Final definition of functional service requirements- Patient Summary

Based on the principles stated in the Foreword, once a common understanding of the Patient Summary service within the epSOS Large Scale Pilot (LSP) framework has been agreed upon and the Use Cases identified, the goal of this deliverable is to identify the requirements necessary to implement a feasible service. This will be based upon the point of view of the health care professional and will take into consideration the level of maturity of the solutions within the Member States. Thus the aim is to focus on strictly necessary requirements in order to achieve a minimum but safe and secure service.

The discussion and the content regarding this deliverable start with some concepts, ideas and recommendations from Work Package 1.1 ‘Analysis and Comparison of national plans/solutions’, where the solutions of the different countries are analysed. They are also based on the outputs of the previous deliverable, D3.2.1 ‘Draft definition of functional service requirements – Patient Summary’, WT 5.2.1 ‘Initial Scope’, ‘Concepts paper epSOS LSP’, and WP 2.1 ‘Analysis and comparison of legal and regulatory issues‘. The purpose of this document is to simplify the services, and avoid already existing complex matters (from the functional and legal perspective) in the different Member States. WP 3.2 focuses on the medical aspect and clinical purpose of the services; technical issues are dealt with in other WPs. The methodology of this WP, which was used to produce this Deliverable, is described in a separate document.

The primary application of an electronic Patient Summary is to provide the healthcare professional with a dataset of essential and comprehensible information at the point of care. This should facilitate safe patient treatment during both scheduled and unscheduled care, with maximum impact on unscheduled care.

Access to the Patient Summary information is required when a resident of one country necessitates healthcare whilst visiting another country. It is also essential that the Patient Summary made available to the healthcare professional contains updated and reliable information. At a European level, it is likely that the patient may have more than one electronic PS in one or more countries, made available abroad in a structured way compliant with the requirements drafted in this document. It has been agreed that only one epSOS PS per country will be provided. This will be accessible from outside its country of origin.

A unique or potentially centrally stored European PS is outside of the scope of epSOS.

It is also outside of the scope of this deliverable to analyse the methodology that each Member State plans to use to produce a valid PS, neither are medical processes in each Member State analysed.

epSOS cross-border care has been specifically designed for two Use Cases which include scheduled and unscheduled scenarios. Use Case 1 refers to an occasional visitor in Country B and Use Case 2 refers to a regular visitor or long-term visitor to Country B. In this deliverable, the Use Cases were analysed jointly as there are no differences regarding the terms of the services and the information required by the final user. A list of possible cases in which access to Patient Summary would support better treatment of cross-border patients is presented in section 9 of this document (‘Storyboards’).

The functional requirements identified to fulfil the Use Cases are related to:

• the security of the service, i.e. identification, authentication or patient consent access to the information from/to another country
• the correct interpretation of the information the information required by the physician
• provision of the minimum information needed to fulfill all steps of the PS service.

Non-functional requirements have been identified in addition to functional requirements. These are necessary in order to fulfil the functional requirements, and also directly relate to the experience of the HCP and to the security of the process. This is the list of the identified requirements:

It is important to note that the description of Use Cases and Functional Requirements presuppose that: ’Only the PS of Country A (which is the MS of affiliation) will be shown to HCP of Country B.’ This decision was made in order to reduce complexity and facilitate the viability of the pilots in the epSOS scenario. Nevertheless, the approach Multiple Patient Summaries (meaning that the healthcare professional is given access to the list of existing Patient Summaries for that patient and selects and asks for any of them) is presented in Annex A of this deliverable for information purposes in preparation for a possible future epSOS LSP extension.

It is also an objective of this WP to agree that not only a minimum, but also a maximum Patient Summary dataset will be interchanged. Furthermore, it has been agreed that the Patient Summary dataset has to be defined from a medical standpoint. This common structure for the fields in the PS (epSOS PS) will be employed in each national application according to the local template. A classification of the different information datasets identified was developed based on their degree of relevance to the PS service:

• Minimum dataset of the PS is defined as the agreed set of essential health information (‘Basic dataset’) that is required from the clinical point of view for safe patient care to be delivered, particularly in the case of unscheduled care). It may be sent with a value null flavor if the source system of the country does not track that information
• Mandatory dataset: this is a subgroup of the ‘Minimum dataset’, which must contain valid information. If the information is not valid, the PS will be rejected
• Maximum dataset is an agreed ‘Extended dataset’ of desirable health information, which can be exchanged among the epSOS countries. It is, however, not mandatory to send these fields.

The common dataset to be exchanged was agreed upon by WP 3.2 in a face-to-face meeting in Paris on July 22nd 2009, and is presented in section 6 of this document (‘Common structure of Patient Summary’).

During the entire process, a set of issues and recommendations for other WPs has been identified. One of the most important recommendations is addressed to the Semantic Work Package. This strongly advises that Patient Summary information is coded for using currently available classification systems so as to support semantic interoperability services foreseen within the scope of epSOS.

During the work carried out by WP 3.2, the possible inclusion of a new Use Case (‘Use Case 3’) has also been considered. This would analyse the access of the patient to his Patient Summaries located in a country different from Country A without the intermediation of a HCP. It was agreed that this Use Case is outside of the scope of epSOS. This analysis is included in Annex A of this deliverable for information purposes in preparation for a possible future epSOS LSP extension.