4 Healthcare Regulations You Need To Know

Amber Ratcliffe
two healthcare professionals walking in a hallway

Healthcare is an industry governed by countless regulations and standards. These regulations exist to protect everyone involved: patients, families, providers, caregivers, and beyond. Adhering to healthcare regulations is the best way to reduce risk, improve safety, boost patient and provider satisfaction, and enhance service quality.

While it can sometimes feel like there are dozens and dozens of different healthcare standards, the biggest governing policies really boil down to four major regulations. Get familiar with the big four, and you’ll be well on your way to navigating healthcare compliance with confidence.

Why Are Healthcare Regulations Important?

Healthcare regulations are crucial for several reasons. Above all, they play a fundamental role in protecting patient safety and ensuring the delivery of high-quality healthcare services.

Regulations establish standards and guidelines that healthcare providers must adhere to, covering areas such as patient care, medication safety, infection control, and medical equipment standards. By enforcing these regulations, governments and regulatory bodies aim to prevent medical errors, improve patient outcomes, and maintain trust in the healthcare system.

Healthcare regulations and standards also serve to safeguard the rights and interests of patients, including privacy and confidentiality. These regulations grant individuals control over their health information, regulate the sharing and disclosure of sensitive data, and empower patients to make informed decisions about their healthcare.

Additionally, healthcare regulations address issues of accessibility and affordability, aiming to ensure healthcare services are available to all individuals, regardless of their socioeconomic status or insurance coverage. By promoting equity and fairness in healthcare delivery, regulations prevent discrimination, ensure equal access to care, and reduce health disparities.

Who Establishes Rules and Regulations in Healthcare?

Most rules and regulations in healthcare are established by government agencies with the goal of protecting patients. It can be a challenge to maintain compliance with so many different groups who establish rules and regulations in healthcare. Here’s a breakdown of the key players:

  • Federal Government: The Department of Health and Human Services (HHS) is the primary federal agency responsible for health affairs.
  • State Government: Each state has its own regulations around professional licensure, operations, and safety.
  • Accrediting Organizations: Independent organizations, such as The Joint Committee, usually require organizations seeking accreditation to meet higher standards of patient safety and quality of care.
  • Professional Associations: Specialty organizations, such as the American Medical Association (AMA), often establish guidelines and codes of ethics that their members are encouraged to follow.

4 Healthcare Regulations You Need To Know

As mentioned, there are plenty of regulatory standards healthcare organizations need to be familiar and compliant with. However, there’s often overlap and most standards have roots in the big four healthcare regulations. Here are the ones you need to know above all others:

1. Health Insurance Portability and Accountability Act (HIPAA)

HIPAA focuses on protecting the privacy and security of patients’ health information, and establishes rules and standards for the use, disclosure, and safeguarding of protected health information (PHI). The Office of Civil Rights (OCR) is responsible for HIPAA enforcement.

HIPAA’s Privacy Rule grants patients control over their health information by providing them with rights to access, amend, and obtain an accounting of their PHI. The Security Rule sets requirements for implementing administrative, physical, and technical safeguards to protect electronic PHI. HIPAA also addresses the electronic exchange of health information, ensuring secure transactions through the use of standardized code sets and unique identifiers.

Compliance with HIPAA is of utmost importance as it helps maintain patient confidentiality, promotes trust between patients and healthcare organizations, and mitigates the risk of data breaches and unauthorized access to sensitive health information.

2. Health Information Technology for Economic and Clinical Health Act (HITECH)

HITECH is an essential component of the American Recovery and Reinvestment Act of 2009. It complements HIPAA by expanding its privacy and security provisions concerning electronic health records (EHRs) and health information technology (HIT).

HITECH emphasizes the importance of protecting patients’ health information in the digital era and encourages the use of secure technology to improve the quality and efficiency of healthcare services. HITECH encourages the adoption of EHRs by providing incentives to healthcare providers who demonstrate meaningful use of certified EHR technology. It also strengthens HIPAA’s enforcement mechanisms, imposing stricter penalties for non-compliance, and establishes breach notification requirements.

By promoting the adoption of EHRs and strengthening privacy and security provisions, HITECH plays a significant role in enhancing patient care coordination, reducing medical errors, and fostering innovation in healthcare delivery.

3. Emergency Medical Treatment and Labor Act (EMTALA)

Everyone has the right to receive critical care when they need it, thanks to EMTALA. This federal law ensures individuals receive emergency medical care regardless of their ability to pay or insurance status.

Under EMTALA, all Medicare-participating hospitals with emergency departments are required to provide a medical screening examination to anyone who seeks treatment for a potential emergency condition. If an emergency condition is identified, the hospital must stabilize the patient’s condition or arrange for an appropriate transfer to another facility.

EMTALA’s primary objective is to prevent patient dumping, where hospitals deny treatment or transfer patients based on their financial situation. It’s crucial in guaranteeing equal access to emergency medical services and upholding ethical standards in healthcare delivery.

4. Fraud and Abuse Laws

Fraud and abuse laws — such as the False Claims Act, the Anti-Kickback Statute, and Stark Law — create accountability, transparency, and trust within the healthcare industry:

  • The False Claims Act prohibits knowingly submitting false claims to the government for payment, imposing substantial penalties and liability for individuals or organizations found in violation.
  • The Anti-Kickback Statute prohibits the exchange of anything of value in return for referrals of federal healthcare program beneficiaries, ensuring healthcare decisions are based on the patient’s best interests rather than financial incentives.
  • Stark Law prohibits physicians from referring patients for certain designated health services to entities with which they have financial relationships, to avoid conflicts of interest.

Compliance with fraud and abuse laws is essential in maintaining the integrity of the healthcare system, protecting public funds, and ensuring patients receive appropriate and unbiased care. These laws help prevent fraud, unnecessary procedures, and conflicts of interest, ultimately safeguarding patients and preserving the trust between healthcare providers.


Be ready for inspections from OSHA, OCR, CMS, and OIG.

Remaining Compliant With Healthcare Regulations and Standards

Training on regulations and having policies that align with critical standards are essential for healthcare organizations of all sizes.

Education ensures employees are well-informed about healthcare regulations and standards they need to follow in their daily operations. Using a healthcare-specific learning management system (LMS) offers peace of mind that training meets regulatory and accreditation standards and is updated as regulations change. Courses can cover a wide range of topics, including patient privacy, data security, patient and worker safety, and ethical considerations. Both regulatory agencies and accreditation organizations conduct surveys to ensure organizations are maintaining compliance and an LMS simplifies the tracking and reporting that is required.

Having policies in place further supports compliance efforts by providing clear guidelines and procedures for employees to follow. Policies serve as a roadmap, outlining the expected behaviors and actions that align with regulatory requirements. Keeping documents and policies in an online compliance platform makes them easier to access for employees, and easier for admins to secure electronic attestations.

See how MedTrainer can help you stay on top of healthcare regulations.