Health law sets the rules for how healthcare organizations function, and those rules change frequently. For example:
- Reimbursement structures get more complicated
- Privacy requirements shift
- Licensing standards vary by state
Regulatory counsel and compliance officers must figure out how to keep pace.
That means drafting policies that meet Medicare and Medicaid participation requirements, conducting Health Insurance Portability and Accountability Act (HIPAA) risk assessments before audits highlight problems, and building telehealth protocols that work across jurisdictions without triggering practice violations.
The stakes don’t end with paperwork. Medical errors contribute to over 200,000 deaths annually in the U.S.1 Many stem from systemic failures that compliance programs are supposed to address. Inadequate reporting systems create gaps, and poorly designed safety protocols leave vulnerabilities. Health law provides the regulatory framework to address these institutional weaknesses through mandatory quality metrics and enforcement actions.
This post examines how health legislation has developed and why regulatory knowledge matters for professionals designing compliance programs and advising healthcare organizations.
The Evolution of Health Legislation
Early medical practices operated with minimal oversight until scandals forced change. The Food and Drug Administration’s (FDA) roots go back to 1906, when it was created to enforce the Pure Food and Drugs Act of 1906.2 FDA enforcement has evolved in the ensuing years. Medicare came in 1965, covering Americans aged 65 and older. Before that, only 56% of older Americans had hospital insurance compared to 75% of younger adults.3
HIPAA established privacy rules in 1996, while the Affordable Care Act (ACA) extended coverage and created marketplaces in 2010.4 Telehealth expansion during the 2020 pandemic transformed remote care rules almost overnight.4
Technologies such as telehealth platforms and electronic health records are transforming healthcare delivery faster than existing regulations can keep pace. Policy changes will need to address emerging challenges around data security, interstate licensing, and AI-assisted diagnostics.
What Are the Main Branches of Health Law?
Health law includes several distinct practice areas. Public health law establishes population-wide requirements, such as mandatory vaccination programs and infectious disease reporting systems. Bioethics addresses policy questions around scarce resource allocation, such as determining organ transplant priority criteria or defining the circumstances under which life-sustaining treatment can be withdrawn.
Healthcare regulation sets the licensing standards for providers and facilities. Privacy law governs patient data protection through frameworks like HIPAA. Violations get expensive fast. In 2024, regulators announced 20 enforcement actions involving HIPAA violations and collected over $9.9 million in settlements.5
Many of these areas overlap. A hospital implementing a new electronic health records system must comply with privacy standards and meet state licensing requirements simultaneously. Data access then creates additional legal challenges. Regulatory counsel and compliance officers must determine where the requirements conflict and which take precedence.
How Does Health Law Affect Patients?
Every patient interaction is subject to specific regulations that protect patients and hold healthcare organizations accountable.
Informed consent requirements mean providers must explain procedures and risks before treatment. Anti-discrimination laws prohibit denying care based on race or disability. The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals to stabilize anyone who presents to the emergency department, regardless of ability to pay.6 That means a hospital can’t transfer an uninsured patient having a heart attack to another facility until they’re medically stable.
Patient rights extend beyond the exam room. Patients can access their medical records and request corrections. They can file complaints about privacy violations. Healthcare organizations pay attention because federal enforcement actions are expensive.
Hospital law dictates how institutions balance patient rights against operational constraints. Managing emergency department capacity during a surge is subject to specific regulations, as are visitor policies during outbreaks. For compliance officers and regulatory counsel, understanding these frameworks means knowing which regulations apply when patient rights and institutional needs collide.
Key Legal Principles in Healthcare
Healthcare operates on four legal principles.7 Duty of care comes first. This duty arises when a healthcare professional accepts someone as a patient. An emergency department can’t turn away someone experiencing chest pain once the assessment begins.
Second is breach of duty by falling below the standard of care. Standard of care means what a reasonably competent practitioner in the same specialty would do in similar circumstances. A rural clinic with limited imaging might not be held to the same diagnostic standard as a major urban hospital.
Third is causation in negligence. The breach must cause harm. And fourth comes actual damages.
These principles shape how organizations operate. Hospitals build clinical protocols around standard-of-care benchmarks. Risk management programs analyze incident reports to spot patterns before they become systemic problems. Compliance officers audit chart documentation to verify that the care delivered matches the care documented.
The Intersection of Law and Healthcare Ethics
Legal requirements do not always match ethical obligations. Sometimes they diverge in ways that create real tension for providers.
Take mandatory reporting laws.8 Many states require providers to report suspected child abuse, even when doing so might damage the therapeutic relationship. A doctor’s ethical duty to maintain patient confidentiality conflicts directly with their legal obligation to report. The law wins that battle every time.
End-of-life decisions create similar tensions. Families sometimes request interventions that providers believe are medically futile. The law generally supports patient autonomy, but providers aren’t obligated to deliver treatment they consider harmful.9
Resource allocation also raises difficult questions. Providers often navigate gray areas where legal requirements provide minimum standards but ethical practice demands more. Legal obligations create the floor, not the ceiling, for acceptable conduct.10
Healthcare professionals must balance ethical standards and legal obligations simultaneously. Meeting one doesn’t mean you’ve satisfied the other. Privacy concerns compete with transparency needs. Cost containment sometimes clashes with quality standards. Providers and organizations have to manage both sets of demands simultaneously, which is why specialized training in medical law has become increasingly valuable.
Elevate Your Career With Hofstra’s Health Law and Policy Programs
For professionals seeking specialized knowledge in health law and policy, Hofstra University’s Maurice A. Deane School of Law offers online graduate programs. The online Master of Arts (MA) in Health Law and Policy program provides a flexible pathway for non-lawyers seeking regulatory expertise, while the Certificate in Health Law and Policy program is a great starting point if you aren’t sure whether or not you’re ready to commit to a full graduate program. Any credits earned in the certificate program can be applied to the MA program.
Want to deepen your understanding of the law in healthcare and benefit from the flexibility of earning a degree online? Apply to one of Hofstra’s health law programs or schedule a call with an admissions outreach advisor to see how these programs align with your professional goals.
- Retrieved on November 20, 2025, from ncbi.nlm.nih.gov/books/NBK499956/
- Retrieved on November 20, 2025, from fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
- Retrieved on November 20, 2025, from ssa.gov/history/pdf/WhatMedicareMeant.pdf
- Retrieved on November 20, 2025, from pmc.ncbi.nlm.nih.gov/articles/PMC10810293/
- Retrieved on November 20, 2025, from nycdentalsociety.org/news-publications/nysda-publications/2025/01/08/ocr-highlights-2024-hipaa-accomplishments
- Retrieved on November 20, 2025, from cms.gov/medicare/regulations-guidance/legislation/emergency-medical-treatment-labor-act
- Retrieved on November 20, 2025, from pmc.ncbi.nlm.nih.gov/articles/PMC8667701/
- Retrieved on November 20, 2025, from psychiatryonline.org/doi/full/10.1176/appi.ajp-rj.2024.200107
- Retrieved on November 20, 2025, from houstonlawreview.org/article/90798-when-providers-and-families-cannot-agree-a-new-look-at-due-process-for-end-of-life-care-disputes
- Retrieved on November 20, 2025, from jheaonline.org/pdf/Miller_jhea.6.7164.pdf

