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

“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

“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

“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 IMPACT 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 IMPACT 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 IMPACT Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

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 IMPACT 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 IMPACT 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 IMPACT 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 IMPACT Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

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 IMPACT 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 IMPACT 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 IMPACT 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 IMPACT 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 IMPACT 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 IMPACT member, demonstrates the value of V1C in action.

“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 IMPACT 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.

“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

Omada’s white paper, developed in partnership with DiMe and with insights from Rock Health, shares how leveraging the V1C care model drives clinical outcomes with strong engagement, high-quality data science, and human-led care delivery. 

Omada’s white paper, developed in partnership with DiMe and with insights from Rock Health, includes a case study about how a buyer improved engagement and outcomes by partnering with Omada and leveraging its fully integrated virtual first care model.

Omada’s white paper, developed in partnership with DiMe and with insights from Rock Health, highlights the shift from virtual care to virtual-first care, why visionary buyers are keen to implement this patient-centric model, and how they prioritize this shift.

“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.

“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

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

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

Learn more about this V3 in Action story:

“We did analytics validation [step two of V3] in healthy populations versus disease populations in this case [because] gate and balance features can be recorded in both populations. In many cases, this is an optimal first step because testing novel algorithms [e.g., those developed by Koneksa] may require multiple iterations. – Elena Izmailova, Chief Scientific Officer, Koneksa

Learn more about this V3 in Action story:

“The first step [of V3] is sensor verification, and to understand the accuracy of accelerometers of [three devices], we put them on top of the Shake Table, which is the gold standard benchtop device for evaluating sensor accuracy…[we determined that] all three devices are fit-for-purpose to record gait and balance… [When looking at] hand tremors, another feature of Parkinson’s Disease, the accuracies are different… if we didn’t do this verification and we wanted to use these devices for collecting hand tremors it shows that this solution is not optimal.” – Elena Izmailova, Chief Scientific Officer, Koneksa

Learn more about this V3 in Action story:

“The goal of this [validation study, the final step in V3] was to determine if this portable [and] understand the clinical validation in the specific narcolepsy population.  With the goal of saying, if this is fit-for-purpose, how can we use this in our future clinical trials?” – Ariel Dowling, Head of Sensing and Measurement, Takeda

Learn more about this V3 in Action story:

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

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

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

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

“The workbook for prepping end users is a great reference tool to consult as we teach our volunteers how to best tell their story and communicate the things that matter to them with those health care stakeholders.” — Nicole Braccio, Policy Director, NPAF

“It’s imperative for CHC to build an environment where participants feel comfortable and respected. Participants aren’t going to come back if they don’t trust the program and if they don’t understand its value.”– Kharla Colon-Vazquez, Program Specialist at Community Health Center, Inc.

Freespira exemplifies IMPACT’s Care Transition resources’ best practices by sharing engagement, adherence, and clinical outcome metrics with payer partners.

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

The Nocturnal Scratch project team demonstrated several concepts from the communications guide in DATAcc’s Toolkit for Inclusive Deployment to ensure their survey communications were inclusive and appropriate for each cohort of participants.

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

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

“The Playbook was helpful because it allowed teams across our organization to align on the industry’s standard terms and vocabulary for digital clinical measures.” – Basker Gummadi, Head of Digital Health at Gilead, Digital Health Evangelist, and Adjunct Professor at UCSD

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

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

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

“The V3 framework was transformational for educating the scientific community, making it receptive to the ideas of how to validate biometric monitoring technologies for use in clinical trials.” — Elena Izmailova, PhD, Chief Scientific Officer, Koneksa

“By accessing and citing DiMe’s library of digital endpoints, I was able to contextualize the increasing level of interest in digital endpoints to my team and our partners and show that collectively we are a leader in the broader movement of using digital health technologies in studies.” — Marie McDonald, Vice President of Sales and Customer Success, Altoida

“Working on the Nocturnal Scratch paper with DiMe colleagues has expanded my knowledge about the most effective use of digital endpoints in clinical research and practice. As a result, I will have more to offer in future collaborations.” — Pat French, Left Lane Communications

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

“DiMe’s Endpoints Library exposed the need for the industry to pursue only measures that matter as digital endpoints.” — Manny Fanarjian, Head of Applied Sciences, HumanFirst

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

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

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

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

“The experience we have working on DiMe projects has helped Labcorp build credibility and respect with our partners. They value the know-how we bring to the table about The Playbook: Digital Clinical Measures.” — Susan Foose, MLIS, Director, Decentralized Trials and Patient Centricity, Labcorp

“Not being able to bring patients into our traditional care environment because of COVID-19 presented a real challenge, but our team found innovative ways to deliver the same experience virtually” — Dr. Karl Koenig, Medical Director and Orthopedic Surgeon, Musculoskeletal Institute, UT Health Austin

Iredia M Olaye and the authors of Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies used V3 and other published literature to conduct a systematic review of published studies reporting adherence captured by BioMeTs.

