Resources in Action Hub

“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

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

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

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.”

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.”

“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

“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

“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

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.

“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

“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

“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

Benjamin Vandendriessche recognizes DiMe’s V3 framework as “a great equalizer in the field at large” and looks forward to contributing to the next V3 iteration that will consider usability and human factors by default.

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

This document summarizes the Parkinson’s Disease (PD) Endpoints Roundtable, which was held in Washington, D.C., on November 2–3, 2022, and hosted by The Michael J. Fox Foundation for Parkinson’s Research, Parkinson’s UK, and Parkinson Canada

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

“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.

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

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

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?

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.

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.

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.

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

Reveles’ mission of Bringing Hope Close to Home, recognizes how critical inclusive engagement is for increasing critical inclusive engagement is for increasing clinical trial awareness and expanding access to all populations who can benefit.

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

“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

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.

“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

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.

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.”

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

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.

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.

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

Cove, an end-to-end migraine solution, leverages a virtual-first approach to ensure migraine sufferers have access to specialist-level care, a full range of personalized treatments spanning innovative Rx, cognitive behavioral therapy, and non-Rx treatments, as well as ongoing care management, including access to an app-based migraine tracker.

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

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.

“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

Wellinks recognized a massive opportunity to make COPD care more human, leveraging personal connection and improved self-management to achieve improved outcomes, cost reductions, and happy patients.

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

“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

“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.

“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

Using Data we can transform outcomes for communities. We have to use technology to understand us [patients], our socio-economic conditions, what’s causing us difficulties in why we aren’t participating and leverage data to better understand how to reach commumunites that have been swept under the therapeutic research spectrum.

“As the leading nonprofit uniquely positioned to highlight the patient voice, AKF looks forward to continuing to work with this project team to improve the enrollment of participants from underrepresented racial and ethnic populations in clinical trials.”

Oshi Health, a fully virtual GI clinic, leverages a purpose-built care team to help patients achieve their goals.

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

“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

“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

January 10, 2023

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.

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.

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.

“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 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.

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

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

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

 -Donna | VP Research

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

Althea transforms data into actionable insights to enable diverse, equitable, and

“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

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.

“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

“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 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

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.

“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

“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.”

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

“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.”

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.

“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

From working with such a group of experts from across the world and in different sectors and industries, I have confidence in the robustness of the set of core digital measures we developed. Because these measures are omni-therapeutic, I will include them in my own work to collect additional information on a range of individuals in the general population with sleep issues.

 — Herman de Vries | Research Scientist, TNO

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

“Patient-centricity is critical to novel biomarker development. The Playbook establishes best practices for patient engagement, including a practical how-to for the industry to follow.”

“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

“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

“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

“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

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

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

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.

The emphasis for a fit for purpose reg strat is practical and not just a theoretical concept that I plan to back to work. 

-Desmond Dorairajoo | Director, DCT

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

“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

“The Playbook was helpful because it allowed teams across our organization to align on the industry’s standard terms and vocabulary for digital clinical measures.” – Basker Gummadi, Head of Digital Health at Gilead, Digital Health Evangelist, and Adjunct Professor at UCSD

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

“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

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

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

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.

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.

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

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.

“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

“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

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

Kimberly Barnholt of Genentech shares how DiMe’s DEI resources help identify known challenges and present solutions and guidance to navigate those challenges, as well provide a network for thought partnership.

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

“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.

“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

“We did analytics validation [step two of V3] in healthy populations versus disease populations in this case [because] gate and balance features can be recorded in both populations. In many cases, this is an optimal first step because testing novel algorithms [e.g., those developed by Koneksa] may require multiple iterations. – Elena Izmailova, Chief Scientific Officer, Koneksa

Learn more about this V3 in Action story:

Amazing content overall! 

– Haresh Keswani | Head of Technology Architecture

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

“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

Zivian matches clinicians with qualified physician collaborators across various specialties and states to build comprehensive provider networks, ensuring patients receive specialized care within the network.

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

Lightship is part of a powerful group network whose goal is to identify and cultivate targeted community partnerships throughout the clinical research space.

“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:

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.

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.

Based upon the learnings from this course I can now help steer my company to proactively develop a regulatory strategy for our technology. The full life cycle, asking the big questions at the development phase and having the resources to support informed decisions are key take aways.

– Barbara Falco | VP Quality, TruTag Technologies

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.

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

VAwerx shared Smit Patel’s LinkedIn post, stating that DiMe and Smit Patel are sharing valuable tips to build businesses that improve “cancer patients’ fighting postures.”

“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 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

“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

“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 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

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

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

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

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

“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

“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

“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

“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.”

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)

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.

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.

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.

Mansa Shroff further talks about taking the “Applied Digital Health Ethics” course, thanking DiMe and course instructors for creating the resource.

“CareHive provides seamless, integrated, and caring communications with our clinicians and patients, ensuring that our practice remains the centralized medical home for our patients.” – Dr. Kevin Spencer, President and CEO of Premier Family Physicians, a CareHive partner

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

“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

“Using DiMe’s V3+ framework, we were able to implement a fast-track process at UCB to make data-driven decisions on selecting fit-for-purpose DHTs for our clinical trials.”

— Ute Conradi, Head of Medical Device Innovation, UCB Pharma

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.”

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

“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

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.

“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

“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