Challenges and Strategies in the Implementation of the International Patient Summary in Accordance with International Standards: A Systematic Review
Resumo
Context: The growing international movement of people necessitates adopting interoperable health data solutions like the International Patient Summary (IPS). Diverse standards, terminologies, and specifications require significant efforts to achieve agility, interoperability, compliance, security, and privacy. Problem: Few studies discuss the challenges and strategies for implementing the IPS in compliance with international standards; additionally, many professionals are unaware of the benefits of compliance, hindering adoption. Solution: This study aims to identify challenges, barriers, strategies, and success factors in IPS implementation, emphasizing interoperability, technical specifications, and health standards. IS Theory: Anchored in Sociotechnical Theory, the study examines how the interaction between technical components (international standards, interoperability) and social components (regulations, collaboration, clinical routines) influences IPS implementation. Method: A systematic review following the PRISMA 2020 protocol identified 43 relevant studies, analyzed quantitatively and qualitatively to consolidate information on compliance standards, challenges, and strategies. Summary of Results: Key challenges include harmonizing international standards, ensuring patient data privacy and security, and interoperability among heterogeneous systems. Effective strategies involve developing harmonized implementation guides and collaboration among standardization organizations like ISO, HL7, and CEN. Contributions and Impacts in the IS area: This study underscores the importance of a sociotechnical approach in IPS implementation per international standards, contributing to public policies and the development of health information systems that integrate technological and organizational aspects, promoting interoperability, security, and privacy of health data.
Referências
ISO. (2021). ISO 27269:2021 - Health informatics - International Patient Summary. International Organization for Standardization (ISO). Available at: [link]
Kay, S. (2021). The international patient summary and the summarization requirement. Studies in Health Technology and Informatics, 285, 17–30. DOI: 10.3233/SHTI210569.
Kay, S., Cangioli, G., & Nusbaum, M. (2020). The international patient summary standard and the extensibility requirement. Studies in Health Technology and Informatics, 273, 54–62. DOI: 10.3233/SHTI200615.
Singh, Hardeep, and Dean F. Sittig. "A sociotechnical framework for safetyrelated electronic health record research reporting: the SAFER reporting framework." Annals of Internal Medicine 172.11_Supplement (2020): S92-S100.
Sittig, Dean F., and Hardeep Singh. "A sociotechnical approach to electronic health record related safety." Key Advances in Clinical Informatics. Academic Press, 2017. 197-216.
Menon, N. M., Yaylacicegi, U., & Cezar, A. (2017). "Information Systems: A Hospital-Based Study." Journal of Management Information Systems, 24(2), 45-70.
CEN. (2019). EN 17269:2019 - Health informatics - The International Patient Summary. European Committee for Standardization (CEN). Available at: [link].
ISO. (2009). ISO/TR 12773-1:2009 - Business requirements for health summary records – Part 1: Requirements. International Organization for Standardization (ISO). Available at: [link].
Antilope Project. (2015). Final Antilope Project Report. Disponível em: [link].
IPS. The International Patient Summary. Disponível em [link]
Comissão das Comunidades Europeias. (2004). e-Health – Melhorando os cuidados de saúde para os cidadãos europeus: Um plano de ação para uma Área Europeia de e-Health. Bruxelas: Comissão Europeia. Disponível em: [link].
European Commission. (2014). epSOS: Smart Open Services for European Patients - Final Project Report. European Commission. Available at: [link].
eHealth Network. (2013). Guidelines on Minimum/Nonexhaustive Patient Summary Dataset for Electronic Exchange in Accordance with the Cross-Border Directive 2011/24/EU. European Commission. Available at: [link].
Trillium Bridge Project. (2015). Bridging Patient Summaries across the Atlantic. European Commission. Available at: [link].
Klein, G. O., Sundvall, E., Karlsson, D., & Aarts, J. (2018). "Interoperability Solutions for Sharing Patient Summary Information: The Trillium Bridge Project." Yearbook of Medical Informatics, 27(1), 41-48. DOI: 10.1055/s-0038-1641194.
Trillium II Project. (2019). Reinforcing the Bridges and Scaling up EU/US Cooperation on Patient Summary. European Commission.
Klein, G. O., Sundvall, E., Karlsson, D., & Aarts, J. (2021). "Advancing International Patient Summary Standards: The Trillium II Project." Journal of Medical Internet Research, 23(4), e23456. DOI: 10.2196/23456.
