Cloud Infrastructure as the Foundation for Digital Health
🏥 The post argues that modern cloud infrastructure is the superior foundation for regulated Software as a Medical Device (SaMD), enabling faster innovation while meeting regulatory obligations. It outlines regulatory shifts in early 2026, including the FDA's QMSR alignment with ISO 13485 and the EU AI Act's applicability for high-risk systems. The author advocates Compliance as Code and describes three architectural planes—data, control, and evidence—on Google Cloud to deliver continuous audit readiness. It also highlights AI-driven monitoring and a shared fate model between cloud providers and manufacturers.
