1 (page number not for citation purpose) EDITORIAL/DISCUSSION The European Digital Identity Wallet: A Healthcare Perspective Danny Van Roijen, MS Business Engineering EU Policy Expert (independent), Brussels, Brussels Metropolitan Area, Belgium Corresponding Author: Danny Van Roijen, Email: danny@childeroland.be DOI: https://doi.org/10.30953/bhty.v7.344 Keywords: cross-border healthcare, data governance, digital identity, health data, interoperability Submitted: August 12, 2024; Accepted: August 20, 2024; Published: August 31, 2024 With the June 2024 elections, the first term of the European Commission under President Ursula von der Leyen came to an end. Within these last 5 years, major strides were made in Europe to write a future-proof rulebook on data and digital. In the shadow of headline-grabbing regulations such as the Digi- tal Markets Act and the AI Act, the eIDAS regulation was revised to establish a European Digital Identity Wallet. eIDAS 2.0 and the European Digital Identity Wallet Published into law 10 years ago, Regulation (EU) No 910/2014 on electronic identification and trust services for electronic transactions in the internal market,1 commonly referred to as the eIDAS (electronic identification and trust services) regulation, established a general legal framework for the (cross-border) recognition and use of electronic identification and trust services. Rules were specified for electronic signatures, electronic seals, electronic time stamps, electronic documents, electronic registered delivery services and certificate services for website authentication. On April 30, 2024, the revised eIDAS regulation was published in the EU’s Official Journal2 (hereafter eIDAS 2.0), extending the covered trust services also to include electronic attestation of attributes, electronic archiving services and electronic ledgers. More importantly, eIDAS 2.0 establishes a harmonized framework supporting a European Digital Identity Wallet (EDIW). The eIDAS, Article 3 definition is presented in Table 1. The eIDAS should enable users to identify themselves electronically and authenticate online and in offline mode across borders to access a wide range of public and pri- vate services. The use of the EDIW shall, however, be voluntary; access to public and private services by other existing identification and authentication means should remain possible. The eIDAS should provide a high degree of transparency, privacy, and control by the users over their personal data. This includes the ability to generate pseudonyms, registra- tion of access activity, and integration of privacy-preserving techniques. A list of reference standards and more detailed specifications in development are listed in Table 2. However, they still need to be developed and announced through sec- ondary legislation. The first public consultations on eIDAS 2.0 implementing regulations launched in August 2024.3 The Current Role of eID Solutions in Access to Health Data In the past, patient access to health data has been lim- ited and fragmented. The digital transformation of health and care provides opportunities to grant patients direct access and control over their health data. Identification and authentication play a crucial role in enabling secure access and exchange of health data. Table 1. eIDAS, Article 3, as defined in the EU’s Official Journal2 (electronic IDs) Article 3 Defined (42) “European Digital Identity Wallet:” An electronic identification means that allows the user to securely store, manage, and validate personal identification data and electronic attestations of attributes for the purpose of providing them to relying parties and other users of European Digital Identity Wallets, and to sign by means of qualified electronic signatures or to seal by means of qualified electronic seals. eIDAS: electronic identification and trust services. Blockchain in Healthcare Today ISSN 2573-8240 mailto:danny@childeroland.be https://doi.org/10.30953/bhty.v7.344 Citation: Blockchain in Healthcare Today 2024, 7: 344 - https://doi.org/10.30953/bhty.v7.3442 (page number not for citation purpose) D. Van Roijen As part of Europe’s Digital Decade Policy Programme 2030, progress is being monitored towards the target of ensuring that 100% of EU citizens have access to their electronic health records (EHRs) by 20304 (the “eHealth target”). This eHealth target is being monitored through 12 sub-indicators spread across four thematic layers. According to the ‘2024 Digital Decade eHealth Indica- tor Study’5 reflecting the state of play as of 31 December 2023, the average composite eHealth score for the EU-27 countries has increased to 79%. Currently, 17 Member States enable citizens to use a secure eID to authenticate themselves when using the online access service (sub- indicator 5). Health Data Access in A Cross-Border Context Access to health data is not only important within a national context; with increasing mobility other relevant use cases are applicable within a cross-border context. This was already identified in the 2011 Patient Rights Directive6 (also known as the Cross-Border Healthcare Directive), where Member States through the eHealth Network were encouraged to develop common identifica- tion and authentication measures to facilitate the trans- ferability of data in cross-border healthcare. The exchange of EHRs is considered one of the essen- tial building blocks in Europe’s digital transformation of health and care. Partially implemented across EU Mem- ber States today, the European Health Data Space7 legis- lative proposal will push for the EU-wide availability and cross-border accessibility of electronic patient summaries, ePrescriptions, images and image reports, lab results, and discharge reports. At the moment, the European Commission is funding four large scale pilot projects to test drive the specifications of the EU Digital Identity Wallet. One of these, Potential for European Digital Identity (POTENTIAL)7 focuses on use cases in six digital iden- tity sectors. Within healthcare, the pilot is exploring, in particular, the use case of electronic prescriptions or e-prescriptions. Table 3. The eHealth target is monitored through 12 sub-indicators spread across four thematic layers as part of Europe’s Digital Decade Policy Programme 20304 Thematic layer Sub-indicator Implementation of electronic access services for citizens 1. Nationwide availability of electronic access service(s) Categories of accessible health data 2. Electronic health records summary data 3. ePrescription/eDispensation data 4. Electronic results and reports Access technology and coverage 5. Access to electronic health records with an eID 6. Access via an online portal or mobile application 7. Percentage of the national population able to access 8. Healthcare providers connected and supplying relevant data Access opportunities for certain categories of people 9. Access for legal guardians 10. Access for authorised persons 11. Assistance for disadvantaged groups 12. WCAG v2.1 and Web Accessibility Directive compliance eID: electronic identification; WCAG: Web Content Accessibility Guidelines. Table 2. A list of reference