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The Playbook: Digital Clinical Measures
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/
Safety first: The nuances of health technology that can hurt your patients
In the modern era, data rights have become a safety issue that extends beyond the body; DiMe's Jen Goldsack and Dena Mendelsohn address the need to redefine patient safety as a result.
August 18, 2020 in DiMe Blog
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
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
With Covid-19 halting clinical trials, wearables could be key — but data ‘wild west’ gets in the way
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
Fit‐for‐Purpose Biometric Monitoring Technologies (BioMeT): Leveraging the Laboratory Biomarker Experience
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
Building Trust In the Health Data Ecosystem
Executive Director Jen Goldsack asserts that in order to ensure the success of Cures 2.0, provisions must be added that bolster public trust in how health data are used.
July 2020
Embracing Biometric Monitoring Technologies and Digital Measurement in Clinical Research
Kathy Vandebelt, VP of Global Innovation at Oracle hosted Jen Goldsack for an episode of Oracle Health Science Podcast, “The Latest Dose” on embracing biometric monitoring technologies.
July 30th, 2020 | The Latest Dose
Underuse of Oral Anticoagulants in Privately Insured Patients with Atrial Fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AFib)
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
Remote Digital Monitoring for Medical Product Development
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
Letter to Congress urging action on telehealth
DiMe urges action from congress to make telehealth flexibilities created during the COVID-19 pandemic permanent
June 29th, 2020
Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
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
Through the Looking Glass: Considerations for health data privacy amid COVID-19 and beyond
DiMe's Rachel Chasse, Marisa Cruz, and Dena Mendelsohn discuss widespread acceptance of large-scale patient surveillance efforts due to Covid19 and the long-term ramifications of this shift.
May 17, 2020 in DiMe Blog
Remote digital monitoring in clinical trials in the time of COVID-19
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
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
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
If you want to improve US healthcare during COVID-19, submit a public comment
DiMe released a Federal Comment Toolkit to educate its members on public comment involvement. This blog dives deeper into the importance of active participation in the process.
April 29, 2020 in DiMe Blog
Modernizing FDA’s Data Strategy
The FDA acknowledges that a large gap separates important scientific advances and the technologies needed to translate those advances into new therapies for patients and new ways to protect the public health. DiMe comments on how the evidence base for the safety and effectiveness of these new products has not kept pace with their development.
April 30th, 2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
This FDA guidance provides general considerations to assurance the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during COVID-19.
April 21st, 2020
Bad Health Information Can Spread as Fast as a Virus
Digital Medicine Society (DiMe) partnered with The Light Collective to create a pocket guide to help you protect yourself and others by combating the spread of misinformation.
April 15th, 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency
The FDA issued a guidance to leverage non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. DiMe provided a public comment.
April 14th, 2020
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
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
Why V3 (verification, analytical validation, and clinical validation)?
DiMe experts elloborate on our V3 publication in NPJ Digital Medicine in this companion piece.
April 2020 in NPJ Digital Medicine
Using connected sensor technologies to measure health at home
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
2020-2025 Federal Health IT Strategic Plan
The Department of Health and Human Services, led by the Office of the National Coordinator for Health Information Technology (ONC), released the draft 2020-2025 Federal Health IT Strategic Plan (plan) for public comment.
March 31, 2020
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
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
Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making
The FDA hosted a public workshop to convene a discussion on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision making. There was a subsequent comment period.
February 4, 2020
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
DiMe colleagues provide a pragmatic guide for designing an evaluation framework for wearables amd connected sensor technologies.
March 2020 in NPJ Digital Medicine
Knowledge Sharing at Lightning Speed: Introducing DiMe’s New Forum for Rapid Collaboration
DiMe hosted our first community-driven presentation series: "Lightning Speed Crowdsourcing"
January 31, 2020 in DiMe Blog
Advancing Digital Medicine to Optimize Human Health: 2019 in Review
DiMe’s first year-end report card highlights seven months of growth, collaboration, and awareness
December 31, 2019 in DiMe Blog
How Can Digital Data and Technologies Improve Health?
