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

ABSTRACT:

Introduction

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.

Methods and analysis

We will conduct an e-Delphi study with up to three rounds to refine and

SUBMITTER: Rocha-Gomes J 

PROVIDER: S-EPMC12911748 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature