Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
The civil monetary penalties for violations of healthcare laws and regulations are on the rise. A few months back, we discussed the sharp increase in penalties under the Federal False Claims Act (FCA). With the initiation of an interim final rule, the per-claim FCA penalty was nearly doubled by the Department of Justice. The reason […]
Accidental discoveries often change the course of history. Take Alexander Fleming’s observation of penicillin, for example. However, in life sciences compliance, data-related discoveries tend to have far less fortunate outcomes. Undetected anomalies, inaccuracies, or misreported transactions can lead to severe regulatory penalties, reputational damage, and loss of trust. As regulatory bodies enforce stricter compliance mandates, […]
Ethical HCP engagement has become a crucial component of ensuring compliance and transparency in the interaction between healthcare professionals (HCPs) and life sciences companies. Engaging HCPs with integrity and following regulatory standards is essential for maintaining the trust of both the public and regulatory bodies, avoiding potential legal pitfalls and financial penalties. As regulatory scrutiny […]
In the reporting year 2023, life sciences companies reported 15.64 million records totaling $12.75 billion in general and research payments, ownership/ investment interests to physicians, teaching hospitals, and other categories. Over 11 years, the Open Payments program has published 84.05 million records, accounting for $72.80 billion in payments. Reporting Open Payments Data to the Centers […]
With regulations such as the U.S. Physician Payments Sunshine Act (Sunshine Act) mandating the disclosure of financial relationships with healthcare professionals (HCPs) and organizations (HCOs), ensuring compliance has never been more crucial. As these reporting requirements grow more complex, life sciences companies are under pressure to find better ways to track, document, and report these […]
As we step into 2025, life sciences companies continue to push the boundaries of breakthrough innovations that improve patient health, all while adhering to the rules and regulations enacted by regulatory authorities. Identifying and mitigating compliance risks remains at the forefront of this transformation, especially with the industry’s top priorities that continue to evolve the […]
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