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Andy Molnar

Pairing Digital Therapeutics with Drugs – A Clearer Path Forward

For years, pharma’s “software + pill” ambition was trapped between low-impact companion apps and rigid combination-product rules. Prescription Drug Use-Related Software (PDURS) opens a pragmatic path: optional, clinically validated software paired with a drug to improve safety, outcomes, and adoption—without making software mandatory for blockbuster brands.

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PDURS has resonated with the healthcare industry as the right way to pair drugs with digital therapeutics.

The historical options were flawed: companion apps couldn’t support regulated claims, while true combination products were too restrictive for multi-billion-dollar therapies. PDURS reframes the model as optional software that clinicians can pair with a prescription when it adds measurable value—supporting comorbidity and side-effect management, monitoring, dosing support, and post-diagnosis continuity. Global pilots are already underway across oncology, hypertension, and chronic care, pointing to safer journeys and better outcomes with workflows providers can actually adopt and payers can recognize.

When Pairing Becomes Practical:
From Companion Apps to PDURS

What you’ll learn

How PDURS differs from companion apps and combination products—and why its optional design lowers adoption barriers
Why patient safety is the first use case—closing the post-visit blind spot on side effects, dosing, and adherence
What clinical scenarios benefit most—from comorbidity support in cancer to chronic disease management with measurable outcomes
Where near-term integration is most realistic—provider workflows and payor models that normalize digital prescriptions
Which policy and reimbursement cues matter—clearer regulatory framing that enables scalable drug-software pairings

Andy Molnar is the Senior Vice President of Industry Affairs and Head of Digital Health at the American Telemedicine Association (ATA). The ATA recently acquired the Digital Therapeutics Alliance (DTA) where Andy was the CEO. Andy was also appointed to the FDA’s Digital Health Advisory Committee in 2024 where he represents digital diagnostics, Augmented Reality (AR)/Virtual Reality (VR), decentralized clinical trials, and real-world evidence. Andy works to shape innovation in digital health, particularly Software as a Medical Device (SaMD), by advancing global regulatory and reimbursement policies. This focus includes digital therapeutics, digital diagnostics, artificial intelligence, combining software and drugs (Prescription Drug Use-Related Software – PDURS), technologies that support aging in place, and more.