Resources in Action Hub

“Freespira’s data analytic capabilities make it possible for us to share adherence, outcome, and cost data with CCHP, allowing us to effectively manage our partnership and benefit both the plan and the members.” – Monica Frederick, Senior Vice President, Strategic Accounts, Freespira

Learn about how Freespira, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

“The EVIDENCE Checklist is like a one stop shop for new teammates looking to understand our evaluation framework and power their decisions.”
— Max Gaitán, Research Lead, HumanFirst

Analytical validation is a key step for developing a high quality sensor-based DHT measures. DiMe has built another extremely valuable resource open to the scientific community that provides examples of well-designed and executed experiments that ensure a deployment of high quality digital measures with a potential to address multiple unmet medical needs. 

— Elena Izmailova, CSO at Koneksa Health

“It was great to be part of this excellent IEP project team. I had previous experience of adapting an existing pharma IEP model to a digital medicine solution. This was quite easily achieved by adopting a cross-functional approach with early identification of key stakeholders and timelines. This helped us address evidence needs optimally. These are only some of the learnings that have helped guide the development of resources which will now be available for other teams. In my view it is essential to have a clear plan for evidence generation in the development of digital health solutions.”

-Malcolm Brown | Early-Stage Medical Affairs Head, Global Specialty TA Astellas Pharma

The need to define a core set of digital measures of physical activity that are meaningful to patients prompted us to participate in this collaborative working group. The process followed was very efficient and enabled us to reach a consensus on digital measures of physical activity.  — Salma Ajraoui | Digital Practice Lead, IQVIA

Szczepan B. stated the potential benefits of digitizing cancer care and spoke about a panel convened by DiMe and Moffitt Cancer Center in December 2021. He shared the five major opportunity areas of the persistent challenges in oncology that digitization could address from that panel.

“The Core Measures of Sleep are going to be really helpful for developing a common language across different groups at levels that everyone can understand. I am always discussing new technologies that we might include in future Takeda clinical trials. One challenge has been that everyone has a different way of talking about something, or measuring something. Now there is a great checklist that DiMe has created that makes those discussions with vendors really helpful from the side of developing novel technologies that can be used in clinical trials.”

– Katerina Placek | Senior Implementation Manager Takeda

“This has been a remarkable opportunity to advocate for children’s needs at such an early and pivotal moment in this industry. At a time when it would be easy to overlook pediatric care in the rush of innovation, I’m grateful that you’ve all taken the time to truly listen and understand what our young patients need.”

– Amy Molten, MD, FAAP | Chair, Section on Advances in Therapeutics & Technology, American Academy of Pediatrics

These resources provide a roadmap for selecting digital measures of physical activity that matter to patients and implementing them in clinical trials. The core set of digital measures and their ontologies greatly facilitate our endpoint discussions.

 — Jie Ren Director, Digital Clinical Measures, Merck

“The first step [of V3] is sensor verification, and to understand the accuracy of accelerometers of [three devices], we put them on top of the Shake Table, which is the gold standard benchtop device for evaluating sensor accuracy…[we determined that] all three devices are fit-for-purpose to record gait and balance… [When looking at] hand tremors, another feature of Parkinson’s Disease, the accuracies are different… if we didn’t do this verification and we wanted to use these devices for collecting hand tremors it shows that this solution is not optimal.” – Elena Izmailova, Chief Scientific Officer, Koneksa

Learn more about this V3 in Action story:

“The EVIDENCE checklist provides a clear process for authors to follow throughout study design, data collection, analysis, and reporting.” 
— Jessie Bakker, MS PhD, Executive Vice President of Medical Affairs,  Signifier Medical Technologies Ltd

“Having a well thought-through evidence roadmap that lays out what level of evidence is needed for whom, and why, is such an important and sometimes overlooked capability in the development of our digital health innovations. The exercise of going through a structured playbook has been immensely helpful to proactively and strategically identify key requirements, partnerships, and evidence generation models that can improve planning for product development and commercial teams.”

– Arun Bhatia | Commercial Strategy Lead, Digital Health, Rx+ Business Accelerator Astellas Pharma

“I appreciated being able to complete a course that allowed me to take a deep dive into Applied Digital Health Ethics. This has given me the tools to be mindful of the intent, impact and how we apply ethics to the development of digital health solutions.”

– Dr. Courisse Knight

Shelly Lanning of Visana Health shares how using V1C’s Core Competencies allowed her company to have a strong foundation to rely upon to practice “good business hygiene.”

“These virtual care teams partner with the patient’s pre-existing, on-the-ground primary and specialty care providers. We’re an extension of their primary care team and we’re here to augment what they’re doing as a support team.” – Maulik Majmudar, CMO, Biofourmis

Learn about how Biofourmis, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

“In creating DEEP’s modular template for developing digital measures, the V3 framework and Measures that Matter publication were useful to build on.” — DEEP co-founders, Janssen

Omada contracts with employers and commercial health plans to offer diabetes and hypertension management services to their members. Employees or members who enroll in the program are connected with a comprehensive care team, including a health coach, dietitian, and behavioral health specialist.

Learn more about how Omada Health, an V1C Coalition member, demonstrates the value of V1C in action.

Digital tools give people new ways to share their data, personal stories, and insights with researchers. These tools give voices to participants’ values and choices. We are especially interested in adapting digital tools to support widespread deployment in lower-resource settings.

The resources we created for the field are the resources I wish I had access to when I first started researching clinical measures of sleep.

– Bohdana Ratitch, Expert Statistician, Bayer

In addition to planning for, achieving and monitoring genomic and metabolic diversity in our study design and execution, GSK recognizes several demographic dimensions within inclusive clinical operations.

“Pediatric research comes with unique challenges, from recruitment to long-term data collection. This playbook is a vital tool for overcoming these barriers, offering insights and strategies that ensure impactful, patient-centered solutions for children everywhere.”

Jan-Peer Elshoff, PhD | Senior Clinical Development Lead, UCB Biosciences GmbH

After publishing Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis, Tim Woelfle, author of the publication shares that “the next step will be to prospectively prove clinical validity, effectively following the V3 standard developed by [DiMe]. The first validation study is already recruiting.” 

Tim Fitzpatrick shared three key takeaways from DiMe’s updated Library of Digital Endpoints, including that the number of digital endpoints included in clinical trials increased 4X between 2019 and 2021.

Decentralized clinical trials and the use of digital technologies can be complex, which means careful planning is required to support diversity.

“An inclusive communications strategy is foundational to our work in our national research program. Using this tool kit allowed us to align our team members to one strategy with clear and accessible expectations.” — Katrina Yamazaki, Principal Investigator and Senior Scientist, CHC

“The Playbook around Digital Measures [is] practical, easy to read, and well written… It zooms people in on the critical things they need to know and the critical common thinking.” – Amy Abernethy, MD, PhD

Koneksa demonstrates the use of The Playbook in a collaboration with Montefiore Medical Center, as detailed in its Digest on Oncology.

“Robust and independent evaluation of the analytical validity of BioMets is necessary in order to extract their full potential to better understand and improve human health.”
— Job Godino, Scientific Director of Laura Rodriguez Research Institute

Carrie Nelson of Amwell discusses how IMPACT’s Core Competencies tool can be used to improve staff efficiency.

“The Playbook highlights innovation in the healthcare space to continually improve patient care. In surgery today, video data is not captured, analyzed, or connected to patient outcomes. To identify best practices and be able to disseminate them in real-time, surgeons and hospitals need to leverage Surgical Intelligence.” — Theator

The Playbook team used the foundation of V3 to build on and produce a more comprehensive manual for successfully developing and deploying digital clinical measures and remote monitoring solutions.

Luca Foschini shared DiMe’s post announcing the Applied Digital Health Ethics course and thanked DiMe for “spearheading this initiative.” He also stated that the course is helpful for discovering potential biases in health/medicine AI tools and learning how to apply “ethical frameworks to engineering problems right from the design phase.”

Dana Wolff-Hughes of the National Cancer Institute shares the importance of V3 in Action at a presentation.

Touch, the Black Breast Cancer Alliance is committed to providing a strong support network for BREASTIES and their communities.

“Working daily with med-tech start-ups this course will help us guide them through regulatory challenges, defining a pathway to move forward.”

– Tanja Hellier | Digital Transformation Project Lead

Oshi Health is a virtual-first gastrointestinal (GI) health service provider that aims to revolutionize the delivery of GI care.

Learn more about how Oshi, an V1C Coalition member, demonstrates the value of V1C in action.

“I found this course has given a very detailed overview of ethics by design approach. It definitely helped me to be more conscious in my work including planning of AI/ML healthtech projects with considerations to ethics as taught here.”

– Babu Ram | Product Development, Senior R&D Manager

“This graphic aided our understanding of novel digital measures internally and encourages us to get specific in the definition early in a project.”

“The EVIDENCE checklist provides a clear process for authors to follow throughout study design, data collection, analysis, and reporting.” — Jessie Bakker, MS PhD, Executive Vice President of Medical Affairs, Signifier Medical Technologies Ltd

“What I love about this journey that we are on with Nocturnal Scratch is that we’re putting the framework to use. We’re applying the measures to a concrete problem and this gives us a tangible way to talk about this problem. In our day-to-day we work with partners in oncology, in neurology, etc., and we are able to use these with them to help think about how can we replicate, perhaps more efficiently, and apply them to other measures and other indications.” – Christine Cong Guo, Chief Scientific Officer, ActiGraph

“The Playbook is driving the industry towards a consistent language and framework for remote monitoring that leads to more productive conversations and empowered decision making.”

“These core [sleep] measures are going be particularly valuable in our interactions with the different vendors that we work with to really streamline our discussion with respect to the metrics that they measure and how they report out their process data.”

– Nina Shaafi Kabiri | Research Scientist Boston University

“I am personally excited that sleep is getting out of the clinic. As these devices continue maturing we can look at sleep not just at night in one instance, but for a variety of populations at home in different settings across the 24 hours.”

