Evidence in Digital Health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED)
The new standard of excellence framework for clinical assessment of digital health products (DHPs).
Without the proper evidence for 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 DEFINED to define ‘what good looks like’ when it comes to evidence evaluation.
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
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:
Evidence DEFINED Resources
Quick Start Guide
A process overview for the Evidence DEFINED Framework
Digital health products are patient-facing products that meet the criteria shown below. Use the table to help define the product you are using.
2. The product is designed to change one or more health behaviors.
3. The value of the product to the evaluator is contingent on the degree to which it improves one or more health outcomes. These can include clinical outcomes (eg, incidence of diabetic retinopathy) or surrogate outcomes (eg, HbA1C).
Analysis of Prior Evidence Assessment Frameworks
A total of 78 prior frameworks were identified as relevant by the Evidence DEFINED team. Prior frameworks are not sufficiently adapted to address evidence considerations unique to digital health, creating ambiguity for various stakeholders. This table includes frameworks that assess evidence alone, or evidence as well as other domains of assessment.
Checklist of Evidence Quality Criteria
Catch the replay!
In this journal club, the co-authors came together to showcase the framework, which offers payers, employers, health systems, and other users a harmonized, rigorous, rapid approach to assessing the clinical value of DHPs and bringing them to market faster.
Engage in an upcoming project
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: