The Regulation Amending the Regulation on Health Information Management Systems was published in the Official Gazette dated 3 July 2026 and numbered 33299 and entered into force on the date of its publication.
The Regulation on Health Information Management Systems (“Regulation“), published in the Official Gazette dated 25 August 2022 and numbered 31934, sets out the procedures and principles regarding the rules applicable to health information management system service providers, the procurement processes and standards of health information management systems, and registration procedures.
The key amendments introduced by the Regulation Amending the Regulation on Health Information Management Systems (“Amendment Regulation“), published in the Official Gazette dated 3 July 2026 and numbered 33299 and which entered into force on the same date, are as follows:
- Removed Definitions: The following definitions have been removed from the scope of the Regulation by the Amendment Regulation, as the substantive requirements relating to these concepts have been eliminated from the Regulation:
- CMMI: Capability Maturity Model Integration,
- SPICE: Software Process Improvement and Capability Determination,
- TSE: Turkish Standards Institution, and,
- UTS: Product Tracking System.
- Registration System Documents: The documents listed below have been removed from the documents required from Health Information Management Systems (“SBYS“) service providers during registration with the Registration System (“KTS“). With this amendment, the required documents are no longer listed within the Regulation, and it is stipulated that the documents required for registration will only be published on the General Directorate’s website.
- (i) TS ISO/IEC 27001 Information Security Management System certificate, (ii) SPICE or CMMI certificate, and (iii) UTS registration document.
- The previously fixed annual deadline for registration with the KTS and submission of documents has been removed, and it has been stipulated that such deadline shall be announced by the General Directorate.
- Deletion from the KTS: Under the Regulation, the one-year re-registration ban applied only to SBYS service providers whose registration was deleted from the KTS on the grounds of submitting false information and documents, engaging in misleading transactions, or sharing the software access code for the purpose of obtaining unfair advantage. Under the seventh paragraph added by the Amendment Regulation, the one-year re-registration ban has been expanded to cover all grounds for deletion.
- Removed Reference to the Public Procurement Law: Under the last amendment introduced by the Amendment Regulation, the reference to the fourth paragraph of Article 38 of the Public Procurement Law numbered 4734, contained in the third paragraph of Article 10 of the Regulation governing SBYS service procurement processes, has been repealed.
You can access the full text of the Amendment Regulation via this link. (Only available in Turkish)
