The cost is determined by the certifying body which grants the certificate.

The daily cost to conduct the audits is at their discretion. The industrial is free to choose which certifying body they want to work with to become certified.

For further information on this topic, we suggest you contact the certifying bodies that have signed a convention agreement with the ANS, listed below:

Your level of access to the ROR data depends on the nature of the data you wish to use (public/restricted) and the perimeter you wish to cover (one ROR or several ROR directories).

The ROR data in public access:

• is available as opendata since mid-2022;
• will be available directly on the national ROR with no specific procedure in early 2023.

The ROR data in restricted access (professional access):

• for one regional ROR, you must complete a request form to join the regional circle of trust and send it to the region’s GRADeS;
• for several ROR directories, you must complete a request form to join the national circle of trust and send it to the ROR program team.

Generally speaking, the PGSSI-S needs to be applied as soon as personal health data are being handled. It is relevant to the public sector as well as the private sector, health professionals, workers of the social-health and social sectors, healthcare establishments and service providers. 

As a patient, the PGSSI-S is a seal of guarantee on the accountability of digital health ecosystems.

Complying with the PGSSI-S frames of reference is either required by law (if the documents have been approved by a ministerial decree) or meant to be followed on a short-term basis until the documents are approved by the ministry.

Yes, you need to have the ISO 9001 or the ISO 13485 certification to be eligible. You may begin the QHN certification process while you are in the course of making an application for/or renewing these ISO 9001 or the ISO 13485 certifications.

Yes, as long as the industrial remains responsible for the compliance of these processes with the requirements set out to obtain the QHN certification – regardless of hired external contractors or if some of the components are published or made by third-party companies.

Indeed, in the whole production system’s organisation, the industrial is the direct contact with a health professional or structure, and must make sure each requirement set out in the “Référentiel Qualité Hôpital Numérique” (QHN Referential, available in our Documentation section) is met.

PLATINES is a platform dedicated to interoperability tests for eHealth. It stimulates a ROR (version 2.4) and gives you the opportunity to use “test” data via several professional cases (a total of 94 test scenarios are available). These test scenarios are valid for the current ROR as well as the national ROR.

You must contact the ROR program team to request access to PLATINES.