HIQA's Review of the National Standards for Safer Better Healthcare: What's Driving It

HIQA has begun reviewing the National Standards for Safer Better Healthcare, driven by the EU AI Act, NIS2, CER and new patient safety legislation. What's changing and what providers should do now.

Johnny Meagher
Updated

HIQA has begun reviewing and updating the National Standards for Safer Better Healthcare — the standards that define expected quality and safety of care across HSE-provided and HSE-funded primary, community and acute healthcare services, and, since 2025, private hospitals too. First published in 2012 and revised in September 2024, these standards underpin HIQA's entire regulatory monitoring and inspection role in Irish healthcare, so an update of this scale is significant for anyone working under HIQA's remit, from ward-level clinical governance leads to boards responsible for organisation-wide compliance strategy.

Why HIQA is updating standards it only revised in 2024

HIQA has been explicit about what's driving this review, and the list is broader than any single piece of legislation. It cites legislative reform around patient safety and open disclosure, the ongoing commencement of the Assisted Decision-Making (Capacity) Act, a structural shift from hospital-centred to community-based care delivery, the lasting operational impact of COVID-19, the growth of digital and technology-enabled care, and a cluster of new EU and national law — the EU AI Act 2024, the NIS2 cybersecurity directive, the Critical Entities Resilience (CER) directive, and the European Health Data Space regulation.

That combination signals something important: this isn't primarily a patient-safety-driven revision in the way past updates often were. A significant part of what's pulling these standards forward is digital, cybersecurity and AI-governance law that simply didn't exist, or wasn't binding, when the standards were last substantively shaped. Healthcare providers should expect the updated standards to bring meaningfully more emphasis on technology governance, data resilience and AI oversight than previous versions did.

What the standards currently apply to

As things stand, the Safer Better Healthcare standards apply to HSE-provided and HSE-funded primary, community and acute healthcare services, excluding mental health services, which are covered by separate frameworks. Since 2025, the standards have also extended to private hospitals — a significant expansion of scope that brought a large part of Ireland's private healthcare sector under the same quality and safety framework as the public system for the first time.

Where the process stands

HIQA has said it is currently conducting an evidence review, with a public consultation to follow once that review is complete. No specific completion date has been published for either stage, so providers should treat this as an active, multi-stage process without a confirmed end date rather than assuming a near-term deadline. HIQA's Director of Health Information and Standards, Rachel Flynn, has said the update "will incorporate these changes and focus on what outcomes are important for people using healthcare services" — language that, consistent with HIQA's other recent standards reviews, signals a continued shift toward outcomes-focused rather than purely process-based inspection criteria.

What this means in practice for providers

Given the drivers HIQA has named, healthcare providers under its remit — including the private hospitals now newly in scope — should treat this as an early signal to start strengthening exactly the areas the cited legislation targets: cybersecurity and data resilience practices consistent with NIS2 and CER, any use of AI in clinical or administrative processes documented and governed in a way that would satisfy EU AI Act-style transparency expectations, and information-sharing practices that anticipate the European Health Data Space's interoperability goals. Waiting for the formal consultation and finalised standards before starting this work risks a compressed scramble later, in exactly the pattern seen with other HIQA standards updates working through the system in parallel — see our coverage of the updated National Standards for Residential Disability Services for a closely related example of HIQA building similar rights-based and technology-governance expectations into a different part of its standards framework.

This review also sits alongside HIQA's core inspection practice more broadly — organisations already working through the practical side of that, covered in our guide to HIQA inspections and staff training requirements, are generally better placed to absorb whatever the Safer Better Healthcare update ultimately requires.

FAQs

Do the current 2024 standards still apply while the review is underway? Yes — the existing standards remain in force. HIQA has not indicated any suspension of current requirements during the evidence-review and consultation process.

Will there be a chance to give feedback before the standards are finalised? Yes — HIQA has said a public consultation will follow the current evidence review, though no date has been confirmed.

Do these standards apply to private hospitals? Yes, since 2025 — an expansion from the standards' original HSE-provided and HSE-funded scope.

What's the biggest likely change based on what's driving the review? A stronger focus on cybersecurity, data resilience and AI governance, driven by the EU AI Act, NIS2 and CER directives and the European Health Data Space regulation, alongside continued movement toward outcomes-focused inspection criteria.

Learnsignal's Healthcare Compliance & CPD courses cover the quality and safety standards Irish healthcare providers are expected to meet as HIQA's regulatory framework continues to evolve.

This page was last updated:

Johnny Meagher

Expert Tutor at Learnsignal

Qualified professional with years of experience helping students advance their professional careers.

View all posts by Johnny Meagher

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