Regulatory Framework
- Law 41/2002 of 14 November, is a basic regulation concerning patient autonomy, patient rights, and patient obligations with regards to the provision of information and clinical documentation.
- Order SCO/393/2006 of 8 February, established the organization and operation of the National Bank of Cell Lines.
- Law 14/2007 on Biomedical Research.
- Royal Decree 1716/2011 of 18 November established the basic requirements of the authorization and operation of biobanks which have the purpose of biomedical investigation and of the treatment of the biological samples of human origin. This decree regulates the operation and organization of the National Registry of Biobanks for biomedical research.
- Decree 1/2013 of 8 January, regulates the authorization for the constitution and operation of biobanks for research purposes in Andalusia and establishes the Biobank of the Public Health System of Andalusia.
- Order ECC/1404/2013 of 28 June, modified the annex of the Royal decree 1716/2011 of 18 November and established the basic requirements for the authorization and operation of biobanks which engage in biomedical investigations and deal with biological samples of human origin. Furthermore, this order and regulates the operation and organization of the National Register of Biobanks for biomedical research.
- Order of 15 June 2015, addresses the domain of the Council of Equality, Health, and Social Policies and regulates the use of personal data associated with donors of samples that are used for biomedical research in Andalusia.
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 addresses the protection of natural persons with regard to the processing of their personal data and on the free movement of such data. This regulation repeals Directive 95/46/EC (General Data Protection Regulation).
- Decree 49/2017 of 21 March established the Andalusian Network of Transfusion Medicine, Tissue, and Cells and regulates its organisational structure and operation.
- • Organic Law 3/2018 of 5 December addresses the protection of personal data and guarantees citizens their digital rights..
