Digital Medicine Society (DiMe)

Strados Labs, a medical technology company focused on improving patients' lives with respiratory disease through innovative technology, created the RESP Biosensor, a wearable device that allows clinicians to remotely detect changes in patient symptom and enable the real-world monitoring of lung health. However, as Strados Labs engaged with sponsor organizations' clinical trial teams, they faced a recurring challenge: effectively communicating the regulatory clearances and validation work behind their RESP Biosensor. 📔 To overcome this challenge, Strados Labs turned to DiMe’s The Playbook: Digital Clinical Measures to help bridge the communication gap. The Playbook served as the perfect tool to clarify critical points such as regulatory clearances, the validity of their measures, and the differentiation between data validation and regulatory clearance, as well as refine Strados Labs’ communication of regulatory requirements. “The Playbook has been an invaluable resource for us in conversations with clinical trial teams at life sciences organizations,” said Nick Delmonico, CEO of Strados Labs. Incorporating The Playbook into its communications strategy was vital for Strados Labs to effectively frame conversations around its technology and allowed them to build trust and confidence with sponsor organizations while ensuring they fully understood the FDA framework for evaluating wearable sensors and digital measures. 👉 Read more about Strados Labs’ success here: https://bit.ly/4erFv9u

👏 We're proud to share that DATAcc by DiMe has been awarded a grant from the FDA to develop a comprehensive "How-To Guide" for using sensor-based digital health technologies (sDHTs) as digital endpoints in clinical trials! While sDHTs offer groundbreaking potential to transform drug and medical device development by measuring previously inaccessible aspects of disease, uncertainty remains across the developer and life sciences communities about the evidence needed to rely on sDHTs as drug development tools (DDTs) and medical device development tools (MDDTs). Key features of the guide will address specific market challenges by including: ▪️ A central, interactive hub that compiles scientific knowledge, regulatory guidance, and practical examples from across the industry. ▪️ Clear recommendations for life science teams on selecting and validating digital endpoints, and for developers on building sensor-based sDHTs that will meet market needs. ▪️ Insights on how sDHTs can reduce timelines, accelerate the introduction of life-saving therapies, and enhance diversity and inclusion in trials through more generalizable findings. With a clear, step-by-step process, this guide will break down complex barriers to adoption, enabling the broader use of digital endpoints in trials—essential for the future of personalized, patient-centric and life-saving therapies. Stay tuned for more! 📚 DiMe has several projects on the horizon to advance the use of digital health measures in research to improve lives. Join projects such as the pediatric rare disease initiative, a collaboration to define high-quality digital measures to accelerate research and deliver life-saving therapies to children with rare diseases around the world: https://bit.ly/3NagKmk

Imagine being a new mom, filled with excitement after giving birth, only to be quickly overshadowed by overwhelming concerns. When you left the hospital, you were given limited resources, particularly regarding infant feeding. Now that you’re home, you need feeding support, but living in a rural area makes it challenging to find local lactation consultants, and juggling appointments while caring for your newborn adds to the stress. Plus, you’re left wondering if your insurance covers the support you desperately need. #Maternal mortality and morbidity often peak during the vulnerable postpartum period, and follow-up care is alarmingly inadequate. New mothers require in-person and virtual care to effectively address their health, well-being, breastfeeding, and infant care needs. 🤝 SimpliFed recognizes that #lactation support is crucial for the health of both mothers and their babies. It empowers women during this vital time and enhances overall health outcomes. By integrating a virtual first care (V1C) approach, SimpliFed makes it easier for new moms to access essential support. This model promotes a culture of preventative care, encouraging women to seek regular medical attention for themselves and their families. In our recent deep dive, we spoke with Andrea Ippolito, CEO and Founder of SimpliFed, about how SimpliFed uses the V1C Health System Maturity Model - created by the V1C Coalition by DiMe - to expand its virtual services. 📚 Read the full story here: https://bit.ly/4gIT0Dt