“The Playbook around Digital Measures [is] practical, easy to read, and well written… It zooms people in on the critical things they need to know and the critical common thinking.” – Amy Abernethy, MD, PhD

“Nobody in the Tech world would develop a product without first talking to the consumers of that product. In the health world, those consumers are the patients… [and to outline the engagement required] we relied heavily on Digital Measure that Matter to Patients.” – Ieuan Clay

“We are being intentional in how we find companies to partner with. That underscores the goal with The Playbook and our bigger digital health strategy… We want to make it clear to the world that the VA wants to collaborate.” – Dr. Arash Harzand, MD, MBA

“With the VHA being the largest integrated health care system in the country, both the agency and private companies have a vested interest in testing AI and machine learning models against the VA’s large volume of data. It is essential that the VA scales technologies with software partners in accordance with The Playbook’s recommendations to be successful.” – Dr. Arash Harzand, MD, MBA

“We have to bring in human-centered design to make use of AI or machine learning models and make sure that there’s trust in those models and that we can clearly articulate value for the clinicians and care teams on the ground.” – Dr. Amanda Purnell, Director of Data and Analytics Innovation at the U.S. Department of Veterans Affairs
View Case Study

“There is a lot of very specific terminology that we [in healthcare] are all used to in our everyday life, but someone coming from a different field isn’t necessarily used to that… [to connect the dots] we leaned very heavily on the Digital Medicine Primer.” – Ieuan Clay

“At Verily we used DiMe resources to build both internal and external vernacular and a structured way of presenting information that lined up with [V3]…this gave us the tooling that we needed so we could move fast.” – Amy Abernethy, MD, PhD, President, Clinical Studies Platforms, Verily

“Places like DiMe are where people can bring good ideas to the table and create the right forum to figure out how to get [data] right” – Amy Abernethy, MD, PhD, President, Clinical Studies Platforms, Verily

“V3, EVIDENCE Checklist, and The Playbook are excellent resources that we leveraged extensively in the writing of our manuscript.” – Charmaine Demanuele, PhD, DiMe Research Committee Member, and Executive Director at Pfizer

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

In The Patient Matters in the End(point), Griffiths, et al. use DiMe’s Digital Measures That Matter to Patients to highlight the need of beginning research with an understanding of what is important to patients.

In The Patient Matters in the End(point), Griffiths, et al. speak to the importance of pre-competitive collaborations to develop patient-centered endpoints, using DiMe’s Nocturnal Scratch project as an example.
View Case Study

“The DATAcc Toolkit for Inclusive Deployment of Digital Health is a valuable addition to our Resource Library, for site users seeking data and best practices to improve health in Northeast Ohio.” — Healthy Northeast Ohio Staff

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

Dreem established trust with a large network of payers by demonstrating its health economics, supported by its use of existing CPT codes, allowing it to gain awareness and build relationships with referring providers (General Practitioners).

Dreem built its entire patient journey using existing CPT codes, which makes it easier to work with payers that use traditional payment models and allows Dreem to promote greater accessibility.

“The DiMe toolkits have been invaluable for my work helping health systems and technology companies ensure that digital health products mitigate, rather than exacerbate health inequities. The synergistic power of the digital health and the digital inclusion ecosystems can now be leveraged at scale.” — Amy R Sheon, PhD, President, Public Health Innovators, LLC

“An inclusive communications strategy is foundational to our work in our national research program. Using this tool kit allowed us to align our team members to one strategy with clear and accessible expectations.” — Katrina Yamazaki, Principal Investigator and Senior Scientist, CHC

“The informed consent is critical to the success of participant engagement in any project. The DATAcc toolkit helps to ensure we are considering the critical points of the process.” — Katrina Yamazaki, Principal Investigator and Senior Scientist, CHC

