Kristen Rosati Plans and Moderates AHLA Convener Session on AI in Healthcare

Kristen Rosati Discusses Compliance Considerations When Sharing Health Data

Looking to educate health system clients about how they can enable compliant data partnerships between hospitals and companies, healthcare data company OMNY turned to Kristen Rosati to address the changing landscape, legal considerations and opportunities for future innovation. Kristen, one of the nation’s leading HIPAA compliance attorneys, joined OMNY Chief Operating Officer Sunny Grewal for a virtual fireside chat highlighting some of the finer details of HIPAA compliance. The conversation disclosure requirements and a discussion of HIPAA Privacy Rule de-identification methods. She also discussed how healthcare systems can use data for innovation, while remaining compliant with HIPAA and other regulations. OMNY is among the leading healthcare data companies in the nation. Through its work with healthcare facilities and companies, the organization supports data-driven innovation to improve patient...

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Kristen Rosati Plans and Moderates AHLA Convener Session on AI in Healthcare

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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