The additional provision of Order SSI/1356/2015 of 2 July 2015 amending Annexes II, III and VI to Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the European Union The National Health System and the procedure for its updating, and the studies of monitoring techniques, technologies and procedures are regulated, notes that within the maximum period of two months from the entry into force of that order will be established by resolution of the holder of the General Directorate of the Basic Services of the System Services National Health and Pharmacy, the specific technical requirements of each of the monitoring studies listed in Annex II to that standard, on a proposal from the Commission on benefits, insurance and funding.

In this resolution, the evaluation agency will also be determined to be responsible for the technical coordination of the study, counting, if necessary, with the favorable report of the corresponding autonomous community.

In order to make this provision effective, the content of this resolution, through which specific requirements are laid down, was presented to the Commission on 2 September 2015. for the implementation of the above monitoring studies.

In application of the provisions of the additional provision of Order SSI/1356/2015, of July 2, this Directorate General resolves:

First.

The Agencies which will technically coordinate the monitoring studies provided for in Annex II of Order SSI/1356/2015 of 2 July, amending Annexes II, III and VI to Royal Decree 1030/2006, of 15 June 2015, September, which establishes the portfolio of common services of the National Health System and the procedure for its updating, and regulates the studies of monitoring of techniques, technologies and procedures, previous favorable report respectively of the Basque Country and the Canary Islands, shall be:

Monitoring Studies

Agency
Oesophageal Stent Biodegradable.	Carlos III Health Institute Health Technology Assessment Agency
Endobronchial Valve.	Evaluation and Planning Service of the Canarian Health Service (SESCS).
Percutaneous Valve Repair System by clip.	Health Technology Assessment Service-OSTEBA. Basque Government Health Department
device (occlusion) of the left atrial ear.	Evaluation Agency Health Technologies of the Carlos III Health Institute

Second.

To facilitate the reception by the coordinating agencies of the information provided by the centers participating in these four monitoring studies, the computer application of the System of collection of Information on Monitoring Studies (SIEM) that will be accessible through the website of the Ministry of Health, Social Services and Equality. The General Secretariat of the Basic Portfolio of Services of the National Health System and Cohesion Fund will be responsible for bringing to the attention of the participating centers, the respective autonomous communities and the coordinating agencies. the date from which that application will be available.

Third.

The participating centres will be registered in the General Register of health centres, services and establishments (REGCESS) and will be inexcusably provided with the health authorization of the corresponding autonomous community of According to the provisions of Royal Decree 1277/2003 of 10 October 2003 laying down the general bases for the authorisation of health centres, services and establishments, with at least the following care offer:

Monitoring Studies

Care
Stent Biodegradable esophageal.	General and digestive surgery. Digestive Tract. Radiodiagnosis (Vascular and Interventional Radiology). Anesthesia and resuscitation. intensive medicine body
endobronchial valve.	Pneumonia. Thoracic surgery. Anesthesia and Resuscitation. Intensive Medicine
Percutaneous Valve Repair System by clip.	Cardiology. Surgery heart. Hemodynamics. Anesthesia and resuscitation. Intensive medicine
Closure (Ocluser) of the Left Auricular Orejuela.	Cardiac Surgery. Cardiology. Hemodynamics. Anesthesia and Resuscitation. Intensive Medicine.

To do this, a copy of the corresponding authorization of the autonomous community will be submitted with the document of accession of the participating centers referred to in the fourth point.

Fourth.

As an annex to this resolution, we include the model of accession of the participating centers in these four monitoring studies, counting on the approval of the managing director of the center and that of the respective autonomous community. In the case of an autonomous community opting for an alliance between centers to participate in a monitoring study, the accession document will pick up this circumstance, with the approval of the address of the centers where they are located. the services or units that are part of the alliance. This document, once completed, will be forwarded by the respective community to the General Secretariat of the Basic Portfolio of Services of the National Health System and the Cohesion Fund.

Fifth.

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

Madrid, September 3, 2015. -Director General of the Basic Portfolio of Services of the National System of Health and Pharmacy, Agustín Rivero Cuadrado.

ANNEX

Document of adherence of the participating centers in the monitoring studies

D. ..................................................................................................................., clinical officer of the monitoring study .................................................... to be carried out in the Service/Care Unit ........................................ of the hospital ......................................................, states that:

A. It is informed that this technique is currently under study for monitoring in the National Health System, as determined by Order SSI/1356/2015 of 2 July, amending Annexes II, III and VI of the Royal Decree of the European Decree 1030/2006, of 15 September, establishing the portfolio of common services of the National Health System and the procedure for its updating, and regulating the studies of the monitoring of techniques, technologies and procedures.

B. The center has been designated by its autonomous community to participate in the monitoring study.

C. The Service/Care Unit brings together the experience, technical conditions and the human and material resources needed to carry out this with sufficient guarantees for the users.

By virtue of all this, it expresses its desire to participate in the monitoring study of ................................................................................................................., and accepts the following commitments:

1. Fully subscribes to the content of the agreed protocol, for the development of the monitoring study .......................................................

2. Assumes that the technical coordination of the monitoring study will be carried out by the Evaluation Agency .................................................................................. It therefore authorises the Agency to coordinate the study to use the precise information to be carried out, ensuring the confidentiality of patient data, in accordance with current legislation.

3. It undertakes to send the information relating to its patients, referred to in the protocol in the form and deadlines set out in it, guaranteeing the confidentiality of the information. Likewise, the signature of this document implies that the data will not be transferred to other studies without the express authorization of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy.

4. Patients shall be informed of the application of the above mentioned technique of monitoring, which shall be recorded in the informed consent document which they shall sign. The ethical principles inherent in all clinical research will be preserved.

5. It is learned that it will be able to withdraw at any time from the participation in the monitoring study, which will have to communicate in writing the corresponding autonomous community to the General Subdirectorate of the Basic Portfolio of Services of the National Health and Cohesion Fund system, and therefore, from that moment on, the centre will not be able to continue carrying out the technique submitted to the monitoring study as part of the common portfolio of services.

In accordance with the above commitments, the clinical officer subscribes to this accession document with the approval of the managing director of the center and the respective autonomous community.

In .........................., a ......... of ......................... of 201 ....

Fdo: .......................................................................................

Cargo .............................................................................

Clinical responsible for the monitoring study

D. ..............................................................................................., Managing Director of the hospital ............................................. is committed to the center:

(a) Check that the monitoring study complies with the requirements of the legislation in force in this field, in particular those relating to the precise medical devices used for the use of the technical a monitoring study.

(b) It shall adhere to the economic conditions agreed with the undertakings as provided for in Article 8 of Order SSI/1356/2015 of 2 July.

And gives the go-ahead to the center's participation in the monitoring study under the above conditions.

Fdo: .......................................................................................

Managing Director of .......................................................................................

D. ....................................................., certifies that the center has the mandatory authorization of the autonomous community of the care offer of the units participating in the mentioned study (the corresponding authorization is attached) and gives the go-ahead from the autonomous community to the participation of the center in the monitoring study under the above conditions.

Fdo: .......................................................................................

Autonomous Community .....................................................................................................

Cargo ...........................................................................................................