🚨Happening TOMORROW! 🚨 Join us on Oct. 3 at 11 a.m. ET for our FREE monthly Journal Club on Wearable Digital Health Technology. We’re bringing together experts like: 🗣️ Geoffrey S. Ginsburg, MD, PhD All of Us Research Program, The National Institutes of Health 🗣️ Rosalind Picard, Sc.D. MIT Media Lab, Empatica 🗣️ Stephen H. Friend, MD, PhD University of Oxford, Warneford Hospital 🗣️ Bert Hartog, MSc, PhD, Digital Medicine Society (DiMe) There is a growing body of evidence to support the integration of digital health technologies into clinical care, yet several roadblocks must still be addressed to fully realize the potential of DHTs to advance the understanding of health and disease. This work describes several of these challenges, including data ownership, patient trust and empowerment, data standards and interoperability, and return of value for health systems, and a call to action for the DHT community to align on solutions to ensure the greatest impact to patients. 🔗 Haven’t signed up yet? There’s still time! Register now: https://lnkd.in/ePydiN_n

Digital measures offer the clinical trials community unparalleled insights into people’s real-life experiences, enhancing our understanding of numerous conditions. So, why haven’t we implemented digital endpoints on a larger scale? 🗓️ Mark your calendar for Oct. 16 at 11 a.m. ET and join our FREE monthly Journal Club. A panel of experts from leading organizations like Tufts Center for the Study of Drug Development, Digital Medicine Society (DiMe), Roche, Bayer, Takeda, UCB, MindMed, and Genentech will discuss the net financial benefits of digital endpoints. Findings from research conducted by Digital Medicine Society (DiMe), Tufts Center for the Study of Drug Development, Johnson & Johnson, Roche, Genentech, UCB, Bayer, Takeda, and MindMed, now published in the Journal of Clinical & Translational Science, showcase evidence of significant cost reductions and financial benefits tied to leveraging digital endpoints in trials. Key findings include: ▪️ Digital endpoints significantly shorten trial phases and permit smaller trial enrollment sizes ▪️ For phase 2 trials, the increase in eNPV varied from $2.1 million to $3.3 million, with ROIs between 30% to 48% per indication ▪️ The net benefits were substantially higher for phase 3 trials, with the increase in eNPV varying from $24 million to $40 million, with ROIs that were four to six times the investment 📰 Get ready for the conversation by reading the paper we'll be discussing: https://bit.ly/3YusSW3 👉 Join this Journal Club to learn more about these findings and how digital endpoints get the right treatments to patients faster and more efficiently. Click here to register: https://bit.ly/3zsEhM8

📣 Did you hear the news? The Connected Health Collaborative Community (CHcc), co-hosted by the Digital Medicine Society (DiMe) and Consumer Technology Association (CTA)—is launching and kicking off its inaugural project, Advancing a Sustainable Hospital-at-Home Ecosystem at Scale with UMass Chan Medical School’s Program in Digital Medicine as the project’s Impact Partner. This project will accelerate the potential of the hospital-at-home model – including cost savings, improved resource management, increased patient satisfaction, and better patient outcomes. Medically Home, a project partner and inaugural member of CHcc, is committed to prioritizing patient needs while enhancing health systems by developing scalable and sustainable care models. We’re working together to pave the way for a more decentralized, #patientcentered approach to health.  It’s not too late to become part of the pivotal moment in shaping the future of #healthcare. Learn more about joining this effort: https://lnkd.in/gjbG-dtg Consumer Technology Association, UMass Chan Medical School’s Program in Digital Medicine, Abbott, AdvaMed, Amazon Web Services (AWS), b.well Connected Health, Health Advances, Mass General Brigham (MGB), Medically Home, Sparx Engineering, Verily, U.S. Department of Veterans Affairs (VA), Vivalink, Vitls Inc, and Ypsomed AG.

🎉 Exciting announcement! The Connected Health Collaborative Community (CHcc), co-hosted by the Digital Medicine Society (DiMe) and Consumer Technology Association—is launching and kicking off its inaugural project, Advancing a Sustainable Hospital-at-Home Ecosystem at Scale, with UMass Chan Medical School’s Program in Digital Medicine as the project’s Impact Partner. Project partners include industry leaders, such as Consumer Technology Association, Digital Medicine Society (DiMe), UMass Chan Medical School’s Program in Digital Medicine, Abbott, AdvaMed, Amazon Web Services (AWS), b.well Connected Health, Health Advances, Mass General Brigham, Medically Home, Sparx Engineering, Verily, U.S. Department of Veterans Affairs, Vivalink, Vitls Inc, Ypsomed AG, and more. We will work together to create action-oriented, open-access resources to help achieve the promise of a #digitallyenabled hospital-at-home model. Together, we will identify how #digitaltechnologies can support a hospital-at-home model to create a more efficient #healthcare system. 🌟 And, this also presents another great opportunity for project partners! By joining this project, you’ll automatically become an inaugural CHcc member. As part of this collaborative community, you’ll leverage interdisciplinary expertise and research to establish best practices and address fragmentation in connected health. It’s not too late to join us! Learn about the next steps to becoming a project partner and inaugural member of CHcc: https://bit.ly/3Bto3Ti

