Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
The importance of adhering to regulatory demands continues an upward trend. Life science compliance is becoming more complex with heightened regulatory demands and evolving rules and regulations. With compliance programs playing a crucial role in risk identification, management, and remediation, leveraging a data-driven compliance solution to augment compliance program capabilities seems to be the way […]
Life sciences companies continue introducing novel therapies, treatments, and new scientific discoveries, such as Abbvie’s hepatitis C treatment [1] Mayvret, for treating patients without cirrhosis and with compensated cirrhosis. However, changing regulations, heightened scrutiny, and regulatory expectations have impacted life sciences companies and compliance professionals. The impact came with both challenges and opportunities for compliance […]
73%[1] of compliance officers indicate “increasing regulatory expectations” and “scrutiny with boards/regulators” as the top two sources of pressure. In the life sciences compliance world, non-compliance’s consequences are far from trivial. They can result in not only hefty fines but also potential criminal charges. Picture your organization facing a government investigation, and you’ll quickly understand the […]
Let’s start with the DOJ’s updated compliance guidance[1] for life sciences companies. They put forward clear expectations related to compliance, audits, and other functions and emphasized the importance of having access to data. But beyond access to data, they advised organizations to use data analytically to assess compliance throughout the organization, test the compliance program, […]
Life sciences companies rely on speaker programs to educate healthcare professionals (HCPs) about their products and services. However, these programs can also risk violating the Anti-Kickback Statute (AKS), which prohibits offering or receiving anything of value to induce or reward federal healthcare program business referrals. Data-driven compliance monitoring in the life sciences industry involves collecting […]
According to a study by the Office of the Inspector General (OIG), from 2016 to 2020, 13% of all Anti-Kickback Statute (AKS) enforcement actions involved kickbacks to HCPs. This suggests that the problem of kickbacks is still prevalent in the life sciences industry. What is AKS? AKS is a federal law that prohibits the offering […]
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