Kristen Rosati

Kristen Rosati Explains De-Identification at Privacy and Security Academy Workshop

A complicated web of laws regulates de-identification, including U.S. federal laws, state laws and the EU General Data Protection Regulation. During a workshop for the Privacy and Security Academy, Kristen Rosati provided a comprehensive overview of these overlapping regulations as well as a more in-depth look at HIPAA de-identification and associated challenges. Kristen’s presentation explored the HIPAA Privacy Rule de-identification methods, including expert determination and safe harbor. She also explained when genetic information is considered protected health information, and the prospect of the Common Rule treatment of genetic information identifiability changing over time. Finally, Kristen discussed “future proofing” data for evolving standards of de-identification. As a highly regarded “Big Data” and HIPAA compliance attorney, Kristen is a frequent speaker on topics related to health information exchange, health...

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ASU College of Health Solutions Lauds Mel Soliz’s Contributions to MDC Advisory Board

Mel Soliz Speaks at Health Current Summit about New Interoperability Rules

The deadlines to comply with new ONC and CMS interoperability, patient access, and information blocking rules are coming. Speaking at the Health Current Virtual Summit, Mel Soliz helped attendees understand the new rules and best practices to implement compliance. Health Current is Arizona’s primary resource for healthcare information technology and exchange, bringing together communities and information across Arizona. The organization helps more than 3,000 Arizona providers use information technology to improve people’s lives. Active in state and federal policymaking on data privacy and health information exchange, Mel frequently shares insights on these topics for local and national forums as well as industry publications. Additionally, she serves as a board member for the Arizona Society of Healthcare Attorneys.  Learn more about the Health Current Virtual Summit here. ...

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Kristen Rosati

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

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 Co-Presents National Business Institute Webinar on Start-to-Finish Nonprofit Formation

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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