Given that e-Health is a priority for Romania during its presidency of the Council of the European Union, the Romanian Ministry of Health (“MoH”) has launched a draft Government Ordinance (“Draft GO”) establishing the National Agency for Health Digitalisation (“Agency”).

The Agency would be coordinated by the MoH and tasked with elaborating, promoting, implementing, monitoring and evaluating the National e-Health Strategy, as part of the National Health Strategy in Romania.

If approved, the Draft GO will amend Law no. 95/2006 regarding the reform in the health sector. Interested persons have until 21 January 2019 to submit observations and suggestions on the Draft GO.

Under the Draft GO, the Agency’s main objectives include:

  • pooling, analysing and disseminating data in the health system and sharing the results with the MoH and other relevant authorities;
  • development of digitalisation standards;
  • development of minimum data sets (which are becoming increasingly important in healthcare);
  • development of telemedicine systems and of cross-sharing data platforms allowing the exchange between patients and service providers, and also between healthcare professionals and health information networks;
  • development of guidelines regarding access to data held by health bodies; and
  • creation of the most adequate specifications regarding acquisition of technology for the health system.

Despite the progress already made with regard to e-Health, the maximum potential of Information and Communications Technology (ICT) has not yet been reached in the Romanian health sector and the MoH considers that the Agency’s establishment is necessary to secure fair and efficient spending of the health budget.

Upon approval of the Draft GO, the Romanian Government will issue a government decision on the Agency’s organisation and functioning within 60 days from the date of publishing the approved version in the Official Gazette.