Resources in Action Hub
Learn how DiMe resources position our community to redefine healthcare and improve lives
DiMe’s Resources in Action Hub spotlights how leaders, innovators, and digital enthusiasts use DiMe’s work to advance the use of digital medicine to redefine healthcare and improve lives.
Browse our Hub to learn about the:
DiMe Case Studies
DiMe’s case hub spotlights how teams drive impact using DiMe resources in their work. Browse the cases from leaders in the field below and to learn how you can start leveraging DiMe resources in action today.
- American Kidney Fund
- American Physical Therapy Association
- Aural Analytics
- Benjamin Vandendriessche
- Caption Health
- Carrie Northcott
- Christian Born Djurhuus
- Cleveland Clinic
- Community Health Center
- Consumer Technology Association
- Critical Path
- DiMe Academy Testimonial
- DiMe Academy Testimonials
- DiMe Project
- DiMe Research Committee
- Digital Therapeutics Alliance
- Elevance Health
- Eli Lilly
- Family Health Centers of San Diego
- Healthy Northeast Ohio
- Heartbeat Health
- Institute for eHealth Equity
- Jeremy Wyatt
- Junchi Lu
- Kristofer Caya
- Mansa Shroff
- Mix Talent
- National Cancer Institute
- National Digital Inclusion Alliance
- National Institutes of Health
- Northwestern University
- Omar Manejwala
- Oshi Health
- Paul Martinetti
- Public Health Innovators
- Rand Corporation
- Research Publication
- Rubix LS
- Rubix LS’s Accountability
- Sage Bionetworks
- Shimmer Americas
- Steve Xu
- Thirty Madison
- Touch BBCA
- UT Health Austin
- Veterans Health Administration
- Visana Health
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
“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
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
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)
“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
Kristofer Caya of Aetna discussed how the IMPACT Core Competencies tool provides his teams with a common foundation for diligence.
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
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)
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.
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.
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.
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.
Among the first authorized products with FDA’s new Predetermined Change Control Plan (PCCP) is providing expanded access to cardiac care.
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
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
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
More aware of what to look for in ethically sound digital health companies when considering using their products
– Huma Sumar | Physician, Veterans Affairs
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
This course gave me additional insights that I can apply and share with our clients.
-Donna | VP Research
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
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.
“The V3 framework established by the DiMe Society provides a unified evaluation framework for digital tools such as SBs.” — Authors of Validation of the Remote Automated ki:e Speech Biomarker for Cognition in Mild Cognitive Impairment
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.
With its value-based care focus, Oshi’s incentives are aligned for whole-person care that is complementary to traditional brick-and-mortar GI care, exemplifying IMPACT best practices. This creates the necessary environment for a trusting partnership with referring providers and encourages effective V1C care transitions.
“Working on DATAcc, I learned from the diverse stakeholders. Developing inclusive devices is not a job for one part of the industry – it requires a collaborative community to gain a common consensus.” — Md Mobashir Hasan Shandhi, Ph.D., Postdoctoral Researcher, BIG IDEAS Lab, Biomedical Engineering, Duke University
“The payoff [of using digital biomarkers] ultimately benefits all parties — each one of the Three Ps… the sooner we work together to develop streamlined processes and a common vocabulary related to digital biomarker technology, the sooner it can begin making a real impact.” — Biogen
In IQVIA’s webinar titled “Enhancing Our Understanding of the Patient Experience,” panelists explored how digital tools can advance patient experience endpoints and the benefits of using digital technologies to understand better how patients feel and function. The organization leveraged DiMe’s Library of Digital Endpoints to contextualize the current landscape of digital endpoints usage for webinar attendees.
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.”
“To redefine value beyond dollars and cents, VHA must ensure that every dollar invested returns value to the Veterans they serve and measures value across the domains of access, effectiveness, efficiency, and equity.” — Ryan Vega, MD, MSHA, Chief Officer, VHA OHIL
“V3 helps to define the clinical validation strategy and unite scientists and engineers from multiple disciplines, which is crucial for the successful clinical evaluation of a novel digital biomarker.” —Willem van den Brink, Scientist, Netherlands Organisation for Applied Scientific Research (TNO)
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.
NIH National Institute of Neurological Disorders and Stroke working group uses the V3 framework as a blueprint for the “Validation of Digital Medical Products” section of the report to establish how future PD studies using digital technologies should validate measurement products.
“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.
Enhancing care coordination and user experience across the board and driving improvements in access, equity, effectiveness, and efficiency can be done using IMPACT’s Care Transition Toolkit. Learn how Zipnosis exemplifies these best practices recommended by IMPACT.
“A couple of years ago most of these [digital endpoints] would have been exploratory. Now, over 100 are primary and 200 are secondary endpoints in these trials. This is real progress.” — Arthur Combs, MD, Senior Clinical Advisor, Activinsights
“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
“Value-based, goal-directed payment for whole person chronic care management – this is what the market wants.” – Geoff Matous, Wellinks
“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
“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
“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.”
“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
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.
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.
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.
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.
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.
“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.”
“We found IMPACT resources have helped us establish a framework that guided us in navigating negotiations with various payers and served as a counterbalance to some burdensome demands.” — Sloan Saunders, CEO, Intellihealth
“The V3 framework is the foundational resource our team uses to ensure Atlas reflects the highest quality evidence.” — Caprice Sassano, Head of Applied Sciences, HumanFirst
“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.
“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:
“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.”
“Althea.ai is proud to be a contributing member of the DiMe Diversity, Equity, and Inclusion clinical projects team to end inequities in access to clinical trials. We are thrilled to partner on this important work developing tools and best practices that will break down barriers to inclusion and create meaningful innovation for everyone.” — Kathy Johnson, Pharma Business Development & Go to Market, Althea.ai
“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 Digital Health team at Gilead accesses DiMe’s Digital Measures Development: Nocturnal Scratch resources to better understand how Nocturnal Scratch is deployed as a digital endpoint in clinical trials.
“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
“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
“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
“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
“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
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“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.
“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
“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
“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