Digital Medicine Society Convenes Industry Leaders to Streamline Path to Commercial Success for Digital Health Product Developers

DiMe is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products 

BOSTON, Jan. 23, 2024 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) announced it's 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.

In today's rapidly evolving and maturing business landscape, addressing the challenges that arise from a lack of evidence for DHPs is crucial. This latest project from DiMe will address these obstacles to help streamline the path to broad adoption of evidence-based digital health technologies, build confidence with digital health purchasing organizations, and optimize health outcomes for the greatest number of patients – all while advancing innovation in the digital health landscape. 

The project team – 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 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, Inc., 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), U.S. Food and Drug Administration (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 (DHPs). 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, DiMe CEO. "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 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 help 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."

"At ZS, we're focused on accelerating the future of healthcare that uses digital medicine products in conjunction with intelligent care pathways, analytics, and evidence generation to drive meaningful adoption and transformation," said Ahmed Albaiti Principal, Practice Lead, Digital & Connected Health, ZS. "Working collaboratively and pre-competitively with a broad group of stakeholders is critical to advance health products and paradigms that are trusted by patients, clinicians, and payers alike. We're excited to work with DiMe and leverage our extensive insights on this important effort."

The resources developed will be created over the next year. This work builds on DiMe's successful U.S. Digital Health Regulatory Pathways for DHPs and Evidence DEFINED framework to advance the use of IEPs for developing DHPs. Sign up for DiMe's newsletter here to stay up-to-date on this project and ongoing regulatory work and projects.

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.

About the Peterson Health Technology Institute: The Peterson Health Technology Institute (PHTI) provides independent evaluations of innovative healthcare technologies to improve health and lower costs. Through its rigorous, evidence-based research, PHTI analyzes the clinical benefits and economic impact of digital health solutions, as well as their effects on health equity, privacy, and security. These evaluations inform decisions for providers, patients, payers, and investors, accelerating the adoption of high-value technology in healthcare. PHTI was founded in 2023 by the Peterson Center on Healthcare. For more information, please visit PHTI.com.

About ZS: ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage our leading-edge analytics, plus the power of data, science and tech products, to help our clients make more intelligent decisions, deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 13,000 employees in 35 offices worldwide. To learn more, visit www.zs.com or follow us on LinkedIn.

Media Contact: Carla English, [email protected]

SOURCE Digital Medicine Society (DiMe)