What Is Compliance in Healthcare? Overview and FAQ

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Reviewed by Aldo Zilli, Esq. Senior Manager, B2B Content, IntelyCare
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Regulatory compliance refers to an organization’s adherence to industry-specific laws, rules, and standards. In the healthcare industry, compliance is overseen by government agencies like the Centers for Medicare and Medicaid Services (CMS) to prevent abuse, fraud, and waste within each organization. As a facility administrator, compliance in healthcare is essential to ensuring your patients receive the high-quality care they deserve.

In this article, we’ll introduce the concept of regulatory compliance and explain how it impacts healthcare facilities. We’ll also review examples of healthcare compliance laws and regulations and answer frequently asked questions to help you optimize your team’s compliance practices.

What Is Regulatory Compliance in Healthcare?

In healthcare, the term regulatory compliance is used to describe the federal, state, and local regulations that organizations must follow. These laws cover matters such as patient safety, data security, care quality, and credentialing requirements.

In addition to the mandatory regulations set by oversight agencies, some organizations also develop their own compliance rules to ensure minimum care standards are met within their own facility. This helps to ensure that each organization’s care practices promote patient privacy, dignity, and safety in a way that aligns with their core values.

Legal Examples of Compliance in Healthcare

There are at least 629 compliance regulations that impact healthcare organizations. Of these, 341 are hospital-related requirements and 288 are related to post-acute care. We’ll review key laws for a few of the important compliance domains in the table below.

Compliance Domains and Regulations
Patient Safety
Data Security
Care Quality
Fraud/Abuse

Promoting Regulatory Compliance: Facility FAQ

Now that we’ve introduced the concept of regulatory compliance, you may be curious what these processes look like in practice. Below, we’ll answer some frequently asked questions to give you a better understanding of how compliance impacts your facility, your staff, and the patients you care for.

What is the importance of compliance in healthcare?

If you’re a facility leader, compliance may sound daunting. However, it’s important to note that regulatory oversight exists to hold facilities accountable for the care they provide, not to punish clinicians or shut down facilities. By developing strong regulatory compliance practices, organizations are able to:

  • Improve patient satisfaction and trust.
  • Ensure equal access to care services.
  • Optimize care quality and health outcomes.
  • Minimize the risk of adverse events and medical errors.
  • Avoid potential fines, lawsuits, and reputation damage.

Which agencies regulate compliance?

There are primarily four federal entities that oversee the 629 regulatory compliance requirements pertaining to healthcare organizations. We’ll review the functions of these agencies in the table below.

Federal Entity Function
Centers for Medicare and Medicaid Services (CMS) Regulates reimbursement for healthcare goods and services
Office of the Inspector General (OIG) Ensures that programs under HHS operate with integrity, efficiency, and accountability
The Office of the National Coordinator for Health IT (ONC) Oversees improvements to healthcare information technology and security and data management to ensure patient privacy and confidentiality
The HHS Office for Civil Rights (OCR) Enforces laws that protect patient rights of nondiscrimination, conscience, religious freedom, and health information privacy

There are also other federal entities that can play a role in regulating certain aspects of healthcare, as well as state and local organizations that provide input on healthcare management. Some of these include, but are not limited to, the:

  • Food and Drug Administration (FDA)
  • Centers for Disease Control and Prevention (CDC)
  • Drug Enforcement Administration (DEA)
  • Department of Labor (DOL)
  • Occupational Safety and Health Administration (OSHA)
  • Federal Emergency Management Agency (FEMA)
  • Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

How is regulatory compliance audited?

Each agency utilizes their own specific processes and protocols to ensure that facilities comply with their laws and regulations. Generally, regulatory compliance is audited by a combination of on-site facility inspections, employee interviews, and electronic health record (EHR) data analysis.

How can an organization improve its compliance practices?

As an administrator, it can be challenging to stay on top of regulatory compliance without proactive management strategies in place. Luckily, there are a few things you can do to prepare for the auditing process and limit your organization’s risks.

One way to get a firm handle on compliance is by hiring a healthcare compliance officer to your administrative team. Compliance officers can help your team develop sound employment policies, prepare for audits, and consult with your legal team when issues arise. These employees usually hold a certification in healthcare compliance, making them subject matter experts on the intricacies of healthcare regulations.

It can also help to develop a culture of safety at your organization. Educate your staff members about compliance requirements and encourage them to speak up if they witness any fraudulent or unprofessional behavior. You can also empower your clinicians to get involved in policy development by forming shared governance councils.

Discover More Ways to Optimize Your Care Practices

Navigating the nuances of compliance in healthcare can be challenging, but we’re here to help. At IntelyCare, our team of clinical and legal experts has compiled a diverse resource of healthcare resources and guides to help you enhance care quality, patient satisfaction, and staff wellness.

 

Legal Disclaimer: This article contains general legal information, but it is not intended to constitute professional legal advice for any particular situation and should not be relied on as professional legal advice. Any references to the law may not be current, as laws regularly change through updates in legislation, regulation, and case law at the federal and state level. Nothing in this article should be interpreted as creating an attorney-client relationship. If you have legal questions, you should seek the advice of an attorney licensed to practice in your jurisdiction.


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