DiMe Webinar Series
Accelerating the Path to Approval: Validating Novel Digital Clinical Measures
Novel digital measures offer a huge potential to capture meaningful aspects of health in ways that have been previously impossible to assess. These measures can capture new concepts that focus on how a patient feels, functions, or behaves and can capture them in real-world environments at a significantly increased frequency without clinician supervision.
However, the increasing adoption of these novel digital measures is limited by a gap in the clinical and regulatory science underpinning their validation. By addressing these gaps, we’re establishing a stronger evidence base for digital health tools, making it easier for regulators, payors, and clinicians to adopt these technologies confidently.
DATAcc by DiMe, along with a multi-stakeholder group of statistical experts, digital health technology pioneers, and regulatory colleagues, developed a new framework and interactive platform to simplify and standardize the statistical evaluation of DHTs. These new resources validate novel digital clinical measures, establish systematic criteria for selecting suitable reference measures for new digital clinical measures, and evaluate their performance requirements.
Join us to learn more about the framework and simulation toolkit and how they can support your work in validating and developing novel digital clinical measures.
Watch Previously Recorded Webinars
Scaling Digital Health Globally: Navigating National Pathways for Patient Access
Watch the public launch of DiMe’s International Regulatory Pathways (IRP) project, including resources designed to address the challenges of navigating digital health product regulations across global markets.
Achieving success in digital health technology (DHT) today demands a multi-market strategy that goes beyond basic regulatory knowledge. The IRP project delivers crucial insights into the intersections of regulatory pathways, health technology assessments, and clinical evidence requirements, equipping you with a comprehensive, global toolkit for DHT scalability.
This launch event provides an in-depth look at key project findings developed with global thought leaders. You will get exclusive access to the global Library of Digital Health Regulations, country-specific pathways and guides, case studies from top digital health companies with successful market entry, and essential tools for navigating complex regulatory landscapes.
As digital health becomes central to patient care worldwide, the IRP project offers a critical guide to scaling innovative healthcare technologies and getting them to the patients who need them most. Don’t miss this opportunity to see how IRP can support your organization’s global impact and help bring your technologies to patients around the world!
Transforming Alzheimer’s Disease and Related Dementia Research: New Core Digital Clinical Measures
Alzheimer’s disease and related dementias (collectively referred to as ADRD) have become a public health epidemic. Globally, ADRD affects 47 million people and the expected growth is staggering, with cases expected to double every 20 years.
Even with the increased number of ADRD cases, progress in using digital technologies in clinical research has been limited, and there’s been very little work done to understand meaningful aspects of health for people with ADRD and care partners.
DATAcc by DiMe, with the inclusive group of global multistakeholder experts, has developed a core set of digital measures for ADRD—a set of patient-centered digital measures that bring together research and treatment innovation and the real-world needs of patients, care partners, and clinicians. These measures focus on what truly matters to people living with ADRD and their care partners, ensuring that clinical trials are designed to reach outcomes that reflect meaningful and tangible benefits.
Advancing Equity and Reducing Financial Toxicity in Cancer Care: Resources to Quantify and Maximize the Value of Digital Patient Navigation
Patient navigation programming is highly effective in facilitating equitable access to cancer care, reducing financial toxicity, and improving health and quality of life outcomes for cancer patients. However, resource limitations impact the ability of health systems and their partners to scale patient navigation programs to meet comprehensive care needs.
Health systems and their partners can leverage digital solutions to address capacity and efficiency issues in cancer patient navigation. Still, they must first build a business case for investment and a strategy for implementation.
The CancerX Digital Navigation ROI Calculator and CancerX Patient Navigation Blueprint directly support scaled, sustainable navigation to improve access, cost, and health outcomes for more cancer patients. These free resources are designed to support health systems and patient navigators in developing a business case and strategy for digital patient navigation programming.
View the slides
Watch the recording
Explore the resources
Public Workshop | Using Patient Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Lifecycle
Join us to help advance the use of patient-generated health data (PGHD) to support improved trials, medical device development products, and regulatory science!
During this public meeting led by FDA and the Digital Medicine Society (DiMe), we will explore how PGHD can advance remote clinical trial data collection and facilitate high-quality clinical outcome assessment. Attendees will have the opportunity to learn about and discuss:
- How to implement PGHD throughout the total product life cycle development of medical devices
- Tangible case examples of how PGHD has informed medical device development
- How PGHD can help improve health equity by promoting inclusivity in research studies
- Case-based learning on the use of PGHD for medical device developers, scientists, and patients
Register today for this unique opportunity to learn alongside industry leaders and contribute to future work on resources to advance the use of PGHD in clinical research and regulatory science.
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This public meeting will take place on June 26 – 27, 2024 from 11 a.m. – 3 p.m. ET.
Visit the webpage to learn more
Digital Measurement of Nocturnal Scratch: New Developments – A Series
Few measurements in the digital realm have garnered such momentum and dedication as the digital measurement of nocturnal scratch. Through the lens of digital tools and sensor-generated data, clinical researchers and drug developers can now capture crucial information regarding patients’ nighttime scratching habits, quantifying these actions in real time.
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Building upon the collaborative work of DiMe in advancing nocturnal scratch as a digital endpoint for atopic dermatitis and the follow-up work conducted in collaboration with DEEP, we will host webinar sessions on:
Webinar 1: Recent Regulatory Feedback
We’ll address the most recent regulatory feedback garnered through FDA’s Critical Path Innovation Meeting forum and the EMA’s Innovation Task Force (ITF) briefing meetings under the EMA pilot conducted with EFPIA and DEEP.
