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6.03.26
The Life Sciences Report – June 2026
This latest edition features articles on accelerating new therapies under the new FDA administration, cash-pay healthcare companies possibly facing kickback and fee-splitting risk under federal and state laws, building in-house legal teams for biotech, digital health, and medical devices companies, and life sciences venture financings for firm clients across 1H2025 and 2H2025.
News Articles
4.10.26
Jodi Daniel Quoted by KFF Health News and CNN on Healthcare Privacy Concerns
Wilson Sonsini partner Jodi Daniel was recently quoted in a KFF Health News article, which was also featured by CNN. The piece, titled "Trump’s Personnel Agency Is Asking for Federal Workers’ Medical Records," explores the Trump administration's notice regarding access to medical records of federal workers, retirees, and their families. The proposal has raised concerns about whether the collection meets requirements under the HIPAA privacy rules, which only allows health plans to disclose individually identifiable health information for limited purposes and even then only the minimum necessary. Concerns have also been raised about the Office of Personnel Management (OPM) having access to large amounts of health information, which would no longer be subject to HIPAA. Jodi, who played a pivotal role in shaping the legal framework for the HIPAA privacy rules over 20 years ago, commented, “The language in it [the OPM notice] seems quite broad and encompasses potentially a lot of information and data and is light on justification."
Alerts
4.06.26
FTC Announcement of Healthcare Task Force Coincides with Joint DOJ/FTC Appearance at ONC Annual Meeting
Two recent developments suggest that enforcers are poised to grapple with antitrust concerns in health tech, signaling an escalation of scrutiny into Information Blocking1 tactics that have persisted despite U.S. Department of Health and Human Services (HHS) rules and regulations designed to curtail such practices. Stakeholders and industry participants should be prepared for potential outreach.
Alerts
1.22.26
2026 Antitrust Year in Preview
Last year was a landmark in the development of antitrust law. Enforcers, legislators, and private parties grappled with the fundamental shift represented by artificial intelligence (AI) technologies, the resolution of important digital technology antitrust cases, and significant divergence in policy across a presidential administration transition. The changes will not stop in 2026. In this preview, we focus on several economic sectors that were most impacted by developments in antitrust law in 2025 to identify the trends that will drive governmental and private activity in antitrust in 2026.
News Articles
1.06.26
Wilson Sonsini Lawyer Andrea Linna Quoted by Inside Health Policy on State Laws Regulating AI in Mental Health Care in 2026
Wilson Sonsini partner Andrea Linna was quoted in an Inside Health Policy article titled “State Legislatures to Weigh AI Mental Health, Transparency and Sandbox Bills In 2026,” providing insight on state-level regulatory oversight of AI in mental health care. Andrea described how AI in the context of mental health remains top of mind for state legislatures “with states such as Illinois restricting how AI can be used in counseling services.”
News Articles
12.08.25
Wilson Sonsini Lawyer Andrea Linna Quoted by WSJ on AI in Healthcare
Wilson Sonsini partner Andrea Linna was quoted in a Wall Street Journal article titled “Counsel Health Grabs $25 Million for AI-Augmented Healthcare Service,” offering insight on federal regulatory oversight of AI in healthcare. Andrea explained that whether such systems fall under U.S. Food and Drug Administration regulation generally depends on “the intended use of the AI, whether a provider is in the loop and if the provider can make independent, informed clinical decisions and independently review the basis for the AI’s recommendations.”
Alerts
12.05.25
FDA Issues Updated Guidance on Expanded Access to Investigational Drugs
The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can obtain investigational drugs outside traditional clinical trials.
Client Highlights
11.17.25
Wilson Sonsini Advises Kura Oncology on Patent and Trademark Matters Related to KOMZIFTI’s FDA Approval
On November 13, 2025, Kura Oncology (Kura) and Kyowa Kirin announced that the U.S. Food and Drug Administration (FDA) has granted full approval for KOMZIFTI™ (ziftomenib). Wilson Sonsini Goodrich & Rosati advised Kura on patent and trademark matters.