{"@context":"https://schema.org","@type":"Legislation","name":"DIVERSE Trials Act","description":"

Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act

This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies.

Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology.

In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials.

The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs.

Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.

","legislationIdentifier":"HR 5030","legislationType":"Bill","legislationLegalForce":"NotInForce","legislationJurisdiction":"USA","author":[{"@type":"Person","name":"Raul Ruiz","url":"https://legisdaily.com/mp/raul-ruiz-us"}],"about":{"@type":"Thing","name":"Health"},"keywords":"Administrative law and regulatory procedures, Cardiovascular and respiratory health, Child health, Community life and organization, Congressional oversight, Department of Health and Human Services, Drug safety, medical device, and laboratory regulation, Emergency medical services and trauma care, Government studies and investigations, Health care coverage and access, Health information and medical records, Health personnel, Health programs administration and funding, Health technology, devices, supplies, Immunology and vaccination, Infectious and parasitic diseases, Medical education, Medical research, Medical tests and diagnostic methods, Minority employment, Minority health, Public contracts and procurement","dateModified":"2025-04-07T00:00:00.000Z","url":"https://legisdaily.com/bill/USA-117-HR-5030"}

Raul Ruiz

Raul Ruiz

Ways and Means Committee, Health Subcommittee, Health Subcommittee, Energy and Commerce Committee