Result card

  • LEG29: Is the health care personnel using Genetic Test for breast cancer according the professional standards?
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Is the health care personnel using Genetic Test for breast cancer according the professional standards?

Authors: Marina Casini, Emanuela Midolo, Marco Marchetti

Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač

The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.

Certainly, all health professionals, including those who use genetic testing are subject to compliance with the standards of professional ethics and the law. Some of these standards can be found in the following documents: the European guidelines for quality assurance in breast cancer screening and diagnosis{33}; Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use{34}, as well as the requirements for the authorisation of the manufacturing or importation of such products and the Additional Protocol of the Oviedo Convention on Human Rights and Biomedicine concerning Genetic Tests{2}.

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Completely
Casini M et al. Result Card LEG29 In: Casini M et al. Legal aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

References