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

Kristen Rosati Discusses De-identification Legal Standards During AHLA Webinar

As a nationally recognized leader in health information privacy and security, Coppersmith Brockelman’s Kristen Rosati was asked to participate in a 90-minute webinar “De-identification Demystified: Legal Standards, Risks, and Mechanisms to Prevent Re-identification” for the American Health Law Association (AHLA). Kristen explained the evolving legal standards for the de-identification or anonymization of data under various privacy laws, including HIPAA, 42 C.F.R. Part 2, the Common Rule, the California Consumer Privacy Act, and the European Union General Data Protection Regulation. She also discussed how to “future proof” de-identified data during this time of changing legal standards, through using the statistical expert method of de-identification.  A Past President of AHLA, Kristen is a respected mainstay within the nation’s largest educational organization devoted to legal issues in the health care field.  Kristen...

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