Apr 9, 2024
In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or...
Apr 1, 2024
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The...
Mar 26, 2024
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The...
Mar 5, 2024
In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance...
Oct 12, 2023
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators,...