Health Law Scan

Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.

We hosted a very informative Fast Break session last week discussing what healthcare providers need to know as they prepare their employees to return to work and try to get back to a sense of normalcy. If you weren’t able to join us for the live program with Daniel Kadish, one of the leaders of Morgan Lewis's COVID-19 compliance and counseling team, be sure to access the presentation on demand or peruse the main takeaways below.

Members of our digital health and technology, outsourcing, and commercial transactions teams recently published a resource providing analysis of key considerations for tech service providers and life sciences companies collaborating in the digital health space, whether in regards to the development of artificial intelligence or other software, the provision of data hosting and analysis services, or a more complex collaboration.

Members of our labor and employment team recently published a LawFlash discussing the US Department of Labor’s (DOL’s) April 14 issuance of three pieces of subregulatory guidance addressing the cybersecurity practices of retirement plan sponsors, vendors, and plan participants respectively. This resource, which includes our team’s analysis and observations, may be of particular interest to employers in the healthcare sector, who are all too familiar with how important it is to keep data secure.

We invite Health Law Scan readers to join Morgan Lewis for an upcoming webinar series, Privatization of the Vaccine Rollout, which will explore the legal and regulatory issues for businesses that have become increasingly central to rolling out vaccines in the United States and around the globe.

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated.

Last month we had an incredibly insightful Fast Break analyzing a significant HIPAA enforcement victory for The University of Texas MD Anderson Cancer Center (MD Anderson) in the US Court of Appeals for the Fifth Circuit. If you missed our live program with Morgan Lewis partner Scott McBride and MD Anderson Deputy Chief Compliance Officer Krista Barnes, you can still view the presentation, or check out the highlights below.

Our immigration team recently published a resource discussing the expiration of Presidential Proclamation 10052 (PP 10052). This resource may be of interest to Health Law Scan readers, as this action may impact visa holders in the healthcare sector and will be highly beneficial for companies and employees seeking to resume global mobility.

It’s now been over a year since the COVID-19 pandemic was declared a public health emergency, ushering in monumental changes for telehealth regulation. If you’ve been following Health Law Scan, we hope our updates have provided some clarity to the everchanging regulatory healthcare framework and the legal issues that can vary across payers, across states, and even across countries.

We invite Health Law Scan readers to join Morgan Lewis for a sampling of upcoming webinars and speaking engagements featuring members of our healthcare industry team.