OPINION: How a national data infrastructure transformed cardiac safety, compliance and clinical efficiency, and why Australia is primed to follow.

When Ireland replaced its static cardiac registry with a real-time, fully connected national system, it didn’t just modernise a database, it reshaped how an entire country manages device safety, compliance and patient care.

The transformation from retrospective reporting to living intelligence has created a model that other health systems, including Australia’s, are now watching closely. With new TGA Unique Device Identification (UDI) regulations due in March 2026, the timing for a similar move could not be better.

From static archives to living intelligence

Cardiac registries were created to improve accountability and track outcomes. But in practice, most remain clinically irrelevant archives: inaccurate, incomplete, and too slow to impact patient care.

They rely on manual data entry, introducing errors and inconsistencies. Many capture only the implant procedure and fail to follow the patient through years of device checks, remote monitoring, and replacements. Data is typically uploaded sporadically, then published in retrospective reports months or years later, far too late to guide real-world care.

Most importantly, these registries do not create a longitudinal patient record. Each entry sits in isolation, disconnected from what happens next. The result is a compliance tool, not a clinical tool.

As digital health systems mature and regulators demand full traceability, a new model is emerging, one that turns registries from static archives into living, learning infrastructures.

From static reporting to a living registry

What is needed now is a new model: the living registry.

A living registry is more than a database. It becomes the system of record for every implant and every follow-up. It captures not only the procedure but the full journey of the patient. And it connects hospitals so that clinicians share a single, real-time view.

This means:

• Every implant is logged at the source in theatre, with device and lead details captured accurately.

• Every follow-up and remote transmission is linked back, building a continuous longitudinal record.

• Hospitals and clinicians are connected so patients carry a single national record, not fragmented notes across institutions.

Instead of being a retrospective audit, a registry becomes a living, connected infrastructure that actively supports care delivery.

Compliance and traceability

Regulation is tightening worldwide. In Europe, the Medical Device Regulation (MDR) requires all implantable Class III devices such as pacemakers, ICDs and leads to be precisely identified and traceable. Hospitals must electronically capture and record these details across the full lifecycle of the device.

A living registry makes this seamless: every implant is logged at source, every lead traceable, every replacement recorded. Instead of adding burden, compliance becomes a by-product of normal workflow.

Making the registry part of clinical care

The key is ensuring the registry is not a bolt-on reporting tool, but a central part of clinical workflow. When data capture happens in theatre, and follow-ups and remote transmissions flow directly into the patient record, the registry stops being “extra admin” and becomes the backbone of safer, more efficient care.

That is how registries move from compliance to value, delivering better patient outcomes, fewer duplications, and earlier interventions.

A proven national model: The Irish example

Ireland has demonstrated the power of this approach by successfully implementing a truly national cardiac device registry.

Heart Rhythm Ireland (HRI), formally recognised by the Health Information and Quality Authority (HIQA) as Ireland’s national cardiac device registry, has operated for more than 15 years. The shift from a static, partially digital system to a fully connected living registry began in 2021, transforming how cardiac devices are tracked, managed, and monitored across the country.

The transformation was driven by:

• Integration with all major manufacturer programmers
• Automated extraction of structured data from device reports
• Barcode scanning at implant to capture device and lead identifiers

Today, all 50+ public and private cardiac hospitals in Ireland are connected to the registry, creating a national infrastructure for implants and follow-ups. The registry has now tracked over 100,000 patients and recorded more than one million follow-ups.

Hospitals have achieved full compliance with EU MDR Class III traceability requirements, and the registry has become central to how Field Safety Notices (FSNs) are managed nationally. More than 100,000 physical and virtual device ID cards have been issued to patients, giving them secure access to their own device data.

Clinicians report faster workflows, fewer data entry errors, and complete lifetime traceability of devices and leads, greatly improving patient safety. The registry is also enabling AI-based predictive analytics to identify early warning signs of patient deterioration and device-related complications, further strengthening Ireland’s leadership in connected cardiac care.

The system has been privately developed and funded, with strong collaboration from Ireland’s cardiac hospitals and industry partners.

Why monitoring platforms are not enough

Remote monitoring and data aggregation platforms have made progress. They consolidate multi-vendor data, reduce manual work, and even introduce AI filters.

But these tools are snapshots, not systems. They do not hold the national longitudinal record. They do not connect hospitals across the country. And they do not form the foundation for population-level predictive analytics. Only a registry can do that.

Australia’s opportunity

Australia has a unique chance to build on this proven model. With its strong digital health infrastructure, clinician-led innovation culture, and foundational elements like My Health Record, Australia can leapfrog past the limitations of static registries and siloed vendor portals.

The Therapeutic Goods Administration’s (TGA) new Unique Device Identification (UDI) regulations, due to be implemented in March 202, will accelerate the need for digital device traceability.

Australia would not necessarily need new legislation to create its own living registry. It could be achieved through national policy alignment and collaboration between hospitals, professional societies, and regulators, leveraging existing frameworks such as My Health Record, the Australian Digital Health Agency, and TGA standards.

Interest is already emerging from Australian clinicians and hospital leaders who see the potential of adopting a similar model. There is clear appetite to improve connectivity, compliance, and patient outcomes through real-time registry data.

Imagine:

• A national registry that shows every implant and follow-up in real time, connecting practitioners across states and territories.

• Seamless data flow between public and private hospitals, creating a unified patient journey.

• A longitudinal dataset powering AI models to predict complications, prevent hospital admissions, and support preventive care on a population scale.

By adapting the living registry model, Australia could not only improve outcomes but also relieve pressure on a health system where cardiac care remains a primary driver of cost and capacity strain.

Conclusion

Traditional registries are stuck in the past. They don’t give clinicians the full picture, and they do not save lives.

The next generation of registries must be living, predictive infrastructures, connecting hospitals, capturing every patient touchpoint, and transforming data into actionable intelligence.

Ireland has shown it can be done. Australia now has the opportunity to lead.

Because registries that only look backwards cannot change outcomes. But registries that look forward can.

About the author

Robert is the Founder and CEO of Heart Rhythm Ireland and the pioneer of the ‘Living Registry’ model. HRI is recognised by the Health Information and Quality Authority (HIQA) as Ireland’s national cardiac device registry and serves as the global blueprint for connected cardiac care.