Alternative Reimbursement Regulation published
As a consequence of lawsuits filed against provisions of the Alternative Reimbursement Regulation dated 10 February 2016, due to the regulation being published without obtaining the Ministry of Health’s opinion, the articles subject to the lawsuits were cancelled based on formal deficiency. On 12 May 2023, a Alternative Reimbursement Regulation (Regulation) was published in the Official Gazette numbered 32188 and entered into force on the date of publication. While the… »
Evaluating ChatGPT and AI Applications from the Personal Data Protection Perspective
AI Applications Under the Radar of Data Protection Authorities Concerns about how artificial intelligence (AI) systems use and store data collected from users have been frequently debated by data protection authorities and professionals dealing with data security and privacy issues lately. These discussions are kept in the public eye through decisions, publications, and press releases related to the subject. The Italian Data Protection Authority, Garante per la Protezione dei… »
Personal Data Protection Board Decisions on Commercial Electronic Messages
Along with the progress in information technologies, the fact that even the smallest daily needs are met through electronic commerce has resulted in the advertisement and marketing of goods and services mainly through telecommunication networks. With the effect of the Covid-19 pandemic, the sales of goods and services in electronic environment, which have reached a serious potential in recent years, have also caused an increase in the personal data processing activities of… »
New Guidelines on Named Patient Program was Published
The pharmaceuticals not authorized in Turkey or those not available in the market, despite being authorized, shall be procured from abroad upon the request of a physician and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guidelines on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("TİTCK"). In line with… »
Turkish MDR and IVDR Amended
On 2 April 2023, regulations amending the Turkish Medical Device Regulation (Turkish language) and the Turkish In Vitro Medical Device Regulation (Turkish language) were published in the Official Gazette numbered 32151. They amend he transitional provisions stipulated in the which was published in the Official Gazette numbered 31499 to be in line with the transitional provisions applicable to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The… »
Communiqué on Electronic Instructions For Use of Medical Devices Published (Turkey)
On 6 April 2023, the Turkish Medicines and Medical Devices Agency (Agency) published a new Communiqué on Electronic Instructions for Use of Medical Devices (Turkish language) (Communiqué) in the Official Gazette numbered 32155. The Communiqué replaced the version dated 2 April 2015 numbered 29314 and entered into force on the day of its publication. The Communiqué has been updated in line with Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for… »