The Complete Guide to Using AI in the Healthcare Industry in Malta in 2025

Malta's 2025 healthcare AI scene is a sprint: a national AI strategy, the MDIA's updated certification framework and the incoming EU AI Act are reshaping how hospitals and startups pilot tools from telemedicine to AI‑assisted imaging, while MDIA grants have already funded health projects including drug‑interaction research - clear signals that regulators and funders want innovation, not chaos.

Legal analysis warns laws will be strained as systems become more “life‑like,” and surveys and IMF studies point to skills gaps, rising compliance concerns and the need for cross‑functional governance, so clinicians, IT teams and legal officers must coordinate to manage privacy, liability and bias.

For Maltese healthcare professionals seeking practical, workplace-ready AI skills - prompting, tool use and governance - the 15‑week AI Essentials for Work bootcamp teaches applied techniques to help teams adopt AI safely and effectively; explore Malta's legal landscape and training options via Malta AI laws and regulations and the AI Essentials for Work bootcamp.

Malta's national AI blueprint - branded in policy documents as “The Ultimate AI Launchpad” - aims to turn the islands into a practical, investment‑friendly testbed where innovation meets governance: three strategic pillars (investment/startups & innovation, public‑sector adoption and private‑sector adoption) are backed by enablers in education and workforce development, ethical/legal frameworks and ecosystem infrastructure, all overseen by the Malta Digital Innovation Authority.

The strategy explicitly supports cross‑sector pilots (six pilots span areas including health, education and traffic) to demonstrate value quickly, and it even launched a world‑first national AI certification pathway to boost trustworthy deployment; an OECD entry notes an estimated budget of roughly €3.5M per year to support these moves.

MDIA has been realigning the plan with intensive stakeholder engagement and public feedback to complete a refreshed Strategy and Vision by 2025, a process that signals regulators want adoption that's both bold and responsible.

Because Malta's size allows pilots to run nationwide, the country can function as a living lab - an advantage for healthcare teams that need whole‑system evidence before scaling new AI tools.

Read the official Malta Digital Innovation Authority AI Strategy and Vision (MDIA) or the OECD summary of The Ultimate AI Launchpad to dive deeper.

“…leverage its natural resources and size, as well as innovative public policy, to translate a bold leadership vision into a set of tools, incentives, resources and collaborative ecosystems that accelerate the journey from AI development to AI adoption, leading to commercial success, social benefit and international recognition.”

For Maltese healthcare teams the legal picture is no longer optional background reading but operational reality: EU rules now treat most clinical AI - especially AI‑based software for diagnostic, triage or treatment purposes - as “high‑risk”, meaning devices often face both the Medical Devices Regulation/IVDR conformity routes and the horizontal obligations of the EU AI Act (risk management, data governance, human oversight and technical documentation), so an AI‑enabled X‑ray or triage tool can feel like a single device carrying two rulebooks.

The AI Act's phased rollout (entry into force in August 2024 with bans and core definitions applying early and high‑risk obligations phased in later) sits alongside the 2025 European Health Data Space, which opens lawful secondary use of health data for AI development but tightens controls on access and trust; at the same time the updated Product Liability regime explicitly treats software (including AI) as a product, increasing manufacturer exposure if a system causes harm.

Industry bodies have warned that without coherent alignment between AI Act and MDR/IVDR authorities, innovation risks costly delays, while guidance from regulators and legal advisors stresses clinical evidence, robust datasets and post‑market monitoring as non‑negotiables.

Maltese deployers should therefore map each AI use case to the AI Act's risk categories, prepare for third‑party conformity where MDR/IVDR applies, strengthen GDPR‑aligned data governance, and build human‑in‑the‑loop controls now rather than later - practical detail and timelines are available from the European Commission's overview on AI in health and sector commentary urging coherent implementation.

Malta's AI ecosystem is anchored not by a single ivory‑tower lab but by a compact, government‑led centre of gravity: the Malta Digital Innovation Authority (MDIA), which keeps a vetted roster of MDIA‑approved Technical Experts - from Alexei Debono and Jose Ignacio de Córdoba Álvaro to Dr Dylan Seychell and Prof. Matthew Montebello - who can be called on to perform technical evaluation, audits and Sandbox v2.0 roles for real‑world pilots; see the MDIA's published MDIA Technical Experts list for Malta for names and application details.

