Romania permanently regulates telemedicine

Romania

On 19 November 2020, Romania enacted Government Emergency Ordinance no. 196/2020 amending Law 95/2006 on the healthcare reform, which introduces a general legal framework for the practice of telemedicine applicable to anyone in Romania seeking remote medical services.

According to the new law, telemedicine will be provided in a non-discriminatory manner to any person. All healthcare professionals can provide this remote care, using information technologies as means of distance communication to exchange valid information for the diagnosis, treatment and prevention of diseases and injuries, research and evaluation, and providing ongoing assistance.

The medical services that can be provided through telemedicine are classified as follows:

  • Teleconsultation: the medical service performed in relation to a patient who communicates remotely with a doctor (through any technology) in order to establish a diagnosis, treatment or measures necessary to prevent disease and their complications.

  • Tele-expertise: the exchange of medical opinions between several doctors by any means of distance communication in order to confirm a diagnosis or therapy, based on data from a patient's medical documents, and without the patient’s physical presence.

  • Telecare: help provided remotely by a doctor to another practitioner who is performing a medical or surgical act, or when a medical staff providing emergency care needs assistance.

  • Teleradiology (radiology and remote medical imaging): the electronic transmission of radiological images using digital image capture technologies for interpretation by specialists in medical radiology-imaging and eventual diagnosis;

  • Telepathology: the remote transmission of microscopic data and images with the purpose of their interpretation by pathologists and providing a diagnosis;

  • Telemonitoring: medical service that allows a specialist doctor to remotely monitor and interpret the medical data of a patient, which was transmitted by the latter through electronic means of distance communication, necessary for medical follow-up, and adjustment of the patient’s therapy, lifestyle and hygiene-dietary regime.

The Ministry of Health has 45 days to issue secondary legislation, covering crucial aspects of telemedicine including:

  • the medical specialties and list of services covered by telemedicine;

  • the conditions for the organisation and operation of telemedicine;

  • the responsibility for establishing and verifying the quality of telemedicine services (under Law no. 185/2017 on quality assurance in the health system); and

  • the manner of providing telemedicine services.

We are monitoring all legislative developments on the regulation of telemedicine in Romania and will update Law-Now readers with any changes. For more information on Romania's pharmaceutical and healthcare sector, contact your CMS partner or local CMS experts Valentina Parvu and Cosmin Cretu.