European Commission. (2023). MyHealth@EU: Cross-Border Health Services.
EHTEL. (2021). 2021 Thought Leader EHTEL Symposium: Imagining a Citizen-Centric Health Data Ecosystem. European eHealth Multidisciplinary Stakeholder Platform.
G7 Health Ministers. (2021). G7 International Patient Summary Roadmap. Department of Health and Social Care, United Kingdom.
Cabral et al. (2024). Providing Interoperability between Wearable Devices and FHIR-based Healthcare Systems. In Proceedings of the 30th Brazilian Symposium on Multimedia and the Web, outubro 14, 2024, Juiz de Fora/MG, Brasil. SBC, Porto Alegre, Brasil, 410-414.
Benson, T., & Grieve, G. (2016). Principles of Health Interoperability: SNOMED CT, HL7, and FHIR (3rd ed.). Springer.
Global Digital Health Partnership. (2021). White Paper on Evidence and Evaluation. Available at [link].
ISO/IEC. (2004). ISO/IEC Guide 2:2004 - Standardization and related activities — General vocabulary. International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC). Available at: [link]
CEN. (2022). EN ISO 27269:2022 - Health informatics - International patient summary (ISO 27269:2021). Comité Europeu de Normalização (CEN).
HL7 FHIR IPS. Available at: [link].
HL7 IPS. Available at: [link].
IHE IPS. Available at: [link].
SNOMED International. Available at: [link].
WHO. (2021a). WHO digital health interoperability framework. World Health Organization. Available at: [link].
World Health Organization. (2022). International Classification of Diseases for Mortality and Morbidity Statistics, 11th Revision (ICD-11). Geneva: World Health Organization. Available at: [link].
World Health Organization. (1994). International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Geneva: World Health Organization. Available at: [link].
Joint Initiative Council. (2018). Guidance Document Patient Summary Standards Set.
Kalra, D., & Stroetmann, V. (2018). "Integrating Digital Health Services: An Open Platform Approach for Sustainable Health Systems." MyRes 2018 Proceedings: Open Platform Africa, 1-10.
Tuler, Elisa; Marcello Ba; Raquel Prates; Leonardo Rocha. (2014). Caracterizando os desafios na modelagem dos dados clínicos em Sistemas de RES baseados no OpenEHR. In Anais do XIV Workshop de Informática Médica, julho 28, 2014, Brasília/DF, Brasil. SBC, Porto Alegre, Brasil, 1780-1783.
HIMSS. (n.d.). Interoperability in Healthcare. Available at: [link].
World Bank. (2023). Interoperability in Health. [link].
Office of the National Coordinator for Health Information Technology. (2020). International Patient Summary (IPS) Guidance. U.S. Department of Health and Human Services.
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & The PRISMA Group. (2015). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Medicine, 6(7), e1000097. DOI: 10.1371/journal.pmed.1000097.
[A. Neocleous, M. Papaioannou, P. Savva, F. Miguel, A. Panayides, Z. Antoniou, M. Neofytou, E. C. Schiza, K. Neokleous, I. Constantinou, G. Panos, C. N. Schizas, & C. S. Pattichis. (2022). The International Patient Summary: Proposal for a National Implementation for Cyprus. 2022 E-Health and Bioengineering Conference (EHB), 1–5. DOI: 10.1109/EHB55594.2022.9991445.
A. Estelrich, H. Solbrig, G. Cangioli, M. Melgara, & C. Chronaki. (2014). European Patient Summary guideline and Continuity of Care Document: A comparison. Computing in Cardiology 2014, 481–484.
