Compliance Management

Your Trusted Resource for Compliance Management

Explore our collection of valuable insights and practical tips to keep your organization ahead in the world of compliance. If you're looking to streamline your compliance processes, don't hesitate to get in touch with us. Let’s navigate compliance together.
Blog Hero
Blog > Steps for Successful Healthcare Compliance Assessment

Steps for Successful Healthcare Compliance Assessment

VComply Editorial Team
July 3, 2024
8 minutes

In today’s healthcare landscape, both risk management and compliance are essential. They help providers identify potential problems, understand existing obstacles, and develop protocols to investigate control and program failures. They also help come up with practical solutions to address these issues. If there’s a failure in either area, it can have serious consequences for the organization.

Healthcare compliance assessment is essential for maintaining the safety, integrity, and efficiency of healthcare operations. It involves ensuring that healthcare organizations adhere to industry standards and legal requirements. By focusing on compliance, organizations can avoid legal penalties, enhance patient safety, and improve overall operational effectiveness. Compliance assessments play a pivotal role in healthcare risk management, ensuring that regulatory standards are met consistently.

Why is it Important to Conduct Compliance Assessments?

Compliance programs need to be customized to meet each company’s specific needs and challenges, covering all identified risks in a detailed manner.. An effective compliance program can lead to leniency from regulators during corporate misconduct investigations. 

The U.S. Department of Justice Criminal Division updated its guidance in April 2019 and March 2023 on evaluating corporate compliance programs. The DOJ advises prosecutors to consider if the compliance program is designed to detect the types of misconduct most likely to happen in the corporation’s line of business and regulatory environment.

A detailed compliance assessment should start with a detailed understanding of the compliance environment your company operates in. To achieve this, start by answering two key questions: 1) Where are you doing business? 2) What regulations apply to businesses like yours? This base knowledge will help guide the compliance assessment process effectively.

For example, if you’re working with healthcare customers, make sure your systems handling patient data comply with HIPAA security requirements. If you deal with data from EU residents, you must comply with GDPR. If you engage with third parties, suppliers, or subcontractors, see if they have adequate compliance programs to address information security, privacy, and fraud risks.

The most crucial aspect of your compliance efforts is to focus on the risks most critical to your business. An effective compliance assessment should also provide a clear picture of your organization’s operations. Understand the “who, what, where, when, and how” of your company’s day-to-day activities.

Steps for a Successful Healthcare Compliance Assessment

A compliance assessment in healthcare is a key process for identifying and lowering potential risks that could lead to non-compliance with regulatory requirements and industry standards. Here are the detailed steps to conduct a successful healthcare compliance assessment:

The first step in a healthcare compliance assessment involves a detailed process to identify and analyze compliance-related risks within the organization. This includes evaluating the potential for non-compliance with regulatory requirements such as HIPAA, HITECH, and CMS guidelines. Identifying these risks is integral as they can lead to big time legal, financial, or reputational harm. The goal is to pinpoint areas where the organization may be vulnerable and to develop strategies to tackle these risks.

#Step 2: Reviewing Policies, Procedures, and Regulatory Process

A key component of a compliance assessment in healthcare is the review of existing policies and procedures. This involves examining whether the organization’s current practices align with applicable laws and regulations. The assessment checks whether the policies are up-to-date, comprehensive, and effectively implemented across the organization. Regular reviews help in identifying gaps and areas needing improvement, ensuring continuous compliance with regulatory standards.

#Step 3: Doing Staff Training and Education Programs

Staff training and education are critical elements of compliance. The assessment evaluates the effectiveness of the organization’s training programs, ensuring that all employees are knowledgeable about compliance requirements and capable of following them. This includes regular training sessions, updates on new regulations, and assessments to gauge understanding and compliance. A well-informed group of staff are essential for maintaining a culture of compliance and reducing the risk of violations.

