US Medical Law

Sources of US Medical Law

US medical law derives from a complex interplay of state and federal authority. Medical malpractice and physician licensure are primarily matters of state law, while the federal government exercises significant power through Medicare, Medicaid, the Affordable Care Act (ACA), the Food and Drug Administration (FDA), and the Health Insurance Portability and Accountability Act (HIPAA). State courts develop the common law of medical negligence, and state legislatures enact statutes of limitations, damage caps, and procedural rules for malpractice actions. Federal pre-emption occasionally limits state authority, particularly regarding drug and device labelling.

Medical Malpractice

Medical malpractice is a species of professional negligence requiring proof of four elements: duty, breach, causation, and damages. The physician-patient relationship establishes a duty of care. The standard of care historically followed the locality rule, under which a physician was held to the standard of practice in the same or similar community. Most jurisdictions have abandoned this in favour of a national standard of care, recognising that modern communication and certification create uniform expectations.

Informed Consent

The informed consent doctrine, articulated in Canterbury v Spence, 464 F.2d 772 (D.C. Cir. 1972), requires physicians to disclose material risks, benefits, and alternatives that a reasonable person would need to make an informed decision. The majority of states follow the reasonable-patient standard; a minority retain the physician-based standard. Expert testimony is typically required to establish both the standard of care and causation in informed consent claims.

Procedure and Limitations

Expert witnesses must be licensed in the same specialty as the defendant in many states. Statutes of limitations for medical malpractice typically range from one to three years from the date of discovery, with repose periods of three to seven years. Some states impose caps on non-economic damages, upheld against constitutional challenge in some jurisdictions and struck down in others. The contingency fee system, under which counsel receives a percentage of the recovery, is the predominant method of financing medical malpractice litigation.

Health Insurance Regulation

The ACA fundamentally restructured US health insurance. The individual mandate, upheld as a constitutional exercise of the taxing power in NFIB v Sebelius, 567 U.S. 519 (2012), required most individuals to maintain health insurance. The ACA established essential health benefits that must be covered by qualified health plans, prohibited pre-existing condition exclusions, and created health insurance marketplaces with premium subsidies. The Medicaid expansion, made optional for states by NFIB, extended coverage to adults with incomes up to 138% of the federal poverty level in participating states.

FDA Regulation

The FDA regulates drugs and medical devices under the Federal Food, Drug, and Cosmetic Act. New drugs require pre-market approval through a New Drug Application demonstrating safety and efficacy. Medical devices are classified into three categories with corresponding regulatory controls. The FDA also oversees clinical trials, good manufacturing practices, and post-market surveillance.

HIPAA and Privacy

The HIPAA Privacy Rule establishes national standards for the protection of individually identifiable health information. Covered entities — health plans, health care clearinghouses, and health care providers — must implement administrative, physical, and technical safeguards. Patients have rights to access their medical records and request amendments. The HIPAA Security Rule specifically addresses electronic protected health information.

EMTALA

The Emergency Medical Treatment and Active Labor Act requires hospitals participating in Medicare to provide stabilising treatment to any individual presenting with an emergency medical condition, regardless of insurance status or ability to pay. EMTALA imposes a screening obligation and a stabilisation obligation, with civil monetary penalties and private enforcement through patient dumping claims.

Medicare and Medicaid

Medicare, established in 1965, provides federal health insurance for persons aged 65 and older and certain younger individuals with disabilities. It comprises Part A (hospital insurance), Part B (medical insurance), Part D (prescription drug coverage), and Part C (Medicare Advantage). Medicaid, a joint federal-state programme, covers low-income individuals and families. States administer Medicaid within federal parameters and may seek waivers for innovative coverage approaches.

Fraud and Abuse

The Stark Law prohibits physician referrals for designated health services to entities with which the physician has a financial relationship, subject to enumerated exceptions. The Anti-Kickback Statute criminalises the knowing and wilful offer or receipt of remuneration to induce or reward referrals for items or services payable by federal health care programmes. Violations carry criminal penalties, civil monetary penalties, and exclusion from federal health care programmes.