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
UK government launches new Industrial Strategy and Advisory Council to boost economic growth
On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.
The Industrial Strategy will
Virtual and Digital Health Digest – October 2024
This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.
Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life
AI or not AI ? Réflexions sur l’« AI-Washing » à l’aune du droit français
IA par-ci, IA par là. L’intelligence artificielle est aujourd’hui incontournable et devient un argument de vente : « Notre produit à la pointe de la technologie utilise de l’IA ». A l’instar du « greenwashing », peut-on parler d’AI-washing ? Aux Etats-Unis, la SEC a récemment sanctionné plusieurs sociétés pour avoir fait croire à leurs clients qu’ils utilisaient des outils d’intelligence
Critical and Emerging Technologies Funding
Critical and Emerging Technologies (CET) are of vital importance to the U.S. government. Therefore, it has made CET funding and support a top priority.
The U.S. National Security Strategy identifies expanding economic prosperity and opportunity as one of three primary goals.
The following critical and emerging technology areas are deemed of critical importance to U.S.
UK government launches new Regulatory Innovation Office to reduce red tape
On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.
The RIO, established within the Department of Science,
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.
New California law to regulate automated claims processing using modern technology, like AI
California’s new law, SB 1120, set to take effect on January 1, 2025, regulates how health care service plans (HCSPs) and disability insurers use automated decision-making tools, such as artificial intelligence, to analyze medical necessity in utilization reviews affecting California enrollees. Compared to federal guidelines, this law is more prescriptive, requiring HCSPs and disability
EMA adopts reflection paper on the use of Artificial Intelligence (AI)
Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July 2023, and following many months of review of the feedback collected from the relevant stakeholders,
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