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.
Legal Insights and Perspectives for the Healthcare Industry
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.
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.
Our FDA team recently published an Insight covering key considerations for artificial intelligence (AI) healthcare application developers and users, highlighting the FDA’s current regulatory scheme for AI/machine learning (ML)-based software, potential FDA enforcement discretion that may apply, and recent FDA developments impacting AI/ML technologies.
In the most recent edition of our global telehealth series, we take a look at the United Kingdom’s telehealth expansion, discussing the UK National Health Services’ recently released guidance providing a set of best practice principles for third-party partners to follow. The LawFlash covers telehealth laws and regulations and the role of the EU General Data Protection Regulation, as well as looks forward to future changes and reform.
Our healthcare team recently published a LawFlash covering President Joe Biden’s two new health-focused executive actions, the Strengthening Medicaid and the Affordable Care Act and the Protecting Women’s Health at Home and Abroad memorandum.
Our healthcare team recently published a LawFlash on a significant victory in the US Court of Appeals for the Fifth Circuit for The University of Texas MD Anderson Cancer Center. The case involved an appeal of a proposed civil money penalty (CMP) related to a Health Insurance Portability and Accountability Act data breach enforcement action brought by the US Department of Health and Human Services' Office for Civil Rights (OCR).
Insight from our antitrust team was recently featured in an article for the American Health Lawyers Association’s Journal of Health and Life Sciences Law.
Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021.
The US Department of Health and Human Services (HHS) announced on Friday, January 15, 2021, one month before the former reporting deadline, that it will push back the CARES Act Provider Relief Fund (PRF) reporting timeline due to the enactment of the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 (the Act).