Resolution Of 25 September 2015, Of The Instituto De Salud Carlos Iii, That Will Create And Modify Personal Data Files.

Original Language Title: Resolución de 25 de septiembre de 2015, del Instituto de Salud Carlos III, por la que se crean y modifican ficheros de datos de carácter personal.

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-10912

Article 20 of the organic law 15/1999, of 13 December, of protection of data of a Personal nature, establishes that the creation, modification or deletion of files of public administrations only may be through general provision published in the «Official Gazette» or in the relevant official journal.

Furthermore, the regulations implementing the organic law 15/1999, of 13 December, of protection of data of a Personal nature, approved by Royal Decree 1720 / 2007, of 21 December, provides in article 52 that just may be the creation, modification or deletion of files of public ownership by general provision or agreement published in the «Official Gazette» or corresponding official journal. Also, in article 53 determines that when the provision refers to entities or organizations linked or dependent on the General Administration of the State, you can take the form of resolution of the owner of the structure or corresponding body.

The Carlos III Health Institute is a public research body created by law 14/1986 of 25 April, General health, with the nature of an autonomous body. It corresponds today to the Ministry of economy and competitiveness, which has as a superior organ of the Secretariat of State for research, development and innovation, the proposal and implementation of the policy of the Government in the field of scientific research, technological development and innovation in all sectors, as well as the coordination of the public State-owned research institutions. The Royal Decree 345/2012, 10 February, whereby the basic organizational structure of the Ministry of economy and competitiveness, is developed in article 10.7 includes the Instituto de Salud Carlos III between the public research institutions attached to the Ministry of economy and competitiveness, through the Secretariat of State for research, development and innovation.

In order to comply with the provisions of this organic law, and ensure the exercise of their legitimate rights to managed, complete the relationship of the files managed by the Instituto de Salud Carlos III with the creation of new files that are contained in the annex to the present resolution.

Those affected may exercise the right of access, rectification and cancellation of the personal data contained in these files, in accordance with the provisions of law 15/1999, of 13 December, of protection of data of a Personal nature.

By virtue, following a report from the Spanish Agency of data protection, I have: first. Creation of files.

Create the files of personal data listed in the annex to the present resolution, under the terms and conditions laid down in the organic law 15/1999, of 13 December, of protection of data of a Personal nature, and its regulation of development approved by Royal Decree 1720 / 2007, of 21 December.

In the cited annex is point them organs responsible of these files and also, with regard to each one of them, listed them following ends: name of the file, purpose and uses planned, people and collective affected, procedure of collection of data, structure Basic, data of character personal included in the file, assignments of data planned, transfers planned to third countries, services / units before which exercise them rights of access rectification, cancellation and opposition, and level of security.

Final disposition. Entry in force.

This resolution shall enter into force the day following its publication in the "Official Gazette".

Madrid, 25 September 2015.-the Director of the Instituto de Salud Carlos III, Jesús Fernández Crespo.

ANNEX 1 start-up files. Identification of the file name of the file: management services of genetic diagnosis of the rare diseases Research Institute.

Purpose of the file and intended use: database of the service of genetic diagnosis for the provision of diagnostic services and research projects and epidemiological.

Origin of the data: professional medical that request studies genetic.

People and groups affected: people that is a genetic study and that they have previously signed a consent to these genetic studies, the incorporation of his/her data to the file and the use for biomedical research in the terms provided in the Act 14/2007, 3 July, on biomedical research.

Procedure of collection of data: forms referred by them medical applicants of them studies genetic and results of the tests performed in the service.

Basic structure: treatment system: sheets in paper and electronic files.

Personal data included in the file: patient: name, sex, date of birth, number of medical history, clinical information, results of laboratory studies. Medical studies applicants: name, hospital.

Transfers of data planned: the results of them studies genetic made is communicate through reports clinical to them seekers of the study. Is can give this information to other databases of ownership public with late epidemiological and of health public, but always of form added. Transferable to other researchers with projects approved by the relevant ethics committees, provided that this option will be recorded on the relevant informed consent. In the latter case personal data are not transferred and you are only lease reversibly dissociated relevant information.

Transfers to third countries: data irretrievably unlinked to researchers belonging to countries with appropriate level of protection that provides the organic law 15/1999, of 13 December, of protection of data of a Personal nature. Data will not be transferred to countries that do not provide adequate levels of protection.

Administrative body responsible for the file: Research Institute of rare diseases. Institute of health Carlos III services / units before which exercise them rights of access, rectification, opposition and cancellation: Institute of research of diseases rare, Institute of health Carlos III, carretera Majadahonda-Pozuelo, km 2, 28220 Majadahonda (Madrid).

Measures of security: level high.

2. identification of the file.

File name: national database of mutations in germ-line SpainMDB.

Purpose of the file and intended use: communication and consultation of mutations in germ line with a view to improving health care in the context of epidemiological knowledge on these diseases and genetic diseases.

Data source: biomedical professionals registered in the system.

People and groups affected: patients with a pathology of genetic basis that have previously signed a consent to the realization of the genetic study, the incorporation of his/her data to the file and the use for biomedical research in the terms provided for in the Act 14/2007 of 3 July, on biomedical research.

Data collection procedure: sheets in paper and electronic forms.

Basic structure: treatment system: electronic files.

Personal data included in the file: patient: age, sex, ethnicity, location, clinical information and results of genetic studies. Of the professional biomedical registered in the system: name, email, and data of the work center.

Planned transfers of data: information added to bodies of public ownership for the realization of public health and epidemiological studies and official statistical agencies.

Transfers to third countries: data irretrievably unlinked to researchers belonging to countries with appropriate level of protection that provides the organic law 15/1999, of 13 December, of protection of data of a Personal nature. Data will not be transferred to countries that do not provide adequate levels of protection.

Administrative body responsible for the file: Research Institute of rare diseases. Instituto de Salud Carlos III.

Services/units that exercise your rights of access, rectification, opposition and cancellation: Research Institute of rare diseases, Instituto de Salud Carlos III, carretera Majadahonda-Pozuelo, km 2, 28220 Majadahonda (Madrid).

Security measures: high level.