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The Global Investigations Review Guide to Compliance

Client Alert | 1 min read | 08.12.24

As the primary civil enforcement statute for investigating and remedying fraud in connection with United States government programs, the False Claims Act (FCA) has resulted in more than $75 billion in recoveries of government funds since 1986. The FCA imposes liability on any person or entity that knowingly submits false claims or certifications to the government or improperly retains money owed to the U.S. government.

In this first-ever chapter on the False Claims Act published by the Global Investigations Review Guide to Compliance, Crowell attorneys provide an informed practical explanation of the requirements of the FCA for both U.S. and international companies and institutions. The chapter describes issues that arise in the investigation and litigation process, as well as common theories of liability in two industries that continue to be targets for FCA actions: government contracts and healthcare.

Insights

Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .  ...