2024-03-01 10:31:24
Teleconsultation companies are defined and authorized to operate by article 53 of the social security financing law (LFSS) for 2023 (and by the decree relating to teleconsultation companies (
The creation of an ad hoc status for these companies aims to meet the needs of the population, improve the supervision of their offer and encourage its deployment in an ethical, secure and equitable framework, consistent with the existing supports.
These companies will have to meet requirements in terms of legal structuring and governance, practice, ethics, and quality of care and finally security and interoperability of the digital solutions used.
What is a teleconsultation company?
A teleconsultation company is a commercial status company, whose status (exclusive or not) is to offer teleconsultations carried out by doctors it employs and covered by compulsory health insurance. These teleconsultations are provided in compliance with the medical convention.
The approval provided for by the social security financing law for 2023 and the decree relating to teleconsultation companies only concerns:
teleconsultation companies which employ doctors and offer teleconsultations to patients > companies which only offer a tool for connecting a patient and a medical professional to carry out a teleconsultation, but which do not employ a doctor to carry out these teleconsultations, are not affected; only teleconsultations carried out by doctors > support for teleconsultation (by a healthcare professional) or teleconsultations carried out by midwives are not affected.
– See article 53 of the LFSS and the decree relating to teleconsultation companies
What is the purpose of approval for teleconsultation companies?
The approval issued by the Ministry of Health allows:
teleconsultation companies to bill compulsory health insurance for teleconsultations carried out by the doctors they employ; patients who use teleconsultation companies to be covered by health insurance; to ensure the quality and safety of care provided remotely (compliance with the medical convention, the care pathway, the security of care, etc.)
What guarantees are provided for healthcare professionals?
Specific guarantees are provided for healthcare professionals, in terms of:
deontology : companies must transmit to the Council of the Order of Physicians and the Minister responsible for health their activity report and their action program (this program aims to guarantee compliance with the obligations imposed on companies). Furthermore, companies must not put doctors in situations that would prevent them from practicing in compliance with ethical rules (advertising); prevention of conflicts of interest : companies must not be under the control of manufacturers, distributors of medicines or medical devices in order to prevent induced prescriptions. Furthermore, doctors who are members of the medical committee cannot exercise managerial functions within the company which employs them; control of medical governance : medical committees will be set up within each teleconsultation company. They will be responsible for giving their opinion on the company’s medical policy, contributing to the definition of its medical policy and its policy regarding quality and safety of care and ensuring the consistency of the continuing training of salaried doctors;
What guarantees are provided for patients?
Specific guarantees are provided for patients, in terms of:
homogeneity of support : a teleconsultation carried out via a teleconsultation company meets the same requirements as a teleconsultation carried out with a private doctor or a health establishment. The provisions of the medical agreement are fully involved (video transmission, respect for the coordinated care pathway, territoriality, alternation with face-to-face consultations, etc.); quality and safety of care : the teleconsultation company must comply with a framework of good professional practices developed by the High Health Authority (HAS); its tools must comply with the security requirements developed by the Digital Health Agency (ANS); the approval of companies can be withdrawn immediately in the event of an emergency relating to patient safety and in the event of fraud… representation within medical governance : the medical committees of companies are notably composed of patient representatives; indemnification : ban on management/service fees (companies cannot charge for their activities covered by health insurance other services than teleconsultations) and mandatory information on the companies’ website of information relating to prices and to care; accessibility : teleconsultations covered by health insurance are invoiced at the applicable rate (known as “sector 1”), without excess fees and carried out within the framework of the medical agreement.
How to obtain approval?
The candidate company must send its approval application file to the following address:
[email protected]
A response will be provided within 4 months.
What documents must be provided to request approval?
