Two ways to build a device registry
The submission model
Clinical work happens in one system. Afterwards, someone extracts or re-enters a subset of it and submits it to a registry. Completeness depends on every centre finding the time, the record stops at the moment of submission, and the registry can describe the past but cannot act in the clinic.
The Living Registry
The clinical system and the registry are the same thing. Implants, follow-ups, remote transmissions and safety actions are captured once, as care happens, and stay connected to the patient. The registry is current, longitudinal, and able to put a safety flag in front of a clinician.
Five things a modern registry has to do
A static registry is something you query after the fact. A living registry is something you operate every day.
- Update continuouslyData is captured as part of routine workflow, not retrospectively. That is when it is most accurate and least burdensome.
- Connect the full device storyDevices, leads, procedures, follow-ups, outcomes and replacements linked into one longitudinal record.
- Support decisions at the point of careWhat device does this patient have? Is the lead MRI conditional? Has it been replaced? Answered in seconds.
- Deliver traceability by defaultAudit logs, structured capture, consistent identifiers and device-level traceability built in, not layered on afterwards.
- Enable the next layer of carePredictive analytics and early warning are only possible if the underlying data is timely, structured and longitudinal.
What builds it
- ImplantsPatient, generator and leads captured in the lab, serials validated. Implant workflow
- Follow-upsIn-clinic checks, including programmer data. ProLink
- RemoteTransmissions reviewed in one queue. Remote Link
- Field safetyNotices, affected patients, actions and outcomes. Field Safety
- MovementPatients followed up, revised or replaced at another hospital
What the first hospital in a new country gets
A network takes time to build. None of these depend on one.
- A whole-life device record from day oneImplant, programmer, clinic and remote data in one place, rather than a remote-monitoring inbox beside a separate implant database.
- Field safety across your own sites, in minutesBulk serial matching, group actions and clinical intercept work within a single hospital or network from go-live.
- No separate HRI registry data-entry stepRegistry-grade data is created through the clinical workflow rather than re-entered into a separate form. Any external statutory reporting your country requires is handled separately.
- A network that compoundsEach hospital that joins extends the same record, so patients who move are no longer lost between systems.
How the National Registry is governed in Ireland
The National Cardiac Device Registry in Ireland operates under a defined two-layer governance model. For clinical care delivered through HRI Pro, each hospital is data controller and HRI acts as its data processor, acting on the hospital’s instructions. For the cross-hospital National Cardiac Device Registry, HRI acts as data controller under data sharing agreements with participating hospitals.
HRI sets the registry architecture, cross-hospital access controls, retention framework and registry governance. Access is role-based and activity is audit logged. HRI’s role as registry controller does not provide unrestricted rights over patient data. Research and secondary use are subject to an appropriate lawful basis, governance, ethics requirements and technical controls.
Governance arrangements outside Ireland are established for each market and deployment in accordance with local law, health-system requirements and the agreed roles of participating organisations.
What a living registry makes possible
Cross-hospital safety
A field safety flag raised in one hospital appears on the patient's record in every participating hospital, and completed actions report back. The Mater case study
No recorded follow-up, anywhere on the network
A hospital knows who missed its own clinic, not whether they were seen elsewhere. Where an expected next follow-up is recorded, HRI can surface patients with no recorded follow-up anywhere on the network within that window. Patient lists
Continuity for patients who move
Device history follows the patient between public and private hospitals, and into their own hands through HRI Plus. Nearly half of Ireland's registry data now originates from private hospitals, in one framework with public services. HRI Plus
Research on whole-life data
Longitudinal histories spanning implantation and follow-up provide a different foundation for predictive research than remote transmissions alone. Research and AI
Further reading from News & Insights
- The death of the annual reportWhy static registries fail modern cardiac care, and what a registry has to do instead.
- The data that disappearsWhen device records scatter across hospitals, clinicians decide with incomplete information.
- Ireland as a living laboratory for global health infrastructureLarge enough to deploy nationally, cohesive enough to align quickly.
- Pulse+IT: Ireland's Living Registry, a blueprint for connected cardiac care in AustraliaAustralia's health technology publication on the Living Registry model and the coming TGA device identification rules.