Sponsor Oversight of Digital Health Technologies in Decentralised Clinical Trials: A Regulatory Guide

Sponsor as a “Regulatory Actor”

DHTs often straddle the boundary between consumer tools and regulated medical devices. Sponsors who deploy them in trials become de facto regulatory actors under device law:

• United States (FDA): Even if a wearable is commercially available, when used to capture trial endpoints it falls under 21 CFR Part 812 provisions for device use in investigations. Sponsors must ensure fit-for-purpose validation (ensuring a device’s data is reliable and suitable for its intended clinical use), verification, and risk management (FDA, 2023; Kunkoski et al., 2025).
• European Union (MDR/IVDR): When importing or distributing CE-marked devices into trials, sponsors (or their partners) may legally assume roles of importer (Article 13) or distributor (Article 14), triggering obligations for labeling verification, complaint handling, vigilance, and field safety corrective actions (EFPIA, 2025).
• Other jurisdictions: Canada, Japan, China, and the UK similarly recognize sponsors as manufacturers, importers, or distributors depending on device movement and intended use (Health Canada, 2023; PMDA, 2014; NMPA, 2021).

Thus, oversight is not optional—it is a statutory responsibility.

Chart Description (for screen readers): This grouped bar chart compares oversight priorities for digital health technologies in clinical trials across FDA, EU MDR, and MHRA, with scores from 1 (low) to 5 (high). EU MDR consistently scores highest, especially in vendor oversight (5), while FDA emphasizes validation (5), and MHRA maintains balanced priorities (4).

Graph: The scores are derived from regulatory guidance (e.g., FDA’s 2023 DHT guidance, EU MDR Articles 13-14, MHRA UKCA rules) and cross-referenced with industry analyses

Key Oversight Domains

1. Device Selection and Classification

Sponsors must first determine whether a DHT meets the definition of a medical device or SaMD (Software as a Medical Device). Misclassification risks ethics board rejection or regulatory hold. Jurisdiction-specific frameworks such as IMDRF SaMD principles, EU MDR Rule 11, and FDA’s Digital Health Policy Navigator provide guidance (Health Advances, 2023).

2. Fit-for-Purpose Verification and Validation and Risk Management

Validation and Risk Management: Sponsors must ensure DHTs are scientifically valid and mitigate risks like data loss or cybersecurity threats (ISO 14971, FDA 2023) (TransCelerate, 2017) (EFPIA, 2025).

4. Data Integrity and Records

Electronic data capture via DHTs falls under 21 CFR Part 11 (electronic records/signatures) and EU GCP expectations. Sponsors are accountable for ensuring audit trails, record retention, and secure transmission (FDA, 2003; Kellar et al., 2017).

5. Training and Oversight of Stakeholders

Training must extend beyond site personnel to include patients and caregivers, ensuring DHTs are used correctly. FDA guidance highlights the importance of usability assessments with diverse trial populations (FDA, 2023; Aryal et al., 2024).

6. Vendor and Economic Operator Oversight

Provisioning vendors often act as distributors or importers under MDR/UKCA, meaning sponsors must oversee their compliance. Contractual agreements should map responsibilities explicitly to prevent regulatory gaps (Marra & Stern, 2024).

Case Examples

• Stride Velocity 95th Centile (EMA, 2019): A wearable-derived mobility endpoint in Duchenne muscular dystrophy was accepted as a secondary endpoint. This milestone underscores that DHT data can support regulatory decisions—but only with robust validation and oversight (Perry et al., 2023).
• COVID-19 Pandemic Adaptations: Rapid deployment of DHTs enabled remote monitoring, but also highlighted oversight gaps in device usability and data synchronization. Sponsors learned that ad hoc deployment without structured governance compromised data quality (Sehrawat et al., 2023; Huber et al., 2021). Inconsistent wearable synchronization led to missing data in 15% of participants, underscoring the need for robust vendor oversight (Sehrawat et al., 2023).
• Patient-Centric Digital Measures: FDA’s rejection of several DHT-based COAs (e.g., smartphone tapping tests for Parkinson’s) revealed that measures not meaningful to patients will not pass regulatory scrutiny, regardless of technical sophistication (Aryal et al., 2024).

The Strategic Imperative

Sponsors must embrace oversight not as a regulatory burden but as a trust-building mechanism. Proper governance ensures:

• Regulatory Acceptance: Well-documented DHT validation supports submissions and labeling claims.
• Operational Resilience: Anticipating risks prevents costly delays (estimated at $600K–$1M per month in global trial starts) .
• Patient Trust: Transparent communication on data handling and usability enhances engagement and retention.

Conclusion

In decentralized trials, sponsors cannot treat DHTs as ancillary tools. They are integral to evidence generation and fall under the same scrutiny as investigational products. Oversight responsibilities span classification, validation, risk management, data integrity, training, and vendor governance. Regulatory agencies worldwide are clear: sponsors inherit compliance obligations when DHTs are used for endpoint collection. By proactively embedding oversight into trial planning and execution, sponsors can mitigate risks, enhance patient-centricity, and accelerate the path to regulatory and scientific acceptance.

As AI-driven DHTs and harmonized global standards (e.g., IMDRF updates) emerge, sponsors must adapt oversight strategies to stay ahead of regulatory expectations.

References

• Aryal, S. et al. (2024). Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance. NPJ Digital Medicine.
• EFPIA (2025). Reflection Paper on the challenges of integrating medical devices into medicinal product trials. Brussels: EFPIA .
• FDA (2003). Part 11, Electronic Records; Electronic Signatures — Scope and Application. U.S. Food and Drug Administration .
• FDA (2023). Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry. U.S. Food and Drug Administration .
• Health Advances (2023). Guidance to Industry: Classification of Digital Health Technologies. Digital Therapeutics Alliance .
• Huber, S. et al. (2021). An overview of technology availability to support remote decentralized clinical trials. International Journal of Medical and Health Sciences .
• Kellar, E. et al. (2017). Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology Landscape. Therapeutic Innovation & Regulatory Science
• Kunkoski, E., Saha, A. & Kam, M. (2025). FDA Perspective on the Importance of Digital Health Technologies in Clinical Trials. JAMA Health Forum .
• Lai, J. et al. (2020). Drivers of Start-Up Delays in Global Randomized Clinical Trials. Therapeutic Innovation & Regulatory Science .
• Marra, C. & Stern, A. (2024). Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms. Clinical Pharmacology & Therapeutics .
• Perry, B. et al. (2023). Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints. Digital Biomarkers .
• Sehrawat, O. et al. (2023). Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials. Mayo Clinic Proceedings .