The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August 15, 2023. This guidance supersedes the FDA’s 1998 guidance
Health Care Law Today
Health Care Law Today, published by Foley & Lardner LLP, focuses on legal developments and regulatory issues affecting the healthcare industry. The blog covers topics such as digital health investment trends, telehealth privacy and security best practices, Medicare policy changes including behavioral health service expansions, remote patient monitoring regulations, and compliance with state vaccination requirements for healthcare facilities. It addresses the intersection of healthcare delivery, technology, and law, providing updates on federal and state regulations, reimbursement policies, and risk management strategies relevant to healthcare providers, payers, and investors.
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Decentralized Clinical Trials: Sponsor Responsibilities
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft guidance. While Sponsors’ core…
Episode 28: Let’s Talk Compliance: Medicare Advantage Compliance Enforcement Underway
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group interviews partner Michael Tuteur of Foley’s Government Enforcement & Defense Investigations Practice Group and Valerie Rock, Principal of PYA on Medicare Advantage compliance and enforcement trends and…
Podcast Episode 107: Sheridan Organ, Summer Associate
This episode of The Path & The Practice features a conversation with Sheridan Organ a summer associate in Foley’s Boston office. Sheridan discusses growing up in Winnetka, Illinois, attending McGill University and Boston University School of Law. She reflects on…
California: Proposed Regulations Impacting the M&A Market in California
Below we outline what you need to know from the recently proposed regulations if you are a health care entity evaluating a transaction in California that is expected to close on or after April 1, 2024.
Since the establishment of…
Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): A Deep Dive into Proposed Medicare Changes
On July 13, the Centers for Medicare & Medicaid Services (CMS) released its annual Proposed Rule updating the Medicare Physician Fee Schedule (PFS) for calendar year (CY) 2024, which includes various proposed changes related to the provision of remote physiologic monitoring…
Gender Affirming Care in Florida: Current Rules of the Road
Special thanks to summer associate Sheridan Organ for her contributions to this article.
On May 4, 2023, the Florida Senate passed SB 254 by a sweeping vote of 83 to 23. This law, which imposes restrictions on gender-affirming care in…
HRSA Uninsured Program COVID-19 Services: What Were the Standards to Determine Uninsured Status?
The Health Resources and Services Administration (HRSA) Uninsured Program (UIP), which reimbursed providers for provision of COVID-19 related services to uninsured individuals, paid out more than $24.5 billion in claims. Given this amount, it is no surprise that government enforcers…
Software as a Medical Device (SaMD): Health Care Regulatory Considerations
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the point that they themselves are now classified as medical devices…
The No Surprises Act: A District Court’s Decision Results in Federal IDR Outage
Although the No Surprises Act was signed into law almost three years ago and has been in effect for the past year and a half, there have been numerous delays in implementation and execution due to the complexity of elements…