Digital Medicine Society (DiMe)

ICYMI - We recently featured a series of videos from our founder and CEO Jen Goldsack, discussing the current challenges and opportunities in the digital health software market. Click the link below to watch the series in full. https://bit.ly/3Z616Og As Jen notes, the digital health market is transforming patient care, yet buyers and end users—health systems, payers, and patients—struggle to navigate a crowded landscape filled with inconsistent quality and trust issues. Developers building exceptional solutions face a similar challenge: standing out and earning the recognition they deserve. We are proud of our efforts to address these critical issues with the launch of the DiMe Seal. After extensive research, including the review of 1,000+ scientific articles, 47 regulatory guidances, and 100+ industry standards, we’ve built an evidence-based framework to establish a universal benchmark for digital health software quality. The DiMe Seal framework supports developers in proving their product’s trustworthiness while helping end users make better, faster decisions. ?? Get involved! Are you a developer of a digital health software product? Head to https://bit.ly/4e39jbx to start your evaluation today! And for the health systems, providers, payors, and patients looking for software products built for quality and trust, visit our website to learn more about the benefits of selecting DiMe Seal-awarded products, and sign the open letter of support from the adopter community. The future of healthcare depends on trust in digital health. Let’s build it together.

Over 1 in 11 Americans live with diabetes, a condition that impacts millions worldwide. Despite advancements in connected technologies and digital health innovations, a critical gap remains: integrating patient-generated data (PGHD) into diabetes clinical care and coverage decisions is still insufficient. ?? FDA-cleared continuous glucose monitors (CGMs) provide invaluable PGHD, yet this data often falls short in effectively informing treatment decisions and influencing reimbursement policies. The result? Treatment gaps, detrimental comorbidities, inequities in care, and a healthcare system burdened by more than $400 billion annually. ?? DATAcc by DiMe is leading the charge to address urgent unmet needs, bringing together industry leaders—including pharmaceutical and medical device manufacturers, payors, health systems, regulators, and patients—to pave the way for integrating sensor-based health data into care. By joining this project, you will: ?? Shape the future by developing the industry's first comprehensive framework for incorporating PGHD into care models ?? Transform treatment decisions by ensuring sensor-based health data improves patient outcomes ?? Collaborate on policy recommendations to ensure the success of digital health technologies in diabetes care ?? Build strategic relationships and gain market insights from pharmaceutical companies, medical device developers, payors, health systems, and regulators ?? Together, we can reduce healthcare burdens and improve care for millions with diabetes. Learn more and join us: https://lnkd.in/ej2MJpTZ #DiabetesManagement #DigitalHealth #MarketAccess

“If we want to have therapies and drugs available across ethnicities and social groups, we need to recognize that not all of these people are living right where scientists happen to work.” ?? Well said by panelist Brian Murphy of Cumulus Neuroscience in our public launch of DATAcc by DiMe’s core set of digital measures and resources for Alzheimer’s disease and related dementias (ADRD)! It’s true that research often fails to include diverse populations, particularly in harder-to-reach communities and underrepresented groups such as Hispanic and non-white populations. This lack of diversity leaves significant gaps in understanding how different communities experience #ADRD and respond to treatments. DATAcc’s new unified core measures for ADRD are specifically designed to bridge these gaps, prioritize the needs of diverse patients and caregivers, and improve our understanding of ADRD’s impact across a range of populations and settings. These new resources: ?? Reflect meaningful, patient-centered aspects of health in the #dementia community ?? Are designed for rapid implementation across varied research and care settings ?? Include updates to DATAcc’s Library of Digital Measurement Products, a global, evidence-based resource for selecting digital health technologies (DHTs) to support these core measures DATAcc’s globally accepted core ADRD measures are reshaping digital measure development by moving beyond fragmented approaches. By centering diverse patient voices in treatment development, we fuel meaningful progress in addressing ADRD’s complexity and diversity. ?? View the resources here: https://bit.ly/3O6lUQE ??? Watch the public launch replay here: https://bit.ly/3Ogsvbj AbbVie Alzheimer's Drug Discovery Foundation Altoida, Inc. Aural Analytics Biogen BioSensics Boston University Cambridge Cognition Cogniant Cognito Therapeutics, Inc. Cogstate Cumulus Eisai US ki:elements Koneksa Eli Lilly and Company Linus Health Luca Healthcare Medidata Solutions Merck Oregon Health & Science University Foundation Roche Sage Bionetworks VivoSense, Inc. Winterlight Labs

