Cecily Zamora
Healthcare laws are created by governments, health workers, companies, civil society, and the population of a country. These laws are essential for ensuring the quality and safety of medical care while protecting the rights and interests of all parties involved in the healthcare system. Healthcare laws are created to formalize commitments to goals, such as universal health coverage, and to enable cooperation and the achievement of health goals. They also establish health organizations and networks, define mandates, duties, and accountabilities, and manage and respond to risks to personal health and a country's health security. Healthcare laws also play a crucial role in addressing emerging challenges and trends in the industry, such as transparency in prescription drug pricing and protecting the rights of low-income individuals.
| Characteristics | Values |
|---|---|
| Purpose | To set standards of care, protect patient rights, and ensure access to quality health services |
| Who does it apply to? | Healthcare providers, hospitals, insurance companies, government agencies, and patients |
| Who enforces it? | Healthcare lawyers |
| Examples of laws | The Health Maintenance Organization Act of 1973, The Hill-Burton Act of 1946, Medicare and Medicaid programs, The Health Information Technology for Economic and Clinical Health Act (HITECH), The Patient Safety and Quality Improvement Act (PSQUIA), The Americans with Disabilities Act of 1990 (ADA), The Affordable Care Act |
| Examples of regulations | HIPAA Privacy Rule, Occupational Safety and Health Act (OSHA) |
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What You'll Learn
Health Information Technology for Economic and Clinical Health Act (HITECH)
The Health Information Technology for Economic and Clinical Health Act, or HITECH Act, was enacted under Title XIII of the American Recovery and Reinvestment Act of 2009. The law was considered "the most important piece of healthcare legislation to be passed in the last 20 to 30 years" at the time of its enactment.
The HITECH Act set meaningful use of interoperable EHR adoption in the US healthcare system as a critical national goal and incentivized EHR adoption. Doctors who did not adopt an EHR by 2015 were penalized 1% of their Medicare payments, increasing to 3% over three years. The HITECH Act (ARRA) required doctors to show meaningful use of an EHR system to receive the EHR stimulus money.
The Act also strengthened the privacy and security provisions of HIPAA, extending its reach to business associates of covered entities, who were now accountable for failures of HIPAA compliance. It introduced tougher penalties for violations of HIPAA and required covered entities to notify individuals of data breaches.
The HITECH Act also included measures that enabled individuals to take a proactive interest in their health. It incentivized the adoption and use of health information technology, enabled patients to take a proactive interest in their health, and paved the way for the expansion of Health Information Exchanges.
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Patient Safety and Quality Improvement Act (PSQUIA)
On July 29, 2005, the Patient Safety and Quality Improvement Act of 2005 (PSQIA) was signed into law by the President. The Act amended Title IX of the Public Health Service Act to improve patient safety and reduce the occurrence of events that negatively impact patient safety. The Act established patient safety organizations (PSOs) and a national patient safety database. These organizations work with healthcare providers to improve the quality and safety of patient care by collecting and analyzing confidential data on patient safety events.
The PSQIA encourages the reporting and analysis of medical errors by providing federal privilege and confidentiality protections for patient safety information, known as patient safety work product (PSWP). PSWP includes data, reports, records, analyses, and statements related to patient safety events and can identify patients, healthcare providers, and individuals who report medical errors. This information is generally privileged and confidential, with limited disclosure exceptions, such as to law enforcement in cases of criminal activity.
The Act also established protections for Patient Safety Work Product to encourage broad discussion and reporting of adverse events, near misses, and dangerous conditions. The Agency for Healthcare Research and Quality (AHRQ) is responsible for listing PSOs, and the Act authorizes the Department of Health and Human Services (HHS) to impose civil penalties for violations of PSWP confidentiality.
The PSQIA requires the Secretary of HHS, in consultation with the Director of the Agency for Healthcare Research and Quality (AHRQ), to prepare a report on strategies to reduce medical errors and improve patient safety. A draft of the report was made available for public comment and submitted for review to the National Academy of Medicine (NAM). The final report, "Strategies to Improve Patient Safety," was submitted to Congress in November 2021.
