Regulatory topics

Understand the key aspects of e-health regulations and identify the topics relevant to your solutions.

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24 results in "Regulatory Issues”

ApCV

ApCV

The France Connect authentication system and the Carte Vitale app (ApCV) will guarantee a secure connection.

Safety

Recommended

Convergence

Convergence

    Tool for declaring the maturity of their information system compared to the target defined by the roadmap.

    Safety

    Soon enforceable

    Cyber-surveillance

    Cyber-surveillance

    Cyber-surveillance is a service to diagnose and evaluate the security of the information system with regard to the Internet.

    Safety

    Enforceable

    e-CPS

    e-CPS

    e-CPS is a means of electronic authentication for healthcare professionals.

    Safety

    Recommended

    e-Prescription

    e-Prescription

    E-prescription is about making the prescription process between the relevant professionals more digital.

    Core services

    Soon enforceable

    Ethics toolbox

    Ethics toolbox

    The aim of the Ethics Unit is to provide an ethical framework for the development of eHealth.

    Ethics

    Recommended

    FINESS+

    FINESS+

    The Health Directory is the national reference directory containing the identification data of all professionals involved in the health system.

    Safety

    Soon enforceable

    French National eHealth ID (INS)

    French National eHealth ID (INS)

    The French National eHealth ID (INS) allows all stakeholders to use the same unique, permanent identity visible to the user.

    Safety

    Enforceable

    General Security Policy for HIS

    General Security Policy for HIS

    The General Security Policy for Health Information Systems (PGSSI-S) provides a common framework for securing information systems in the health sector.

    Safety

    Soon enforceable

    HDS

    HDS

    Health data hosting (HDS) must be carried out under security conditions appropriate to the data's criticality.

    Safety

    Enforceable

    Health Data Hub

    Health Data Hub

    Facilitating access to health data for innovative projects of public interest, under high security conditions and with respect for citizens' rights.

    Digital platforms

    Recommended

    Health Terminology Management Centre (CGTS)

    Health Terminology Management Centre (CGTS)

    A national public portal that distributes free semantic resources for the health and social care sector.

    Interoperability

    Recommended

    Medical Devices

    Medical Devices

    A medical device (MD) is an instrument, apparatus, equipment or software intended by its manufacturer to be used in humans for purposes such as diagnosis, prevention, control, treatment, mitigation of disease or injury.

    Safety

    Enforceable

    Mon Espace Santé

    Mon Espace Santé

    Mon Espace Santé is a personal space where users manage their health data.

    Digital platforms

    Soon enforceable

    Overview of eHealth Regulations
     

    As a reminder, according to the CNIL, health data is data concerning the physical or mental health of an individual, whether past, present or future. Your digital tools, connected objects, and medical devices may use, process, or store personal health data. If this is the case with your innovation, you must comply with a strict security framework to ensure the protection of patients' personal and health data. 

    This part of the site compiles all regulatory issues applicable to eHealth in the form of fact sheets. All these regulatory aspects are consolidated in the ministerial roadmap to promote according to the CNIL and are classified according to their functionality: 

    Security 
    This includes regulations relating to secure connection services (ApCV (Carte Vitale application), e-CPS, Pro Santé Connect), the General Data Protection Regulation (GDPR), regulations and national services relating to directories and repositories in the medical field (ROR, RPPS+,FINESS+), regulations concerning the hosting of health data (HDS), regulations concerning the French National eHealth ID (INS), the General Security Policy for Health Information Systems (PGSSI-S), regulations applicable to medical devices, and more.


    Interoperability
    The interoperability domain is composed of the Interoperability Framework for Health Information Systems (CI-SIS), which sets the rules for communicating health information, the health terminology management centre (CGTS), which distributes semantic resources for the health and social care sector free of charge, and the Multi-Terminology Server (SMT), which is the tool for disseminating and managing health terminologies.


    Core services
    This domain includes all the basic services such as the shared medical record (DMP), the e-Prescription, which entails making the prescription process more digital, and finally the secure messaging system for professionals and citizens (MSSanté).


    Digital platforms
    A package of services allows health professionals to access several services in a single place, the Health Data Hub, which facilitates access to health data for innovative general-interest projects under highly secure conditions that preserve citizens' rights, and My Health Space (MES) which is a personal space where users manage their own health data.


    How can G_NIUS help me better understand regulatory issues?


    The regulatory framework varies depending on the nature and purpose of your innovation project (medical device, digital application, healthcare service, etc.), on the technologies used for processing and/or storing personal data, on who its end-users are (healthcare professionals, healthcare institutions, the general public, etc.).


    The National Portal for eHealth Innovation (G_NIUS), which is the result of the roadmap for digital health from the Ministerial eHealth Delegation (DNS) and is operated by the Agence du Numérique en Santé (ANS), is a portal for services and content designed to accelerate the digital shift through the development of harmonised, communicating, interoperable digital services. Our platform helps you to know and understand the legal framework that will govern your digital project, by offering you a toolbox containing a according to the CNIL and fact sheets, all with the aim of getting your digital eHealth tool to market faster.

     

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