CURRENT LEGAL ARTICLES

Dylan Green | Green & Associates Solicitors | Updated 25th March 2025

Artificial Intelligence (AI) is rapidly reshaping the face of modern healthcare — from enhancing diagnostic accuracy and supporting complex surgical procedures to forecasting patient outcomes and streamlining hospital operations. In Ireland, both public and private healthcare providers are beginning to adopt AI-driven systems to improve clinical decision-making and deliver faster, more efficient patient care.

However, alongside these technological advances comes a growing wave of legal uncertainty. As AI becomes more embedded in Irish hospitals and clinics, critical questions arise around accountability, safety, and professional responsibility. What happens when AI gets it wrong? If a patient is misdiagnosed by an AI tool or harmed due to a system error, who is legally liable — the treating doctor, the hospital, or the technology provider?

These questions are no longer theoretical. As AI continues to shape patient care, both clinicians and patients are now navigating unfamiliar legal territory. In this article, we examine the evolving legal landscape of AI-related medical negligence in Ireland — exploring how liability is determined, what legal protections currently exist, and what patients need to know if they’ve suffered harm linked to AI-influenced treatment or diagnosis, particularly within the framework of Irish medical negligence law.

Artificial Intelligence (AI) in medicine refers to the use of machine learning algorithms, data-driven systems, and predictive models that support healthcare professionals in diagnosing, treating, and managing patient care. These technologies are designed to enhance clinical decision-making, increase efficiency, and reduce human error by analysing vast amounts of data at speeds far beyond human capability.

In practice, AI is being applied in various areas of healthcare, including:

• AI-assisted diagnostics – interpreting medical images such as CT, MRI, and X-rays with high levels of accuracy, helping detect early signs of disease.
• Clinical Decision Support Systems (CDSS) – offering evidence-based recommendations to clinicians by analysing patient records, medical histories, and the latest research.
• Robotic surgery platforms – improving precision in complex procedures through computer-assisted robotic systems.
• Virtual triage and symptom checkers – using algorithms to assess patient-reported symptoms and guide them to the appropriate level of care.

Although AI adoption in the Irish healthcare system is still in its early stages, both public and private institutions are exploring its potential through pilot schemes and research collaborations. Notably, some Irish hospitals are trialling AI tools in radiology and diagnostics to alleviate resource pressures and support clinical staff. These innovations not only enhance clinical accuracy and workflow efficiency but also aim to improve patient safety by reducing diagnostic errors and treatment delays.

As these technologies continue to evolve and gain trust, the distinction between clinical judgment and machine-generated recommendations becomes increasingly blurred. This evolving dynamic raises important legal and ethical questions — particularly as Irish clinicians begin to rely more heavily on algorithmic input in patient care.

Under Irish law, medical negligence arises when a healthcare provider fails to deliver care that meets the expected professional standard, resulting in harm to the patient. To succeed in a medical negligence claim, four essential elements must typically be proven:

• Duty of care – the healthcare provider owed a professional obligation to the patient.
• Breach of duty – the provider failed to meet the standard expected of a reasonably competent practitioner.
• Causation – the breach directly caused injury or harm.
• Damages – the patient suffered measurable loss, whether physical, psychological, or financial.

This standard is typically assessed by considering whether a responsible body of medical professionals would have acted in a similar way — an approach influenced by the Bolam and Bolitho principles, which have been recognised in Irish case law when determining medical negligence.

In the context of artificial intelligence, a new layer of complexity arises. The key question becomes whether the medical professional relied on AI in a manner that deviated from accepted clinical standards or failed to apply proper independent judgment. If a clinician accepts a diagnostic output from an AI system without adequate scrutiny — and that leads to a misdiagnosis or treatment error — they may still be held liable under negligence law.

Importantly, AI does not remove or reduce the clinician’s duty of care. If its use undermines the standard of care expected in the circumstances, liability may arise. As outlined in our related article, Rising Medical Malpractice Claims in Ireland: Why Are Payouts Increasing?, the courts are increasingly scrutinising how modern tools and systems impact clinical responsibility — and compensation awards are reflecting this shift.

