Information on transition to “Official operation” of accreditation activity

The accreditation activity carried out by the Maintenance and Operation Department of the National Healthcare Service Center (EESZT) is classified as an official administrative procedure by Decree No. 37/2020 (X. 30.) of the Ministry of Human Capacities on the amendment[1] of the ministerial decrees related to the operation of the National eHealth Infrastructure, as of its entering into force, i.e. from 31.10.2020.

In view of the above, the so-far accustomed accreditation process in the future will be divided into “inspection” and “authorisation” phases, as follows:

  • Inspection and authorisation phases: in all cases with respect to software that do not yet have a serial number issued by the National Directorate General for Hospitals.
  • Authorisation phase: with respect to software that have a serial number issued by the National Directorate General for Hospitals. Decree No. 37/2020 (X.30.) of the Ministry of Human Capacities on the amendment of the ministerial decrees related to the operation of the National eHealth Infrastructure, determines 31.12.2020 as a deadline for the possibility to submit applications for authorisation.

 

  1. Inspection phase

Related legislation: Decree No. 39/2016. (XII.21.) of the Ministry of Human Capacities, amended by Decree No. 37/2020. (X.30.) of the Ministry of Human Capacities

  1. The Partner submits its documents on the cooperation with the EESZT to the National Directorate General for Hospitals. This way the accession process is started.

Further information: https://e-egeszsegugy.gov.hu/web/eeszt-information-portal/developers

-After processing the documents, system accesses and authorisations required for the inspection will be allocated and the development documentation for accession becomes available.

-The Partner complements the operation of the software with the expected features based on the published development documentation.

  1. The Partner submits an application form for the software inspection to the National Directorate General for Hospitals. If it has not been completed before, access to the test environment (TST) is also requested in this step.
  2. The Partner downloads the self-test scenario, performs the tests according to the list of requirements, records the result in the report, and then sends it to the National Directorate General for Hospitals.
  3. The National Directorate General for Hospitals examines the submitted test scenario and agrees with the Partner on the correction of any possible errors.

After a successful self-test, the National Directorate General for Hospitals agrees on a go-live testing date.

  1. During the go-live testing, the Partner presents the test cases on a shared screen and hands over to the National Directorate General for Hospitals the training guides prepared for the software.
  2. After successful go-live testing, a “Certificate of Completion of the Inspection Phase” will be issued.

Additional questions that arise during the inspection phase within the Redmine 18. Accreditation Processes project will be answered by our expert colleagues.

 

  1. Authorisation phase

Related legislation: Act CL of 2016 on general administrative order

  1. The Partner can submit to the EESZT the application form on the initiation of the official procedure for authorisation on the webpage magyarorszag.hu, by selecting the following case type published by the National Directorate General for Hospital: “Healthcare” / “Health insurance and healthcare services” / “Authorisation of software to be used for the accession to the EESZT” and by starting the completion of the form there.

The application shall indicate the identification number of the document certifying successful testing.

 

To expedite the process, please submit proof of payment of the duty as an attachment.

  1. If the National Directorate General for Hospitals concludes during the procedure that the system meets the requirements for authorisation, the authorisation will be issued in the form of an official decision.
  2. The Partner and its authorised software will be included in a publicly available register of authorised software.

 

For further information on the accession and inspection processes, see the Redmine 18. Accreditation Processes Wiki.


Updated: 19.11.2020 10:22