In Focus
Can artificial intelligence revolutionise haemovigilance?
AI models with opportunities and risks

Can Artificial Intelligence (AI) revolutionize haemovigilance? To answer this question, we must begin by defining our terms. Haemovigilance is “a set of surveillance procedures designed to improve safety and outcomes of transfusion recipients and blood donors through the collection and assessment of information about unexpected and/or undesirable effects resulting from the donation and therapeutic use of blood and labile blood products, and to prevent their occurrence or recurrence”1
The FDA defines AI as a “machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. AI systems use machine- and human-based inputs to perceive real and virtual environments; abstract such perceptions into models through analysis in an automated manner; and use model inference to formulate options for information or action”2. The Merriam Webster dictionary defines revolution as “a sudden, radical, or complete change.”
AI is one of the most exciting developments of the twenty-first century. It has enhanced our ability to quickly bring information to our attention, to synthesize large amounts of data, to predict outcomes, to recommend approaches and solutions, and to identify hidden patterns within data that would be inaccessible to human review. And not surprisingly, exploration of its potential for medical systems has increased steadily over the past ten years. Many investigations into the use of AI in transfusion medicine (TM) have been published and present both opportunities3 and risks4. I’ll describe a few of the studies which address what would conventionally be considered haemovigilance applications5,7, some necessary cautions, and the promise of the future.
Fung et al. conducted an evaluation of a Gen AI model or chatbot6 to diagnose 36 adverse reaction case scenarios using the CDC National Healthcare Safety Network haemovigilance criteria. The responses were compared to survey responses from human TM specialists from a previous study7. Interestingly, the chatbot correctly diagnosed the most challenging scenarios, including acute and delayed haemolytic transfusion reactions, transfusion-associated circulatory overload and transfusion-related acute lung injury, outscoring the human TM specialists in each scenario. The AI scored equivalent to or worse than the TM specialists for all other transfusion reactions. It also misclassified most of the ‘no reaction’ control cases and was incapable of assigning severity and imputability to most cases. The authors agreed that this AI was not ready to be used for categorization purposes, yet they suggested that with prompt modifications and exploration of newer Gen AI models, a better result might be obtained.
Taking another approach, the FDA Biologics Effectiveness and Safety initiative used Natural Language Processing and Machine Learning (ML) to develop a model to identify allergic reactions (AR) from the electronic medical record (EMR)8. The dataset included all AR reports and a subset of transfusions without a reported AR from a single medical system. The model included both structured data (e.g. ICD-10 codes) and unstructured data extracted from the EMR’s clinical notes. The model identified five key elements from the structured and unstructured data to predict ARs. While not perfect, the balance of sensitivity and specificity in these models suggests a future of enhanced workflow and reduced workload, the possibility to identify overlooked adverse events (AE), and tools for education of transfusion medicine professionals. To facilitate clinician validation in this study, programs were developed to consolidate the clinical data, lab results, medications, and notes needed to confirm or reject the AI interpretation. While never formally operationalized, these features could be incorporated into EMR and clinical decision support software along with the capacity to report (deidentified) confirmed cases to national haemovigilance systems.
A number of studies suggest that we must be wary of the risks of Gen AI use at its present state of development4. Gen AI models are known to “hallucinate,” to fabricate answers that “sound” authoritative yet are incorrect. Gen AI programs are rapidly improving but require human-in-the-loop validation. For example, misclassification in haemovigilance support tools can affect diagnosis of serious AEs or create clinician alert fatigue when every patient with a fever is reported as having an AE. Another concern with the use of AI is systemic bias. AI models are trained on existing datasets, which may inherently reflect racial, gender, or rural bias, as Obermeyer et al. reported when Black patients’ needs were underestimated due to the use of healthcare spending as a proxy for illness burden8.
Donor and recipient privacy is another challenge, since these AI models require large datasets for training and fine-tuning. Approaches, called federated learning, have been developed to decentralize the use of healthcare big data in order to maintain local control and confidentiality while models are trained on individual datasets9. Data can be analyzed locally without requiring physical data transfer, subsequently the results of the local analysis and model training can be uploaded to a central site for aggregation and further analysis. Development of data standards is another critical step in the process of building robust haemovigilance across hospitals, systems, regions, and countries.
