The Digital Medicine Society (DiMe), in collaboration with the Peterson Health Technology Institute (PHTI), ZS Associates, and other key industry organizations, has unveiled new resources designed to help digital health technologies (DHTs) navigate Integrated Evidence Plans (IEP). These tools are intended to assist DHT developers in generating the appropriate evidence required to meet the needs of decision-makers, paving the way for commercial success.
As regulatory expectations continue to evolve, the need for DHT developers to take a proactive, evidence-based approach to innovation has never been greater. The IEP toolkit provides a structured and transparent framework that helps innovators address evidentiary requirements, market access challenges, reduce risks, and accelerate the path to widespread adoption.
This initiative aligns with a key priority identified in the 2023 Digital Health Industry Regulatory Needs Assessment, which called for better alignment between regulatory requirements and the decision-making needs of downstream payers and purchasers.
“Even after receiving FDA approval, many DHTs face challenges in achieving widespread adoption due to unclear evidentiary requirements and misaligned strategies,” said Smit Patel, Program Director at DiMe. “Without addressing the needs of stakeholders such as payors, providers, and health systems, the commercial success of these technologies remains uncertain. The resources launched today offer a coordinated and adaptable strategy that aligns with the needs of stakeholders, ensuring faster market entry and broader adoption.”
This effort builds on DiMe’s successful initiatives, including the U.S. Digital Health Regulatory Pathways and the Evidence DEFINED framework, which aim to further advance the use of IEPs in the development of DHTs. The new resources include:
IEP Toolkit: A comprehensive guide for creating evidence plans, featuring best practices, templates, checklists, and case studies.
Stakeholder Map: A detailed list of decision-makers influencing DHT adoption, along with their specific needs to ensure alignment across the product lifecycle.
High-Quality Evidence Checklist: A checklist designed for DHT developers to ensure they generate evidence that meets the needs of downstream decision-makers.
“We’re excited about our partnership with DiMe and the cross-industry team that has created these groundbreaking resources,” said Maurice Solomon, Principal, Digital & Connected Health at ZS. “These tools offer a blueprint for overcoming the time, cost, and effort challenges involved in generating the right evidence, ultimately helping to deliver new digital solutions to clinicians and patients at scale.”
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