Draft definition of functional service requirements- Patient Summary

Based on the principles stated in the foreword, the goal of this Deliverable was to identify the requirements necessary to implement a feasible Patient Summary service adopting the point of view of healthcare professionals and taking the level of maturity of the solutions in the member states into consideration. Prerequisite for this was to have reached agreement on the common understanding of the Patient Summary service within the epSOS LSP framework and that the Use Cases have been identified. In consequence, the aim was to focus on those requirements strictly necessary to achieve a minimum but secure service.

The discussion and the content of this Deliverable was based on concepts, ideas and recommendations from WP 1.1 ‘Analysis and Comparison of national plans/solutions’ in which the solutions of different countries are analysed, and from WP 5.2.1 ‘Initial Scope’, in which the initial scope regarding the Use Cases as well as a number of initial issues need to be addressed by this WP. The scope of the document intends to simplify the services and to avoid already existing complex matters (from the functional and legal perspective) in the different Member States.

The concept driving WP 3.2 was to focus on the medical perspective and clinical purpose, while technical issues were 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 in turn is intended to allow safe patient care both during unscheduled care as well as planned care, with maximum impact in the case of unscheduled care. Any access to the Patient Summary information is made when a resident of one country necessitates healthcare when 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 can be assumed 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. Agreement has been met that only one epSOS PS per country will be provided, which will be accessible from outside. A unique or potentially centrally stored European PS is out of the scope of epSOS.

This Deliverable does not analyse the medical process or the methodology, which each member state envisions for the production of a valid PS. 

epSOS cross-border care has been specifically designed for two Use Cases and includes scheduled and unscheduled encounters. 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, both Use Cases were analysed jointly as there are no differences regarding the terms of the services and the information requirements for the final user.

The functional requirements identified have been related to ensure:

• 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
• that the information needs of the physician is met
• 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, as they are not only needed to fulfill the functional ones, but also because they are directly related to the HCP experience 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 PSs (meaning that the healthcare professional is given access to the list of existing PSs for that patient and selects and asks for any of them) was also analysed by WP 3.2. This analysis will be included in D3.2.2 for information purposes in due preparation of a possible future epSOS scope 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 (epSOS PS). Furthermore, agreement has been met that the Patient Summary dataset has to be defined from a medical standpoint. This common and agreed structure of the fields in the PS (epSOS PS) will be represented 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 in 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 to be sent to deliver safe patient care focused in 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 have a valid value. If the values are not valid, the PS will be rejected
• Maximum dataset is an agreed ‘Extended dataset’ or desirable health information from the clinical point of view, which can be exchanged among the epSOS countries. It is, however, not mandatory to send these fields. In this Deliverable, the presented proposal of a ‘minimum PS dataset’ (chapter 6.1.1) has been agreed to in WP 3.2 although consolidation to be implemented in D3.2.2 is still pending. The 'maximum dataset' will be addressed in more detail in D3.2.2.

During the work carried out in WP 3.2, a PS questionnaire was circulated among all MS. The objective was to find out which data items were available in the different MS of the PS.

The Patient Summary must be presented in structured modular data groups or sections (sorted under the correct nesting headers) and containing related items of information. 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 WP: coding of the PS information with currently available classification systems is strongly advised to support semantic interoperability services foreseen within the scope of epSOS.

This Deliverable contains a set of open questions regarding some of the issues that need to be answered by WP 2.1 "Legal and Regulatory issues" and whose answers will be included in the final Deliverable for this WP (D3.2.2: "Final definition of functional service requirements- Patient Summary").

During the work carried out by WP 3.2, the possible inclusion of a new Use Case ('Use Case 3') has also been analysed: the access of the patient to his PS located in a country different from Country A without the intermediation of a HCP. It was agreed that this UC is outside of epSOS' scope.

This analysis will be included in D3.2.2 only for information purposes in preparation of a possible future epSOS scope extension.

The following will be included in D 3.2.2:

• The final agreed ‘basic dataset’ and ‘extended PS dataset’
• A comparison between the 'basic' and "extended' agreed dataset and the available datasets in the MS (identified by the questionnaire)
• A set of storyboards; this represents a list of possible cases in which access to a Patient Summary would support better treatment of cross border patients. They will be included in D3.2.2 to be aligned with WP 3.1 which does not include the storyboards in D3.1.1
• The consolidation of the legal open questions
• Information requested by technical groups
• The relevant aspects of sharing multiple PSs in several MS in preparation of a possible extension of the epSOS project
• UC3 in preparation of a possible extension of the epSOS project