Comment Examples

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Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability.”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

View DiMe Comment

Using Digital Health Technologies in Remote Data Acquisition in Clinical Investigations

The DiMe community, as leading experts in digital measurement, responded to the FDA draft guidance with support and suggestions.

March 2022

View DiMe Comment

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

View DiMe Comment

Building trust in the health data ecosystem

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

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

View DiMe Comment

Standard Public Comment Request*

Tech
Companies

Life
Sciences

Healthcare System/Clinicians

Patient
Groups

Non-Profit and
Consortium

Request for Information (RFI)*

* 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.

Comment Examples

Our submitted comments

Comment on U.S. Food and Drug Administration (FDA) Request for Public Comment: Measuring and Evaluating AI-enabled Medical Device Performance in the Real-World (FDA-2025-N-4203)

Response to White House Office of Science and Technology Policy (OSTP) Request for Information: Regulatory Reform on Artificial Intelligence (OSTP-TECH-2025-0067-0411)

Response to Request for Information in CY 2026 Medicare Physician Fee Schedule Proposed Rule (CMS-1832-P)

Response to Request for Information; Health Technology Ecosystem (CMS-0042-NC)

DiMe response to FDA request for input on certain non-device software functions and impacts to patient safety

Stakeholder letter requesting Drug Enforcement Administration (DEA) to issue a revised proposed rule to regulate the prescribing of controlled substances through telehealth

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff

Stakeholder Leter Urging Switft Action on on Practitioner Reporting of Home Address for Medicare Enrollment and Billing

Medicare Program; Transitional Coverage for Emerging Technologies

Methodological Challenges Related to Patient Experience Data

Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-Making Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

DiMe signs on to broad industry support for the Telehealth Expansion Act

DiMe responds to request for comments to future telehealth coverage and payment policy

DiMe Responds to Request for Information Regarding Emergency Clinical Trials

FDA Diversity Plan Clinical Trials

Using Digital Health Technologies in Remote Data Acquisition in Clinical Investigations

DiMe responds to the White House OSTP RFI on DHTs

Building trust in the health data ecosystem

Letter to Congress urging action on telehealth

Modernizing FDA’s Data Strategy

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

2020-2025 Federal Health IT Strategic Plan

Congress seeks input on Cures 2.0

Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

21st Century Cures: Establishment of the BEST Resource Taxonomy

Standard Public Comment Request*

Tech Companies

Life Sciences

Healthcare System/Clinicians

Patient Groups

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.

Tech
Companies

Life
Sciences

Patient
Groups

Non-Profit and
Consortium

Tech
Companies

Life
Sciences

Patient
Groups

Non-Profit and
Consortium