The increased use of artificial intelligence (AI) in the banking, insurance, and financial services industries has led the New York State Department of Financial Services (NYDFS or Department) to publish an Industry Letter on October 16, 2024, that highlights cybersecurity risks resulting from the use of AI, the dangers posed by threat actors utilizing AI,
Virtual and Digital Health Digest – November 2024
This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.
Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government
Practice & Procedure: Generative AI practice note.
Practice Note SC 23 (Link to Supreme Court NSW)
Use of Generative Artificial Intelligence (Gen AI)
With thanks to Justine Anderson for drawing attention to NSW Supreme Court Practice Note SC 23, issued today with a view to commencement on 3 February 2025. Associated amendments to the Uniform Civil Procedure Rules will also come
New York State Department of Health Adopts Hospital Cybersecurity Regulations
Keypoint: With the increased frequency and severity of cyberattacks against healthcare systems, state and federal agencies strive to improve cybersecurity controls with varied success.
In November 2023, New York Governor Kathy Hochul announced proposed regulations that would be the first state regulations for hospitals in New York. The governor described the proposed regulation as a
The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk
A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain,
California Limits Health Plan Use of AI in Utilization Management
California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health care provider oversight when payors use AI to assess the medical necessity of requested medical services, and
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
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