🚨 Take action today - don’t miss your LAST chance to participate in shaping the future of AI in healthcare! 🤖 AI is driving a digital revolution in healthcare, promising to enhance patient care, streamline operations, and bolster cybersecurity. Yet, implementing #AI innovations while balancing the need for caution in navigating existing healthcare infrastructure and norms remains a challenge. 📘 DiMe’s new “The Playbook: Implementing AI in Healthcare,” project will support the seamless integration of AI into patient care, streamlining processes, enhancing clinical decision-making, and improving outcomes. 🤝 By joining this project, you’ll collaborate with industry leaders, regulatory bodies, and researchers across the field to outline the critical steps of AI implementation and optimization. Together, we will bridge the gap between cutting-edge technology and practical implementation, ensuring that AI's benefits reach every patient, caregiver, and #healthcare professional! 🔗 Share your interest in joining the project here: https://bit.ly/3xtKqGQ

Counting down to our next Journal Club on Oct. 3 at 11 a.m. ET! We're excited to welcome a panel of industry experts from the The National Institutes of Health, All of Us Research Program, Empatica, MIT Media Lab, University of Oxford, and Digital Medicine Society (DiMe). This month's topic: Wearable Digital Health Technology. We’ll discuss the integration of digital health technologies into clinical care and the challenges we must address, such as data ownership, patient trust and empowerment, data standards and interoperability, and return of value for health systems. 📰 Check out the paper we'll be discussing to dive deeper: https://bit.ly/3MS10UW 🔗 Secure your spot today and join in on the conversation: https://bit.ly/3XYUmmd

We are proud to highlight our dedicated Partner, The Digital Medicine Society (DiMe) – a global non-profit and the professional home for digital medicine driving broad adoption of digital approaches to advance the practice of medicine to enhance public health. 🌎 ❤️🩹💡 Join DiMe next month and catch the forward-thinking session featuring their very own CEO – 𝐄𝐦𝐞𝐫𝐠𝐢𝐧𝐠 𝐝𝐢𝐠𝐢𝐭𝐚𝐥 𝐡𝐞𝐚𝐥𝐭𝐡 𝐜𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐚𝐧𝐝 𝐨𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐟𝐨𝐫 𝐝𝐫𝐮𝐠 𝐬𝐚𝐟𝐞𝐭𝐲 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐬 𝐚𝐧𝐝 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲, coming to our Digital Transformation & Partnerships track stage October 29 with... ▶ Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech ▶ Jennifer Goldsack, Chief Executive Officer, Digital Medicine Society (DiMe) ▶ Peter Hjelmstrom, Director and Chief Executive Officer, Uppsala Monitoring Centre 🚨 Our final ticket sale expires this week and 𝐭𝐢𝐜𝐤𝐞𝐭𝐬 𝐠𝐨 𝐮𝐩 𝐭𝐨 𝐟𝐮𝐥𝐥 𝐩𝐫𝐢𝐜𝐞. Book now to save on tickets before it's too late: https://lnkd.in/gqpN6izz There are 𝐥𝐞𝐬𝐬 𝐭𝐡𝐚𝐧 𝟐𝟓 𝐟𝐫𝐞𝐞 𝐩𝐚𝐬𝐬𝐞𝐬 𝐫𝐞𝐦𝐚𝐢𝐧𝐢𝐧𝐠 for the first pharma and biotechs that apply here: https://lnkd.in/gFzSXQf9 #WorldDrugSafety #DigitalMedicine #DigitalHealth #Pharmacovigilance #DrugSafety #PV #PublicHealth