Article 2, Definitions, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. For the purposes of this Regulation, following definitions shall apply:
(a) the definitions in Regulation (EU) 2016/679;
(b) the definitions of ‘healthcare’, ‘Member State of affiliation’, ‘Member State of treatment’, ‘health professional’, ‘healthcare provider’, ‘medicinal product’ and ‘prescription’, pursuant to Article 3 (a), (c), (d), (f), (g), (i) and (k) of Article 3 of the Directive 2011/24/EU;
(c) the definitions of ‘data’, ‘access’, ‘data altruism’, ‘public sector body’ and ‘secure processing environment’, pursuant to Article 2 (1), (8), (10), (11) and (14) of [Data Governance Act COM/2020/767 final];
(d) the definitions of ‘making available on the market’, ‘placing on the market’, ‘market surveillance’, ‘market surveillance authority’, ‘non-compliance’, ‘manufacturer’, ‘importer’, ‘distributor’, ‘economic operator’, ‘corrective action’, ‘risk’, ‘recall’ and ‘withdrawal’, pursuant to Article 2 (1), (2), (3), (4), (7), (8), (9), (10), (13), (16), (18), (22) and (23) of the Regulation (EU) 2019/1020;
(e) the definitions of ‘medical device’, ‘intended purpose’, ‘instructions for use’, ‘performance’, ‘health institution’ and ‘common specifications’, pursuant to Article 2 (1), (12), (14), (22), (36) and (71) of the Regulation (EU) 2017/745;
(f) the definitions of ‘electronic identification’, ‘electronic identification means’ and ‘person identification data’ pursuant to Article 3 (1), (2) and (3) of the Regulation (EU) No 910/2014.
2. In addition, for the purposes of this Regulation the following definitions shall apply:
(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed in relation to the provision of healthcare services, processed in an electronic form;
(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
(c) ‘electronic health data’ means personal or non-personal electronic health data;
(d) ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social security, administrative or reimbursement services;
(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;
(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers;
(h) ‘registration of electronic health data’ means the recording of health data in an electronic format, through manual entry of data, through the collection of data by a device, or through the conversion of non-electronic health data into an electronic format, to be processed in an EHR system or a wellness application;
(i) ‘electronic health data access service’ means an online service, such as a portal or a mobile application, that enables natural persons not acting in their professional role to access their own electronic health data or electronic health data of those natural persons whose electronic health data they are legally authorised to access;
(j) ‘health professional access service’ means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatment;
(k) ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;
(l) ‘telemedicine’ means the provision of healthcare services, including remote care and online pharmacies, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;
(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;
(n)‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;
(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, such as well-being and pursuing healthy life-styles;
(p) ‘CE marking of conformity’ means a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable requirements set out in this Regulation and other applicable Union legislation providing for its affixing;
(q) ‘serious incident’ means any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following:
(i) the death of a natural person or serious damage to a natural person’s health;
(ii) a serious disruption of the management and operation of critical infrastructure in the health sector;
(r) ‘national contact point for digital health’ means an organisational and technical gateway for the provision of cross-border digital health information services for primary use of electronic health data, under the responsibility of the Member States;
(s) ‘central platform for digital health’ means an interoperability platform providing services to support and facilitate the exchange of electronic health data between national contact points for digital health;
(t) ‘MyHealth@EU’ means the cross-border infrastructure for primary use of electronic health data formed by the combination of national contact points for digital health and the central platform for digital health;
(u) ‘national contact point for secondary use of electronic health data’ means an organisational and technical gateway enabling the cross-border secondary use of electronic health data, under the responsibility of the Member States;
(v) ‘central platform for secondary use of electronic health data’ means an interoperability platform established by the Commission, providing services to support and facilitate the exchange of information between national contact points for secondary use of electronic health data;
(x) ‘HealthData@EU’ means the infrastructure connecting national contact points for secondary use of electronic health data and the central platform;
(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;
(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;
(aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;
(ab) ‘dataset’ means a structured collection of electronic health data;
(ac) ‘dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner and consists of a user-oriented public part, where information concerning individual dataset parameters is accessible by electronic means through an online portal;
(ad) ‘data quality’ means the degree to which characteristics of electronic health data are suitable for secondary use;
(ae) ‘data quality and utility label’ means a graphic diagram, including a scale, describing the data quality and conditions of use of a dataset.