Kristen Rosati Provides Overview of COVID-19 Response and Other 2020 Developments at AHLA Fraud and Compliance Forum

Kristen Rosati Provides Overview of COVID-19 Response and Other 2020 Developments at AHLA Fraud and Compliance Forum

At the annual American Health Law Association (AHLA) Fraud and Compliance Forum, Kristen Rosati informed health care lawyers on regulatory developments in 2020, including the public health and statutory responses to the COVID-19 pandemic.  Kristen’s presentation explored various pandemic-related legislation, including the Families First Coronavirus Response Act and the CARES Act, and pandemic-related regulatory guidance, such as HIPAA waivers. Kristen also discussed health care reform developments, including litigation over ACA premium stabilization and the Supreme Court decision on health plan coverage of birth control. Finally, Kristen explored the new information blocking regulations and developments in HIPAA enforcement.  Among the nation’s leading HIPAA compliance and “Big Data” attorneys, Kristen brings extensive professional experience to data breaches, health information exchange, data sharing for research and clinical integration initiatives. A former president...

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Sam Coppersmith to Co-Present at National Business Institute Webinar Tackling Intricacies of Non-Profit Law

Sam Coppersmith to Co-Present at National Business Institute Webinar Tackling Intricacies of Non-Profit Law

Non-profits with questions about bylaws, governance and taxation will benefit from Sam Coppersmith’s Oct. 26 webinar for the National Business Institute (NBI). In “Top Tips & Traps – Non-Profit Governance, Bylaws and Operations,” Sam will discuss IRS rules and state law considerations, while also providing tips for bylaw drafting and board committee structure. Sam has more than three decades of experience assisting local and national businesses, non-profit entities and individuals. A regular speaker for NBI, he covers a range of non-profit-related topics, including private foundations, forming a nonprofit, tax-exempt organizations, and serving on a non-profit board. Learn more about the webinar here, and use the promo code FSP50N when registering to receive a $50 discount. ...

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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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Sam Coppersmith to Co-Present at National Business Institute Webinar Tackling Intricacies of Non-Profit Law

Sam Coppersmith Educates National Business Institute Members About Nonprofit Board Oversight

Advising a nonprofit board requires extensive knowledge about duties, risks, and compliance obligations. During a recent National Business Institute (NBI) webinar, “Nonprofit Board Governance: Overcoming Common Challenges,” Sam Coppersmith led two one-hour sessions to help nonprofits set goals, monitor progress, and ensure bylaws and policies remain up to date.  Specifically, Sam offered guidance on identifying who is responsible for oversight, tasks that can and can’t be delegated, important questions to ask when reviewing finances, pitfalls to avoid, and the variety of policies and rules nonprofits must have in place for their protection.   Sam has more than three decades of experience assisting local and national businesses and nonprofit entities as well as individuals and small businesses. A regular speaker for NBI, he covers a range of nonprofit-related topics, including private foundations, forming...

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Kristen Rosati Explains Complicated Web of Laws Regulating Privacy in Oncology Treatment and Research at National Cancer Policy Forum

Kristen Rosati Explains Complicated Web of Laws Regulating Privacy in Oncology Treatment and Research at National Cancer Policy Forum

Kristen Rosati addressed the National Academies of Science, Engineering and Medicine National Cancer Policy Forum workshop on the role of digital health applications in oncology research and care. Kristen’s presentation addressed legal considerations around patient privacy and data security, in digital health applications. One of the nation’s leading “Big Data” and HIPAA compliance attorneys, Kristen focused on how the patient right of access, the patient right to direct disclosures to third parties, and the new information blocking and interoperability rules affect oncology digital health apps. She also provided an overview of privacy requirements for data sharing in cancer treatment and research, discussing the evolving standards for de-identification of genomic information.  With deep experience in data sharing for research and clinical integration initiatives, clinical research compliance, and biobanking and genomic...

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Kristen Rosati Recaps a Year of Health Law Developments for the AHLA Annual Meeting

Kristen Rosati Recaps a Year of Health Law Developments for the AHLA Annual Meeting

The COVID-19 pandemic dramatically changed the health law landscape, and Kristen Rosati helped summarize its impact in a year-in-review plenary session at the American Health Law Association (AHLA) Annual Meeting.  Kristen, a past president of AHLA and nationally recognized leader in health information privacy and security, joined two industry colleagues in highlighting key developments in health law from the last year, including the CARES Act and other COVID-related legislation; blanket regulatory waivers for Stark/AKS, HIPAA and coverage rules; the rise of telemedicine; significant Supreme Court decisions regarding health care reform; information blocking and interoperability; and OCR enforcement and data breaches. A respected mainstay within the nation’s largest educational organization devoted to legal issues in the health care field, Kristen has served in numerous leadership positions, including president of the...

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