Ministry of Health Amends Draft Ordinance on Telemedicine, Requirement for NHIS as Sole Channel Dropped

The Ministry of Health has prepared a new draft ordinance on telemedicine, withdrawing its initial proposal for the National Health Information System (NHIS) to be the sole channel for providing such services. This was reported by the specialized publication Zdrave Net.

It is worth noting that the first version of the ordinance faced significant criticism from experts and organizations within the sector. As Zdrave Net points out, the general consensus at the time was that the texts not only failed to support the development of telemedicine in the country but even posed a risk of blocking it. One of the most contested proposals was precisely the linking of telemedicine services exclusively to the NHIS, which, according to specialists, contradicts the regulatory framework and would complicate the work of doctors who already use established digital channels to communicate with their patients.

In the new draft published by the Ministry of Health, the controversial text has been removed. Instead, it is envisioned that healthcare facilities providing remote medical assistance will use a specialized communication channel, with the system operator bearing responsibility for personal data protection. The draft also includes requirements for equipment certification, including under the European certification system (CE), Zdrave Net specifies.

Another significant change concerns the scope of healthcare facilities that are not permitted to perform telemedicine services. While the initial version included hospices in the ban, the new document applies the restriction only to blood centers and tissue banks, due to the specific nature of their activities.

The new texts also simplify the process of providing informed consent—patients will no longer be required to provide a written document and will instead be able to choose the form of consent.

The deadlines for recording the results of telemedicine examinations in the patient’s health record within the NHIS have also been adjusted. Instead of the initially proposed 10 minutes for standard cases and 60 minutes for more complex ones, the new ordinance extends these deadlines to 30 and 120 minutes, respectively. This was also among the key recommendations made by experts, reports Zdrave Net.

View all proposals in the ordinance here, and the supporting motives here. You can review the Ministry of Health’s initial proposals here.