Resources in Action Hub

“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

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

“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.

“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

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

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

“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.

“The Playbook guided our team to prioritize the most important elements of our project and helped us stay focused on patient-centricity.”
— Celia Fidalgo, Sr. Product Lead, Product, Winterlight labs

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.”

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

“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.”

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.

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

“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

“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

“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

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.

“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

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

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

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

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.

“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.

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.

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

– Huma Sumar | Physician, Veterans Affairs

Jeremy Wyatt, ActiGraph, details the measures used for the Nocturnal Scratch project and how work is being validated in the field.

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

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

“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

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.

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.”

“This project was a chance to work with passionate researchers, clinicians, and device developers in advancing pediatric digital health. The collaboration allowed us to approach the field from various perspectives, and the resulting playbook distills our collective expertise into an informative guide for developing and implementing DHTs -to better meet the needs of pediatric patients and their families.”

-Virginia Parks – Christina Marchand – Pauline Rivet – Laurence Leber | Servier

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.

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.”

“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.”

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.

“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.”

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

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.

“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.

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

“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

“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 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.

“Using the VA-DiMe value-driven framework, the VHA and physIQ deployed a virtual-care solution providing early identification of worsening heart failure enabling timely intervention and reducing readmission.”
—Karen Larimer PhD, ACNP-BC, FAHA, FPCNA VP of Clinical Development, PhysIQ

“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.”

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.

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.

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

“The Playbook will become a well trusted reference for academics and commercial entities alike.”

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

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.

“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.”

“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

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

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

The course provides great foundational awareness to incorporate ethics into every decision making step in the process of bringing a device to market. E.g., as a design input requirement.
– Suj Shah | Public Health/Regulatory, QARA

“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

“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 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

“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

“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

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’re often asked about “fit-for-purpose” with regards to our technology products. We really appreciate how the five components of fit-for-purpose are articulated in The Playbook (V3, security practices, data rights & governance, utility & usability, and economic feasibility). It’s important to understand each of these, because when executing a clinical trial, someone is going to care about each aspect somewhere down the line.” – Jeremy Wyatt, CEO, ActiGraph on The Playbook’s role in creating a shared foundation

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 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

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

Paul Martinetti shares that he’s obtained a new certification: Applied Digital Health Ethics from DiMe.

“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

“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

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

“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:

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

“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

“This playbook fills a critical gap for organizations like ours by providing a clear, actionable framework for navigating the complexities of pediatric digital health. It’s a much-needed resource for developing solutions that meet the unique needs of children and their caregivers while advancing the field.”

-Katerina Placek, PhD |Senior Manager, Digital Health Sciences, Takeda Pharmaceuticals

“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

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

“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

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.

“I use DATAcc learnings to help me guide conversations around inclusive digital measurement. For example, I used the development toolkit to help me formulate thoughts on inclusive pulse oximetry measurement in preparation for a meeting.” — René Quashie, VP Digital Health, Consumer Technology Association (CTA)

“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

“I see the profound impact of our work in using wearables for pediatric cancer survivors. It underscores the need for robust guidelines and frameworks in human-centered design, ensuring that technology not only advances scientific research but also genuinely serves the needs and improves the lives of children and families.”
— Emre Sezgin, PhD, Principal Investigator, Intelligent Futures Research Lab at NCH

“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.

“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 

“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

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.

“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 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

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.

“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

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)

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.

“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

“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.

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

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.

“The Playbook has been and will continue to be a reference point for our team. It is the resource the industry was missing.”
— Marianna Xenophontos, Director of Marketing, Empatica

“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

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.”

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 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

“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

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!

“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

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

“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

“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)

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.

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

“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 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!”

“Working with the IMPACT contracting toolkit, we’ve been able to explain key concepts far more clearly and concisely with at-risk entities, leading to faster ramps to execution and successful implementation.”
— Pete Celano, SVP, Business Development, Heartbeat Health

“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

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.

“The contracting toolkit helps us accelerate our sales cycles and reduce our contracting times.” — Joe Connolly, Co-Founder & CEO, Visana Health

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

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.

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

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.

“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.”

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.”

“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

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

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.”

“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 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

“The fact that these tools were collaboratively developed by a diverse group of experts with various stakes has made it an invaluable resource that we can confidently reference.”

One of my clients has a new clinical research program and is open to innovation. We will develop technologies that reach patients and clinicians, and we will need to work closely with the FDA. I will return to this course to refresh on needed actions and take advantage of the organized, linked external resources and explanations. This course also provides the evidence we need to justify early and often communication with the FDA. 

– Paul Martinetti | Principal Consultant, Digital Science Technologies LLC

“This playbook offers an invaluable resource for anyone involved in developing or deploying pediatric digital health tools. Our contribution of accurate gaitmat data bridges the gap between aspiration and execution, offering clear reference data that can be immediately implemented into clinical research and care to improve or create technology that’s not only actionable but also effective and sustainable.”

-Michael Rowling | Owner, Protokinetics

“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

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

“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

“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.

“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.

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

“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

“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

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 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