On September 24, 2024, the Office of Management and Budget (OMB) released Memorandum M-24-18, Advancing the Responsible Acquisition of Artificial Intelligence in Government (Memo). The 36-page Memo builds on OMB’s March 2024 guidance governing federal agencies’ use of AI, Memorandum M-24-10, which we reported on here. The Memo addresses requirements and guidance for agencies acquiring
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Stringent Requirements for Pleading Fraud Under Rule 9(b).
Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”). Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws. Last week, the United
General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss
The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals. The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud
The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services
In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.
Putting the “AI” in Compliance—DOJ Updates its Corporate Compliance Program Guidance to Address Emerging AI Risks and Leveraging Data
On Monday, September 23, 2024, the Department of Justice (DOJ), released an update to its Evaluation of Corporate Compliance Programs (ECCP) guidance. The ECCP guidance was last revised in March 2023, which brought a number of significant changes, including a focus on compensation and incentive structures (e.g., clawbacks), and third party messaging applications. This
Future Promises of Compliance with Federal Laws Cannot Form the Basis of a False Claims Act Violation
The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit. The core issue in United States ex rel. Lynn v. City of Detroit revolved around Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition
How much (information) is too much? Caselaw shines a light on avoiding privilege waiver.
United States of America v. Sutter Health is exemplary of the delicate balance courts must strike when dealing with attorney-client privilege. Here, the United States District Court for the Northern District of California denied the relator’s motion for determination as to waiver of privilege, but granted alternative relief.
This case involves alleged violations of
Natural Intelligence: NIST Releases Draft Guidelines for Government Contractor Artificial Intelligence Disclosures
On August 21, 2024, the National Institute of Standards and Technology (NIST) released the Second Public Draft of Digital Identity Guidelines (hereinafter, “Draft Guidelines”) for final review. The Draft Guidelines introduce potentially notable requirements for government contractors using artificial intelligence (AI) systems. Among the most significant draft requirements are those related to the disclosure and
HHS Reorganizes ONC and Bolsters AI Leadership
On July 25, the Department of Health and Human Services (HHS) announced a number of organizational changes, including renaming the Office of the National Coordinator for Health Information Technology (ONC) to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), among other actions. These organizational changes reflect
Turning up the Heat on Junk Fees and Drip Pricing: Federal and State Regulations Require Increased Transparency into Pricing and Contract Cancellation
Call it the summer of junk fees and drip pricing. In July, California’s new drip pricing law went into effect and in August the federal government announced further proposed rules into junk fees and subscription services. Regulators say these proposed price transparency laws and regulations are consumer protection tools that will save consumers money, help