Webinar 2: Updates from R&D on Algorithms and Tools
In this session, we’ll showcase the latest updates from technological research and development, showcasing the remarkable progress in the development of algorithms and tools designed to measure nocturnal scratch.
Webinar 3: Processes, Validation, and Adoption
We’ll discuss steps forward in the validation and adoption of digital measurements of nocturnal scratch. We will showcase frameworks and processes poised to facilitate researchers from diverse backgrounds in their quest to deliver novel measurements that meaningfully address patients’ experiences and conditions.
View Slides
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Don’t miss this opportunity to register now to secure your spot in our webinar series. Join us along with DEEP, FDA and other industry colleagues as we chart a course toward a future where digital measurements guide us toward a deeper understanding of patients’ conditions and everyday experiences.
DiMe Webinar: With tightening digital health funding and escalating expectations, how can innovators efficiently construct evidence for their products?
The digital health sector in Q1 of 2024 is experiencing an interesting shift – despite $2.7B investment, 133 digital health venture deals are showing higher deal volume at lower check sizes. Developers face ongoing demands to demonstrate tangible clinical and economic outcomes, but with tightening budgets and on shorter timelines. With such a dynamic landscape, there is a pivotal debate taking place across the industry focused on the optimal strategy for 1) building the right evidence strategy using effective methodologies with limited timelines, and 2) addressing the needs and expectations of a diverse range of stakeholders and decision-makers — including payers, purchasers, clinicians, and patients — in the development and deployment of DHTs for broad acceptance.
Advancing Sleep Research: New Core Digital Measures & Resources
Access to natural, out-of-lab sleep assessment technology has exploded. With so many options, how do you decide what to measure and how to measure it?
DATAcc by DiMe has been working with a world-leading group of experts to clarify that choice. We have developed a set of Core Digital Measures of Sleep that can be applied across therapeutic areas, a sleep system, and other tools to help you document your sleep research transparently and systematically.
Sleep is a pillar of health, and it needs better and more frequent measurement to increase understanding of diseases. Watch the recording of the webinar to hear about the new, free tools and their potential impact on your research.
DiMe Webinar: Clinical trial efficiency using data and digital health tech
As pharma and academic groups need to do more with less, there is a lot of interest in using data and digital health technologies to improve clinical trial efficiency. Examples range from using devices for endpoint detection outside of the clinic, near and real-time data collection outside of the clinic, more precise recruitment and trial site selection. This webinar hosted speakers across this range of topics to discuss what is working well and how to continue to do more with less in clinical trial operations.
V3+: An extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies
As clinical research sponsors and healthcare organizations take digital clinical measures to scale, new challenges related to the usability of sDHTs across diverse populations, settings, and implementation approaches have become pressing. DATAcc by DiMe has built on the foundation of the original V3 framework by adding a fourth evidence-based component addressing sDHT usability validation. Along with the V3+ manuscript, the project team has developed new, free resources to support research and clinical teams implementing the V3+ recommendations for best practices.
Listen now to learn more about implementing V3+ usability validation with our new resources, as well as DiMe’s new “Building Fit-for-Purpose Sensor-based Digital Health Technologies: A Crash Course,” aimed at educating learners on V3+ fundamentals and helping them understand how to use the framework in their work.
Making Strides with Digital Measures of Physical Activity: A Digital Strategy for the 6th Vital Sign
The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is excited to launch our core set of digital measures of physical activity! Join us as we discuss the digital measurement of physical activity and the resources developed to support the adoption of measures in clinical research and practice.
DATAcc has led a pre-competitive collaboration consisting of patient organizations, biopharmaceutical companies, digital sensor technology companies, and leaders in physical activity to define a core set of digital clinical measures for physical activity that matter to patients across therapeutic areas. By defining these measures and developing practical resources to support their adoption, we have focused the transformational power of innovation and competition on a set of common targets to support quality treatment and care that meet the needs of patients, care providers, industry, and regulators.
We are thrilled to reveal the core digital measures of physical activity and practical resources and hold panel discussions with leaders in the digital measurement and physical activity field.
Library of Digital Endpoints: Celebrating Four Years!
The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) celebrated the fourth anniversary of the crowdsourced Library of Digital Endpoints!
The Library of Digital Endpoints was published in 2019 as a comprehensive list of digitally collected endpoints used in industry-sponsored studies. Since then, the evolution of the Library has indicated the increasing adoption and trust in digital health measurement for clinical research. It has also led to progress in clinical trials and patient care.
We invited webinar attendees to actively participate in the discussion and come with stories to share about using the Library of Digital Endpoints in their everyday work. Watch the recording to celebrate the library’s impact on the field and developments in digital measurement!
A common language for digital endpoint development
As we continue to advance the development of high-value digital endpoints, a common, unifying language is essential.
Successful collaboration across different stakeholders and broad adoption across multiple regulatory regions are contingent on scientific conversations where experts can talk to, not past, one another. Regulatory acceptance requires that we don’t abandon the scientific lexicon that has served us so well for decades of safe and successful drug development.
So how do we avoid getting trapped in a digital Tower of Babel as we advance digital endpoints for use in drug development?
Join experts from EMA, FDA, and the life science and med-tech industries as they discuss the lingua franca that binds them.
Referencing the digital health glossaries from the Digital Medicine Society (DiMe) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), these experts will debunk some of the language trends that have caused confusion – that’s right, not everything we measure digitally is a biomarker! – and share case examples illustrating how core scientific concepts, appropriately articulated using the right scientific terms, have powered outsized success in digital endpoint development and deployment.
Navigating Reimbursement for Virtual First Care (V1C)
The virtual first care community has developed solutions that increase access to affordable primary and specialty care and address limitations that historically created barriers to healthcare delivery. The sustainability of these innovative models is critical to expanding affordable access to quality care.
