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The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.

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Articles

Unmuck Your Contract Lifecycle Management (CLM) Implementation

By Rebecca Yoder, Director, Legal Operations Consulting, Epiq

Contract Lifecycle Management (CLM) is often caught in cross-functional turf wars. Consequently, many find that the system in place is not the hoped-for “silver bullet,” especially as unmet requirements surface across the organization. Moreover, the benefits documented in the CLM business case may always seem just beyond reach, especially as phased roll-outs stall amidst frustration and disappointment that what was pitched by the vendor turned out to be more difficult to actualize than it seemed.

Articles

Navigating Multistate Practice for In-House Counsel

By Association of Corporate Counsel

In-house counsel in the U.S. are moving from state to state now more than ever. If you are going to work as in-house counsel in a state where you are not licensed, what do you need to consider?

Articles

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

By Nathan A. Beaver, Nathaniel M. Lacktman, Thomas B. Ferrante, Rachel B. Goodman, and Kyle Y. Faget (Foley & Lardner LLP)

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.

Articles

Employee Benefit Plans: Applying the ERISA Controlled Group and Affiliated Service Group Rules in the Health Care Industry

By Casey D. Knapp, Gage M. Maurer (Foley & Lardner LLP)

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.

Articles

FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices

By Jessa Boubker, Kyle Y. Faget, Nathan A. Beaver, Monica R. Chmielewski (Foley & Lardner LLP)

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. 

Articles

Florida’s New Prohibition on Offshoring Patient Information

By Jennifer J. Hennessy, Aaron T. Maguregui, Kate L. Pamperin (Foley & Lardner LLP)

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.

Articles

Software as a Medical Device: Challenges Facing the Industry

By Kyle Y. Faget, Nathan A. Beaver, Jessa Boubker, Thomas B. Ferrante, Rachel B. Goodman, Eric L. Sophir, Nicholas J. Zepnick, Austin J. Kim (Foley & Lardner LLP)

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).