The strategic allure of the U.S. Healthcare and Life Sciences (HCLS) market—as detailed in our previous installments—is undeniable. However, for a European acquirer, the transition from “Strategic Intent” to “Value Realization” requires successfully navigating a regulatory landscape that is currently undergoing its most significant shift in decades. In 2026, the complexity of this “maze” has intensified, driven by a post-shutdown FDA backlog, a new era of “relative” data privacy standards, and aggressive national security oversight.