Integrated Evidence Plans for Digital Health Products

In the recent Digital Health Industry Regulatory Needs Assessment conducted by DiMe, the top priority reported by industry leaders is to align best practices between FDA regulatory requirements and decision-making with downstream payers and purchasers.

Addressing this industry need, DiMe has partnered with Peterson Health Technology Institute (PHTI), ZS Associates, and other industry leaders to conduct an Integrated Evidence Plans (IEP) for Digital Health Products (DHPs) project. This work will identify core components of an integrated evidence plan to streamline the collection of necessary evidence for all decision-makers on the path to market and optimize developers’ opportunities for commercial success.

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The project team will develop resources that:

Facilitate the successful market entry of high-value solutions by communicating to executive leadership and developers the types of commercial pathways and associated evidence requirements available for DHPs

Enable DHP developers to generate necessary clinical and health economic evidence as efficiently and effectively as possible

Help to advance a single, consolidated, evidence-generation strategy for DHPs to satisfy the needs of all downstream stakeholders and streamline the path to regulatory, commercial, and health outcome success

Ultimately, the project will promote the successful introduction of high-quality digital health innovations to the market, preventing them from failing due to uncertainty.

Our partners

This project brings together leaders in digital health product development, regulation, reimbursement, and commercial strategy with United States payers, purchasers, policymakers, clinicians, and patient groups.