ARTIFICIAL INTELLIGENCE SYSTEMS USED FOR DIAGNOSIS AND TREATMENT IN THE CONTEXT OF MEDICAL DEVICE LAW

Aliye Akgün Toker

Article Details

ARTIFICIAL INTELLIGENCE SYSTEMS USED FOR DIAGNOSIS AND TREATMENT IN THE CONTEXT OF MEDICAL DEVICE LAW

Authors:

Aliye Akgün Toker

Publisher:

Dokuz Eylul University

Main Topics:

Tıbbi ve Sağlık Hukuku | Hukuk (Diğer)

Journal:

Dokuz Eylül Üniversitesi Hukuk Fakültesi Dergisi Vol.27 Issue 1, pp.769-824

Document Type:

Article

Publication Date:

5/2025

Document Language:

Turkish

Document ID (Org No.):

2001349277

pISSN:

1303-6963

Keywords:

Abstract:

 Artificial intelligence systems used for diagnostic and treatment purposes are classified as medical devices. Therefore, the placement of AI systems used in diagnosis and treatment on the market is subject to the provisions outlined in the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Given the various characteristics of AI systems, it is necessary to assess whether the regulations concerning medical devices are sufficient to ensure the safe market introduction of AI systems classified as medical devices. In this context, the study examines the placing on the market of AI systems used in diagnosis and treatment, and whether there is a need to amend the legislation under Turkish law. Additionally, since it is significant under Turkish law, the relevant provisions of the Artificial Intelligence Act, which also encompasses medical devices, are examined within the scope of the study.

 Artificial intelligence systems used for diagnostic and treatment purposes are classified as medical devices. Therefore, the placement of AI systems used in diagnosis and treatment on the market is subject to the provisions outlined in the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Given the various characteristics of AI systems, it is necessary to assess whether the regulations concerning medical devices are sufficient to ensure the safe market introduction of AI systems classified as medical devices. In this context, the study examines the placing on the market of AI systems used in diagnosis and treatment, and whether there is a need to amend the legislation under Turkish law. Additionally, since it is significant under Turkish law, the relevant provisions of the Artificial Intelligence Act, which also encompasses medical devices, are examined within the scope of the study.

 Artificial intelligence systems used for diagnostic and treatment purposes are classified as medical devices. Therefore, the placement of AI systems used in diagnosis and treatment on the market is subject to the provisions outlined in the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Given the various characteristics of AI systems, it is necessary to assess whether the regulations concerning medical devices are sufficient to ensure the safe market introduction of AI systems classified as medical devices. In this context, the study examines the placing on the market of AI systems used in diagnosis and treatment, and whether there is a need to amend the legislation under Turkish law. Additionally, since it is significant under Turkish law, the relevant provisions of the Artificial Intelligence Act, which also encompasses medical devices, are examined within the scope of the study.

 Teşhis ve tedavi amacıyla kullanılan yapay zekâ sistemleri tıbbi cihaz niteliği taşımaktadır. Bu nedenle teşhis ve tedavide kullanılan yapay zekâ sistemlerinin piyasaya arz edilebilmesi Tıbbi Cihaz Yönetmeliği ve İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliğinde yer alan hükümlere tabidir. Yapay zekâ sistemlerinin taşıdıkları çeşitli özellikler nedeniyle, tıbbi cihazlara ilişkin düzenlemelerin tıbbi cihaz niteliğindeki yapay zekâ sistemlerinin güvenli bir şekilde piyasaya arz edilmeleri için uygun olup olmadığının değerlendirilmesi gerekir. Bu kapsamda, çalışmada Türk Hukuku bakımından teşhis ve tedavide kullanılan yapay zekâ sistemlerinin piyasaya arzı ve mevzuatta değişiklik yapılması ihtiyacının bulunup bulunmadığı ele alınmıştır. Ayrıca Türk Hukuku bakımından önem arz ettiği için tıbbi cihazları da kapsamına alan Yapay Zekâ Tüzüğünün ilgili hükümleri çalışma kapsamında incelenmiştir.

Article Details

ARTIFICIAL INTELLIGENCE SYSTEMS USED FOR DIAGNOSIS AND TREATMENT IN THE CONTEXT OF MEDICAL DEVICE LAW

Authors:

Aliye Akgün Toker

Publisher:

Dokuz Eylul University

Main Topics:

Tıbbi ve Sağlık Hukuku | Hukuk (Diğer)

Journal:

Dokuz Eylül Üniversitesi Hukuk Fakültesi Dergisi Vol.27 Issue 1, pp.769-824

Document Type:

Article

Publication Date:

5/2025

Document Language:

Turkish

Document ID (Org No.):

2001349277

pISSN:

1303-6963

Artificial Intelligence Systems

Medical Device

Placing on the Market of Medical Devices

Medical Device Regulation

Artificial Intelligence ActYapay Zekâ Sistemleri

Tıbbi Cihaz

Tıbbi Cihazların Piyasaya Arzı

Tıbbi Cihaz Yönetmeliği

Yapay Zekâ Tüzüğü

Issues

Article Details

Authors: Aliye Akgün Toker

Publisher: Dokuz Eylul University

Main Topics: Tıbbi ve Sağlık Hukuku | Hukuk (Diğer)

Journal: Dokuz Eylül Üniversitesi Hukuk Fakültesi Dergisi Vol.27 Issue 1, pp.769-824

Document Type: Article

Publication Date: 5/2025

Document Language: Turkish

Document ID (Org No.): 2001349277

pISSN: 1303-6963

Issues

Authors:

Aliye Akgün Toker

Publisher:

Dokuz Eylul University

Main Topics:

Tıbbi ve Sağlık Hukuku | Hukuk (Diğer)

Journal:

Dokuz Eylül Üniversitesi Hukuk Fakültesi Dergisi Vol.27 Issue 1, pp.769-824

Document Type:

Article

Publication Date:

5/2025

Document Language:

Turkish

Document ID (Org No.):

2001349277

pISSN:

1303-6963