Beyond the digital leaflet
Patient information leaflets have always had an essential purpose: to support patients to understand their medicine and guidance on relevant risks and know when to seek advice. Electronic product information, or ePI, is an important step in this evolution. Yet the most valuable future is not a leaflet that has simply moved from paper to screen. The real opportunity begins when approved product information becomes structured data that can be consumed by every patient and healthcare systems and services.
A static document can inform. Structured information can participate. It can be searched, exchanged, filtered, linked and combined with other trusted health data. In this sense, ePI can become a regulatory-grade knowledge layer for digital healthcare rather than only a publication format.
From general information to patient context
Today, product information largely describes a medicine in isolation. Patients receive comprehensive information for a broad population, while healthcare professionals must connect that information with the individual patient situation: diagnoses, allergies, renal or hepatic function, pregnancy status, current medicines and recent laboratory values. In polypharmacy, high-risk situations and transitions of care, this manual combination of data is complex and vulnerable to gaps.
Structured ePI changes the starting point. If dosage information, contraindications, warnings, interactions and administration instructions are available in a machine-readable and interoperable format, they can be connected more consistently with clinical systems. European ePI work and common standard initiatives point in this direction: product information should be usable across digital channels, not locked inside static documents [1]. Interoperability standards such as HL7 FHIR provide a broader framework for exchanging health and medication-related information [2].
Connecting ePI with the electronic health record
The most compelling vision emerges when structured ePI is combined with the wider digital health infrastructure. The European Health Data Space is intended to create a common framework for the use and exchange of electronic health data across the EU, improving access and control for individuals and supporting healthcare, research, innovation and regulatory purposes [3]. In such an ecosystem, ePI could act as a trusted source within a personalized patient-centered information landscape.
When a patient receives new medication. Instead of only opening a digital leaflet, the care system could compare structured ePI data with relevant information in the electronic health record. It could consider other medicines, documented allergies, kidney function, age, treatment transitions or recent laboratory results. The result would not replace clinical judgement. It would create a better-informed starting point for an active partnership between patient, physician and pharmacist, which can improve medication adherence.
Medication safety as the central benefit
Medication-related harm remains a major global challenge. The World Health Organization describes unsafe medication practices and medication errors as leading causes of injury and avoidable harm in healthcare systems worldwide. According to a 2024 WHO systematic review, preventable medication-related harm affects an estimated 1 in 20 patients globally - with almost a quarter of these cases classified as severe or life-threatening [4]. Its Medication without harm initiative aims to reduce severe avoidable medication-related harm globally and highlights polypharmacy, high-risk situations and transitions of care as key action areas [5]. These are exactly the moments where connected, structured patient information can add value.
The scientific literature on clinical decision supports the broader principle that digital systems can improve care when they provide relevant information in the workflow. A systematic review by Bright and colleagues found that clinical decision-support systems can improve healthcare process measures [6]. Bates and Gawande also described how information technology can support safety through better access to information, monitoring and decision support [7]. For ePI, the lesson is clear: approved product information becomes more powerful when it is embedded into real medication-use processes.
AI needs trusted foundations
Artificial intelligence will likely support this future, but it should not be seen as the foundation. AI may help translate complex language, prioritize relevant sections, detect patterns and generate patient-friendly explanations. However, AI-supported healthcare depends on trustworthy data, clear governance and transparent use. WHO guidance on AI for health emphasizes ethics, governance, responsibility and trustworthiness. Structured, approved ePI can provide the reliable knowledge base that such tools require [8].
The promise is not that technology replaces professionals or regulatory information. The promise is that structured ePI helps approved information become easier to connect, easier to interpret and easier to act upon.
Conclusion
The future of patient information is not more information. It is better information delivered at the right moment, in the right context and in a form that supports action. By connecting structured ePI with electronic health records, medication plans and other trusted data sources, healthcare systems can help patients and healthcare professionals make better-informed decisions.
This vision is ambitious, but practical. The building blocks already exist: regulatory product information, interoperability standards, electronic records, patient portals, medication plans and European digital health policy. The next task is to connect them in a trustworthy and usable way. If we succeed, patient information will no longer be something people only search for when they have a question. It will become part of an intelligent medication journey, helping medicines to be taken in at the right amount, at the right time and with better awareness of each patient’s risks and needs.
Selected sources:
[1] European Medicines Agency. Electronic product information for human medicines in the European Union and EU common standard materials. Link
[2] HL7 International. FHIR specification and MedicationKnowledge resource. Link
[3] European Commission. European Health Data Space Regulation (EHDS): Public Health information page. Link
[4] World Health Organization. Global burden of preventable medication-related harm in health care: a systematic review. WHO, 2024. Link & World Health Organization. Medication Without Harm: WHO Global Patient Safety Challenge on Medication Safety. Link
[5] World Health Organization. Medication safety in polypharmacy: technical report. Geneva: WHO; 2019. Link
[6] Bright TJ, Wong A, Dhurjati R, et al. Effect of clinical decision-support systems: a systematic review. Annals of Internal Medicine. 2012;157(1):29-43. Link
[7] Bates DW, Gawande AA. Improving safety with information technology. New England Journal of Medicine. 2003;348:2526-2534. Link
[8] World Health Organization. Ethics and governance of artificial intelligence for health. Geneva: WHO; 2021. Link
Note: This is a thought-leadership article, not medical, legal or regulatory advice. Future use cases should be validated against applicable regulation, governance and implementation constraints before external publication.