To address this, IMPACT created the Payment & Coding Toolkit to dispel that myth by showing providers, investors, payers, policymakers, and other stakeholders: “You can get paid for offering V1C services!”
Hear insights from Dr. Zeke Silva, Lucia Savage, Dr. Ryan Vega, Don Jones, and Abby Sugg and an inspiring discussion on how you can use these new tools to identify applicable coding strategies regardless of your clinical focus easily.’
How to build a fit-for-purpose regulatory strategy to advance your business strategy
Innovation is rapidly accelerating the use of digital health across various medical conditions. Yet, the current regulatory landscape can be difficult to navigate because regulatory science and requirements are ever-evolving within the digital health field. It’s difficult for innovators to know how to keep up. During this webinar, attendees will hear from regulatory and industry experts on keeping pace in this dynamic space.
You will learn how:
- In today’s market, a fit-for-purpose regulatory strategy is a good business strategy.
- Using resources available today – including online tools and a new education course – you can build a regulatory strategy to ensure that your digital health products meet necessary regulatory requirements.
- Ensuring product safety and effectiveness are seen as more marketable and reliable by investors and payers, leading to more capital investment and a higher likelihood of payers’ acceptance.
Striding Past the 6MWT: Complementing Physical Activity Assessment with a Consensus Set of Digital Clinical Measures
Physical activity (PA) is essential for the maintenance of health across virtually all therapeutic areas and is often recognized as a ‘sixth vital sign’. While it is becoming clear that relying on point-in-time, clinic-based walking tests are insufficient to accurately capture physical function in a meaningful way, digital health technologies (DHTs) present an opportunity to measure activity in real life.
The Digital Medicine Society (DiMe) is currently leading a pre-competitive collaboration to define a core set of digital clinical measures for physical activity (PA) across therapeutic areas. With more than 70 unique digital endpoints for PA currently being used, we aim to move away from innovating in siloes and leverage multi-stakeholder collaboration to answer tough digital measures questions, demonstrating a process of what good looks like. Understanding which digital measures matter for physical activity can speed up the development of therapeutics and enable the field to respond swiftly and meaningfully, equipped with the right evidence for decision-making.
Women Centric Digital Measurements and Monitoring; Tales from the Lived Experience with Connected Health
While DHTs have come a long way and there is clear signal within digital measures to have the ability to detect pregnancy as well as monitor prenatal wellbeing, many of the existing commercially available health and wellness tools are not designed to be inclusive of the realm of maternal and fetal medicine. This webinar explored personal use cases and design & development expert opinions for how currently available tools can and have been used within this space and where there are glaring unmet needs and opportunities for the industry to improve connected care.
IMPACT V1C Core Competencies: The Hallmarks of High Quality, Trustworthy Virtual First Care
The potential benefits of a remodeled delivery system based on virtual first care (V1C) are tremendous – in terms of patient access and experience, workforce efficiency, and improved health and economic outcomes. At the same time, in the post-pandemic era, solutions of varying quality and reliability are flooding the market. Without consistent evaluation criteria to guide builders and buyers towards high-quality V1C, the trust of this movement is at stake.
To address this need, IMPACT, the multi-stakeholder V1C initiative co-hosted by the Digital Medicine Society (DiMe) and the American Telemedicine Association (ATA) has developed an industry-vetted V1C Checklist. This tool defines essential competencies and hallmarks of high quality, trustworthy V1C.
The deadly state of surveillance capitalism
In this historical moment the gap between legislation that does not yet exist and institutional practices that are not yet regulated leaves people without the essential protections they need to maintain their privacy and their basic rights. This leaves online patient communities vulnerable to privacy violations, identify theft, scams, discrimination, disinformation, ad targeting, harassment and other forms of exploitation that can steal their security and undermine their health, wealth and overall well-being of patient populations.
This panel explored how The Light Collective, a network of tech savvy patient communities, came together to address this problem. Their founder, Andrea Downing, discussed their published research on Meta Pixel and cross-site tracking that sparked congressional investigations, and drove HHS guidance.
A Path Forward: New Tools to Navigate Digital Health Regulations
In 2023, one thing is evident – A fit-for-purpose regulatory strategy is a good business strategy for digital health innovators!
DiMe’s Digital Health Regulatory Pathways project team has developed tools and resources for innovators.
Leading regulatory experts from across the digital health field discussed how:
1. You can use regulatory strategy to become a
commercial differentiator for your digital health solutions
2. To bridge modern-day software-based digital health
products with the new and past FDA regulations
3. You can identify the right regulatory pathway for your
medical product to impact reimbursement, patient adoption,
and health outcomes
What are YOU doing to increase diversity, equity, and inclusion in clinical trials?
The call for diversifying clinical trials and creating a more equitable and inclusive clinical trials industry has gotten louder. Are you ready to take action?
DiMe’s Diversity, Equity, and Inclusion in Digitized Clinical Trials project team is launching resources demonstrating how digital tools can be used to tackle many of the challenges facing clinical trials, from patient engagement, recruitment, and retention to more robust data collection and better outcomes.
Join us for the launch of these resources, insights from FDA Commissioner Rob Califf, and an inspiring discussion on how you can use these new tools, now, to advance DEI in clinical trials.
We have the opportunity to advance health equity and transform the clinical trials industry. Join DiMe’s team of leading experts to learn how you can implement these resources, now.
Increasing software innovation in digital health products through unified cross architecture programming
Digital health innovation has grown exponentially in recent years. Teams developing digital health products and technologies have developed their products using unique, multi-faceted programming modalities to support an evolving set of features to meet the diverse needs of user populations. While this has enabled products to be fit-for-purpose, this has also resulted in disparate products that exacerbate the challenges of interoperability, making retrofit and digital transformation more challenging.
