(c) commit to the development of any necessary additional standards, preferably open standards on a global scale, involving the relevant European and international standardisation bodies in the key areas where shortcomings have been identified;
(d) analyse the achievements of the Mandate M 403: ‘Mandate to the European Standardisation Organisations CEN, Cenelec and ETSI in the field of Information and Communication Technologies, applied to the domain of eHealth’ in order to provide optimal technological foundations, infrastructure, safety and regulatory integration in Europe and within global markets.
Semantic interoperability of electronic health record systems
8. Semantic interoperability is an essential factor in achieving the benefits of electronic health records to improve the quality and safety of patient care, public health, clinical research, and health service management. The Member States should:
(a) establish an appropriate mechanism in cooperation with the relevant standards development organisations, the Commission and the World Health Organisation, to involve national research centres, relevant industries and stakeholders in the development of health semantics to advance in implementation efforts of interoperable electronic health record systems;
(b) wherever possible, consider the suitability of international medical-clinical terminologies, nomenclatures and classifications of diseases, including those for pharmacovigilance and clinical trials; the establishment of competence centres for multilingual and multicultural adaptation of international classifications and terminologies should also be encouraged;
(c) agree on standards for semantic interoperability to represent the relevant health information for a particular application through data structures (such as archetypes and templates), and subsets of terminology systems and ontologies responsive to local user needs;
(d) consider the need for a sustainable reference system of concepts (ontology) as a basis for mapping multilingual lexicons that take into account the difference between professional healthcare languages, lay terminologies and traditional coding schemes;
(e) support the widespread availability of methodologies and tools for incorporating the semantic content into practical applications as well as the development of relevant human capacity and skills in this domain;
(f) demonstrate the benefits and/or shortcomings of current and future systems through scientifically sound evaluation and assessment.
Certification of electronic health record systems
9. There is a need for a mutually recognisable conformity testing procedures that are valid throughout the Community or which serve as a basis for each Member State’s certification mechanism. Therefore Member States should:
(a) apply properly the existing eHealth standards and profiles, namely those related to interoperability of electronic health record systems, in order to enhance users’ confidence in those standards;
(b) put into place a joint or mutually recognised mechanism for conformity testing and certification of interoperable electronic health records and other eHealth applications, such as the techniques and methodologies offered by various industry consortia;
(c) consider the industry self-certification and/or conformity testing activities as a mechanism to reduce delays in bringing interoperable eHealth solutions to the market;
(d) take into account national and international practices, including those which exist outside Europe.
Protection of personal data
Feedback