#Step 4: Benefits from Conducting Effective Compliance Assessments

Effective compliance assessments bring multiple benefits to healthcare organizations. Primarily, they ensure compliance with regulatory and industry standards, bringing down the risk of legal and financial consequences such as fines, penalties, and lawsuits. Additionally, they help in uplifting patient care and safety by identifying and rectifying areas of non-compliance. Streamlining compliance efforts results in significant time, cost, and resource savings by addressing potential risks early and maintaining efficient operations.

Compliance CTA

#Step 5: Improving Patient Care and Safety

Compliance assessments play a key role in shaping patient care and safety. By seeing that all practices meet regulatory standards, healthcare organizations can provide higher-quality care, reduce the risk of errors, and protect patient rights. Identifying and addressing non-compliance areas leads to improved clinical outcomes and a safer healthcare environment for patients.

#Step 6: Streamlining Compliance Efforts

Effective compliance assessments streamline compliance efforts by identifying potential risks early and addressing them proactively. This approach saves significant time, cost, and resources by preventing the costly fallout of non-compliance. Streamlined processes improve operational efficiency, allowing organizations to focus on delivering quality patient care while maintaining regulatory compliance.

#Step 7: Steps for Conducting an Extensive Assessment

A well-structured and detailed assessment consists of several guiding steps for maximum effectiveness and thoroughness:

  • Identifying the Scope and Objective: Determine the specific areas and processes to be evaluated and set clear goals for the assessment based on regulatory requirements.
  • Creating a Customized Assessment Plan: Create a plan with clear timelines, required resources, and assigned responsibilities to conduct the assessment systematically and efficiently.
  • Conducting the Assessment: Perform a thorough review of compliance across policies, procedures, and practices, including gathering data, interviewing staff, and reviewing documentation.
  • Addressing Non-Compliance: After identifying areas of non-compliance, prioritize these issues based on their potential impact and develop strategies to address them. This involves performing corrective actions, updating policies, and giving additional training as needed.
  • Continuous Monitoring and Review: Maintain compliance by regularly assessing the effectiveness of compliance measures, updating policies and procedures as necessary, and conducting periodic audits to ensure ongoing adherence to regulatory standards.

Using and applying a structured and systematic approach to compliance assessments helps to maintain the highest standards of care and operational excellence.

What is the Role of Assessment in Healthcare Compliance Management?

Risk assessment is like the heartbeat of healthcare compliance management. It’s all about identifying potential risks that could impact patient safety, data privacy, financial stability, and regulatory compliance. By regularly conducting these assessments, healthcare organizations can pinpoint their weak spots, allocate resources where they’re needed most, and put strategies in place to reduce the chances and impact of any negative events.

When healthcare providers spot potential issues and obstacles, they can develop protocols to investigate why certain controls and programs failed and figure out solutions to fix these problems. A thorough risk assessment not only helps ensure regulatory compliance but also fosters a culture of safety and accountability, which ultimately enhances the quality of care and patient outcomes.

Risk Management vs. Compliance in Modern Healthcare

In today’s healthcare landscape, both risk management and compliance are essential. They help providers identify potential problems, understand existing obstacles, and develop protocols to investigate control and program failures. They also help come up with practical solutions to address these issues. If there’s a failure in either area, it can have serious consequences for the organization.

With healthcare providers facing more threats and compliance issues than in the past, it’s crucial that these organizations prioritize their risk assessment and management efforts. This can go a long way in helping them improve operations, even despite regulatory burdens. Prioritizing these efforts ensures that healthcare providers are not just surviving but thriving in a challenging environment.

Technological Advancements in Compliance Assessments

  1. Use of Compliance Assessment Software

Compliance assessment software improves the efficiency and accuracy of healthcare compliance assessments. These tools facilitate data collection, analysis, and processing, allowing organizations to quickly identify and address potential compliance issues.

  1. Incorporating Mapping and Automation Tools

Mapping and automation tools can improve risk visualization and management. These tools help organizations map out compliance processes, automate repetitive tasks, and track compliance metrics in real time, making it easier to manage and mitigate risks.

