Information Technology and Medical Device Integration
IT and medical device integration tests how devices join networks and clinical systems without creating new clinical risk. The focus is interoperability, cybersecurity, change control, and shared responsibility across clinical engineering and IT.
Core rules and concepts
- IEC 80001-1: risk management for IT networks incorporating medical devices; the connecting organization owns network risk, not just the device vendor.
- Interoperability: DICOM for imaging, HL7 v2 for many interfaces, FHIR for modern APIs; map data fields and test message integrity.
- Cybersecurity: inventory, segmentation, patching, default-credential removal, least privilege, and remote-access controls; FDA premarket cybersecurity expectations and SBOMs support assessment.
- Privacy: HIPAA safeguards apply to PHI on devices and interfaces.
- Change control: a network change can alter alarm delivery, latency, or availability; test before go-live. Network diagrams and asset inventories are prerequisites.
Worked example
A monitor is connected to the EHR through an HL7 interface. The risk review should examine data accuracy, latency, interface downtime, and unauthorized access. If the vendor cannot support patching, segmentation or replacement is a risk control, not an IT preference.
Traps
Do not assume encryption solves clinical availability. Do not leave default passwords. Do not treat a networked device as purely an IT asset after go-live.