Leveraging heterogeneous computing with unified cross architecture programming allows digital health products to utilize open source industry specifications that allow software application development to be hardware agnostic, which in turn enables product developers and healthcare systems using those products to deploy innovative solutions off-the-shelf on their existing heterogeneous infrastructure. As a result, the barrier to entry for many often overlooked consumers is reduced, ensuring that no matter where it’s implemented, an innovative product can remain patient-centric.
Watch as we discuss how digital health product teams can deliver groundbreaking solutions that are both innovative and equitable. Thought leaders at Intel, Canon Medical, and Oracle discuss how they’ve implemented a unified cross programming model for heterogeneous computing to increase software innovation and expand market access to digital health technologies to deliver patient-centric care solutions to those in need.
The State of the Virtual Care Industry: Results from a New Benchmark Survey from Omada Health, DiMe & Rock Health
By now most of us have participated in a video healthcare visit, a result of the sweeping pivot to telemedicine driven by the pandemic. But how much did the pandemic really accelerate the digitization of healthcare delivery? How widespread is awareness and implementation of truly transformative, digitally-enabled care that improves access, experience, and outcomes, what we call, Virtual-First Care?
Omada Health, in partnership with DiMe and with support from Rock Health, surveyed over 750 decision-makers in the healthcare purchaser industry to find out. The results of this study show surprising variation across the purchaser community regarding adoption drivers, program priorities, and, importantly, reveal fundamental confusion about what is meant by ‘virtual care’ and the cost, quality, and access benefits it can deliver for patients, purchasers, and providers.
On December 1st, leaders from across the healthcare ecosystem discussed the results of this benchmarking study of employers and health plans.
Thought leaders representing virtual first care, medical providers, employers and healthcare investors will reflect on implications of the survey results and together share insights for strategies and actions that will enable full potential of virtual first care.
Accountability for the Diversity Plan to Improve Enrollment of Underrepresented Populations in Clinical Trials
Everyone’s talking about the lack of diversity, equity, and inclusion in clinical trials. The FDA issued draft guidance to provide recommendations to help clinical trial sponsors develop a Race and Ethnicity Diversity Plan. Some House Democrats are also pushing for Congressional legislation to secure more representation in clinical trials. We all recognize the need to do something about it, but who’s going to lead the efforts? Who’s going to be accountable for increasing diversity in clinical trials?
Leaders from across the clinical trials ecosystem give an update on the Diversity, Equity, and Inclusion in Digitized Clinical Trials project, and an in-depth discussion on what different stakeholders can do to ensure digital technologies are used to increase diversity, equity, and inclusion in clinical trials.
V3 in Action
V3 combines widely recognized practices from both software and clinical development to establish the shared foundation for evaluating whether digital clinical measures are fit for purpose. Since its publication in 2020, V3 has been adopted by over 45 teams developing and deploying digital clinical measures as well as the European Medicines Agency (EMA).
But what has the process for adoption been within organizations? And how have organizations upleveled their processes around evaluation of digital sensing products, algorithms, and clinical use cases across the board to embed V3 into a systematic approach?
Listen to learn more about how companies have applied V3 to ensure their digital measures are fit for purpose. Hear from digital leaders at Takeda and Koneksa about how their organizations have implemented this framework, and how it’s helped them navigate the complexity of digital measurement more thoughtfully and effectively.
The Clinical Strength of Digital Health in Key Ecosystems
Nocturnal Scratch as a Digital Endpoint for Atopic Dermatitis: A Public launch event
For the first time ever, we have a blueprint for developing and deploying digital endpoints in medical product development.
On Sept. 8, industry leaders Abbvie, Janssen, Novartis, Pfizer, UCB, Advancing Innovation in Dermatology, Almirall, GSK, Leo Pharma, Eli Lilly, and Sanofi collaborated to research the meaningfulness of nocturnal scratching to atopic dermatitis (AD) patients and developed new resources for deploying scratch digital measures in clinical trials.
In addition to addressing an unmet need for AD patients, this work lays the groundwork for advancing the use of digital endpoints in medical research and care. Event attendees learned about:
- Results from a study on the meaningfulness of nocturnal scratch as a digital endpoint for AD patients
- Best practices, definitions, and additional resources for understanding what good digital endpoint development and deployment look like
- New tools that help you move beyond “what endpoints exist to measure?” to “I will use and measure this digital endpoint.”
- What additional work is being done to advance the use of digital endpoints in medical research and care
DiMe’s own, Lucy Cenakova, moderated a panel with Matthew Diamond, Chief Medical Officer at FDA, and Thorsten Vetter, Senior Scientific Officer at EMA.
Explore the Nocturnal Scratch resources
View the Nocturnal Scratch launch Webinar Slides
Sensor data integrations to power better decisions, faster, across healthcare and research
Sensor data has the potential to transform how we define health and disease and increase our ability to make better decisions, faster, across patient care and clinical research.
To realize this potential at scale, organizations from across the tech and healthcare sectors have developed an open access toolkit through the Digital Medicine Society (DiMe) Sensor Data Integrations project. Join us on July 18 as experts from Amazon Web Services, Anthem, Evidation, FDA, IEEE, Moffitt Cancer Center, Human First, Medable, Open mHealth, Oracle, Takeda, Savvy Co-op, and the Veteran’s Health Administration report on the state of sensor data use in healthcare and unveil these new resources for the first time.
Micky Tripathi, National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services, kicked off this public launch event with opening remarks.
