TransCelerate Research Examines the Role of Digital Health Technologies in Patient Safety, Published in DIA's Therapeutic Innovation & Regulatory Science

Peer-reviewed manuscript highlights regulatory gaps, industry challenges, and opportunities to strengthen pharmacovigilance as digital health technology adoption accelerates

PHILADELPHIA, May 14, 2026 /PRNewswire/ -- TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the peer-reviewed publication of research in Therapeutic Innovation & Regulatory Science (DIA TIRS) examining the importance of digital health technologies (DHTs) to the future of patient safety around the world.

The article, "Pharmacovigilance Data from Digital Health Systems: Regulations, Implications, and Opportunities – A TransCelerate Perspective," reports on how data generated by DHTs have been used in safety monitoring practices and identifies regulatory and operational considerations for pharmaceutical companies integrating digital tools into pharmacovigilance systems.

As digital health tools generate increasing volumes of real-world data, pharmacovigilance teams face evolving questions about how safety information should be defined, interpreted, and reported. TransCelerate's assessment draws on a review of global regulatory frameworks across six continents, published literature, and an industry survey of 17 leading biopharma companies to establish a baseline understanding of how DHT-generated data are currently managed. Findings indicate that while interest in and deployment of digital health tools continue to grow, regulatory clarity specific to pharmacovigilance applications remains limited and uneven across regions.

Although most survey respondents report that DHT-generated individual safety reports currently represent less than 1% of total annual safety reports, 76% anticipate growth as adoption expands. The findings underscore the complexity of implementation: 59% of respondents reported challenges determining whether DHT-generated data qualify as reportable adverse events, and while 82% conduct technical validation of digital health tools, fewer than half perform clinical validation.

"There is growing momentum behind the use of digital health technologies, but pharmacovigilance practices are navigating a rapidly evolving regulatory environment without fully harmonized definitions or consistent regulatory expectations," said Jeneen Donadeo, Executive Director of Portfolio Management at TransCelerate. "This research helps frame those challenges, identify critical gaps, and offer practical considerations that can support more  proactive approaches to patient safety."

In addition to analyzing regulatory and operational complexities, the manuscript spotlights a Digital Health Pharmacovigilance Considerations Guide developed through TransCelerate's collaborative work. The guide is intended to facilitate the user's identification and independent assessment of various factors that may significantly affect pharmaceutical operations when introducing new DHTs in the ecosystem. Users can access additional TransCelerate-produced resources including a comprehensive glossary of DHT terms, available both in English and Japanese.

The research builds on TransCelerate's long-standing Interpretation of Pharmacovigilance Guidances and Regulations program, which focuses on advancing shared understanding and practical solutions in areas where regulatory guidance around patient safety is emerging or evolving.    

The full open-access manuscript is available in Therapeutic Innovation & Regulatory Science.

About TransCelerate BioPharma
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently. Headquartered in the Philadelphia area, TransCelerate has 18 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit https://www.transceleratebiopharmainc.com/who-we-are/.

SOURCE TransCelerate BioPharma