Summary of the context and overall objectives of the project
The objective of the EURO-CAS project was to specify a Conformity Assessment Scheme (CAS) for Europe (CASforEU), that is based on the EU Refined Interoperability Framework, builds upon the conformity assessment schemes already in use today, and ensures that the same tests are run using the same procedures on the same validated test platforms by uniformly qualified personnel in a rigorous test environment for consistent results between test laboratories. The project addresses a recommendation of the Antilope project that called for the development of a European CAS. This scheme will help EU 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 paves the way for a mutual recognition of test reports across member states and prevents duplication of efforts. Member states will be able to integrate test results into their certification scheme and ease the procurement process at hospital level.
The CASforEU is a major innovation in European eHealth interoperability. It allows the conformance of eHealth devices and IT systems with eHealth standards and profiles across European countries ensuring interoperability across borders and avoiding costly and time-consuming further testing. The CASforEU also includes cybersecurity-related profiles for a safe deployment of clinical exchanges between healthcare professionals.
In many countries, testing programs for health IT systems have been established. Currently conformity assessment is highly fragmented. Each eHealth project defines its own scheme, has to educate the market and requires the same product to be tested repeatedly, resulting in fragile results and high costs. CASforEU will bring the EU eHealth ecosystem closer to the Digital Single Market by streamlining conformity assessment of interoperable products and solutions in Europe, benefitting EU citizens and patients.
EURO-CAS achieved its main objective aligned with collected recommendations and requirements. The CASforEU is a pragmatic, realistic scheme in terms of governance and execution: selected profiles are already broadly deployed in many countries and testing tools as well as expertise and accredited ISO/IEC 17025 testing laboratories are available. CASforEU is ready to be deployed. With 16 Letters of Intent signed by key stakeholders from across Europe, there is also a clear willingness and demand for a scheme and a European organization to ensure good coordination.
First the inputs to the CASforEU (obj. 1, 2) were prepared. A glossary of terms and definitions was created, which was used as a reference to support good discussions and increase consistency. Conformity Assessment bodies were formed based on a questionnaire distributed among the partner’s network. Each WP analysed and synthetised the results that were validated during validation workshops. Clarification on standards (ISO/IEC 17025 vs ISO/IEC 9001) to be used for the specifications of the CASforEU and requirements mapping with the EIF were also part of the work.
The outputs are (1) state of the art on CAS and recommendations and (2) stakeholder requirements and a first set of profiles to be tested.
The next step was the design of the CASforEU (obj. 3), with an aim to open it for other domains, such as cybersecurity. The main lesson learned is that it was possible to find consensus, as CASforEU is designed based on international standards and already adopted by partners in their professional processes.
CASforEU was developed in two iterations. The pre-final version was put forward internally and to the country workshops for discussion and refinement. In parallel the implementation guide was derived from this work. The feedback served as a validation of the work done. Minor updates were introduced in the final version that can be considered a robust framework ready for implementation. The final CASforEU is the main exploitable result of the project.
The next step was modelling the business plan for CASforEU including the value proposition for each category of stakeholders identified (obj. 4). After collecting information from organisations performing interoperability testing and from potential future members of the EURO-CAS organisation (ECO), a strategy to deploy the ECO was developed. Issues related to the financial aspect were presented in the validation workshops to ensure expectations of future members are met. Ultimately, it was decided to start small and gradually increase the size in relation to the adoption of CASforEU.
The main activity in communication (obj. 6) included the project website, flyers and newsletters. Four validation workshops (obj. 5) were held for a better understanding of the project, the implementation of the business plan. Surveys, round tables, public sessions and presentations were performed to inform about CAS in eHealth, commonalities and differences. Performed tasks supported to test part of a system, how to manage local specificities, how to make it adopted and to brainstorm about how to recruit the founding members of ECO. EURO-CAS met 8 countries and regions to capture needs and ensure alignment. The workshops also helped understand how each actor can benefit from CASforEU and how the project can provide applicable guidelines.
Progress beyond the state of the art and impacts
The main achievement beyond the state of the art is the design of CASforEU in line with recommendations made by previous EU projects HITCH (2011) and Antilope (2015) and the requirements collected within EURO-CAS. A plan for establishing the CASforEU based on identified need and requirements has been developed. In addition, a governance structure and business plan to maintain the CASforEU were elaborated.
A process for publishing test reports of accredited test labs has been defined that foresees a repository for healthcare procurers to find solutions and services that fit their needs and are compliant with the EIF
CASforEU’s assessment of industry-defined profile implementations in a uniform manner will allow procurers to clearly articulate product requirements so that vendors can then provide assurances that these are satisfied.
The CASforEU will facilitate greater development and testing within cross-border, national and regional projects, as it allows easier and more efficient conformity assessment of the interoperability between components, EHR systems, mobile applications and healthcare devices.
With the elaboration of the CASforEU, common standards will be adopted and validated by the CAS, allowing eHealth implementers to benchmark their guidelines on interoperability.
The benefit of using CASforEU includes economy of scale for governments, buyers and healthcare providers, reduced fragmentation for the healthcare industry, more cost-effective multi-national market access for companies, more competition and better product choice for buyers of healthcare ICT and devices, and lower time-to-market and procurement time.