchange (PIE) Act. This statute theoretically expedites patients’ ability to access novel drugs and devices by allowing payers to review clinical-trial and real-world evidence prior to FDA clearance or approval. Payers could thus determine pricing and reimbursement strategies as the FDA simultaneously considers whether to approve a new DHT, potentially expediting a DHT’s availability to patients. Ultimately, how this plays out in practice remains uncertain, as does the extent to which payers will consider pre-approval data for making coverage decisions.

Looking to the Future

To help manufacturers and the FDA align more closely on statutory and regulatory priorities for DHTs and medical devices, the FDA launched the Total Product Lifecycle Program (TAP) on January 1, 2023, to study the feasibility of new frameworks to facilitate speedier and more equitable access to medical devices. Additionally, insights generated by TAP may help the FDA and payers understand how best to harmonize their regulatory requirements to better comply with the PIE Act.

Avalere Health’s expertise in digital health regulation and market access enables us to guide digital health innovators through the FDA’s regulatory pathways and payers’ coverage and reimbursement guidance. Our team of experts advises manufacturers on when and how best to engage with the FDA and payers throughout a product’s lifecycle. To learn more about how we can support your market access priorities to meet patients’ needs with novel digital health technologies, connect with us.