Summary: S.2278 — 109th Congress (2005-2006)All Information (Except Text)

There is one summary for S.2278. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (02/14/2006)

Heart Disease Education, Analysis, and Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by gender, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.

Requires the Comptroller General to study the drug approval process to ensure compliance with this Act.

Requires the Secretary to require that all nonidentifiable patient safety work product reported to a patient safety database be stratified by gender.

Amends title XVIII (Medicare) the Social Security Act (SSA) to require the Secretary to make hospital quality data relating to the quality of care in inpatient settings available to the public stratified by gender.

Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to report to Congress concerning the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.

Requires utilization and quality control peer review organizations to offer quality improvement assistance aimed at eliminating gender disparities.

Amends title IX (employment security provisions) of SSA to require that data be stratified by gender when collected and used in surveys evaluating whether Medicare providers meet applicable conditions of participation or coverage.

Provides for an educational campaign relating to heart disease, stroke, and cardiovascular diseases in women.