The cloud platform is part of the connected medical device
A glucose meter syncs to a phone app and a clinician portal. A monitor streams telemetry to a hospital system. A therapeutic device reports usage and receives configuration. The backend carries obligations of its own.
What the platform does
Device provisioning and identity
Every unit in the field is uniquely known, authenticated, and can be revoked.
Telemetry ingestion
Receiving readings and status from devices at whatever scale the fleet reaches, usually over MQTT or a similar lightweight protocol.
Data storage and access
The patient data model, retention, and permissions designed for the regulatory regime the device falls under.
Clinician and patient interfaces
Web portals and mobile apps that present the data usefully.
Fleet management
Pushing firmware updates and configuration, and monitoring device health across the whole installed base.
The obligations
Privacy
In the US, device data tied to a patient is protected health information under HIPAA, which drives encryption in transit and at rest, access logging, least privilege, and a business associate agreement with the cloud provider. Other jurisdictions have their own regimes, and a device sold internationally has to satisfy all of them.
Cybersecurity
A connected device extends the attack surface from the device to every system it touches. Threat modeling covers the full path, and FDA's premarket cybersecurity expectations apply to the platform as well as the device.
Availability
A platform a clinician depends on cannot go dark. Redundancy, monitoring, and tested disaster recovery are part of the design.
Traceability
Changes to the platform are changes to a regulated system. Release management, validation of changes, and audit trails apply in the cloud just as they do in firmware.
Interoperability
Device data is worth more when it flows into the wider clinical record. HL7 FHIR is the standard for that exchange, and a platform that can publish device observations as FHIR resources integrates far more easily with hospital systems than one that exposes a proprietary API.
HL7 FHIR Integration →SequoiaAT builds the cloud side of connected medical devices as part of its hardware, firmware, and cloud device engineering, with the same design controls and validation frameworks applied end to end.
Related public work includes a HIPAA compliant AWS environment supporting real time HL7 FHIR R4 exchange across a multi site hospital network, and embedded systems and IoT work for connected medical devices and wearables.
Case study →