Resources in Action Hub

“Silicon Labs is proud to sponsor Silicon Labs DiMe Society. Their partnership has been invaluable to the success of our initiatives in the connected health space, from speaking at our Works With Summit to industry networking events. We look forward to continuing our collaboration and achieving even greater milestones together.”

-Janet Collins| Senior Manager, Marketing Partnerships, Silicon Labs

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

-Olivier Staquet | Chief Technology Officer, Gabi SmartCare

“Pediatric research comes with unique challenges, from recruitment to long-term data collection. This playbook is a vital tool for overcoming these barriers, offering insights and strategies that ensure impactful, patient-centered solutions for children everywhere.”

Jan-Peer Elshoff, PhD | Senior Clinical Development Lead, UCB Biosciences GmbH

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.

From working with such a group of experts from across the world and in different sectors and industries, I have confidence in the robustness of the set of core digital measures we developed. Because these measures are omni-therapeutic, I will include them in my own work to collect additional information on a range of individuals in the general population with sleep issues.

 — Herman de Vries | Research Scientist, TNO

Shelly Lanning of Visana Health highlights how V1C’s Toolkit for Contracting has been helpful as a young company for developing internal processes and procedures.

The need to define a core set of digital measures of physical activity that are meaningful to patients prompted us to participate in this collaborative working group. The process followed was very efficient and enabled us to reach a consensus on digital measures of physical activity.  — Salma Ajraoui | Digital Practice Lead, IQVIA

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

Oshi Health, a fully virtual GI clinic, leverages a purpose-built care team to help patients achieve their goals.

Learn about how Oshi Health, an V1C Coalition Member, is successfully integrating V1C care transitions and helping to transform our existing healthcare system.

Kristofer Caya of Aetna states that he thinks V1C’s Core Competencies will provide a great starting point and structure for what needs to be covered and put out in the RFP and makes it easy for organizations to add more tailored or nuanced questions for their specific needs.

“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

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

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

Kristofer Caya of Aetna Virtual Care shares how V1C Core Competencies “creates a common foundation for diligence” and creates a “shared language” for the organization to have a conversation around the opportunities and partners in consideration.

Shelly Lanning of Visana Health shares that she likes that the V1C Core Competencies provides consistency for dealing with the “common denominators” that will help various employers and constituents.

Elizabeth Zech of Mercer explains how V1C Core Competencies is helpful for preparing to “make a solid business case that’s going to resonate with an employer.”

Luca Foschini shared DiMe’s post announcing the Applied Digital Health Ethics course and thanked DiMe for “spearheading this initiative.” He also stated that the course is helpful for discovering potential biases in health/medicine AI tools and learning how to apply “ethical frameworks to engineering problems right from the design phase.”

Linda Ngo shares that she recently completed DiMe’s Applied Digital Health Ethics course and “earned the respective badge.” She states that the course has deepened her understanding of “the impact that ethical challenges have on digital medicine and healthcare as a whole.”

Mazin Osman announced that he obtained the Applied Digital Health Ethics certification from DiMe and stated that the course taught him about the “ethical considerations surrounding the use of technology in healthcare” and how to “navigate the complex digital landscape.” He also recommended the course to “healthcare professionals looking to deepen their knowledge and skills in this critical area.”

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

– Michael Starling | Scrum Master, Qualifacts

“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

Mansa Shroff, WKD.SMRT, 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.”

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

The content was concise and points helpfully illustrated with real life examples and linked to them for more in-depth study. Was also nice to have a mix of different learning modes including short video snippets. Key takeaways after each section was great and overall well-structured, thank you!

– Digital Medicine Academy Learner | Medical Head for Digital Healthcare

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

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

– Huma Sumar | Physician, Veterans Affairs

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

“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

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

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

Shrawan Patel, MD shares that he is honored to be a part of the development of DiMe’s new course on Digital Health Regulatory success and praises the DiMe team on creating a course that will help educate others and simplify complex topics to positively impact the industry.

Felix Lee announces that he has obtained certification in Applied Digital Health Ethics from DiMe and that the course provided him with tools to use digital inclusion strategies and helped him reflect on the importance of implementing ethics by design.

“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

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

The program provided a comprehensive understanding of ethical considerations in healthcare technology and equipped me to navigate the digital landscape with confidence and integrity. The instructors were experts and the curriculum covered a wide range of topics. I highly recommend this course to any healthcare professional looking to deepen their knowledge in digital ethics. Thank you, DiMe, for such a valuable learning experience.

