Policies & Regulations

• Health Information Technology Standards
• Health Information Privacy (HIPAA)
• Laws & Regulations

• Policies & Guidelines
• Review Boards
• Testimony

• Privacy of Health Information Home Page
• Fact Sheet: Protecting the Privacy of Patients' Health Information
• How to File a Health Information Privacy Complaint [En Español]

• Frequently Asked Questions about Privacy of Health Information
• For Small Providers/Health Plans/Other Businesses

Civil & Privacy Rights:

• Office for Civil Rights
• Civil Rights Laws and Welfare Reform - an Overview
• HIPAA Rules and More… (IHS)
• HIPAA Privacy Rules for HRSA Grantees (HRSA)
• The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (CMS)
• Selected Federal and State Laws and Regulations Requiring Language Assistance

Drug & Food:

• Food Law and Regulations (Foodsafety.gov)
• Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information (FDA)

Fraud, Waste, & Abuse:

• HHS Office of the Inspector General Exclusions Database (OIG)
• HHS Office of the Inspector General Federal Register Notices (OIG)
• HHS Office of the Inspector General Regulatory Authority (OIG)

Medical & Health Care:

• Healthcare Informatics and Standards (AHRQ)
• Select Agent Transfer Program: Regulation and Supporting Material (CDC)
• National Program of Cancer Registries (CDC)

Medicaid/Medicare:

• Changes to the Medicare Claims Appeal Procedures (PDF - 646K ) (CMS)
• CMS and Related Laws and Regulations (i.e. Medicare, Medicaid, HIPAA) (CMS)

Research:

• Health Research Extension Act of 1985 (“Animals in Research”) (NIH)

Tribes:

• Treaties and Law (IHS)

HHS Employment:

• Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002 (No FEAR Act)

Significant Guidance Documents

• Agency Sites Listing Significant Guidance Documents

Human Services:

• Office of Human Services Policy (ASPE)

Drug & Food

• Compliance Policy Guides Manual (FDA)
• Inspection Guides for Biotechnology, Biologics, Computer Issues, Devices, Drugs, Foods, Cosmetics, and Other Materials (FDA)
• Policy for Foods Developed by Biotechnology (FDA)

Medical & Health Care:

• Clinical Practice Guidelines (AHRQ)
• Guideline on Hand Hygiene in Healthcare Settings (CDC)
• Guideline for Isolation Precautions in Hospitals (CDC)
•  
  Guidelines and Supplements (CIT) (NIH, National Institute on Drug Abuse)
• Guidelines for Medically Underserved Areas (MUAs) and Populations (MUPs) Designation (HRSA)
• Guidelines for the Diagnosis and Management of Asthma (NIH, National Heart, Lung, and Blood Institute)
• Guidelines to Address Cardiovascular Disease in American Indians and Alaska Natives (IHS)
• HHS Guide For Implementing An Alternative Discipline Program
• Human Embryonic Stem Cells, Germ Cells, and Cell-derived Test Articles Research Guidance (Health and Human Services, Office for Human Research Protections) [PDF]
• Medical Management Guidelines (MMGs) for Acute Chemical Exposures (ATSDR)
• Medicare Coverage Policy (CDC)
• National Institute of General Medical Sciences Notices and Policies (NIH, National Institute of General Medical Sciences)
• Policies and Procedures for Requesting Materials (DNA) and Genetic Data (NIH, National Heart, Lung, and Blood Institute)
• Rural Health Policy (HRSA)
• Sexually Transmitted Diseases Treatment Guidelines 2002 (CDC)
• Student Financial Aid Guidelines (HRSA)
• National Guideline Clearinghouse: A Public Resource for Evidence-based Clinical Practice Guidelines  (National Guideline Clearinghouse)

Freedom of Information:

• HHS Freedom of Information Act
• FDA Freedom of Information Act (FDA)
• HRSA Freedom of Information Act (HRSA)
• IHS Freedom of Information Act (IHS)
• SAMHSA Freedom of Information Act (SAMHSA)
• AoA Freedom of Information Act (AoA)
• ACF Freedom of Information Act (ACF)
• AHRQ Freedom of Information Act (AHRQ)
• CDC Freedom of Information Act (CDC)
• CMS Freedom of Information Act (CMS)
• Freedom of Information Act (FOIA) Policies (NIH)

Civil & Privacy Rights

• Limited English Proficiency (OCR)
• National Origin Discrimination (OCR)
• National Standards to Protect the Privacy of Personal Health Information (OCR)
• HHS Office of Civil Rights
• HHS Privacy Committee

Financial/Budget/Contracts:

• ACF Budget and Policies (ACF)
• Funding Opportunities (Includes Policies and Guidelines) (NIH, NCI)
• Grant Policy and Guidance (NIH)
• Grant/Contract Information and Policies (NIH, National Heart, Lung, and Blood Institute)
• Poverty Guidelines (HHS, ASPE)
• Grant Policy and Guidance (NIH)
• OER Grants: Funding Program Guidelines (NIH, Office of Extramural Research)
• Procedure for Notification of Grant Awards (ASL)
• HHS Small Business Impact Analysis Guidelines

Research/Evaluation:

• OER: Peer Review Policy and Issues (NIH, Office of Extramural Research)
• Policies Concerning Animal Welfare (OLAW) (NIH)
• Policy for Ancillary Studies (NIH, National Heart, Lung, and Blood Institute)
• Policy for Data and Safety Monitoring of Clinical Trials (NIH, NCI)
• Policy Information Center (ASPE)
• Research Policies (AHRQ)
• Research and Funding Policies (NIH, NCI)

HHS Information & Technology Management:

• Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by HHS Agencies
• HHS Information Management
• HHS Procedures for Utilization of GSA SmartBuy [PDF]
• HHS Policy Manuals
• HHS Web Policies, Standards and Guidelines

• HHS Advisory Committee on Blood Safety & Availability
• HHS Departmental Appeals Board
• HHS Freedom of Information Act Contacts

• HHS Office of Equal Employment Opportunity (EEO)
• HHS Privacy Act Contacts

• About NIAAA: Congressional Activities and Testimony (NIH, National Institute on Alcohol Abuse and Alcoholism)
• HHS Congressional Testimony (ASL)
• Congressional Testimony by ATSDR Staff (ATSDR)
• Congressional Testimony and FDA Speeches (FDA)
• Hearing Testimony (HHS, OIG)

• CMS Testimonies (CMS)
• NCMHD Congressional Testimony (NIH, National Center on Minority Health and Health Disparities)
• NEI Congressional Testimony (NIH, NEI)
• NIAID Congressional Testimony (NIH, NAID)
• Secretary: Congresional Testimony
• Speeches and Testimony (HRSA)