DiMe submitted a letter in response to the request for input on the initial vision for Cures 2.0; suggestions for Cures 2.0 highlighted the capabilities of digital data and technologies
December 18, 2019 in DiMe Blog
Congress seeks input on Cures 2.0
U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released their initial vision for their landmark Cures 2.0 legislation and called on experts and stakeholders to submit their ideas and feedback on the plan.
December 16, 2019
Digital Medicine 101
Amazon Web Services (AWS) and DiMe partner up to discuss innovation and advancements in biomedical research and patient care using digital medicine tools.
December 12, 2019 | FiercePharma
People Always, Patients Sometimes
Janet Kennedy interviews DiMe Executive Director Jen Goldsack to discuss the digitalization and democratization of medicine.
December 2, 2019 | SpencerHealth Solutions
mHealth and patient generated health data: stakeholder perspectives on opportunities and barriers for transforming healthcare
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
Former Olympian Champions Digital Health
Kevin Edwards interviews DiMe Executive Director, Jen Goldsack for the Real Leaders podcast during the 2019 Exponential Medicine Conference
November 11, 2019 | RealLeaders
Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference?
This blog post is co-authored by experts from DiMe, the Digital Therapeutics Alliance, HealthXL, and NODE.Health. It describes our proposed framework for categorizing the digital health industry.
November 10, 2019 in DiMe Blog
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Many DiMe members contributed to the Clinical Trials Transformation Initiative (CTTI) recommendations published here.
November 6, 2019 in Digital Biomarkers
Digital endpoints library can aid clinical trials for new medicines
DiMe leadership describe the importance of our library of digital endpoints in this STAT News First Opinion piece.
Novemer 6, 2019 in Stat News
The Digital Medicine Society (DiMe): advancing the use of digital medicine to optimize health
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
What it Takes to Lead in the New Field of Digital Medicine: Being Terrified, Apparently…
In this DiMe blog post, Executive Director Jen Goldsack reflects on her experience submitting DiMe's first public comment to FDA.
September 30, 2019 in DiMe Blog
21st Century Cures: Establishment of the BEST Resource Taxonomy
The FDA established a public docket to receive comments from interested parties on the Agency's publication of a glossary of terms which is part of the BEST (Biomarkers, EndpointS, and other Tools) Resource Taxonomy.
September 23, 2019
Digital Medicine Standards 101
In this guest authored DiMe blog, Christine Manta cuts through the noise around standards in digital medicine to summarize the information we all must know.
September 12, 2019 in DiMe Blog
DiMe at DEF CON 27: What We Can Learn from the Security Research Community
A review of DiMe's participation in the Biohacking Village at DEF CON, 2019, the case for prioritizing security research, and DiMe wins an award!
August 14, 2019 in DiMe Blog
Lessons Learned Implementing Apple ResearchKit for a Study at Mount Sinai
In our first guest authored DiMe blog, Noah Zimmerman shares his experience with Apple Research Kit
August 5, 2019 in DiMe Blog
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
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
Let's Talk About DiMe - A New Society of Digital Medicine Professionals!
Host Erin Albert interviews executive director Jen Goldsack about the first few months of DiMe.
July 4, 2019 | The Dr. Erin L Albert Podcast
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
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
The Digital Medicine Society (DiMe) Manifesto: A Commitment to Achievement
In this DiMe blog post we lay out our manifesto, clearly stating our goals for DiMe.
June 10, 2019 in DiMe Blog
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
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
DiMe: Calling all who serve in 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
Laying the Foundation: Defining Digital Medicine
Read DiMe’s first official blog post. It lays the foundation for the Society by defining digital medicine.
June 3, 2019 in DiMe Blog
Introducing the Digital Medicine Society (DiMe)
Learn about why DiMe co-founder, Andy Coravos, and Scientific Leadership Board member, Bray Patrick-Lake, believe in an important future for DiMe.
May 29, 2019 in Duke Forge Blog
A New Chapter
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
Tech world and medicine come together to harness digital medicine
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
Digital Medicine: A Primer on Measurement
DiMe’s first publication provides a brief introduction to the core concepts and terms that define digital medicine.
May 10, 2019 in Digital Biomarkers
Advancing Digital Medicine: Stronger, Smarter and Faster
Host Dan Kendall interviews DiMe Executive Director, Jennifer Goldsack, about the new Society
May 13, 2019 | Digital Health Today Podcast