– Raúl Torres | Principal Data Scientist Takeda

“I really want to congratulate everyone on these [Nocturnal Scratch] activities. We have been in conversations with DiMe and other actors for a long while, and I think we all have to acknowledge that we learn a lot every time we talk about these promising and valuable measures.” – Dr. Thorsten Vetter MD, Senior Scientific Officer, Scientific Advice Office, EMA

Sleep is being increasingly recognized as a critical aspect of health. Sleep disturbances are often seen as symptoms of underlying chronic conditions. We viewed the Core Measures of Sleep project as an opportunity to unite resources on a pre-competitive basis and present the case for the development of novel digital endpoints for assessing sleep function. A pharmaceutical trial endpoint is not just a measurement, it is a clinically validated development tool.

 — Michael Kremliovsky  Sr. Director, Medical Devices & eHealth, Bayer

“Silicon Labs is proud to sponsor Silicon Labs DiMe Society. Their partnership has been invaluable to the success of our initiatives in the connected health space, from speaking at our Works With Summit to industry networking events. We look forward to continuing our collaboration and achieving even greater milestones together.”

-Janet Collins| Senior Manager, Marketing Partnerships, Silicon Labs

For many patients, Tele911 enables treatment in place without requiring the expense, time, and hassle of an ED visit. For others, Tele911 supports navigation to an in-network facility, avoiding unnecessary ambulance transports to an ED. As a result, Tele911 is enhancing the efficiency of the EMS system.

Learn more about how Tele911, an V1C Coalition member, demonstrates the value of V1C in action.

Steve Xu, Northwestern University, emphasizes the importance of patient input in building clinical trials using digital technology, citing Nocturnal Scratch as an example.

Shrawan Patel, MD shares that he is honored to be a part of the development of DiMe’s new course on Digital Health Regulatory success and praises the DiMe team on creating a course that will help educate others and simplify complex topics to positively impact the industry.

Iredia M Olaye and the authors of Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies used V3 and other published literature to conduct a systematic review of published studies reporting adherence captured by BioMeTs.

Dr. Courisse Knight happily shares that she has obtained a new certification from DiMe in Unlocking Regulatory Success for Digital Health Product Developers.

“This playbook is an invaluable resource for anyone involved in developing or implementing pediatric digital health tools. It bridges the gap between product development and execution, offering clear, actionable steps to create technology that’s not only innovative but also effective and sustainable.”

-Helen Hughes, MD, MPH | Medical Director, Office of Telemedicine, Johns Hopkins Medicine

Assistant Professor of Pediatrics, The Johns Hopkins University School of Medicine

“There is a lot of very specific terminology that we [in healthcare] are all used to in our everyday life, but someone coming from a different field isn’t necessarily used to that… [to connect the dots] we leaned very heavily on the Digital Medicine Primer.” – Ieuan Clay

“We strive to be pioneers in speech biomarkers and The Playbook provided us with rich and helpful resources to structure our development work towards this goal.”
— Jian Zhao, Regulatory Compliance Manager, Regulatory and Compliance, ki:elements

“The Playbook: Digital Clinical Measures is a great educational tool, with easy visualisations to outline the processes involved for measures across different therapeutic areas to verify and validate meaningful measures for patients. It is something we continue to utilize and share with our clients that are developing novel, objective digital endpoints outside the clinic.” — Stephanie Sargeant, Commercial Manager, Activinsights

“Throughout these past years, we’ve seen these great frameworks ensure that the data that we’re collecting is accurate, valuable, meaningful, and will add to the toolbox that we have to understand not only how drugs work, but the diseases they will treat. This will only help patients, healthcare, and science as we go forward. And it’s been really exciting to see Nocturnal Scratch be one of those frameworks that has been tested and I’m really excited to where this is going to go in the future.” -Carrie Northcott PhD, Head of Digital Sciences, Pfizer

HLTHXL shares it’s new HLTHXL tool, which builds upon the earlier work of the DiME V3 framework, the CTTI checklist and the HealthXL Vendor Assessment Guide.

“IMPACT has been of great help in communicating the benefits of Diagnostikare as a Virtual first care solution, based on evidence and with proven positive outcomes.” — Rafael López, Diagnostikare, Co-founder and Managing Director

“This course has provided a great foundation to help us develop our regulatory strategy, as well as communicate the ‘what’ and the ‘why’ behind activities and processes introduced as a result of regulatory requirements. In particular, the course provided a solid foundation to work towards a robust quality management system.”

– Sophie Valentine | Senior Product Manager, Healios

“The Playbook helped us create a team agnostic with the goal of supporting any sponsor looking for digital endpoints in their clinical trials.”
— Ariel Aguilo, M.D., Head of Oncology for the Americas, Labcorp

“With Abridge, you have the doctor’s summary and what you talked about, right there for you all the time. A lot of times you can’t always remember what the doctor said. With the summary in Abridge, it brings back everything.”

Learn how Abridge, an V1C Coalition member, demonstrates the value of V1C in action.

“Collaborating with DiMe on this project has been a game-changer for pediatric innovation. This playbook is a testament to what’s possible when diverse stakeholders come together to build meaningful solutions. It’s a guide that will inspire and empower the next wave of digital health tools designed specifically for kids.”

-Jen Ruschman | Assistant VP, Digital Health Cincinnati Children’s Hospital Medical Center

“Our work showed us that it’s feasible to utilize smartphones and digital tools to engage and coach this population effectively. The Smart Health Education and Rehab Technology (SmartHEART) Program uses smartphone technologies and telehealth capabilities to deliver cardiac rehabilitation (CR) to Veterans.”
–Dr. Arash Harzand, MD, MBA

Clario’s patented, synchronized Opal sensors capture DiMe’s standardized measures of physical activity, ambulation, and balance to help reduce the sample size and duration of clinical trials. — Fay Horak, PhD Chief Scientist, Clario – Precision Motion

“The V3 Framework is a critical component for assessing quality evidence ingested in Atlas. With accessible definitions and common language, it provides a clear guide for our customers to confidently select fit-for-purpose tools.”

— Caprice Sassano, Research Lead, Human First

The clinical trials industry recognizes that lack of diverse participants is a problem. With demonstrated accountability there is the opportunity to collect more information and allocate resources to areas with large knowledge gaps.

“Early patient involvement is key to develop digital outcome measures that matter. It will lead to outcomes that truly support value-based healthcare for diabetes and chronic diseases in general.”
— Willem van den Brink, Scientist, TNO

“The V3+ framework highlights the need for early and iterative involvement of end-users and stakeholders to align user requirements and technical specifications.”

— Marian Schoone Consultant, TNO Healthy Living

We work with sponsors to build customized key performance indicators and dynamic data dashboards to monitor and respond to diversity metrics.

“Pediatric innovation has always come with unique challenges—from fragmented care models to a shortage of digital health solutions designed specifically for kids. This playbook provides the roadmap we need to bring safer, more effective, and scalable digital health technologies to children and families. We’re excited to support this effort and can’t wait to see the real impact it will have.”

-Sarah Scalia | Director, Innovation & Business Development, Boston Children’s Hospital

“It’s imperative for CHC to build an environment where participants feel comfortable and respected. Participants aren’t going to come back if they don’t trust the program and if they don’t understand its value.”– Kharla Colon-Vazquez, Program Specialist at Community Health Center, Inc.

This methodology [and ontologies] that we’ve developed enables structured data that can then be computed upon, and really impressive models can be developed, that will push forward digital endpoints in clinical trials and the use of digital measures in clinical care, pushing them into the EHR in a useful way. Overall, being able to map this data into something structured is a game changer. – Jessilyn Dunn | Assistant Professor, Director of BIG IDEAs Lab, Duke University

“Bringing in learnings from the Nocturnal Scratch project was incredibly helpful to define our pilots and inform clinical strategy.” — Monideepa Chand, Dermatology Early Patient Value Mission, UCB

By providing opportunities for more diverse clinicians to participate, Inlightened build trust with our community of providers so that they feel comfortable sharing their expertise and knowledge with client partners from across the clinical trials ecosystem.

“When we shift the approach from treatment to prevention, we empower Veterans, improve outcomes, and save lives.”
– Jonathan Brantley, DPM Chief of Podiatric Medicine and Surgery, Richmond VA Medical Center

It’s exciting to see software as medical device and artificial intelligence technologies moving from the early adopter phase I witnessed at FDA to the mainstream market in recent years. There’s still a lot of challenges ahead and clinical problems to solve for clinicians and patients. These tools help early-stage innovators understand where the starting line is and the commonalities and differences between various markets which is critical for decision making.

“DEEP is planning to utilize the output from this DiMe Nocturnal Scratch Project in the upcoming pilot with the EMA in collaboration with FPS to start thinking through how to actually do this in practice.” — Stefan Avey, Principal Data Scientist, Digital Health, Janssen

Jeff Abraham, Health Advances, shares how the Digital Endpoints ROI Calculator simplifies quantifying digital endpoints and will evolve yearly to stay industry-aligned.

Charlie Health shares that they are “honored to be featured” in DiMe’s V1C Directory and explains how the resource can help people learn more about the virtual care space, the work being done, and more.

Shelly Lanning of Visana Health shares that she likes that the V1C Core Competencies provides consistency for dealing with the “common denominators” that will help various employers and constituents.

“What surprised us was how well Veterans embraced the technology. Our work showed us that it’s feasible to utilize smartphones and digital tools to engage and coach this population effectively.”
—Dr. Arash Harzand, MD, MBA Senior Innovation Fellow, VHA Innovation Ecosystem Director of Digital Cardiology & Vascular Medicine, Atlanta VA Medical Center

Omada Health became the first virtual-first healthcare provider to earn NCQA’s PHP Accreditation for its Type 2 Diabetes and Type 2 Diabetes+Hypertension programs.

Learn more about how Omada Health, an V1C Coalition member, demonstrates the value of V1C in action.

