This checklist provides a means to determine if your business is affected by the Utah Consumer Privacy Act (UCPA). If your business falls under this category, this checklist also covers building action items that move the organization toward compliance.
This article from Womble Bond Dickinson assesses some of the drivers of supply chain disruption in the U.S. and Europe and considers what businesses can do to mitigate the risks. These issues are likely to impact all sectors, however, they have particularly impacted the construction industry in recent years.
Despite improvements in cybersecurity-related disclosures, the SEC observed inconsistency in reporting practices. The objective of the new rules is to achieve uniform, comparable, and decision-useful disclosures that empower investors to make well-informed evaluations of a company’s cybersecurity posture. This resource from Womble Bond Dickinson delves into the final rules that enhance cybersecurity disclosure.
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 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This article discusses the U.S. Food and Drug Administration's draft guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.
This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.
The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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).