– Mazin Osman | Pharmacist at TLC

“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

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

“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

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

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

Anne Kilburg highlights key insights from DiMe’s webinar on “New Tools to Navigate Digital Health Regulations” and speaks about the importance of “regulatory strategy as a value driver of digital health interventions.”

“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

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

“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

“I appreciated being able to complete a course that allowed me to take a deep dive into Applied Digital Health Ethics. This has given me the tools to be mindful of the intent, impact and how we apply ethics to the development of digital health solutions.”

– Dr. Courisse Knight

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

-Donna | VP Research

“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

Alessandro Ocera posts that he successfully completed the Applied Digital Health Ethics certificate, shares the insights he gained, and thanks DiMe for allowing him to gain knowledge related to his MSc program.

“From now on at work, when an sDHT has a role in a clinical study, I will ensure that it is evaluated with V3+ as well as for security, privacy, and economic feasibility.”

– Dr. Paul Martinetti, Senior Partner, The Bracken Group

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

– Bert Hartog

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

– Desmond Dorairajoo, Director, Clinical Operations Strategy

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

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

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

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

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

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

Joseph DiMasi, Tufts Center for the Study of Drug Development, highlights how the Digital Endpoints ROI Calculator will expand to new therapeutic areas and improve with more data over time.

Libby Floden, Eninova, discusses how these resources enhance efficiency, align strategies, and deliver both financial and patient benefits.

“Verily has invested in an ecosystem to improve research and patient care, distinguished by our data and AI expertise. By leveraging DiMe’s collaborative platforms and resources, which provide a forum for aligning with regulatory bodies, clinical experts, and other industry leaders, we’ve accelerated innovation and implemented more precise, data-driven solutions. DiMe has been key in advancing our understanding of digital endpoints, helping us build a more robust and reliable path forward.”

– Caroline Currie | Head of Product, Digital Measures, Verily

“Thanks to the work from DATAcc by DiMe and Tufts, we can now point more specifically to the financial value of digital endpoints—in addition to the scientific evidence.”
– Kristen Sowalsky, PhD, DC, VP of Medical & Scientific Affairs, Clario

Marissa Dockendorf, Merck, highlighted the power of collaboration in this project, emphasizing how bringing together stakeholders from different companies fostered knowledge-sharing and led to the development of these valuable tools.

Martha O’Neill, Health Advances, outlined the Digital Endpoints ROI Calculator methodology, highlighting its flexibility in assessing financial impact, demonstrating value, and testing scenarios.

Advancing nano-rare disease treatment with Syde technology in clinical trials

“As the field of DHT-enabled measures continues to mature, it was very illuminating and reassuring to hear from the biopharmaceutical industry, the technology sector, and academia about progress made in the field since the inception of DiMe and the publication of the V3 framework, which were fundamental to the field. We have heard each other’s stories, shared experiences, and developed resources that will help us move forward together and faster.”

– Elena Izmailova | Chief Scientific Officer, Koneksa Health

Value of novel digital endpoints in late-stage trials

“Digital endpoints must provide a clear return on investment so they may progress from the research and development realm and deliver on the promise of these technologies and measures. The resources developed in this project will provide decision-makers with tools and confidence to evaluate the value of using digital health technology in a registrational clinical trial.”

– Dudley Tabakin | Founder and Chief Executive Officer, VivoSense

“DiMe’s Business Case project offers a comprehensive overview of the value of digital endpoints in clinical trials and beyond. Utilizing the value framework and ROI calculator equips users with practical tools to assess the value for specific use cases. This enables TNO to focus their digital endpoint development on applications that yield the greatest impact.”

– Annika van Rosmalen | Business Development Manager, Pharma & Digital Health, Netherlands Organisation for Applied Scientific Research (TNO)

Merck aspires to be the premier research-intensive biopharmaceutical company. For over 130 years, we’ve brought hope to humanity by developing important medicines and vaccines. Merck is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Multimodal digital measures demonstrate greater responsiveness and sensitivity to disease progression and treatment effects than traditional clinical scales

“DiMe’s Business Case project provides the digital health technology ecosystem with standard language to articulate the value of digital endpoints. With the output from this project, we look forward to seeing accelerated adoption of digital endpoints across the industry.”

