OPEN CALL FOR PROJECT TEAM EXPERTS European Standard for Patient Summary

Transcription

1 OPEN CALL FOR PROJECT TEAM EXPERTS European Standard for Patient Summary Specific Agreement: SA/CEN/GROW/EFTA/000/ Aim: To participate in the creation of an International Patient Summary specification, at a global level, and turn this European knowledge and interests into a European Standard, in line with the Guidelines on Minimum/Nonexhaustive Patient Summary Dataset for Electronic Exchange as adopted by the European ehealth Network. Under an EC/EFTA funding, the project aims to support the development of a European Standard for the Patient Summary, together with implementation guidance described in a CEN Technical Specification. The funding is available via the specific Grant Agreement between CEN and the European Commission. The official starting date of the Grand Agreement is Through this open call for Project Team experts, CEN invites applications (by filling in the Application form) from experts who would like to support the standardization work on: European Standard (EN) for the Patient summary; CEN Technical Specification (CEN/TS) for the implementation guide for the Patient Summary. The project team is responsible for both deliverables. The Terms of Reference (ToR) of the Project Team are attached in the Annex. The selection and appointment of the Project Team experts will be made by a selection panel whose composition is: Robert Stegwee, Chairman of CEN/TC 251 Maud Damme, Manager NEN Health Care Alexandre della Faille de Leverghem, Programme Manager CCMC (CEN-CENELEC Management Centre) Shirin Golyardi, Secretary of CEN/TC 251 Health informatics Ioanna Zerva, European Commission (DG GROW) The selection panel will select the 4 experts and appoint, among them, the Project Team leader as described in the ToR. Interested candidate experts are kindly requested to send their applications by , to Shirin Golyardi (shirin.golyardi@nen.nl), CEN/TC 251 Secretary. Preferred method is by . Applications shall be composed of the application form duly filled in as well as a short and concise Curriculum Vitae focused on the experience, publications, achievements and skills relevant to the project. The proposed estimated number of man-days the expert will have to perform the task, and the man-day rate based on real costs also need to be provided. Please refer to Clause 6 of the ToR for a description of the expertise needed for this project. We look forward to receiving your applications. Yours sincerely, Shirin Golyardi CEN/TC 251 Secretary

2 Terms of Reference for IPS Project Team 1. Scope These Terms of Reference (ToR) are prepared to support the selection of four Project Team (PT) experts to: a. support full European participation in the development of an International standard building on the European experiences, resources and the 2 nd revision of the ehealth Network (ehn) Guidelines; b. develop a European Standard (EN) for a European Patient Summary, profiling the International work to ensure compatibility in line with the Guidelines on Minimum/Non-exhaustive Patient Summary Dataset for Electronic Exchange as developed and adopted by the ehn; c. produce an accompanying CEN Technical Specification (CEN/TS) for the implementation guidance. 2. Context This proposal addresses the 2015 Rolling Plan on ICT standardization and in particular Action 4, in which the work of the Joint Action Supporting the ehealth Network (JAseHN) is specified. Currently, the Joint Initiative Council on Global Health Informatics Standardization (JIC) is launching a global standardization activity resulting in a set of implementable standards for the exchange of an International Patient Summary. A draft outline of this work is published for commenting purpose ( This proposal aims to support 1) the European participation in this global standardization activity and 2) the development of a European Standard on Patient Summaries, based on the global standardization work. After its official publication by CEN, the latter will be subject of approval by the ehealth Network (ehn), who are the principal stakeholder and have an ongoing role in establishing Patient summary guidelines (see section 1, 1.3). The Multi-annual Work Plan ( ) of the ehealth Network identifies both the work on the cross-border exchange of Patient Summary data and the alignment of standardization activities in ehealth as key priority areas. The JAseHN has incorporated both in their work plan, with work package 5 aiming at the alignment of standardization activities. This action aims to support the JAseHN WP5 specifically in the standardization of the Patient Summary. In addition, the Horizon 2020 PHC34 CSA project estandards is also providing support to the International Standard for Patient Summaries, as per task 5.2 of Work Package 5. Their bandwidth is limited and does not provide room for actual leadership and participation in standardization activities, but this proposed action will reach out to get full backing in terms of the knowledge and evidence gathered by WP5 and to report the global SDO progress and experiences for further assessment and funnelling into the final deliverable of the estandards project: the roadmap for a sustainable and collaborative standards development. The wider context of EU-US collaboration will also be taken into account by this proposal. There have already been successful collaborative precursors, e.g. the Trillium Bridge project, and the intent is to build upon that legacy. Furthermore, the upcoming H2020 call will be tracked, and any synergies that might strengthen the outcome of this proposal will be investigated and capitalised on when appropriate. For example, this proposal will actively look at potential beneficial initiatives such as the proposed interoperability roadmap SC1-HCO project that is anticipated to start by the end of 2016.

