DiMe Unveils Open-Source Toolkit to Facilitate Digital Health Evidence Development
BOSTON, March 18, 2025 /PRNewswire/ — The Digital Medicine Society (DiMe), supported by the Peterson Health Technology Institute (PHTI) and ZS Associates, today announced the release of new resources to assist developers of digital health technologies (DHTs) in navigating Integrated Evidence Plans (IEPs). This initiative, involving several leading industry organizations, aims to empower DHT developers to generate evidence that meets the requirements of various decision-makers, thereby boosting commercial success.
In an environment of evolving regulatory standards, a proactive and evidence-based approach to innovation is vital. The IEP toolkit offers a clear, structured framework to streamline the process of meeting evidentiary demands, addressing market access obstacles, mitigating risks, and accelerating commercialization—ultimately fostering broader adoption of these technologies.
This project addresses a key priority identified in the 2023 Digital Health Industry Regulatory Needs Assessment: harmonizing best practices between regulatory standards and decision-making processes involving downstream payers and purchasers.
“Even after receiving FDA authorization, many DHTs face adoption hurdles due to opaque evidentiary needs and misaligned strategies. Without addressing the needs of stakeholders, including payers, providers, and health systems, commercial success remains uncertain,” explained Smit Patel, Program Director at DiMe.
“The resources launched today offer a versatile strategy that coordinates activities to fulfill stakeholder requirements across the entire product lifecycle, enabling a faster time-to-market and increased adoption.”
This effort builds upon DiMe’s previous work, including the U.S. Digital Health Regulatory Pathways for DHTs and the Evidence DEFINED framework, with the goal of expanding the implementation of IEPs in DHT development.
The new resources include:
- IEP Toolkit: A comprehensive roadmap for building evidence plans, providing industry-leading best practices, templates, checklists, and case studies.
- Stakeholder Map: Illustrates the decision-makers who influence DHT adoption and outlines their specific needs, fostering alignment throughout the product’s lifecycle.
- High-Quality Evidence Checklist: A detailed checklist to guide DHT developers in generating high-quality evidence, aligning with the evidentiary needs of downstream decision-makers.
“We are pleased to collaborate with DiMe and a strong cross-industry team to create these exceptional resources, which will assist both large and small companies in taking a holistic view of evidence development for novel digital solutions,” said Maurice Solomon, Principal, Digital & Connected Health, ZS.
“This work provides a roadmap for efficiently generating the necessary evidence and demonstrating the value of new digital tools, getting them into the hands of providers and patients at scale.”
DiMe is at the forefront of significant projects focused on utilizing digital measures for the secure and effective application of digital technologies to enhance patient outcomes. The organization is currently focused on continuous glucose monitoring to improve market access for efficacious diabetes therapies and treatment pathways, as well as defining core digital measures for common mental health disorders to advance objective, scalable endpoints for assessing treatment effectiveness.
About the Digital Medicine Society:
DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.
Media Contact:
Carla English, [email protected]
SOURCE Digital Medicine Society (DiMe)