Benjamin Schwartz shares that he had early access to the Unlocking Regulatory Success for Digital Health Product Developers course and highly recommends it “for anyone building in digital health.”

Lightship designs clincal trials to encourage easy and convenient participation while satisfying each study milestone. Lightship’s inclusive delivery models provide at-home and near-home flexibility for every step of the process, including informed consent.

Martha O’Neill, Health Advances, outlined the Digital Endpoints ROI Calculator methodology, highlighting its flexibility in assessing financial impact, demonstrating value, and testing scenarios.

“The entire course was extremely valuable. The most important part was how devices are classified and what are the steps in the regulator process for each class”

– Huma Sumar | Clinical Director, Advanced Cardiac Imaging

“I’m confident that my amazing team members often think I’m crazy when I deliberate or nitpick over the use of a single word. The point is words matter…One of the most useful features [in The Playbook] is the purposeful use of language and defining standard terms used in Digital Medicine.”

physiQ shared the results of a Moffitt Cancer Center and DiMe study, which found that the benefits of telehealth could reduce the financial toxicity of cancer care, one of the persistent challenges in oncology care.

Alessandro Ocera posts that he successfully completed the Applied Digital Health Ethics certificate, shares the insights he gained, and thanks DiMe for allowing him to gain knowledge related to his MSc program.

“Understanding the current state of digital measurement in Parkinson’s disease has historically been challenging—almost a ‘wild west’ where numerous entities operate independently, with limited collaboration or productive information-sharing. That’s why this inventory is so essential. Importantly, it’s grounded in evidence-based searches across meaningful health aspects, aligning with the core principles of patient-focused drug development, where the patient’s voice drives every decision. 

At CPP, DiMe, and MJFF,  we share a vision that centers on the patient’s voice, values transparency and open data, and supports evidence-based platforms to guide informed, technology-agnostic decisions. We share our gratitude for Dr. Anat Mirelman, whose invaluable expertise and vision guided this collaboration. 

This inventory enables us, through open science, to capture the broader digital measures landscape and make patient-centered, evidence-based decisions, ultimately advancing research and care for Parkinson’s disease” – Diane Stephenson, Executive Director, Critical Path Institute (C-Path)

In The Patient Matters in the End(point), Griffiths, et al. use DiMe’s Digital Measures That Matter to Patients to highlight the need of beginning research with an understanding of what is important to patients.

Multimodal digital health technologies (DHTs) allow for more ecient and less costly recruitment and reduced patient burden with decentralized clinical trials

“Since coming to the group, I no longer want to kill myself. I have found others who support me.”
—Veteran Patient, Hampton VA Medical Center

In July of 2021, the Clinical Trials Transformation Initiative (CTTI) convened experts to discuss: (1) barriers and solutions to the adoption of DHT-derived endpoints into pivotal trials; (2) data needed to prove that a DHT-derived endpoint is ready for a pivotal trial; (3) how collaboration and other new efforts can advance the adoption of DHT-derived endpoints. A framework from The Playbook: Digital Clinical Measures was used during a breakout session to discuss what’s needed to demonstrate the meaningfulness of an endpoint for Atopic Dermatitis.

I work for multiple health startups now and all of them play in a regulated space but very few have a grasp of the regulations that govern their businesses. I’ve found tremendous value in being the guy who can bridge business, healthcare, and law/reg and this course has helped cement some of the regulatory concepts I struggled with in digital health as well as gives me a cool certification to put some weight behind my experience without having “regulatory” on my resume.

– Matthew Potts | Sr. Manager, Strategic Finance and Business Analytics, HALO Precision Diagnostics

Sibel Health is a medical device company that has developed a wearable, wireless scratch sensor to automatically detect scratching using AI/ML algorithms. The technology was accepted to the FDA’s drug development tool (DDT) program and is currently undergoing qualification to act as an endpoint in clinical studies determining the efficacy of therapeutics for atopic dermatitis. DiMe organized a Critical Path Innovation Meeting between pharmaceutical companies, patient advocacy groups, dermatologists, members of the FDA, and digital health technology manufacturers like Sibel to discuss the digital measurement of nocturnal scratch. Having a shared terminology and ontology for nocturnal scratch facilitated conversation between Sibel, the FDA, pharmaceutical companies, and other stakeholders by ensuring that everyone had the same baseline understanding of the concept. Interviews conducted by DiMe with both pediatric and adult atopic dermatitis patients and their family members established the clinical meaningfulness of nocturnal scratch to patients. Inputs from these interviews were critical in determining the outcome measure that would be most valuable to patients in drug development.

“V3 is a very helpful framework, clarifying the evidence required to support the digital measures we provide and leverage the benefits of multidisciplinary collaboration.”
— Christine Guo, Chief Scientific Officer, ActiGraph

“Having a common language from which to operate regardless of background or expertise has helped improve efficiency and project outcomes both internally and externally.”

“This course was robust, comprehensive, and indispensable in bringing forth and understanding of the regulatory issues in building digital health products and services. It provides a thorough framework for developing a successful product and business strategy for anyone designing a digital health product or service.”

– Ben Schwartz | Orthopedic surgeon

“Adolescents have unique healthcare needs that require thoughtful, tailored approaches. This playbook provides the tools and insights necessary to design digital health solutions that truly resonate with this age group, empowering them to take an active role in their own care while addressing the challenges they face.”

-Lindsay Stevens, MD, FAAP, FAMIA | Clinical Professor of Pediatrics and Clinical Informatics, Stanford University School of Medicine

Co-Chair, Stanford Pediatric Digital Health Taskforce

“Working on the Nocturnal Scratch paper with DiMe colleagues has expanded my knowledge about the most effective use of digital endpoints in clinical research and practice. As a result, I will have more to offer in future collaborations.” — Pat French, Left Lane Communications

“This initiative is an important step toward bringing rigor and structure to evidence generation for digital health tools. By providing a strategic framework, IEP is enabling internal stakeholders to align on immediate evidence needs while keeping long-term financial viability in mind. It ensures efficient resource use, prevents redundant investments, and maximizes impact. Such a well-structured approach to evidence generation builds trust, supports scalability, and ultimately drives better patient outcomes.”

-Terri Kim | Head of Strategy and Corporate Development Lunit

“Our virtual-first provider customers have so much on their plates, and we are committed to ensuring our Zus solutions fit seamlessly into their existing workflows. We used IMPACT’s toolkits to help make sure we can support all of the innovative ways in which these providers are designing their care models.” — Caitlin Reiche, Chief Commercial Officer, Zus

“Generating timely, cost-effective, and fit-for-purpose evidence is essential to accelerating the adoption of digital health technologies. By leveraging standardized frameworks, we can streamline evidence generation, enhance regulatory and payer confidence, and deliver digital health solutions to patients faster. 

Resources like DiMe’s IEP Framework are instrumental in guiding our approach, ensuring that our evidence aligns with the needs of all stakeholders, including regulators, clinicians, payers, and patients. This initiative is critical to building trust in digital health, and I am proud to contribute to a future where safe and effective digital health technologies are widely accessible through an integrated evidence-driven approach.”

-Nesrine Lajmi | Evidence Lead for Clinical Insights Roche

“V3 established a common language around evaluation of digital biomarkers that was grounded on familiar terms. This made its adoption in digital health natural.”
— Visar Berisha, Co-Founder, Aural Analytics

“The ROI calculator will have a significant impact across multiple areas. It will help tech developers create digital endpoints that meet economic and clinical needs, improving marketability. Researchers and institutions can use it to justify funding by demonstrating cost-effective, data-backed outcomes. It will be particularly valuable in Phase 2 and Phase 4 trials, where digital endpoints are widely used, providing more data. Healthcare payors and insurers may leverage it to assess long-term cost savings and treatment benefits, potentially influencing coverage decisions and reimbursement strategies. Additionally, it offers investors a clear financial rationale for funding companies developing or utilizing digital endpoints, attracting more capital to the space.”

– Szczepan Baran | Founder, Tech4Pets

“We believe our platform is helping to set a new, enduring standard for patient care. With over 40,000 patients successfully cared for at home, we’re eager to help define the next phase of scalable, sustainable care models that will continue to decentralize healthcare for the benefit of patients and health systems alike. That’s why Medically Home is excited to participate in the Connected Health Collaborative Community.”

GSK believes that clinical studies should reflect the diversity of populations who are most impacted by a particular disease.

“The Digital Health Deployment Toolkit will be an invaluable resource to support rapid dissemination of the Digital Navigator Model to health care where it’s urgently needed.”
— Angela Siefer, Executive Director, National Digital Inclusion Alliance

“As the field of DHT-enabled measures continues to mature, it was very illuminating and reassuring to hear from the biopharmaceutical industry, the technology sector, and academia about progress made in the field since the inception of DiMe and the publication of the V3 framework, which were fundamental to the field. We have heard each other’s stories, shared experiences, and developed resources that will help us move forward together and faster.”

– Elena Izmailova | Chief Scientific Officer, Koneksa Health

“Important recommendations have recently been published regarding the types of evidentiary evaluations to make when considering digital technologies for interventional clinical trials ([such as from] the Digital Medicine Society).” — Digital Technology Subgroup, Best Practices for Digital Health Outcomes, Version 2.0 Parkinson’s Disease CDE

“There’s flexibility in these measures. Let’s take napping for example. The core measure is based on intentional napping, but it can be modified, as shown in the ontology, to account for unintentional daytime napping. For us at Jazz, this is very important. One of the disorders that we’re really focused on is idiopathic hypersomnia. It’s a disorder in which napping occurs during the daytime, sometimes intentionally, sometimes unintentionally. It causes significant distress and concern for the individuals. We want to make sure that we’re transparent in what we’re measuring and can show a treatment effect with the therapeutics we’ve been creating in a clinical trial setting.”

– Eric Nofzinger | Senior Sleep Medicine Consultant Jazz Pharmaceuticals 

Nocturnal Scratch Project roundtable participants speak to the paradigm shift the project is encouraged through pre-competitive collaboration in the atopic dermatitis space.

