Interoperability & Networked Medical Devices Fundamentals Training by Tonex
Healthcare systems increasingly rely on connected devices exchanging data across hospital networks, cloud platforms, and external partners. This program equips engineers, architects, and compliance teams to design, integrate, and safeguard device data flows without disrupting clinical operations. You will learn how to select and secure communication protocols, harden interfaces, and validate interoperability with rigorous testing. Cybersecurity impact is addressed throughout, emphasizing threat modeling for device-to-cloud and device-to-HIS pathways, secure use of HL7, FHIR, and DICOM, and defense against lateral movement. You’ll leave ready to meet MDR expectations while maintaining safety, reliability, and clinical effectiveness.
Learning Objectives
- Explain end-to-end data flows across devices, gateways, HIS, and cloud
- Compare protocol stacks used in clinical environments
- Map MDR requirements to design controls and verification
- Plan and execute interoperability and conformance testing
- Apply risk management for device-to-cloud and device-to-HIS pathways
- Strengthen cybersecurity by securing HL7, FHIR, and DICOM data exchanges
Audience
- Medical device engineers
- Systems and network architects
- Quality and regulatory professionals
- Clinical informatics specialists
- Product managers and solution owners
- Cybersecurity Professionals
Course Modules
Module 1 – Connected Care Basics
- Clinical data pathways overview
- Device, gateway, HIS roles
- On-prem vs cloud boundaries
- Identity and trust anchors
- Data integrity and provenance
- Safety–security co-engineering
Module 2 – Protocol Foundations
- HL7 v2 message flows
- FHIR RESTful resources
- DICOM network services
- IEEE 11073 device profiles
- MQTT/AMQP for telemetry
- TLS and mTLS handshake
Module 3 – Device-to-Cloud & HIS Risks
- Threats in northbound traffic
- East–west lateral movement
- API exposure and abuse
- Token theft and replay risk
- PHI leakage and mapping
- Misconfigurations at scale
Module 4 – Securing HL7, FHIR, DICOM
- HL7 over TLS and routing
- FHIR scopes and OAuth2
- DICOM TLS and AE titles
- Schema/Value-set validation
- Message signing and hashing
- Audit, trace, and logging
Module 5 – Interoperability Testing
- Conformance vs compatibility
- Negative and fuzz testing
- Contract testing for APIs
- Plug-a-thon style checklists
- Synthetic data and fixtures
- Test automation pipelines
Module 6 – MDR Compliance in Practice
- MDR essential requirements mapping
- Risk controls and verification
- SBOM, patching, and updates
- Post-market surveillance signals
- Supplier and interface control
- Technical file documentation
Ready to build safe, compliant, and cyber-resilient integrations across devices, HIS, and cloud? Enroll in the Tonex Interoperability & Networked Medical Devices Fundamentals Training and empower your team to deliver interoperable systems that meet MDR expectations without compromising clinical care.