Heart Disease Education, Analysis, and Research, and Treatment for Women Act

Bill: 109-s-2278
Sponsor: Sen. Stabenow, Debbie [D-MI]
Introduced: 2006-02-14 in the Senate
Policy area: Health
Subjects: Access to health care
Accreditation (Medical care)
Administrative procedure
Cardiovascular diseases
Clinical trials
Commerce
Communication in medicine
Communication in science
Congress
Congressional investigations
Congressional reporting requirements
Data banks
Department of Health and Human Services
Drug approvals
Drug industry
Drugs
Education
Food and Drug Administration (FDA)
Government Operations and Politics
Government paperwork
Government publicity
Governmental investigations
Health education
Health information systems
Health surveys
Higher education
Hospital care
Indian medical care
Indian women
Law
Medical education
Medical malpractice
Medical records
Medical screening
Medical statistics
Medical supplies
Medical tests
Medically uninsured
Medicare
Minorities
Minority health
Native Americans
Peer review organizations (Medicine)
Pharmaceutical research
Physicians
Poverty
Preventive medicine
Quality of care
Science, Technology, Communications
Social Welfare
Standards
Stroke
Women
Women's health

Summary:
action_date: 2006-02-14
text: 
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.


Legislative actions:
action_date: 2006-02-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2006-02-14
text: Sponsor introductory remarks on measure. (CR S1176-1177)
action_date: 2006-02-14
text: Introduced in Senate