Let us return to the question, “Can AI revolutionize haemovigilance?” I believe the answer is yes, AI can, and over time will change the way hemovigilance is conducted. AI promises to make haemovigilance tasks easier, from detection of transfusion related AEs through the use of Gen AI and onto the use of agentic AI, which can plan and execute multi-step tasks, speeding the aggregation of event reports and reporting into anonymized and centralized haemovigilance systems (ideally with human-in-the-loop review) where analysis of huge datasets can occur, and ultimately to generate widespread communication of findings to enhance patient safety. For donor haemovigilance, ML models that can predict donor AEs (e.g., vasovagal reactions) are already in use10 and AI is poised to assist with donor recruitment and retention. Models that identify AEs and flag them for clinician attention and centralization can be expected as well. From an educational perspective, Gen AI Chatbots will evolve to synthesize and serve up more accurate donation and transfusion information to donors and patients.
I expect the AI changes will occur over a period of a few years. Each new application will feel quite revolutionary as AI is applied to new tasks and provides services that were previously unavailable. Incorporation of these tools into everyday use, into the EMR for example, will require new regulatory pathways varying by country/region. Ideally, the use of AI will assist low-and-middle-income countries to engage in advanced haemovigilance processes, using smart phone apps and tools for detecting and reporting to centralized systems where further aggregation, analytics, and benchmarking can be possible. The future of haemovigilance is bright and AI will evolve to speed the process.
References
- International Haemovigilance Network. https://www.ihn-org.com/about/haemovigilance. Accessed on 01/03/2026.
- FDA Digital Health and Artificial Intelligence Glossary. https://www.fda.gov/science-research/artificial-intelligence-and-medical-products/fda-digital-health-and-artificial-intelligence-glossary-educational-resource#g:~:text=The%20class%20of%20AI%20models%20that%20emulate%20the. Accessed 05/03/2026.
- Li N, Goel R, Raza S, Riazi K, Pan J, Nguyen, HQ, et al. Artificial Intelligence and Machine Learning in Transfusion Practice: An Analytical Assessment. Transfus Med Rev. 2025 Oct;39(4):150926. doi: 10.1016/j.tmrv.2025.150926. Epub 2025 Aug 24. PMID: 40972186.
- Jung OS, Kundu P, Edmondson AC, et al. Resilience vs. Vulnerability: Psychological Safety and Reporting of Near Misses with Varying Proximity to Harm in Radiation Oncology. Jt Comm J Qual Patient Saf. 2020 :S1553-7250(20)30241-5.
- Fung MK, Aubuchon JP, Stephens LD. Classification of posttransfusion adverse events using a publicly available artificial intelligence system. Transfusion. 2024;64:590–596. DOI: 10.1111/trf.17702
- 6. AuBuchon JP, Fung M, Whitaker B, and Malasky J. 2014. AABB validation study of the CDC’s National Healthcare Safety Network Hemovigilance Module adverse events definitions protocol. Transfusion 54(8):2077-2083.
- Whitaker B, Pizarro J, Deady M, Williams A, Ezzeldin H, Belov A, et al. Detection of Allergic Transfusion-Related Adverse Events from the Electronic Medical Record. Transfusion. 2022; 62(10): 2029-2038. https://doi.org/10.1111/trf.17069
- Obermeyer Z, Powers B, Vogeli C, and Mullainathan S. Dissecting racial bias in an algorithm used to manage the health of populations. Science. 2019;366:447-53.
- Na L, Lewin A, Ning S, Waito M, Zeller M, Tinmouth A, et al. Privacy-preserving federated data access and federated learning: Improved data sharing and AI model development in transfusion medicine. Transfusion 2025; 65:22-28. DOI: 10.1111/trf.18077
- Suessner S, Niklas N, Bodenhofer U, Meier J. Machine learning-based prediction of fainting during blood donations using donor properties and weather data as features. BMC Med Inform Decis Mak. 2022 Aug 20;22(1):222. doi: 10.1186/s12911-022-01971-x.