The Authority's governance and hands‑on executive team (CEO Kenneth Brincat; Chief Strategy officer Gavril Flores; Chief Innovative Technology Officer Dr Jean Marie Mifsud; Chief Operations Officer Clinton Pace) provide policy, certification and upskilling programs that make Malta punch above its weight - a striking detail: a small agency (listed at roughly 11–50 staff) is running a national certification and sandbox programme that startups and hospitals rely on to move AI from prototype to patient care.

For a quick look at who runs the show, MDIA's organisational chart is online at the Authority's MDIA organisational structure page.

Practical AI in Maltese healthcare has already moved from concept to concrete pilots: national projects range from the Central Procurement & Supplies Unit's forecasting tool to smooth medicine procurement, to Malta's February 2025 entry into the four‑year, EU4Health‑backed “BreastScan” radiology initiative, and hands‑on trials inside the MDIA technology assurance sandbox that let hospitals and startups test systems under regulatory oversight; for imaging specifically, the European Cancer Imaging Initiative (EUCAIM) is knitting together a Cancer Image Europe platform that already links 57 imaging datasets covering over 47,000 subjects to accelerate algorithm testing and federated validation.

These pilots illustrate a practical playbook for Maltese teams - start small with forecasting or triage pilots, run imaging algorithms alongside radiologists (AI as assistant, not replacement), and use sandboxes for evidence generation before scaling - so a district hospital can feasibly run a real‑world mammography AI validation across the whole island without shipping data abroad.

Learn more about the national legal and pilot context in Ganado's Malta AI practice guide and the EUCAIM imaging initiative for Europe.

“If we progressively align this type of projects like EUCAIM or EUCanScreen with the HealthData@EU infrastructure of the European health data space, then we can bring cancer data at the forefront and make their reuse one of the first success stories of the European health data space.”

Deploying AI in Maltese healthcare means meeting EU‑wide GDPR rules plus Malta's Data Protection Act 2018 and sectoral subsidiary legislation, so design choices - from model training to patient consent and logging - must be framed as legal controls, not optional features: health data is a

special category

and large‑scale or research uses often trigger mandatory DPIAs and, in some cases, prior consultation with the Office of the Information and Data Protection Commissioner (OIDPC); controllers that process genetic, biometric or health data for research must expect that scrutiny.

See the Malta Data Protection Commissioner guidance on health data.

Incident response is literal: the 72‑hour breach notification clock under GDPR can transform a minor leak into a regulatory crisis unless teams have tested playbooks and encryption/pseudonymisation in place.

Malta's planned Health Data Access Body under the European Health Data Space adds another layer - secure processing environments, metadata catalogues and formal compliance checks before any secondary use - so hospitals and startups can't treat cross‑border data sharing as

just engineering

.

See the European Health Data Space overview, including the Health Data Access Body.

One striking local detail: Malta has specific subsidiary rules (eg. SL 586.10/586.12) and yet no bespoke national carve‑out for professional secrecy in data‑access requests, so clinical teams must bake robust legal & governance steps (DPOs, clear lawful bases, documented DPIAs and strict contracts with processors) into every AI pilot to keep patients' rights and regulators satisfied.

Generative AI in Maltese healthcare lands at the crossroads of copyright, data rules and traditional tort law: as an EU Member State Malta is directly bound by the EU AI Act, so hospitals and startups must grapple with training‑data limits, the new “opt‑out” text‑and‑data‑mining regime and transparency duties that even require summaries of training content for large general‑purpose models (see the Global Legal Insights: AI, Machine Learning and Big Data Laws and Regulations - Malta chapter).

National law adds sharper edges: the Maltese Copyright Act treats a computer program as protectable code but defines “author” as a natural person, so fully autonomous outputs may lack copyright while prompts and prompt‑engineering can be protected as trade secrets - in short, the prompt that beats the radiology model may become the clinic's “secret recipe” and should be contractually shielded (see Ganado Malta AI practice guide - Artificial Intelligence 2025).

Training on copyrighted or sensitive health data also risks GDPR and secondary‑use breaches unless lawful bases, anonymisation and the Processing of Personal Data (Secondary Processing) rules are followed; procurement contracts therefore need back‑to‑back indemnities and technical guardrails to limit exposure.

