Regulatory topics

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

Filter your results

Maturity of my project
Obligation
Nature
Domain

24 results in "Regulatory Issues”

Multi-Terminology Server

Multi-Terminology Server

The Multi-Terminology Server (MTS) is the technical tool of the Health Terminology Management Centre (CGTS) for the dissemination and management of health terminology.

Interoperability

Recommended

Pro Santé Connect

Pro Santé Connect

Pro Santé Connect is a centralising authority for identity providers.

Safety

Soon enforceable

Processing personal health data

Processing personal health data

Identify the formalities required for the processing of personal health data.

Safety

Enforceable

ROR

ROR

The Operational Directory of Resources (ROR) is the data repository describing the health care available in both the medical and social care sectors.

Safety

Soon enforceable

RPPS+ (French HPs shared directory)

RPPS+ (French HPs shared directory)

The RPPS is the leading directory for identifying individual professionals working in the health, medical and social care sectors.

Safety

Soon enforceable

Service package

Service package

The service package allows healthcare professionals to access multiple services in one place.

Digital platforms

Recommended

Shared Medical Record (DMP)

Shared Medical Record (DMP)

The Shared Medical Record (DMP) is a personal eHealth file.

Core services

Soon enforceable

SIS Interoperability Framework

SIS Interoperability Framework

The interoperability framework for health IT systems (CI-SIS) sets the rules for compatible health information systems.

Interoperability

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.

 

Show more