– Rachel Chasse | Associate Director, Digital Science Strategy, AbbVie

Driving innovation in Huntington’s Disease by tracking progression through at-home digital measurements

Simulator of study power for Parkinson’s Disease trials

Accelerated trial setup & operations: A case study in Cystic Fibrosis to illustrate the ROI of improved data availability

Estimating the benefits of digital and plasma-based pre-screening in Alzheimer’s Disease trial recruitment

Multimodal digital health technologies (DHTs) allow for more ecient and less costly recruitment and reduced patient burden with decentralized clinical trials

Martha O’Neill, Health Advances, explains how the calculator fosters cross-organization discussions on digital endpoint benefits, with future data enabling even greater impact quantification.

“The ROI calculator will have a significant impact across multiple areas. It will help tech developers create digital endpoints that meet economic and clinical needs, improving marketability. Researchers and institutions can use it to justify funding by demonstrating cost-effective, data-backed outcomes. It will be particularly valuable in Phase 2 and Phase 4 trials, where digital endpoints are widely used, providing more data. Healthcare payors and insurers may leverage it to assess long-term cost savings and treatment benefits, potentially influencing coverage decisions and reimbursement strategies. Additionally, it offers investors a clear financial rationale for funding companies developing or utilizing digital endpoints, attracting more capital to the space.”

– Szczepan Baran | Founder, Tech4Pets

Jeff Abraham, Health Advances, shares how the Digital Endpoints ROI Calculator simplifies quantifying digital endpoints and will evolve yearly to stay industry-aligned.

physiQ shared the results of a Moffitt Cancer Center and DiMe study, which found that the benefits of telehealth could reduce the financial toxicity of cancer care, one of the persistent challenges in oncology care.

VAwerx shared Smit Patel’s LinkedIn post, stating that DiMe and Smit Patel are sharing valuable tips to build businesses that improve “cancer patients’ fighting postures.”

“We believe our platform is helping to set a new, enduring standard for patient care. With over 40,000 patients successfully cared for at home, we’re eager to help define the next phase of scalable, sustainable care models that will continue to decentralize healthcare for the benefit of patients and health systems alike. That’s why Medically Home is excited to participate in the Connected Health Collaborative Community.”

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

“We are hyper-focused on improving clinical outcomes and reducing health disparities through pragmatic use of technology. We believe that the biggest impact of digital medicine can be realized by having an interconnected system that enables proactive decision-making. To accomplish this, we are excited to participate in the Connected Health Collaborative Community, comprising industry, government, and academic partners. This will allow us to continuously learn and improve our practices for the betterment of our patients and frontline health workers.“

“These resources provide a roadmap for selecting digital measures of physical activity that matter to patients and implementing them in clinical trials. The core set of digital measures and their ontologies greatly facilitate our endpoint discussions.” — Jie Ren, Director, Digital Clinical Measures, Merck

These standardized measures are really critical to be captured by digital health. It’s becoming standard of practice to use digital health to assess physical activity in research studies. For the purpose of patient workflow, national surveillance systems, and research, getting to core measures for physical activity is critical in all the work that we’re doing. – Laurie Whitsel | National Vice President of Policy Research and Translation and Senior Advisor, Physical Activity Alliance, American Heart Association

“The work here is a very important starting point for better understanding patients’ physical activity and functioning. The core measures came from the patient voice and clinician perspectives on what’s meaningful to patients. These measures can be very important tools to aid important care decisions like the timing of intervention or treatment choice, titration dosing of the treatment, and, of course, basic evidence needed – according to the V3 framework that DiMe developed. This work really provides the critical foundation on core measures, ontologies and really paved the way for future development.”

– Sooyoon Shin | Clinical Science Lead, Digital Biomarkers, Verily Life Sciences

This methodology [and ontologies] that we’ve developed enables structured data that can then be computed upon, and really impressive models can be developed, that will push forward digital endpoints in clinical trials and the use of digital measures in clinical care, pushing them into the EHR in a useful way. Overall, being able to map this data into something structured is a game changer. – Jessilyn Dunn | Assistant Professor, Director of BIG IDEAs Lab, Duke University

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

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

– Nina Shaafi Kabiri | Research Scientist Boston University

“I am personally excited that sleep is getting out of the clinic. As these devices continue maturing we can look at sleep not just at night in one instance, but for a variety of populations at home in different settings across the 24 hours.”

