Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.
Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial
For anyone working in the health and life sciences industries and looking to complete a few final CLE hours before the end of 2025, Reed Smith will be hosting its annual Virtual Life Sciences CLE Week, taking place from November 3 through November 7, 2025.
This week-long event will feature a series of timely and
This post is the first in our three-part series, Gearing Up for HTLH USA 2025, where our team of attorneys will share insights on intellectual property, equity, and exit strategies and how these issues intersect in the transactional context.
Physicians are driving much of today’s health innovation. From new devices and digital tools to
This post is co-authored with Lauren Ludwig, legal intern at Robinson+Cole. Lauren is not admitted to practice law.
The Joint Commission (TJC) and Coalition for Health AI (CHAI) recently published the Guidance on the Responsible Use of Artificial Intelligence in Healthcare (Guidance), which outlines strategies for health care organizations to optimize their integration of health AI
Disaster telemedicine has transformed how medical teams respond to crises—from hurricanes and wildfires to pandemics and conflict zones. When physical access to healthcare becomes impossible, digital medicine becomes a lifeline. Yet, its implementation brings serious ethical, legal, and social questions.
The ethical challenge lies in balancing patient care quality with technological limitations. In emergency situations,
On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”).
The Request acknowledges the opportunities for AI,
We were quoted in a Law360 article summarizing a September 2025 decision by a Utah federal court to dismiss False Claims Act (FCA) allegations against our clients.
Butler and National Disability Insurance Agency (NDIS) [2025] ARTA 1579 (Link to AUSTLII)
In this matter the Tribunal affirmed the NDIA decision under review, in relation to reasonable and necessary supports.
Of interest are the comments of the Tribunal in relation to some expert opinions, following the NDIA’s submissions regarding the use of artificial
In recent weeks, vaccine policy has become a flashpoint at the state level. On September 3, 2025, the governors of Oregon, California, and Washington inaugurated a West Coast Health Alliance, a regional partnership aimed at preserving scientific integrity in vaccine policy amid growing skepticism toward federal health leadership. Through this partnership, the three states
Telemedicine Risks Have Evolved
In the early days of telemedicine, lawyers routinely counseled physicians on the “big risks,” which included: