Kristen Rosati

Kristen Rosati Recaps a Turbulent Year in Healthcare at the American Health Law Association Academic Medical Centers and Physicians-Hospitals Institutes

After more than two years of pandemic challenges and a string of new legal developments, Kristen Rosati reviewed the years’ challenges at the American Health Law Association (AHLA) Academic Medical Centers and Teaching Hospitals Institute and the AHLA Physicians and Hospitals Law Institute. Rosati educated legal counsel, compliance officers, and government representatives about health care reform efforts, vaccine mandates and COVID-related legislation and funding, HIPAA and other health information privacy and security developments, and hot news in clinical research and the life sciences industry. As one of the nation’s leading “Big Data” and HIPAA compliance attorneys, Kristen has extensive experience in data sharing and health information exchange, among other areas. Kristen is a Past President of AHLA and is sought-after speaker on these issues....

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Amanda Coulter Provides Insight into COVID-19’s Impact on Clinical Research in AHLA Podcast

To examine how COVID-19 has impacted clinical research, the American Health Law Association (AHLA) assembled an impressive panel of experts that included Amanda Coulter. Amanda, who routinely advises health care industry clients on clinical research matters, shared her insights on AHLA’s Speaking of Health Law podcast. In addition to discussing the pandemic’s short- and long-term impacts on clinical research, the panelists provided insight on the expanded access pathway for unapproved drugs, biologics, and medical devices, as well as COVID-19 vaccine development. In addition to developing research compliance policies and processes, template forms, and template agreements, Amanda reviews and negotiates clinical trial agreements, confidentiality agreements, data use agreements, business associate agreements, and federal grants and subcontracts. Listen to the full podcast here. ...

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