– Raúl Torres | Principal Data Scientist Takeda

“The Core Measures of Sleep are going to be really helpful for developing a common language across different groups at levels that everyone can understand. I am always discussing new technologies that we might include in future Takeda clinical trials. One challenge has been that everyone has a different way of talking about something, or measuring something. Now there is a great checklist that DiMe has created that makes those discussions with vendors really helpful from the side of developing novel technologies that can be used in clinical trials.”

– Katerina Placek | Senior Implementation Manager Takeda

“The lab is a lab. It is a simulation environment. None of it is real. As researchers, we do our best to recreate real-world experiences, but there’s always this gap. For me personally, I’ve done the overnight studies. Getting strapped up to as many electrodes as there are and having stuff around your chest and your legs and on your face – it’s just so different from what it feels like to have a regular night’s sleep or even taking naps during the day.”

-Farah Hasan | Expert Advisory Board Member and Patient Speaker Project Sleep 

“There’s flexibility in these measures. Let’s take napping for example. The core measure is based on intentional napping, but it can be modified, as shown in the ontology, to account for unintentional daytime napping. For us at Jazz, this is very important. One of the disorders that we’re really focused on is idiopathic hypersomnia. It’s a disorder in which napping occurs during the daytime, sometimes intentionally, sometimes unintentionally. It causes significant distress and concern for the individuals. We want to make sure that we’re transparent in what we’re measuring and can show a treatment effect with the therapeutics we’ve been creating in a clinical trial setting.”

– Eric Nofzinger | Senior Sleep Medicine Consultant Jazz Pharmaceuticals

Geeta Nayyar shares that she is on the leadership council for DiMe and highlights three main goals for the Core Measures of Sleep research initiative.

Cindy Varga, Atrium Health, highlights how a risk prediction model helps determine inpatient vs. outpatient care and identify patients at risk for CRS complications, emphasizing the importance of these tools.

In this clip, Nazila Shafagati of John’s Hopkins Medical Oncology emphasizes the importance of remote monitoring as a critical safety net for patients with lower health literacy or unreliable caregiving, helping to catch illness earlier and improve outcomes.

“Leveraging DiMe’s ontology for data transfer specifications and standardizing data collection ensures uniform collection of all variables and enhances the reliability and comprehensiveness of our study observations.  

This advancement paves the way for future research, ensuring Takeda remains at the forefront of innovative healthcare solutions.”

-Melinda Chen | Senior Scientist, Digital Biomarker Lead, Oncology Precision Translational Medicine, Takeda

-Erik Koenig | Head, PTM Strategic Innovation, Takeda

Erik Koenig from Takeda highlights the need for standardized data transfer specifications and harmonization as a foundation for developing products applicable outside the hospital, enabling future modeling and predictive capabilities.

“Removing barriers to the adoption of novel and potentially game-changing therapies is at the core of what we do at Canopy. We’re proud to partner with the DATAcc by DiMe and other leaders to turn that vision into reality.”

– Lavi Kwiatkowsky | Founder & CEO, Canopy

“Early detection of Cytokine Release Syndrome (CRS) using digital health products and predictive algorithms will enable us to maximize the potential of cell therapies and T-cell engagers.

The collaboration with DATAcc by DiMe has been instrumental in supporting the industry towards this objective. I am optimistic about a future where more patients will have access to and benefit from these transformative therapies.”

– Premal Kamdar | Director, Digital Health Product Management, Bristol Myers Squibb

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing people better health and a brighter future worldwide.

ActiGraph is pioneering the digital transformation of clinical research. We empower researchers to unleash the potential of big data and AI with a device-agnostic, decentralized trial platform backed by proven operational, scientific, and regulatory expertise.

“The Digital Clinical Measures for CRS will be a key reference for tailoring ADI’s RPM solution to capture the right data. They will help align our technology with clinical needs, delivering relevant insights to enhance patient care. Participation in the DATAcc by DiMe project has enriched our understanding of CRS management, thanks to the multidisciplinary expertise of the working group.”

-Milos Todorovic | Director of Biomedical and Clinical Engineering, Analog Devices, Inc.

“The right data to develop or validate a useful product depends on precisely understanding how it will be used, how it fits in existing clinical workflows, and its benefits to care providers and patients. 

