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2021 in Review: DiMe Comes of Age

Jennifer Goldsack

This has been a monumental year for science and innovation in healthcare. From the approval of life-saving vaccines to unprecedented growth in digital health, 2021 will be defined as an inflection point for healthcare. 

It has also been a transformative year for DiMe. Building on the success of our early research initiatives such as V3, the original work on The Playbook, and our framework to guide the selection of digital measures that matter to patients, we launched seven new resources this year, published 16 papers, and partnered with 112 organizations from around the world in our project portfolio. 

This year we are proud to have partnered across our portfolio with 112 organizations leading the field of digital health.

How we advanced the field in 2021

The DiMe community has a lot to celebrate this year, including high impact milestones such as:

  • In April, along with 23 partners, we launched over 110 new resources and a reimagined web version of The Playbook. Already, we have more than a dozen case examples of The Playbook in action and more being added every week — a testament to the impact this work has had on the field. 
  • Our new EVIDENCE checklist is being used as a go-to guide for many in our community who are publishing their research on digital measurement products, as well as those of us who review them.
  • Our IMPACT community, convened only in January of this year, released a series of resources to advance their shared goal of supporting virtual first care (V1C) companies and their commitment to high-quality care built around the patient, not the clinic. After defining V1C, our IMPACT team – leaders from health tech, payer, patient, and investor orgs – also released a Payer-V1C contracting toolkit to address reimbursement challenges.
  • Staying with healthcare delivery, in October, we co-hosted the inaugural Digital Health Industry Symposium with our partners at Veterans Affairs (VA), building on previous work to discuss best practices for advancing the accessible, effective, efficient, and equitable use of digital solutions at scale in healthcare by identifying opportunities and strategies for successfully selecting, operationalizing, and scaling fit-for-purpose solutions within the largest healthcare system in the U.S.
  • Throughout the year, we also made substantial updates to our Expert Speaker Directory, spotlighting the leaders among our membership, continued to maintain our Library of Digital Endpoints — now reporting 225 unique digital endpoints being used by 69 different sponsors — and launched our Digital Health Resources Library, a curated, open-access catalog of digital health resources. 
  • Finally, this year we published 16 manuscripts, underscoring that everything we do is predicated on advancing digital medicine as an evidence-based field. And though we don’t short change the impact of our scientific publications, this fall we hit the headlines when one of our systematic reviews reported blind spots in academic research. 

In 2021 we combined the release of action-oriented research with over a dozen scientific publications to advance our field of digital medicine.

Looking ahead to 2022

Ongoing commitment to equity and inclusion

The new resources we released this year will continue to advance the safe, effective, ethical, and equitable use of digital medicine to optimize health. These projects have also laid the successful foundations for our project portfolio that continues to tackle the most challenging issues facing healthcare in the ever-growing digital era. 

Learn more about Collaborative Communities, an FDA CDRH strategic priory here.

In May, we launched the Digital Health Measurement collaborative community (DATAcc), convening the broad and inclusive range of stakeholders necessary to modernize the way we measure and define health and disease using digital approaches and technologies. This  community has led with courage and conviction since their founding this year, selecting two projects addressing equity and inclusion as priority areas of focus. In spring 2022, we will launch a framework, toolkit, and value model to drive inclusion in digital measurement product development, as well as recommendations and resources to support the equitable deployment of digital clinical measures across healthcare and research. In the summer, we will announce an open call for new members of DATAcc and launch the second wave of projects in pursuit of our mission.

Our commitment to diversity, equity, and inclusion in the digital era of healthcare does not end with our DATAcc initiatives. Early in the new year, we will also launch a new Tour of Duty dedicated to ensuring that the digitization of clinical trials results in a more accessible and inclusive clinical research enterprise. This work will help produce more generalizable findings and extend the benefits of new medical products to all members of the population, not just a select, overrepresented few.

Continuing to fuel innovation

Building on the success of The Playbook and the proliferation of endpoints in our library, we launched a landmark project this year: the first industry-led pre-competitive development of a digital endpoint for use in medical product development. And this project will not be the first with three digital measure development programs planned to develop core digital measure sets in the new year: For Alzheimer’s Disease with a disease-specific focus; and, separately, physical activity and sleep. Want to get involved? Let us know.  

