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Definitions For the purposes of this Regulation, the following definitions apply:

(1) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin, as referred to in Article 2(1), which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;

(2) ‘case definition’ means a set of commonly agreed diagnostic criteria that have to be fulfilled in order to accurately identify cases of a serious cross-border threat to health in a given population, while excluding the detection of unrelated threats;

(3) ‘communicable disease’ means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector, animal, fomite, product or environment, or exchange of fluid, which is contaminated with the contagious agent;

(4) ‘contact tracing’ means measures to identify persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of being infected or being infectious or who have developed a communicable disease, through manual or other technological means, with the sole objective of rapidly identifying potentially newly infected persons who may have come into contact with existing cases, in order to reduce further onward transmission;

(5) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues;

(6) ‘monitoring’ means the continuous observation, detection or review of changes in a condition, in a situation, or in activities, including a continuous function that uses systematic collection of data on and analysis of specified indicators relating to serious cross-border threats to health;

(7) ‘One Health’ means a multi-sectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions;

(8) ‘Health in All Policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity;

(9) ‘public health measure’ means a decision or an action which is aimed at preventing, monitoring or controlling the spread of diseases or contamination, combatting severe risks to public health or mitigating their impact on public health;

(10) ‘medical countermeasures’ means medicinal products for human use as defined in Directive 2001/83/EC of the European Parliament and of the Council , medical devices as defined in point 12 of this Article and other goods or services that are necessary for the purpose of preparedness for and response to serious cross-border threats to health;

(11) 'International Health Regulations' means the International Health Regulations (IHR) adopted by the World Health Organization (WHO) in 2005;

(12) ‘medical device’ means both a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council , read in conjunction with Article 1(2) and Article 1(6), point (a), of that Regulation, and an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746 of the European Parliament and of the Council ;

(13) ‘health system capacity’ means the degree to which a health system maximizes its performance on the following six health system core components or building blocks:

(i) service delivery, (ii) health workforce, (iii) health information systems, (iv) access to medical countermeasures, (v) financing, and (vi) leadership/governance; for the purposes of this Regulation, this definition applies only to the parts of health system components or building blocks affected by serious cross-border threats to health.