  1. Adopting Workflow Management Software

Workflow management software can enhance task coordination and progress tracking during compliance assessments. These tools ensure that all assessment activities are completed on time, responsibilities are clearly defined, and progress is monitored effectively.

  1. Real-Time Monitoring and Reporting

Advanced technological solutions enable real-time monitoring and reporting of compliance risks. This allows organizations to detect and address potential issues promptly, ensuring continuous compliance and reducing the risk of non-compliance. To learn how VComply’s compliance monitoring helps in raising the quality or level of scrutiny and management within an organization, read our detailed article on “Beyond Tracking: How VComply’s Compliance Monitor Elevates Oversight.” 

  1. Adherence to Best Practices in Healthcare Compliance Assessment

Establishing a comprehensive compliance assessment framework within healthcare organizations is important. This framework should include standardized processes, clear guidelines, and robust assessment tools to ensure consistency and accuracy.

  1. Involvement of Stakeholders Across Various Levels

Involving stakeholders across various levels of the organization is essential for a unified approach to compliance assessment. This ensures that all relevant perspectives are considered, and that compliance efforts are supported and reinforced throughout the organization.

  1. Regular Use of Software Tools

Regular use of software tools for streamlined and centralized assessment processes can significantly improve the efficiency and effectiveness of compliance assessments. These tools facilitate data management, analysis, and reporting, enabling organizations to maintain a proactive approach to compliance.

  1. Documentation and Communication of Results

Effective documentation and communication of assessment results to relevant stakeholders are crucial for ensuring that identified risks are addressed promptly. This involves creating detailed reports, sharing findings with leadership and staff, and developing action plans to mitigate risks.

Frequency and Evaluation of Healthcare Compliance Programs

  • Regular Assessments

Regular healthcare compliance program assessments are necessary to ensure ongoing adherence to regulatory requirements. This involves conducting periodic evaluations to identify potential compliance issues and implementing corrective actions as needed.

  • External and Internal Assessments

Both external and internal assessments are essential for a comprehensive compliance evaluation. External assessments provide an objective perspective and help identify areas that may be overlooked internally, while internal assessments ensure continuous monitoring and improvement.

  • Comprehensive Compliance Programs

Ensuring that the compliance program encompasses all critical elements for effective violation prevention and management is crucial. This includes robust policies, regular training, continuous monitoring, and a clear process for addressing compliance issues.

  • Employing Healthcare Compliance Tools for Patient Information Security

Significance of HIPAA Guidelines

HIPAA guidelines are fundamental for ensuring the security and privacy of patient information. Compliance with these guidelines helps protect patient data from breaches and unauthorized access, maintaining the trust and confidence of patients.

  • Utilization of Compliance Risk Assessment Tools

Compliance risk assessment tools can help safeguard against data breaches and unauthorized access by identifying and mitigating potential risks. These tools enable healthcare organizations to proactively manage data security and ensure compliance with regulatory requirements.

  • Organized Approach to Risk Management

Implementing an organized approach for identifying, prioritizing, and mitigating risks related to patient information is essential for effective compliance management. This involves developing comprehensive risk management strategies, conducting regular assessments, and continuously monitoring data security.

Compliance CTA

Key Parts of a Healthcare Compliance Assessment

Step 1 – Understand the Current State of Affairs Begin by identifying and documenting key company processes, systems, and transactions. Look for existing business process materials, possibly created for contract certification purposes. Meet and interview key personnel to understand their roles, motivations, and stress points.

Step 2 – Map Potential Risk Contact Points With a comprehensive understanding of your company’s operations and compliance landscape, identify compliance risk contact points—specific operations with potential regulatory violations. Evaluate each key process, system, and transaction from Step 1 in terms of relevant regulatory questions or issues.

Step 3 – Assess Current Controls Determine if existing procedures and controls effectively address the identified risk contact points. For each contact point, identify the applicable policy, procedure, work instruction, or control. Assess the sufficiency of these controls based on your knowledge of each contact point, considering the likelihood of a violation, detection capability, and potential impact.

