Life Sciences

Earlier this month, Judge Rakoff of the Southern District of New York issued a first-of-its-kind ruling in United States v. Heppner. The case involved a criminal defendant, Heppner, who used a public generative AI platform (Claude) to “prepare reports that outlined his defense strategy (what he might argue with respect to the facts and the law that [his attorneys] anticipated that the government might be charging”). Although the defendant prepared the documents on his own, he later shared them with his attorneys. Heppner argued that these AI-generated documents should be protected by attorney-client privilege and the work product doctrine.

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This is the fourth in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals.

Many MedTech companies begin with one important relationship.

A health system agrees to test the product.
A strategic customer agrees to move first.
A commercial partner helps validate the market.

That is often how the first traction happens.

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This is the third in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals. On March 15, during SXSW, Husch Blackwell’s healthcare team will host two panels, bringing together founders and investors from healthcare, technology, and early-stage companies for candid discussion, practical insights, and plenty of time to connect.

Register here.

Department of Justice Bulk Sensitive Personal Data Transfer Rule (28 CFR Part 202) 

This post is part of our The Top 2025 Privacy and Security Issues Still Shaping Healthcare series, in which our team of attorneys provides essential strategies and insights for healthcare privacy and security.

Overview 

On February 28, 2024, President Biden signed Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” This order, implemented through the Department of Justice (DOJ) regulations (28 C.F.R. Part 202) and Cybersecurity and Infrastructure Security Agency (CISA) requirements, creates sweeping new restrictions on the transfer of Americans’ health data to certain foreign countries and entities. 

Blog SeriesConference Post (1)

This is the second in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals.

Collaborations often start with a simple premise: build something together, share the risk, and create value.

The complexity shows up later when investors or buyers ask who actually owns the platform.

In co-development structures involving devices and software, ownership and control are rarely binary. They are defined by layered licensing arrangements, regulatory allocations, manufacturing dependencies, and IP assignments that were often negotiated quickly to get a deal done.

Blog SeriesConference Post (1)

This is the first in a series of articles designed to provide SXSW and LSI USA ’26 attendees and other MedTech professionals with practical considerations for efficiently executing mission-critical life science deals.

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Left to right: Talia Rotman (Biomedical Engineering Intern), Julie Yip (Cofounder & Lead Engineer), Anu Parvatiyar (CEO & Cofounder), Saige Sunier (Product Development Engineer), and Hal Katz

What shows up once the story must survive the terms

At the outset of life sciences transactions, there is usually a strong sense of alignment. Founders and investors tend to agree on the importance of discipline, focus, capital efficiency, and long-term value. That was evident throughout JPM Healthcare Week and in conversations around RESI 2026, where many of the same themes surfaced across different rooms and discussions.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus

On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national health priorities and potentially marking a significant shift in the U.S. regulatory landscape for drug development. For life sciences companies, this program presents both a unique opportunity and new strategic considerations; however, while the promise of a much shorter review window is enticing, life sciences innovators would be wise to proceed with caution.

Scientists or physicians analyze sample

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key personnel on current regulations and any changes, and involve them in risk identification and mitigation strategies. Foster a culture of shared responsibility through ongoing training and open communication. Keep detailed documentation of the reasoning behind your procedures and policies, and store all standard operating procedures (SOPs) in a central, easily accessible location. Finally, implement a robust system for managing data and documents to ensure that all necessary information is readily available for internal and external monitors, as well as regulatory agencies.

Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors by medical practitioners, hospitals, clinics, and pharmaceutical companies. The memo set forth guidance for all Department of Justice (DOJ) employees to investigate individuals and entities who provide gender-affirming care to minor patients. To be clear, the memorandum—which has been posted in various locations on the internet and widely reported on by various media outlets but has not been verified as authentic by Husch Blackwell—is an internal policy statement directed to DOJ personnel and is not law. While it purports to issue “guidelines” pursuant to an executive order from the President, that executive order is itself under scrutiny (and has been partially enjoined).