“Engaging with people who have historically been underrepresented in biomedical research was a cornerstone to our mission. The toolkit allowed us to design our outreach strategy in a participant-centric and inclusive way.” — Amy Taylor, Vice President, CHC

“The engagement tool provides for a highly accessible, actionable plan to help organizations more effectively partner with key stakeholders to produce greater benefits for all.” — Amy Taylor, Vice President, CHC

“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

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

“The Playbook: Digital Clinical Measures is a great educational tool, with easy visualisations to outline the processes involved for measures across different therapeutic areas to verify and validate meaningful measures for patients. It is something we continue to utilize and share with our clients that are developing novel, objective digital endpoints outside the clinic.” — Stephanie Sargeant, Commercial Manager, Activinsights

“The Playbook doesn’t tell you what to think or decide, it teaches you how to think and decide – that’s true innovation acceleration.” — Zeenia Laila Framroze, VP, Strategy and Operations, Smart Omix by Sharecare

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

“The primer is a great resource to help understand the complex development of digital measurements within the healthcare and pharmaceutical industries.” — Erick Pasco, Eli Lilly

“HumanFirst uses the Primer to make sure our sales teams, prospects, and customers are using the same language when it comes to digital medicine.” — HumanFirst

“Everyone should read this book within their first 2 weeks of working at HumanFirst. It’s the best way to cover introductory content and get oriented to the industry.” — Head of Product, HumanFirst

“There is great value in having DATAcc as an easily accessible resource that can quickly surface data on one aspect of value that inclusivity brings to the business.” — Celine Marquez, MD, Global Medical Director, Digital Health, Genentech

“V3 is a very helpful framework, clarifying the evidence required to support the digital measures we provide and leverage the benefits of multidisciplinary collaboration.” — Christine Guo, Chief Scientific Officer, ActiGraph

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

“The EVIDENCE checklist provides a clear process for authors to follow throughout study design, data collection, analysis, and reporting.” — Jessie Bakker, MS PhD, Executive Vice President of Medical Affairs, Signifier Medical Technologies Ltd

“The EVIDENCE Checklist is like a one stop shop for new teammates looking to understand our evaluation framework and power their decisions.” — Max Gaitán, Research Lead, HumanFirst

“Our work showed us that it’s feasible to utilize smartphones and digital tools to engage and coach this population effectively. The Smart Health Education and Rehab Technology (SmartHEART) Program uses smartphone technologies and telehealth capabilities to deliver cardiac rehabilitation (CR) to Veterans.”
–Dr. Arash Harzand, MD, MBA

“The Digital Health Deployment Toolkit will be an invaluable resource to support rapid dissemination of the Digital Navigator Model to health care where it’s urgently needed.”
— Angela Siefer, Executive Director, National Digital Inclusion Alliance

“The V3 framework has become the standard framework for discussing validation of digital endpoints in our company and the industry as a whole.”
— Geoffrey Gill, President, Shimmer Americas

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

— Caprice Sassano, Research Lead, Human First

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

— Ritu Kapur, Head of Digital Biomarkers, Verily

“These tools helped us flip the 80/20 rule on its head and prioritize edge cases which result in designs that work for more people and have higher adoption, engagement, and retention.”
— Justin W Ranton, Director, UX, AliveCor

“Just educating during the roll out of a product is not enough; we need to make sure that the data input that informs products are also enabling inclusivity early in the data collection phase in order to minimize unintentional exclusion.”
— Kalvin Yu, MD, VP, Medical Affairs, US Region, BD

“Wearable devices offer an incredible opportunity to increase diversity in clinical studies, but they need to be accessible to a broader set of users to make this vision true.”
— Kristin Size, Head of Study Devices, Verily

“When we shift the approach from treatment to prevention, we empower Veterans, improve outcomes, and save lives.”
– Jonathan Brantley, DPM Chief of Podiatric Medicine and Surgery, Richmond VA Medical Center

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

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

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

“Tools like The Playbook are being adopted by companies of all sizes. It provides a framework allowing you to understand how regulators, sponsors, and vendors can collaborate on the use of novel methods in clinical trials. ”
— Matt Biggs, VP of Applied Science, ActiGraph

