Boston, January 23, 2024 – Today, the Digital Medicine Society (DiMe) announced its collaboration with the Peterson Health Technology Institute (PHTI), ZS Associates, and other leading industry organizations to develop, optimize, and leverage Integrated Evidence Plans (IEPs) to support the regulatory and commercial success of digital health products (DHPs) on an accelerated timeline. The goal is to simplify the path to successful commercialization of evidence-based DHPs, addressing the key priorities identified by industry leaders in a recent Digital Health Industry Regulatory Needs Assessment conducted by DiMe: aligning best practices between regulatory requirements and decision-making by payers and purchasers.
In today’s rapidly evolving and maturing business landscape, it is crucial to address the challenges arising from the lack of evidence for DHPs. The latest DiMe project aims to overcome these obstacles, streamlining the adoption of evidence-based digital health technologies, building trust among technology purchasing organizations, and optimizing health outcomes for a larger number of patients while promoting innovation in digital health.
The project team, composed of experts in DHP development, regulation, reimbursement, and commercial strategy, U.S. payers, purchasers, policy makers, physicians, and patient groups, will develop publicly available and interactive resources for DHP creators. DiMe is collaborating with organizations such as PHTI and ZS, as well as 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, 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 promote this work.
Instead of quoting Jennifer Goldsack, CEO of DiMe, it can be said that DiMe’s goal is to ensure that the previously identified needs of later-stage decision-makers are not overlooked. Therefore, DiMe convenes industry experts to promote the use of Integrated Evidence Plans that optimize evidence generation strategies for both regulatory and commercial success.
The resources developed by DiMe will assist digital health companies in clearly defining the full set of evidence needed for different decision-makers on the path to market, including regulators, investors, payers, healthcare systems, and patients. These resources will also help creators significantly reduce the costs and timelines of evidence generation, by identifying the necessary evidence and presenting evidence collection strategies that minimize the burden of data collection, consolidating the needs of different stakeholders into one purpose-fit strategy.
It is worth highlighting that “we are pleased to support DiMe in helping creators generate better evidence to increase buyer confidence in new, valuable technologies,” said Meg Barron, Managing Director of Engagement and External Affairs at PHTI. “PHTI focuses on independent evaluations of health technologies to improve health and lower costs. Patients need and deserve effective new solutions that help improve health outcomes, increase access, and reduce costs.”
“ZS focuses on accelerating a future rooted in healthcare that leverages digital medicine products along with intelligent care pathways, analytics, and evidence generation for substantial adoption and transformation,” said Ahmed Albaiti, Principal, Head of Digital & Connected Health Practice at ZS. “Partnering pre-competitively and collaboratively with a broad range of stakeholders is essential to promoting products and health paradigms trusted by patients, physicians, and payers. We are delighted to collaborate with DiMe and leverage our extensive knowledge for this important endeavor.”
The resources will be developed over the next year. This work builds on DiMe’s previous success in the U.S. Digital Health Regulatory Pathways for DHPs and the Evidence DEFINED framework, aimed at promoting the use of IEPs for DHP development. To stay up to date with the progress of this project and DiMe’s ongoing regulatory work and projects, you can sign up for the DiMe newsletter here.
About Digital Medicine Society: DiMe is a global non-profit organization and a professional home for the digital medicine community. Together, we solve the toughest challenges in digital medicine, develop clinically sound resources on time, and deliver those resources to the field through open-source channels and educational programs.
About Peterson Health Technology Institute: Peterson Health Technology Institute (PHTI) provides independent evaluations of innovative health technologies to improve health and lower costs. Through rigorous evidence-based research, PHTI analyzes the clinical benefits and economic impact of digital health solutions, as well as their impact on health equity, privacy, and security. These evaluations inform decisions for providers, patients, payers, and investors, accelerating the adoption of high-value technologies in healthcare. PHTI was founded in 2023 by the Peterson Center on Healthcare. For more information, visit PHTI.com.
About ZS: ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We harness advanced analytics, data power, science, and technology to help our clients make smarter decisions, deliver innovative solutions, and improve outcomes for all. ZS has been in operation since 1983 and employs over 13,000 professionals across 35 offices worldwide. To learn more, visit www.zs.com or follow us on LinkedIn.
Media Contact: Carla English, [email protected]
FAQs About DiMe’s Collaboration with PHTI to Develop Integrated Evidence Plans for Digital Health Products (DHPs):
1. What is the Digital Medicine Society (DiMe)?
The Digital Medicine Society (DiMe) is a global nonprofit organization and a professional home for the digital medicine community. Their goal is to address challenges in digital medicine by developing clinically sound resources and delivering them to the industry through open-source channels and educational programs.
2. What are the objectives of DiMe’s collaboration with PHTI?
The collaboration between DiMe and the Peterson Health Technology Institute (PHTI), along with other industry organizations, aims to develop, optimize, and leverage Integrated Evidence Plans (IEPs) for digital health products. The goal of this collaboration is to simplify the path to commercializing DHPs, improve regulation, and support the success of these products.
3. What are Integrated Evidence Plans (IEPs)?
Integrated Evidence Plans (IEPs) are strategies developed by creators of digital health products to optimize evidence generation plans for both regulatory and commercial success. They aim to provide a comprehensive set of evidence needed for different decision-makers on the path to market, including regulators, investors, payers, healthcare systems, and patients.
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