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Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an
João Rocha-Gomes1, Bernardo Sousa-Pinto2, Ana Luisa Neves2,3
1Faculty of Medicine, Department of Community Medicine, Health Information and Decision, University of Porto, Porto, Portugal jngomes@med.up.pt.
BMJ Open
|February 15, 2026
Summary
This study develops a policy maturity framework to assess readiness for prescription digital therapeutics (PDTx). The eDelphi study aims to guide consistent adoption of these software-based health solutions.
Area of Science:
- Digital Health
- Health Policy
- Healthcare Innovation
Background:
- Prescription digital therapeutics (PDTx) offer novel treatment solutions but face fragmented policy landscapes.
- Variations in regulation, reimbursement, and integration create adoption uncertainties for stakeholders.
- A systematic approach is needed to assess national or regional preparedness for PDTx.
Purpose of the Study:
- To develop and validate a comprehensive policy maturity framework for assessing PDTx adoption readiness.
- To guide policymakers, developers, and providers in navigating the complexities of PDTx implementation.
- To establish a consensus-driven tool for benchmarking and advancing PDTx integration into health systems.
Main Methods:
- An e-Delphi study involving up to three rounds with diverse experts from six stakeholder groups.
- Purposive sampling prioritizing European experts, with potential for broader international perspectives.
- Utilizing a 5-point Likert scale for quantitative data and open-text prompts for qualitative insights, with consensus defined as ≥70% agreement.
Main Results:
- The study protocol outlines the iterative refinement and validation of a PDTx policy maturity framework.
- Consensus will be reached on framework domains, scoring criteria, and maturity thresholds.
- The validated framework will capture essential elements for PDTx policy development and implementation.
Conclusions:
- The developed framework will provide a reference for assessing and advancing PDTx adoption.
- It aims to reduce uncertainties and foster consistent policy development across jurisdictions.
- Dissemination through publications and policy briefs will support digital health governance.
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