To advance the development of regulatory science, strategy, and policy that supports this goal, DiMe conducted a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers.

August 2023

Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED).

May 31, 2023

This work is intended to serve as a foundation for the future development of unified and well-described digital health technologies measuring nocturnal scratching and should enable better communication and sharing of results between various stakeholders taking part in research in atopic dermatitis and other inflammatory skin conditions.

DiMe Research Committee working group reviews methods and definitions by which adherence has been captured and reported using BioMets in order to identify gaps and provide recommendations to the field.

July 28, 2022

DiMe Research Committee working group explores the potential, risks, and key considerations for organizations to consider when using a “BYOD” approach in clinical research

July 28, 2022

In partnership with IMPACT member Wellinks, DiMe leadership discuss how virtual-first care can improve patient experience and engagement across the care journey and optimize handoffs between care settings

July 27, 2022

DiMe CEO, Jen Goldsack, describes the imperative for preparing for the use of sensor data at scale

July 26, 2022

The Digital Medicine Society and American Telemedicine Association have developed a new toolkit to support the integration of virtual and in-person healthcare.

June 28, 2022

DiMe, Johns Hopkins, and BlueHealth Intelligence publish one of the first studies probing telehealth outcomes during the pandemic.

April 27, 2022

DiMe leadership describe the opportunity of virtual-first care, or V1C, to increase the quality of healthcare and make it more patient-centric by letting patients combine in-person visits with virtual options such as video for seeing their care providers.

April 14, 2022

DiMe and German Federal Ministry of Health publish global priorities for innovation in real-world evidence generation to advance digital health applications

DiMe and VA leadership defines characteristics of a value-chain approach to successful digital health innovation in practice

Sensor Data Integration Tour of Duty expert collaborators published a review of the current state of sensor data integration in health care, and examined the importance of sensor data integration in achieving the promise of digital health to improve clinical research and patient care at scale, and offered a vision of what overcoming these challenges and continuing progress will enable.

November 9, 2021 in JMIR

DiMe participated in this HealthXL consortium to develop an open-source operational due diligence to faciliate vendor qualification assessments for clinical trials.

September 23, 2021 in HealthXL

DATAcc leads the way toward the great promise of digital health measurement 

September 15, 2021 in Med Device Online

Playbook collaborators published findings of a systematic review that identifies the need for more research funding related to digital clinical measures

September 15, 2021 in JMIR

DiMe expert leaders of the research committee provide a critical review of the state of art for multimodal BioMeTs in clinical care by identifying three unmet clinical needs and providing practical recommendations to drive the evolution from in-clinic assessments to at-home data collection with a focus on prevention, personalization, and long-term outcomes.

August 10, 2021

DiMe collaborated with colleagues at AllWays Health Partners, Atrius Health, Change Healthcare, Harvard Medical School, Massachusetts Health Quality Partners, Mayo Clinic, and
MITRE to examine trends in telehealth during the pandemic.

August 10, 2021

DiMe leadership, in partnership with Evidation Health, describe the critical role of computer scientists, electrical engineers and others with a data or computing background to successful digital biomarker development

July 25, 2021 from the Proceedings of the 2021 Future of Digital Biomarkers

To continue advancing digital innovation at the Veterans Health Administration, DiMe leadership shares key insights on harnessing the enormous promise of digital health technologies to improve Veteran-centered care

June 16, 2021

A subset of The Playbook Driving Adoption Tour participants reflected on the paucity of digital clinical measures in oncology care.

May 2021 in the Journal of Clinical Oncology

The EVIDENCE Tour of Duty developed the EVIDENCE checklist to promote high-quality reporting in studies where the primary objective is an evaluation of a digital measurement product or its constituent parts.

May 2021 in Karger Digital Biomarkers

In the World Economic Forum’s ‘Agenda’, DiMe’s Executive Director tackles what it means to take the “right” approach to using wearables data to improve public health.

May 2021 in World Economic Forum

DiMe contributed to this study along with colleagues from AMA, ATA, Change Healthcare, Mayo Clinic, Mitre, and others

April 30, 2021

In partnership with our colleagues at the Deloitte Center for Health Solutions, DiMe collaborated on the report, “Personalized therapies in the Future of Health: Winning with digital medicine products,” which proposes a framework for successful partnerships between pharma and tech companies.

March 2021 in Deliotte Insights

DiMe leadership illustrate the risk of sharing anonymized fitness data and call for systematic reform.

February 2021 in MobiHealth News

To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, experts present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures.

January 2021 in Digital Biomarkers

DiMe leadership reminds us that multi-stakeholder effort is required in digital endpoint development. One size does not fit all.

DiMe experts co-authored this publication on how the advancement of DHT can be most effectively be achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies; and additionally, can specifically support the advancement of Parkinson Disease treatments.

December 2020 in Karger Digital Biomarkers

DiMe experts co-authored this publication on how the advancement of DHT can be most effectively be achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies; and additionally, can specifically support the advancement of Parkinson Disease treatments.