3 3. Description of work programme The submitted project proposal originally comprised two phases, the start-up and the much longer unwieldy closing phase. Whereas the deliverables and the timetable related to their delivery are exactly the same as defined by the original proposal, it has been found that it is easier to envisage, manage, and present the project by refining the language and terms used as follows: The project comprises a start state period of 3 months (comprising the call for experts, contracts, and team orientation), a middle period of just under 3 years (comprising a set of three substantive phases around the work and products of standardization), and a final state period of two months in which the final report is delivered and the project is formally closed. Each part of the project is described next using these terms over the entire time-line. The start state period is primarily administrative in nature and is very important for placing the project on a firm foundation. The project team of appointed experts will begin to examine the various projects and initiatives relating to the standardization of an International Patient Summary. The landscape is very rich and is in a state of flux, which underlines the initial requirement and emphasises the project s importance. It is important to restate that this project work cannot be delivered or act in isolation; it is not producing entirely new standards that are inconsistent or conflicting with other international efforts; rather it is targeted on producing an international solution that satisfies the European requirements. There are a number of important inputs that must be taken into consideration. The most important of these is the e-health Network Guidelines for European Patient Summary that are undergoing their second revision. Analysis of sector needs and recommendations for specific developments will subsequently be carried out in full consultation with other international partners and the participation that this project affords will reflect the need for a coherent, consistent approach to providing an International Patient Summary that meets the needs of the European community and citizens. The start state period will start the process by forging relationships, collecting relevant documentation and user experiences; the process itself will continue throughout the lifetime of the project. The main, middle period of the project comprises three substantive phases around the work and products of standardization. These phases are associated with the three balloting events within CEN. The first phase is establishing the new work item proposals for an EN, which will be closely tied to the ehn Guidelines, and a CEN/TS, which will be the implementation guide accompanying the European Standard. At this time, these will both be in outline, but will convey sufficient detail to permit the formal process to begin. The second phase is concerned with the balloting of the initial content and the consideration and reconciliation of comments from the European and international communities regarding the EN. The CEN/TS will follow the same course, although it is expected to be a larger and more complex document. The third phase includes any possible second ballots, reconciliation and consensus before agreements on submitting final ballots. There is sufficient contingency built into the second and third phases to make sure the project fulfils its contractual obligations and delivers the EN and CEN/TS.

4 The two-month final period is to formally close the project with the provision and acceptance of the final report. The duration of the action (Start + 36) will deliver 2 interim progress reports (S + 12 and S +24) and a final report (S+36). Performance Indicators for Effectiveness and Stakeholder engagement in the project will assure routine summary reports will be delivered to the ehn meetings. Dissemination will be through global SDO meetings, relevant projects and through publication of the EN and TS in CEN. In reality, these three key performance indicators are interrelated. The Effectiveness indicator essentially requires consistent products that are delivered; the wide stakeholder engagement will permit the effectiveness indicator to be realized, and the dissemination can only be delivered and done in relationship with the key stakeholders. Dissemination and promotion of adoption are the means to socialize the deliverables from the project. 4. Timetable Consideration will be given to the relevant ISO and JIC initiatives and the on-going EU-US collaboration, particularly building links with the INTERPAS project. As all these initiatives are ongoing concurrently with this project, dialogue will continue throughout the project and therefore will also be an integral part of all phases of the project. Ballot Cycles and meetings in other SDOs will also require reconciliation efforts. Activity Date 1. Open call for the Project Team, plus work plan for the Project team; compilation, review and assessment of the global PS initiatives. 2. ehn 2 nd revision of PS guidelines (expected November 2016, as is the JIC Standards Sets). New work item proposals for EN + CEN/TS plus first draft (outline) to be presented to CEN/TC 251; These will take the form along general lines, expected table of contents, to be presented to the ehn for feedback prior to formal balloting in CEN. 3. Receive feedback, assure quality content and reconciliation with the ehn & other initiatives by SDOs. 4. Open face-to-face meeting for validation. TBD 5. Assess feedback of the JIC Standards Set for trial March 17 use and its implications for the International Patient Summary interaction and liaison. 6. Enquiry draft pren for TC commenting period (first interim report), based on global draft standard. Three-Month Commenting period in CEN/TC 251 {three-month ballot, 2 month translation}, and reconciliation with global SDO process. Start State (S): May - Aug 16 Phase 1 (S+4): September 16 & November 16 November 16- Feb 17 Phase 2 (S+12): April July Interim report on the project s activities to be S+12 submitted to the EC by CEN nd Open face-to-face meeting for validation. TBD 9. Final Draft FprEN for Formal Vote April 2018 (S+23- Phase 3 (S+21): 25) {two-month ballot} 10. The 2 nd Interim report on the project s activities to be submitted to the EC by CEN S+24

