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Articles

Considerations When Conducting Decentralized Clinical Trials

By Kyle Y. Faget

Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.

Articles

What FQHCs Need to Know About Telehealth After the PHE

By Samantha Robbins Jamali Adam J. Hepworth

This blog focuses on the Biden Administration’s announcement on its intention to end the COVID-19 public health emergency (PHE) on May 11, 2023. For Federally Qualified Health Centers (FQHCs), flexibilities offered under the PHE expanded opportunities to be paid for telehealth services, particularly for Medicare patients. Any FQHC relying on PHE flexibilities should begin preparing for the end of the PHE to ensure its service offerings are in compliance with post-pandemic requirements.

Articles

Do Your Diligence: M&A Considerations Following OIG’s Special Fraud Alert on Telemedicine

By Asher D. Funk, Jonathan M. Ishee, Erin S. Whaley, and Michael J. Paluzzi, Troutman Pepper Hamilton Sanders LLP

Any entities that plan to invest or are already invested in digital health companies, entities that contract with them, or providers that offer in-house telehealth modalities must be aware of the significant regulatory oversight the industry faces. This article discusses the US Department of Health and Human Services' Office of Inspector General's Special Fraud Alert published on July 20, 2022, which was the same day the US Department of Justice announced a massive fraud takedown, targeting telemedicine providers and physicians that netted criminal charges against 36 defendants in schemes that allegedly defrauded the government out of more than $1.2 billion.

Articles

HHS Updates Pixels and Trackers Guidance for HIPAA Regulated Entities

By Aaron T. Maguregui and Jennifer J. Hennessy, Foley & Lardner LLP

Pixels, cookies, and trackers continue to be front of mind for HIPAA regulated entities seeking clarity on their ability to advertise, market, and engage with existing and prospective patients. On March 18, 2024, the U.S. Department of Health and Human Services (HHS) issued updated guidance on the topic.

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