The DiMe CRS initiative brought together a diverse group of stakeholders to understand these perspectives better, providing invaluable insights about the types of data we need to gather to tackle immunotherapy patient monitoring. We will work closely with our partners and employ digital products to transform clinical research, gathering the right data to empower care providers and patients alike in this space.”

– Michael Pettinati | Senior Data Scientist, ActiGraph

“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

Analytical validation is a key step for developing a high quality sensor-based DHT measures. DiMe has built another extremely valuable resource open to the scientific community that provides examples of well-designed and executed experiments that ensure a deployment of high quality digital measures with a potential to address multiple unmet medical needs. 

— Elena Izmailova, CSO at Koneksa Health

“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

“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

“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 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.

“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

These resources provide a roadmap for selecting digital measures of physical activity that matter to patients and implementing them in clinical trials. The core set of digital measures and their ontologies greatly facilitate our endpoint discussions.

 — Jie Ren Director, Digital Clinical Measures, Merck

“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

“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

“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

“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 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

“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 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

“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

“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)

“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.

“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

“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

“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.”

“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

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

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.

Kimberly Barnholt of Genentech shares how DiMe’s DEI resources help identify known challenges and present solutions and guidance to navigate those challenges, as well provide a network for thought partnership.

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.

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

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.

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

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

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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

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

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

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.

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

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.

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

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.

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

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

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.

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

Clario’s Precision Motion solutions, including the Opal V2® wearable sensor system featured in DiMe’s Library of Digital Measurement Products, are at the forefront of digital outcome development. The Opal V2® system is designed to capture crucial data on gait, balance, tremor, bradykinesia, and physical activity in Parkinson’s disease (PD), showcasing the library’s commitment to cutting-edge tools.

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

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

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

“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

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

– Tony J. Simon Ph.D.

“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 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

“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

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.

“Learned a lot from this module! Thank you for the insightful course!”

– Digital Medicine Academy Learner

“Fantastic course. loved the examples integrated into various sections; helped contextualize and apply the concepts taught.”

– Digital Medicine Academy Learner

“Having a well thought-through evidence roadmap that lays out what level of evidence is needed for whom, and why, is such an important and sometimes overlooked capability in the development of our digital health innovations. The exercise of going through a structured playbook has been immensely helpful to proactively and strategically identify key requirements, partnerships, and evidence generation models that can improve planning for product development and commercial teams.”

– Arun Bhatia | Commercial Strategy Lead, Digital Health, Rx+ Business Accelerator Astellas Pharma

“Generating timely, cost-effective, and fit-for-purpose evidence is essential to accelerating the adoption of digital health technologies. By leveraging standardized frameworks, we can streamline evidence generation, enhance regulatory and payer confidence, and deliver digital health solutions to patients faster. 

Resources like DiMe’s IEP Framework are instrumental in guiding our approach, ensuring that our evidence aligns with the needs of all stakeholders, including regulators, clinicians, payers, and patients. This initiative is critical to building trust in digital health, and I am proud to contribute to a future where safe and effective digital health technologies are widely accessible through an integrated evidence-driven approach.”

-Nesrine Lajmi | Evidence Lead for Clinical Insights Roche

“This initiative is an important step toward bringing rigor and structure to evidence generation for digital health tools. By providing a strategic framework, IEP is enabling internal stakeholders to align on immediate evidence needs while keeping long-term financial viability in mind. It ensures efficient resource use, prevents redundant investments, and maximizes impact. Such a well-structured approach to evidence generation builds trust, supports scalability, and ultimately drives better patient outcomes.”

-Terri Kim | Head of Strategy and Corporate Development Lunit

“In digital health, evidence isn’t just about proving a product works—it’s about demonstrating clinical impact, improving patient outcomes, and integrating seamlessly into healthcare workflows. It’s collaborations like these that push digital health forward, ensuring that innovation is backed by strong, clinically relevant evidence. The IEP resources—including toolkits, checklists, and case studies—ensures that innovators have the guidance they need to build strong, adaptive evidence plans.”

-Shilpa Patel | Managing Director, Innovation & Product Strategy American College of Cardiology (ACC)

“It was great to be part of this excellent IEP project team. I had previous experience of adapting an existing pharma IEP model to a digital medicine solution. This was quite easily achieved by adopting a cross-functional approach with early identification of key stakeholders and timelines. This helped us address evidence needs optimally. These are only some of the learnings that have helped guide the development of resources which will now be available for other teams. In my view it is essential to have a clear plan for evidence generation in the development of digital health solutions.”