M. S. Neofytou, K. Neokleous, A. Aristodemou, I. Constantinou, Z. Antoniou, E. C. Schiza, C. S. Pattichis, & C. N. Schizas. (2015). Electronic Health Record Application Support Service Enablers. 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 1401–1404. DOI: 10.1109/EMBC.2015.7318631
S. Mohammed, J. Fiaidhi, & D. Sawyer. (2021). Generating Physician Standing Orders for Unplanned Care Scenarios using the HL7 FHIR Patient Summaries. 2021 International Conference on E-Health and Bioengineering (EHB), 1–4. DOI: 10.1109/EHB52898.2021.9657715
Tanno, L. K., Perie, A., Bernstein, J. A., Sublett, J. L., Davtyan, K., Berard, F., Pawankar, R., Valentin Rostan, M., Chong, H., Yañez, A., Ansontegui, I. J., Ebisawa, M., Wong, G. W. K., Morais-Almeida, M., Martin, B., Briand, Y., & Demoly, P. (2024). Allergic and hypersensitivity condition in the International Patients’ Summary (IPS) standard: The need of updates through the International Classification of Diseases (ICD)-11. World Allergy Organization Journal, 17(8), 100921. DOI: 10.1016/j.waojou.2024.100921
Wagelaar, D. (2022). The TTC 2023 KMEHR to FHIR case. CEUR Workshop Proceedings, 3620. [link]
Stanimirovic, D., & Tepej Jocic, L. (2023). The Slovenian Patient Summary: One Digital Record, Multitude of Applications. Studies in Health Technology and Informatics, 305, 295–298. DOI: 10.3233/SHTI230487
de Beijer, I. A. E., van den Oever, S. R., Charalambous, E., Cangioli, G., Balaguer, J., Bardi, E., Alfes, M., Nieto, A. C., Correcher, M., da Costa, T. P., Degelsegger-Márquez, A., Düster, V., Filbert, A.-L., Grabow, D., Gredinger, G., Gsell, H., Haupt, R., van Helvoirt, M., Ladenstein, R., … Schneider, C. (2024). IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey. Journal of Medical Internet Research, 26. DOI: 10.2196/49910
Rigby, M. J., Chronaki, C. E., Deshpande, S. S., Altorjai, P., Brenner, M., & Blair, M. E. (2020). European Union initiatives in child immunization - The need for child centricity, e-health and holistic delivery. European Journal of Public Health, 30(3), 449–455. DOI: 10.1093/eurpub/ckz199
Stegwee, R., Gille, H., & Chronaki, C. (2019). IPS Governance Framework: Current Practices in Specification Use and Updates. Studies in Health Technology and Informatics, 262, 202–205. DOI: 10.3233/SHTI190053
Mohammed, S., Fiaidhi, J., & Sawyer, D. (2022). Introducing QL4POMR CRUD BFF for Processing IPS Standard Patient Summary Report on FHIR. Proceedings of the 2022 IEEE 4th Eurasia Conference on Biomedical Engineering, Healthcare and Sustainability (ECBIOS 2022), 48–53. DOI: 10.1109/ECBIOS54627.2022.9945031
Lee, A. R., Kim, I. K., & Lee, E. (2021). Developing a transnational health record framework with level-specific interoperability guidelines based on a related literature.
Kay, S., Cangioli, G., & Nusbaum, M. (2020). The International Patient Summary Standard and the Extensibility Requirement. Studies in Health Technology and Informatics, 273, 54–62. DOI: 10.3233/shti200615
Krastev, E., Kovatchev, P., Tcharaktchiev, D., & Abanos, S. (2020a). International Patient Summary Standard Based on Archetype Concepts. International Journal on Advances in Life Sciences, 12(1 & 2).
Cerizza, D., della Valle, E., Foxvog, D., Krummenacher, R., & Murth, M. (2006). Towards European Patient Summaries Based on Triple Space Computing. European Conference on EHealth 2006, Proceedings of the ECEH 2006, 143–154.
Nalin, M., Baroni, I., Faiella, G., Romano, M., Matrisciano, F., Gelenbe, E., Martinez, D. M., Dumortier, J., Natsiavas, P., Votis, K., Koutkias, V., Tzovaras, D., & Schera, F. (2024). A framework for the adoption of International Patient Summary standards in Europe. Journal of Medical Internet Research, 26. DOI: 10.2196/49911
Schippers, D., & Stegwee, R. A. (2024). Exploring the clinical value of the International Patient Summary - A systematic review. Proceedings of the 2024 ACM Conference on Health Informatics, 78–86. DOI: 10.1145/3641142.3641160
Vasili, A., Schiza, E., Schizas, C. N., & Pattichis, C. S. (2024a). Integrating Chatbot Functionality in a Patient Summary-Based Healthcare System. Studies in Health Technology and Informatics, 316, 296–300. DOI: 10.3233/SHTI240402
Tanjga, N., & Krauss, O. (2024). Dual Implementation Guides in FHIR and CDA. Studies in Health Technology and Informatics, 313, 49–54.
