Resources in Action Hub

“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

Amazing content overall! 

– Haresh Keswani | Head of Technology Architecture

“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

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

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.

“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

“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

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

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

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.” 

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

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

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

“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

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.

“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.”

This source is very valuable by providing a holistic view of regulatory landscape of Digital Health products. Building responsible innovations is the fundamental key to develop a successful digital health product. 

– Junchi Lu | Senior Manager, Strategy & Business Excellence, BMS

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.

“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

“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

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.

“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

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.”

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.

“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 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

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.

“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

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.

“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

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

“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

“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

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

“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

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.

Including napping in the core measures set is invaluable to those wishing to study sleep disorders outside typical lab conditions whether intentional or not, daytime napping is a key marker of excessive daytime sleepiness and a meaningful outcome for patients.

– Raul Torres & Katerina Placek | Senior Manager, Quantitative Sciences, Takeda, Senior Implementation Manager, Digital Health Sciences, Takeda

“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

“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

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

“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)

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.

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

“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

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 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

“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

“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 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.

“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

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

– Michael Starling | Scrum Master, Qualifacts

“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.”

“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.”

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.

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

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

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.

“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.”

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

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.

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

“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

“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

“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.

“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

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.

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

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.

“We have used data from the Library of Digital Endpoints to understand the trend and landscape in the industry, in combination with our internal and clinicaltrial.gov datasets. The database helps our clients to appreciate the level of adoption and maturity of digital endpoints, and provides a great starting point to develop the digital endpoint development roadmap.”

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.”

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 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

“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

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

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

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.

“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

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.

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

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.

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

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.”

“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

“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

“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

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.

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

“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

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

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

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

“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!”

“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

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

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.

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

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.

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

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.

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.

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

“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

“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

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.

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.

“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.“

“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

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 Playbook provides a practical ‘how to’ guide for trial teams on coordinating the multi-functional efforts involved in implementation of digital measures in clinical trials”

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

“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

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!

“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

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

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.

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.

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.

“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

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

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

“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

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

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.

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.

“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

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.

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

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

“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

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

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

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.

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

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

– Huma Sumar | Physician, Veterans Affairs

“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.”

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.

“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

“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