(a)

‘patient’ means any natural person who receives or wishes to receive health care in a Member State;

(b)

‘health professional’ means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (7) or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC;

(c)

‘electronic health record’ means a comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form, and providing for ready availability of these data for medical treatment and other closely related purposes;

(d)

‘electronic health record system’ means a system for recording, retrieving and manipulating information in electronic health records;

(e)

‘patient’s summary, emergency data set, medication record’ mean subsets of electronic health records that contain information for a particular application and particular purpose of use, such as an unscheduled care event or ePrescription;

(f)

‘ePrescription’ means a medicinal prescription, as defined by Article 1(19) of Directive 2001/83/EC of the European Parliament and of the Council (8), issued and transmitted electronically;

(g)

‘interoperability of electronic health record systems’ means the ability of two or more electronic health record systems to exchange both computer interpretable data and human interpretable information and knowledge;

(h)

‘cross-border interoperability’ means interoperability between neighbouring and non-neighbouring Member States and their entire territories;

(i)

‘semantic interoperability’ means ensuring that the precise meaning of exchanged information is understandable by any other system or application not initially developed for this purpose.

(a)

To achieve this, Member States are invited to undertake actions at five levels, namely the overall political, the organisational, the technical, the semantic and the level of education and awareness raising.

(b)

Underpinning these activities will be full compliance with national as well as Community legal instruments, in particular for the protection of personal data, including confidentiality and data security. The necessary legal safeguards should be ensured, together with the embedding of data protection safeguards in the design and implementation of electronic health record systems. Furthermore, it is indispensable to develop mechanisms for education of both patients and professionals as well as for the evaluation and monitoring of activities necessary for ensuring the interoperability of electronic health record systems.

(a)

commit politically and strategically to the implementation at local, regional and national level of electronic health record systems that are capable also of interoperating with electronic health record systems in other Member States;

(b)

engage in active cooperation with other Member States and relevant stakeholders to ensure the adoption and implementation of standards that make the cross-border interoperability of electronic health record systems feasible and; secure

(c)

implement interoperability of electronic health record systems as an integral part of regional and national eHealth strategies;

(d)

consider the inclusion of eHealth in national and regional strategies for territorial cohesion and development and analyse the results of already deployed electronic health record systems at the level of eHealth policy and financing possibilities. For the period 2007-2013 the support for developing eHealth interoperability through investments in eHealth and trans-national and cross-border activities is provided within the framework of cohesion policy;

(e)

analyse the risks, barriers or missing elements in relation to achieving cross-border interoperability of electronic health record systems, and identify the necessary preconditions and relevant incentives to solve the problems;

(f)

reserve adequate resources, for example by means of direct incentives, to invest in electronic health record systems;

(g)

recognise that investments in both technical and semantic interoperability can be beneficial in the shorter term, applying a step-by-step approach and examples of best practice, drawing on priorities and expertise of Member States;

(h)

consider the creation of other financial indirect incentive mechanisms to enable the adoption, acquisition and/or modernisation of interoperable electronic health record systems;

(i)

plan the activities directed to ensure the interoperability of electronic health record systems ahead for at least five years. Such a timescale is deemed appropriate to ensure policy consistency — which is often a precondition for increasing investment and innovation;

(j)

accompany implementation of electronic health record systems by strong involvement of users and other stakeholders in establishing adequate governance, management, public-private partnerships, public procurement, planning, implementation, evaluation, training, information and education;

(k)

raise awareness among relevant stakeholders such as local and regional authorities, health professionals, patients and industry of the benefits and need for interoperability of electronic health record systems.

(a)

agree on a European governance process to establish guidelines for developing, implementing and sustaining cross-border interoperability of electronic health record systems covering management for reliable identification of patients and authentication of health professionals as well as other relevant issues as described in points 7, 8, 9 and 14;

(b)

consider policies and incentives to increase demand for procuring eHealth services to enable interoperability of electronic health record systems;

(c)

analyse the factors which render the standardisation processes leading to higher levels of interoperability of electronic health record systems such a long, complex and expensive activity, and devise measures to speed up these processes.

(a)

undertake a comprehensive survey of existing technical standards and infrastructures that may facilitate the implementation of systems supporting cross-border healthcare and the provision of healthcare services throughout the Community, especially those related to electronic health records and exchange of information;

(b)

analyse the use of standardised information models and standards-based profiles when developing and implementing interoperable electronic health record systems and services solutions. Consider standardised information models and standards-based profiles to be part of national or regional specific interoperability specifications. Where appropriate, these information models and profiles should make use of existing European and international standards, and be based on the approaches and achievements of relevant industrial initiatives;

(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.

