S.438 - Heart Disease Education, Analysis, Research, and Treatment for Women Act

A bill to amend the Public Health Service Act to improve women's health by prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. view all titles (3)

All Bill Titles

  • Official: A bill to amend the Public Health Service Act to improve women's health by prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. as introduced.
  • Short: Heart Disease Education, Analysis, Research, and Treatment for Women Act as introduced.
  • Short: HEART for Women Act as introduced.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
03/02/11
 
 
 
 
 
 
 

Official Summary

Heart Disease Education, Analysis, Research, and Treatment for Women Act or the HEART for Women Act - Directs the Comptroller General to report on whether the presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups complies with Food and Drug Administr

Official Summary

Heart Disease Education, Analysis, Research, and Treatment for Women Act or the HEART for Women Act - Directs the Comptroller General to report on whether the presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups complies with Food and Drug Administration (FDA) requirements. Requires the Secretary of Health and Human Services (HHS) to submit a response to such report, including a corrective action plan as needed. Requires the Director of the Office of Women's Health of FDA to report on the compliance of clinical studies of women's health with such FDA requirements, including requirements regarding:
(1) the adequacy of representation of females, racial and ethnic minorities, and adults of all ages in approved clinical studies; and
(2) the extent to which a summary of product safety and effectiveness data disaggregated by sex, age, and racial subgroup is available to the public. Requires the Director of the Office of Minority Health of FDA to submit a report that includes such information with respect to clinical studies of minority health. Amends the Public Health Service Act to require the Secretary to report on the quality of, and access to, care for women with heart disease, stroke, and other cardiovascular diseases and to include recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women. Reauthorizes a program to award grants for preventive heath services and referrals for medical treatment for women through entities that are screening women for breast or cervical cancer. Requires the Secretary to study the impact of the Patient Protection and Affordable Care Act on such services and make recommendations for improvement.

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Organizations Supporting S.438

  • American Heart Association
  • Society for Women's Health Research
  • WomenHeart
  • Sudden Arrhythmia Death Syndromes Foundation
  • Alliance for Aging Research
  • American Association of Colleges of Pharmacy
  • ...and 35 more. See all.

Organizations Opposing S.438

  • None via MapLight at this time.


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