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Many laws affect the work of HHS.  The Department issues regulations to implement these laws and develops policies and guidance for industry, state and local governments, and other organizations. The topics of Health Information Technology Standards, Additional Laws & Regulation, and Policies & Guidelines open-up to display many links to helpful information.

Health Information Privacy (HIPAA)

The Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. The Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.

Human Research Protections

If your institution is engaged in human subjects research (not otherwise exempt, and is supported by HHS), your institution must have an Office for Human Research Protections-approved assurance of compliance with the HHS regulations for the protection of human subjects.

  • Protection of Human Subjects (Office for Human Research Protections, HHS)
    45 CFR 46 – text of the federal regulation
  • Policy Guidance (Office for Human Research Protections, HHS)
    Arranged by topic
  • Office for Human Research Protections (HHS)
    Home page provides links to all aspects of the human research protections topic, including registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Health Information Technology Standards

How often have you sat in a doctor's office, writing your health information on yet another set of paper forms? Waited for lab results to be sent to your doctor? Hand-carried X-rays from one office to another?

Electronic health records (EHRs) save everyone time and money. They reduce the chance of medical error. And when information can be securely shared, electronically, it impacts every step in the health care process.



Additional Laws & Regulations

Find laws and regulations on civil and privacy rights, food and drugs, medical and health care, Medicaid and Medicare, research, fraud prevention and detection, tribal matters, and HHS employment.

Civil and Privacy Rights

Food & Drugs

Fraud Prevention & Detection

Freedom of Information Act & Privacy Act

Medical & Health Care

CMS Regulations, Guidance & Legislation (i.e. Medicare, Medicaid, HIPAA) (Centers for Medicare & Medicaid Services)



HHS Employment (No Fear Act)
Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002 (No FEAR Act) (Equal Employment & Opportunity Division)



Policies & Guidelines

Read about civil rights, financial, food and drug, human services, medical and health care, poverty, research, evaluation, information technology, Web, and administrative policies and guidance.

Significant Guidance Documents
Agency Sites Listing Significant Guidance Documents
Browse HHS significant guidance documents issued  to the public, regulated entities, and to its staffs.

Civil Rights

  • Limited English Proficiency (Office for Civil Rights)
    Find guidance, tools, and resources to better assist persons whose primary language is not English.
  • National Origin Discrimination (Office for Civil Rights)
    Read laws, rulings, and guidance documents regarding discrimination based on national origin.

Food & Drug

Compliance Policy Guides Manual (Food and Drug Administration)
Browse the CPG Manual, which advises the FDA field inspection and compliance staffs on the standards and procedures to apply when determining industry compliance.

Human Services Policy
Office of Human Services Policy (Office of the Assistant Secretary for Planning & Evaluation)
View information on welfare, poverty, service delivery issues, data for research, policies affecting children, youth, and families, and economic matters affecting the Department.

Medical & Health Care

Poverty Guidelines
Poverty Guidelines, Research and Management (Office of the Assistant Secretary for Planning and Evaluation)
Read guidelines, statistics, and research findings on people living in poverty in the United States.


HHS Information & Technology Management

HHS Administration
HHS Administrative Manuals
Browse manuals used to manage various HHS functions and services.