Order Ssi / 1656 / 2015, Of 31 Of July, By Which Is Modifies The Order Of 21 Of July Of 1994, By Which Will Regulate Them Files With Data Of Character Personal Managed By The Ministry Of Health And Consumption.

Original Language Title: Orden SSI/1656/2015, de 31 de julio, por la que se modifica la Orden de 21 de julio de 1994, por la que se regulan los ficheros con datos de carácter personal gestionados por el Ministerio de Sanidad y Consumo.

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-8863

The order of 21 July 1994, for regulating files with personal data managed by the Ministry of health and consumption, gave compliance provisions of additional provision second, 2, of the organic law 5/1992 of 29 October, regulation of the automated treatment of the personal data.

Subsequently, the law organic 15 / 1999, of 13 of December, of protection of data of character Personal, decided, in its article 20.1, that the creation, modification or suppression of them files of them administrations public only may make is by means of available general posted in the «newsletter official of the State» or in the daily official corresponding.

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

He system national of health has considered the possibility of treat to a number high of patients with hepatitis C chronic, in different stages of evolution of the disease, and for know of form agile and simple it effectiveness therapeutic of them drugs used has planned carry to out the tracking therapeutic of these patients, creating a file of character automated called «system of information of monitoring therapeutic of patients with Hepatitis C chronic (SITHepaC)» why it is necessary to amend Annex 1 of the order of 21 July 1994.

In the processing of this order has issued report required the Agency Spanish of protection of data.

By virtue, I have: article 1. Creation of file.

Expands the contents of annex 1 «files of health"of the order of 21 July 1994, which regulates the files with personal data managed by the Ministry of health and consumption, with the creation of a new database called «Information system of therapeutic monitoring of patients with Chronic Hepatitis C (SITHepaC)» , whose data are contained in the annex of this order.

Article 2. Responsible for the file.

The General Directorate of basic services of the national system of health and pharmacy portfolio will be the administrative body responsible for the file characteristics and content are described in the annex.

Article 3. Management and organization of the file.

The responsible for the file owner shall adopt, under the higher direction of the titular person of the Ministry of health, social services and equality, measures of organization and management as needed, ensuring in every case the confidentiality, security and integrity of the data, as well as the leading to make effective warranties, obligations and rights established in the organic law 15/1999 , of 13 of December, of protection of data of character Personal, in the Royal Decree 1720 / 2007, of 21 of December, by which is approves the regulation of development of it law organic 15 / 1999, of 13 of December, of protection of data of character personal and other standards applicable.

Article 4. Transfer of data.

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

Available end only. Entry in force.

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

Madrid, 31 July 2015.-the Minister of health, social services and equality, Alfonso Alonso Aranegui.

(ANNEX creation of file to) name of the file: System of information of monitoring therapeutic for patients with Hepatitis C chronic (SITHepaC).

((b) use and purpose of the file: obtaining the information needed to track monitored all patients of chronic hepatitis C treatment, which have the status of insured or beneficiary of the national health system, for the adequate control of the therapeutic effectiveness of new antivirals direct action by means of the collection of the data referred to in paragraph j) of this annex.

(c) individuals and groups affected: sufferers of chronic hepatitis C treatment, with the condition of the insured or beneficiary of the national health system.

(d) procedure of collection of data: remission of a file that contains them data of them patients and their treatments pharmacological, both to the home of the treatment as in them visits later or its interruption, or by the access and rear filling of them data, to the application operational in them Services Central of the Ministry of health, services social e equality. The data will be provided by the autonomous communities and cities of Ceuta and Melilla.

(e) basic structure: automated information system.

(f) planned assignments: the data contained in this single file may transfer to the autonomous communities and cities of Ceuta and Melilla for statistical purposes.

(g) the responsible for the file administration organ: the General direction of basic services of the national system of health and pharmacy portfolio will be the unit responsible for maintaining the file under the conditions laid down in this order.

(h) unit or service to which you can exercise the right of access, rectification, cancellation and opposition: Sub-Directorate General of quality of medicines and health products. Directorate-General of basic services of the national system of health and pharmacy portfolio.

(i) security measures: high level.

(j) data of character personal included in the file: code call sign of the patient.

Sex.

Date of birth.

Nationality.

Data source.

Clinical data: genotype; degree of fibrosis; cirrhosis (compensated/Decompensated); situation regarding liver transplantation (transplanted/waiting list); hepatocellular carcinoma; extrahepatic disease by HCV; load malware; co-infection; progression/regression of the disease.

Therapeutic data: previous treatments; treatment started and interrupted with dates.