Healthcare is subject to extensive regulation at both the federal and the state level, much of which "arose haphazardly". Under this system, the federal government cedes primary responsibility to the states under the McCarran-Ferguson Act. Essential regulation includes the licensure of health care providers at the state level and the testing and approval of pharmaceuticals and medical devices by the U.S. Food and Drug Administration (FDA), and laboratory testing.

These regulations are designed to protect consumers from ineffective or fraudulent healthcare. Additionally, states regulate the health insurance market and they often have laws which require that health insurance companies cover certain procedures, although state mandates generally do not apply to the self-funded health care plans offered by large employers, which exempt from state laws under preemption clause of the Employee Retirement Income Security Act.

At the federal level, US Department of Health and Human Services oversees the various federal agencies involved in health care. The health agencies are a part of the U.S. Public Health Service, and include the Food and Drug Administration, which certifies the safety of food, effectiveness of drugs and medical products, the Centers for Disease Prevention, which prevents disease, premature death, and disability, the Agency of Health Care Research and Quality, the Agency Toxic Substances and Disease Registry, which regulates hazardous spills of toxic substances, and the National Institutes of Health, which conducts medical research.

State governments maintain state health departments, and local governments (counties and municipalities) often have their own health departments, usually branches of the state health department. Regulations of a state board may have executive and police strength to enforce state health laws. In some states, all members of state boards must be health care professionals.