Insights

Washington – June 17, 2025: Sharmistha Das, who most recently served at the U.S. Department of Homeland Security as deputy chief of staff and deputy general counsel, has rejoined Crowell & Moring as a partner in the firm’s Government Contracts Group. She also joins the firm’s Regulatory and Policy Department and will play a leading role in Crowell’s National Security practice, drawing on her experience at DHS working on highly sensitive intelligence matters.

On April 29, 2025, the Supreme Court heard oral argument in Laboratory Corporation of America Holdings, dba Labcorp, v. Luke Davis, et al., No. 22-55873. The Supreme Court had granted a petition for writ of certiorari in the case as to the following question: “[w]hether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” The Justices focused much of the oral argument on whether the case was moot, suggesting they may not reach the merits. And when soliciting argument on the merits, the Court appeared divided as to how to answer the question.

The Department of Health and Human Services (HHS) continues its push on health data interoperability with a proposed rule, HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology.  Specifically, HHS proposes to modify the Health and Human Service Acquisition Regulation (HHSAR) to implement an HHS-wide policy to align requirements related to the procurement of health IT with standards and implementation specifications adopted by the Office of the National Coordinator for Health IT (ONC) or compliance with the voluntary ONC Health IT Certification Program.  This proposed rule was published on August 9, 2024, just 4 days after the ONC proposed HTI-2 rule was published in the Federal Register.

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.