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The Hill-Burton Act
The Hill-Burton program had specific requirements for recipient facilities. These included a prohibition on discrimination based on race, colour, national origin, or creed, although separate but equal facilities in the same area were permitted. Hospitals were also mandated to provide a "reasonable volume" of free or reduced-cost care annually for those unable to pay, initially for 20 years after receiving funding. To receive funding, states and local municipalities had to match the federal grant or loan, with the federal portion accounting for only one-third of the total construction or renovation cost.
The Hill-Burton program ended in 1974, and the provision requiring non-discrimination was eliminated by the Civil Rights Act of 1964. However, as of 2023, about 127 healthcare facilities nationwide are still obligated to provide free or reduced-cost care under the program. Eligibility for such care is based on income, with individuals required to apply and provide documentation verifying their financial status.
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The Health Maintenance Organization Act of 1973
The HMO Act of 1973 was driven by rising healthcare costs and concerns about inferior care quality in the US. The Act aimed to address these issues by providing grants and loans to establish, expand, and support HMOs. Health maintenance organizations are a type of managed care health insurance plan that offers a network of healthcare providers for a prepaid cost. By combining financing and care delivery, HMOs are intended to incentivize cost-efficient, quality care.
The Act included several key provisions:
- It authorized the Secretary to make loans and loan guarantees for initial operation costs for HMOs, with specific appropriations allocated for fiscal years 1974 to 1977.
- It mandated that employers offering health benefits plans must give their employees the option of joining an HMO if they offered traditional health insurance. However, it did not require employers to offer health insurance in the first place.
- The Act prioritized projects and HMOs serving residents in medically underserved areas when considering applications for grants and contracts.
- It established requirements for applicants to receive funds under the Act, including fiscal soundness.
- The Act included a mandated Dual Choice provision under Section 1310.
The impact of the HMO Act was significant. By December 31, 1977, the Department of Health, Education, and Welfare had awarded over $130 million in grant and loan assistance, leading to the establishment and expansion of numerous HMOs. The Act solidified the term HMO and increased its popularity, making it a prominent method of health insurance in the United States.
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The Americans with Disabilities Act of 1990 (ADA)
The ADA is divided into five titles or sections that relate to different areas of public life. Title I covers the employment practices of private employers with 15 or more employees, state and local governments, employment agencies, labour unions, agents of the employer, and joint management labour committees. Title II applies to all state and local governments, their departments and agencies, and any other instrumentalities or special purpose districts of state or local governments. It also clarifies the requirements of Section 504 of the Rehabilitation Act of 1973 for public transportation systems that receive federal financial assistance. Title III requires telephone and Internet companies to provide a nationwide system of telecommunications relay services, enabling individuals with hearing and speech disabilities to communicate over the telephone. It also mandates closed captioning of federally funded public service announcements. Title IV contains various provisions relating to the ADA as a whole, including its relationship to other laws, state immunity, insurance providers and benefits, prohibition against retaliation and coercion, illegal use of drugs, and attorney's fees.
The ADA was passed as a "Public Law" by Congress and was later reformatted and published in volume 42 (title 42) of the United States Code to make it more widely available. The ADA Amendments Act (ADAAA) of 2008 made significant changes to the definition of "disability," and these changes apply to all titles of the ADA. The ADA provides powers, remedies, and procedures for addressing discrimination on the basis of disability, with enforcement authorities for employment discrimination allegations under the ADA and the Rehabilitation Act of 1973 developing procedures to avoid duplication.
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Frequently asked questions
This law was created by Congress a little over a decade ago as electronic health records (EHRs) became the new standard for recording patients' medical histories. It requires healthcare providers to show that electronic health records are used to measure the improvement of healthcare delivery, including increased engagement between the patient and doctor, and a reduction in healthcare disparities.
This act was created by Congress to allow healthcare workers to report medical errors and unsafe conditions in their workplace without retaliation.
This law, also known as EMTALA or the Patient Anti-Dumping Law, was enacted by Congress in 1986 to stop hospitals that receive federal funds from refusing to treat patients in emergency situations due to their inability to pay.
This civil rights law was enacted by Congress to prohibit discrimination based on disability. It affords similar protections against discrimination to Americans with disabilities.
