D7.4 V2 Pilot Readiness Assessment

Ref. Ares(2021)1515471 - 26/02/2021 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Grant Agreement No. 875299 Project acronym: UNICOM Project full title: Up-scaling the global univocal identification of medicines in the context of Digital Single Market strategy Call identifier: H2020-SC1-DTH-2019 WP7 eHDSI cross-border / national eHealth services piloting D7.4 V2: Pilot Readiness Assessment Version: 2 Status: Final version Dissemination Level1: PU Due date of deliverable: 31/05/2024 Actual submission date: 31/05/2024 Work Package: WP7: eHDSI cross-border / national eHealth services piloting Lead partner for this deliverable: ARIA Partner(s) contributing: SPMS, IHE, HL7, INDRA, KELA, HZZO, INFARMED, REGLOMB, GNOMON, IDIKA, ELGA, IEDOH, SAS, HL7, HZZO. Deliverable type2: R Main author(s): Alberto Zanini, Marcello Melgara, Angela Ferrara, Luca Garbarino (ARIA SpA) Other author(s): 1 Dissemination level: PU: Public; CO: Confidential, only for members of the consortium (including the Commission Services); EU-RES: Classified Information: RESTREINT UE (Commission Decision 2005/444/EC); EU-CON: Classified Information: CONFIDENTIEL UE (Commission Decision 2005/444/EC); EU-SEC Classified Information: SECRET UE (Commission Decision 2005/444/EC) 2 Type of the deliverable: R: Document, report; DEM: Demonstrator, pilot, prototype; DEC: Websites, patent fillings, videos, etc.; OTHER; ETHICS: Ethics requirement; ORDP: Open Research Data Pilot UNICOM – D7.4: Pilot Readiness Assessment Page 2 of 29 Revision history Version Date Changes made Author(s) 0.1 15/09/2023 Table of contents, first draft of contents Marcello Melgara, Angela Ferrara, Luca Garbarino (ARIA SpA) 0.2 30/09/2023 Implementation of contents Marcello Melgara, Angela Ferrara, Luca Garbarino (ARIA SpA) 0.3 15/10/2023 Implementation of contents All Task partners 0.4 31/10/2023 Finalization of v1 of the Deliverable All Task partners 0.5 01/02/2024 Final version of v1 of the Deliverable Marcello Melgara, Luca Garbarino (ARIA SpA) 0.6 30/03/2024 Revision of previous version Alberto Zanini, Luca Garbarino (ARIA SpA) 0.7 30/04/2024 Finalization of V2 Alberto Zanini, Luca Garbarino (ARIA SpA) + Task partners 1.0 29/05/2024 Final version submitted to the coordination team Statement of originality This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. UNICOM – D7.4: Pilot Readiness Assessment Page 3 of 29 Deliverable abstract Deliverable 7.4 (D7.4) stems from the D7.1 Piloting Strategy and the D7.2 Proof of concept demonstrator, as well as the results shown in D7.3 Pilot deployment report, particularly focused on the contributions coming from Italy, Finland and Portugal. It aims at highlighting the readiness level demonstrated by countries throughout the pre-production testing and conformance testing phases, following in particular the readiness strategy highlighted in D7.1. The Deliverable, following an analysis and description of the Change Management process for the IDMP adoption in eHealth services and the procedures, key performance indicators and tools exploited in order to assess the readiness levels, summarizes the results in the functional and extended pre-production testing of the aforementioned countries, therefore assessing their readiness levels demonstrated. Key words: ISO IDMP; EMA; eHealth, ePrescription, Patient Summary, UNICOM, CDA Implementation Guide, ValueSets. This document contains material, which is the copyright of the members of the UNICOM consortium listed above and may not be reproduced or copied without their permission. The commercial use of any information contained in this document may require a license from the owner of that information. This document reflects only the views of the authors, and the European Commission is not liable for any use that may be made of its contents. The information in this document is provided “as is”, without warranty of any kind, and accept no liability for loss or damage suffered by any person using this information. © 2019-2023. The participants of the UNICOM project. UNICOM – D7.4: Pilot Readiness Assessment Page 4 of 29 Table of Contents Deliverable abstract .......................................................................................................................3 List of Figures ................................................................................................................................5 List of Tables .................................................................................................................................5 