AI systems, no matter how advanced, are not legal entities — meaning they cannot be held legally liable. Responsibility for medical decisions, even those guided by AI, remains with human actors. When errors occur, liability typically falls on one or more of the following:

• Clinicians, who may be held accountable if they place undue reliance on AI-generated outputs without applying their own clinical judgment. For instance, accepting a diagnosis or treatment recommendation from an AI system without verifying its accuracy or relevance could constitute a breach of duty under Irish negligence law. This aligns with the Medical Council of Ireland’s Guide to Professional Conduct and Ethics, which emphasises that responsibility for clinical decisions rests with the practitioner — regardless of any technological assistance.
• Hospitals and healthcare providers, which may be liable under the principle of vicarious liability if an employee, such as a doctor or radiologist, misuses an AI tool or fails to properly question its recommendations. They may also be directly liable if they implement AI systems without adequate oversight, governance, or staff training.
• Software developers and medical device manufacturers, who may face product liability claims under Irish and EU law if a system is defective, produces misleading outputs, or fails to perform as expected. These claims are typically brought under the Liability for Defective Products Act 1991, which allows injured parties to seek compensation without needing to prove negligence. This is particularly relevant for AI systems classified as software-as-a-medical-device (SaMD), which must meet safety and regulatory standards under EU medical device frameworks.

As AI systems become more autonomous — and increasingly influence clinical decisions — these legal questions grow more complex. This is especially true when clinicians rely on black-box algorithms whose internal workings they may not fully understand, yet remain legally accountable for their outcomes.

Until regulatory frameworks in Ireland and across the EU fully address the use of AI in clinical care, liability will continue to be assessed under existing legal doctrines, often on a case-by-case basis. For patients, this evolving legal landscape can lead to confusion and frustration when seeking redress for errors involving advanced medical technologies.

The forthcoming EU Artificial Intelligence Act, which classifies healthcare AI systems as high-risk, is expected to introduce new regulatory obligations and accountability standards. Once implemented, it may significantly reshape how liability is assessed in AI-related medical negligence cases across Ireland and the wider European Union.

In Irish medical law, informed consent is a fundamental legal and ethical requirement before any treatment or procedure is carried out. It ensures that patients understand and voluntarily agree to the nature of the care they are receiving. For consent to be valid, it must be free, informed, and specific to the treatment involved.

Patients must be made aware of:

• The nature and purpose of the treatment or procedure
• The risks and potential side effects
• Any reasonable alternatives available
• Who — or what — will be involved in the decision-making process, including digital tools or AI systems

Informed consent is not merely a signed form — it is a process of communication and understanding between the clinician and the patient.

This duty is clearly established in both the Medical Council of Ireland’s Guide to Professional Conduct and Ethics and Irish case law. In particular, the High Court decision in Fitzpatrick v. White [2007] IEHC 506 confirmed that failure to properly inform a patient may result in a successful negligence claim — even if the treatment itself was carried out competently.

As the use of AI in Irish healthcare continues to grow, clinicians are increasingly relying on AI-driven platforms to assist with diagnosis and treatment planning. However, if a clinician uses an AI tool without informing the patient — especially when it plays a substantial role in decision-making — this may amount to a breach of the duty to obtain informed consent.

For example, if a patient is diagnosed using an AI-assisted imaging system and is not told that an algorithm played a key role, they may later argue that they were not fully informed. If this results in a delayed or incorrect diagnosis, the lack of transparency may give rise to a legal claim — not only for negligence but also for failure to obtain valid consent.

Transparency about AI’s role in clinical care is not optional. It is essential for maintaining ethical integrity and legal compliance. Clinicians should clearly explain:

• Whether AI is being used
• The extent of its involvement
• Any known limitations or risks associated with the system

This allows patients to make informed decisions about their own care — and protects their rights in an increasingly AI-driven healthcare system.

To date, no major Irish court decision has directly addressed the question of liability in AI-related medical negligence. However, legal developments in the UK and EU are already shaping how courts and regulators are beginning to respond to the growing use of AI in healthcare.

In a recent UK case, an AI-driven imaging tool failed to detect signs of cancer, leading to a significant delay in diagnosis. While the case was settled confidentially, it raised serious questions around algorithmic accountability — specifically whether the fault lay with:

• The clinician who relied on the AI tool
• The NHS Trust that implemented the system
• Or the software developer that built and deployed the technology

This case marked a turning point in public and legal scrutiny of AI’s role in clinical decision-making.

Across the EU, legal scholars and healthcare regulators are actively examining how traditional negligence doctrines apply to automated decision-making systems. The upcoming EU Artificial Intelligence Act is particularly relevant here — it classifies healthcare AI as “high-risk” and mandates:

• Transparency about how decisions are made
• Traceability of AI outcomes
• Human oversight to ensure accountability

These principles are likely to influence how liability is assigned when errors occur involving AI-supported treatment decisions.

While no Irish precedent exists yet, the integration of AI into diagnostic and clinical pathways is accelerating. It is increasingly likely that a case will arise in which a court must decide how liability is shared between clinicians, institutions, and technology providers.

The first such case in Ireland could establish an important legal precedent — one that shapes the future of patient safety, accountability, and medical negligence in an AI-powered healthcare system.

