2014/286/EU: Commission Delegated Decision of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil Text with EEA relevance

This Decision lays down: (a) the criteria and conditions that the Networks referred to in Article 12 of Directive 2011/24/EU must fulfil; and (b) the criteria and conditions required from healthcare providers wishing to join a Network referred to in Article 12 of Directive 2011/24/EU.

For the purpose of this Decision and in addition to the definitions laid down in Article 3 of Directive 2011/24/EU the following definitions shall apply: (a) ‘Member of a Network’ means healthcare providers that are in compliance with the list of criteria and conditions laid down in Article 5 of this Decision and have been awarded with the membership of a given Network; (b) ‘Highly specialised healthcare’ means healthcare that involves high complexity of a particular disease or condition in its diagnosis or treatment or management and high cost of the treatment and resources involved; (c) Complex disease or condition' means a particular disease or disorder which combines a number of factors, symptoms, or signs that requires a multidisciplinary approach and well-planned organisation of services over time because it implies one or several of the following circumstances: a large number of possible diagnoses or management options and comorbidity, difficult interpretation of clinical and diagnostic tests data, a high risk of complications, morbidity, or mortality related to either the problem, the diagnostic procedure or the management; (d) ‘Multidisciplinary healthcare team’ means a group of health professionals from several fields of healthcare, combining skills and resources, each providing specific services and collaborating on the same case and coordinating the healthcare to be provided to the patient; (e) ‘Informed consent under the framework of European Reference Networks’ means any freely-given, specific, informed and explicit indication of a subject's wishes by which he or she, either by a statement or by a clear affirmative action, signifies agreement to the exchange of her or his personal and health data between healthcare providers and Members of a European Reference Network as provided in this Delegated Decision.

Networks shall fulfil the criteria and conditions necessary to enable them pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU set out in Annex I.

Networks shall be composed of healthcare providers identified as Members of the Network. For each network, one Member will act as Coordinator.

All applicants wishing to join a given Network must have knowledge and expertise or offer a diagnosis or a treatment that focusses on a disease or condition falling within the field of specialisation of the Network and shall fulfil the criteria and conditions set out in Annex II.

This Decision shall enter into force on the 10th day following that of its publication in the Official Journal of the European Union.