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...

Read MoreRead More

Department of Labor Issues Initial Guidance and Mandatory Poster

A week after enactment of the Families First Coronavirus Response Act (FFCRA), the United States Department of Labor (DOL) has begun issuing guidance regarding the emergency paid leave provisions of the new law. (For our summary of the FFCRA, click here.) Employers should take particular note that the DOL’s news release and related Questions and Answers set the effective date of the FFCRA as April 1, 2020.  This is one day earlier than widely expected. The guidance documents published by the DOL include a Fact Sheet for Employers, a similar Fact Sheet for Employees, and a very helpful Q&A document that clarifies answers to some common questions. Some of these guidance documents have already been updated by the DOL since their initial publication, so the landscape is changing quickly. We recommend that employers review the...

Read MoreRead More
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...

Read MoreRead More

Kristen Rosati’s Health Care Data Expertise Included in Proceedings from National Academies Workshop on Neuroscience Data in the Cloud

The National Academies of Science, Engineering and Medicine just published its workshop proceedings from the Neuroscience Forum Workshop on Neuroscience Data in the Cloud. Coppersmith Brockelman’s Kristen Rosati, who was on the planning committee for the event and moderated the discussion of recommended privacy protection of data in the cloud, is prominently featured in the third chapter. One of the nation’s leading “Big Data” and HIPAA compliance attorneys, Kristen led a robust discussion of standards for de-identification, the risks of re-identification, and compliance with varying regulatory standards in Europe and the U.S.  Kristen has deep experience in data sharing for research and clinical integration initiatives, clinical research compliance, and biobanking and genomic privacy.  She is a Past President of the American Health Lawyers Association, the nation's largest educational organization devoted to legal issues in the...

Read MoreRead More
Scott Bennett Informs Healthcare Risk Management Readers About Compensation Compliance

Scott Bennett Brings Insight, Expertise to Webinar Exploring Artificial Intelligence and Healthcare Law

Artificial intelligence is poised to transform healthcare – and health attorneys must be prepared for it. Coppersmith Brockelman attorney Scott Bennett participated in a webinar hosted by the American Health Lawyers Association. Scott discussed the current legal framework for artificial intelligence in healthcare. He examined the FDA’s regulation of AI software, the FTC’s potential role in addressing consumer applications of AI, and the tension between existing privacy laws and the use and development of AI technologies. Scott is among the state’s leading attorneys representing hospitals and other healthcare providers. His extensive knowledge about data privacy and security, especially when it comes to HIPAA and protecting sensitive healthcare information, helps companies comply with the complex web of federal and state laws and regulations that govern the industry.  ...

Read MoreRead More

Kristen Rosati Appears on AHLA Speaking of Health Law Podcast

As a Past President of the American Health Lawyers Association, and a member of the planning committee of the 2020 AHLA Academic Medical Centers and Teaching Hospitals Institute, Coppersmith Brockelman’s Kristen Rosati was asked to record podcast about the AHLA AMC Institute  Speaking of Health Law podcast. During the 20-minute “2020 Outlook for Teaching Hospitals and Academic Medical Centers” episode, Kristen shared highlights from the AMC Institute and about her legal practice.One of the nation’s leading “Big Data” and HIPAA compliance attorneys, Kristen has deep experience in data sharing for research, development of artificial intelligence and clinical integration initiatives, clinical research compliance, and biobanking and genomic privacy.  Kristen, a Past President (2013-2014) of AHLA, is a sought-after national speaker on these issues and has been active in national healthcare policy.   Learn...

Read MoreRead More