Allergic and hypersensitivity condition in the International Patients’ Summary (IPS) standard: The need of updates through the International Classification of Diseases (ICD)-11

Abstract

In 2010, the United States Human and Health Services (US HHS) and the European Union's (EU) Directorate General for Communications Networks, Content and Technology signed a memorandum of understanding to stimulate cooperation surrounding health-related information communications technology. The key project that emerged from this agreement is the International Patient Summary (IPS), intended to provide succinct clinically relevant patient summaries, which are generalizable and condition-independent, that can be readily used by all clinicians for the care of patients. Although allergies are included in the main information required by the IPS library and framework, it is misrepresented which leads to underdiagnosis or misdiagnosis of patients suffering from allergic and hypersensitivity conditions (A/H). The French and Montpellier World Health Organization (WHO) Collaborating Centres have provided arguments for supporting representation of A/H in the IPS. These are based on the relevance of the new classification of A/H in the WHO International Classification of Diseases 11th version (ICD-11), and the need for alignment of eHealth tools with harmonized health information. We first present the A/H in the IPS initiative with the mission of producing an international information system that can be used globally in electronic health records to standardize clinical diagnoses and facilitate communication between clinicians caring for patients with A/H diseases. It is believed this initiative will provide a strong voice for the allergy community and an effective process for improving the quality of health data that will optimize medical care for our patients worldwide.

The International Patients Summary

The International Patient Summary (IPS) perspective

Allergic and hypersensitivity conditions (A/H) are increasing in numbers and complexity worldwide, creating difficult challenges for health care professionals who are initially encountering these patients without a documented medical history. Access to a summary of a patient's clinical data provides health professionals the essential information needed to manage unexpected or unpredicted medical situations, such as anaphylaxis, an acute asthma exacerbation or an acute pneumonia in patients with a beta-lactam allergy. However, this information can also be very useful for providing planned medical care when patients relocate to a different city or country or when they change healthcare payor systems.^1,2

With the rapid globalization of healthcare and the need for Digital Health Information System (d-HIS) supported by electronic processes and communications, the United States Human and Health Services (US HHS) and the European Union's (EU) Directorate General for Communications Networks, Content and Technology (DG-CONNECT) signed in 2010 a memorandum of understanding to initiate cooperation for developing health-related information communications technology (ICT). The focus of this transatlantic cooperative agreement was on d-HIS and health ICT.^3,4 The key project that emerged from this agreement is the International Patient Summary (IPS), led by the Health Level Seven International (HL7) and the European Committee for Standardization/Comité Européen de Normalisation (CEN) Technical Committee 251 (CEN/TC251) of the European Union.^5,6 This ambitious project provides generic solutions to standardize electronic health records globally. CEN/TC 251 is a technical decision-making body working on Health ICT standardization in the European Union⁷ and HL7 is a not-for-profit organization, providing a set of standards for transferring clinical and administrative data between hospital information systems.⁸

It has been agreed that for this project to be successful, a single, common IPS approach, that is readily accessible by clinicians throughout the world, should be implemented so patients who present for healthcare emergently or unexpectedly can be managed more effectively. The IPS specification system emphasizes the importance of generating succinct but generalizable patient summaries, that are clinically relevant to all healthcare providers globally. Thus, the IPS is intended to represent a standardized electronic health record that extracts all essential healthcare information about a patient to ensure safe and secure healthcare wherever they are seen clinically in the world.^5,10 The principles of IPS must be: (i) easily implemented, (ii) globally applicable, (iii) widely accessible, and (iv) sustainable.^7,10

The International Patient Summary framework

The IPS library structure is composed of a set of robust, well-defined, and potentially reusable core data items (Fig. 1). All inserted data must be agreed upon by the patient and health professional. There are 4 sections that must be completed: 1) header, 2) required data, 3) recommended data, and 4) optional information (Fig. 1). Allergies are included among the primary information required in the IPS library framework.⁸ However, they are not properly documented, which generates challenges for health care professionals who are firstly encountering A/H patients without a documented medical history.

Fig. 1.

International Patient Summary (IPS) framework

Allergy and hypersensitivity conditions in the International Patient Summary

Scope of the problem

Allergy and hypersensitivity constitute one of the fastest growing non-communicable group of conditions worldwide. According to the World Health Organization (WHO), 50% of the European population may develop an allergy in the next 10 years.⁹ Since 2012, the Montpellier WHO Collaborating Centre (WHO CC) has led an international scientific and academic initiative to develop a better representation of these conditions in the International Classification of Diseases (ICD)-11.10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35 This work has been acknowledged internationally by the 6 major international and regional allergy organizations: the American Academy of Allergy Asthma and Immunology (AAAAI), the European Academy of Allergy and Clinical Immunology (EAACI), the World Allergy Organization (WAO), the American College of Allergy Asthma and Immunology (ACAAI), the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI), and the Latin American Society of Allergy, Asthma and Immunology (SLAAI).³⁵

The primary outcome of this collaboration was the creation of an “Allergic and Hypersensitivity (A/H) conditions” section for the ICD-11 with changes in the WHO ICD mortality coding rules, that now allow them to be used as underlying causes of death in death certificates.^14,36 As a result of this work, in 2018 WHO designated the Montpellier WHO CC to oversee the validation, implementation, and surveillance of this new A/H coding section.

A major limitation was that it did not include health professional communities as stakeholders during the initial conception of these codes. As a result, allergic conditions are still met with significant confusion leading to misdocumentation and miscoding of A/H conditions.^8,9

Therefore, the IPS intends to adopt worldwide recognized coding tools to harmonize data and information. It is recommended that the ICD-11 “Allergic and Hypersensitivity conditions” section be used in this process, requiring that the terminology and concepts of the ongoing IPS framework be updated. Since the Montpellier WHO CC is representing the Allergy/Immunology specialty in this initiative, this technical work will be coordinated with the French WHO CC to ensure optimal representation of A/H in the IPS.

