TicSalut
Generalitat de Catalunya - Departament de Salut
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Frequently asked questions (FAQ's)

The most frequently asked questions arising from the systems, devices and services approval processes are given below:

Where can I find information on the approval of systems, devices and services?

On the associated links, you can consult the complete iHealth interoperability approval process and the steps to take to apply for the approval of systems, devices and services.

Furthermore, you can send your queries to homologacio(ELIMINAR)@ticsalut.cat.

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How can I assess the capacity of my system, device or service to meet the conformity criteria before making effective the “Application for approval”?

All of the conformity criteria that will be used to assess that your system, device or service meets the established requirements are available for consultation on the website of the Office of Standards and Interoperability, each in the open area that corresponds to them. Bear in mind that 100% compliance with the compulsory conformity criteria is required in order for your system, device or service to be approved.

Furthermore, the Office of Standards and Interoperability is available to companies to help to understand the conformity criteria and to answer any of your questions at homologacio(ELIMINAR)@ticsalt.cat.

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What can I do if I am not sure how to classify my system, device or service in the open areas published on the website of the Office of Standards and Interoperability?

If you are not sure how to qualify your system, device or service in the list of open areas, you can send your queries to homologacio(ELIMINAR)@ticsalut.cat.

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What can I do if my system, device or service is not included in any of the open areas published on the website of the Office of Standards and Interoperability?

We are currently working on defining new areas. It may be that your system, device or service belongs to one of these areas being defined.

You can send your queries to homologacio(ELIMINAR)@ticsalut.cat, and we will give you all the help and information you need.

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What do I have to present on the day of the process of approval of my system, device or service?

You will have to have the system, device or service to be approved totally operative in order to demonstrate that it meets the established conformity criteria, and all support documentation you believe necessary for this.

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Who has to come on the day of the process of approval of my system, device or service?

The person or people with the necessary technical skills and experience to prepare and demonstrate that the system, device or service suitably meets the conformity criteria.

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What happens if my system, device or service fails to pass the approval process?

If your system, device or service fails to meet 100% of the established compulsory conformity criteria, the Office of Standards and Interoperability will send you two documents: the approval report with the breakdown of the results of the process, and the non conformity report with the breakdown of the shortcomings of your system, device or service.

Once you have corrected the shortcomings of your system, device or service, you may ask for a revision of the approval process, by asking for the "Approval revision application form" from homologacio(ELIMINAR)@ticsalut.cat.

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Where can I find information on the systems, devices or services approved by the Office of Standards and Interoperability?

All of the systems, devices and service approved by the Office of Standards and Interoperability of the Fundació TicSalut are presented on its web site, always at the end of the approval process.

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