List of Abbreviations ......................................................................................................................5 1 Executive summary ................................................................................................................7 2 Introduction .............................................................................................................................8 2.1 Background .....................................................................................................................8 2.2 Introduction to D7.4 ........................................................................................................8 2.3 Scope of the document...................................................................................................9 3 Change Management process for IDMP adoption in eHealth Services ..............................10 3.1 Procedure Scope ..........................................................................................................10 3.2 Best cases ....................................................................................................................10 3.3 Real cases ....................................................................................................................10 4 Evaluation of the Improved Services in the process for IDMP adoption in eHealth Services ..............................................................................................................................................12 4.1 Procedures to Key Performance Indicators Data ........................................................12 4.2 Key Performance Indicators .........................................................................................13 4.3 End-to-end Functional Testing performance indicators results ...................................22 5 Participating Deploying countries and results: Overview .....................................................25 5.1 EXTENDED PPT - Countries and results WAVE 6 .....................................................26 6 Conclusion and further actions .............................................................................................29 UNICOM – D7.4: Pilot Readiness Assessment Page 5 of 29 List of Figures Figure 1: KPI 1.3 - Number of ePrecriptions exchanged Q4 2022. ...............................................13 Figure 2: KPI 1.3 - Number of ePrecriptions exchanged Q1 2023 ................................................14 Figure 3: KPI 1.3 - Number of ePrecriptions exchanged Q2 2023 ................................................14 Figure 4: KPI 1.3 - Number of ePrecriptions exchanged Q3 2023 ................................................15 Figure 5: KPI 1.3 - Number of ePrecriptions exchanged Q4 2023 ................................................15 Figure 6: KPI 1.4 - Number of eDispensations exchanged Q4 2022 ............................................16 Figure 7: KPI 1.4 - Number of eDispensations exchanged Q1 2023 ............................................17 Figure 8: KPI 1.4 - Number of eDispensations exchanged Q2 2023 ............................................17 Figure 9: KPI 1.4 - Number of eDispensations exchanged Q3 2023 ............................................18 Figure 10: KPI 1.4 - Number of eDispensations exchanged Q4 2023 ..........................................18 Figure 11: KPI 1.5 Number of Patient Summaries Exchanged Q4 2022 ......................................19 Figure 12: KPI 1.5 Number of Patient Summaries Exchanged Q1 2023 ......................................20 Figure 13: KPI 1.5 Number of Patient Summaries Exchanged Q2 2023 ......................................20 Figure 14: KPI 1.5 Number of Patient Summaries Exchanged Q3 2023 ......................................21 Figure 15: KPI 1.5 Number of Patient Summaries Exchanged Q4 2023 ......................................21 List of Tables Table 1: KPI 1.3 Number of ePrescriptions exchanged details .....................................................13 Table 2: KPI 1.4 Number of eDispensations exchanged details ...................................................16 Table 3: KPI 1.3 Number of Patient Summaries exchanged details .............................................19 Table 4: Summary of Exchanged Documents ...............................................................................21 Table 5: Evaluation forms – Wave 5 ..............................................................................................22 Table 6: Evaluation forms in details – Wave 5 ...............................................................................23 Table 7: Evaluation forms – Wave 6 ..............................................................................................23 Table 8: Evaluation forms in details – Wave 6 ...............................................................................24 Table 9: Evaluation forms – Wave 7 (Autumn) ..............................................................................25 Table 10: Evaluation forms – Wave 7 (Spring) ..............................................................................25 Table 11: Extended Formal and Upgrade PPT Wave 6: Participating Deploying Countries ........28 List of Abbreviations Abbreviation Complete form ADE Adverse Drug Event API Active Pharmaceutical Ingredients ATC Anatomical Therapeutic Chemical Code CEF Connecting Europe Facility CEN European Committee for Standardization eD eDispensation DSS Decision Support System EPF European Patients’ Forum eHDSI Health Digital Service Infrastructure EHR Electronic Health Record EMA European Medicines Agency eP ePrescription UNICOM – D7.4: Pilot Readiness Assessment Page 6 of 29 epSOS Smart Open Services for European Patients EU European Union FDA USA Federal Drug Agency GDPR General Data Protection Regulation GP General Practitioner GS1 Global Standards One HCPO Healthcare Provider Organisation HDR Hospital Discharge Report HL7 Health Level Seven HP Health Professional ICD-10 International Statistical Classification of Diseases and Related Health Problems, 10th revision IDMP Identification of Medicinal Products IHE Integrating the Healthcare Enterprise ISO International Organization for Standardization LTF Legal Task Force MPD Medicinal Product Dictionary MS Member State MVC Master Value Catalogue NCA National Competent Authority (for human medicines) NCP National Contact Point NCPeH National Contact Point eHealth NIA National Identification Authority Ophelia OPtimising HEalth LIterAcy OTC Over the Counter PhP Pharmaceutical Product PhPID Pharmaceutical Product identifier PS Patient Summary UNICOM – D7.4: Pilot Readiness Assessment Page 7 of 29 1 Executive summary The primary goal of the UNICOM project is to simplify the execution of a range of practical scenarios, with a specific emphasis on advancing the Identification of Medicinal Products (IDMP). IDMP functions as a global, clear-cut identification system for pharmaceuticals, with a particular focus on supporting cross-border ePrescription and eDispensation. Comprised of five ISO standard specifications, IDMP defines the essential data components and formats necessary for the smooth identification and sharing of information about medicinal products. By embracing this method for identifying medicines, the project aims to enhance patient safety within individual nations and on an international scale. Deliverable D7.4, builds upon D7.1, which defined the Piloting Strategy and D7.2, which demonstrated how ePrescriptions, enhanced with IDMP data, can be used in the country of treatment to identify the Medicinal Products, and provide suggestions to Member States implementing pilot services, as well as through the work done in Deliverable 7.3, which is structured as a pilot deployment report, especially through the gathering and commenting of the test’s results, particularly focused on the contributions coming from Italy, Finland and Portugal. It aims at highlighting the readiness level demonstrated by countries throughout the pre-production testing and conformance testing phases, following in particular the readiness strategy previously highlighted in D7.1. The following chapters therefore contain the evaluation of the readiness levels reached by Member States during the Wave 6 by the end of the pre-production phase, including change management processes, conformance testing and end-to-end testing, overall assessing the syntactical correctness of exchanged information. The readiness depends on the process that led to the results of the PPT (D7.3), specifically: • Whether what has been demonstrated for the critical test data can be extended to all drugs. • Whether the compliance check process has been successful. The close collaboration with National Contact Points of those Countries participating in the cross-border piloting was an essential contribution to the writing of this Deliverable. UNICOM – D7.4: Pilot