By leveraging recommendations from The Playbook: Digital Clinical Measures, the Nocturnal Scratch Project team was able to have a valuable conversation with regulators.

“Digital tools give us a unique opportunity to detect early warning signs of events like OUD relapse and intervene before it happens. By harnessing continuous data from wearables and smartphones, we hope to be able to support people with OUD in real time, when and where they can benefit most.”

– Jessilyn Dunn, Assistant Professor of Biomedical Engineering, Director
BIG IDEAs Lab, Duke University

Sage Bionetworks is enthusiastic about leveraging digital technology to create self-paced participant-centric eConsent experiences that engage and educate people about biomedical research.

“In the rapidly evolving landscape of digital health, an Integrated Evidence Plan (IEP) is not just a strategy—it’s the bridge between innovation and impact. By aligning clinical, economic, and patient-centric evidence, IEPs ensure that digital health technologies are not only scientifically validated but also commercially viable. Without it, even the most groundbreaking technologies risk failing to gain trust, market access, and long-term adoption.”

-René Quashie | Vice President, Digital Health Consumer Technology Association

“The Playbook has helped provide a usable and acceptable framework for discussing the use of digital health technologies with regulators as a primary endpoint.”
— Thomas Switzer, Principal Digital Health Scientist, Early Clinical Development Informatics, Genentech

DiMe’s International Regulatory Pathway project is the first global deep dive of the international digital health landscape on the current Health Authority policies and guidance surrounding technologies. These resources will make a large impact on how traditional pharma companies navigate the global landscape in clinical trial strategies and beyond!

“At Medidata, we participate in the Alzheimer’s Digital Measures Project to help us deepen our understanding of important and clinically relevant digital biomarkers to this disease. Working with DiMe has resulted in a closer relationship and shared perspective with a broad group of ecosystem stakeholders that share our vision for better endpoints and next-generation treatments.” – Ben Schlatka, VP of Digital Biomarker Solutions, Sensor Cloud, Medidata

“Fantastic course. loved the examples integrated into various sections; helped contextualize and apply the concepts taught.”

– Digital Medicine Academy Learner

“Recovering from opioid use is not a solo journey, but requires an integrated system of personal, peer, and professional resources.”

– Dr. Anthony Steele, Director of Medical Services
Alcohol and Drug Services (ADS)

“Excellent overview and refresher on the regulatory landscape and frameworks for digital health. FDA has collaborated with the industry and made great strides on leading efforts within the digital health space to provide clarity and guidance on various topics.”

– Ninad Gujar | Vice President, Samsung (NeuroLogica)

The Inlightened platform democratizes access to the only marketplace of curated, vetted, and engaged clinicians and healthcare professionals, passionate about shaping the future of their fields.

“We are being intentional in how we find companies to partner with. That underscores the goal with The Playbook and our bigger digital health strategy… We want to make it clear to the world that the VA wants to collaborate.” – Dr. Arash Harzand, MD, MBA

Shelly Lanning of Visana Health highlights how V1C’s Toolkit for Contracting has been helpful as a young company for developing internal processes and procedures.

Accelerated trial setup & operations: A case study in Cystic Fibrosis to illustrate the ROI of improved data availability

“Digital measurements must become another element of the overall clinical outcome assessments used for assessing effectiveness of potential new therapeutics.”
— Brian E. Winger, PhD., Senior Advisor for Digital Health, Eli Lilly

“The bar for clinical grade speech analytics has to be high given what’s at stake. The V3 framework allows us to provide evidence to ourselves and our customers that our metrics clear that bar.”
— Julie Liss, Co-Founder, Aural Analytics

“V3 has been transformative for us as it’s served as a guiding framework for how we operationalized validation internally, and how we communicate with partners externally.”
— Visar Berisha, Co-Founder, Aural Analytics

“These considerations have been a useful aid in developing an internal checklist we can use in progressing operational readiness of digital clinical measures.”

“As a company working on every aspect of the virtual care value chain, having a common internal product and regulatory development language is very important. The V3 framework provides that language.”
—Benjamin Vandendriessche, CMO at Byteflies

“We believe pre-competitive collaboration is essential and are looking forward to working with like-minded innovators within DiMe to accelerate this important work in the fight against Alzheimer’s disease and related dementias public health epidemic.”
— Martin Dubec, Head of Biogen Digital Health

A trusted personalized relationship is critical for successful DEI recruiting and RWE clinical trials. Our Digital Assistant platform builds human-like trusted relationships and enables behavior-based real-time interventions…all within the context of trial protocols and stringent medical-legal-regulatory frameworks.

Haresh Keswani happily shares that he obtained a new certification from DiMe in Applied Digital Health Ethics.

“The Playbook is my go-to reference when bringing those new hires into this industry, and has been indispensable in our product development.” — Zeenia Laila Framroze, VP, Strategy and Operations, Smart Omix by Sharecare

Advancing nano-rare disease treatment with Syde technology in clinical trials

Advancing digital biomarkers to accelerate Parkinson’s disease drug development

Geeta Nayyar shares that she is on the leadership council for DiMe and highlights three main goals for the Core Measures of Sleep research initiative.

“The engagement tool provides for a highly accessible, actionable plan to help organizations more effectively partner with key stakeholders to produce greater benefits for all.” — Amy Taylor, Vice President, CHC

“We have the technical capability, we now need to have the clinical focus and context of use to pursue digital biomarkers. That is what [the V3 framework] is about.” — Arthur Combs, MD, Senior Clinical Advisor, Activinsights

Reconstructing the whole sleep care pathway enables Dreem to optimize many of the unique benefits of V1C: Dreem offers a cheaper, bundled V1C experience to insurance companies that matches insomnia outcomes and exceeds OSA outcomes.

Learn more about how Dreem, an V1C Coalition member, demonstrates the value of V1C in action.

DCT brings a unique set of challenges and significant concerns around “trust”. As clinical data and documents are being collected by, store in, and exchanged an increasing number and variety of systems and devices, trial stakeholders struggle to ensure integrity and authenticity of the research data. As result, we believe that blockchain and distributed ledger technology can improve accuracy, encourage data sharing, and ensure regulatory compliances.

“LVAD patients require close monitoring in the outpatient setting and home monitoring plays a crucial part of their outpatient management. The use of Stel Bluetooth transmissions gives us the confidence that we can report more accurate results in a timely manner to their care team.”
— Terea Williamson
Director of Diagnostics/VP of Operations, Orthodynamics Company, Inc.

“The Playbook provided a comprehensive and well-structured information resource that helps our organization to build a common language and establish a common knowledge baseline for different functions to be able to engage in a more constructive and streamlined fashion.”

“The most critical step in designing a digital product is working hand in hand with those experiencing the burden and unmet need you’re solving for.” — Meg Dryer, Chief Marketing and Design Officer, Evidation

“The end-user must be at the center of the development process. This is even more important when considering the unique needs of the pediatric population. It involves not just the young patients but also their families and care providers. The recommendations in this playbook serve as practical guidelines that you can use to create impactful digital health solutions.”

-Olivier Staquet | Chief Technology Officer, Gabi SmartCare

“Koneksa’s work, aimed at bringing new treatments for patients with PD, is fully aligned with the V3+ framework.”

— Jennie Lavine, PhD, Sr. Applied Data Scientist, Koneksa Health

— Kelly Scherer, MPH, Sr. Product Manager, Koneksa Health

— Elena Izmailova, PhD, CSO, Koneksa Health

“The Playbook provides a compelling framework for communication across the digital healthcare spectrum.” — Kevin Duffy, Co-Founder and COO, KELLS

Heartbeat Health partners with ACOs for effective care transitions for higher acuity patients.

“When you’re using a sensor in a clinical context, you ensure it’s being used appropriately. Using the resources that DiMe has put together is critical.” – Jordan Silberman, Elevance Health

The V3 framework and The Playbook: Digital Measures Edition are a core part of Nestlé Research’s sensor assessment methodology, enabling us to access real-time clinical data via wearables for clinical and consumer research.”

Inlightened was founded on the principle that diverse insights are key to advancing healthcare innovation for all. Ensuring clinical trial personnel are empowered with information and tools to optimize their experience will support their ongoing involvement, and that of the patients who have historically been so underserved.

“Morse Clinics is excited to partner on this pilot to continue making strides to help individuals who experience opioid use disorder!”

– Samantha Burggraf, Opioid Treatment Program Director
Morse Clinic of Zebulon

Martha O’Neill, Health Advances, explains how the calculator fosters cross-organization discussions on digital endpoint benefits, with future data enabling even greater impact quantification.

Byteflies’ CovidCare@Home demonstrated that replacing and extending a part of care traditionally provided inside the hospital or clinic with remote patient monitoring is feasible and can be orchestrated quickly when a critical mass of stakeholders rally around providing a safe and pragmatic V1C solution.

Learn more about how Byteflies, an V1C Coalition member, demonstrates the value of V1C in action.

“HumanFirst uses the Primer to make sure our sales teams, prospects, and customers are using the same language when it comes to digital medicine.” — HumanFirst

“This model has been an effective tool to communicate the types of value to be achieved, and then to aid internal regulatory communications about the progress of ‘intended use’ as a digital measure develops.”

“The experience we have working on DiMe projects has helped Labcorp build credibility and respect with our partners. They value the know-how we bring to the table about The Playbook: Digital Clinical Measures.” — Susan Foose, MLIS, Director, Decentralized Trials and Patient Centricity, Labcorp

Kristofer Caya of Aetna states that he thinks V1C’s Core Competencies will provide a great starting point and structure for what needs to be covered and put out in the RFP and makes it easy for organizations to add more tailored or nuanced questions for their specific needs.

The Nocturnal Scratch project team demonstrated several concepts from the communications guide in DATAcc’s Toolkit for Inclusive Deployment to ensure their survey communications were inclusive and appropriate for each cohort of participants.

