DIVERSE Trials Act

Bill: 117-hr-5030
Sponsor: Rep. Ruiz, Raul [D-CA-36]
Introduced: 2021-08-13 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2021-08-13
text: 

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.


Legislative actions:
action_date: 2021-08-16
text: Referred to the Subcommittee on Health.
action_date: 2021-08-13
text: Referred to the Subcommittee on Health.
action_date: 2021-08-13
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2021-08-13
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2021-08-13
text: Introduced in House
action_date: 2021-08-13
text: Introduced in House