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Published on: December 11, 2016
How Digital Health Technologies have been Used to Support Regulatory Drug Approval
Agathe Thierry1,2, Antoine Manson3, Hans-Peter Podhaisky4
1Bayer AG, Research & Development, Pharmaceuticals, Regulatory Affairs, Berlin, Germany.
Therapeutic Innovation & Regulatory Science
|July 13, 2026
Summary
Digital Health Technologies (DHTs) support drug approvals, primarily using electronic patient-reported outcomes (ePRO) tools. Collaboration is key for advancing sophisticated digital tools and regulatory pathways.
Area of Science:
- Clinical Trials
- Regulatory Science
- Digital Health
Background:
- Digital Health Technologies (DHTs) offer potential benefits in clinical trials, including improved patient recruitment and data collection.
- A complex regulatory landscape currently hinders the widespread adoption of DHTs in drug development.
Purpose of the Study:
- To review the utilization of DHTs in supporting regulatory decision-making for drug marketing authorization in the US and Europe.
- To detail the types and applications of DHTs that have been approved by regulatory bodies.
Main Methods:
- Quantitative analysis of 60 DHT-related drug approvals between September 2021 and March 2025.
- Qualitative case studies to illustrate the nature and implementation of DHTs.
Main Results:
- The European Medicines Agency (EMA) granted more approvals (63%) than the US Food and Drug Administration (FDA) (37%).
- Electronic patient-reported outcome (ePRO) tools were the predominant DHTs (70%), often utilizing smartphones (66%).
- No drug approvals were based solely on DHT-derived primary endpoints; DHTs primarily supported safety and efficacy data collection in Phase 3 trials.
Conclusions:
- DHTs are increasingly acknowledged and utilized by regulatory authorities for decision-making in drug approvals.
- Current approvals predominantly feature basic ePRO tools, but more advanced DHTs, including sensor-based devices and AI/ML, are emerging.
- Enhanced collaboration between industry stakeholders and regulatory bodies is crucial for establishing clear qualification pathways for novel DHTs.
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