Del-Pinto, W., Schmidt, R. A., Gao, Y., Alghamdi, G., Osornio, A. L.; Roy, S. (2024). International Patient Summary Terminology. Studies in Health Technology and Informatics, 310, 63–67. DOI: 10.3233/shti230928
Song, C.; Nakayama, M. (2023). Implementation of a Patient Summary Web Application According to the International Patient Summary and Validation in Common Use Cases in Japan. Journal of Medical Systems, 47(1), 100. DOI: 10.1007/s10916-023-01993
Neocleous, A., Papaioannou, M., Savva, P., Miguel, F., Yiasemi, C., Panayides, A., Antoniou, Z., Neofytou, M., Michael, C., Melios, P., Constantinou, I., Cânciu, I. C., Adamides, G., Christodoulou, M., & Pattichis, C. (2023). eHealth4U: A DEMO of a Prototype National Electronic Health Record for Cyprus. Studies in Health Technology and Informatics, 305, 349–352.
Kramer, M. A., & Moesel, C. (2023a). Interoperability with multiple Fast Healthcare Interoperability Resources (FHIR®) profiles and versions. JAMIA Open, 6(1), ooad001. Healthcare (Switzerland, 9(1). DOI: 10.3390/healthcare9010067
Agroti, L., Canciu, I. C., Christodoulou, M., Papaioannou, M., Neocleous, A., Savva, P., Yiasemi, C., Solomou, T., Panayides, A., Antoniou, Z., Neofytou, M., Constantinou, I., & Pattichis, C. S. (2023). MYeHealthAppCY: A Healthcare Mobile Application in Cyprus. Studies in Health Technology and Informatics, 305, 311–314. DOI: 10.3233/shti230491
Dimitrov, A., & Duftschmid, G. (2022). Generation of FHIR-Based International Patient Summaries from ELGA Data. Studies in Health Technology and Informatics, 293, 1–8. DOI: 10.3233/shti220339
Kase Tanno, L., Perie, A., Bernstein, J. A., Sublett, J. L., Davtyan, K., Berard, F., Pawankar, R., Rostan, M. V., Chong, H., Yañez, A., Ansontegui, I. J., Ebisawa, M., Wong, G. W. K., Morais-Almeida, M., Martin, B., Briand, Y., & Demoly, P. (2024). Allergic and hypersensitivity condition in the International Patients’ Summary (IPS) standard: The need of updates through the International Classification of Diseases (ICD)-11. World Allergy Organization Journal, 17, 100921. DOI: 10.1016/j.waojou.2024.100921
Tcharaktchiev, D., Krastev, E., Petrossians, P., Abanos, S., Kyurkchiev, H., & Kovatchev, P. (2020). Cross-Border Exchange of Clinical Data Using Archetype Concepts Compatible with the International Patient Summary. Studies in Health Technology and Informatics, 270, 552–556. DOI: 10.3233/shti200221
Lee, H. A., Kung, H. H., Lee, Y. J., Chao, J. C., Udayasankaran, J. G., Fan, H. C., Ng, K. K., Chang, Y. K., Kijsanayotin, B., Marcelo, A. B., & Hsu, C. Y. (2020). Global Infectious Disease Surveillance and Case Tracking System for COVID-19: Development Study. JMIR Medical Informatics, 8(12), e20567. DOI: 10.2196/20567
Kay, S. (2021). The International Patient Summary and the Summarization Requirement. Studies in Health Technology and Informatics, 285, 17–30. DOI: 10.3233/shti210569
Heitmann, K. U., Cangioli, G., Melgara, M., & Chronaki, C. (2018). Interoperability Assets for Patient Summary Components: A Gap Analysis. Studies in Health Technology and Informatics, 247, 700–704.
Berler, A., Tagaris, A., & Chronaki, C. (2016). European Patient Summary Guideline: Focus on Greece. Studies in Health Technology and Informatics, 224, 1–6.
Maarseveen, E., Thorp, J., & others. (2014). Guidelines on the European patient summary dataset. Eurohealth, 20(1), 25–28.
