Every day, healthcare providers must perform the nerve-racking task of complying with increasing healthcare regulations. According to one report, the healthcare industry spends nearly $39 billion every year on the administrative burdens of regulatory compliance.

Today, healthcare organizations must comply with more than 600 regulatory requirements. These compliance laws encompass numerous occupational sectors, from pharmacies and insurance companies to cloud service providers.

This article aims to provide a solid starting point for establishing a robust regulatory compliance program. It offers guidance and insights to healthcare professionals looking to ensure adherence to the myriad regulations that shape their industry.

What Does ‘Regulatory Compliance’ Mean?

Regulatory compliance is the set of processes and procedures that support an organization’s adherence to the regulations and other requirements wherever the organization operates. This includes national or state laws, industry regulations, or contractual obligations.

Although many healthcare facilities may consider healthcare compliance requirements to hinder success, an effective program to comply with regulatory obligations can be a competitive advantage.

What Is Regulatory Compliance in Healthcare?

Compliance obligations specific to healthcare can include a broad spectrum of practices. Still, most healthcare compliance issues relate to patient safety, the privacy of patient information, and government reimbursement for healthcare expenditures. In the most significant sense, regulatory compliance in healthcare is about providing high-quality patient care.

Healthcare professionals routinely compile and access electronic health records. Therefore, maintaining patient privacy and results as data are collected has become vital to the industry. Failure to protect healthcare data — failing to meet compliance obligations — can result in costly monetary penalties from regulators.

For example, as of August 2021, the U.S. Department of Health & Human Services had imposed monetary penalties in more than 100 cases totaling $135.3 million. Given that financial threat, understanding your compliance obligations and meeting those obligations can save millions of dollars in penalties (on top of the value of patient trust).

What are the three main areas of healthcare compliance?

In the highly regulated world of healthcare, regulatory compliance is the foundation upon which patient care and ethical practice are built. To better understand this intricate landscape, let’s delve into the three critical areas of healthcare compliance. 

These pillars are the foundation for ensuring the delivery of quality healthcare while adhering to compliance regulations and ethical standards. 

  • Patient Safety: This area is a forefront of healthcare compliance efforts. It involves measures to prevent medical errors, ensure infection control, and safeguard patients from harm during their healthcare journey.
  • Patient Privacy and Data Security: Protecting patient information is paramount. Compliance in this area revolves around maintaining patient privacy and data security, strictly adhering to regulations like HIPAA to safeguard sensitive health information.
  • Billing and Coding Compliance: Accurate and ethical billing and coding practices are vital for healthcare providers. This compliance aspect ensures that billing is done correctly, adhering to coding systems and anti-fraud laws.

Regulatory Requirements for Healthcare Organizations

Healthcare is more heavily regulated than almost any other industry. Below, we explain five significant laws that govern healthcare compliance in the United States.

1. Health Insurance Portability and Accountability Act (HIPAA)

HIPAA compliance comprises the rules on privacy and security, breach notification, and enforcement for protecting healthcare system information.

The HIPAA Privacy Rule applies to all healthcare providers and entails electronic, paper, and oral media. It grants patients the right to see their Protected Health Information (PHI) and requires disclosure of how that information is used. Healthcare facilities must also update security measures to safeguard medical records in a changing environment. 

2. Anti-Kickback Statute and Stark Law

The Anti-Kickback Statute and the Stark Law are designed to keep medical treatment decisions free from the influence of hidden financial arrangements between healthcare workers and hospitals. These laws are essential because improper financial incentives can lead to inappropriate medical decision-making and higher Medicare and Medicaid services expenses.

3. Patient Safety and Quality Improvement Act (PSQIA)

The law established new Patient Safety Organizations (PSOs) to prevent the data from being used in lawsuits against the PSO.

The PSO acts as the principal vehicle to gather data about adverse medical events and assist providers in implementing practices to reduce adverse events and build safety cultures while increasing the quality of care.

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

The HITECH Act reinforces two significant initiatives: promoting the proper use of electronic health records and cybersecurity measures and further supporting HIPAA enforcement.

Before the HITECH Act, only a few hospitals adopted electronic medical record systems, leading to inefficiencies in public health. HITECH was meant to encourage more use of electronic medical records while preserving the privacy and security of healthcare data.

5. Affordable Care Act (ACA)

As the name says, the ACA aims to extend health and insurance coverage to more people and encourage innovative medical care delivery methods to minimize healthcare costs.

The ACA created a Health Insurance Marketplace, stopping insurance organizations from refusing coverage because of pre-existing conditions.

Common Challenges in Regulatory Compliance in Healthcare

Ensuring healthcare regulatory compliance is critical to providing safe and effective patient care. However, healthcare organizations often need help in meeting the evolving regulatory requirements. Here are some common challenges:

Ever-Changing Regulations

Healthcare regulations frequently evolve at both federal and state levels. Staying current with compliance updates can take time and effort for healthcare providers. For instance, recent updates include the introduction of the CMS Interoperability and Patient Access Rule, which focuses on improving patient data access and sharing through Electronic Health Records (EHRs).

HIPAA & Data Breaches

Data breaches, especially in the digital age, threaten the healthcare sector significantly. State-specific laws add complexity, differing in how they define personal information, mandate breach notifications, and impose penalties on non-compliance. Protecting patient data remains an overarching priority.

Interoperability and Data Exchange

The seamless sharing of patient data among healthcare systems remains a significant challenge. The 21st Century Cures Act and the ONC’s Information Blocking Rule aim to facilitate data interoperability, mandating that healthcare providers adopt technologies that allow for easier exchange of patient information. Compliance with these updates is crucial to enhance patient care coordination.

False Claims & Whistleblower Suits

Healthcare’s battle against false claims and whistleblower actions, often under the purview of the False Claims Act, is ongoing. This act encompasses fraud in federally funded programs, including Medicaid and Medicare. Recent legislative changes empower whistleblowers, making it easier for them to initiate claims against healthcare organizations.

Make Compliance Part of Your DNA With ZenGRC

At RiskOptics, we know that having a solid compliance program that adheres to HIPAA and other regulations is part of your commitment to quality patient care. For that reason, we built ZenGRC to help you stay on top of the compliance requirements.

If you are overwhelmed with managing health information and compliance in spreadsheets, ZenGRC is the solution for a more efficient compliance process. Schedule a demo now, and we will show you how ZenGRC can simplify your processes, build more effective compliance, and drive your business forward.

3 Challenges Healthcare Compliance Teams Are Set
to Overcome with Reciprocity ZenGRC in 2022