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Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare
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For the purposes of this Directive, the following definitions shall apply:
‘healthcare’ means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices;
‘insured person’ means:
persons, including members of their families and their survivors, who are covered by Article 2 of Regulation (EC) No 883/2004 and who are insured persons within the meaning of Article 1(c) of that Regulation; and
nationals of a third country who are covered by Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010, or who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits;
‘Member State of affiliation’ means:
for persons referred to in point (b)(i), the Member State that is competent to grant to the insured person a prior authorisation to receive appropriate treatment outside the Member State of residence according to Regulations (EC) No 883/2004 and (EC) No 987/2009;
for persons referred to in point (b)(ii), the Member State that is competent to grant to the insured person a prior authorisation to receive appropriate treatment in another Member State according to Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010. If no Member State is competent according to those Regulations, the Member State of affiliation shall be the Member State where the person is insured or has the rights to sickness benefits according to the legislation of that Member State;
‘Member State of treatment’ means the Member State on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established;
‘cross-border healthcare’ means healthcare provided or prescribed in a Member State other than the Member State of affiliation;
‘health professional’ means a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, 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, or a person considered to be a health professional according to the legislation of the Member State of treatment;
‘healthcare provider’ means any natural or legal person or any other entity legally providing healthcare on the territory of a Member State;
‘patient’ means any natural person who seeks to receive or receives healthcare in a Member State;
‘medicinal product’ means a medicinal product as defined by Directive 2001/83/EC;
‘medical device’ means a medical device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC;
‘prescription’ means a prescription for a medicinal product or for a medical device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC who is legally entitled to do so in the Member State in which the prescription is issued;
‘health technology’ means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare;
‘medical records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process.
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