(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.

(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.

(a)

analyse different personal data protection impacts of organisational alternatives for storing personal data concerning health and establish organisational structures for electronic health record systems in view of the specific risks for the rights and freedoms of data subjects, which best reflect the national, regional and local specifications and practices;

(b)

guarantee the patient’s self-determination by allowing for the patient’s autonomous and freely taken decision, supported by means of user-friendly technology, as to which personal data concerning health are to be stored and disclosed to whom in his or her electronic health record unless expressly required by national law. This decision shall be without prejudice to the possibility for the relevant healthcare body or doctor to store this data for treatment purposes;

(c)

establish that electronic health record systems are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible. In particular, use is to be made of the possibilities for pseudonymisation or rendering persons anonymous, insofar as this is possible and the effort involved is reasonable in relation to the desired level of protection;

(d)

provide for an assessment of the information security risks and personal data protection impacts prior to the implementation of an electronic health record system, in view of the specific risks for the rights and freedoms of data subjects;

(e)

clarify the extent to which categories of personal data concerning health should be made available in electronic form or online. In particular, certain categories of personal data concerning health such as genetic or psychiatric data may have to be excluded from online processing altogether or at least be subject to especially strict access controls;

(f)

prescribe that processing of personal data in electronic health records and their systems must be required and carried out only by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person subject to an equivalent obligation of secrecy; ensure a reliable identification of patients and health professionals;

(g)

determine the conditions under which health data contained in electronic health record systems can be lawfully accessed and processed by persons other than the individual concerned, and for what predefined health purposes, including the security that should be assured while processing health data; specify these issues as policies that can be practically applied, technically implemented and enforced, inter alia, by the national data protection supervisory authorities;

(h)

ensure that patients are fully informed on the nature of the data and the structure of the electronic health record containing them. Patients should have alternative (conventional) means to access personal data concerning health related to him or her. In this context it is important to ensure that information provided to data subjects uses language and a layout that is easy to understand and is given in an appropriate manner to persons with special needs (e.g. children or elderly persons);

(i)

provide for special measures to prevent patients from being illegally induced to disclose their personal data contained in electronic health record systems;

(j)

make sure that any processing — especially the storage — of personal data in electronic health record systems takes place within jurisdictions applying Directive 95/46/EC or those with an adequate level of protection of personal data;.

(k)

lay down detailed auditing requirements for the purpose of ensuring compliance with data protection obligations, such as reliable system of electronic identification and authentication, data access logging, documentation of all processing steps, duration of maintaining the auditing information, effective back up and recovery systems, and enforce the adoption of these requirements or solutions according to best practices for information handling;

(l)

guarantee the confidentiality of electronic health record systems as well as provide for appropriate technical and organisational measures, including rules on incident detection and management processes, in case of a breach of security or identity mechanisms leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of or access to personal data transmitted, stored or otherwise processed in electronic health record systems. Incidents or violations should be identified promptly and effectively and measures or solutions should be put in place to manage such incidents, including informing and involving the individuals concerned, the national data protection supervisory authorities, and other appropriate stakeholders.

(a)

stimulate the deployment of security-enhancing products, processes and services to prevent and fight identity theft and other privacy-intrusive attacks;

(b)

ensure that data protection safeguards are embedded in electronic health record systems, including through the widest possible use of Privacy Enhancing Technologies (PETs) in their design and implementation.

(a)

consider the possibilities for setting up a monitoring observatory for interoperability of electronic health record systems in the Community to monitor, benchmark and assess progress on technical and semantic interoperability for successful implementation of electronic health record systems;

(b)

undertake a number of assessment activities. These could include defining the quantitative and qualitative criteria for measuring the eventual benefits and risks (including economic benefits and cost-effectiveness) of interoperable electronic health record systems and assessing the benefits and risks achieved by the systems and services developed by such practical demonstrators as the Large Scale Pilot projects (Pilot Actions A) that are incorporated within the Competitiveness and Innovation Programme ICT Policy Support Programme.

(a)

increase awareness about the benefits of and need for standards in electronic health record systems and their interoperability among producers and vendors of information and communication technologies, healthcare providers, public health institutions, insurers and other stakeholders;

(b)

consider requirements for education and training with regard to health policy-makers and health professionals;

(c)

pay particular attention to education, training and dissemination of good practices in electronically recording, storing and processing clinical information as well as in gaining informed consent of the patient and lawfully sharing patient’s personal data;

(d)

provide parallel information and training, including awareness raising, for all individuals, in particular patients. Such an approach would make for more effective use of health information as patients move between a variety of healthcare providers, along the continuum of care, and receive whenever possible treatment, care and data in their own homes.