Richard Schwabacher shared that he completed the Applied Digital Health Ethics course by DiMe and praised the course for being “thoughtful” and stated that DiMe does a great job of “creating a shared understanding of key themes and challenges.”

“With the VHA being the largest integrated health care system in the country, both the agency and private companies have a vested interest in testing AI and machine learning models against the VA’s large volume of data. It is essential that the VA scales technologies with software partners in accordance with The Playbook’s recommendations to be successful.” – Dr. Arash Harzand, MD, MBA

“Everyone should read this book within their first 2 weeks of working at HumanFirst. It’s the best way to cover introductory content and get oriented to the industry.” — Head of Product, HumanFirst

“These tools helped us flip the 80/20 rule on its head and prioritize edge cases which result in designs that work for more people and have higher adoption, engagement, and retention.”
— Justin W Ranton, Director, UX, AliveCor

Felix Lee announces that he has obtained certification in Applied Digital Health Ethics from DiMe and that the course provided him with tools to use digital inclusion strategies and helped him reflect on the importance of implementing ethics by design.

“Nobody in the Tech world would develop a product without first talking to the consumers of that product. In the health world, those consumers are the patients… [and to outline the engagement required] we relied heavily on Digital Measure that Matter to Patients.” – Ieuan Clay

“It’s been a good process. I love the collaborative nature of it – bringing together all the different perspectives and then having DiMe bring it to life keeping kids at the forefront. And it’s been fun to be a part of it – to meet the broader community that’s passionate about pediatrics.”

-Krista Nelson | Director, Innovation Development, Children’s Mercy Hospital

“More aware of what to look for in ethically sound digital health companies when considering using their products”

– Huma Sumar | Physician, Veterans Affairs

Dr. Courisse Knight shares how completing DiMe’s Applied Digital Health Ethics Course gave her the tools to be mindful of the intent and impact that the application of digital ethics can have to the development of digital health solutions.

“Amazing content overall!”

– Haresh Keswani | Head of Technology Architecture

“Value-based, goal-directed payment for whole person chronic care management – this is what the market wants.” – Geoff Matous, Wellinks

Learn about how Wellinks, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

“The V3 framework was invaluable in helping UCB and our partners navigate the complexity of building a robust corpus of clinical evidence underpinning the core features and functionality planned for our upcoming smartphone based application.”
— Emily Kunka, Global Digital Transformations Lead, UCB

“This outstanding and practical course helps to reflect on the importance of ethics when working on digital health and demonstrates to you the necessity of being an active contributor.”

– Jose Brogeras | Technical/IT

Ophelia treats opioid addiction and co-occurring mental health conditions without requiring in-person treatment by combining virtual capabilities, proven science, and a consumer-first approach.

Learn more about how Ophelia, an V1C Coalition member, demonstrates the value of V1C in action.

More publications, describing how to apply the V3 framework in real life are needed as these publications build a common language, joint understanding within the scientific community, and therefore propel the field forward. 

— Elena Izmailova, CSO at Koneksa Health

“I gained a better understanding of the ethics associated with providing useful digital health solutions to patients. I will be more diligent and specific in communications with partners and vendors.”

– Philippe Lucarelli |  CEO/Senior Executive, Digital Strategy Lead, Gerresheimer

Customized solutions are needed to advance public health and to make a difference and create products for people who could not see the light of day of gain that access. Rubix’s digital platforms will allow us to launch solutions tailored at every stage of development.

In The Patient Matters in the End(point), Griffiths, et al. speak to the importance of pre-competitive collaborations to develop patient-centered endpoints, using DiMe’s Nocturnal Scratch project as an example.
View Case Study

“We are extremely proud of our involvement in the development of The Playbook, and wanted to promote The Playbook while demonstrating how our work exemplifies the principles it sets out.”

“The Digital Clinical Measures for CRS will be a key reference for tailoring ADI’s RPM solution to capture the right data. They will help align our technology with clinical needs, delivering relevant insights to enhance patient care. Participation in the DATAcc by DiMe project has enriched our understanding of CRS management, thanks to the multidisciplinary expertise of the working group.”

-Milos Todorovic | Director of Biomedical and Clinical Engineering Analog Devices, Inc.

Anne Kilburg highlights key insights from DiMe’s webinar on “New Tools to Navigate Digital Health Regulations” and speaks about the importance of “regulatory strategy as a value driver of digital health interventions.”

“Places like DiMe are where people can bring good ideas to the table and create the right forum to figure out how to get [data] right” – Amy Abernethy, MD, PhD, President, Clinical Studies Platforms, Verily

“The modular V3+ framework will help ensure picking digital measurement solutions that do what they’re supposed to do; now also including user acceptance, often overlooked but critical for adoption.”

– Bert Hartog

“The V3+ framework will enable better patient-centered research in pediatrics and pediatric cardiology by creating a structure for the evaluation of sensor-based digital health technologies. This is a vital need in the field, given how new this all is for children!”
— Animesh (Aashoo) Tandon, MD, MS, Director of Cardiovascular Innovation, Cleveland Clinic Children’s

ActiGraph leverages concepts from The Playbook: Digital Clinical Measures, specifically the four stages of operational considerations when deploying remote monitoring,  in a presentation titled Operationalizing Digital Health Technologies: Successes and Failures in Clinical Research.

Riddhi Kapoor announced that she obtained the Applied Digital Health Ethics certification from DiMe.

Elizabeth Zech of Mercer speaks about the dual purpose use of V1C Coalition Core Competencies as an evaluation tool that can help each client meet their specific goals and priorities.

“Just educating during the roll out of a product is not enough; we need to make sure that the data input that informs products are also enabling inclusivity early in the data collection phase in order to minimize unintentional exclusion.”
— Kalvin Yu, MD, VP, Medical Affairs, US Region, BD

“OUD is a complex challenge, and complex challenges require innovative collaboration and solutions. Our team is working to incorporate the many issues at play for those facing OUD and build a tool that can meaningfully change the arc of OUD relapse and save thousands of lives.”

– Candice Taguibao, Associate Program Director
DiMe

“The right data to develop or validate a useful product depends on precisely understanding how it will be used, how it fits in existing clinical workflows, and its benefits to care providers and patients. 

The DiMe CRS initiative brought together a diverse group of stakeholders to understand these perspectives better, providing invaluable insights about the types of data we need to gather to tackle immunotherapy patient monitoring. We will work closely with our partners and employ digital products to transform clinical research, gathering the right data to empower care providers and patients alike in this space.”

– Michael Pettinati | Senior Data Scientist, ActiGraph

“Thank you for this file [the CSV Download of the Library]. At this moment in time, I am using it for my own personal knowledge and development. As I am looking to educate myself more into the clinical space for DTx, versus the commercial world”

“3D printing is a great method to address unique Veteran needs through innovative rapid prototyping and custom solutions, both quickly and in a cost-effective manner.”
—Kaila Grenier, Clinical rehabilitation engineer, Eastern Colorado VA Health Care System

“V1C is about complete care” – Emily Rymland, Director of Nursing, Nurx

Learn about how Thirty Madison, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

Mansa Shroff shares her experience in taking the “Applied Digital Health Ethics” course and outlines learnings “in the hope that it inspires anyone reading this post to take the right actions to reduce the digital divide.”

“Great and comprehensive course about the regulatory strategy one has to consider while developing a digital health solution.”

– Philippe Lucarelli | Digital Strategy Lead

“Developing V3 with DiMe & concurrently running the very first V3 study provided a chance to combine theory and practice – it was thrilling!”
— Jessilyn Dunn, Assistant Professor, Duke Big Ideas Lab

“By accessing and citing DiMe’s library of digital endpoints, I was able to contextualize the increasing level of interest in digital endpoints to my team and our partners and show that collectively we are a leader in the broader movement of using digital health technologies in studies.” — Marie McDonald, Vice President of Sales and Customer Success, Altoida

What I love about DiMe is that it’s informed by an incredibly rigorous research process, but with an eye toward practical applicability. I’ve already used the Core Measures in my own work and am excited to share this resource with colleagues in both academia and the tech industry.

– Jonathan Berent , CEO, Founder,  NextSense, Inc

“My interest is primarily in understanding the depth and extent of endpoints in various indications, especially in NAFLD.”

– Dr Mihir Ghari, Lead Medical Affairs, Tatvacare

“As a digital health professional and a Responsible Innovation Fellow earlier in my career, I always possess a deep appreciation for the significance of regulatory strategy across all phases of company development. ” – Junchi Lu

Learning from industry experts throughout this course was very impactful. The course helped me appreciate the challenges and successes of digital innovation using real world cases and provided an understanding of available toolkits to thrive in this volatile and uncertain landscape. I really appreciated the parts of the course that emphasized the need for partnership in development at every stage and the quality improvement tips provided.

– Courisse Knight | Patient Safety and Healthcare Quality Graduate

Estimating the benefits of digital and plasma-based pre-screening in Alzheimer’s Disease trial recruitment

“DiMe’s Business Case project provides the digital health technology ecosystem with standard language to articulate the value of digital endpoints. With the output from this project, we look forward to seeing accelerated adoption of digital endpoints across the industry.”

– Rachel Chasse | Associate Director, Digital Science Strategy, AbbVie

January 10, 2023

“Validation of a novel device intended for remote clinical monitoring is essential to determine if the device is fit-for-purpose for the specific patient population.”
— Ariel Dowling, Director of Digital Strategy, Takeda

The V3 framework is our go-to framework for establishing usability and clinical validity of any new digital measure. With evolving local regulatory guidance, our study was a significant step forward to implement rigorous validation techniques in South East Asia.”

In The Digitally Enabled Physical Therapist: An APTA Foundational Paper, APTA uses The Playbook: Digital Healthcare Edition in the Digital Healthcare 101 section. Leveraging DiMe’s definitions of digital health, digital medicine, and digital therapeutics, APTA sets the stage for how different technologies can be leveraged in the field of physical therapy. Aligning on a common language, APTA can better articulate the opportunities to integrate digital into physical therapy.