At DATAcc by DiMe, we’re committed to breaking down barriers in digital health and advancing impactful solutions through collaboration and open-source measurement resources. ?? We recently joined forces with the The Michael J. Fox Foundation for Parkinson's Research to expand our Library of Digital Measurement Products, cataloging validated digital tools to support researchers, developers, and clinicians to advance #Parkinson’s Disease (PD) research. ???? Through this open-source initiative, we’re simplifying #digital measurement in PD and beyond—making validated digital tools accessible to all. As Yuge Xiao, who leads MJFF's digital measures efforts, shared during a recent deep dive interview, “The digital space involves so many stakeholders, making it essential to learn and adapt together.” This partnership empowers #researchers to maximize the potential of digital tools, aligning with our mission to support open, pre-competitive partnerships. ?? Dive into how this collaboration is driving meaningful progress for PD: https://lnkd.in/eYnpU3y5

What if validating sensor-based digital health technologies (sDHTs) was simpler? With the new resources from DATAcc by DiMe, it can be. DATAcc has developed new resources to simplify and standardize the statistical evaluation of sDHTs. These resources bridge the gap in clinical and regulatory processes for regulatory, payor, and downstream clinical decision-making that prevent the widespread use of digital health measures after they enter the market. ??? During our launch event, “Accelerating the Path to Approval: Validating Novel Digital Clinical Measures” on Tues., Dec. 10 at 11 a.m. ET, you’ll discover: ? How to validate novel digital clinical measures with confidence ? Systematic criteria for selecting appropriate reference measures for new digital clinical measures ? Tools to enhance the quality and effectiveness of sDHT evaluation, driving better patient care and improved health outcomes We’re eliminating the barriers that make developing sDHTs challenging by providing a standardized approach to validation. This will not only boost innovation but also ensure quality and real-world impact. ?? Curious to learn more? Register for the launch event and be among the first to access these resources! https://bit.ly/4fpq3uW FDA Amsterdam UMC Bayer Stats-of-1 | Inference for the Individual Cove Neurosciences Inc.

?????? NEW resource alert! Today, DiMe introduced the International Regulatory Pathways (IRP) project resources to help developers bring their digital health technologies (DHTs) to global markets! ???Scaling globally comes with significant challenges. Each country has its own complex, rapidly evolving regulations, and without a clear understanding of these pathways, it can be difficult to scale globally. The IRP resources are designed to help developers gain actionable insights to understand and compare regulatory environments across Asia Pacific, Europe, and North America. They include country-specific guides, step-by-step flowcharts, and supporting resources that will help you streamline your go-to-market strategies and bring your DHTs to patients worldwide faster and more efficiently. ??? At our public webinar "Scaling Digital Health Globally: Navigating National Pathways for Patient Access," we shared: ?? Actionable insights that will help you prepare for the complexities of market access, pricing, reimbursement, and patient access infrastructure ?? Detailed insights into regulatory pathways to help developers evaluate the time, cost, and risk when entering new markets ?? Real-world case studies from organizations such as Big Health, Empatica, and Huma, who have successfully navigated regulatory pathways to bring their innovations to patients globally The future of healthcare is digital, but to realize its full potential worldwide, DHT developers need clarity on complex regulatory requirements across diverse jurisdictions. The IRP resources fill this gap to help you streamline your global go-to-market strategies, bringing your solutions to market more quickly and efficiently and into patients' hands globally. ???Ready to explore new global pathways? View the resources here and scale your innovations in new markets:? https://lnkd.in/g64fZD8z AbbVie, ABHI, ANDHealth, Asia Pacific Medical Technology Association (APACMed), Complear, DGG, D-Health Consulting, Digital Therapeutics Alliance, embecta, Empatica, Google, Harvard-MIT Center for Regulatory Science, Hasso Plattner Institute, Huma, Luca Healthcare, MCRA, an IQVIA business, S3 Connected Health, SDA Bocconi, Spitzenverband Digitale Gesundheitsversorgung, University of Oxford