To complement our work on the science of digital measurement, we’ve also been working in stealth mode with a project team to ensure that investments in digital endpoint development return to all. With a series of workshops planned for January 2022, we anticipate releasing a framework that supports a transparent, consistent, and patient-centered decision process for digital endpoints as value-evidence, accompanied by a considerations document outlining factors influencing decision making in different countries and regions, in the spring. 

Putting digital health into practice

To advance the effective and efficient use of digital health products at scale in clinical research and patient care, we are building a framework and toolkit to establish best practices for all stakeholders engaged in scoping, selecting, and/or implementing the integration of sensor data and algorithms to a cloud platform.

With our project team partners, we aim to position these resources to improve access at scale to trustworthy, relevant data to let clinicians, researchers, and patients make better decisions, faster. We will launch the framework and toolkit in spring 2022, along with several use cases across the care continuum. 

We are also convening leaders in digital product development and regulatory science to build a decision tool to guide digital innovators as they consider the optimal regulatory pathway for their products. Our ultimate goal is to power digital health innovation that considers regulatory strategy as part of a successful product and portfolio strategy. We will lock the project team at the end of this year (here is our last call for partners)  in anticipation of a spring 2022 launch. 

In addition, our VA partnership continues into next year when we plan to release a comprehensive toolkit to effectively measure, evaluate, and implement digital health solutions to improve the lives of Veterans and the people that care for them. We’ll be at HIMSS22 for live launches and you can keep up to date async, too, by signing up for updates. 

Our V1C initiative, IMPACT, is currently working to address care transitions between virtual-first care providers, as well as bi-directionally between virtual-first and traditional brick and mortar facilities. Resources are due this spring, alongside announcements of our next projects and new members. 

Lastly, in partnership with our colleagues at Moffitt Cancer Center and other leading experts in digital innovation and oncology, we are working to define the root causes of the lag in digital innovation in cancer care and research. In addition to reporting these root causes in a publication, next year we plan to launch at least one project focused on advancing digital innovation in oncology to ensure that the full promise of digital health innovation is realized for every cancer patient.

Building the workforce needed for the success of digital health 

DiMe is first and foremost a convener; the professional home for every individual seeking to advance the safe, effective, ethical, and equitable use of digital medicine to optimize health. From citizen science and cybersecurity experts to payers and regulators, we are incredibly proud of our extraordinary and diverse membership who inform the direction of our project portfolio and drive our impact on the field through implementation. 

The DiMe community now spans 59 countries and six continents and next year we plan to expand the global reach of our projects and programming to serve the needs of this global community. In 2022, we will offer a digital fundamentals course for pharma, a CME course for clinicians, and direct-to-learner offerings later in the year. 

Introducing formal offerings completes the “DiMe Flywheel” where 1) our community identifies the most pressing challenges to the field, 2) we seek to address them through action-oriented, applied research, and 3) we ensure the impact of these new materials through communication and education initiatives that disseminate this knowledge. 

Our Team

None of our success at DiMe is possible without an extraordinary team. And our team is not only the best, it has layers!

This year we launched a formal corporate sponsorship program for organizations that support our mission broadly. We are incredibly proud that 15 organizations have now raised their hand and stepped forward to champion our full scientific portfolio and programming activities. 

Our Strategic Advisory and Scientific Leadership Boards continue to provide DiMe with support and guidance while serving as ambassadors for our work and mission in their own daily work as leaders of the field. 

Finally, Team DiMe. We’ve grown three-fold this year and I’m incredibly proud of the extraordinary individuals that I have the privilege of working alongside each day. They share my passion for our mission, rival my tenacity for “getting it done”, and better my ideas – and me – daily. 

And, as we round out this watershed year, I cannot help but share just a little peek into the non-work achievements that brought Team DiMe joy this summer. In the Olympic year that came late but no less magically, our Director of Operations Michelle Sechser raced in Tokyo setting the second-fastest time in history and placing fifth in the final of the women’s lightweight double in the rowing events. She brought our virtual team together in a way I couldn’t imagine possible and inspired all of us.

As we all look ahead to 2022 and hope for a better year around the world, I hope you are as inspired by Michelle as we were. Please rest, be safe, and have a happy and joyful holiday season. We look forward to doing great work together next year. 

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