“Engaging with people who have historically been underrepresented in biomedical research was a cornerstone to our mission. The toolkit allowed us to design our outreach strategy in a participant-centric and inclusive way.” — Amy Taylor, Vice President, CHC

Carrie Nelson of Amwell shares how V1C’s core competencies can be “equity enablers,” especially for those with disabilities.

“The informed consent is critical to the success of participant engagement in any project. The DATAcc toolkit helps to ensure we are considering the critical points of the process.” — Katrina Yamazaki, Principal Investigator and Senior Scientist, CHC

Cole Zanetti speaks about the the VHA’s collaboration with DiMe to create a value-driven framework to measure the impact of new healthcare innovations.

“There is great value in having DATAcc as an easily accessible resource that can quickly surface data on one aspect of value that inclusivity brings to the business.” — Celine Marquez, MD, Global Medical Director, Digital Health, Genentech

“The work that has been undertaken has already made great strides in understanding the significance of nocturnal scratching to patients and caregivers, how to make this endpoint a reality operationally, as well as alignment of terminology regarding this novel digital endpoint.”
— Carrie Northcott, PhD, Director & Research Lead for Digital Endpoints, Pfizer

“What I learned going through the peer review process [for a recently published paper] is that the V3 framework not only guides the community on how to design and execute experiments, it [also] helps build a [common] language… We were able to easily explain to the reviewers why [analytical and clinical validation] is important… in the absence of V3, that would be harder to do.” – Elena Izmailova, Chief Scientific Officer, Koneksa

Learn more about this V3 in Action story:

In the Digital Therapeutics Alliance’s report Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard, V3 is cited as a foundational concept: “In general, it is not possible to set a blanket threshold for all types of statistical assessments of clinical validation, as these will differ depending on the clinical measurement, patient population, and context of use.”

“We have to bring in human-centered design to make use of AI or machine learning models and make sure that there’s trust in those models and that we can clearly articulate value for the clinicians and care teams on the ground.” – Dr. Amanda Purnell, Director of Data and Analytics Innovation at the U.S. Department of Veterans Affairs
View Case Study

Visana’s evidence demonstrates that its virtual care programs improve outcomes, mental health, missed work days, and our members’ healthcare experience. Data also shows that they can provide a 4:1 ROI for employers and payers by reducing healthcare costs.

A report from RAND Corporation features our Measures that Matter resource and highlights DiMe’s digital measures and diagnostics work as a case study of organizations’ ongoing efforts
to develop COAs, DHTs, and endpoints relevant to
clinical trials for early PD.

“New DHT tools can help move the field of CNS drug development forward, but their disruptive potential can only be realized through coordinated and early interactions between all the stakeholders.” — Mantua, et al.

“It’s thrilling to join the launch of this collaborative community focusing on hospital at home. Science has shown us the best way to care for patients is to maximize time healing at home. Well-designed technological advancements will advance the breadth of opportunity to reach more patients. I’m excited to see the impact of this initiative and its potential to transform how we approach acute healthcare.”

Multimodal digital measures demonstrate greater responsiveness and sensitivity to disease progression and treatment effects than traditional clinical scales

Kristofer Caya of Aetna Virtual Care shares how V1C Core Competencies “creates a common foundation for diligence” and creates a “shared language” for the organization to have a conversation around the opportunities and partners in consideration.

“If not for DiMe and its active Slack community, my startup would have failed due to pandemic limitations. Instead, DiMe enabled me to find the perfect strategic partner, merge our companies and succeed in continuing to move towards bringing groundbreaking neurological assessments, diagnostics and treatments in digital form to millions in need of this help around the world.”

 – Tony J. Simon Ph.D.

“The V3 framework has helped set an industry standard for evaluating digital measures and has guided our rigorous research and development of novel speech-based measures.”
— Jessica Robin, Director Clinical Research, Winterlight Labs

In Koneksa’s Playbook Digest, the company demonstrates the real-world impact of The Playbook in the field of pulse oximetry.

Representatives from Johnson & Johnson, Haleon, and HumanFirst leverage The Playbook: Digital Clinical Measures in their SXSW panel application titled Your Body is a Unique Database. Who Owns It?

“There can be small, medium, and large t-shirt sizes of implementing IEPs for DHTs, but make sure you do it in some way. Not every team will do it to the same degree of granularity and specificity. In our experiences, it can be a single workshop that brings stakeholders together and just starts thinking about this all the way through to a formal plan with research and structure to it. A little bit of thinking ahead is crucial, but it doesn’t have to be overwhelming and these resources will support you throughout.”

– Maurice Solomon | Principal, Digital Health Strategy & Innovation, ZS Associates

Using the Core Digital Measures of Sleep, we set a foundation of transparency in our measurement science. It allows us to ensure patient relevance while answering the necessary clinical questions. Using the evidence reporting template will set us up for success in our development activities.

 — Eric Nofzinger, MD Senior sleep medicine consultant to Jazz Pharmaceuticals

“Verily has invested in an ecosystem to improve research and patient care, distinguished by our data and AI expertise. By leveraging DiMe’s collaborative platforms and resources, which provide a forum for aligning with regulatory bodies, clinical experts, and other industry leaders, we’ve accelerated innovation and implemented more precise, data-driven solutions. DiMe has been key in advancing our understanding of digital endpoints, helping us build a more robust and reliable path forward.”

– Caroline Currie | Head of Product, Digital Measures, Verily

“XR is changing how the VA delivers care – one way is by augmenting and increasing access to care for Veterans. We’ve seen it decrease pain, decrease anxiety, and provide positive distraction for patients. We can bring relief in a non-pharmacological, non-invasive way that brings joy to and invigorates the healthcare system.” — Anne Lord Bailey, PharmD, BCPS, Director, Clinical Tech Innovation at U.S. Department of Veterans Affairs

The course provided a simple and efficient approach to developing a general understanding of the regulatory frameworks for digital health products–with links and references to dive deeper as needed.
– Omar Manejwala, M.D. | Chief Medical Officer, DarioHealth

“I love the (infographic). It has changed my life. I finally understand how to use these socks.”
—Veteran, User of PSMT during pilot testing

Shelly Lanning of Visana Health recommends that startup companies take advantage of the V1C tools available on the website and explains how it helped her identify key core constituents and provided a foundation to develop KPIs and procedures around.

“We are hyper-focused on improving clinical outcomes and reducing health disparities through pragmatic use of technology. We believe that the biggest impact of digital medicine can be realized by having an interconnected system that enables proactive decision-making. To accomplish this, we are excited to participate in the Connected Health Collaborative Community, comprising industry, government, and academic partners. This will allow us to continuously learn and improve our practices for the betterment of our patients and frontline health workers.“

eConsent is a scalable and flexible approach to streamline the consenting process. The process becomes more interactive and allows for engaging more diverse populations.

“This course was extremely timely and valuable for our company. As the digital health space evolves, we can count on DiME to put forth clear, concise content and frameworks that are recognized across all industry stakeholder groups to help guide small companies like ours as we bring forth new innovative technology aimed at benefiting end users – patients and clinicians.”

– Jeanette Tighe | VP Smart Medicines, TruTag Technologies

“The V3 framework was transformational for educating the scientific community, making it receptive to the ideas of how to validate biometric monitoring technologies for use in clinical trials.” — Elena Izmailova, PhD, Chief Scientific Officer, Koneksa

“Wearable devices offer an incredible opportunity to increase diversity in clinical studies, but they need to be accessible to a broader set of users to make this vision true.”
— Kristin Size, Head of Study Devices, Verily

“One of the areas we’ve been exploring (at Stanford) is caregivers. There’s a lot of commonality in caregivers, both for the frail, elderly, and for pediatrics. And since the family is kind of the ultimate healthcare delivery system, it may be possible to develop digital health tools that have greater applicability across different ages.”

– David Bergman | Stanford University School of Medicine

“Usability of digital adherence solutions is the key to success in achieving comprehensive patient data on drug exposure.” — Oana Paun, Quality Assurance Manager, AARDEX Group

“For years we have been searching for the “manual” on how to create an integrated evidence plan for our digital biomarkers & therapeutics for mental health. This “manual” is finally here. The IEP guide for DHTs provides the extraordinary value of expediting decision making with internal teams and facilitating external collaboration, all with the goal to demonstrate the necessary clinical validity and viability for market adoption.”

-Sharon Kaplow, LCSW | Vice President of Clinical Operations Feel Therapeutics

“I found the building for adaptability portion to be the most helpful — We live and breathe a culture of iterative innovation which requires us to formulate a very forward-thinking regulatory strategy and continue to improve upon this strategy as the product development process progresses. The importance of this message/section in the content cannot be overstated.”

– Emily Lewis | Global Digital Business Transformation Lead

By embracing digital measures, pharma can accelerate drug development, improve patient outcomes. Pharma can and will continue to compete on assets, but should not compete on (digital) endpoints. We require industry collaborations in order to usher in a new era of medicine.

Carrie Northcott, Pfizer, discusses the importance of pre-competitive collaboration as a key to success with the Nocturnal Scratch project and its work, including the measures terminology and ontology resources.

“A great course in a very user/business friendly format to educate cross-functional colleagues who work in this space. Very helpful frameworks and resources to help formulate a fit-for-purpose regulatory strategy for future offerings.”

– Sapan Anand | New Product Commercialization & Portfolio Strategy, Bayer Pharmaceuticals

“A complete catalog of digital medicine studies (ideally linked to ClinicalTrials.gov study record) has a potential to advance regulator’s view of digital medicine. DiMe’s Library of Digital Endpoints can greatly contribute to creation of such a catalog.” — Vojtech Huser, Pfizer

“The Playbook doesn’t tell you what to think or decide, it teaches you how to think and decide – that’s true innovation acceleration.” — Zeenia Laila Framroze, VP, Strategy and Operations, Smart Omix by Sharecare

Andy Coravos of HumanFirst uses The Playbook: Digital Clinical Measures Quick Start Guide in a presentation at the University of Buffalo titled The Future of Clinical Trials: How Will New Technologies Affect The Lives Of Participants?