Readiness Assessment Page 8 of 29 2 Introduction 2.1 Background The exchange of interoperable health data is nowadays a key priority. The opportunities arising from the possibility of having an interoperable and fruitful exchange of a vast array of primary and secondary healthcare data across Member States faces various challenges, which projects such as UNICOM try to overcome, throughout the creation of powerful consortiums willing to cooperate. Many mechanisms and tools have been broadly put into place to tackle challenges linked to interoperability and cross-borders information exchange. The Connecting Europe Facility (CEF) established the eHealth Digital Service Infrastructure (eHDSI) to manage the implementation and functioning of cross-border health data exchange services. Within the eHDSI framework, essential and versatile services such as Patient Summary (PS) and ePrescription (eP) are established and activated to streamline data exchange at both national and European Union (EU) levels. This infrastructure facilitates the provision of Cross-Border eHealth Information Services (CBeHIS). The global challenge of unambiguously identifying medicinal products is impeded when countries work independently, obstructing the seamless exchange of detailed, interoperable medicine information within the European Union, across the Atlantic, and worldwide. The UNICOM project collaborates with various stakeholders in health systems to take the lead in addressing this challenge, aiming to expedite the widespread adoption of ISO IDMP standards (Identification of Medicinal Products). Quoting, the UNICOM official website, UNICOM is about improved patient safety and better healthcare for all – it focuses on the implementation of the International Organization for Standardization (ISO) suite of IDMP (IDentification of Medicinal Products) standards. Work will involve further development, testing, implementation and diffusion of these standards for: • regulatory purposes of national medicinal products authorities and the European Medicines Agency (EMA) • global pharmacovigilance • advancing cross-border digital health services, particularly ePrescription • better healthcare for all, public health services, clinical research, big data analytics, artificial intelligence applications. 2.2 Introduction to D7.4 The assessment of Pre-Production Tests (PPT), established and executed in Tasks 7.1 and 7.3 and described in D7.3, will adhere to the readiness criteria specified in Task 7.1. Specifically, for cross-border pilots and pertinent national/regional pilots, specifications and test tools developed by WP5 and WP6 will be employed to ensure the syntactical accuracy of exchanged information. Pharmacists and physicians will contribute support in conducting cross-document validation and end-to-end Functional Testing. Depending on the pilot's scope, it may be necessary to align the work in this task with the corresponding activities of eHDSI, including testing and audits. For pilots independent of operational eHDSI services, a self-assessment and partial peer-to-peer assessment will be conducted in accordance with the defined readiness criteria. The ultimate decision for a pilot to go live will be formally determined by the steering boards of MyHealth@EU, based on the assessment results. If the pilot is part of the operational eHDSI services, the relevant decisions will follow the standard eHDSI processes. UNICOM – D7.4: Pilot Readiness Assessment Page 9 of 29 2.3 Scope of the document The objective of this report is that of providing a first version report describing the readiness of countries before entering operations, following the pilot strategy elaborated in Deliverable 7.1 and the results of the eP/eD and PS exchanges during the pre-production test phase, partially described in the first version of the Pilot Deployment report (Deliverable D7.3). To pursue this goal, the present deliverable is structured in the following chapters: • Chapter 1, Executive Summary; • Chapter 2, Background and Introduction; • Chapter 3, Overview and description of the Change management process for the IDMP adoption in eHealth Services; • Chapter 4, Evaluation of the Improved Services in the process for IDMP adoption in eHealth Services, with a focus on KPIs in Operation and end-to-end functional testing; • Chapter 5, Participating Deploying Countries and their extended PPT results for Wave 6; • Chapter 6, Conclusions and further actions. UNICOM – D7.4: Pilot Readiness Assessment Page 16 