Sometimes we feel as though we have gone back in time. The Super Bowl is in San Francisco this week, as it was 10 years ago, although this time around, the atrium lobby of our building has been converted into an ESPN studio. We are the temporary home of the Rich Eisen Show, with the
Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work
Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly affect the prices of the
Updating the Model Ag Data Use Agreement
Five years ago, the Ag Data Transparent (ADT) organization was receiving inquiries from companies who supported transparency efforts but didn’t know where to start in developing their agreements with farmers. To address this need, ADT developed a “Model” Ag Data Use Agreement for companies collecting agricultural data from farmers. The model agreement was a huge
Texas Denies Tax Exemption for Hydrogen Fuel in Data Centers
Investment into data centers continues to increase significantly as the country builds out infrastructure to accommodate the digital economy and growth of artificial intelligence. Many states, including Texas, have now implemented various tax incentives to encourage investment in the state while simultaneously grappling with the taxable aspects of data center fuel. In November 2025, the
AI in Vendor Workflows: Protecting IP Through Contract Design
Vendors are going to use AI. In software work, it now sits inside everyday delivery: summarizing requirements, turning meeting notes into action items, accelerating early code scaffolding, generating test cases, even helping troubleshoot bugs. A services agreement works best when it assumes that reality and then asks a more practical question: where does the client’s
“Deregulation” on the Menu: Big Changes for Wellness and CDS Technologies
Last week, the U.S. Food and Drug Administration (“FDA”) rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final guidance documents released on January 6, 2026 pertain to (1) General Wellness Devices and (2) Clinical Decision Support Software,
FDA Continues Crack Down on DTC Advertising: Untitled Letter Highlights Pitfalls in Schizophrenia Drug Promotion
Just in time for the holidays, on December 15, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued an untitled letter (the “Letter”) to Karuna Therapeutics, Inc., a Bristol Myers Squibb Company, concerning a direct-to-consumer broadcast ad for Cobenfy™ (xanomeline and trospium chloride), a drug approved for the treatment
Guest Post – The AI LEAD Act: A Step Toward Regulating AI Product Liability in the United States
Today’s guest post is by Reed Smith‘s Jamie Lanphear. Like Bexis, she follows tech issues as they apply to product liability litigation. In this post she discusses a pro-plaintiff piece of legislation recently introduced in Congress that would overturn the current majority rule that electronic data is not considered a “product” for purposes
Fusion Energy: Powering the Future
Fusion energy, the same process that powers our sun and stars, is rapidly moving from scientific theory to commercial reality. In a fusion reaction, two light atoms—typically deuterium and tritium—combine to form a helium nucleus and a neutron, releasing an immense amount of energy. This energy, primarily in the form of heat, can be harnessed
European Commission Adopts Proposal for the Biotech Act
Introduction
On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here). The Proposal follows a public consultation held between August 2025 and November 2025 (see here