-Malcolm Brown | Early-Stage Medical Affairs Head, Global Specialty TA Astellas Pharma

“For years we have been searching for the “manual” on how to create an integrated evidence plan for our digital biomarkers & therapeutics for mental health. This “manual” is finally here. The IEP guide for DHTs provides the extraordinary value of expediting decision making with internal teams and facilitating external collaboration, all with the goal to demonstrate the necessary clinical validity and viability for market adoption.”

-Sharon Kaplow, LCSW | Vice President of Clinical Operations Feel Therapeutics

“In the rapidly evolving landscape of digital health, an Integrated Evidence Plan (IEP) is not just a strategy—it’s the bridge between innovation and impact. By aligning clinical, economic, and patient-centric evidence, IEPs ensure that digital health technologies are not only scientifically validated but also commercially viable. Without it, even the most groundbreaking technologies risk failing to gain trust, market access, and long-term adoption.”

-René Quashie | Vice President, Digital Health Consumer Technology Association

“There can be small, medium, and large t-shirt sizes of implementing IEPs for DHTs, but make sure you do it in some way. Not every team will do it to the same degree of granularity and specificity. In our experiences, it can be a single workshop that brings stakeholders together and just starts thinking about this all the way through to a formal plan with research and structure to it. A little bit of thinking ahead is crucial, but it doesn’t have to be overwhelming and these resources will support you throughout.”

– Maurice Solomon | Principal, Digital Health Strategy & Innovation, ZS Associates

“With a well-crafted IEP, digital health innovators can efficiently generate the evidence needed to demonstrate patient benefits, support market access and reduce risk of failure. The IEP resources will support companies in building smarter, efficient and more strategic evidence plans over the entire product lifecycle—turning great ideas into evidence based digital health products that provide value to patients and the health care system.”

-Sean Tunis | Senior Fellow, Tufts Center for the Evaluation of Value and Risk in Health (CEVR) and Principal, Rubix Health

“Digital health has the power to transform the lives of those suffering from disease—guiding them from the onset of their condition to the right diagnosis, connecting them with appropriate care, ensuring access to life-changing therapies, and supporting them in the continuation of care. However, for digital health to truly succeed, we must address the evidence needs of all stakeholders—regulators, payors, clinicians, and, most importantly, patients and caregivers. By building the trust, efficacy, and value story for each of these groups, we can drive adoption, regulatory authorization, and reimbursement, ensuring that digital health solutions fulfill their promise across the healthcare ecosystem. The assets produced by the IEP project will equip digital health sponsors with the tools to efficiently and effectively generate the evidence needed to support this mission.”

-Jeff Gombala | Digital Health Consultant – An independent member of The Stem

“The IEP for DHT is consistent with the continuum from FDA labeling to CPT coding and then CMS/payer coverage envisioned in our article in npj Digital Medicine, Current Procedural Terminology for the Work Done by Machines¹. In this explication of Appendix S to the CPT Code Set, the “AI Taxonomy”, the authors advocate harmonization of the lexicons, synchronization of the evidentiary standards, and alignment on the impact of the output. Your IEP is a giant leap toward synchronization, for which I congratulate DiMe as a great service to innovators.”

– Richard Frank, MD, PhD | Co-chair, AMA/CPT’s, Digital Medicine Coding Committee

“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

Tim Fitzpatrick shared three key takeaways from DiMe’s updated Library of Digital Endpoints, including that the number of digital endpoints included in clinical trials increased 4X between 2019 and 2021.

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.

“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

January 10, 2023

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

– Marcus Bates Vice President, Global Business Development, Aptar Digital Health

“We have used data from the Library of Digital Endpoints to understand the trend and landscape in the industry, in combination with our internal and clinicaltrial.gov datasets. The database helps our clients to appreciate the level of adoption and maturity of digital endpoints, and provides a great starting point to develop the digital endpoint development roadmap.”

– Christine Guo, Chief Scientific Officer | Digital Health, ActiGraph

“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

“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

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

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

– Dr Mihir Ghari, Lead Medical Affairs, Tatvacare

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

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.

“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

“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

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

“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

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.