Public Launch Event: Care Transitions Supporting Effective Virtual First Care (V1C)
IMPACT is a pre-competitive industry collaborative co-hosted by the American Telemedicine Association (ATA) and the Digital Medicine Society (DiMe) dedicated to expanding high quality, evidence-based virtual first care (V1C) for patients, healthcare providers, and payers to improve clinical and health economic outcomes, enhance access, and provide a better overall patient experience. IMPACT members work together to advance the most pressing opportunities for V1C.
Care transitions between V1C providers and other practitioners and sites of care (both virtual and bricks and mortar) present an opportunity to optimize access, patient and provider experience, efficiency, and clinical outcomes.
Join us for this 90-min launch event to learn about the overarching vision of IMPACT, meet experts from the IMPACT Steering Committee guiding its direction, and get a first look at a new suite of resources and best practices to optimize care transitions across the care continuum that will facilitate full integration of V1C into the healthcare delivery ecosystem.
Learn more at impact.dimesociety.org
Driving inclusion in digital health measurement product development and deployment
In the quickly evolving ecosystem of digital medicine, interdisciplinary collaborative forums will be critical for solving challenges facing the healthcare sector. DiMe partnered with FDA’s Center for Devices and Radiological Health (CDRH), to host the Digital Health Measurement Collaborative Community (DATAcc).
DATAcc convened a broad range of stakeholders to modernize the way we measure and define health and disease using digital approaches and technologies. The two inaugural projects are modeled on the FDA’s device development process. One project identifies and supports the application of inclusive elements at each phase of the digital measurement product development process. The second operationalizes inclusion in the deployment of digital health measurement products across contexts of use.
In this 2-hour launch event, learn about the overarching vision of DATAcc, meet the experts from the DATAcc Steering Committee guiding its direction and the project teams who were instrumental in developing these two suites of products. Get a first look at a suite of products that will help the field make great strides of addressing historic biases, realizing the broad benefits of inclusivity, and improving lives, for everyone.
Powering Digital Health Innovation through Successful VC Funding
Listen in to the recording from our DiMe Webinar, “Powering Digital Health Innovation through Successful VC Funding” by Aaron Gani, CEO at BehaVR, Owen McCarthy, Co-founder of MedRhythms Inc, and Ben Lewis, CEO of Limbix.
The right investment strategy is critical for long-term success, and digital health is very much a long-term industry. How can you balance selecting the best-fit investor and your Round One valuations? Check out this discussion with the experts! This webinar is proudly sponsored by First Republic Bank. DiMe proudly banks with Managing Director Anthony Cuadro, who specializes in startups, alternative investments, life sciences, and Medtech banking. Interested in doing business with FRB? Contact Anthony at acuadro@firstrepublic.com to get started!
Powering Digital Health Innovation through Successful VC Funding: Slide Deck
The 3Ps of Digital Endpoint Value | Public Launch Event
Our industry has spent years working to develop the evidentiary best practices to try and ensure that regulators accept evidence from digital endpoints in support of new drug approvals. But, to date, we’ve thought very little about how payers and HTAs may consider data from digital endpoints in reimbursement and pricing decisions.
In this webinar, DiMe and our partners from Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op introduced a new suite of resources to support evidence generation strategies for the use of data generated by digital endpoints in value and reimbursement discussions for new drugs.
Securing our healthcare systems in the digital era: Tools you can use from the US Federal Cybersecurity and Infrastructure Security Agency (CISA)
In the digital era of healthcare, cybersecurity must be a priority for every healthcare system, tech developer, clinician and patient. But where can we find solutions ready to use today as the threat or cyber harms loom large? The US Federal Cybersecurity and Infrastructure Agency (CISA) has an open access suite of resources designed to support the industry in maintaining cybersecurity and many are fit-for-purpose for healthcare. Join us on March 15 at 11 am ET as Tom Millar, Senior Advisor at Cybersecurity and Infrastructure Security Agency (CISA), walks us through resources available to you today as you protect your systems and patients from cyberharms in the digital era.
Mr. Millar has served in CISA for 10 years, working to strengthen the agency’s information-sharing capabilities, increasing the level of public, private, and international partner engagement, and supporting initiatives to improve information exchange by both humans and machines, such as the standardization of the Traffic Light Protocol and the development of the Structured Threat Information eXpression. Prior to his cybersecurity career, he served as a linguist with the 22nd Intelligence Squadron of the United States
Air Force.
Putting Digital Health Into Practice | A CTA-DiMe Seminar Series: How’s Your Digital Transformation Going?
Listen in to Part 2 of “Putting Digital Health Into Practice | A CTA-DiMe Seminar Series.” This session focused on the opportunities and challenges tech companies are experiencing as they navigate the complex healthcare system
Panelists:
- Jennifer Goldsack, Chief Executive Officer, Digital Medicine Society
- Aaron Martin, Executive Vice President, Chief Digital Officer, Providence St. Joseph Health
- Hon Pak, MD, Chief Medical Officer, Samsung
- David Rhew, MD, Chief Medical Officer, Microsoft
Moderator:
- Drew Schiller, Chief Medical Officer, Validic
Putting Digital Health Into Practice | CTA – DiMe Seminar Series: Addressing Bias in the Evolving Landscape of AI in Health Care
The Consumer Technology Association (CTA) and Digital Medicine Society (DiMe) partnered to co-host a two-part seminar series focused on solutions to the most pressing challenges impeding the successful digitization of healthcare at scale. Listen in as leading experts from healthcare and technology came together to deliver ‘real talk’ on Addressing Bias in the Evolving Landscape of AI in Health Care
This session explored the role of bias related to the use of data for AI in health care solutions and how clinicians, tech companies, and other stakeholders are learning mitigation approaches as the AI landscape evolve
Panelists:
- Sarah Awan, Equity Fellow with CEO Action for Racial Equity; Senior Manager, PwC
- Milissa Campbell, Managing Director, Health Insights Lead, NTT DATA Services
- Carol McCall, Chief Health Analytics Officer, Closed AI
Moderator:
- Ami Bhatt, MD, Chief Innovation Officer, American College of Cardiology; Director, MassGen Adult Congenital Heart Disease Program
State of digital medicine: DiMe strategies to address key challenges in 2022
Join DiMe CEO, Jennifer Goldsack, and COO, Claire Meunier for an update on the DiMe project portfolio, key activities planned for 2022, and their take on the greatest challenges our field faces in advancing the safe, effective, ethical, and equitable use of digital medicine to optimize health.
