Recent Food and Drug Administration (FDA) guidance clarifies how Prescription Drug Use-Related Software (PDURS) may be developed and marketed under existing regulatory frameworks. PDURS applies to software solutions tailored to specific medications, supporting the creation of optimized treatment experiences that directly improve patient health and wellbeing. It provides pharmaceutical companies with an opportunity to pair medicines with clinically validated software that can improve adherence, strengthen therapeutic outcomes, and support patient engagement with treatment.
Why PDURS Matters for the Advancing Digital Health Coalition
The Advancing Digital Health Coalition (ADHC) was formed to bring together leaders across the digital health ecosystem to advance policy solutions that enable responsible adoption of digital health technologies. PDURS sits at the intersection of several key policy priorities for the coalition:
- Integrating innovative health care technologies into therapeutic care pathways
- Establishing sustainable reimbursement and coverage models
- Protecting patient access to innovative technologies while ensuring clear and predictable risk-based pathways for healthcare innovation.
As the healthcare system increasingly relies on digital tools to support treatment and disease management, PDURS represents a foundational framework that could shape how software becomes part of routine clinical care.
Why ATA Action Is Leading This Work
ATA Action, the advocacy arm of the American Telemedicine Association, is uniquely positioned to lead policy efforts around PDURS and related digital health innovations.
For more than three decades, the ATA has been at the forefront of advancing telehealth, digital therapeutics, and technology-enabled care. Through ATA Action and the Advancing Digital Health Coalition, we bring together diverse stakeholders with a shared goal: building policy frameworks that allow innovation to reach patients safely and effectively.
ATA Action’s leadership in this space is grounded in:
- Deep policy expertise in virtual care delivery, health care innovation and government health care programs.
- Established relationships with federal policymakers and regulators
- A broad coalition representing the full digital health ecosystem
- A track record of advancing pragmatic, bipartisan solutions
PDURS represents a pivotal moment for digital health policy — and getting implementation right matters enormously. ATA Action and the Advancing Digital Health Coalition are at the forefront of this effort, equipping policymakers with the evidence, expertise, and stakeholder perspectives needed to make this framework work for all.
Our coalition speaks for the full digital health ecosystem — providers, innovators, and patients – to ensure PDURS implementation reflects their realities and advances a regulatory and reimbursement environment fit for modern medicine.
Join the Effort
As PDURS policy continues to evolve, collaboration across industry, government, and the healthcare community will be essential. The Advancing Digital Health Coalition is actively engaging stakeholders to help shape policy approaches that support innovation while protecting patients and improving care. Organizations interested in contributing to this work are encouraged to join the coalition and participate in shaping the future of digital therapeutics and software-enabled care.
Resources
- ATA Policy Principles: Policy Principles for Prescription Drug Use-Related Software (PDURS)
- ATA Action Policy Brief: Advancing Prescription Drug Use‑Related Software: Priorities for Updated FDA Guidance
- npj digital medicine: Policy and Reimbursement Strategies to Improve Patient Access to Prescription Digital Therapeutics
- ATA Educational Piece: The Future of Medicine: Optimizing the Patient Experience With PDURS
- Press Release (Nov 2025): ATA Action Submitted Comprehensive Comments on FDA Draft Guidance for Prescription Drug-Use Related Software (PDURS), Expressed Enthusiastic Support for PDURS Framework
- Press Release (May 2025): ATA Action Strongly Supports Prescription Digital Therapeutics Act to Close Gaps in Care for Medicare and Medicaid Population
To learn how your organization can get involved, please contact Lani Reilly at lreilly@ataaction.org.