“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

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

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

“I really want to congratulate everyone on these [Nocturnal Scratch] activities. We have been in conversations with DiMe and other actors for a long while, and I think we all have to acknowledge that we learn a lot every time we talk about these promising and valuable measures.” – Dr. Thorsten Vetter MD, Senior Scientific Officer, Scientific Advice Office, EMA

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

“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

“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

“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

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

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

“Throughout these past years, we’ve seen these great frameworks ensure that the data that we’re collecting is accurate, valuable, meaningful, and will add to the toolbox that we have to understand not only how drugs work, but the diseases they will treat. This will only help patients, healthcare, and science as we go forward. And it’s been really exciting to see Nocturnal Scratch be one of those frameworks that has been tested and I’m really excited to where this is going to go in the future.” -Carrie Northcott PhD, Head of Digital Sciences, Pfizer

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.

“Digital tools give us a unique opportunity to detect early warning signs of events like OUD relapse and intervene before it happens. By harnessing continuous data from wearables and smartphones, we hope to be able to support people with OUD in real time, when and where they can benefit most.”

– Jessilyn Dunn, Assistant Professor of Biomedical Engineering, Director
BIG IDEAs Lab, Duke University

“For individuals striving to regain their health and productivity as part of opioid addiction recovery, preventing relapses is essential… Our Triangle CERSI program serves as the ideal platform for this work, bringing together academia, industry, and the FDA to address high-priority regulatory needs and accelerate solutions.”

– Christin Daniels, Executive Director
Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI)

“OUD is a complex challenge, and complex challenges require innovative collaboration and solutions. Our team is working to incorporate the many issues at play for those facing OUD and build a tool that can meaningfully change the arc of OUD relapse and save thousands of lives.”

– Candice Taguibao, Associate Program Director
DiMe

“Morse Clinics is excited to partner on this pilot to continue making strides to help individuals who experience opioid use disorder!”

– Samantha Burggraf, Opioid Treatment Program Director
Morse Clinic of Zebulon

“Partnering with DiMe aligns with our mission to improve clinical trials through digital innovation. Together, we’re bringing digital solutions to the forefront of clinical research, creating streamlined, patient-centered experiences and empowering all participants with advanced tools and support.”

– Chris Venezia, CEO
ProofPilot

“Recovering from opioid use is not a solo journey, but requires an integrated system of personal, peer, and professional resources.”

– Dr. Anthony Steele, Director of Medical Services
Alcohol and Drug Services (ADS)

“Leveraging technological advancements to help develop evidence-based protocols for individuals living with OUD, as well as their families, loved ones, and care teams, will position these interventions for success. We’re proud to support this study by providing continuous health monitoring and personalized, data-driven insights.”

– Shyamal Patel, Senior Vice President of Science
ŌURA

It’s exciting to see software as medical device and artificial intelligence technologies moving from the early adopter phase I witnessed at FDA to the mainstream market in recent years. There’s still a lot of challenges ahead and clinical problems to solve for clinicians and patients. These tools help early-stage innovators understand where the starting line is and the commonalities and differences between various markets which is critical for decision making.

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

“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

“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

The Landscape of Standards has become an important element when presenting our standard-related work. It shows what standards already exist in this space and helps focus the conversation on implementation and expansion.

— Simona Carini, Open mHealth Data Scientist

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.”

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

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

Sleep is being increasingly recognized as a critical aspect of health. Sleep disturbances are often seen as symptoms of underlying chronic conditions. We viewed the Core Measures of Sleep project as an opportunity to unite resources on a pre-competitive basis and present the case for the development of novel digital endpoints for assessing sleep function. A pharmaceutical trial endpoint is not just a measurement, it is a clinically validated development tool.

 — Michael Kremliovsky  Sr. Director, Medical Devices & eHealth, Bayer

What I love about DiMe is that it’s informed by an incredibly rigorous research process, but with an eye toward practical applicability. I’ve already used the Core Measures in my own work and am excited to share this resource with colleagues in both academia and the tech industry.

– Jonathan Berent , CEO, Founder,  NextSense, Inc

The Core Digital Measures of Sleep project and resources advocate for transparent measurement of sleep staging, the link between clinical biomarkers and patient-relevant aspects of sleep, and the ability to measure this from the comfort of the patient’s own home. These are all level-ups for clinical research and practice of sleep and sleep disturbance, which is facilitated by the work we do at Beacon Biosignals. 

