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).
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State AG Updates: January 18-24, 2024
Each week, Crowell & Moring’s State Attorneys General team highlights significant actions that State AGs have taken. Here are this week’s updates.
Multistate
- A coalition of 26 state attorneys general sent a letter to the Federal Communications Commission (FCC) emphasizing the potential harm in the use of artificial intelligence by telemarketers and asking the FCC
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.
FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).
Crowell Presents “AI and Health Care: Perspectives from Policymakers and Movers in the Industry”
On November 2, Crowell hosted an in-person roundtable discussion, featuring government officials, industry experts and other stakeholders, to discuss the development of artificial intelligence (AI) and machine learning (ML) systems and tools in the healthcare sector as well as the government’s role in regulating such technology. Policy makers, thought leaders, healthcare innovators, and business executives
World Bank Issues Digital Health Recommendations in Report
On August 18, 2023, the World Bank issued a publication entitled, “Digital-in-Health: Unlocking the Value for Everyone (“World Bank Report”),” which recommends to governments a new digital-in-health approach where digital technology and data are infused into every aspect of health systems management and health service delivery to improve individuals’ health outcomes. The stated goal of
How President Biden’s Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence Addresses Health Care
On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” which establishes a policy framework to manage the risks of artificial intelligence (“AI”), to direct agency action to regulate the use of health AI systems and tools, and to guide AI innovation
Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
On November 8, 2023, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security discussed the impact of artificial intelligence (AI) on the healthcare sector in the Committee’s second AI hearing in nine days. The hearing comes as the White House and Congressional leaders seek to quickly respond to
European Data Protection Supervisor Releases New Opinion on the EU’s Proposed AI Act
On October 24, 2023, the European Data Protection Supervisor (EDPS), which is the supervisory authority for the EU institutions, bodies, offices and agencies (EUIs), published a new opinion on the widely discussed proposal for an EU Regulation laying down harmonized rules on artificial intelligence (commonly known as the AI Act Proposal). Although the EDPS
Biden’s Executive Order on Artificial Intelligence
On October 30, 2023, President Biden released an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI). This landmark EO seeks to advance the safe and secure development and deployment of AI by implementing a society-wide effort across government, the private sector, academia, and civil society to harness