Cybersecurity compliance for SaMD reached a new level of rigor in 2025 with the full implementation of the PATCH Act (Protecting and Transforming Cyber Healthcare). All SaMD manufacturers must now provide a comprehensive Software Bill of Materials (SBOM)—a machine-readable inventory of all third-party and open-source components used in the software. This allows hospitals to instantly identify which devices are at risk when a new "Zero-Day" vulnerability is discovered in a common code library.

The 2025 standards also mandate "Vulnerability Disclosure Processes" (VDP), requiring manufacturers to provide patches for security flaws within a 30-day window. For a technical breakdown of the encryption standards (AES-256) and the "Zero-Trust" architectures required for cloud-based SaMD, refer to the Software as a Medical Device Market industry analysis. As SaMD increasingly handles sensitive genomic and biometric data, these cybersecurity frameworks have become as critical to FDA clearance as clinical efficacy.