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...more
Known for being resistant to grease, oil, water, and heat, per- and polyfluoroalkyl substances (PFAS) have had a number of applications in food-contact materials regulated by the US Food and Drug Administration (FDA)....more
Health care providers looking to explore or expand their involvement in value-based care through affiliation with an accountable care organization (ACO) have a large number of options available to them. In the Medicare space,...more
Steve Pine and Alexa Sengupta address the Centers for Medicare and Medicaid Services’ emerging focus on ESG and health equity priorities, and how these priorities are impacting health data collection and Medicare value-based...more
On 24 February 2022, the Centers for Medicare and Medicaid Services (CMS), through the Centers for Medicare and Medicaid Innovation (CMMI), unveiled the new “ACO REACH” Model (Accountable Care Organization Realizing Equity,...more