“The DATAcc Toolkit for Inclusive Deployment of Digital Health is a valuable addition to our Resource Library, for site users seeking data and best practices to improve health in Northeast Ohio.” — Healthy Northeast Ohio Staff

(Evaluating partnerships) Carrie Nelson of Amwell states that she envisions using the core competencies to evaluate partnerships and potential partnerships

I think the regulatory chart/table for the different device categories is extremely helpful. I also think the outline for developing a fit-for-purpose regulatory strategy provides key guidance to unify the development of trusted digital health products.

 -Samantha McClenahan | Program Associate, DiMe

“Your work has proved invaluable in distilling the current landscape into easy-to-understand terminology.”

– Desmond Dorairajoo, Director, Clinical Operations Strategy

“As patients and care teams evolve the standard of care to the home, common barriers emerge around complexity with access, usability, security, and supply chain.”

— Erica Spatz, MD, MS, Associate Professor, Section of Cardiovascular Medicine, Yale Center for Outcomes Research and Evaluation, Yale School of Medicine

NIH National Institute of Neurological Disorders and Stroke working group included a summary from the EVIDENCE Checklist in their recommendations, noting that all studies using digital health outcomes should at least report items noted on the checklist.

Jeremy Wyatt at Actigraph highlights items from DiMe’s The Playbook that get him excited about the opportunity to partner with some of the best and the brightest in the industry to move the needle forward and ultimately help patients live longer, better lives.

Curai Health is on a mission to expand access to high-quality, affordable healthcare for everyone. Curai Health works with health systems, health plans, and third-party administrators to provide a new level of primary and urgent care by leveraging deep clinical and machine-learning expertise.

Learn more about how Curai Health, an V1C Coalition member, demonstrates the value of V1C in action.

The program provided a comprehensive understanding of ethical considerations in healthcare technology and equipped me to navigate the digital landscape with confidence and integrity. The instructors were experts and the curriculum covered a wide range of topics. I highly recommend this course to any healthcare professional looking to deepen their knowledge in digital ethics. Thank you, DiMe, for such a valuable learning experience.

– Mazin Osman | Pharmacist at TLC

Heartbeat has developed a robust approach to offering their V1C solution through payers, where Heartbeat programs are offered to members in order to realize cost savings, coordination of care, and improved access.

Learn more about how Heartbeat Health, an V1C Coalition member, demonstrates the value of V1C in action.

“Long-term, continuous data collection puts usability front and center. We debated each and every detail, such as size and weight of the watch, the shape of the PPG lens, the watch band materials, and so on, to deliver this unique DHT product with high usability and technical excellence.” — Christine Guo, Chief Scientific Officer, ActiGraph

“Partnering with DiMe aligns with our mission to improve clinical trials through digital innovation. Together, we’re bringing digital solutions to the forefront of clinical research, creating streamlined, patient-centered experiences and empowering all participants with advanced tools and support.”

– Chris Venezia, CEO
ProofPilot

“The lab is a lab. It is a simulation environment. None of it is real. As researchers, we do our best to recreate real-world experiences, but there’s always this gap. For me personally, I’ve done the overnight studies. Getting strapped up to as many electrodes as there are and having stuff around your chest and your legs and on your face – it’s just so different from what it feels like to have a regular night’s sleep or even taking naps during the day.”

-Farah Hasan | Expert Advisory Board Member and Patient Speaker Project Sleep 

“The V3 framework helped us add the concepts of verification and validation to the product development life cycle, which enabled our team to move faster and have greater impact.”

— Ritu Kapur, Head of Digital Biomarkers, Verily

“By engaging with the DiMe professional community, we better understand that this relatively new industry, which uses a different approach to treating illnesses and diseases, requires a different approach to hiring and scaling businesses.” — Paul Sinclair, Director, Client Solutions, Mix Talent

SimpliFed is a leading virtual-first healthcare provider specializing in maternal care at home.

Learn more about how SimpliFed, an V1C Coalition member, demonstrates the value of V1C in action.

“The measurement checklists provide a framework for best practices in developing and validating novel digital measures. These will help bring consistency and scientific rigor to the field!”

“Digital endpoints must provide a clear return on investment so they may progress from the research and development realm and deliver on the promise of these technologies and measures. The resources developed in this project will provide decision-makers with tools and confidence to evaluate the value of using digital health technology in a registrational clinical trial.”

– Dudley Tabakin | Founder and Chief Executive Officer, VivoSense

Acclinate integrates community engagement with trust-enabling technology to help pharmaceutical companies, CROs, and healthcare organizations access and engage communities of color so their research efforts are more inclusive and reflect the populations they serve.

“At Verily we used DiMe resources to build both internal and external vernacular and a structured way of presenting information that lined up with [V3]…this gave us the tooling that we needed so we could move fast.” – Amy Abernethy, MD, PhD, President, Clinical Studies Platforms, Verily

The clinical trials industry needs specific metrics to benchmark and assess performance their efforts to make critical adjustments for increasing diversity in clinical trials.

“The primer is a great resource to help understand the complex development of digital measurements within the healthcare and pharmaceutical industries.” — Erick Pasco, Eli Lilly

“This course gave me additional insights that I can apply and share with our clients.”

-Donna | VP Research

I use it to help steer the teams into ethical software development.

– Michael Starling | Scrum Master, Qualifacts

“The DiMe Society resources, especially V3, really helped me wrap my brain around how the different types of validation need to be studied differently, and provided the vocabulary to differentiate these concepts.” – Animesh (Aashoo) Tandon, MD, MS, Director of Cardiovascular Innovation, Cleveland Clinic Children’s

“Digital health has the power to transform the lives of those suffering from disease—guiding them from the onset of their condition to the right diagnosis, connecting them with appropriate care, ensuring access to life-changing therapies, and supporting them in the continuation of care. However, for digital health to truly succeed, we must address the evidence needs of all stakeholders—regulators, payors, clinicians, and, most importantly, patients and caregivers. By building the trust, efficacy, and value story for each of these groups, we can drive adoption, regulatory authorization, and reimbursement, ensuring that digital health solutions fulfill their promise across the healthcare ecosystem. The assets produced by the IEP project will equip digital health sponsors with the tools to efficiently and effectively generate the evidence needed to support this mission.”

-Jeff Gombala | Digital Health Consultant – An independent member of The Stem

FDA Digital Health Center of Excellence  shared details on DiMe’s Sensor Data Integrations project in its bulletin, which provides updates from CDRH:

“These toolkits were created for key stakeholders, to advance their use of sensor data to make better decisions, faster, in healthcare and research.”

“If you’re interested in learning more about #remotemonitoring across #clinical research, clinical care, and #publichealth – with a specific focus on connected #sensor products – DiMe Playbook is your one stop shop.”

Sam Holliday from Oshi discussed how virtual care companies came together to create the payment and coding toolkit at V1C Coalition to assist with reimbursement for V1C services offered.

Lightship’s specialized patient engagement teams design inclusive and adaptable outreach strategies customized for success within each patient community.

Despite being one of the instructors in the course, I definitely learned one or two new things. However, maybe more importantly, the well thought through course structure really lends itself to seeing the bigger picture of digital health product regulation and how to use it to frame product development.

– Shrawan Patel | Managing Director, Strategy Health

Touch BBCA drives collaborative efforts across the breast cancer ecosystem to work towards the common goal of eradicating Black Breast Cancer.

“If we are ever going to get a handle on Parkinson’s we must consider the breadth of impairments and use digital techniques to collect data continuously. The CPP team has done a remarkable job in constructing a viable approach.”
— John Crawford, Biotech executive living with Parkinson’s, Critical Path Institute

Value of novel digital endpoints in late-stage trials

“I’m going to use this tool to help develop new drugs for #patients. We’ll get a truer indication of the patient’s status, not just when they come into the clinic.” – Michael Benecky, UCB

Paul Martinetti shares that he has happily obtained the Applied Digital Health Ethics certification from DiMe.

“Leveraging technological advancements to help develop evidence-based protocols for individuals living with OUD, as well as their families, loved ones, and care teams, will position these interventions for success. We’re proud to support this study by providing continuous health monitoring and personalized, data-driven insights.”

– Shyamal Patel, Senior Vice President of Science
ŌURA

“Tools like The Playbook are being adopted by companies of all sizes. It provides a framework allowing you to understand how regulators, sponsors, and vendors can collaborate on the use of novel methods in clinical trials. ”
— Matt Biggs, VP of Applied Science, ActiGraph

The work here is a very important starting point for better understanding patients’ physical activity and functioning. The core measures came from the patient voice and clinician perspectives on what’s meaningful to patients. These measures can be very important tools to aid important care decisions like the timing of intervention or treatment choice, titration dosing of the treatment, and, of course, basic evidence needed – according to the V3 framework that DiMe developed. This work really provides the critical foundation on core measures, ontologies and really paved the way for future development.  – Sooyoon Shin | Clinical Science Lead, Digital Biomarkers, Verily Life Sciences

Christian Born Djurhuus says he could “see value in augmenting the DiMe V3 model to emprace Care Ops beyond clinical validation” and comments on the importance of observing and testing products in the real world for products to “maintain their relevance.”

“The workbook for prepping end users is a great reference tool to consult as we teach our volunteers how to best tell their story and communicate the things that matter to them with those health care stakeholders.” — Nicole Braccio, Policy Director, NPAF

“Digital Medicine Society (DiMe) continues to pioneer in #digitalhealth education. I recently took their course on #regulatory strategies focused on US FDA, which was outside of my expertise (this is my first class!) but every #healthcare professional is aware of the critical importance of understanding and implementing regulatory systems for the success of their digital health products.”

