A medical device does not operate in isolation. Its hospital connections, cloud services, and software update path extend the attack surface and can affect patient safety.
Illustrative connected-device architectureEach boundary needs its own controls
Clinical data
Release artifacts
Verified install
Clinical data
Authenticated APIs
Authenticated APIs
Release artifacts
Clinical data may flow in both directions. The release path delivers authenticated software to the device; it is not a patient-data path. Cloud use, direct connectivity, and installation workflows vary by product.
Example only, not a validated product architecture. Hospital-managed gateways or offline update media may replace some connections.
Medical device
Cyber risk
Exposed services, weak credentials, or altered software can affect device availability and the integrity of clinical measurements.
Safeguards
Restrict interfaces, use unique identities, protect boot integrity, and define safe behavior if connectivity is lost.
Evidence to retain
Interface inventory, safety-linked threat model, and security test results.
Follow the connections into your threat model
Map the actual interfaces and trust boundaries for your product. For each connection, identify what crosses it, who controls it, and how a loss of confidentiality, integrity, or availability could affect clinical use.
1. Define the system. Include device software, gateways, hospital integrations, remote services, and the release pipeline. Record dependencies even when another organization operates them.
2. Connect cyber harm to clinical harm. Consider delayed therapy, unavailable measurements, altered patient data, and loss of essential performance, not only data breaches.
3. Agree on shared responsibilities. Document manufacturer, hospital, and service-provider responsibilities for configuration, access, monitoring, updates, and incident response.
4. Test failures as well as attacks. Verify behavior during network loss, cloud outages, rejected updates, and recovery under representative clinical conditions.