The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction...
Telemedicine is governed by Article L6316-1 and R6316-1 and seq of the French public health code (code de la santé publique (CSP).
The term “telemedicine” is defined as encompassing “medical acts performed remotely, by means of a device using information and communication technologies”.
Notably the three following acts are classified as telemedicine and defined in the regulations:
- teleconsultation, corresponding to a remote consultation provided by a medical professional (i.e. a physician, dental surgeon or midwife) to a patient,
- tele expertise, which allows a medical professional to request remotely the opinion of one or several other medical professionals, considering their specific background or skills,
- tele monitoring, which allows a medical professional to interpret remotely the data necessary for the medical follow-up of a patient, and possibly to take decisions as to his medical care.
The regulations governing telemedicine are protective of patients’ rights.
They specify notably that telemedicine acts, as any medical act, require the prior free and informed consent of the patient.
Identification of the patient, authentication of the medical professional and access by the medical professional to the necessary health data necessary for the performance of the act shall be ensured.
Telemedicine acts are also subject to specific security and interoperability standards, aiming to guarantee the quality, confidentiality and protection of the processed health data.
The specific requirements of French law for the hosting of health data also apply to health data collected in the framework of telemedicine.
Concerning the modalities of telemedicine activities, a decree of 13 September 2018, in force since 15 September, simplified their implementation by suppressing notably the former requirement of a contract with the Agence régionale de santé (ARS) (regional health agency).
The Haute Autorité de Santé (Health Authority) (HAS) published some recommendations on quality and security of teleconsultation and tele expertise and announced the publication of more complete guidance, which remains awaited.
Teleconsultation can, (since 15 September 2018), be reimbursed to all patients by their social security, provided that some conditions are met. Notably, to be reimbursed, teleconsultation should take place in the framework of the patient’s regular care path and the teleconsulting physician should already have met the patient in person in the preceding twelve months, with, the exception of some situations such as urgency or where the patient’s designated treating physician is not available.
Tele expertise remains for the time being reserved to some categories of patients considered as priority ones, considering their condition or geographical situation, and will be generalized progressively.
Tele monitoring remains under experimentation, with an arrêté of 11 October 2018 setting out the conditions of its implementation.
The French National Body of Physicians (CNOM) is committed to ensure compliance with the regulations governing telemedicine and does not hesitate to take action against the service providers it considers to be in breach, notably when it comes to advertisement of telemedicine services (for example, the CNOM issued a formal notice against the platform Qare in October 2018).
