The eStandards CSA is proposed by HL7, CEN TC251, & IHE, leading Standards Organizations (SDOs), and is supported by the eHealth Network, ISO TC215, GS1, IHTSDO, IEEE11073, and IMIA to advance eHealth interoperability and global alignment of standards with seven objectives: 1. Join up with Stakeholders in Europe and globally to build consensus on eHealth standards, accelerate knowledge-sharing, and promote wide adoption of standards. 2. Deliver an evidence-based Roadmap for alignment, iterative consolidation, and broad acceptance of eStandards that is endorsed by SDOs, the eHealth Network, the providers, and the Industry. 3. Contribute to the eHealth Interoperability Framework use cases focusing on clinical content modelling for different paradigms and embed a Quality Management System for interoperability testing & certification of eHealth systems. 4. Collect evidence and provide guidance on the coexistence of competing or overlapping standards in large-scale eHealth deployment nationally and cross-border. 5. Participate in EU/US MoU roadmap actions as the international patient summaries standard. 6. Explore socio-economic aspects of eHealth interoperability, revisiting the language for user-vendor interaction that embodies ‘co-making’ in trust, collaboration and long-term engagement. 7. Align across PHC-34 to nurture innovation, sustainability & growth under CEF and beyond contributing to Key actions of the Digital Agenda 2020. The proposal’s ambition is to strengthen Europe’s voice and impact, while reinforcing the bridges established with the EU Patient Summary guideline across the Atlantic in Trillium Bridge and among MS with epSOS, eSENS, Antilope, and EXPAND. The eStandards Roadmap and associated evidence base, a white paper on the need for formal standards, and two guidelines addressing how to work with: (a) clinical content in profiles and (b) competing standards in large-scale eHealth deployments will be pragmatic steps toward alignment and convergence.

There is a growing recognition that health and wellness apps need to play a much stronger role in health care systems, self-care and health prevention than they do today. However, health care systems, health professionals, patients and citizens lack means to adequately assess the quality and reliability of the many apps to choose from, for every purpose, in each app store. Suppliers experience the varying national approval processes as confusing and unclear as to what is expected and the depth of evidence that is required by each approval body. We intend to break through the impasse by leveraging the golden opportunity of the publication in July 2021 of the ISO 82304?2 Technical Specification (TS) and its health app quality label. Work is now needed to turn this globally endorsed quality assessment and health app quality label into the EU assessment and EU mHealth label, embed it within the approval and reimbursement processes of European countries and foster cross-country alignment of these approval processes. The objective of Label2Enable is threefold: achieve trust, use and adoption. We will pursue: 1. trust with an EU certification scheme that results in consistent compliant inclusive app assessments 2. use with: - a more detailed health app quality report that enables health professionals to recommend apps and insurers to speed up decisions on reimbursements - supporting communication that enables all patients, citizens and carers to use the label in considering health apps - social experimentation to promote app stores, app libraries and other routinely used trusted sources that (seek to) offer health apps to effectively publish the label alongside them 3. adoption of the TS and cross-country recognition with pilots, use stories, advocacy, mass communication and targeted multi-stakeholder engagement, affordable app assessments and a sustainable non-profit entity that will maintain the scheme, accredit app assessors and promote the TS after the project.

EURO-CAS, European eHealth Interoperability Conformity Assessment Scheme aims at maintaining and developing the adoption and take-up of testing the interoperability of ICT solutions against identified eHealth standards and profiles defined in the eHealth European Interoperability Framework (eEIF). The key deliverable is a sustainable Conformity Assessment Scheme (CAS) for Europe. Based on recommendations of the Antilope project and the state-of-art in interoperability testing in eHealth, EURO-CAS is committed to putting in place an operational CAS based on ISO/IEC 17025 that will meet the interoperability requirements of European eHealth projects as well as national and regional eHealth programs. This will allow testing the interoperability capabilities of products and services for a single digital market in eHealth in Europe in line with the Digital Agenda for Europe and based on international profiles and standards. The project will gather a multi-disciplinary consortium of high-level expertise, including organizations focused on implementing international standards as well as industry stakeholders and healthcare providers that will 1) review the state of the art of existing interoperability CAS, 2) collect the requirements and needs from cross border, national/regional levels, 3) establish the CAS for Europe with implementation guidelines and governance, 4) propose business models for the CAS for Europe, 5) validate results and foresee national/regional adoption, 6) inform and educate eHealth stakeholders and motivate industry and projects to participate in a European accreditation process. The CAS for Europe will provide a comprehensive framework completing the eEIF and aligned with the international CAS. Its flexibility will allow better sustainability and harmonization at European, national and regional levels.

DigitalHealthEurope will provide comprehensive, centralised support to the digital transformation of health and care (DTHC) priorities of the Digital Single Market. The partners bring a broad range of collective knowledge and expertise, originating from the longstanding leadership and engagement in the whole spectrum of activities, from interoperability and standards to health service innovation and from the technical to the policy level. The project will support large-scale deployment of digital solutions for person-centred integrated care by identifying, analysing, and facilitating the replication of highly impactful best practices, utilising the consortium’s exceptional expertise on knowledge management and impact assessment (EIP on AHA repository of innovative practices, MAFEIP), twinning schemes, and mobilisation of stakeholders. A marketplace will enable organisations to find suitable partnerships. At least 46 twinnings ranging from adaptation of impactful best practices to full adoption will be carried out. A funding advice service and capacity building framework will be provided to further stimulate deployment and scale up. Building on the unique composition of the consortium, the project will establish and manage 3 collaboration platforms to align all efforts of ongoing and future initiatives supporting the 3 DTHC priorities. The partners will utilise their vast network of more than 1,100 members representing national, regional, and EU-wide stakeholders. The collaborative work will lead to common strategic agendas and commitments for action that will boost innovation and progress in the respective topics. A Board of Associated Experts with proven high-level competence on all key fields will support the delivery of an actionable strategic vision and recommendations for EU policy beyond 2020.