standards and more detailed specifications in the development of eIDAS (electronic identification and trust services)3 European Digital Wallets URL Certification https://ec.europa.eu/info/law/better-regulation/have-your-say/ initiatives/14337-European-Digital-Identity-Wallets-certification_en Integrity and core functionalities https://ec.europa.eu/info/law/better-regulation/have-your-say/ initiatives/14341-European-Digital-Identity-Wallets-integrity-and-core-functionalities_en Person identification data and electronic attestations of attributes https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14340-European-Digital- Identity-Wallets-person-identification-data-and-electronic-attestations-of-attributes_en Protocols and interfaces to be supported https://ec.europa.eu/info/law/better-regulation/have-your-say/ initiatives/14339-European-Digital-Identity-Wallets-protocols-and-interfaces-to-be-supported_en Trust framework https://ec.europa.eu/info/law/better-regulation/have-your-say/ initiatives/14338-European-Digital-Identity-Wallets-trust-framework_en Source: Public consultation via the European Commission’s “Have Your Say” website. https://ec.europa.eu/info/law/better-regulation/have-your-say_en https://doi.org/10.30953/bhty.v7.344 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14337-European-Digital-Identity-Wallets-certification_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14337-European-Digital-Identity-Wallets-certification_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14341-European-Digital-Identity-Wallets-integrity-and-core-functionalities_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14341-European-Digital-Identity-Wallets-integrity-and-core-functionalities_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14340-European-Digital-Identity-Wallets-person-identification-data-and-electronic-attestations-of-attributes_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14340-European-Digital-Identity-Wallets-person-identification-data-and-electronic-attestations-of-attributes_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14339-European-Digital-Identity-Wallets-protocols-and-interfaces-to-be-supported_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14339-European-Digital-Identity-Wallets-protocols-and-interfaces-to-be-supported_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14338-European-Digital-Identity-Wallets-trust-framework_en https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14338-European-Digital-Identity-Wallets-trust-framework_en https://ec.europa.eu/info/law/better-regulation/have-your-say_en Citation: Blockchain in Healthcare Today 2024, 7: 344 - https://doi.org/10.30953/bhty.v7.344 3 (page number not for citation purpose) European Digital Identity Wallet The European Digital Identity Wallet: Use Cases As mentioned above, several use cases can be facilitated through the EU Digital Identity Wallet. These include access to health, sharing health data, cross-border use cases, and integration of digital health technology into existing care pathways. Access to Health Data First, the EU Digital Identity Wallet can be a trusted and secure platform to collect and/or access a person’s health data. On the one hand, this can be clinical data that have been collected upon instruction of or interaction with health and care services—public or private. The Wallet can also be a repository of person-generated health data, for instance, self-reported or measured through the use of sensors and wearables. Sharing Health Data The EU Digital Identity Wallet will hand back control to the citizen in managing their health data. This will allow people to more actively share data with those involved in their direct, indirect, and informal care. Next to that, peo- ple will be able to share data more consciously with third parties while retaining control over the level of detail they wish to share or reveal. Cross-border use cases As mentioned, the use of the EU Digital Identity Wallet could be a facilitator for cross-border healthcare services. We can make a distinction between the following scenar- ios (Table 4). Integration of Digital Health Technology Into Existing Care Pathways The uptake of digital health technologies has been, to a certain extent, limited due to the inability to integrate eas- ily into existing care pathways. Several technical and orga- nizational issues are at the root of this, such as a lack of interoperability, a proliferation of data silos, repetitious input of available information, or questions and doubts about data protection and cybersecurity. The EU Digital Identity Wallet will support the once-only principle and will enable straightforward and secure data access. In this way, it can help foster trust and stimulate the use of digital health technologies in daily practice and routine. Conclusion With the eIDAS 2.0 regulation, Europe is building the foundations for the EU Digital Identity Wallet. Defining a clear legal and technical framework will help create trust and credibility for the development and application of new use cases. Not only will the EU Digital Identity Wal- let empower patients to access and manage their health data, but it will also facilitate their access to cross-bor- der health services and enable better integration of digital health technology into existing care pathways. In the end, the patient will only stand to benefit from this. Funding No funding was provided. Conflicts of Interest Danny Van Roijen is a member of the BHTY Editorial Board. Contributors The author developed concepts, wrote the manuscript, reviewed comments, and made all revisions. Data Availability Statement (Das), Data Sharing, Reproducibility, and Data Repositories Not applicable. Application of Ai-Generated Text or Related Technology Not applicable References 1. Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23  July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC, EUR-Lex [Internet]. Europa.eu. 2014. Available from: https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX:32014R0910 2. Regulation EU) 2024/1183 of the European Parliament and of the Council of 11 April 2024 amending Regulation (EU) No 910/2014 as regards establishing the European Digital Identity Framework, EUR-Lex [Internet]. Europa.eu. 2024. Available from: https://eur- lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1183 3. Public consultation via the European Commission’s “Have Your Say” website. 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Available from: https://health.ec.europa.eu/ ehealth-digital-health-and-care/european-health-data-space_en Copyright Ownership: This is an open-access article distributed in accordance with the Creative Commons Attribution Non-Commercial (CC BY-NC 4.0) license, which permits others to distribute, adapt, enhance this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0. https://doi.org/10.30953/bhty.v7.344 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011L0024 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011L0024 http://health.ec.europa.eu https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en http://creativecommons.org/licenses/by-nc/4.0