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

Year 2020, Volume: 1 Issue: 1, 187 - 210, 25.12.2020

Filippo Pesapane Caterina Volonté Marina Codari Francesco Sardanelli Translator: Emine Meliknur Kılıç

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

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