The Digital Medicine Society (DiMe) has announced that it is partnering with Peterson Health Technology Institute (PHTI), ZS Associates and other leading industry organizations to define how Integrated Evidence Plans (IEP) can be developed, optimized and used to support the regulatory and commercial success of digital health products (DHPs) on an accelerated timeline. The goal is to streamline the pathways to successful commercialization of high-value, evidence-based DHPs, addressing the top priority reported by industry leaders in DiMe’s recent Digital Health Industry Regulatory Needs Assessment: to align best practices between regulatory requirements and decision-making with downstream payers and purchasers.

The project team, which is comprised of experts from across DHP development, regulation, reimbursement and commercial strategy; U.S. payers; purchasers; policymakers; clinicians; and patient groups, will develop open access, interactive resources for DHP developers.

DiMe is collaborating with organizations such as PHTI and ZS, and is joined by the Alliance of Community Health Plans (ACHP), Altoida, American College of Cardiology (ACC), Astellas Rx+, Brown-Lifespan Center for Digital Health, Consumer Technology Association (CTA), Feel Therapeutics, Galen Growth, Genentech – a member of the Roche Group, Google, Lunit, Lura Health, Mika Health, Neuralight, Otsuka Pharmaceuticals, Point32Health, ScreenPoint Medical, Takeda, Tufts Center for the Evaluation of Value and Risk in Health, University of Michigan WIRED-L Center, U.S. Department of Veterans Affairs (VA), FDA and Verily to advance this work.

“Developers have been very successful at securing FDA acceptance and market access opportunities for their digital health products. However, the needs of downstream decision-makers remain opaque. Consequently, early and considerable investments in evidence generation for DHPs have become excessively tailored to meet the needs of regulators, resulting in missed opportunities for designing more efficient and effective studies that generate the necessary evidence for all decision-makers including regulators, payers, purchasers and end users of these products,” said Jennifer Goldsack, CEO of DiMe. “To avoid future collapses and closures and to ensure that innovative DHPs that improve patient care are broadly adopted, DiMe is convening industry experts to advance the use of integrated evidence plans that optimize evidence generation plans for both regulatory and commercial success.”

Resources developed by DiMe will be available to assist digital health companies in clearly defining the full suite of evidence needed for the various decision-makers along the path to market, including regulators, investors, payers, healthcare systems and patients. The resources will also be geared toward helping developers dramatically reduce the cost and timelines of evidence generation by articulating what evidence is needed and outlining evidence-collection strategies that minimize the burden of collection, essentially integrating the needs of various stakeholders into a single, fit-for-purpose strategy.

“We are pleased to support DiMe in helping developers generate better evidence to increase purchaser confidence in adopting new, high-value technologies,” said Meg Barron, Managing Director, Engagement and Outreach, PHTI. “PHTI is focused on independent evaluations of healthcare technologies to improve health and lower costs. Patients need and deserve effective new solutions to help improve health outcomes, increase affordability and expand access to care.”

The resources will be created over the next year. This work builds on DiMe’s existing U.S. Digital Health Regulatory Pathways for DHPs and Evidence DEFINED framework to advance the use of IEPs for developing DHPs.