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Comment Examples
Our submitted comments
Using Digital Health Technologies in Remote Data Acquisition in Clinical Investigations
The FDA released a draft guidance regarding the use of digital health technologies in remote clinical investigation.
March 2022
DiMe responds to the White House OSTP RFI on DHTs
On behalf of the DiMe community, we submitted a response to the White House Office of Science and Technology Policy (OSTP) RFI highlighting the power of DiMe’s multi-stakeholder, interdisciplinary program delivery model to transform community health, individual wellness, and health equity. Connected community health requires meeting the needs of the community through services and improved knowledge for the community and those working with them.
February 2022
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
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
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
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
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
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
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
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
Standard Public Comment Request*
Tech
Companies
Life
Sciences
Healthcare System/Clinicians
Non-Profit and
Consortium
Request for Information (RFI)*
Tech
Companies
Life
Sciences
Healthcare System/Clinicians
Patient
Groups
Non-Profit and
Consortium
* We selected these examples to provide a range of perspectives and approaches used in Federal Comments. Their inclusion here does not indicate DiMe’s endorsement.
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