In many cases, AI tools used in healthcare — particularly those that assist with diagnosis, triage, or treatment recommendations — are classified as medical devices under both EU and Irish law. These tools are subject to regulatory requirements under the EU Medical Device Regulation (MDR) (EU) 2017/745, which applies to software-as-a-medical-device (SaMD) when used for clinical purposes.

If an AI system used in a healthcare setting is defective, malfunctions, or fails to perform as intended, the technology provider — including software developers, distributors, or system integrators — may be exposed to liability. Under Irish law, such claims are governed by the Liability for Defective Products Act 1991, which implements the EU Product Liability Directive.

Claims against developers or suppliers may be brought where harm is caused due to:

• Design flaws or coding errors in the algorithm
• Inadequate user instructions or warnings
• System failure during use in a clinical setting
• Unexpected performance issues, even in CE-marked products

It is not necessary for a patient to prove negligence — only that the product was defective and caused injury. This is a strict liability regime under Irish and EU law.

While many AI healthcare tools carry a CE mark, this only indicates compliance with minimum safety and performance standards under EU regulation. If a CE-marked tool does not perform safely in practice or creates an unacceptable level of risk, liability can extend beyond medical professionals to the companies that designed or distributed the system.

Unlike static tools, many AI systems continue learning after deployment — which can introduce unpredictable outcomes unless properly monitored.

This is especially relevant for AI platforms that evolve over time through machine learning. Where software behaviour changes after deployment, courts may need to examine whether adequate safeguards and post-market monitoring were in place to protect patients. Under the EU Medical Device Regulation, post-market surveillance is a formal regulatory requirement — meaning developers must proactively track performance, report safety issues, and take corrective action if risks emerge.

As Irish healthcare providers increasingly adopt AI tools, it’s critical to understand that responsibility does not rest solely with clinicians or hospitals. Technology providers may share liability if patients are harmed due to defective software — whether through design, functionality, or lack of proper disclosure.

This area of law is likely to evolve as courts test the boundaries of product liability in a digital, AI-assisted healthcare environment.

Artificial intelligence systems used in healthcare rely heavily on large volumes of sensitive patient data, such as medical histories, diagnostic images, and personal health information. The use of this sensitive data places significant obligations on both healthcare providers and technology vendors to ensure robust data protection measures are in place.

When AI systems experience a security breach, technical failure, or mishandling of patient information, this not only endangers patient confidentiality but also triggers legal consequences under Irish and European law.

Under the General Data Protection Regulation (GDPR) and the Irish Data Protection Act 2018, organisations must adhere to strict rules regarding data protection and patient privacy. If an AI-driven healthcare system is compromised, both healthcare providers (e.g., hospitals, clinics) and software developers/vendors may face:

• Significant fines and enforcement actions (potentially reaching millions of euros or up to 4% of global annual turnover under GDPR)
• Civil claims for compensation brought by patients affected by a data breach
• Regulatory investigations by the Data Protection Commission (DPC), Ireland’s data privacy authority

Healthcare providers and software developers alike must demonstrate proactive compliance by implementing technical and organisational safeguards, performing regular privacy impact assessments, and promptly reporting any breaches to the Data Protection Commission. Under GDPR, data breaches involving personal health data must generally be reported to the Data Protection Commission within 72 hours of becoming aware of the breach.

In the event of a data breach involving healthcare AI systems, affected patients have specific rights and legal remedies available to them under GDPR and Irish data protection legislation, including:

• The right to be informed about how their data is being processed and stored
• The right to access and rectify personal data held by healthcare providers or tech vendors
• The right to claim compensation for damage (financial, psychological, or reputational) arising from unauthorised access, loss, or misuse of their personal health data

Irish courts and the Data Protection Commission are increasingly vigilant in protecting patient rights regarding privacy and personal data, particularly as healthcare becomes more reliant on complex AI technologies.

As Ireland’s healthcare system continues to embrace AI-driven solutions, robust data privacy management is not merely good practice—it’s a legal requirement. Providers and software developers must remain diligent, not just to avoid fines, but also to uphold patient trust and ensure legal compliance within the rapidly evolving field of AI and healthcare data management.

The rapid integration of artificial intelligence into healthcare presents complex legal challenges that Irish law is only beginning to address. While Ireland currently relies on traditional legal frameworks—such as medical negligence law, product liability law, and data protection regulations—the growing use of AI-driven technologies highlights the need for clearer legal guidance and potentially new regulatory approaches.

In the coming years, Irish healthcare and legal professionals may need to navigate significant changes, driven by emerging European regulatory trends and national legal developments.

