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EU eHealth Interoperability Conformity Assessment Scheme

Periodic Reporting for period 1 - EURO-CAS (EU eHealth Interoperability Conformity Assessment Scheme)

Reporting period: 2016-12-01 to 2017-11-30

As digital technology advances and new eHealth solutions become available, facilitating interoperability is vital to healthcare systems and patients. In order to ensure that this growing array of eHealth solutions in the European single market can communicate with one another, healthcare providers and authorities need to set standards and assess compliance. As much existing interoperability conformity assessment is carried out by national or regional authorities in Europe, providing a common European scheme will ease the burden of developing individual schemes while ensuring greater harmonisation among countries and regions.

Launched in December 2016, the EURO-CAS project aims to deliver an eHealth Interoperability Conformity Assessment Scheme for Europe, which will be known as CASforEU. This scheme will help European health systems assess the conformity of eHealth products and solutions with international standards, while enhancing the market by offering public recognition of an eHealth product’s conformity. This will significantly advance eHealth interoperability, bringing us closer to a digital single market in the European health and care sectors, and facilitating the sharing of information for better and more personalised healthcare.

EURO-CAS is set to support the maintenance of the Refined eHealth Interoperability Framework (ReEIF), which is already endorsed by the eHealth Network (eHN). A previous EU-funded project, Antilope, served to refine the eHealth Interoperability Framework, which already contains recommendations and a description of the quality label and certification processes. These will be further built on by the EURO-CAS project and complemented by defining a specific and uniform maintenance process and governance structure to maintain the CASforEU.

The dissemination and adoption of the CASforEU throughout Europe is also a key objective of the EURO-CAS project. This is being achieved by working closely with centres of competence and organisations directly involved in such conformity assessment in countries and regions throughout Europe.

In summary, the main goals of the EURO-CAS project are to:
• Integrate recommendations from the Antilope project on quality label and certification processes
• Define a Conformity Assessment Scheme for Europe (CASforEU) that can also be recognised at the international level. This will facilitate interoperability and the testing of ICT solutions developed by industry and eHealth projects (projects and geographic levels)
• Link the CASforEU with the ReEIF for endorsement by the eHN in order to facilitate the development of a single market in Europe and include the assessment of the identified profiles listed in the ReEIF
• Support regions/countries that want to deploy a harmonised conformity assessment scheme for their own needs that reduces costs and increases quality of products by providing uniform processes and procedures, test plan and test methods

The EURO-CAS project is due to conclude in November 2018 with the finalised CASforEU ready for presentation and adoption by national and regional initiatives, vendors and end-users throughout Europe.
In the first period of the EURO-CAS project (December 1, 2016 to November 30, 2017) the interoperability requirements of European health systems were assessed and existing testing and certification schemes were analysed by the project’s core team.

Through a deliberative process among the core team of the project, five existing conformity schemes were selected and surveyed to determine their differences and similarities while gaining insight into best practices and optimal approaches. At the same time, a group of 50 regional and national eHealth initiatives, vendors and other end-user organisations were selected in order to establish a representative overview of the requirements and needs of users in Europe. A collaborative, bottom-up approach was taken to identify these requirements using a survey of the representative group. The survey was further complemented with workshops to validate the findings and gather specific feedback from users and project advisers. Two workshops were held with the project’s external advisers and deployment members (National eHealth initiatives who will serve as pilot users of CASforEU). The first workshop took place in Paris, France on June 13, 2017 and the second took place during eHealth Forum in Athens, Greece on October 20, 2017. The survey and validation workshops provided a great deal of useful data on the requirements for European conformity assessment scheme.

Based on the findings and analysis of the survey on existing conformity schemes and the survey on user requirements, work began as planned towards the end of the first period on establishing the content of the CASforEU and developing a business plan to ensure its sustainability after the project concludes.

The project consortium was highly active in publicising the objectives of the project and the benefits of the forthcoming CASforEU. Key members of the consortium spoke at sessions at events such as Med-e-Tel 2017 in Luxembourg (April 2017), the eHealth Week in Malta (May 2017), the Forum eHealth in Gdansk, Poland (September 2017), and the eHealth Forum in Athens, Greece (October 2017).
In the second and final period of the project (December 1, 2017 to November 30, 2018), the participants are continuing to work on the defining and establishing the final CASforEU. They then aim to deploy the CASforEU in several regions in Europe, guided by an advisory board of additional experts and policymakers. In order to ensure adoption and maintenance of the CASforEU after the project concludes in November 2018, initial planning has begun on the financial and administrative sustainability of the scheme. The project aims to set up a non-profit body, to be known as the EURO-CAS Organisation (ECO), in which all stakeholders will be represented and involved in its development. The goal is for the ECO to be financially self-sufficient and, as the EURO-CAS project enters its second and final period, the participants are focusing on the development of a business model to facilitate to meet these needs through close consultation with national and regional initiatives, as well as various stakeholders from across Europe. The project will also host its first Stakeholder Conference event during the IHE Connectathon which takes place in the Hague/NL from April 16 – 20, 2018. This will serve to raise awareness of the EURO-CAS project and the forthcoming CASforEU and inform stakeholders from all over Europe of the benefits of the new Conformity Assessment Scheme for Europe. Additionally the project team is planning country workshops that the aims is to present the CASforEU, to collect their feedback and to encourage them to be member of the EURO-CAS organisation. The first workshop will take place on February in Luxemburg.
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