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
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
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
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
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
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,
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
The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create far reaching legal and policy questions in the clinical research context.
In one of the latest installments of Reed Smith’s video series “AI explained”, Reed Smith attorneys Nancy Bonifant Halstead and Sarah Thompson Schick
In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world’s first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the
This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024 from United Kingdom, and European Union.
Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy