On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions
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.
Latest from Health Care Law Today - Page 5
Episode 26: TLDR: A General Counsel’s Perspective on Digital Health
We are excited to announce a special series, TLDR. TLDR is focused on the digital health industry and the lawyers operating inside the companies innovating in the space, their work, the industry, and their experiences. In this episode of TLDR, my…
Regulation of Digital Health Products by FDA
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other…
AI in Health Care: Regulatory Landscape & Risk Mitigation
Health care, like most industries, is grappling with the proliferation of artificial intelligence (AI) and the novel risks and benefits it presents. Balancing these risks and benefits can be especially challenging for attorneys, as the laws and regulatory regimes that…
Episode 25: Post Pandemic: Time to Refocus on Your Compliance Program
In this episode, Judy Waltz, Co-Chair of Foley’s Health Care Practice Group, and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA, dive into what it takes to get back to “normal” for compliance programs following the…
IP Contracting Considerations for Software as a Medical Device (SaMD)
Advancements in the medical device space are increasingly driven by integrations of software, oftentimes as the fruit of the symbiosis between engineers at software development firms working with clinicians at research institutions. These technologies have the potential to improve the…
Protecting Innovations in SaMD & Biomedical Applications
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032. Innovations in biomedical…
Decentralized Clinical Trials Blog Series
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s home. Access to telehealth providers, local laboratories and…
CMS’ Latest Innovation Model – The Making Care Primary (MCP) Model Includes Focus on Social Determinants of Health
On June 8, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary primary care model, the Making Care Primary (MCP) Model. Highlights include the following:
- The MCP Model will run for 10.5 years, commencing on
…
Episode 24: The Rules Have Changed: Decentralized Clinical Trials for Drugs
In this episode, Partner and Co-Chair of the Firm’s Health Care Practice Group Kyle Faget, and Partner Monica Chmielewski are joined by Jodi Akin, Founder and CEO of Hawthorne Effect. Hawthorne Effect has embraced the decentralized clinical trial model…