Roche and other companies’ increasing reliance on digital and AI systems is colliding with stricter oversight and governance requirements. The European Medicines Agency said it will need to extensively rebuild the EU clinical trials database (CTIS) to comply with the proposed EU Biotech Act, which would affect roughly 70% of current CTIS functionality and support faster assessments and greater flexibility. In the US, new compliance pressure is emerging around free diagnostic testing programs. A report highlights enforcement risk under Anti-Kickback rules when test data is used to generate prescription leads, raising questions about how companies structure patient access initiatives without triggering regulatory violations. Meanwhile, companies and health systems are also grappling with operational reliability. Earlier detection tools for conditions like cognitive decline may create a “duty” gap when alerts aren’t linked to clinical pathways, according to commentary, amplifying the need for governance that connects model output to accountable care actions.