Radyolojide Tıbbi Bir Cihaz Olarak Yapay Zeka: Avrupa ve Amerika Birleşik Devletleri'nde Etik ve Yasal Sorunlar

Abstract

Yapay zeka (AI) uygulamalarına dünya çapında ilgi hızla artmaktadır. Tıpta, makine öğrenmesi/derin öğrenmeye dayalı cihazların, özellikle de görüntü analizi için kullanılanların çoğalması yapay zekanın sağlık hizmetlerinde kullanımı için yeni önemli zorluklar ortaya çıkaracaktır. Bu durum kaçınılmaz olarak çok sayıda yasal ve etik soruyu gündeme getirmektedir. Bu yazıda, tıbbi cihaz geliştirme bağlamında yapay zeka düzenlemesinin durumunu ve gelecekte yapay zeka uygulamalarını güvenli ve kullanışlı hale getirme stratejilerini analiz ediyoruz. Şu anda meydana gelen gelişmeleri değerlendirerek, Avrupa ve Amerika Birleşik Devletleri'nde tıbbi cihazları ve veri korumayı düzenleyen yasal çerçeveyi analiz ediyoruz. Avrupa Birliği (AB) bu alanlarda yeni mevzuatla ile (Genel Veri Koruma Yönetmeliği [GDPR], Siber Güvenlik Yönergesi, Tıbbi Cihazlar Yönetmeliği, in vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği) reformlar yapmaktadır. Bu reformlar kademeli olmakla birlikte ilk etkisini Mayıs 2018'de yürürlüğe giren GDPR ve Siber Güvenlik Yönergesi ile yaptı. Amerika Birleşik Devletleri (ABD) ise düzenleme yetkilerini ağırlıklı olarak Gıda ve İlaç Dairesine bırakmıştır. Bu makale hem yasal hem de etik hesap verebilirlik konularını ele almaktadır. Tıbbi cihaz karar verme süreçleri büyük ölçüde öngörülemez, bu nedenle yaratıcıları bundan sorumlu tutmak açıkça endişelere yol açacaktır. AI uygulamalarını düzenlemek için yapılabilecek çok şey var. Bu doğru ve zamanında yapılırsa, yapay zeka tabanlı teknolojinin radyoloji ve diğer alanlarda potansiyeli paha biçilmez olacaktır.

Keywords

• Yapay zeka
• Mevzuat
• Politika
• Gizlilik
• Radyoloji

Artificial Intelligence as a Medical Device in Radiology: Ethical and Regulatory Issues in Europe and the United States

Abstract

Worldwide interest in artificial intelligence (AI) applications is growing rapidly. In medicine, devices based on machine/deep learning have proliferated, especially for image analysis, presaging new significant challenges for the utility of AI in healthcare. This inevitably raises numerous legal and ethical questions. In this paper we analyse the state of AI regulation in the context of medical device development, and strategies to make AI applications safe and useful in the future. We analyse the legal framework regulating medical devices and data protection in Europe and in the United States, assessing developments that are currently taking place. The European Union (EU) is reforming these fields with new legislation (General Data Protection Regulation [GDPR], Cybersecurity Directive, Medical Devices Regulation, In Vitro DiagnosticMedical Device Regulation). This reform is gradual, but it has now made its first impact, with the GDPR and the Cybersecurity Directive having taken effect in May, 2018. As regards the United States (U.S.), the regulatory scene is predominantly controlled by the Food and Drug Administration. This paper considers issues of accountability, both legal and ethical. The processes ofmedical device decision-making are largely unpredictable, therefore holding the creators accountable for it clearly raises concerns. There is a lot that can be done in order to regulate AI applications. If this is done properly and timely, the otentiality of AI based technology, in radiology as well as in other fields, will be invaluable.

Keywords

• Artificial intelligence
• Legislation
• Policy
• Privacy
• Radiology

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