Digital Medicine Research & Development in Low-Resource Settings
COVID-19 has highlighted the inequity in digital medicine, specifically in low-resource settings. In this webinar, we bring experts Dr. Brinnae Bent, Dr. Christopher James, and Santosh Shevade together to discuss challenges that affect how digital medicine is implemented in low-resource settings, and current limitations in usability evaluation and research implementation that are further exacerbating disparities in digital medicine. The discussion will focus on the need to have patients as partners and will highlight recommendations on implementing research in low-resource settings. Equity in digital medicine is critical to the success of the field, and viewers will come away from the webinar with a better understanding of the current state of digital medicine in low-resource settings, and ways in which research and development can become more equitable.
Moving the Needle: ACRO Toolkit to Advance Decentralized Clinical Trials Technology
The world of digital medicine and clinical trials is swiftly evolving. In order for scientific and technological innovation to be realized effectively, regulatory adaptation and reform need to keep pace.
This session examined the end-to-end clinical trial process and discusses some of the collaborations in the industry supporting teams right now. One such collaboration is the Association for Clinical Research Organization’s (ACRO) toolkit to advance decentralized clinical trials technology that is advancing the field, such as how technology is supporting clinical strategy and operations and catalyzing regulatory reform. Listen in to learn more about ARCO and the success of this project!
Death by Pilot: How Solid Evidence can help Digital Health Vendors Achieve Scale
By generating solid clinical evidence, digital health vendors may increase confidence in the reproducibility of clinical trial data and claims (i.e., their capacity to deliver clinical value). This can help vendors establish trust and progress more rapidly from pilot partnerships to scaled deployments. Novel frameworks for clinical evidence assessment, incorporating the latest scientific methods for predicting clinical impact of digital health solutions, may help vendors develop compelling clinical validation strategies, support clinical trials and optimize their likelihood of growth.
IMPACT Payer-V1C Contracting Toolkit Launch
As virtual first care (V1C) gains momentum, standard provider and vendor contracting models fail to account for the range of features and format of these services, leading to delays and challenges in contracting. Recognizing these breakdowns, IMPACT members from over 30 virtual first care, payer, funder, digital health, and services companies have come together to address the greatest barriers to V1C adoption at scale.
On October 1st IMPACT launched the Payer-V1C Contracting Toolkit – a suite of action-oriented resources, such as the Guide to Payer-V1C Model Contracting, Guide to V1C payment models, and V1C Coding Library. The toolkit will support alignment between payer’s systems and processes around new modalities of care to facilitate contracting and ultimately drive more effective adoption of V1C.
The meeting featured expert remarks by Saurabha Bhatnagar, Chief Health Officer, Commure. Donald Jones, Co-Founder of IMPACT also provided an expert V1C solution perspective based on his renowned digital health expertise and extensive advisory work in the field.
Claire Meunier, DiMe’s COO and Executive Lead on IMPACT then moderated a panel discussion featuring IMPACT members Joe Connolly, Co-Founder & CEO, Visana Health, Lucia Savage, Chief Privacy & Regulatory Officer, Omada Health, and Marcus Thygeson, Chief Health Officer, Bind Benefits.
Patient Engagement and Activation for Better Adherence Using Digital Platforms
Digital health is growing as a vital part of healthcare, and with a rise in data-driven solutions and digital platforms, digital health technology can be an accurate and efficient way to empower patients. Digital pills can measure medication intake data and report it to care teams in real time, providing a platform to engage with patients about their treatment plan. Patients face many challenges with medication adherence — from complex dosing regimens to access to the medications themselves — and high-quality, evidence based technology can help. In this session, we discussed how even small care teams can use digital pill technology to help their patients stay on track with their therapy in real time, discover how to transform engagement with their patients, and uncover the wide-reaching clinical and commercial potential for this type of digital transformation. Hear from an expert patient, clinician, regulatory professional, pharma executive, and RWE researcher on how we can build better digital pills to support care teams and the patients they serve.
DiMe Presents: Digital Endpoints Webinar Series
Digital endpoints offer enormous promise to transform medical product development and the reach of new therapies to all patients, including individuals typically underrepresented in clinical research.
This summer, DiMe is collaborating with colleagues at the Clinical Trials Transformation Initiative (CTTI), and Transcelerate to highlight the best resources available to sponsors, digital product manufacturers, and researchers committed to harnessing the power of digital clinical trials to advance the safe, effective, ethical, and equitable use of digital technologies to improve lives through new approaches to medical product development. Register now for the first session, led by DiMe CEO Jen Goldsack and moderated by Rachel Chasse, in the three-part series from CTTI, DiMe, and TransCelerate.