of 29 • End Time (e.g. 2016-12-14 09:25:09) • Type of Exchanged Documents Table 2: KPI 1.4 - Number of eDispensations exchanged/provided In particular, considering from Wave 5 to today, and therefore Q4 of 2022, and Q1, Q2, Q3 and Q4 2023 (data of which have been depicted in the Figures below), of which we have data on the KPI platform, the eDispensations transactions registered are a total of 29,591, out of a total of 64,686 globally reported on the platform. Figure 6: KPI 1.4 - Number of transactions to exchange eDispensations during Q4 2022 UNICOM – D7.4: Pilot Readiness Assessment Page 17 of 29 Figure 7: KPI 1.4 - Number of transactions to exchange eDispensations during Q1 2023 Figure 8: KPI 1.4 - Number of transactions to exchange eDispensations during Q2 2023 UNICOM – D7.4: Pilot Readiness Assessment Page 18 of 29 Figure 9: KPI 1.4 - Number of transactions to exchange eDispensations during Q3 2023 Figure 10: KPI 1.4 - Number of transactions to exchange eDispensations during Q4 2023 Similarly to ePrescriptions, for eDispensations as well it has to be mentioned that to estimate the total number of actual ePs exchanged, the total number of transactions reported in the aforementioned KPI data should be divided in half, as the total number includes both transactions happening in Country A and Country B. KPI 1.5 Number of Patient Summaries exchanged/provided Differently to the previous KPIs, this indicator allows filtering for additional countries such as France, Luxembourg, Malta, and the Netherlands, in addition to the previously mentioned ones. The primary objective associated with this KPI is to enhance the unique identification of medicines through IDMP data on Patient Summaries (PS). UNICOM – D7.4: Pilot Readiness Assessment Page 19 of 29 KPI KPI-1.5: Number of PS exchanged Description Description Measure the number of PS documents requested by a Country of treatment (Country B) from a Country of affiliation (Country A). Data set For each PS document requested, the following details will be reported: • Start Time (e.g. 2016-12-14 09:25:02) • End Time (e.g. 2016-12-14 09:25:09) • Type of Exchanged Document Table 3: KPI-1.5: Number of PS exchanged Description In particular, considering from Wave 5 to today, and therefore Q4 of 2022, and Q1, Q2, Q3 and Q4 2023 (data of which have been depicted in the Figures below), of which we have data on the KPI platform, the transactions registered for Patient Summaries are a total of 1,856, out of a total of 3,948 globally reported on the platform. Figure 7: KPI 1.5 - Number of transactions to exchange Patient Summaries during Q4 2022 UNICOM – D7.4: Pilot Readiness Assessment Page 20 of 29 Figure 8: KPI 1.5 - Number of transactions to exchange Patient Summaries during Q1 2023 Figure 9: KPI 1.5 - Number of transactions to exchange Patient Summaries during Q2 2023 UNICOM – D7.4: Pilot Readiness Assessment Page 21 of 29 Figure 9: KPI 1.5 - Number of transactions to exchange Patient Summaries during Q3 2023 Figure 9: KPI 1.5 - Number of transactions to exchange Patient Summaries during Q4 2023 The subsequent table presents the summary of the number of exchanged documents during Pre-Production Testing and Routine Operation until Q4/2022. Type of Service N° of Documents exchanged until Q2/2023 ePrescriptions (HL7 CDA L3 and PDF) 162.950 eDispensations 64.686 Patient Summaries (HL7 CDA L3 and PDF) 3,948 Table 4: Summary of Exchanged Documents It's noteworthy that the volume of exchanged Patient Summaries is notably lower than that of ePrescriptions, partly due to recent entries of a few Member States into routine operation with this service. Additionally, the COVID-19 pandemic has had an impact on international travel. In the case of ePrescriptions, a substantial number has been exchanged, prompting questions about the disparity between 100,000 ePrescriptions and "only" 40,000 eDispensations. Several factors may contribute to non-dispensing, including retrieving the incorrect ePrescription, patient refusal for economic reasons, pharmacist misunderstanding, unavailability of the prescribed medicinal product in the Country of Treatment, and restrictions on substitution. UNICOM – D7.4: Pilot Readiness Assessment Page 22 of 29 Efforts are underway to improve the clarity of ePrescriptions, including proposed changes in the List of ePrescriptions. However, challenges related to patient refusal for economic reasons fall outside the purview of UNICOM and MyHealth@EU. A significant objective is to enhance the understanding of ePrescriptions by progressively mandating the use of coded data, beginning with Dose Form, Substances, and Strength. Regarding substitution issues, the potential of "smart substitution" proposed by UNICOM WP6 should be considered by the MyHealth@EU ePrescription Cluster to bolster safe substitution. These considerations offer insights for refining specifications and implementation in MyHealth@EU Wave 6. 