Looking ahead, several key developments are likely to shape the future legal landscape around AI in Irish healthcare:

• Shared liability models involving clinicians, hospitals, and technology companies, recognising the complexity and collaborative nature of AI-based decision-making.
• Establishment of clearer case law precedents, as test cases emerge that require Irish courts to define boundaries between human oversight and algorithmic responsibility clearly.
• AI-specific regulations, particularly through the anticipated EU Artificial Intelligence Act. The EU AI Act proposes stringent compliance standards for high-risk AI systems—including healthcare tools—and mandates requirements such as transparency, oversight, and accountability. Once enacted, this legislation will directly impact Irish law, compelling regulatory authorities, healthcare providers, and technology companies to adopt stricter governance practices around AI technologies.

The EU Artificial Intelligence Act, currently being finalised, represents Europe’s first comprehensive framework explicitly regulating artificial intelligence. This legislation classifies healthcare AI systems as “high-risk,” imposing obligations such as:

• Transparent documentation of AI decision-making processes
• Mandatory human oversight mechanisms
• Robust risk assessments and post-market surveillance
• Clear accountability frameworks for developers and users

Ireland, as an EU member state, will be required to integrate these regulations into national law. This will significantly influence how Irish healthcare organisations and technology providers develop, deploy, and maintain AI-based solutions, reinforcing the need for proactive compliance and diligent risk management.

Until dedicated AI legislation takes effect, Ireland’s existing legal frameworks—primarily medical negligence law, product liability law, and data protection regulations such as GDPR—will continue governing AI-related medical errors and patient claims.

During this interim period, courts will apply these existing laws case-by-case, adapting established legal principles to address novel situations presented by AI-driven healthcare. This transitional phase highlights the importance of careful risk management, clear communication with patients, and proactive compliance strategies by healthcare providers and technology companies alike.

Artificial intelligence offers extraordinary potential to improve healthcare in Ireland—from faster and more accurate diagnoses to enhanced treatment and patient outcomes. Yet, alongside these significant benefits come important questions of legal responsibility and patient protection. As AI systems become more deeply integrated into clinical decision-making, it is essential to clarify who is accountable when mistakes occur.

When a patient suffers harm due to an AI-influenced healthcare decision, responsibility may rest with:

• The clinician, who must exercise independent judgment and ensure proper oversight.
• The hospital or healthcare provider, responsible for adequate training, systems management, and governance.
• The software or technology provider, accountable for product safety, effectiveness, and compliance with regulatory standards.

For patients affected by AI-driven medical errors, transparency and accountability are paramount. Patients have a right to know how their care is influenced by AI and must understand clearly where liability falls if something goes wrong.

For medical professionals, healthcare institutions, and technology developers, embracing AI requires a commitment to robust ethical, legal, and regulatory safeguards. This includes clear communication with patients, rigorous oversight of AI systems, and compliance with emerging European regulations, notably the forthcoming EU Artificial Intelligence Act.

Irish courts will inevitably shape how liability is ultimately assigned, setting precedents as new cases emerge involving AI-driven medical errors. Ultimately, the future of AI in healthcare depends not only on technological advances but on trust, accountability, and a clear legal framework that protects patient rights. Irish healthcare providers, regulators, and legal professionals must work proactively to ensure that the integration of AI supports—and does not undermine—patient safety, transparency, and justice.

At Green & Associates Solicitors, we specialise in medical negligence cases involving AI and healthcare technology. Our expert team provides:

• Clear, confidential legal advice tailored to your situation
• Support in gathering medical records and evidence
• Proven expertise in complex clinical negligence and product liability cases

As an ISO 9001-accredited firm, we’re committed to excellence, clarity, and compassion. If AI-related healthcare decisions have led to harm or misdiagnosis, we’re here to protect your rights.

Contact us today for a confidential consultation.

The information provided in this blog is intended for general informational purposes only and does not constitute legal, medical, or professional advice. While Green & Associates Solicitors has made every effort to ensure accuracy and relevance at the time of publication, the information may not reflect the most recent legal developments, regulatory changes, or case outcomes in Ireland.

Every medical negligence case is unique. The examples, insights, and explanations provided here are not a substitute for formal legal consultation. If you believe you’ve suffered harm due to an AI-related medical error, misdiagnosis, delayed treatment, or any form of substandard care, we strongly recommend you seek professional legal advice specific to your circumstances.

Reading this blog does not create a solicitor-client relationship with Green & Associates Solicitors. Legal outcomes vary based on individual case details, and relying solely on this blog’s content without a legal consultation may lead to misunderstandings or incorrect assumptions.

Green & Associates Solicitors accepts no liability for any loss or damage resulting from reliance on the information presented. For tailored advice and legal representation, please contact our office directly to arrange a confidential consultation with a qualified solicitor.