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

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

“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

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

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

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

“V3 has been transformative for us as it’s served as a guiding framework for how we operationalized validation internally, and how we communicate with partners externally.”
— Visar Berisha, Co-Founder, Aural Analytics

“Developing V3 with DiMe & concurrently running the very first V3 study provided a chance to combine theory and practice – it was thrilling!”
— Jessilyn Dunn, Assistant Professor, Duke Big Ideas Lab

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

“Robust and independent evaluation of the analytical validity of BioMets is necessary in order to extract their full potential to better understand and improve human health.”
— Job Godino, Scientific Director of Laura Rodriguez Research Institute

“We believe pre-competitive collaboration is essential and are looking forward to working with like-minded innovators within DiMe to accelerate this important work in the fight against Alzheimer’s disease and related dementias public health epidemic.”
— Martin Dubec, Head of Biogen Digital Health

“The work that has been undertaken has already made great strides in understanding the significance of nocturnal scratching to patients and caregivers, how to make this endpoint a reality operationally, as well as alignment of terminology regarding this novel digital endpoint.”
— Carrie Northcott, PhD, Director & Research Lead for Digital Endpoints, Pfizer

“3D printing is a great method to address unique Veteran needs through innovative rapid prototyping and custom solutions, both quickly and in a cost-effective manner.”
—Kaila Grenier, Clinical rehabilitation engineer, Eastern Colorado VA Health Care System

“Since coming to the group, I no longer want to kill myself. I have found others who support me.”
—Veteran Patient, Hampton VA Medical Center

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

“The V3 framework has helped set an industry standard for evaluating digital measures and has guided our rigorous research and development of novel speech-based measures.”
— Jessica Robin, Director Clinical Research, Winterlight Labs

“The V3 framework was invaluable in helping UCB and our partners navigate the complexity of building a robust corpus of clinical evidence underpinning the core features and functionality planned for our upcoming smartphone based application.”
— Emily Kunka, Global Digital Transformations Lead, UCB

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

“If you’re interested in learning more about #remotemonitoring across #clinical research, clinical care, and #publichealth – with a specific focus on connected #sensor products – DiMe Playbook is your one stop shop.”

“The measurement checklists provide a framework for best practices in developing and validating novel digital measures. These will help bring consistency and scientific rigor to the field!”

“Patient-centricity is critical to novel biomarker development. The Playbook establishes best practices for patient engagement, including a practical how-to for the industry to follow.”

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

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

“The Playbook provided a useful reference and a single place where we could find the answers to many questions as well as credibility to our work.”

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

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

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

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

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

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

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

“This model has been an effective tool to communicate the types of value to be achieved, and then to aid internal regulatory communications about the progress of ‘intended use’ as a digital measure develops.”

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

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

“If we are ever going to get a handle on Parkinson’s we must consider the breadth of impairments and use digital techniques to collect data continuously. The CPP team has done a remarkable job in constructing a viable approach.”
— John Crawford, Biotech executive living with Parkinson’s, Critical Path Institute

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

“Using the DiMe IMPACT Guide to V1C Payment Models, we were able to internally train our commercial team, and also explain V1C to investors.”
— Geoff Matous, President and Chief Commercial Officer, Wellinks

“DiMe’s toolkit served as a valuable translation tool and allowed us to clearly articulate the business goals and priorities, saving precious (and expensive!) time and cutting likely back-and-forth of drafts in half.”
— Geoff Matous, President & Chief Commercial Officer, Wellinks

“The EVIDENCE checklist provides a clear process for authors to follow throughout study design, data collection, analysis, and reporting.” 
— Jessie Bakker, MS PhD, Executive Vice President of Medical Affairs,  Signifier Medical Technologies Ltd

“The EVIDENCE Checklist is like a one stop shop for new teammates looking to understand our evaluation framework and power their decisions.”
— Max Gaitán, Research Lead, HumanFirst

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

“What surprised us was how well Veterans embraced the technology. Our work showed us that it’s feasible to utilize smartphones and digital tools to engage and coach this population effectively.”
—Dr. Arash Harzand, MD, MBA Senior Innovation Fellow, VHA Innovation Ecosystem Director of Digital Cardiology & Vascular Medicine, Atlanta VA Medical Center

“V3 is a very helpful framework, clarifying the evidence required to support the digital measures we provide and leverage the benefits of multidisciplinary collaboration.”
— Christine Guo, Chief Scientific Officer, ActiGraph