Digital Medicine Society (DiMe)

💡 Here’s another key insight on patient-generated #healthdata (PGHD)... 🎙️ Howard Look, President & CEO of Tidepool, talks about the need for new devices in PGHD to be user-friendly and easy to use. He emphasized that patients being able to easily learn and use a device will directly lead to them feeling empowered to then incorporate it into their routine and use that data to manage their condition. 🎥 To hear more about the process behind device creation for PGHD among other topics, listen to the full session here: https://lnkd.in/ePrnWdMV

🌐 The promise of digital health technologies (DHTs) in revolutionizing healthcare access, equity, affordability, and patient outcomes is undeniable. Yet, the journey from innovation to patient access can be complex. 🩺 In 2023, the FDA authorized a record number of novel medical devices, a testament to the progress in the field. However, obtaining regulatory authorization is only the beginning. On average, it takes 5.7 years for these devices to achieve nominal coverage, delaying patient access and stifling innovation. 📆 Over the next few weeks, we will explore five innovative strategies to help developers navigate the regulatory process. 1️⃣ First up in our real-world examples are AppliedVR and JOGO Health, whose regulatory approaches highlight the importance of diversifying commercialization pathways. Thanks to strategic engagement with the #FDA and #CMS, AppliedVR's RelieVRx therapy and JOGO’s provider services are now reimbursed under #Medicare. 🚀 Their success demonstrates the need for a balanced approach, navigating regulatory pathways while optimizing for downstream patient access and commercial success. 🔗 Learn more about their regulatory journeys here: https://lnkd.in/dbQNzJFR

👏 We're proud to cheer on Katie Gagel, a valued member of Team DiMe and a dedicated patient expert, as she commits to walking 50 miles for American Diabetes Association's Step Out walk fundraiser. DiMe has kicked things off with a donation to support her incredible initiative. Join us in making a difference—every step counts! 💪 Support Katie's cause and help us beat diabetes together! Visit Katie's fundraising page here: https://lnkd.in/dZVfhneH 🔗 Learn more about the event and how you can get involved at ADA Step Out Walk: https://lnkd.in/dH97ibEC

📊 Curious about patient-generated #healthdata (PGHD) from an engineering POV? 🔬 Kimberly Kontson, a biomedical engineer in the Office of Science and Engineering Laboratories, FDA/CDRH, emphasized the importance of accuracy in patient-centric designs. She states that her team uses a strong data quality assurance and control system to prioritize the collection of high-quality, high-accuracy data, which allows them to minimize frustrations and burdens in the patient experience. 🎥 To learn more about PGHD, listen to the full session from a recent workshop led by DiMe and FDA here: https://lnkd.in/ezaQPwCY

🎉 DATAcc by DiMe is proud to announce a significant milestone in the fight against Parkinson's disease (PD)! 🤝 With our partners at The Michael J. Fox Foundation for Parkinson's Research and the Critical Path Institute (C-Path)'s Critical Path for Parkinson’s consortium, we have expanded our Library of Digital Measurement Products by integrating 94 additional digital solutions that support Parkinson's disease (PD) research and care. This collaboration enhances the existing resources of the library, providing a more comprehensive toolset for the PD community. 🛠️ Due to diverse and fluctuating symptoms, designing patient-centric digital interventions and therapeutics for PD can be challenging. Sensor-based digital health technologies (sDHTs) bridge this gap by enabling remote and frequent measurement of PD symptoms, supporting early intervention, innovative treatments, and improved patient outcomes. 📚 The expanded library supports clinicians, researchers, and developers with validated tools and streamlined evidence to advance digital health strategies and accelerate the path to improved patient outcomes. 🌐 As part of the expansion of digital solutions to support PD research and care, we have also enhanced the library with a user-friendly interface and intuitive user journey to enable faster, more efficient access to tailored digital health solutions. The library features meaningful concepts of physical activity (PA), Parkinson’s Disease (PD), Sleep, and Alzheimer’s disease and related dementias (ADRD). 💪 This collaboration represents a pivotal step forward in PD research and patient care and exemplifies the power of working collectively to address complex health challenges. We are grateful to our partners for their collaboration and shared vision in advancing digital health solutions for Parkinson's disease. 🔗 Explore the expanded library here: https://bit.ly/3A0Mers

