Dime Bio Co., Ltd.

A new online database from the Digital Medicine Society enables health systems, providers, patients and the general public to learn about which digital health products meet baseline privacy, security and equity standards, and make more informed decisions about which ones they use. Digital health developers can apply for the new Digital Medicine Society Seal online through a series of attestations and questions that cover industry standards, such as SOC 2 Type II, HITRUST, Carin Code of Conduct, WCAG, ISO 27001 and more, according to the organization. WHY IT MATTERS There are more than 400,000 health software applications available to consumers and 30,000 for providers, health systems and other enterprise organizations, DiMe said in a statement last week. "Digital health software products are driving transformational innovation in healthcare," DiMe CEO Jennifer Goldsack tells Healthcare IT News. "However, the burden of derisking software purchase decisions remains unacceptably and unsustainably high for end users." Gaining the DiMe Seal is meant to connote the software meets quality standards and is trustworthy. Its standards were developed through a collaboration with more than 150 industry leaders who reviewed nearly 50 pieces of regulatory guidance, more than 100 industry standards and quality programs and 1,000+ scientific articles, according to the organization. DiMe said it also convened experts from across the digital health software ecosystem – including clinicians, developers, regulators, payers and patient advocates – to help create the comprehensive framework. "Until now, there was no standard or efficient way to evaluate digital health software products," John Brownstein, chief innovation officer at Boston Children's Hospital and member of the DiMe Seal governance committee, said in the announcement. Technologists at provider organizations "spend countless hours vetting products," he noted. "We need a new way to advance digital innovation and get the best products into the hands of the providers and patients who will benefit from them." More than 150 developers have already signed up to have more than 50 products – from apps for glucose monitoring to platforms that integrate data and digital interventions to improve patient outcomes – for a DiMe Seal evaluation. Determining "what good looks like with respect to digital health products" is a previously unmet need, said Grace Cordovano, cofounder of Unblock Health, patient-in-residence at DiMe and governance committee member. "There are resources available in the public domain to help guide informed decision-making about things like cars, colleges and home renovations," she said. "We must prioritize getting the right tools to patients when they need them most or we as an industry risk losing trust in the transformative potential of digital health." The DiMe Seal governance committee also includes, among others: Dr. Jackie Gerhart, Epic's vice president of clinical informatics. Stephen Hughes, the American Hospital Association's director of healthcare IT policy. Kate Berry, America's Health Insurance Plans' senior vice president of clinical affairs and strategic partnerships. Aneesh Chopra, Arcadia's chief strategy officer. Adrienne McFadden, Elevance Health's vice president and chief medical officer of Medicaid. Kimberly McManus, deputy chief technology officer and deputy chief artificial intelligence officer for the Department of Veterans Affairs. DiMe said that it will also launch a benchmarking database to categorize product comparisons with details on regulatory status, common therapeutic areas and more later this year. THE LARGER TREND Providers and consumers struggle to evaluate which digital health tools will meet their needs and streamline regulatory compliance. Recognizing the challenge presented by software developers embracing artificial intelligence across products, Epic Systems released a tool to help hospitals and health systems, which often lack resources, to properly assess and validate AI models . One healthcare AI validation tool the electronic health record giant calls its "seismometer suite" is a Fairness Audit that organizations can use to evaluate any AI model, including homegrown models, against local population data. It's used to score a model's fairness across different protected classes and demographic groups, Corey Miller, Epic's VP of research and development, explained to Healthcare IT News in May. AI quality, of course, is just one issue healthcare decision-makers need to think about when they consider software purchases. Cybersecurity is another that presents a mountain of challenges, from the constant need to patch vulnerabilities to factors of human accountability across organizations. While myriad tools exist to help the exploding digital health software industry – including various pieces of regulatory guidance and government-directed health IT certification programs – healthcare cyberattack disruptions are becoming more frequent and thousands of medical devices and systems still pose security risks . To that end, the U.S. Health and Human Services announced more than $50 million for the development of tools that protect hospital operations from ransomware vulnerabilities to address the drastic uptick in vulnerabilities being weaponized . The Universal PatchinG and Remediation for Autonomous DEfense, or UPGRADE, program announced earlier this year targets medical device security and patient care continuity. ON THE RECORD "The DiMe Seal will give digital health innovators a shared language with their customers that helps buyers easily validate their products," Annie Collins, Bio + Health investment partner at a16z and DiMe governance committee member, said in a statement. "As the market for these products becomes increasingly crowded and complicated, the value of a unifying framework to identify high-quality, trustworthy solutions holds enormous value for both the end users of digital health software products as well as their developers seeking to differentiate their products," Goldsack said by email. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS Media publication. The HIMSS Healthcare Cybersecurity Forum is scheduled to take place October 31-November 1 in Washington, D.C. Learn more and register .