Liability remains practical and person‑centred under Maltese tort law and the Civil Code (the bonus paterfamilias standard), and the evolving Product Liability rules and sector guidance mean deployers and developers should assume accountability now, not later - so build logging, human oversight and clear supplier liability into any pilot.

For a compact checklist on generative AI and copyright risks, the EU IP Helpdesk offers practical guidance for deployers.

“the greatest art heist in history.”

Begin any Maltese healthcare AI rollout by treating governance like clinical triage: first classify the system under the EU AI Act and local device rules so teams know whether it's “high‑risk” and needs conformity checks, then map roles (who is controller, deployer and provider) and document data flows and purposes before a single record is touched; the Malta Data Protection Commissioner's DPIA guidance makes clear a Data Protection Impact Assessment must be done early for systematic or large‑scale health processing, and the Global Legal Insights Malta chapter explains how national certification, MDIA sandboxes and procurement rules layer on top of EU obligations - so plan for both technical and contractual guardrails.

Run a DPIA that reads like a living patient chart (describe processing, test necessity/proportionality, score likelihood/severity of harms, and list mitigations such as pseudonymisation, synthetic or minimized training data, logging and human‑in‑the‑loop controls), consult clinicians and patients, and if the AI is high‑risk add a Fundamental Rights Impact Assessment to capture broader harms and oversight measures.

Use incremental pilots in an MDIA sandbox or a district hospital, validate accuracy across demographic groups, bake monitoring and incident playbooks into contracts, and insist on explainability thresholds and supplier indemnities before scaling island‑wide - one vivid rule of thumb: treat the DPIA like a medication chart that must be updated at every handover to avoid a regulatory overdose.

For checklists and legal detail start with the Malta DPIA page and the Malta AI laws & regulations overview to align technical steps with Maltese law and procurement practice.

“Article 113 of the EU AI Act states that the Regulation ‘[…] shall apply from 2 August 2026'.”

Global leaders set the pace - the United States still dominates model development and private investment (about $109.1B in 2024), while countries in Asia show the strongest public optimism about AI (China 83%, Indonesia 80%, Thailand 77%), yet healthcare overall lags other sectors in real‑world AI rollout; the World Economic Forum notes health is below average in adoption even as hospitals and vendors push pilots in imaging, triage and admin automation.

For Malta, that global context is an opportunity: falling inference costs, growing enterprise uptake (roughly 78% of organisations now use AI in at least one function) and expanding regulatory clarity mean the islands can act as a compact living lab - running island‑wide imaging or triage validations without fragmenting datasets - while watching how heavyweight markets (US, China) translate investment into regulation and clinical evidence.

Read the broader trends in Stanford HAI's 2025 AI Index and the World Economic Forum's piece on AI transforming healthcare to see where Malta fits in the global race.

“healthcare is "below average" in its adoption of AI compared to other industries” - World Economic Forum

For beginners in Malta's healthcare sector the path forward is practical and well-trodden: start by building AI literacy with short, free courses (for an accessible primer try the Elements of AI free online course) and local workshops, then learn workplace‑ready skills - prompting, tool selection and governance - through a focused programme such as the 15‑week Nucamp AI Essentials for Work bootcamp (15 Weeks); parallel to training, map your project against national rules and support structures by consulting the legal playbook in Ganado Advocates Malta AI practice guide (2025) and the Malta Digital Innovation Authority (MDIA) sandbox and certification.

Small pilots are the smartest first step - use a district hospital or MDIA sandbox to validate models with clinicians, run DPIAs early, lock contracts with clear supplier liability and logging, and iterate before scaling island‑wide; thinking of the sandbox as a “test ward” helps: it's where tools earn their clinical stripes before wider use.

With Malta's strategy, funding and sandboxes in place, beginners who combine basic literacy, a short applied bootcamp and early legal checks will move from curiosity to safe, compliant pilots that generate real patient value.

“If we progressively align this type of projects like EUCAIM or EUCanScreen with the HealthData@EU infrastructure of the European health data space, then we can bring cancer data at the forefront and make their reuse one of the first success stories of the European health data space.”