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Evidence in Digital Health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED)

Without the proper evidence for digital health products (DHPs), stakeholders across the healthcare ecosystem, including payers, will encounter obstacles that can result in companies being unable to bring their products to market. Evidence is needed to determine the reliability and value of DHPs and ensure commercial success.

To help, DiMe collaborated with healthcare stakeholders to create Evidence in Digital Health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED) – the new standard of excellence framework for evaluating the clinical assessment of DHPs and defines ‘what good looks like’ when it comes to evidence evaluation.

Learn more about the Evidence DEFINED framework and how it:
  • Offers payers, employers, health systems, and other stakeholder users a harmonized, rigorous, rapid approach to assessing the clinical value of DHPs
  • Underlies the evidence to help payers make quicker coverage decisions on DHPs being presented to them daily to ensure good market access for innovative health interventions
  • Helps DHP companies navigate their commercial strategy and demonstrate the value of their product to payer audiences

Quick Start Guide

A process overview for the Evidence DEFINED Framework

Meet the experts who developed the Evidence DEFINED framework

A group of 17 experts with different disciplinary backgrounds collaborated to develop the Evidence DEFINED framework. This sprint team represented experts from a variety of different work settings and multiple regulatory and geographic regions.

Meet the team:

Get Involved!

Join the Virtual Journal Club

We’ll showcase and discuss the framework with co-authors of the Evidence DEFINED publication during a DiMe Journal Club on Thursday, July 20, at noon ET. Register here and be a part of the discussion!

Engage in an upcoming project

DiMe’s upcoming project, Integrated Evidence Plans (IEP) for Digital Health Products, will build on the success of DiMe’s Digital Health Regulatory Pathways work. It will bring together leaders in digital health product development, regulation, reimbursement, and commercial strategy with payers, purchasers, policymakers, clinicians, and patient groups to identify core components of an integrated evidence plan.

  • If you would like to engage in DiMe’s upcoming IEP project and help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients, learn more and share your interest to join:

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