3.0.0 2706 2022-12-30T11:03:20Z 2022-12-30T11:03:20Z Senate S 2021-08-10 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-08-10T23:13:01Z DIVERSE Trials Act 117 5030 HR 2021-08-16 Referred to the Subcommittee on Health. Identical bill CRS Health Equity and Accountability Act of 2022 117 4486 S 2022-06-23 Read twice and referred to the Committee on Finance. Related bill CRS 2021-08-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-08-10 Introduced in Senate IntroReferral 10000 9 Library of Congress M000639 Sen. Menendez, Robert [D-NJ] Robert Menendez D NJ N S001184 Sen. Scott, Tim [R-SC] Tim Scott R SC 2021-08-10 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2021-10-19 False S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2021-11-30 False B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2022-03-17 False P000145 Sen. Padilla, Alex [D-CA] Alex Padilla D CA 2022-03-28 False B001243 Sen. Blackburn, Marsha [R-TN] Marsha Blackburn R TN 2022-06-13 False V000128 Sen. Van Hollen, Chris [D-MD] Chris Van Hollen D MD 2022-06-13 False R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. 2022-07-11 False M000133 Sen. Markey, Edward J. [D-MA] Edward Markey D MA J. 2022-07-13 False M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2022-07-13 False C000141 Sen. Cardin, Benjamin L. [D-MD] Ben Cardin D MD 2022-07-13 False Y000064 Sen. Young, Todd [R-IN] Todd Young R IN C. 2022-09-06 False S001191 Sen. Sinema, Kyrsten [D-AZ] Kyrsten Sinema D AZ 2022-09-06 False K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2022-09-06 False M000934 Sen. Moran, Jerry [R-KS] Jerry Moran R KS 2022-09-13 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2022-09-13 False C001113 Sen. Cortez Masto, Catherine [D-NV] Catherine Cortez Masto D NV 2022-09-13 False D000622 Sen. Duckworth, Tammy [D-IL] Tammy Duckworth D IL 2022-09-13 False B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2022-09-13 False C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2022-09-15 False S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2022-12-08 False C000174 Sen. Carper, Thomas R. [D-DE] Thomas Carper D DE R. 2022-12-08 False C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2022-12-08 False L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2022-12-08 False T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2022-12-08 False K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2022-12-08 False Health 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 Health 00 2021-08-10 Introduced in Senate 2022-01-12T17:27:09Z 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.

]]> DIVERSE Trials Act Display Title DIVERSE Trials Act Official Title as Introduced A bill to improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health. Introduced in Senate IS Short Title(s) as Introduced DIVERSE Trials Act Introduced in Senate IS Short Title(s) as Introduced Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act Introduced in Senate IS Introduced in Senate 2021-08-10T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s2706is/xml/BILLS-117s2706is.xml 2021-08-10 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.