Former U.S. Deputy Attorney General Paul McNulty once said, “If you think compliance is expensive, try non-compliance.”
This makes it imperative for compliance officers to meet the stringent compliance demands enacted by the regulatory authorities in the life sciences industry.
Amid the heightened scrutiny and regulatory enforcement, risk-based monitoring tools are emerging as significant changes in navigating the complex regulatory environment.
With the inception of technologies such as artificial intelligence, machine learning, and more, assuring compliance with applicable rules and regulations is becoming convenient for compliance officers and life sciences companies.
By leveraging advanced technologies combined with data analytics, life sciences companies can enhance the effectiveness of compliance programs, streamline operations, and take an effective route to identify, assess, prioritize, and mitigate risk.
Let us look at some of the best ways risk-based monitoring tools are augmenting the capabilities of compliance programs, making them more efficient and effective.
Understanding Risk-Based Monitoring
What is Risk-Based Monitoring?
Risk-based monitoring (RBM) is a strategic approach that prioritizes resources and remedial action based on the level of risk. It involves identifying, assessing, and mitigating risks to ensure compliance with regulatory standards.
The regulatory standards referred to above are the ones enacted by regulatory bodies such as the U.S. Department of Justice (DOJ), Office of Inspector General (OIG), Centers for Medicare and Medicaid Services (CMS), and more.
Unlike traditional risk monitoring, which treats all aspects equally, RBM focuses on areas with the highest risk, making the process more efficient and effective.
Through RBS, compliance officers opt for addressing compliance issues that have a higher probability of escalating to critical levels. Some examples include:
- Off-Label Promotion: Promoting a drug for uses not approved by regulatory agencies.
- Anti-Kickback Violations: Offering or accepting incentives to influence the prescription or use of a product.
- False Claims: Submitting false information for reimbursement from government healthcare programs.
- Bribery and Corruption: Engaging in bribery or corrupt practices to gain regulatory approvals or business advantages.
- Inaccurate Reporting: Misreporting aggregate spend data to the CMS can result in fines and penalties of up to $1,000,000.
Historical Context and Evolution
The concept of risk-based monitoring is not new, but it has evolved over the years, particularly in the high life sciences risk monitoring areas.
Initially, monitoring was a one-size-fits-all manual approach, but the advent of technologies and data analytics has paved the way for more informed and effective compliance strategies.
RBM has evolved into a more sophisticated approach that integrates seamlessly with existing processes, augments the capabilities of compliance programs, and provides a holistic view of risks to compliance officers, enabling quick risk remediation.
Types of Risk-Based Monitoring Tools
Various tools cater to various aspects of risk-based monitoring, from data analytics platforms to AI-driven compliance solutions.
The purpose-built solutions are designed to help compliance officers automate certain aspects of risk monitoring to ensure effective risk mitigation. Such tools help organizations assess and prioritize risks, monitor compliance in real-time, and implement corrective actions proactively.
Example of an Effective RBS Tool
qordata’s Risk-Based Scoring platform stands out as a leading solution. RBS is equipped with advanced technology to detect non-compliant activities, such as non-conducive venues and repeat attendance by program attendees.
Leveraging Data Science and Machine Learning, RBS calculates and refines Aggregate Risk Scores, simplifying the selection of events for your monitoring activities.
Benefits of Risk-Based Monitoring in Compliance
· Effective Regulatory Adherence
Risk-based monitoring ensures that your organization stays compliant with regulatory demands. By focusing on high-risk areas, you can allocate resources more efficiently and meet regulatory standards consistently.
· Improved Risk Prioritization
One of the significant benefits of RBM is improved risk prioritization. It enables organizations to identify and focus on the most critical compliance issues, thereby reducing the likelihood of regulatory breaches.
· Enhanced Accuracy and Efficiency
RBM tools streamline compliance processes, enhancing accuracy and efficiency. Automated monitoring reduces the margin of human error, ensuring that compliance data is accurate and up to date.
· Proactive Risk Identification and Mitigation
Proactive risk identification is another crucial advantage of RBM. By continuously monitoring compliance activities, these tools can identify potential risks before they escalate, allowing compliance officers to take timely remedial action.
· Data Integrity and Quality
Maintaining data integrity and quality is paramount in the life sciences industry. RBM tools ensure that all compliance-related data is accurate, reliable, and secure. This allows compliance officers to work with quality dating and make informed decisions regarding compliance.
Implementing Risk-Based Monitoring Tools
Steps for Successful Implementation
Implementing RBM tools requires a structured approach. Here are some essential steps:
- Assessment: Evaluate your current compliance framework and stature while simultaneously identifying key areas that would benefit from the implementation of RBM.
- Selection: Choose an RBM or Risk Based Scoring (RBS) tool that aligns with your organizational compliance demands.
- Integration: Integrate the tool with your existing compliance processes and procedures. Companies offering compliance systems can help in configuring the RMB tool according to your specific requirements.
- Training: Train your compliance team to use the tool effectively.
- Monitoring: Continuously monitor the tool’s performance and make necessary adjustments along the way to unlock the full potential of RBM.
Challenges Associated with Risk-Based Monitoring and Solutions
Common Obstacles in Adoption and Integration
Adopting RBM tools is not easy and certainly has its challenges and considerations.
Common obstacles include resistance to change, lack of technical expertise, and more. We will be focusing solely on the above challenges for today to see how they hinder the integration of RBM tools into your compliance framework and how you can address them.
Strategies to Overcome These Challenges
Overcoming these challenges requires a strategic approach. Here are some effective strategies:
- Change Management: Foster a culture of change by educating your team about the benefits of RBM, the totality of risks, and how this new solution can streamline compliance, enabling compliance officers to effectively assure risk mitigation.
- Technical Training: You can ask the company from whom you are buying the RMB tool to train your internal team on how they can leverage the solution to identify, assess, and prioritize risks as per their severity.
Conclusion
Risk-based monitoring tools are revolutionizing compliance strategies in the life sciences industry.
By focusing on high-risk areas and leveraging advanced technologies, these tools enhance regulatory adherence, improve risk prioritization, and ensure data integrity.
If you are looking to stay ahead in the competitive landscape of life sciences, adopting risk-based monitoring tools is not just an option—it is a necessity.