The EU’s Artificial Intelligence Act (AI Act), enacted in 2024, is a landmark piece of legislation that will significantly impact the use of AI across Europe, including in community pharmacies. Instead of outright banning most AI, the Act takes a risk-based approach, placing different obligations on systems based on their potential for harm. For community pharmacies, this means the more critical and patient-facing the AI system, the more stringent the rules it must follow.
The EU AI act’s risk categories explained
The AI Act classifies AI systems into four categories:
- Prohibited risk: These are AI systems considered a clear threat to fundamental rights and are banned. For instance, AI that uses subliminal techniques to manipulate people would fall into this category. While not a typical use case for pharmacies, it’s important to be aware of the «red line» for AI in the EU.
- High risk: This is the most relevant category for community pharmacies. It includes AI systems that are a safety component of a regulated product, like a medical device. Examples include AI-powered software used for clinical decision support, diagnostic tools, or systems that evaluate a patient’s eligibility for a health service. If a pharmacy uses these systems, they must comply with strict rules on data quality, transparency, human oversight and documentation.
- Limited risk: This category applies to AI systems with specific transparency obligations. Generative AI tools, like chatbots used for patient queries, must clearly inform users that they are interacting with an AI. This is crucial for building trust and ensuring patients understand the nature of the information they’re receiving.
- Minimal risk: The vast majority of AI applications, such as AI-powered inventory management or automated administrative tasks, fall into this category. These systems are not subject to the same strict regulations as high-risk AI, allowing pharmacies to innovate with less red tape.
How the EU AI act impacts community pharmacies
The AIA (The EU’s Artificial Intelligence Act) is set to bring significant positive changes to community pharmacies. Here’s a closer look at how it will reshape various aspects of pharmacy operations.
AI can automate tasks like inventory management, prescription preparation and billing, freeing up pharmacists to focus on what matters most: patient care. The AIA ensures these systems are reliable and secure.
AI can also supercharge supply chain management through accurate demand forecasting by analysing historical data and external factors to predict medication demand, reducing stockouts and optimising inventory levels.
Also, AI systems can provide real-time tracking, trigger automatic reorders and monitor expiration dates, minimising waste and ensuring continuous availability of medications.
The Act’s focus on safety and ethics will directly translate into better patient outcomes. For instance, AI tools can provide instant alerts about potential drug interactions and the AIA ensures these systems are rigorously tested for accuracy and reliability.
AI can also analyse patient data to suggest tailored medication regimens, with the AIA’s stringent data protection rules guaranteeing this is done securely and transparently, protecting patient privacy.
Finally, AI-powered reminders and monitoring tools can help patients adhere to their medication schedules, provided they meet the AIA’s standards for transparency and data protection.
Ensuring compliance for community pharmacies
The AIA mandates stringent data governance standards, crucial for maintaining patient confidentiality and trust. All AI systems used in pharmacies will be subject to oversight by notified bodies, with regular audits and certification processes to ensure they meet the necessary safety and ethical standards.
The role of vendors in EU AI act compliance
Pharmacy system vendors are key to the successful adoption of AI. Beyond simply complying with the AIA, they can leverage AI to create powerful, practical solutions:
- Vendors can integrate AI-powered analytics to provide pharmacists with actionable insights, from identifying medication usage trends to optimising inventory.
- AI-powered chatbots and virtual assistants can answer patient queries, provide medication information and send refill reminders, enhancing patient interaction and adherence.
- AI can be used to develop advanced security features like real-time fraud detection, ensuring the safety and integrity of patient data and building trust.
- AI can streamline pharmacy operations by automating routine tasks and optimising resource allocation, such as managing staff schedules more efficiently.
Vendors must ensure their AI solutions are compliant with the AIA’s stringent requirements, provide comprehensive training and support to pharmacists and design systems that integrate seamlessly with existing pharmacy workflows.
Ireland’s phased approach to the EU AI Act
The Artificial Intelligence Act is set to be enacted in Ireland in 2025. The implementation will follow a phased approach, with initial focus on high-risk applications in healthcare, allowing businesses and organisations to adapt smoothly.
Key authorities, including the Department of Enterprise, Trade and Employment, the Data Protection Commission (DPC), the Health Products Regulatory Authority (HPRA) and a new AI Advisory Council, will collaborate to ensure the AIA is effectively implemented. This collaborative approach will ensure AI systems in Ireland adhere to the highest standards of safety, transparency and accountability.
Conclusion: The future of community pharmacy under the EU AI Act
The AIA represents a significant step forward, not just for AI regulation but for the future of healthcare. The act ensures that AI technologies can be harnessed responsibly in community pharmacies to enhance operational efficiency, improve patient safety and ultimately, provide better care. For community pharmacies in Ireland and across the EU, the AIA is a roadmap to a more efficient, ethical and patient-centric future.