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  • LEG3: Is the voluntary participation of patients guaranteed properly?
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Is the voluntary participation of patients guaranteed properly?

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Internal reviewers: Ingrid Rosian

Convention on Human Rights and Biomedicine CETS No: 164 (including the Explanatory report to Biomedicine convention).

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

The Convention on Human Rights and Biomedicine includes respect for integrity and right to fundamental freedom with regard to the application of medicine. The interest of the human being shall prevail over the sole interest of society or science, people have the right to equal access on healthcare of appropriate quality according to their needs. An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. {6}

In a situation of cross-border healthcare (i.e. a patient was treated at a heart center in EU member state A and want’s to participate in the recommended telemonitoring by structured telephone support) a cross-border communication, transfer and/ or reimbursement can be the case. Then the regulations of data protection, data transfer and the need for prior authorisation have to be clarified. {7}

For structured telephone support as a telemonitoring approach for patients with chronic heart failure there is a need of patient-cooperation which implies the will of the patient to take this kind of healthcare. The voluntary participation is guaranteed with the will of cooperation.

General provisions

  • Convention on Human Rights and Biomedicine CETS No: 164 (including the Explanatory report to Biomedicine convention) {6}

Chapter I – General provisions

Article 1 – Purpose and object

“Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.”

Article 2 – Primacy of the human being

“The interests and welfare of the human being shall prevail over the sole interest of society or science.”

Article 3 – Equitable access to health care

“Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.”

Article 4 – Professional standards

“Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.”

Chapter II – Consent

Article 5 – General rule

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.”

Chapter III – Private life and right to information

Article 10 – Private life and right to information

  1. “Everyone has the right to respect for private life in relation to information about his or her health.
  2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.
  3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.”
  • 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. {7}

Chapter II Article 5 Responsibilities of the Member State of affiliation

“The Member State of affiliation shall ensure that:

    1. the cost of cross-border healthcare is reimbursed in accordance with Chapter III;
    2. there are mechanisms in place to provide patients on request with information on their rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards the terms and conditions for reimbursement of costs in accordance with Article 7(6) and procedures for accessing and determining those entitlements and for appeal and redress if patients consider that their rights have not been respected, in accordance with Article 9. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004;
    3. where a patient has received cross-border healthcare and where medical follow-up proves necessary, the same medical follow-up is available as would have been if that healthcare had been provided on its territory;
    4. patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.”

Directives 95/46/EC regulates the data protection, 2002/58/EC regulates the processing of personal data and the protection of privacy in the electronic communications sector.

National contact points for Cross border healthcare can be found here: http://europa.eu/youreurope/citizens/health/help-from-the-pharmacy/prescription/index_en.htm#!lightbox-uid-0

 

 

 

 

  • Important
Important
Wilbacher I, Rupel V Result Card LEG3 In: Wilbacher I, Rupel V Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

References