December 2020 in Karger Digital Biomarkers

DiMe leadership synthesizes and defines a framework of core principles for selecting and developing measurements in research and clinical care that are meaningful for patients.

September 2020 in Karger Digital Biomarkers

The Playbook is the essential guide for developing & deploying digital clinical measures across clinical research, clinical care, and population health surveillance. The first draft was developed by a collaboration between DiMe, Elektra Labs, FDA, Genentech, Koneksa Health, Myokardia, Sage Bionetworks, and Scripps Research.

September 2020 on https://playbook.dimesociety.org/

DiMe’s Research Committee work group complted its first project with this publication. This manuscript addresses the need for a more robust regulatory framework that includes thorough verification, analytical validation, and clinical validation, as well as biomarker qualification evidentiary guidance from the FDA.

August 2020 in Clinical and Translational Science

Jordan Bryanov and DiMe leaders Jen Goldsack and Bill Byrom advocate for the biotech, pharma, and tech sectors to work together and leverage their collective purchasing power to drive the adoption of common standards to scale the use of digital clinical measures in clinical research.

August 2020 in STAT News

DiMe leadership dicusses how remote monitoring systems using BioMeTs can monitor patients with mild COVID‐19 symptoms at home and patients discharged from the hospital after initial improvement for an acute worsening later in their course.

August 2020 in Clinical and Translational Science

DiMe’s Executive Director led the development of this policy proposal in partnership with the Day One Project

July 12, 2020 with Day One Project

A large contingent of DiMe experts contributed to describing key takeaways and calls to action following an outstanding workshop organized by the FNIH Biomarker Consortium.

July 2020 in Clinical and Translational Science

Several members of DiMe’s leadership participated in a study, published in the American Heart Journal, concludes that there is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.

July 2020 in American Heart Journal

In response to the increased demand for remote trials driven by COVID-19, DiMe experts propose a decision tree to support the migration of clinic-to-remote assessments and highlight activities required to ensure that remote measurements are valid, safe, and usable

June 2020 in Clinical and Translational Science

DiMe members and colleagues offer pragmatic guidance regarding BioMeTs, culminating in a proposed framework to advance their development and deployment in healthcare, health research, and health promotion. The framework proposes a process to establish an audit trail of BioMeTs.

May 2020 in IEEE Journal of Translational Engineering in Health and Medicine

With contributions from our DiMe leadership, this brief describes key points from the FNIH workshop on remote digital monitoring in medical product development.

May 2020 in Nature Reviews Drug Discovery

With contribution from our DIMe leadership, this report provides a considered approach tocompiling a comprehensive body of evidence to justify acceptance of mobile sensors for support of new drug applications.

April 2020 in Contemporary Clinical Trials

DiMe members outline frameworks and processes to evaluate the risks and benefits of connected sensor technologies at home in a companion piece to their NPJ Digital Medicine publication.

April 2020 in NPJ Digital Medicine

DiMe experts elloborate on our V3 publication in NPJ Digital Medicine in this companion piece.

April 2020 in NPJ Digital Medicine

DiMe collaborates to establishe core terminology to enable more effective communication, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.

April 2020 in NPJ Digital Medicine

DiMe colleagues provide a pragmatic guide for designing an evaluation framework for wearables and connected sensor technologies.

March 2020 in NPJ Digital Medicine

Many DiMe members contributed to the Clinical Trials Transformation Initiative (CTTI) recommendations published here.

November 6, 2019 in Digital Biomarkers

During the 2019 CNS Summit, DiMe leadership presented an abstract on our work to advance the field of digital medicine.

October 31, 2019 in Innovations in Clinical Neuroscience

DiMe member Debbe McCall co-authored this article on the collection of patient-generated health data and its potential impact on efficient care.

September 20, 2019 in mHealth

DiMe SLB member, Bray Patrick-Lake, and Jennifer Goldsack contributed this editorial to a special issue on citizen science.

July 24, 2019 in The American Journal of Bioethics

With sociologist Dr. Meredith Bergey, DiMe’s Jennifer Goldsack and Edmondo Robinson published qualitative research from the inpatient setting.

June 27, 2019 in Social Science & Medicine

DiMe leadership contributed to this Clinical Trials Transformation Initiative (CTTI) systematic review and living database of feasibility studies of mobile technologies for use in clinical trials.

June 6, 2019 in NPJ Digital Medicine

In this OpEd Jen Goldsack, Beau Woods and Eric Perakslis describe how DiMe is building a digital medicine community to advance the field for the greatest good.

June 5, 2019 in STAT News

Editor-in-Chief of Digital Biomarkers, and member of the DiMe Scientific Leadership Board, highlights the role we all can play in realizing the potential of digital tools to improve health.

May 20, 2019 in Digital Biomarkers

Members of DiMe’s Strategic Advisory Board and Scientific Leadership board describe the evolving field of digital medicine and reflect on the role of supporting organizations.

May 17, 2019 in Maturitas

DiMe’s first publication provides a brief introduction to the core concepts and terms that define digital medicine.

May 10, 2019 in Digital Biomarkers