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.”