The Government Decision no. 1133/2022 regarding the approval of the methodological norms for the implementation of the provisions of Government Emergency Ordinance no. 196/2020 for the amendment and supplementing of Law no. 95/2006 on health reform (the “GD no. 1133/2022” or the “Norms”) was published in the Official Gazette of Romania [1] on 15 September and entered into force on the same day.

Briefly, the Norms contain provisions regarding:

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

▸ conditions for the organization and operation of telemedicine and the modalities for providing telemedicine services.

What does telemedicine actually mean?

Telemedicine refers to any and all medical services provided remotely, without the simultaneous physical presence of the medical personnel and the patient, to establish the diagnosis, indication of treatment, monitoring of certain conditions or indication of methods of disease prevention, in a secure manner, using information technology and electronic means of communication [2].

The platforms for telemedicine

According to the Norms, telemedicine can be provided by medical professionals through audio or video platforms, cable networks, fiber optics, radio or satellite. Such platforms must include the following information:

▸ the name and qualifications of the professionals providing the health services;

▸ how to contact the doctor;

▸ the charges for medical services provided by telemedicine and the possible methods of payment by patients;

▸ details of the technical support service and how to connect;

▸ the limits of telemedicine services and the possibility for the doctor and patient to transform the service into a face-to-face service at any time;

▸ the conditions of personal data processing.

The active role of doctors

In such cases, doctors must register in the consultation register and/or in the patient file the following mentions:

▸ report on the performance of remote medical consultations/services, indicating the means of communication used;

▸ the date and the time interval during which the services were carried out;

▸ the medical prescription and the documents issued as a result of the telemedicine service;

▸ the identity of the medical staff participating in the telemedicine service;

▸ technical incidents occurring during the telemedicine service, if any.

On top of that, following the telemedicine consultations, the doctors can issue documents such as electronic prescriptions, simple prescriptions, referrals for specialized medical examinations, referral/hospitalization notes, treatment schedules, vaccination schedules, medical certificates for pregnancy and child care, medical certificates for examinations and various competitions, medical certificates for schools and kindergartens, medical certificates for sports, a recommendation for home care, medical letters, etc.

Telemedicine & GDPR duo

As a general rule, when providing medical services using telemedicine, the processing of patients’ personal health-related data must comply with the GDPR’s provisions. Moreover, according to the Norms, patients must express their consent to access the platform or provide medical services through telemedicine (emergency medicine represents the exemption). The medical units make the proof of consent by any evidence demonstrating the obtaining of express consent.

As the GDPR has the last word, patients can refuse the telemedicine service.

[1] Published in the Official Gazette Part I, no. 909 from 15.09.2022.

[2] Art. 30¹ para. (2) of Law no. 95/2006 on health reform.