Artificial Intelligence

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas Adams’ “The Hitchhiker’s Guide to the Galaxy of Healthcare.” Well, not healthcare…for that you have to be here in San Francisco for the 42nd edition of this conference. It was indeed an intriguing day, for even without major announcements, there were very clear signs and portents of our coming year in the healthcare industry.Continue Reading Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

Recent developments in Artificial Intelligence (AI) have been transforming several sectors, and the healthcare industry is no exception. In the second episode of Sheppard Mullin’s Health-e Law Podcast, Jim Gatto, a partner at Sheppard Mullin and the co-leader of its AI Team, explores the significant implications and challenges of incorporating AI into the healthcare industry with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses the duality of AI—its promising utility and disconcerting risks—across a range of public and private sectors, including healthcare. Below are five key takeaways from the EO for the healthcare industry.Continue Reading AI’s Executive Order and Its Key Healthcare Implications 

The expanded use of artificial intelligence (AI) in the delivery of health care continues to receive increased attention from lawmakers across the country. Although AI regulation is still in its early developmental stages, there are various efforts underway to address the unintended negative consequences stirred by AI technology, particularly in health care and other key sectors.[1] Of particular interest are regulatory efforts to restrict discrimination through AI and related technologies.Continue Reading At a Glance: Legal Efforts to Limit Discrimination Through AI

At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our top 10 takeaways from what we heard, and did not hear, at HLTH 2023.Continue Reading Sheppard Mullin’s Top 10 Takeaways from HLTH 2023

At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be vastly improved while the costs to the system of unnecessary care can be dramatically reduced. Here at HLTH, venture capital firm General Catalyst announced it is seeking to change that paradigm with the launch of its Health Assurance Transformation Corporation (HATCo), seeking to transform healthcare with global risk arrangements while leveraging data and technology. Continue Reading At HLTH 2023: General Catalyst’s HATCo Introduces a Radically Ambitious and Transformative Model for Healthcare

Since its launch in November 2022, ChatGPT (“GPT” stands for Generative Pre-trained Transformer), a type of artificial intelligence model, has gained over a million users. ChatGPT is used by entities in a wide variety of industries. On March 1, 2023, OpenAI, the developer of ChatGPT, updated its data usage policies[1] noting that (i) OpenAI will not use data submitted by customers to train or improve its models unless customers expressly opt-in to share such data, and (ii) OpenAI also will enter into business associate agreements in support of applicable customers’ compliance with the Health Insurance Portability and Accountability Act (“HIPAA”).Continue Reading ChatGPT And Healthcare Privacy Risks

*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options.
Continue Reading Adapting To FDA’s Proposal For Diagnosis Support Software

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies.
Continue Reading New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Healthcare in the United States is at a crossroads, with technology, new market “disrupters,” and seemingly intractable problems converging. At least that was the central theme we observed at the annual meeting of the American Medical Group Association held from March 27-30, 2019. Over 2,000 medical group executives and physician-leaders descended on National Harbor, Maryland to attend the conference and hear presentations on a wide range of topics. 
Continue Reading Healthcare Executives and Physician Leaders Discuss Latest Trends and Challenges in Delivering High-Quality Patient Care at AMGA’s 2019 Annual Conference