DATAcc is creating an open-source industry guide to address market challenges by bringing clarity on how and why to include digital endpoints in clinical trials BOSTON, Oct. 3, 2024 /PRNewswire/ -- Today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is excited to announce it has been awarded a grant from the U.S. Food and Drug Administration (FDA) to develop a comprehensive "How-To Guide" for technology developers and the life sciences seeking to advance the broad use of sensor-based digital health technologies (sDHTs) to develop digitally-derived endpoints in clinical trials. This guide builds on recent industry findings that endpoints derived from DHTs can substantially reduce clinical trial timelines, improve ROI, and make trials more feasible in challenging markets. It's designed to capitalize on that potential, offering the life sciences community a clear pathway to navigate the complex landscape of digital endpoints and accelerate the path to market for life-saving therapies. As a result, driving substantial returns on investment (ROI) in clinical trials, reducing participant burden in clinical trials, and improving the relevance of the data captured for scientific and clinical decision making. The guide is being created in response to industry challenges surrounding the application of sDHTs to capture digitally-derived endpoints in clinical research. While the science behind these technologies is well-established and the regulatory environment has matured, many developers and life science companies still face significant obstacles in successfully integrating these technologies into trials. The new "How-To Guide" will synthesize existing regulatory guidelines, scientific resources, and a wide array of industry case studies to provide a one-stop resource for developers and clinical trial teams alike. It will demystify the process of selecting and using sensor-based digital health technologies, ensuring their efficacy and acceptance in regulatory submissions. "We're not just consolidating all of the science," said Jennifer Goldsack, CEO of DiMe. "We're creating an interactive platform that will allow life sciences professionals and sDHT developers to clearly understand the steps required to generate high-quality evidence, select appropriate endpoints, and integrate these technologies into trials with confidence to improve ROI while reducing participant burden." Key features of the guide will address specific market challenges including: Comprehensive resource: A central, interactive hub that compiles scientific knowledge, regulatory guidance, and practical examples from across the industry. End-to-end process guidance: Clear instructions for life science teams on selecting and validating digital endpoints, and for developers on building sensor-based DHTs that will meet market needs. Support for faster, more inclusive trials: Insights on how DHTs can reduce timelines, accelerate the introduction of life-saving therapies, and enhance diversity and inclusion in trials through more generalizable findings. The regulatory advancements we've seen to date, along with the extensive case studies drawn from across the industry, make this guide a critical tool for developers and researchers seeking to bring DHT-based products to market. 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. 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 DATAcc by DiMe: The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community with the FDA's Center for Devices and Radiological Health. We provide a forum for collaboration where partners and experts from across the digital health field work to advance the use of digital health measures in research to improve lives. Media Contact: Carla English, [email protected] SOURCE Digital Medicine Society (DiMe) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

16 startups advance digital innovation to improve cancer research and care BOSTON, Aug. 1, 2024 /PRNewswire/ -- Today marks the culmination of the first cohort of the CancerX Accelerator, led by CancerX co-hosts Moffitt Cancer Center and the Digital Medicine Society (DiMe), in partnership with MassChallenge. For four months, 16 startups collaborated with Accelerator Champions, Mentors, federal partners, and CancerX members across the healthcare ecosystem to test and validate their digital innovation solutions and increase their impact on improving the lives of cancer patients. The CancerX Accelerator is the only accelerator program focused on digital innovation in cancer research and care. It uniquely brings together a community of champions, innovators, and users of digital health in oncology to scale ideas that have the potential to solve unmet needs in clinical care, save lives, and improve the experience of cancer patients and their caregivers. The 16 startups graduating the inaugural cohort are: The Blue Box, C the Signs, Cancer Insights, Curiva, EnteroTrack, Gesund.ai, Gray, Lind AI, Mika, Navya, Oatmeal