Leveraging AI in healthcare requires vast amounts of data, but navigating privacy and data security laws is crucial. A recent investigation into Australia’s I-MED Radiology Network highlights concerns about using medical data for AI. This case offers valuable insights for U.S. providers, especially regarding compliance with HIPAA and other regulations. Read more.
Texas Attorney General Settles with Healthcare AI Firm Over False Claims on Product Accuracy and Safety
The Office of the Attorney General of Texas (“OAG”) announced a “first-of-its-kind healthcare generative AI” settlement with Pieces Technology, Inc. (“Pieces”). The settlement related to the Texas OAG allegations that Piece’s advertising and marketing claims about the accuracy of its generative artificial intelligence (GenAI) products in violation of the Texas Deceptive Trade Practices – Consumer
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
Virtual and Digital Health Digest – September 2024
This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.
There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN
Private organizations benefit from HHS plan for state and local governmental AI use
The U.S. Department of Health and Human Services (HHS) has published its Plan for Promoting Responsible Use of Artificial Intelligence in Automated and Algorithmic Systems by State, Local, Tribal, and Territorial Governments in the Administration of Public Benefits (AI Plan for State and Local Governments). It shows the agency’s current thinking on managing risk from
AI: EMA publishes guiding principles on the use of large language models (LLMs)
On 5 September 2024, the European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) published a guidance document (the Guidance) with general principles and recommendations on the use of large language models (LLMs) in regulatory science and the regulation of medicinal products. The guiding principles for users are also summarised in a one-page
Solving for Physician Burnout: How Organizations Can Deploy AI Solutions to Effectively Support Physician Workloads and Avoid Legal Pitfalls
This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians. Clients regularly report that charting and documenting, and communicating with patients via EMR is a substantial contributor to physician burnout. Here, we discuss artificial intelligence
Medical: Professional obligations & AI in healthcare.
Ahpra has published guidance which explains how existing responsibilities in National Boards’ codes of conduct apply when practitioners use AI in their practice.
Some AI tools used in healthcare are regulated by the Therapeutics Goods Administration (TGA). The TGA regulates therapeutic goods that meet the definition of a medical device, which includes software (including AI-enabled
Healthcare & Life Sciences Private Equity Deal Tracker: WindRose Invests in MyndYou
WindRose Health Investors has announced an investment in MyndYou.
MyndYou, founded in 2016 and based in New York, is a provider of conversational artificial intelligence solutions for healthcare.
WindRose, based in New York, pursues control equity investments in healthcare companies. Founded in 2000, the firm invests in a broad range of industry segments,
Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation
In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within