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

Kristen Rosati Addresses Potential COVID-19 HIPAA Violations in Healthcare Risk Management

The COVID-19 pandemic brought increased risk of HIPAA violations, and Healthcare Risk Management turned to Kristen Rosati to help readers understand where they might go astray. In the article, “COVID-19 Changes HIPAA Compliance, But Caution Necessary,” Kristen discussed a possible rise in curiosity viewing. She shared how health care personnel members may want to know if a patient has tested positive for COVID-19, even if they aren’t treating the patient, or may be tempted to look up the records of family members, friends or neighbors. Kristen emphasized personnel should look at a patient’s record only for valid treatment reasons.   Kristen is considered one of the nation’s leading “Big Data” and HIPAA compliance attorneys. With extensive experience in data sharing for research, clinical integration and artificial intelligence initiatives, clinical research compliance, and biobanking...

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Kristen Rosati and Amanda Coulter Advise AHLA on COVID-19’s Impact on Clinical Trials

The COVID-19 public health crisis is having a profound impact on all aspects of the health care system. Kristen Rosati and Amanda Coulter teamed up to inform the American Health Law Association (AHLA) about how it will affect clinical trials.AHLA Weekly published their article, “How the COVID-19 Pandemic Immediately Impacts Clinical Trials: Considerations for Sites and Investigators,” which addresses the need for sites and investigators to be simultaneously rigorous and flexible. It also covers determining criteria to determine which trials will continue; vetting, implementing, and documenting changes for continuing trials; and communicating changes with sponsors and participants. Kristen, a nationally recognized and respected leader in health care law, has served in numerous leadership positions within AHLA – including president of the association from 2013-2014. She is considered one of the nation’s leading Big Data...

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COVID-19 LEGISLATION

COVID-19 LEGISLATION: What Employers Need to Know

In the early morning hours of Saturday, March 14, the U.S. House of Representatives passed the Families First Coronavirus Response Act (Act), which includes two sections providing emergency paid leave rights to employees. After some modifications by the House on Monday, the bill went to the Senate, which overwhelmingly approved it on Wednesday, March 18. President Trump signed it the same day.  The two leave-related components of the legislation take effect on April 2, 2020, 15 days after enactment, and sunset (expire) on December 31, 2020. For unstated reasons – but likely a political compromise – the law applies only to private-sector employers with fewer than 500 employees. (It also applies to public agencies of all sizes.) Below is a summary of what such employers need...

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