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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This article discusses the U.S. Food and Drug Administration's draft guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.

This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.

The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 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 provides an overview of current trends in using AI systems to meet the challenge of extracting clinically useful information from highly complex genomic data.

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).

The recent trial in a case now settled highlights the potential expansion of public nuisance claims under California law, and in large-scale public nuisance actions more broadly.

This article reviews several health care merger and acquisition (M&A) from 2022 and Q1 2023. Many of last year’s deals were underscored by significant ties to artificial intelligence (AI) technologies, a trend likely to become more prevalent going forward.

Canada is an attractive market for pharmaceutical manufacturers. Most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada.

Editor's note: This article was updated to reflect recent developments; the original version of this article was published on December 16, 2020.

The September 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada. That scheme is now much closer to the United States' (US) Hatch-Waxman scheme, but with remaining key differences that are explained in this chart.