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Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability .”
The FDA released a draft guidance regarding the use of digital health technologies in remote clinical investigation.
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.
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.
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
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
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