The current main key issues that must be addressed are: (I) involvement of health professionals as stakeholders in the IPS development process, as this will likely impact technical views of the IPS data inserted, (II) description of A/H as supplementary data into 3 sections of the IPS (general clinical data, medications, clinical description), (III) update A/H diagnoses that would prevent patients from being underrepresented or not represented, and (IV) update current terminology, to coincide with the evolving knowledge in A/H that will avoid inaccurate or ambiguous diagnoses.

Current status and perspectives

Reasons supporting the inclusion of A/H as IPS though ICD-11 have been submitted, which include their relevance to the new WHO ICD-11 A/H classification system and the need to align to d-HIS tools so health information can be harmonized (Table 1).

Table 1.

Key arguments for a better representation of allergic and hypersensitivity conditions (A/H) in the International Patient Summary (IPS) through the ICD-11

The need for recording diseases and mortality data, understanding the evolution of clinical disorders, and tracking areas of interest/investments in the health system, were key factors that originally drew attention for the need to develop a consensus generalizable classification and coding system allowing for worldwide alignment. Many different classifications and terminologies systems including ICD have previously emerged. The ICD is the global health information standard to capture morbidity and mortality statistics (MMS) that is maintained and periodically revised by WHO. The ICD is used as a public health tool to aggregate epidemiological statistics to substantiate decision-making and allocation of resources for both management and research by more than 75% of countries. The ICD-11 has been proposed and fully endorsed during the last World Health Assembly (May 2019) and its implementation is ongoing worldwide (Fig. 2).³⁶ Like ICD-10, ICD-11 is a semantic standard for medical data exchange. The new fully digitalized version is designed to improve ICD usability through compatible electronic interfaces.

Fig. 2.

Current status of the global implementation of the ICD-11 according to the World Health Organization, 2023 (43)

The consolidated new A/H section in the IPS through the ICD-11 will now allow A/H be recognized as the clinical conditions requiring specific documentation and management. By allowing inclusion of all the relevant diagnostic A/H terms into the ICD-11, WHO has recognized their importance to clinicians, epidemiologists, researchers, statisticians, health care planners, and other stakeholders.²⁸ Work is also ongoing to include allergen codes into the ICD-11 to ensure accurate classification of the aetiology/triggers for A/H conditions.

The ICD-11 has a multi-hierarchical online framework, is multilingual, and allows delivering more details to the diseases. It enables diagnoses to be linked to a range of parameters by the addition of one or more “extensions”, classified under the “Extension codes” X chapter in a process termed post-coordination. WHO has been promoting this classification strategy in which a stem entity (eg, anaphylaxis) can be more fully defined by linking it to a range of different value sets including severity, anatomical location, and causal agent.³⁶

The representation of A/H in the WHO ICD-11 coding system is a key health, political, and economic advancement that advocates for the best management and prevention of A/H across different countries. It is believed that A/H inclusion in the ICD-11 coding system will result in greater recognition of these conditions that will generate novel perspectives in the upcoming years. Furthermore, this initiative will ensure that health professionals have easy access to standardized patient electronic health records anywhere in the world.³⁴

Regular technical work has begun in France, and changes have been proposed at the most recent IPS EU business meeting. The next steps of this initiative are to establish bilateral discussions with the EU and US IPS, request modification of current international guidelines for the electronic exchange of health data,⁴ implement updates of the ICD-11 A/H diagnoses in the IPS, and initiate the validation process by the allergy community.

Conclusion

Development of the A/H IPS, which is an international standardized information system for use in electronic health records, that facilitates communication among all physicians and other healthcare providers interested in allergy, has been initiated. Although in the early stages of execution, it is strongly believed that this initiative will provide a strong voice to the global allergy community and that the outcomes of this process will improve heath data and optimize care for patients worldwide. In addition, implementation of ICD-11 in the IPS will also contribute on the A/H documentation.

Abbreviations

AAAAI: American Academy of Allergy Asthma and Immunology; ACAAI: American College of Allergy Asthma and Immunology; APAAACI: Asia Pacific Association of Allergy, Asthma and Clinical Immunology; CEN: European Committee for Standardization; CEN/TC251: European Committee for Standardization Technical Committee 251; DG-CONNECT: Directorate General for Communications Networks, Content and Technology; EAACI: European Academy of Allergy and Clinical Immunology; EU: European Union; HL7: Health Level Seven International-7; ICD: International Classification of Diseases; ICT: Health Information and Communications Technology; IPS: International Patient Summary; SLAAI: Latin American Society of Allergy, Asthma and Immunology; US/HHS: United States Human and Health Services; WAO: World Allergy Organization; WHA: World Heal Assembly; WHO: World Health Organization; WHO CC: World Health Organization Collaborating Centre.

Funding

See acknowledgments section for individual author funding.

Availability of data and materials

Not applicable.

Authors’ contributions

The first and last authors contributed to the construction of the document. All the authors critically revised and approved the final version of the manuscript and agree to be accountable for all the aspects of the work.

Ethics approval

Not applicable.

Authors’ consent for publication

All the authors consent for publication in WAO Journal.

Declaration of competing interest

The authors declare that they do not have any conflict of interests related to the contents of this article.

PI and consultant for: Novartis, Genentech, Sanofi Regeneron, Astra Zeneca/Amgen, GSK, Allakos, Escient/Incyte, Celldex, Areteia, Takeda/Shire, CSL Behring, Biocryst, Pharming, Kalvista, Ionis, Intellia, Biomarin, Astria, Jaspar.