Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an...

Prescription digital therapeutics (PDTx) represent an emerging frontier in healthcare, leveraging software-based solutions to treat or manage specific medical conditions. However, despite rising interest and encouraging evidence of clinical benefits, the policy landscape remains fragmented. Jurisdictions vary widely in their regulatory approaches, reimbursement pathways and processes for clinical integration, thus creating uncertainties for developers, payers and healthcare providers. This protocol outlines an eDelphi study to develop and validate a comprehensive policy maturity framework guiding systematic assessment of national or regional readiness for PDTx adoption.

We will conduct an e-Delphi study with up to three rounds to refine and validate a PDTx policy maturity framework. Experts will be recruited purposively from six stakeholder groups (regulators, healthcare providers, payers/health economists, developers, researchers and patient advocates), prioritising Europe while seeking variation across health system types and levels of economic development; a small number of non-European experts may be invited to broaden perspectives. An optional pilot round will gather initial feedback on the prototype framework, followed by iterative rounds to assess and revise domains, scoring criteria and maturity thresholds. A 5-point Likert scale (from 'strongly disagree' to 'strongly agree') will collect quantitative data, while open-text prompts will capture qualitative insights. Consensus will be defined as ≥70% agreement and/or an IQR ≤1 for critical items. Quantitative summaries and thematic analysis will guide iterative revisions of the model. This Delphi protocol aims to produce a consensus-driven framework that captures the essential elements of PDTx policy development and implementation. If validated, the framework can serve as a reference for policymakers, industry leaders, healthcare providers and researchers seeking to benchmark or advance the adoption of PDTx within health systems.

Ethical approval for this study was obtained from the Ethics Committee of the Faculty of Medicine of the University of Porto (reference: 320/CEFMUP/2025). Panellists will provide electronic informed consent, and data will be kept confidential. The finalised framework will be disseminated via peer-reviewed publications, conference presentations and policy briefs targeting stakeholders involved in digital health governance.