Pedrera-Jiménez, M., Frid, S., Muñoz-Carril, P., & others. (2023). Can OpenEHR, ISO 13606, and HL7 FHIR Work Together? An Agnostic Approach for the Selection and Application of Electronic Health Record Standards to the Next-Generation Health Data Spaces. Journal of Medical Internet Research. DOI: 10.2196/48702
Jung, S., Bae, S., Seong, D., & Yi, B.-K. (2022). Standard Document Development for Health Information Exchange in Korea. Applied Clinical Informatics, 13(03), 592–601. DOI: 10.1055/s-0042-1749331
Papaioannou, M., Neocleous, A., Savva, P., Miguel, F., Panayides, A., Antoniou, Z., Neofytou, M., Schiza, E. C., Neokleous, K., Constantinou, I., & others. (2021). A Prototype of the National EHR System for Cyprus. Proceedings of the 2021 IEEE Engineering in Medicine and Biology Society (EMBC), 2159–2162. DOI: 10.1109/embc46164.2021.9630760
Chen, Y., Couto, I., Cai, W., Fu, C., & Dorneles, B. (2024). SoftTiger: A Clinical Foundation Model for Healthcare Workflows. ArXiv Preprint ArXiv:2403.00868.
Estelrich, A., Chronaki, C., Cangioli, G., & Melgara, M. (2015). Converging Patient Summaries: Finding the Common Denominator Between the European Patient Summary and the US-Based Continuity of Care Document. EJBI, 11(2).
Krastev, E., Tcharaktchiev, D., Kirov, L., Kovatchev, P., Abanos, S., & Lambova, A. (2019). Software Implementation of the EU Patient Summary with Archetype Concepts. Proceedings of GLOBAL HEALTH, 22–26.
Deshpande, S., Chronaki, C., & Rigby, M. (2019). Children’s Immunisation in Europe–A Vision of Using the HL7 International Patient Summary to Transform Local Data into Child-Specific Information and Population Health Knowledge. In Health Informatics Vision: From Data via Information to Knowledge (pp. 154–157). IOS Press.
Erturkmen, G. B. L., Simsek, E., Cangioli, G., & Chronaki, C. (2019). A Privacy Management Analysis (PMA) of Exchanging International Patient Summary. In Health Informatics Vision: From Data via Information to Knowledge (pp. 19–22). IOS Press. DOI: 10.3233/SHTI190006
de Faria Leao, B., Costa, I. M. do A., Machado, J., de Assis Molla, M., Zamarro, A. R., Motter, F. R., Oliveira, G. G., Costa, K. L. de A. C., de Mello, B. H., Souza, E. S., & others. (2024). The Brazilian International Patient Summary Initiative. Oxford Open Digital Health, 2, oqae015–oqae015. DOI: 10.1093/oodh/oqae015
Krastev, E., Abanos, S., & Tcharaktchiev, D. (2022). Health Data Exchange Based on Archetypes of Clinical Concepts. CEUR Workshop Proceedings, 3191, 98–112. [link]
Tageo, V., Dantas, C. B. M. S., Chronaki, C., Lowe, C., Berler, A., & Porcu, F. (2020). Business Model Canvas for Adoption of International Patient Summary Standards in mHealth Industry. Journal of Business Models, 8(3), 91–106.
Council, J. I. (2019). Patient Summary Standards Set. Retrieved In, 7–22.
EU eHealth Network. (2023). eHN Guidelines Patient Summary - Release 3.3.
Menon S , Singh H , Giardina TD, et al . Segurança se reúne para identificar e abordar proativamente a segurança de registros eletrônicos de saúde. J Am Med Inform Assoc. 2017;24:261-7. [PMID: 28031286 ] DOI: 10.1093/jamia/ocw153
Valvi, N., Shivers, J., & G. Biondich, P. (2023). Chapter 20 - Cross-border Health Information Exchange to Achieve World Health Outcomes (B. E. Dixon, Ed.; pp. 435–445). Academic Press. DOI: 10.1016/B978-0-323-90802-3.00029-0
Clemente, F. (2019). The European cross-border health data exchange roadmap: Case study in the Italian setting. J. of Biomedical Informatics, 94(C). DOI: 10.1016/j.jbi.2019.103183
Kitchenham, B., & Charters, S. (2007). Guidelines for performing Systematic Literature Reviews in Software Engineering. EBSE Technical Report EBSE-2007-01. Keele University and Durham University.
IPS – Standards and Specifications. Disponivel em: [link].
Boscarioli, C.; Araujo, R. M.; Maciel, R. S. P. I GranDSI BR Grand Research Challenges in Information Systems in Brazil 2016-2026. Special Committee on Information Systems (CE-SI). Brazilian Computer Society (SBC). ISBN: [978-857-669-384-0]. 2017. 184 p.