“The goal of this [validation study, the final step in V3] was to determine if this portable [and] understand the clinical validation in the specific narcolepsy population.  With the goal of saying, if this is fit-for-purpose, how can we use this in our future clinical trials?” – Ariel Dowling, Head of Sensing and Measurement, Takeda

Learn more about this V3 in Action story:

“The key learning was that the Monk Skin Tone Scale is more inclusive than the Fitzpatrick Scale. I will be a champion of using this scale and ensure that diverse populations are included in my work.”

– Paul Martinetti, MD | Principal Strategist, Digital Science Technologies LLC

Among the first authorized products with FDA’s new Predetermined Change Control Plan (PCCP) is providing expanded access to cardiac care.

“This course provides a clear overview of ethical issues in digital health and their implementation.”

– Jum’atil Fajar | Medical Care Manager, RSUD dr. H. Soemarno Sosroatmodjo Kuala Kapuas

“The V3 framework has become the standard framework for discussing validation of digital endpoints in our company and the industry as a whole.”
— Geoffrey Gill, President, Shimmer Americas

“Digital health tools have not yet shown substantial adoption or impact among underserved populations and this may lead to greater disparities in health outcomes. Our work, along with our DATAcc partners , is specifically designed to change paradigms, and deliver culturally appropriate solutions that shorten the distance between health technology developers, the tools they create, and the underserved community members that benefit from greater inclusivity” — Silas Buchanan, Founder and CEO, Institute for eHealth Equity

Simulator of study power for Parkinson’s Disease trials

“The DiMe toolkits have been invaluable for my work helping health systems and technology companies ensure that digital health products mitigate, rather than exacerbate health inequities. The synergistic power of the digital health and the digital inclusion ecosystems can now be leveraged at scale.” — Amy R Sheon, PhD, President, Public Health Innovators, LLC

“The tremendous amount of information in the endpoints library served as a rich resource to feed DEEP’s catalog.” — Bert Hartog, Co-founder of DEEP and Senior Director, Janssen Clinical Innovation

The Landscape of Standards has become an important element when presenting our standard-related work. It shows what standards already exist in this space and helps focus the conversation on implementation and expansion.

— Simona Carini, Open mHealth Data Scientist

Driving innovation in Huntington’s Disease by tracking progression through at-home digital measurements

“With a well-crafted IEP, digital health innovators can efficiently generate the evidence needed to demonstrate patient benefits, support market access and reduce risk of failure. The IEP resources will support companies in building smarter, efficient and more strategic evidence plans over the entire product lifecycle—turning great ideas into evidence based digital health products that provide value to patients and the health care system.”

-Sean Tunis | Senior Fellow, Tufts Center for the Evaluation of Value and Risk in Health (CEVR) and Principal, Rubix Health

“V3 is a very helpful framework, clarifying the evidence required to support the digital measures we provide and leverage the benefits of multidisciplinary collaboration.” — Christine Guo, Chief Scientific Officer, ActiGraph

“We appreciate that the contracting toolkit is universally applicable to all V1C companies. We continue to leverage it to ensure we’ve covered everything we need to in contracting discussions.” – Visana Health leadership

“I will definitely apply my understanding of the essential questions used in each step of the framework and the understanding of when certain steps in the modular framework may need to be revisited. The inclusion of the human centric elements in usability validation which continues through post market research is essential to ensure that quality is maintained, populations and their experiences are better understood and the hope of better more informed outcomes can be achieved.”

-Dr. Courisse Knight, Patient Safety and Healthcare Quality Professional

These standardized measures are really critical to be captured by digital health. It’s becoming standard of practice to use digital health to assess physical activity in research studies. For the purpose of patient workflow, national surveillance systems, and research, getting to core measures for physical activity is critical in all the work that we’re doing. – Laurie Whitsel | National Vice President of Policy Research and Translation and Senior Advisor, Physical Activity Alliance, American Heart Association

Kristofer Caya of Aetna discussed how the V1C Core Competencies tool provides his teams with a common foundation for diligence.

Linda Ngo shares that she recently completed DiMe’s Applied Digital Health Ethics course and “earned the respective badge.” She states that the course has deepened her understanding of “the impact that ethical challenges have on digital medicine and healthcare as a whole.”

“Early detection of Cytokine Release Syndrome (CRS) using digital health products and predictive algorithms will enable us to maximize the potential of cell therapies and T-cell engagers.

The collaboration with DATAcc by DiMe has been instrumental in supporting the industry towards this objective. I am optimistic about a future where more patients will have access to and benefit from these transformative therapies.”

– Premal Kamdar | Director, Digital Health Product Management, Bristol Myers Squibb

“From now on at work, when an sDHT has a role in a clinical study, I will ensure that it is evaluated with V3+ as well as for security, privacy, and economic feasibility.”

– Dr. Paul Martinetti, Senior Partner, The Bracken Group

“The Playbook provided a useful reference and a single place where we could find the answers to many questions as well as credibility to our work.”

“Leveraging DiMe’s ontology for data transfer specifications and standardizing data collection ensures uniform collection of all variables and enhances the reliability and comprehensiveness of our study observations.  

This advancement paves the way for future research, ensuring Takeda remains at the forefront of innovative healthcare solutions.”

-Melinda Chen | Senior Scientist, Digital Biomarker Lead, Oncology Precision Translational Medicine, Takeda

-Erik Koenig | Head, PTM Strategic Innovation, Takeda

The VA features the value-based framework from The Playbook: Digital Healthcare Edition on its Center for Care and Payment Innovation (CCPI) website and notes that it’s using the tool to create a structured approach to innovation that helps them to:​ 1) identify the need for innovative VBC measures through data-driven insights; 2) proactively identify high-risk, high-need Veterans with various illnesses and in different geographies​, and 3) ensure that health equity is accounted for throughout a pilot’s design and implementation – among many other benefits.

Work by the Diversity, Equity, and Inclusion in Digitalized Clinical Trials project team helped us identify the various ways digital tools can create more access for clinical trials.

“Your work has proved invaluable in distilling the current landscape into easy-to-understand terminology.”

– Desmond Dorairajoo, Director, Clinical Operations Strategy

“Byteflies Care@Home improves the delivery of care by providing the right clinical insights at the right time, in a collaborative effort with ‘brick and mortar’ and virtual providers.”

Learn about how Byteflies, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

Mistrust has been a key reason for lack of diversity in clinical trials, but by engaging with communities of color and potential trial participants early and often, clinical trial sponsors can develop therapies for all who need them.

“DiMe’s Endpoints Library exposed the need for the industry to pursue only measures that matter as digital endpoints.” — Manny Fanarjian, Head of Applied Sciences, HumanFirst

Newfund – a venture capital firm focused on early-stage investment in France and the United States – uses DiMe’s Playbook: Digital Healthcare Edition for market discovery, specifically in the digital startup space. They continue to share the resource with their portfolio companies to ensure they are harnessing the right opportunities in digital health.

“Removing barriers to the adoption of novel and potentially game-changing therapies is at the core of what we do at Canopy. We’re proud to partner with the DATAcc by DiMe and other leaders to turn that vision into reality.”

– Lavi Kwiatkowsky | Founder & CEO, Canopy

“V3+ is a rigorous and thoughtful framework that will inform the ways I evaluate sDHTs in the future.”

– Bill Wood, Professor of Medicine, University of North Carolina

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing people better health and a brighter future worldwide.

Mazin Osman announced that he obtained the Applied Digital Health Ethics certification from DiMe and stated that the course taught him about the “ethical considerations surrounding the use of technology in healthcare” and how to “navigate the complex digital landscape.” He also recommended the course to “healthcare professionals looking to deepen their knowledge and skills in this critical area.”

“If we truly aim to be patient-centered, we must take a measured & patient-first approach to sensors.  The technology will follow.”

Dreem operates within a fee-for-service reimbursement model via contracts with public and private payers that allow primary care providers or specialists to refer their patients directly to the clinic.

Learn more about how Dreem, an V1C Coalition member, demonstrates the value of V1C in action.

“V3, EVIDENCE Checklist, and The Playbook are excellent resources that we leveraged extensively in the writing of our manuscript.” – Charmaine Demanuele, PhD, DiMe Research Committee Member, and Executive Director at Pfizer

“For individuals striving to regain their health and productivity as part of opioid addiction recovery, preventing relapses is essential… Our Triangle CERSI program serves as the ideal platform for this work, bringing together academia, industry, and the FDA to address high-priority regulatory needs and accelerate solutions.”

– Christin Daniels, Executive Director
Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI)

A report from Health Advances and DTX features DiMe’s V3 framework and highlights how the resource can be used to validate claims made by digital diagnostics.

Elizabeth Zech of Mercer explains how V1C Core Competencies is helpful for preparing to “make a solid business case that’s going to resonate with an employer.”

“This course provided tangible, real world examples of ethics in action to guide my every day decision making in building digital health solutions. I especially appreciated the video content featuring thought leaders articulating how they demonstrably apply these core principles in their specific areas of expertise.”

– Emily Lewis | Global Digital Business Transformation Lead, Neurology, UCB

Digital tools provide the opportunity to meet more and diverse patients.

Tommy Vo shares that he has earned a certification in Applied Digital Health Ethics from DiMe.

“At Teladoc Health, inclusivity is a critical best practice in the design of our products. DATAcc’s resources to enhance inclusivity in the development and deployment of digital health products are an important contribution to the field and we’re excited to leverage them to supplement our design process.” — Hau Liu, SVP, Clinical Strategy and Product, Teladoc; Donna Boyer, Chief Product Officer, Teladoc

By the year 2030, the population of BIPOC communities in the United States is projected to represent 44.24%.

The Core Digital Measures of Sleep project and resources advocate for transparent measurement of sleep staging, the link between clinical biomarkers and patient-relevant aspects of sleep, and the ability to measure this from the comfort of the patient’s own home. These are all level-ups for clinical research and practice of sleep and sleep disturbance, which is facilitated by the work we do at Beacon Biosignals. 

— Jacob Donoghue CEO and Founder, Beacon Biosignals