The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. This article discusses legal and regulatory considerations related to Software as a Medical Device (SaMD).
This article provides an overview of current trends in using AI systems to meet the challenge of extracting clinically useful information from highly complex genomic data.
This article covers a newly passed Florida law that requires health care providers and digital health technology platforms using certified electronic health record technology (CEHRT) to ensure that all patient information is physically maintained within the United States or Canada.
This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.
The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" — was issued on April 3, 2023.
This article discusses the U.S. Food and Drug Administration's draft guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.
This article discusses the friendly-PC model, which is a common structure designed to comply with state corporate practice of medicine doctrines. The friendly-PC model involves a professional service corporation (PSC) conducting a medical practice in affiliation with a management services organization (MSO).
Although the friendly-PC model may be a solution to the corporate practice of medicine doctrine, it can create unintended consequences for employee benefit plans sponsored by the PSC and MSO.
This article discusses the US Drug Enforcement Agency's (DEA) new regulation temporarily extending the “full set” of COVID-19 waivers for prescribing controlled substances via telemedicine.
Originally published by Foley & Lardner LLP on May 11, 2023.
This article discusses the ruling by a California Court of Appeal that ultimately determined a hospital's decision to terminate an employee for failing to comply with its flu vaccine mandate did not violate California's Fair Employment and Housing Act (FEHA).