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All the rules are set out in the HDS certification – Accreditation reference system and the COFRAC’s "Exigences spécifiques pour l’accréditation des organismes procédant à la certification de systèmes de management dans le domaine des technologies de l’information" (Specific requirements for structures that certify management systems in the information technology sector), available in our Documentation section.
To find out more about the list of certified and accredited bodies, click on the links below.
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There are 6 types of activities that make you eligible as a health data host:
- providing and monitoring the operations of a physical site that hosts the material infrastructure of the IS used to treat health data;
- providing and maintaining the structural material used by the IS to host health data;
- providing and maintaining a platform that hosts the IS applications;
- providing and maintaining a digital structure for the IS which hosts health data;
- the administration and exploitation of the IS which contains the health data;
- health data backup services.
The full list of HDS-certified activities is available here:
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There are two steps to follow:
Step 1: Administrative phase
Should you wish to order test CPS cards or register authorisations for test software, you may:
- read our complete products offer ;
- place an order
To place an order, select your Profile and your Structure, then choose “Produits de développement. Commander des produits de développement : carte et/ou certificat logiciel de test" (Test products for products, cards and/or test software).
Step 2: Technical phase
Use the card you validated after step 1 in order to connect with the Trusted Platform IGC-Santé. You will be able to order, withdraw, monitor and revoke test certificates through the IHM or Webservice interface.
In order to do so, make sur you have inserted your test card in the card reader.
Read more about specific setup guidelines:
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The evaluation is done in two phases. It is conducted by the certifying body, which must verify the compliance with the certification requirements set out in the HDS Certification document (available below).
The audit also verifies the specific requirements for health data hosting are being met.
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The IGC-Santé is dedicated to the health sector and follows strict procedures in terms of data collection, professional identification, and works with certified authorities (RPPS register, etc.).
The certificates issued by the IGC guarantee the security of software or electronic cards, such as the CPS card.
The IGC also manages the publication of these certificates and can revoke them – this is signalled to the apps using certificates in revocation listings.
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A software publisher usually integrates several terminologies that cover standard usages: common names and codes, language names and codes, countries...
Then they integrate “Base Terminologies” (drug terminologies, billing, administrative) and occupation-specific terminologies (Terminology of the living, cardiology terminology, geriatric terminologies, etc.).
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There are two main reasons for the creation of IGC-Santé :
- guaranteeing the security of private keys and certificates issued by the ANS: the access to these private keys must be limited in order to prevent duplicates or their installation more than one device;
- maintaining a continuity in services: many health apps used to work on certificates issued by former CKI that ceased their activity in January 2021. These apps must be compatible with certificates issued by the IGC-Santé.
In addition, these certificates meet the security standards (risk analysis, safety policies), or “Certifying Policies” that comply with the PGSS-IS guidelines.
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There are several levels of requirements for a module’s integration into the Hospital Information System.
The main requirements set out by the referential are:
- Interfacing, control, security guidelines;
- Prescription process requirements;
- National prescription thesaurus integration requirements;
- Requirements regarding medico-economic and decision processes;
- Guidelines for ergonomics, functions, and notification alerts;
- Settings function requirements.
In total, 139 requirements are used to reach the minimal level of security needed for a solution’s integration into the hospital information system.
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The current referential (2017) was written with industry experts. It introduces the particular context of this mission and the goals to reach in order to improve safety measures in neonatology and paediatric reanimation. The referential walks you through the fundamental concepts you need to grasp to understand the several requirements and protocols involved with software development for this sector.
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Neonatology is a high-risk practice for two main reasons:
- The patients are extremely fragile (premature babies)
- 50% of the drugs used in the sector have yet to receive a marketing authorisation.
A survey conducted in 2014 evidenced a risk in the prescription process across the sector. The digitalisation of prescription is among the 41 recommendations that the report issued in order to increase safety levels.
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The State evaluates the following criteria:
- Terminology conceived by one of the ANS’ Production Units
- Terminology conceived by a Production Unit with a convention
- Terminology in usage
- Terminology compatible with the ANS right imposition
- Reference terminology
- “Open” terminology
- Maturity of the Production Unit in charge of the terminology’s conception and maintenance
- Local terminology sets (“small terminologies”)
- Terminology conceived by a “fragile” Production Unit / Terminology conceived by a Production Unit without a distribution point
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