Health, Orbit Genomics, Realyze Intelligence, Reimagine Care, SurvivorPlan, and XanthosHealth. The program, launched in October 2023, attracted 100+ applicants that were judged by 70+ judges to arrive at the final cohort of 16 companies. Ten organizations served as Champions for this program, offering time and mentorship, as well as a chance to engage in pilots, sign commercial contracts or receive investments from them. In addition, the program leveraged the rich CancerX community to match startups with mentors from a pool of 60+ mentors from the community. "Participating in the CancerX Accelerator has proven pivotal in testing and deploying our technology at the world's most innovative cancer centers," said Tarun Kumar, Co-founder and CEO, Cancer Insights. "We received 4 months of targeted curriculum, curated based on expertise from leading Cancer Centers as well as technology and investment experts like Debiopharm, Oncology Ventures, Intel, Dell, Reveal HealthTech etc. Our Champions also worked hard to get us positive outcomes in a very short amount of time. As an example, our champion health system (Moffitt Cancer Center) was able to move from first demo to a signed contract with us in less than three months!" "After validating our AI solution for patients and experts, we were focused on scaling the adoption of our capabilities among other centers to impact more patients. Through the Accelerator, we partnered with Moffitt Cancer Center to identify a new use case for our product that overcomes a burden for Moffitt and the patients that they serve," said Naresh Ramarajan, MD, Co-Founder, Chief Medical Officer, Navya Network, Inc. "CancerX has not only afforded us a partnership with Moffitt, which shares our vision of scaling access to expertise, but also connected us with mentors in the fields of clinical trial matching, community oncology, and leveraging oncology datasets, all of which are crucial for our continued success and growth and will ultimately enhance cancer care delivery and patient outcomes." The 4-month program has resulted in several positive outcomes including 4+ definitive contracts, 3 LOIs, 2 investment decisions and at least 50+ meetings with frontline healthcare workers. "As a co-host and a champion, we have taken our responsibilities seriously, of setting the standard for how we want startups to be championed," said Xavier Avat, Chief Business Officer at Moffitt Cancer Center. "Our team secured numerous definitive agreements and created meaningful connections. Even when we said 'no', we did it in a way that was meaningful and productive for the startups. Based on our experience, we believe that this accelerator can meaningfully bridge the gaps by providing technologies for entrenched problems that we face as health systems daily". "Aside from being able to attract a large number of companies from across the globe, this accelerator also has perhaps the most diverse set of leaders accepted into the program," added Dr. Doug Mirsky, Vice President, DiMe "with over 50% of founders being BIPOC, women and first-time founders, we've been able to and look to continue to add much needed diversity of voice and perspective to digital innovation in cancer care." "Today is another important milestone for CancerX, celebrating the startups that will bring us closer to achieving the nation's Cancer Moonshot goals," said Stephen Konya, Senior Advisor to the Deputy National Coordinator, and Innovation Portfolio Lead for the Office of the National Coordinator for Health IT (ONC), Department of Health and Human Services (HHS). "The potential to win the battle against cancer is within our grasp. These Accelerator graduates have worked tirelessly over the past few months to build relationships and strengthen the products and services that will change the lives of cancer patients. Now, we're excited to see how these efforts positively impact the lives of cancer patients and their families." After the incredible success of the first cohort, CancerX is excited to announce that submissions for Cohort 2025 will open this fall. If you want to participate in the next CancerX Accelerator as a Startup, Champion, or Mentor, sign up here to be the first to hear about these opportunities. About CancerX: Announced by The White House Cancer Moonshot in February 2023, CancerX is a public-private partnership to boost innovation in the fight against cancer. Co-hosted by the Digital Medicine Society (DiMe) and Moffitt Cancer Center, alongside the Office for the National Coordinator for Health Information Technology (ONC) and Office of the Assistant Secretary for Health (OASH), it convenes the many diverse stakeholders needed to unleash the power of innovation to create a future that's free of cancer burden. To learn more or participate in CancerX's pre-competitive, evidence-generating efforts; Accelerator cohort, or demonstration projects, visit . Media Contacts: Carla English, [email protected] SOURCE Digital Medicine Society (DiMe)