The global compliance landscape is challenging and constantly evolving. Business complexity is increasing, and enforcement risks are intensifying. As a result, we must continuously assess whether we have the tools necessary to proactively identify and manage risks, and ensure these tools engage the entire organization in the compliance process. Understanding our compliance data is becoming increasingly important, making robust data analytics efforts crucial to compliance auditing and monitoring programs. The “compliance by design” revolution has led to the growth of data analytics tools, key performance indicators and dashboards. These innovations help compliance teams monitor day-to-day business activities for risk, identify potential issues before they arise, and inform business and compliance leaders.

Due to the complexity of today’s life sciences risk profile, government entities such as the Department of Justice (DOJ) and the Office of the Inspector General (OIG) expect life science compliance programs to incorporate data analytics into their efforts. Given their extensive access to data, it is unsurprising that they expect you to have access to data as well. For instance, the DOJ instructs its prosecutors to consider how companies collect and analyze data as part of their compliance programs and encourages them to assess the use of data analytics techniques to review business data and identify compliance concerns. Similarly, the OIG encourages entities to consider using data analytics to identify and address compliance risk areas, tailoring these efforts based on an entity’s data volume and analytics capabilities. These are just two examples of a myriad of US and OUS government entities and their expectations of the use of data analytics in compliance programs.

But what is data analytics? Data analytics can be broken into two main components. The first component involves the collection, transformation and organization of data. However, that alone is inadequate. From that data, we need to be able to draw insights, make predictions or conclusions and drive informed decision making. There are four types of data analytics:

  1. Descriptive Analytics: Helps us understand what happened.
  2. Diagnostic Analytics: Explains why something happened.
  3. Predictive Analytics: Forecasts what will likely happen in the future.
  4. Prescriptive Analytics: Advises on how to act.

Analyzing your data is only as effective as the actions that you take as a result. Compliance programs should use data analytics to inform business leadership and compliance committees (e.g., audit, grants, arrangements, pricing). Allow your data to inform when it may become necessary to revise policies and procedures or your compliance training and education. Consider using the data to highlight the need for targeted training based on roles and responsibilities. In case of potential or suspected misconduct, data analytics can be a powerful tool during investigations. Over time, continued data analytics efforts can measure the impact of the measures you have taken and help you build more robust trends.

MediSpend’s Engagement Manager allows life sciences companies to manage the entire life cycle of interactions with healthcare professionals (HCPs). Engagement Manager enables our clients to plan, engage and pay HCP/Os for compliant activities that meet organizational business needs. Given the volume of data within Engagement Manager, incorporating a data analytics tool can provide immeasurable value to your auditing and monitoring program.

MediSpend’s Insights Pro is an incredibly valuable data analytics tool to help you monitor your HCP engagement and transparency compliance programs. Insights Pro can help your organization proactively predict, preempt, monitor and manage HCP program risks. It offers business intelligence and ad-hoc dashboard reporting functionality that allows anytime access to insights into all paid HCP/O engagements. By providing flexibility in creating your own reports and displaying insights professionally, Insights Pro allows you to examine all available data to gain intelligence, further inform strategic business decisions and proactively address compliance risks.

Interacting with HCPs is a key compliance risk for all life sciences companies due to potential US federal Anti-Kickback Statute, False Claims Act, Sunshine Act and other anti-bribery/anti-corruption issues. Because of these risks, data analytics tools are crucial to your HCP engagement auditing and monitoring efforts. Data analytics, through MediSpend’s Insights Pro, allows you to proactively “paint the picture” of how well your HCP program is functioning, identify key watchouts and address potential areas for further review.

Ready to elevate your compliance program with cutting-edge data analytics? Don’t wait for compliance issues to arise—proactively manage risks and drive informed decision-making with real-time insights. To learn more, contact us.

 

Jay Ward
Director of Life Science Solutions

June 5, 2024