Article 20 of Organic Law 15/1999, of 13 December, on the Protection of Personal Data, states that the creation, modification or deletion of the files of the Public Administrations may be made only by means of general provision published in the "Official State Gazette" or in the official journal concerned.

For its part, the Regulation on the Development of Organic Law 15/1999 of 13 December on the Protection of Personal Data, approved by Royal Decree 1720/2007 of 21 December, provides in Article 52 that the creation, the modification or deletion of the files of public ownership can only be made by general arrangement or agreement published in the "Official State Gazette" or corresponding official journal. In addition, in Article 53, it determines that where the provision relates to entities or bodies which are linked or dependent on the General Administration of the State, it may take the form of a decision of the holder of the entity or body. corresponding.

The Carlos III Health Institute is a Public Research Agency created by Law 14/1986, of 25 April, General of Health, with the nature of Autonomous Body. It is now up to the Ministry of Economy and Competitiveness, which has as the top body of the Secretariat of State for Research, Development and Innovation, the proposal and implementation of the Government's policy on Scientific research, technological development and innovation in all sectors, as well as the coordination of State-owned public research bodies. Royal Decree 345/2012 of 10 February, for which the basic organic structure of the Ministry of Economy and Competitiveness is developed, in Article 10.7 includes the Carlos III Health Institute among the public research bodies from the Ministry of Economy and Competitiveness, through the Secretariat of State for Research, Development and Innovation.

In order to comply with the provisions of the aforementioned Organic Law, and thus assure the managed exercise of their legitimate rights, the list of files managed by the Carlos III Health Institute is completed. with the creation of new files set out in the Annex to this 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 December 13, of Data Protection Personal Character.

In its virtue, prior to the report of the Spanish Agency for Data Protection, I have:

First. Creating files.

The personal data files listed in the Annex to this resolution are created in the terms and conditions set out in Organic Law 15/1999 of 13 December on the Protection of Data of Character Personal, and its Development Regulation approved by Royal Decree 1720/2007, of 21 December.

In this annex, the organs responsible for these files are indicated, and in addition, in respect of each one, the following ends: name of the file, purpose and intended uses, persons and collectives affected, procedure for the collection of data, basic structure, personal data included in the file, transfers of planned data, transfers provided to third countries, services/units to which access rights are exercised, rectification, cancellation and opposition, and level of security.

Final disposition. Entry into force.

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

Madrid, September 25, 2015. -Director of the Carlos III Health Institute, Jesús Fernández Crespo.

ANNEX

New Create Files

1. File identification

Name of file: Management of genetic diagnostic services of the Rare Disease Research Institute.

Purpose of the file and intended uses: Database of the genetic diagnostic service for the provision of diagnostic services and research and epidemiological projects.

Data source: Medical professionals applying for genetic studies.

Persons and groups affected: Persons who are studied genetic and who have previously signed an informed consent for the realization of these genetic studies, the incorporation of their data into the file and the use for biomedical research in the terms provided for in Law 14/2007 of 3 July on Biomedical Research.

Data Collection Procedure: Forms referred by the medical applicants for the genetic studies and results of the tests performed on the service.

Basic structure:

Treatment system: Paper sheets and electronic files.

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

Predicted data downturns: The results of the genetic studies conducted are communicated through clinical reports to the study's applicants. This information may be transferred to other publicly owned databases for epidemiological and public health purposes, but always in an aggregated form. They may be given to other researchers with projects approved by the relevant ethics committees, provided that this option is included in the relevant informed consent document. In the latter case, personal data will not be transferred and only relevant reversibly dissociated information will be transferred.

Transfers to third countries: Irirreversibly dissociated data from researchers belonging to countries with adequate level of protection provided by the Organic Law 15/1999 of 13 December on Data Protection Personal Character. Data will not be given to countries that do not provide adequate levels of protection.

Administrative body responsible for the file: Rare Disease Research Institute. Carlos III Health Institute

Services/Units to exercise rights of access, rectification, opposition and cancellation: Rare Disease Research Institute, Carlos III Health Institute, Majadahonda-Pozuelo Road, km 2, 28220 Majadahonda (Madrid).

Security measures: high level.

2. File identification.

File name: National germline mutations database SpainMDB.

Purpose of the file and intended uses: Communication and consultation of germline mutations with a view to improving health care in the framework of genetic-based diseases and epidemiological knowledge in these diseases.

Data source: Biomedical professionals registered on the system.

Persons and groups affected: Patients with a genetic base pathology and who have previously signed an informed consent for the conduct of the genetic study, the incorporation of their data into the file and the use for biomedical research in the terms provided for in Law 14/2007 of July 3, Biomedical Research.

Data Collection Procedure: Electronic forms and paper chips.

Basic structure:

Treatment system: Electronic files.

Personal data included in the file: Of patients: age, gender, ethnicity, location, clinical information and results of genetic studies. Of the biomedical professionals registered on the system: Name, email and data from the job center.

Predicted data downturns: Information aggregated to publicly owned agencies for the conduct of epidemiological studies and public health and official statistical agencies.

Transfers to third countries: Irirreversibly dissociated data from researchers belonging to countries with adequate level of protection provided by the Organic Law 15/1999 of 13 December on Data Protection Personal Character. Data will not be given to countries that do not provide adequate levels of protection.

Administrative body responsible for the file: Rare Disease Research Institute. Carlos III Health Institute.

Services/Units to exercise rights of access, rectification, opposition and cancellation: Rare Disease Research Institute, Carlos III Health Institute, Majadahonda-Pozuelo Road, km 2, 28220 Majadahonda (Madrid).

Security measures: high level.