ABSTRACT
Article 18.4 of the General Constitution of Spain states that 'the law shall restrict the use of informatics in order to protect the honour and the personal and family privacy of Spanish citizens, as well as the full exercise of their rights'. This provision was further developed by Organic Law 5/1992 on the Regulation of the Automatic Processing of Personal Data, published on 31 October 1992 in the Boletin Oficial del Estado. This law was amended by the Organic Law 15/1999 on the Protection of Personal Data (the Organic Law), published on 14 December 1999 in the Boletin Oficial. The latter is the applicable law that implements Directive 95/46/EC into Spanish law. The Royal Decree concerning clinical trials and Law 4112002 states that the utilization of clinical documentation for research purposes must respect Law 15/99. The chapter also outlines the penalties for breaching the principles of data protection.
