The Order of 21 July 1994, which regulates files with personal data managed by the Ministry of Health and Consumer Affairs, has complied with the provisions of the second, second, provision of the Law Organic 5/1992, October 29, regulating the automated processing of personal data.

Subsequently, the Organic Law 15/1999, of 13 December, of Protection of Personal Data, provided, in its article 20.1, that the creation, modification or deletion of the files of the Public Administrations only may be made by means of a general provision published in the Official Journal of the State or in the official journal concerned.

The recent marketing of new direct-acting antiviral drugs allows for the possibility of effective drug treatments for the treatment of people with chronic hepatitis C virus. chronic hepatitis C.

The National Health System has considered the possibility of treating a high number of patients with chronic hepatitis C, in different stages of evolution of the disease, and to know in an agile and simple way the effectiveness The therapeutic use of the drugs used has been intended to carry out the therapeutic follow-up of these patients, creating an automated file called "System of therapeutic monitoring information of patients with Hepatitis C". ',' and it is therefore necessary to amend Annex 1 to the Order of 21 July 2009, 1994.

In the processing of this order, the Spanish Data Protection Agency has issued a mandatory report.

In its virtue, I have:

Article 1. Creating a file.

The contents of Annex 1 "Health Ficheros" of the Order of 21 July 1994, for which files are regulated with personal data managed by the Ministry of Health and Consumer Affairs, are extended, with the the creation of a new automated file called "Chronic Hepatitis C Patient Monitoring Information System (SITHepaC)", the data of which are listed in the Annex to this order.

Article 2. Responsible for the file.

The General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy shall be the administrative organ responsible for the file whose characteristics and content are described in the Annex.

Article 3. Management and organization of the file.

The head of the body responsible for the file shall, under the top management of the person holding the Ministry of Health, Social Services and Equality, adopt the necessary management and organisational measures, ensuring in any case for the confidentiality, security and integrity of the data, as well as for the conduct of the guarantees, obligations and rights recognized in the Organic Law 15/1999 of 13 December on the Protection of Personal Data, In Royal Decree 1720/2007 of 21 December 2007, the European Parliament and the Council of the European development of the Organic Law 15/1999 of 13 December on the protection of personal data and other applicable rules.

Article 4. Data cession.

The data contained in this file may only be transferred in the cases expressly provided for by law.

Single end disposition. Entry into force.

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

Madrid, July 31, 2015. -Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.

ANNEX

Creating a file

a) Name of the file: System of therapeutic monitoring information of patients with chronic hepatitis C (SITHepaC).

b) Use and purpose of the file: obtaining the information necessary to monitor the monitoring of all chronic hepatitis C patients undergoing treatment, who have the condition of insured or beneficiary of the National Health System, for the appropriate control of the therapeutic effectiveness of new direct-acting antivirals by collecting the data referred to in paragraph (j) of this Annex.

c) Persons and groups affected: Chronic hepatitis C patients undergoing treatment, who have the status of insured or beneficiary of the National Health System.

d) Data collection procedure: Emission of a file containing the data of patients and their pharmacological treatments, both at the beginning of the treatment and in subsequent visits or their interruption, or by means of the access and subsequent completion of the data, to the operational implementation in the central services of the Ministry of Health, Social Services and Equality. The data will be provided by the autonomous communities and cities of Ceuta and Melilla.

e) Basic structure: Automated Information System.

(f) Planned recessions: The data contained in this file may only be transferred to the Autonomous Communities and Cities of Ceuta and Melilla for statistical purposes.

g) Body responsible for the file: The General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy will be the Unit responsible for maintaining the file under the conditions set in this order.

h) Unit or Service to which the right of access, rectification, cancellation and opposition can be exercised: Subdirección General de Calidad de Medicos y Productos Sanitarios. General Direction of the Basic Portfolio of Services of the National System of Health and Pharmacy.

i) Security measures: High level.

j) Personal data included in the file:

Patient identification code.

Sex.

Date of birth.

Nationality.

Data source.

Clinical data: Genotype; degree of fibrosis; cirrhosis (compensated/decompensated); situation with respect to liver transplantation (transplant/waiting list); hepatocarcinoma; extrachepatic disease by HCV; viral load; coinfection; progression/regression of the disease.

Therapeutic data: Previous treatments; treatment initiated and interrupted with dates.