— Jacob Donoghue CEO and Founder, Beacon Biosignals

Including napping in the core measures set is invaluable to those wishing to study sleep disorders outside typical lab conditions whether intentional or not, daytime napping is a key marker of excessive daytime sleepiness and a meaningful outcome for patients.

– Raul Torres & Katerina Placek | Senior Manager, Quantitative Sciences, Takeda, Senior Implementation Manager, Digital Health Sciences, Takeda

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

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

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

– Bohdana Ratitch, Expert Statistician, Bayer

“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

“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 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 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!”

“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.”

“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

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.

“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 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

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.

“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 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 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

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?

“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

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

“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 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

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

“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

“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.”

“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.”

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?

“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

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

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

“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

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

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

“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 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.”

“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 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

“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 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 VA features the value-based framework from The Playbook: Digital Healthcare Edition on its Center for Care and Payment Innovation (CCPI) website and notes that it’s using the tool to create a structured approach to innovation that helps them to:​ 1) identify the need for innovative VBC measures through data-driven insights; 2) proactively identify high-risk, high-need Veterans with various illnesses and in different geographies​, and 3) ensure that health equity is accounted for throughout a pilot’s design and implementation – among many other benefits.

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

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

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.

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

“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 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

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.

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.

“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

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

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

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

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

“Adolescents have unique healthcare needs that require thoughtful, tailored approaches. This playbook provides the tools and insights necessary to design digital health solutions that truly resonate with this age group, empowering them to take an active role in their own care while addressing the challenges they face.”

-Lindsay Stevens, MD, FAAP, FAMIA | Clinical Professor of Pediatrics and Clinical Informatics, Stanford University School of Medicine

Co-Chair, Stanford Pediatric Digital Health Taskforce

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

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

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

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

“At Rock Health, we see a real opportunity to align business dynamics, clinical innovation, and digital transformation to drive meaningful change in youth mental and physical health. We’re proud to support DiMe’s playbook in turning that vision into reality.”

-Adriana Krasniansky | Head of Research, Rock Health

“This playbook offers an invaluable resource for anyone involved in developing or deploying pediatric digital health tools. Our contribution of accurate gaitmat data bridges the gap between aspiration and execution, offering clear reference data that can be immediately implemented into clinical research and care to improve or create technology that’s not only actionable but also effective and sustainable.”

-Michael Rowling | Co-founder, Protokinetics

“Pediatric innovation has always come with unique challenges—from fragmented care models to a shortage of digital health solutions designed specifically for kids. This playbook provides the roadmap we need to bring safer, more effective, and scalable digital health technologies to children and families. We’re excited to support this effort and can’t wait to see the real impact it will have.”

-Sarah Scalia | Director, Innovation & Business Development, Boston Children’s Hospital

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

– David Bergman | Stanford University School of Medicine

“This playbook is an invaluable resource for anyone involved in developing or implementing pediatric digital health tools. It bridges the gap between product development and execution, offering clear, actionable steps to create technology that’s not only innovative but also effective and sustainable.”

-Helen Hughes, MD, MPH | Medical Director, Office of Telemedicine, Johns Hopkins Medicine

Assistant Professor of Pediatrics, The Johns Hopkins University School of Medicine

“This project was a chance to work with passionate researchers, clinicians, and device developers in advancing pediatric digital health. The collaboration allowed us to approach the field from various perspectives, and the resulting playbook distills our collective expertise into an informative guide for developing and implementing DHTs -to better meet the needs of pediatric patients and their families.”

-Virginia Parks – Christina Marchand – Pauline Rivet – Laurence Leber | Servier

“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

“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

“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

“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

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

“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

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

“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

“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

“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)

“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

“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

“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

“Amazing content overall!”

– Haresh Keswani | Head of Technology Architecture

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 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

“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.”

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

– Philippe Lucarelli | Digital Strategy Lead

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

“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

“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

“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

“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

“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)

“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

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

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

– Matthew Potts | Sr. Manager, Strategic Finance and Business Analytics, HALO Precision Diagnostics

“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:

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.”

The V3 framework and The Playbook: Digital Measures Edition are a core part of Nestlé Research’s sensor assessment methodology, enabling us to access real-time clinical data via wearables for clinical and consumer research.”

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 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