Artificial Intelligence

*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 The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML)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

Healthcare Information and Management Systems Society (HIMSS) kicked-off its annual global conference this week in Orlando, Florida, addressing leading topics in healthcare information technology. Over 45,000 healthcare and information technology professionals and 1,300+ vendors are expected to attend the week long event.  
Continue Reading HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology