Compliance Quarterly Türkiye

Global

The data-driven future of global digital health

Norton Rose Fulbright partners contributed several chapters to Digital Health 2025 International Comparative Legal Guide, published by ICLG, which is a leading global platform for legal reference, analysis and news. The digital health sector continues its explosive transformation of healthcare delivery, driven by the ability to gather data, generate clinical insights and create actionable solutions. Companies must navigate challenges spanning clinical adoption, complex global regulations and emerging geopolitical factors influencing data access.

Read the full publication, "Digital Health 2025."

Türkiye

The “Regulation on International Health Tourism and the Health of Tourists” has entered into force

The Regulation on International Health Tourism and the Health of Tourists (Regulation), effective April 26, 2025, governs healthcare services for foreign patients and tourists in Türkiye. All healthcare facilities and intermediary organizations must obtain an authorization certificate to operate in international health tourism services. The certificate is issued by the Ministry of Health (Ministry) for healthcare facilities and by Uluslararası Sağlık Hizmetleri Anonim Şirketi (USHAŞ) for intermediary organizations.

According to the Regulation, a complications insurance is mandatory for all surgical and interventional procedures performed in an operating room within the scope of international health tourism. Facilities may accept patients directly and provide remote care, while intermediaries must offer services like accommodation, transport and interpretation through authorized channels. Tourists can receive emergency care regardless of facility authorization, but ongoing treatment requires authorized facilities.

Healthcare facilities must establish an international health tourism unit with at least one foreign-language-speaking staff member and report all activities through the Ministry of Health Integrated Corporate Operations Platform. Services and intermediary activities are centrally recorded and USHAŞ evaluates all entities annually; non-compliance can lead to suspension or revocation of authorization.

The fees for services provided within the scope of international health tourism are determined by the Ministry and compliance with invoicing rules and promotional requirements is mandatory. Existing facilities and intermediaries must comply within six months, with complications insurance required by December 31, 2025 and accreditation or certification by December 31, 2026.

Amendments to the Regulation on the Procedures and Principles Regarding the Investigation of Healthcare Professionals Due to Medical Acts and Practices and the Recourse of Compensation Paid by the Administration

The Regulation on the Procedures and Principles Regarding the Investigation of Healthcare Professionals Due to Medical Acts and Practices and the Recourse of Compensation Paid by the Administration has been amended by the Amendment Regulation dated June 5, 2025.

With these amendments, significant changes have been introduced to the liability and recourse mechanisms applicable to healthcare professionals. The Amendment Regulation provides that compensation claims arising from medical acts will first be directed to the relevant insurance company and recourse to the healthcare professional will only be possible if a final criminal court decision confirms intentional misconduct.

The amendments also introduce procedural innovations, including the use of electronic systems for investigation processes, clarified rules on the calculation of investigation deadlines and revised time limits for the Professional Liability Board and universities to issue recourse decisions.

Overall, the amendments strengthen the insurance-based liability framework and streamline administrative and procedural steps in the investigation and recourse processes concerning healthcare professionals.

New Regulation on Private Hospitals has been published

The Regulation on Private Hospitals (Regulation), published on January 30, 2025, repealed the 2002 Regulation. While some provisions remain, key changes have been introduced. The repealed Regulation covered hospitals owned by natural persons and private legal entities, excluding hospitals owned by the state, special provincial administrations, municipalities, universities and other public legal entities. The new Regulation covers hospitals owned by natural persons or private legal entities, excluding orthodontic and dental hospitals.

Private hospitals must now operate in detached buildings meeting the new standards and obtain accreditation from the Turkish Health Services Quality and Accreditation Institute (TÜSKA) within three years of licensing. Non-accredited hospitals must display a visible sign indicating lack of accreditation. Hospitals licensed before the Regulation must comply within three years.

The Ministry of Health will plan healthcare workforce, service units, technology-intensive medical devices and determine bed capacity, specialized centers, units, medical devices, specialties and staffing for private hospitals. Planning conformity certificates will be issued for approved new hospital openings or changes; if preliminary permission is not obtained within two years, the certificate will be cancelled.

The new “Prohibitions” article forbids outsourcing clinical services listed in the hospital permit, operating outside the licensed building and charging unauthorized fees for healthcare services. Temporary suspensions due to inspection deficiencies must be corrected within six months (previously one year), or the license will be suspended, with an additional six-month correction period granted.

You can access the detailed article with all key changes in the publication, "New Regulation On Private Hospitals."

The Law on Amending Certain Health-Related Laws and Decree Law No. 663, published on July 24, 2025, paves the way for the sale of medical cannabis in pharmacies

On July 24, 2025, “The Law on Amending Certain Health-Related Laws and Decree Law No. 663,” entered into force and amendments were made to the laws concerning medical products. Under the amendment to Article 23 of Law No. 2313 Law on the Control of Narcotic Substances (Law No. 2313) the term “active pharmaceutical ingredient” was changed to “medical products, health products, personal care products and supplementary products”.

The cultivation and harvesting of cannabis are now excluded from the scope; however, its processing, preparation, export and sale will be regulated by a regulation to be issued by the Ministry of Health (Ministry) in consultation with the Ministries of Interior and Agriculture and Forestry. Products derived from cannabis will only be sold in pharmacies, and licensing and tracking system records will be managed by the Ministry.

According to the addition on Law No. 1262 on Narcotic and Medical Preparations, license or permit holders are obliged to report all movements of human medicinal products and foods for special medical purposes within the supply chain to the tracking system in accordance with the procedures and principles determined by the Ministry. Those who act in violation of this rule will be subject to an administrative fine equal to twice the total warehouse sale price of the products subject to the violation; if the same act is repeated within one year, the penalty will be increased by one-fold. The addition to Law No. 6197 Law on Pharmacists and Pharmacies explicitly extends pharmacies’ reporting obligation in the tracking system to include not only medicinal products but also foods for special medical purposes.