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.
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:
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!
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.