?LAST CHANCE to register! Don’t miss your chance to join the "Scaling Digital Health Globally: Navigating National Pathways for Patient Access" webinar, happening tomorrow, Tuesday, Nov. 19, at 10 a.m. ET. Join this webinar to learn more about the International Regulatory Pathways resources and gain actionable insights to understand and compare regulatory environments across Asia Pacific, Europe, and North America. We will explore country-specific guides, step-by-step flowcharts, and supporting resources that will help you streamline your go-to-market strategies and bring your digital health technologies (DHTs) to patients worldwide faster and more efficiently. The future of healthcare is digital, but to unlock its full potential globally, understanding the complex regulatory requirements across different jurisdictions is critical. Here’s what we’re announcing: ??Comprehensive international resources that give insight into the regulatory environments in key markets such as the U.S., Germany, Japan, South Korea, Australia, and more. ??Actionable insights that will help you prepare for the complexities of market access, pricing, reimbursement, and patient access infrastructure. ??Real-world evidence and case studies that showcase targeted, data-driven decision-making that lead to market entry success, helping you to optimize your DHT submissions. ??Resources that will help you build informed strategies for market entry and growth by aligning product development with commercial and regulatory priorities. Don’t miss this free public launch event! Register now: https://bit.ly/40phbRx Complear University of Oxford S3 Connected Health Google Health Spitzenverband Digitale Gesundheitsversorgung Università Bocconi

?LAST CHANCE to register! Don’t miss your chance to join the "Scaling Digital Health Globally: Navigating National Pathways for Patient Access" webinar, happening tomorrow, Tuesday, Nov. 19, at 10 a.m. ET. Join this webinar to learn more about the International Regulatory Pathways resources and gain actionable insights to understand and compare regulatory environments across Asia Pacific, Europe, and North America. We will explore country-specific guides, step-by-step flowcharts, and supporting resources that will help you streamline your go-to-market strategies and bring your digital health technologies (DHTs) to patients worldwide faster and more efficiently. The future of healthcare is digital, but to unlock its full potential globally, understanding the complex regulatory requirements across different jurisdictions is critical. Here’s what we’re announcing: ??Comprehensive international resources that give insight into the regulatory environments in key markets such as the U.S., Germany, Japan, South Korea, Australia, and more. ??Actionable insights that will help you prepare for the complexities of market access, pricing, reimbursement, and patient access infrastructure. ??Real-world evidence and case studies that showcase targeted, data-driven decision-making that lead to market entry success, helping you to optimize your DHT submissions. ??Resources that will help you build informed strategies for market entry and growth by aligning product development with commercial and regulatory priorities. Don’t miss this free public launch event! Register now: https://bit.ly/40phbRx Complear University of Oxford S3 Connected Health Google Health Spitzenverband Digitale Gesundheitsversorgung Università Bocconi

?? Alzheimer's disease and related dementias (ADRD) cases are on the rise globally, causing care costs to soar, with the burden on #caregivers—over 16 million family and friends—growing more complex. Caregivers face emotional, financial, and physical challenges as they manage the progressive nature of #ADRD, often balancing full-time jobs, family responsibilities, and their own health. ???? The urgent need for better, more inclusive research was made clear yesterday during DATAcc’s public launch of its new core set of digital measures for ADRD, when Isaac O’Neal, a care partner to his mother, shared his story. His experience highlighted the critical gaps in understanding and supporting the challenges caregivers face, reinforcing the importance of these new measures to address the needs of both patients and those who care for them. These new core measures reflect the meaningful aspects of health reported by ADRD patients and their caregivers, enabling researchers and clinicians to address these specific challenges. With these measures, ADRD research and care will: ??Standardize digital measures across trials to enable more diverse patient recruitment and deliver faster, cost-effective results ??Capture continuous data to empower clinicians with real-world patient insights, leading to more informed and timely decisions ??Increase trial efficiency, reducing costs and ensuring trials are more representative ??Ensure therapies meet the specific needs of all communities, supporting care that aligns with caregivers’ experiences DATAcc’s new core ADRD measures will transform digital measure development in ADRD, moving beyond fragmented approaches and fostering directed innovation that centers on the voices of patients and their caregivers. ?? View the resources here: https://bit.ly/3O6lUQE AbbVie Alzheimer's Drug Discovery Foundation Altoida, Inc. Aural Analytics Biogen BioSensics Boston University Cambridge Cognition Cogniant Cognito Therapeutics, Inc. Cogstate Cumulus Neuroscience Eisai US ki:elements Koneksa Eli Lilly and Company Linus Health Luca Healthcare Medidata Solutions Merck Oregon Health & Science University Foundation Roche Sage Bionetworks VivoSense, Inc. Winterlight Labs

?? It's #WorldDiabetesMonth, and we are honored to share this article written by two amazing DiMe colleagues, Katie Gagel, and Abby S., MSHCM. ?? We are also excited to announce that we are building the team for a new project to drive #marketaccess for #diabetes management. If you want to join us to collaborate on new work that will change the lives of millions, please reach out today:?https://lnkd.in/ej2MJpTZ