Because SaMD often resides on commercial devices or in the cloud, cybersecurity is a critical engineering requirement. A security breach in a SaMD could lead to the exposure of Protected Health Information (PHI) or, more critically, the delivery of incorrect medical information that could harm a patient. SaMD must be developed following "Security by Design" principles, incorporating encryption, multi-factor authentication, and secure boot processes.

Regulatory bodies now require a "Software Bill of Materials" (SBOM)—a nested list of ingredients that make up the software components. This allows healthcare providers to quickly identify if a SaMD is vulnerable when a new software exploit is discovered. For an analysis of the compliance requirements for HIPAA in the US and GDPR in Europe, the Software as a Medical Device Market industry reports offer a detailed perspective.

Furthermore, data "interoperability" is a major technical focus. SaMD must be able to securely exchange data with Electronic Health Records (EHR) using standardized protocols like FHIR (Fast Healthcare Interoperability Resources). This ensures that the insights generated by a standalone app are integrated into the patient’s broader clinical history, preventing "data silos" and ensuring continuity of care.