Patient Insights: From Clinical Research to Product Development
Companies are learning that in order to create truly patient-centered solutions, they need to incorporate patient insights. Yet, many people—from small startups to large pharmaceutical companies—don’t know where to start. Throw in a global pandemic, and it can seem even more daunting to engage patients. But it doesn’t have to be, and in this session, we will discuss how even a small team can get started. Listen in to the recording of our July webinar to learn how both qualitative and quantitative patient insights can enhance both clinical research and digital product development, which can lead to new features, a better patient experience, and improved outcomes.
Digital Medicine and the Future for Pharmacists
Digital medicine has revolutionized healthcare, but what does this mean for the future of pharmacists? Pharmacists are the first point of care for many people: how will they play a pivotal role in adopting digital products to optimize and advance patient care? With advancements in digital medicine, exciting opportunities emerge for pharmacists to evolve and expand their roles. Listen in to the recorded panel discussion with Aspen RxHealth and RxE2 on how they are innovating the pharmacy world today, and what their vision is for the future.
The Playbook: Driving Adoption
Listen in to DiMe’s successful launch of “The Playbook: Driving Adoption, featuring over 100 new action-oriented resources that make it easier for you to:
- Access information from The Playbook in bite-sized chunks
- Implement best practices from The Playbook using new tools such as checklists, decision tools, and value frameworks
Amy Abernethy, former principal deputy commissioner of the FDA, kicked off our launch event with opening remarks on how to use digital innovation to improve lives. We then unveiled “The Playbook: Driving Adoption” through a series of 9 different panels of experts. You can experience each panel individually or as a complete event on our Tour of Duty, “The Playbook: Driving Adoption” Playlist.
Introducing the PIF Program: A Path to Public Service through Digital Health and Medicine
Curious how you might translate a career in digital medicine or healthcare to public service opportunities? Presidential Innovation Fellows (PIF) is one way to join the federal government and make an impact, and applications are open now!
Presidential Innovation Fellows join the federal government for one to two years as entrepreneurs-in-residence at federal agencies! From COVID-19 to veterans’ benefits f to human-centered design, PIFs will share their experience applying their skills and leadership in partnership with federal leaders. Join a panel of current PIFs and learn about how you could bring vital digital medicine and healthcare experience to key initiatives across the federal government. Apply to PIF through May 14 at apply.pif.gov!
Introducing IMPACT: Analyzing the Virtual-First Care Industry
The ‘IMPACT’ initiative, co-created by DiMe and ATA, aims to go beyond conventional telemedicine efforts that are layered on top of existing healthcare organizations, and to instead develop solutions that its organizers call “virtual-first.” Virtual first medical care combines digital medicine, communications technology, and clinical expertise for patient-centered healthcare. IMPACT is a pre-competitive collaboration of leading digital health companies, investors, payers, and consultants dedicated to supporting virtual-first medical organizations and their commitment to patient-centric care.
Health Moonshots: Improving Global Access to Care with Digital Medicine
Fully half of the world’s population goes without needed healthcare. To improve global access to care, StartUp Health’s innovative group of Health Transformers develop and deploy radical digital medicine solutions that address delivery, cost, geography, and technology.
Listen in to the recording as our panel of experts discuss with three Health Transformers about how they are working towards the Health Moonshot goals of improving global access to care with digital medicine products:
Miguel Johns, CEO of DiabetesCare — providing global diabetes care powered by machine learning
Bryan Mezue, CEO of Lifestores Healthcare — deploying tech-enabled products to create ‘pharmacies of the future’ in Nigeria
Areva Martin, CEO of Butterfly Health — delivering a digital therapeutic for behavioral health providing culturally-sensitive mental healthcare to underrepresented populations in the United States
Diversity in Digital Health Startup Leadership
This year, Rock Health and Dr. Ivor Horn teamed up to launch a new Diversity in Digital Health initiative, with a survey to baseline the racial and ethnic diversity of leadership at digital health startups. Listen in to the recording of Rock Health COO, Megan Zweig, as she shares key findings from the 678 digital health startup leaders who completed the survey and perspectives on how the digital health sector can work toward addressing disparities in entrepreneurial leadership, non-capital support, and funding. Komathi Stem, COO of Glooko, provides her experience as a past founder of a digital medicine company and from her many leadership positions. Access Rock Health’s 2020 Diversity in Digital Health report here!
From Concept to Commercialization: The strategic importance of aligning evidence generation strategies and business models in digital health
This workshop highlighted key papers from the newly released Special Issue of Digital Biomarkers, sponsored by Evidation Health and DiMe.
Digital Health companies face a unique set of challenges and opportunities progressing from concept to commercialization. This DiMe webinar will cover strategic implications and decisions associated with evidence generation strategies, and specifically their impact on stakeholder adoption and commercialization/market access models. Listen in as our fantastic panel of speakers to dive deeper into this topic!
The Future of Digital Health
This workshop highlighted key papers from the newly released Special Issue of Digital Biomarkers, sponsored by Evidation Health and DiMe.
Presented by the lead authors themselves, we examined the latest advances in the Maturation of digital health capabilities, Emerging Applications in how to turn patient and person-generated health data into insights, and how the Talent landscape is developing. This webinar includes an open discussion where the panel shares their experience on data collection outside the clinic, and perspectives on how digital health can enter the clinical practice mainstream.
The workshop is of relevance to everyone interested in, or working on, implementing digital measures into clinical trials, RWE and clinical practice.
The Playbook Masterclass 6: Specific considerations for remote monitoring in public health surveillance
The sixth and final event in our 6-week educational series was presented by Ed Ramos and Katie Baca-Motes. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The Playbook Masterclass 5: Specific considerations for remote monitoring in clinical care
The fifth event in our 6-week educational series was presented by Steve Steinhubl and Sofia Warner. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The Playbook Masterclass 4: Specific considerations for remote monitoring in clinical research.
