Resources in Action Hub

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

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

“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

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.”

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

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.

“Understanding the current state of digital measurement in Parkinson’s disease has historically been challenging—almost a ‘wild west’ where numerous entities operate independently, with limited collaboration or productive information-sharing. That’s why this inventory is so essential. Importantly, it’s grounded in evidence-based searches across meaningful health aspects, aligning with the core principles of patient-focused drug development, where the patient’s voice drives every decision. 

At CPP, DiMe, and MJFF,  we share a vision that centers on the patient’s voice, values transparency and open data, and supports evidence-based platforms to guide informed, technology-agnostic decisions. We share our gratitude for Dr. Anat Mirelman, whose invaluable expertise and vision guided this collaboration. 

This inventory enables us, through open science, to capture the broader digital measures landscape and make patient-centered, evidence-based decisions, ultimately advancing research and care for Parkinson’s disease” – Diane Stephenson, Executive Director, Critical Path Institute (C-Path)

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

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.

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

“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

“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

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.

“Collaborating with DiMe on this project has been a game-changer for pediatric innovation. This playbook is a testament to what’s possible when diverse stakeholders come together to build meaningful solutions. It’s a guide that will inspire and empower the next wave of digital health tools designed specifically for kids.”

-Jen Ruschman | Assistant VP, Digital Health Cincinnati Children’s Hospital Medical Center

“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

Richard Schwabacher shared that he completed the Applied Digital Health Ethics course by DiMe and praised the course for being “thoughtful” and stated that DiMe does a great job of “creating a shared understanding of key themes and challenges.”

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

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

“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

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

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.

“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.”

“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

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.

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

“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

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

“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

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

“One of the areas we’ve been exploring (at Stanford) is caregivers. There’s a lot of commonality in caregivers, both for the frail, elderly, and for pediatrics. And since the family is kind of the ultimate healthcare delivery system, it may be possible to develop digital health tools that have greater applicability across different ages.”

– David Bergman | Stanford University School of Medicine

“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.

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

“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.

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

“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

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.

“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.”

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.

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

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.

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

“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

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

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.

DiMe’s International Regulatory Pathway project is the first global deep dive of the international digital health landscape on the current Health Authority policies and guidance surrounding technologies. These resources will make a large impact on how traditional pharma companies navigate the global landscape in clinical trial strategies and beyond!

“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

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.

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.

“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:

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

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.

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.

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.”

“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.

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.

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.”

“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

“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.”

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.

“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

“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

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

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

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

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

The 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

“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.

“This has been a remarkable opportunity to advocate for children’s needs at such an early and pivotal moment in this industry. At a time when it would be easy to overlook pediatric care in the rush of innovation, I’m grateful that you’ve all taken the time to truly listen and understand what our young patients need.”

– Amy Molten, MD, FAAP | Chair, Section on Advances in Therapeutics & Technology, American Academy of Pediatrics

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.

“It’s thrilling to join the launch of this collaborative community focusing on hospital at home. Science has shown us the best way to care for patients is to maximize time healing at home. Well-designed technological advancements will advance the breadth of opportunity to reach more patients. I’m excited to see the impact of this initiative and its potential to transform how we approach acute healthcare.”

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

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.

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

“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

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.

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

“The end-user must be at the center of the development process. This is even more important when considering the unique needs of the pediatric population. It involves not just the young patients but also their families and care providers. The recommendations in this playbook serve as practical guidelines that you can use to create impactful digital health solutions.”

-Olivier Staquet | Chief Technology Officer, Gabi SmartCare

“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

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

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

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

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.

“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

“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

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.

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.

“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

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

“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

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.

“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

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.

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

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

“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 

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

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

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.

“At Teladoc Health, inclusivity is a critical best practice in the design of our products. DATAcc’s resources to enhance inclusivity in the development and deployment of digital health products are an important contribution to the field and we’re excited to leverage them to supplement our design process.” — Hau Liu, SVP, Clinical Strategy and Product, Teladoc; Donna Boyer, Chief Product Officer, Teladoc

“The 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

“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

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

“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.

“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

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.

“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

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.

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

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

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

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 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

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

“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

January 10, 2023

“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

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.

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.

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

– Huma Sumar | Physician, Veterans Affairs

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.

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

“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

“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.

“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.”

“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 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

“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

“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

“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

“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

“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 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

“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

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

“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)

“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

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.”

“It’s been a good process. I love the collaborative nature of it – bringing together all the different perspectives and then having DiMe bring it to life keeping kids at the forefront. And it’s been fun to be a part of it – to meet the broader community that’s passionate about pediatrics.”

-Krista Nelson | Director, Innovation Development, Children’s Mercy Hospital

“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