4.3 End-to-end Functional Testing performance indicators results Regarding functional end-to-end tests performed, for the different Waves, the tables below represent the total evaluation forms performed considering Patient Summaries, ePrescriptions and eDispensations exchanged. Wave 5 Formal/Upgrade PPT Type of Evaluation Submitted PS evaluations 65 eP evaluations 76 eD evaluations 70 Total 211 Table 5: Evaluation forms – Wave 5 As can be seen from Table 5 above, Wave 5 Formal pre-production testing, no remaining or missing evaluation forms are reported. The complete table containing all details regarding the country-specific detail regarding the PS, eP and eDs evaluation results, both when exchanging as Country A and as Country B, can be found at the following link, and are depicted in table 6 below: Evaluations from the Functional e2e Testing - 2022-02 eHDSI Wave 5 FORMAL and UPGRADE PPT - My Health @ EU - eHealth Digital Service Infrastructure (eHDSI) - EC Extranet Wiki (europa.eu) UNICOM – D7.4: Pilot Readiness Assessment Page 23 of 29 Table 6: Evaluation forms in detail – Wave 5 Wave 6 Formal/Upgrade PPT Type of Evaluation Submitted PS evaluations 75 eP evaluations 74 eD evaluations 77 OrCD 4 Total 230 Table 7: Evaluation forms – Wave 6 The complete table containing all details regarding the country-specific detail regarding the PS, eP and eDs evaluation results, both when exchanging as Country A and as Country B, can be found at the following link: UNICOM – D7.4: Pilot Readiness Assessment Page 24 of 29 Evaluations from the Functional e2e Testing - 2023-02 MyHealth@EU Wave 6 FORMAL and UPGRADE PPT - My Health @ EU - eHealth Digital Service Infrastructure (eHDSI) - EC Extranet Wiki (europa.eu) Table 8: Evaluation forms in detail – Wave 6 Wave 7 Formal/Upgrade PPT (Autumn 2023) Type of Evaluation Submitted PS evaluations 11 eP evaluations 15 UNICOM – D7.4: Pilot Readiness Assessment Page 25 of 29 eD evaluations 10 OrCD 6 Total 42 Table 9: Evaluation forms – Wave 7 Autumn The complete table containing all details regarding the country-specific detail regarding the PS, eP and eDs evaluation results, both when exchanging as Country A and as Country B, can be found at the following link: https://webgate.ec.europa.eu/fpfis/wikis/display/EHDSI/Evaluations+from+the+Functional+e2e +Testing+-+2023-10+MyHealth@EU+Wave+7+Autumn+Test+Session Wave 7 Formal/Upgrade PPT (Spring 2024) Type of Evaluation Submitted PS evaluations 41 eP evaluations 54 eD evaluations 49 OrCD 6 Total 149 Table 10: Evaluation forms – Wave 7 Spring The complete table containing all details regarding the country-specific detail regarding the PS, eP and eDs evaluation results, both when exchanging as Country A and as Country B, can be found at the following link: https://webgate.ec.europa.eu/fpfis/wikis/display/EHDSI/Evaluations+from+the+Functional+e2e +Testing+-+2024-03+MyHealth@EU+Wave+7+Spring+Test+Session 5 Participating Deploying countries and results: Overview The eHDSI Test Framework defines a set of Test Events that eHDSI Deploying Countries SHOULD (optional) and MUST (mandatory) undergo to prove by evidence the NCPeH technical gateway conformance with eHDSI Specifications. The testing strategy delineated a number Member States expected to undergo Wave 6 Formal Pre-Production Testing in Q1/2023 and subsequently transition into routine operation from Q4/2023 onward. In October 2023 and in March 2024, moreover, two Wave 7 test sessions for formal and upgrade pre-production testing/preparatory pre-production testing, happened, involving a total of 23 countries 2 . A Wave 7 summer test session for formale and upgrade pre-production testing is scheduled for May 2024 onwards. Notably, 26 Member States, along with Norway and Iceland, are projected to undergo Pre-Production testing before transitioning into routine operation. Despite certain Member States having successfully completed Formal Wave 5 Pre-Production Testing, they had not yet entered routine operation as of Q4/2022 due to pending steps, 2 https://webgate.ec.europa.eu/fpfis/wikis/pages/viewpage.action?pageId=1786642813