5 11. Draft DTS for formal vote {or (S+30-33) if this is a second DTS ballot)} Dissemination and promotion of adoption 12. Final report on the project s activities to be submitted to the EC by CEN; (S+23-26) Finish (S+36): 5. Project Team A Project Team of 4 experts will be selected and appointed by an open process. In their applications, the candidates should also indicate whether they apply for the position of Project Team leader. Among the 4 selected experts, the Project Leader will be appointed. NEN, responsible for CEN/TC 251 Secretariat, acts on behalf of CEN in the administrator role of the project. Robert Stegwee will provide the managerial oversight as the Chair of CEN/TC 251, and the principal author of the proposal. 6. Eligibility criteria and working conditions The selected experts shall: - Have at least 10 years of professional experience in the area of healthcare informatics; - Have at least 5 years of experience with standardization issues in relation to healthcare informatics at European and/or international level; - Have a broad knowledge of the healthcare informatics needs and issues, not limited to a single application; - Have particular knowledge of, and interest in, electronic health records, data sets, terminologies and understanding of the issues surrounding personal data; - Have knowledge of issues complementary to standardization such as testing and certification or research projects; - Have a good knowledge of English (spoken and written); - Have good analytical skills enabling the analysis of existing standards/specifications and how they address the needs identified; - Have good communication skills. Between them, the Project Team members should have experience of previous and current ehealth-related work in CEN, as well as an understanding of standards issues in other bodies such as ISO, HL7 and industry standards consortia. The Project Leader (PL) is responsible for delivering the (final) drafts for the EN and CEN/TS and will represent the PT in international and stakeholder engagement meetings as well in the coordination with JAseHN WP5, European SDO Platform and other relevant committees. The PL will inform and support NEN (project administrator) in managing the project and provide technical advice for the periodic reports for the EC and other stakeholders. Individuals acting in their own right or on behalf of their employing company may apply. However, contractual arrangements will only be possible with registered companies. Combined applications (two experts as one team) will not be accepted. Experts shall also be prepared to work electronically. They should be prepared to attend Project Team, CEN/TC 251 and/or other (SDO) meetings as necessary. 7. Selection process An open call for candidates is launched on the websites of CEN, NEN and CEN/TC 251 and circulated to relevant mailing lists. Applicants shall submit their candidatures to Ms Shirin GOLYARDI, NEN Standardization Consultant, by

6 Applicants shall send the official application form as well as a detailed curriculum vitae (max. 4 pages) and a cover note explaining the motivation for candidature. The Project Team will be selected by the selection committee: Robert Stegwee, Chairman of CEN/TC 251 Maud Damme, Manager NEN Health Care Alexandre della Faille de Leverghem, Programme Manager CCMC (CEN-CENELEC Management Centre) Shirin Golyardi, Secretary of CEN/TC 251 Ioanna Zerva, European Commission (DG GROW) Selection criteria Price aspects 10% Relevant knowledge and Technical Skills 40% Communication and Language (English) skills (including technical writing and presentations) 20% Knowledge of the European and practices governing framework related to the tasks to be assigned 25% Knowledge of the rules and practices governing CEN technical work 5% Among the 4 experts selected according to the above-mentioned criteria, the expert appointed as Project Leader will be the one with the highest score having indicated his/her interest in that position in the application form. The contracts will be between the Applicant and NEN and will follow standard CEN rules. The timetable for the Project Team selection is as followed: What When Who Announcement of call for Project Administrator experts Deadline for applying Candidates Selection Process July 2016 Selection Committee Project Team kick-off Mid-August 2016 Project Team meeting 8. Contact point Ms Shirin GOLYARDI Standardisation consultant NEN-Healthcare Vlinderweg 6 NL-2623 AX Delft Direct tel shirin.golyardi@nen.nl