To obtain approval, the applicant company must:
Obtain certification of your tools
The teleconsultation company’s tools must obtain certification of compliance with the interoperability, security and ethics framework for teleconsultation information systems, developed by the digital health agency. (As provided for by 3° of Article L4081-2)
Companies must apply on the Convergence platform of the digital health agency at the following address
Submit your request for approval to the Ministry of Health
The request for approval must be sent to: [email protected]
It must include the following elements:
– The SIRET number of the applicant company;
– A description of the organization of the establishment of the medical committee
– The commitment to compliance (compliance with: the medical convention, information to patients on their care, the HAS best practices framework upon its publication and absence of control of a manufacturer or distributor of medicines) > (see proposal for standard document)
– The certificate of conformity to the interoperability and security standards issued by the Digital Health Agency (ANS) (Provisional certificate)
These documents are set by article D. 4081-1 of the public health code.
How does the approval application process take place?
After favorable analysis of the documents transmitted, the Ministry of Health issues approval to the company within 4 months.
During its investigation phase, the ministry may request from the applicant company any supporting document relating to the documents transmitted and request it in the event of missing information.
What do the texts say?
Article 53 of the social security financing law for 2023
Article 53 of the social security financing law (LFSS) for 2023 provides for the regulation of the offer of teleconsultation companies by creating an ad-hoc status allowing them to be covered by health insurance from January 1, 2024. It also provides that certificates of conformity must be issued by the ANS to certify the conformity of information systems and digital health tools with interoperability and security standards.
Article 53 of the LFSS for 2023 provides for approving these companies, for a period limited to two years, in order to allow them to practice on French territory and for patients who use their service to benefit from support. covered by compulsory health insurance.
Concretely, article 53 provides:
– legal structuring companies authorized to practice: commercial companies governed by the commercial code, whose purpose is to offer a medical teleconsultation offer and which are not under the control of manufacturers/distributors of medicines or medical devices;
– clean governance : establishment of a medical committee responsible for giving its opinion on the company’s medical policy, contributing to the quality and safety of care and ensuring the consistency of continuing medical training. The company must also develop an action program aimed at guaranteeing compliance with its obligations and transmit a report on its activities to the CNOM each year;
– a repository of good practices and an evaluation method by the HAS;
– compliance with safety rules and interoperability (data protection and ANS repositories)
– the issuance and renewal of an approval authorizing companies to bill health insurance;
– controls : from the request for approval (legal status, absence of control, IT security, commitment to respect the HAS standard as soon as it is published and the medical agreement); upon request for renewal of approval after 2 years of practice (HAS reference, medical agreement, medical governance); at any time which may lead to suspension/deletion of approval.
The decree relating to teleconsultation companies
This decree establishes the approval procedure for teleconsultation companies as well as the conditions under which, as part of their activity, teleconsultation acts carried out by the doctors they employ are covered by the Health Insurance.
Concretely :
– Articles D. 4081-1 and D. 4081-2 set out the documents that applicant companies must produce to request approval and request its renewal as well as the procedures and deadlines for examination by the administration;
– Article D. 4081-4 sets out the terms and conditions for setting up the medical committee (establishment, composition, operation and organization);
– Article D. 4081-5 details the content of the activity report that the companies must prepare and establishes the possibility for the ministry to define by order common criteria that the action program monitoring indicators must respect;
– Article D. 4081-6 provides that companies guarantee that the doctors they employ respect the rules for Health Insurance coverage and the volume of remote activity. This article also provides that companies do not put the doctors they employ in a situation that would prevent them from practicing in compliance with ethical rules. Finally, it provides for a ban on companies charging patients additional fees than those provided for teleconsultation;
– Article D. 4081-7 sets the conditions for suspension and removal of the approval of teleconsultation companies in the event of breach or fraud.
The decree relating to the issuance of the certificate of conformity mentioned in article L. 1470-6 of the public health code and the deadline for processing applications for approval of teleconsultation companies
This decree creates article R. 4081-3 which provides that silence maintained for four months by the administration on the request for approval or renewal of approval constitutes acceptance of this request.
Useful links and documents
– A standard commitment proposal to be sent with the application file to the following address: [email protected]
– Article 53 of the social security financing law for 2023
– Decree relating to teleconsultation companies
– Decree relating to the issuance of the certificate of conformity mentioned in article L. 1470-6 of the public health code and the deadline for processing applications for approval of teleconsultation companies
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