Health Law Scan

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.

Members of our vaccine taskforce recently published an important Insight outlining a selection of key legal considerations and updates as the COVID-19 vaccine rollout continues to take shape, including the status of the US Food and Drug Administration’s vaccine products, distribution, key legal issues at the state level, employer mandates and employee incentives, and important liability concerns.

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. The article discusses the recently published Federal Trade Commission and US Department of Justice’s Vertical Merger Guidelines as they relate to healthcare professionals considering vertical integration.

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. Catch up on what you may have missed below.

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). HHS has been working to provide updated reporting requirements that comply with this recently passed legislation.

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. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.

Please join us for a webinar on Thursday, January 14 at 3:00 pm ET to discuss the refreshed Paycheck Protection Program (PPP) and the new PPP Second Draw program. This program will highlight key provisions and guidance for businesses seeking to participate in the revived PPP under the Consolidated Appropriations Act, which may be of interest to readers of Health Law Scan.