In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case. United States of America ex rel. Kipp Fesenmaier v. The Cameron-Ehlen Group, Inc., et al., Case No. 13-cv-3003 (D. Minn., Feb. 8 2024) (Dkt. 1086).
HHS Addresses the Growing Influence of Artificial Intelligence in Health Care
This post was co-authored by Blair Robinson, a member Robinson+Cole’s Artificial Intelligence Team.
Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions, it has the potential to enhance patient
WHO Publishes Guidance for Ethics and Governance of AI for Healthcare Sector
The World Health Organization (WHO) recently published “Ethics and Governance of Artificial Intelligence for Health: Guidance on large multi-modal models” (LMMs), which is designed to provide “guidance to assist Member States in mapping the benefits and challenges associated with the use of for health and in developing policies and practices for appropriate development,
Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs
The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the
The First Virtual and Digital Health Digest of 2024
Welcome to the first Virtual and Digital Health Digest of 2024!
ONC Finalizes Information Sharing and Algorithm Transparency Rule
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations
AI, Phishing Attacks, Healthcare, and a $480,000 OCR Settlement under HIPAA
Phishing has long been a favorite tactic for threat actors (hackers) to commence a cyberattack. The rapid expansion of more adaptable and available artificial intelligence (AI) technologies, such as natural language processing and large language models, now fuels more ferocious phishing campaigns. The effects are being felt in many industries, perhaps most notably the healthcare
ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
Healthcare Policy in 2024: What’s Next?
As we head into a new calendar year, in the healthcare space it is worth reflecting on the events of the last few years, as a means of predicting what is likely to come. Last year, the focus in healthcare policy was very much on what will come after COVID; this year, we finally have
Groundbreaking U.S. Artificial Intelligence (AI) Rule May Mean A Healthier New Year In 2025 and Beyond
Exactly 12 days before Christmas, the U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) gave the health industry a unique gift buried in a 900+ page rule adoption. The gift? The first comprehensive U.S. regulation delineating the responsible use and oversight of AI used in connection with health care decision-making.