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Legal Insights and Perspectives for the Healthcare Industry
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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).
Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.
Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.