Step 4 – Prioritize Compliance Enhancement Measures Since resources are limited, prioritize compliance risks by their criticality and the resources needed to mitigate them. Focus on high-risk areas first. Systematically identify and implement projects that address these prioritized compliance gaps, aiming for the enhancements that will provide the most significant benefits.

Step 5 – Periodically Update Your Compliance Assessment Ensure that risk assessments are not one-time events. Periodically review and update them, especially after significant changes like acquisitions, entering new markets, corporate reorganization, or engaging with new customers and regulators. Stay informed on regulatory changes and enforcement interpretations, maintaining a recurring process for updating your risk assessments.

Other key parts are:

  • Data Security Assessment: Evaluate the security measures protecting patient data to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). Spot any possible vulnerabilities in data storage and transmission.
  • Regulatory Analysis: Examine applicable federal, state, and local healthcare regulations, including laws such as HIPAA, the Affordable Care Act, and Anti-Kickback Statutes. Stay informed about any changes or updates to these regulations.
  • Internal Audits and Monitoring: Conduct regular internal audits to detect non-compliance issues, billing discrepancies, or other operational problems. Implement a system for continuous monitoring and reporting.
  • Training and Education: Assess the effectiveness of compliance training programs for staff, ensuring that employees are knowledgeable about relevant laws and regulations.
  • Documentation Review: Review documentation practices to ensure medical records, billing, and other records are accurate, complete, and compliant with regulatory requirements.
  • Policies and Procedures: Update policies and procedures to align with current regulations and best practices, ensuring they are accessible to all employees.
  • Third-Party Vendors: Evaluate compliance risks associated with third-party vendors, contractors, and business associates. Ensure contracts include compliance requirements and monitoring procedures.
  • Incident Response Plan: Develop and maintain an incident response plan to address potential breaches or violations promptly. Ensure employees understand their roles in the event of a compliance issue.
  • Documentation of Remediation: Keep records of any corrective actions taken to address identified compliance risks, including policy changes, staff training, or process improvements.
  • Continuous Improvement: Foster a culture of continuous improvement by regularly reviewing and updating the compliance risk assessment process to adapt to evolving regulations and industry best practices.

How VComply Helps with Healthcare Compliance Assessments

With a user-friendly interface and automated features, VComply, leads the way as one of the leading GRC softwares with a centralized platform to improve risk management in healthcare compliance. You will be able to show compliance in a better way while having a clear visibility into all your policies and programs with a single system of record.

Here are some of the features VComply offers in facilitating a structured healthcare compliance assessment:

  • Centralized Platform: You can show compliance by seamlessly collecting and storing evidence & documents in one centralized repository.
  • Compliance Framework: You can manage multiple compliance frameworks by building an integrated and scalable control management program.
  • Workflow Management: You can automate workflows, get rid of manual processes, monitor tasks performance and improve stakeholder accountability.
  • Risk Register: You can access a centralized risk register for better management and visibility of organizational risks.
  • Risk Assessment: It helps you facilitate inherent and residual risk assessments to prioritize and manage risks effectively.
  • Risk Treatment: Helps you with risk treatment plans and the assignment of controls to terminate identified risks.


Healthcare compliance assessments are essential for maintaining the safety, integrity, and efficiency of healthcare operations. By identifying, analyzing, and mitigating compliance-related risks, healthcare organizations can ensure adherence to regulatory standards, enhance patient care, and avoid legal and financial consequences. 

Doing value-driven assessment practices, seeking the help of online tools, and sticking to best practices can greatly improve the efficiency and effectiveness of compliance efforts. 

As the regulatory landscape continues to evolve, healthcare organizations must remain vigilant and proactive in their compliance risk management efforts to maintain the highest standards of care and operational excellence.

To simplify and streamline your compliance, risk and policy activities, try VComply with a 21-day free trial and enjoy automating your compliance process!