Amendments Introduced to the Regulation on Health Information Management Systems
The Regulation Amending the Regulation on Health Information Management Systems (Regulation), published in the Official Gazette dated 3 July 2026 and numbered 33299, introduces amendments to the regulatory framework governing Health Information Management Systems (SBYS). The Regulation abolishes certain certification requirements applicable to the registration and authorisation processes of SBYS service providers, amends the rules governing registration and re-registration under the Registration and Registry System (KTS), and updates certain procedural requirements applicable to the procurement of HIMS services.
The key amendments introduced by the Regulation are summarised below:
- Certain certification requirements applicable to SBYS service providers have been abolished. The Regulation abolishes the provision requiring SBYS service providers to submit the TS ISO/IEC 27001 Information Security Management System certificate, SPICE or CMMI certificates, and the document relating to ÜTS registration during their registration with KTS. Accordingly, the definitions of CMMI, SPICE, TSE and ÜTS have also been removed from the Regulation.
- The registration process for new SBYS categories under KTS has been revised. Where the General Directorate decides to register a new SBYS category with KTS, the previously prescribed fixed one-year period for the relevant SBYS service providers to register with KTS and submit the required documents has been abolished. The Regulation provides that the applicable period will instead be announced by the General Directorate.
- The rules governing re-registration applications following the removal from KTS have been amended. The Regulation amends the provision governing removal from KTS and introduces a separate paragraph providing that re-registration applications submitted by SBYS service providers removed from KTS will not be processed for a period of one year from the date of their removal.
- The provisions governing KTS authorisation certificates in SBYS procurement procedures have been updated. The Regulation retains the provision requiring contracting authorities to request a KTS authorisation certificate from SBYS service providers in SBYS procurement procedures. However, the reference providing that this requirement would apply in connection with Article 38 of the Public Procurement Law No. 4734, which governs the evaluation of low-priced tenders, has been removed. This amendment indicates that the submission of the KTS authorization certificate is no longer intended to be treated merely as an element confined to the tender explanation process for low-priced tenders, but rather as a more general qualification/compliance requirement in SBYS service procurements.
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