❗Last chance to attend an information session to learn about joining DiMe’s newest project, “The Playbook: Implementing AI in Healthcare”! 🏥 The U.S. healthcare ecosystem continues to struggle with implementing innovations while navigating existing healthcare infrastructure and norms. 📕 This project will create a new roadmap that supports healthcare organizations to seamlessly integrate AI into clinical care at scale, while improving clinical decision-making and enhancing patient outcomes. By participating, you will collaborate with industry leaders, regulatory bodies, and researchers to develop critical steps for AI implementation and optimization. 🤝 Join us for a 30-minute information session to learn more about the project and how you can collaborate with industry leaders, regulatory bodies, and researchers to develop critical steps for AI implementation and optimization. Our last session is on July 24 at 11 a.m. ET! Don’t miss it! 🔗 Sign up here: https://bit.ly/3WfYzRn

More on the power of patient-generated #healthdata (PGHD) 💪🏽 During a recent DiMe and FDA-led public meeting, Elena Izmailova, Chief Scientific Officer of Koneksa, shared how her own PGHD empowered her – through its use, she was able to actively contribute to her medical services as a #patient as opposed to being a “passive recipient.” To hear more from Elena and other leaders during the “Vision 2030: Advancing Clinical Research with Patient-Generated Health Data” keynote, listen to the full session here: https://lnkd.in/eMfnhMM9

🏥 Since 2020, over 300 hospitals have launched CMS-approved Acute Hospital Care at Home (AHCAH) programs and provided care to over 11,000 patients across 37 states. At this trajectory, it’s estimated that 1 in 6 hospitals will have a hospital-at-home program by 2030. Early data shows that participating hospitals achieved reduced costs, improved health outcomes, and better patient experience. 📊 However, until further best practices and optimized case examples are available to guide what “good” looks like, hospitals' enormous potential to scale programs that achieve a double bottom line, delivering patient-centric care and supporting financial sustainability, will not be realized. ⚒️ We’re convening leading hospitals, payors, and digital health innovators to pave the way for hospital-at-home care models that are both scalable and sustainable to deliver outsized benefits to patients and health systems alike. 🤝 Join us in this critical work: https://bit.ly/4eNGql8

🏥 Are you ready to change healthcare with AI? 🤖 Artificial Intelligence (AI) is transforming healthcare, promising enhanced patient care, streamlined operations, and fortified cybersecurity. However, implementing these innovations while navigating the complexities of existing healthcare systems remains challenging. 📘 DiMe’s upcoming project, “The Playbook: Implementing AI in Healthcare,” will create a new roadmap that supports healthcare organizations to seamlessly integrate AI into clinical care at scale, while improving clinical decision-making and enhancing patient outcomes. By participating, you will collaborate with industry leaders, regulatory bodies, and researchers to develop critical steps for AI implementation and optimization. 🤝 Join us for a 30-minute information session to learn more about the project. These sessions are an interactive opportunity for you to learn more about the benefits of joining us and to ask questions! Upcoming sessions: ▪️ Jul 17, @ 12 p.m. ET ▪️ Jul 24 @ 11 a.m. ET 🔗 Sign up here: https://bit.ly/3WfYzRn

Annie Saha, Associate Director for Strategic Initiatives at the FDA's Digital Health Center of Excellence, shares the importance of collaboration with patient-generated #healthdata (PGHD). According to Annie, partnership is the most effective option to ensure efficiency and reduce wasted resources. By using multidisciplinary teams, you can achieve healthcare integration for PGHD tools in a meaningful way across the spectrum and in day-to-day #patient care instead of solely in a clinical design setting. She also shares that the FDA is proud to play a role in this collaboration on the regulatory side. To hear more, listen to the full session here: https://lnkd.in/eMfnhMM9