Comment Examples

April 1, 2024

December 6, 2023

December 6th 2023

October 20, 2023

August 28, 2023

July 5, 2023

July 5, 2023

June 6, 2023

February 10, 2023

January 19, 2023

A letter submitted on behalf of the Digital Medicine Society (DiMe) for consideration by the U.S. Food and Drug Administration (FDA) regarding Docket No. FDA-2021-D-0789 for “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability.”

June 2022

The DiMe community, as leading experts in digital measurement, responded to the FDA draft guidance with support and suggestions.

March 2022

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

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

DiMe urges action from congress to make telehealth flexibilities created during the COVID-19 pandemic permanent

June 29th, 2020

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

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

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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