The fourth event in our 6-week educational series was presented by Victor Chan, Priyanka Agarwal, and Thomas Switzer. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The Playbook Masterclass 3: Equity and Justice in Remote Monitoring
The Playbook Masterclass 3: Equity and Justice in Remote Monitoring
The third event in our 6-week educational series was presented by Adam Brown, Dena Mendelsohn, and John WIlbanks. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The Playbook Masterclass 2: Measure -> Tech -> Ops: Order Matters
The second event in our 6-week educational series was presented by Andy Coravos, Chris Benko, and Christine Manta. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The Playbook Masterclass 1: Why Digital Clinical Measures?
The first event in our 6-week educational series was presented by Gina Valo and Jen Goldsack. Each week experts will:
– Guide you through different sections of The Playbook
– Demonstrate, through worked examples, how you can use this resource to develop and implement digital clinical measures at your organization
To learn more about The Playbook visit playbook.dimesociety.org
The “Digital Measures Playbook” Launch Event
Introducing the essential industry guide for successfully developing & deploying digital clinical measures across clinical research, clinical care, and population health.
Join colleagues from the Food and Drug Administration, Myokardia, Genentech, Scripps, Sage Bionetworks, Koneksa, Elektra Labs and the Digital Medicine Society as they unveil the first draft of this unprecedented, action-oriented guide.
Introducing ENACT: Early Notification to Act, Control, and Treat: Using Wearables for Early Illness Detection
Listen in as we introduce a new program from the US Department of Health and Human Services (HHS)’s Biomedical Advanced Research and Development Authority (BARDA). This is ENACT: Early Notification to Act, Control, and Treat. In this presentation you will:
– Learn how the US government partners with innovators to develop disruptive healthcare technologies with ENACT
– Discover ENACT’s goals: providing actionable health information to patients, healthcare providers, and public health organizations
– Explore how we can approach presymptomatic diagnostics of viral infections
The Importance of Sourcing Diverse Expertise in Healthcare Innovation: Best Practices and Actionable Steps
Listen is as our expert panelists discuss the importance of sourcing diverse patient perspectives and clinical expertise, including ways to reach outside of our immediate network. This webinar:
– Discusses the special considerations that must be made in order to disrupt responsibly
– Provides the best practices and actionable steps on bridging knowledge gaps between healthcare innovators and experts
– Offers guidance to drive the adoption of viable, scalable solutions that meet the needs of both patients and providers
Science as Justice
Listen in as our experts address how systemic racism persists in science and medicine, and what we can do about it.
– How systemic racism perseveres in the realm of scientific and medical research
– Clear examples of how systemic racism leads to inequity in healthcare, particularly harming Black patients
– Actionable solutions we can all take to dismantle systemic research and reach a more just future
Digital Therapeutics 101
Listen in as our experts define Digital Therapeutics and offer an overview of successful digital therapeutic product development and deployment:
– The current state of the industry
– Evidentiary requirements for creating impactful digital therapeutics
– Advice for successfully getting products to patients and creating a sustainable business model
DiMe’s Federal Comment Toolkit
Watch the recording to learn about:
– DiMe’s new Federal Comment Toolkit
– Why it’s important that we participate in the comment process and why our experts are motivated to comment
– Tips and tricks for preparing your own comments in the future
Inclusivity in Innovation: Practical Advice for Developing and Retaining a Diverse Workforce
This session addresses the importance of inclusivity within healthcare development and innovation teams. Listen to gain practical advice on:
– How to build an inclusive team — why it matters and overcoming the pipeline fallacy
– Creating and fostering inclusive workplace cultures
– Keys to successfully retaining talent
Machine Learning, Predictive Glucose Levels, and the Future of Proactive Diabetes Management
Listen as we discuss a brief history of diabetes care innovation as it relates to continuous glucose monitors (CGMs). Experts discuss examples of how machine learning (ML) is replacing retrospective approaches with proactive approaches in patient care, including:
– Case studies in how machine learning has improved care
– Applications for complex patients cohorts, including Type 2 patients
– Predictions for safer care and better management
Xcertia mHealth App Guidelines: Impact on the Market
The official release of the fully-updated version of the Xcertia mHealth App Guidelines provides two key areas of collaboration and education within the digital health marketplace. Listen as experts:
– Share experiences and lessons learned during the updating of the guidelines from the lens of the Xcertia Work Group Leaders
– Explore with the audience how the existence of the Xcertia Guidelines can create opportunities to drive market adoption and use.
Co-Designing Mental Health Apps with Patient Populations
The Collaborative for Recovery and Health works cooperatively with patient populations in co-designing meaningful and effective smartphone interventions. Listen to this resource to:
– Learn about the collaborative role of researchers and patients in digital health development and implementation.
– Understand the intersection between user-centered design and community-engaged research.
Informed Consent in the Era of Digital
Learn about Sage Bionetworks’ Elements of Informed Consent toolkit and review:
– Use cases and real examples describing the Sage approach to the informed consent process, including eConsent.
– Prompt questions to make sure you’ve thought through your approach.
– Sage tools available to you to help support your development of consent documents when using digital medicine tools in research.
Machine Learning for Healthcare Professionals
This webinar will provide a level set for healthcare professionals seeking to:
– Develop an understanding of machine learning methods
– Distinguish between machine learning and other computational approaches for digital health data
– Recognize opportunities to use machine learning to address challenges in healthcare
Selecting and Implementing Digital Solutions in the Clinical Setting, and Beyond
Learn how leading health systems:
– Identify needs that could be well met through digital solutions
– Evaluate digital tools as potential solutions
– Execute successful implementation of digital solutions
