Resources in Action Hub

Anabella Aspiras, The White House, expresses her excitement about CancerX’s launch of navigation resources and its impact on the health system’s ability to provide scaled and sustainable patient navigation. These efforts are needed to ensure equitable access, adoption, and availability of high-quality navigation services.

Danielle Brown, Florida Cancer Specialist, elaborates on how CancerX’s navigation resources have helped to address and reduce barriers to care. She particularly praises the ROI tool that she was able to test, stating that it helped tell the story of what an organization needs and what the ROI can be.

Cate O’Reilly, Cancer Support Community, explains how CancerX’s Digitally Enabled Patient Navigation Blueprint can impact patient and healthcare outcomes, help providers identify and articulate needs, and provide on-demand patient support.

“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

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

“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

Steve Xu praises DiMe for thinking about how words and definitions matter in relation to scratch. To better understand what scratch means, knowing the many different ways to talk about it and having this specificity is important.

Steve Xu appreciates DiMe’s work on ontology, frameworks, and definitions because it directly leads to outcomes, measurements, and technologies. Those tools can be put in front of regulators, which leads to the correct levels of clinical validation and acceptance.

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

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

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.

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

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

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.

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.

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.

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.

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.

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

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.

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.

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

“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.

“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.

“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.

“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.

“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.

AposHealth exemplifies how organizations can leverage V1C components and effectively manage care transitions by leveraging the right technology at the right time in the patient journey, as recommended in the Tech Stack for V1C Care Transitions IMPACT resource.

“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

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

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

“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

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

Shelly Lanning of Visana Health explains how prioritizing and providing strong care navigation requires using a different care model than what is traditionally used in order to get better patient access, have tools that help with consistency for identifying patients, and help contribute to an expansion and development of new models.

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.

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.

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.”

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.

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

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

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.

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

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.

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.

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.

“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

“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.

“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.

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.

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

– Nina Shaafi Kabiri | Research Scientist Boston University

“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 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 

“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

“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 

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 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

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

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

The 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

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

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

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

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

The wealth of materials we have developed in this project effectively addresses a critical issue. Among these challenges is establishing a unified set of definitions to ensure uniformity in communication. The Core Digital Measures of Sleep we have organized not only establish this common ground but also possess the adaptability and flexibility needed in the field.

 — Nina Shaafi Kabiri Research Scientist, Boston University Chobanian & Avedisian School of Medicine

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

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

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

– Bohdana Ratitch, Expert Statistician, Bayer

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

– Bert Hartog

“I will upgrade from V3 to V3+ to support adoption of sDHTs in our end to end product development studies, including also the important aspect of usability. Materials and publications included in the course are excellent.”

– Antonio Del Santo, Principal Medical Director, Product Development Safety, Roche

“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

“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

“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

“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.

“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

“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

“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

“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

“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

“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

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

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

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

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

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

These 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

“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

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

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.

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

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

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

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.”

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

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

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

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.

“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.”

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

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

“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.”

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

– Michael Starling | Scrum Master, Qualifacts

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

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

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

“Really enjoyed Digital Medicine Society (DiMe)‘s course Unlocking Regulatory Success for Digital Health Product Developers.”

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

I 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

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

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

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

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.

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.

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

 – Shrawan Patel | Managing Director, Strategy Health

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.

With the knowledge gained from this course I will now be able to confidently guide my digital health clients on every stage of developing and implementing a robust regulatory strategy.

 – Richard Bartels | President, DTxCC (Digital Therapeutics Commercialization Consultants)

Amazing content overall! 

– Haresh Keswani | Head of Technology Architecture

“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.”

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

 – Tanja Hellier | Digital Transformation Project Lead

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

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

 – Philippe Lucarelli | Digital Strategy Lead

“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

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

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

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

 – Tony J. Simon Ph.D.

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

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)

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

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

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

– Huma Sumar | Clinical Director, Advanced Cardiac Imaging

I 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

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

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.”

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.

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.”

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

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

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.”

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.

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.”

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

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

The 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.

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

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.

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

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

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

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

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

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.

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

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

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

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

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

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

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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

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

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

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.

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

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.”

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

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.

Pamela Tenaerts of Medable elaborates on how DiMe’s DEI resources have helped her create an internal common language and promote diversity at every step.

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.

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.

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

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 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

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

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

The 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 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

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.”

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.

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

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

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

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

– Huma Sumar | Physician, Veterans Affairs

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.”

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

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

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

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.”

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

 -Donna | VP Research

January 10, 2023

I gained a better understanding of the ethics associated with providing useful digital health solutions to patients while still protecting them. As a result of taking this course, I will be more diligent and specific in communications with partners and vendors.

– Christina Won, Associate Director | Clinical Development & Ops

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.”

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.”

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

“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

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

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.

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.”

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.

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

“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 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.

“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

“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

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

“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

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.

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.

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.

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

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

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.

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.

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

“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

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.”

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.” 

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

“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

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.

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?

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

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

“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)

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

Learn more about this V3 in Action story:

“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:

“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 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:

“Through digital health-focused collaborations, CDRH is fostering regulatory science research that enables FDA’s experts to understand and assess benefits and risks of new digital health technologies; and this research helps ensure the safety or reduce the harm of products used by patients and consumers by providing scientific, non-biased, and objective expertise.”

Among FDA’s listed partnerships were the following DiMe work:

• Digital Health Measurement Collaborative Community (DATAcc)
• Nocturnal Scratch Digital Measures Development
• Sensor Data Integrations

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

“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

“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.

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

The 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.

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

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

“The 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

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

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

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

“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

“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

“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

“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

“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

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

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

“The V3 Testing within the DATAcc Toolkit for Development… is where my team in our trying to bring precision health to everyone is building devices and tools that let us generate objective real-world evidence… this is why I love this framing.” – Kristin Size, Head of Study Devices, Verily

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

“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

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 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

“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

“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

“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

“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

“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

“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

“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

“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

In The Patient Matters in the End(point), Griffiths, et al. leveraged DiMe’s Library of Digital Endpoints to contextualize the increased interest of digital endpoints and frame the discussion around why DHTs have yet to be leveraged in any FDA label claim.

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.

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 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

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

“The 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

“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 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

“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

“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

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

“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

“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

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

“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

“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

“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

“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

“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 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

“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

“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

“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 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

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

— Caprice Sassano, Research Lead, Human First

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

— Ritu Kapur, Head of Digital Biomarkers, Verily

“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

“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

“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

“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

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

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

“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

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

“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

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

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

“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

“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

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

“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

“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

“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

“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

“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

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

“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

“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

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

“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 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!”

“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.”

“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.”

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

“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.”

“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”

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

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

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

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

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

“The Playbook is a great “toolbox” when working with a diverse team. It allows for a clear level set on current situations, understand client needs, expand on education, and use technology successfully in a clinical trial.”

“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.”

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

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

“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

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

“The 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

“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

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

“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

“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