{
  "id": 8293,
  "url": "https://doi.org/10.1007/s13244-018-0645-y",
  "title": "Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States",
  "summary": "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 ",
  "authors": "Filippo Pesapane, Caterina Volonté, Marina Codari, Francesco Sardanelli",
  "category": "research",
  "topics": "regulation,healthcare",
  "orgs": null,
  "regions": "us,eu",
  "published_at": "2018-08-15T00:00:00.000Z",
  "fetched_at": "2026-07-14T16:33:37.175Z",
  "source_slug": "openalex",
  "source_name": "OpenAlex",
  "source_homepage": "https://openalex.org",
  "ethics_ai_record_url": "https://ethics.ai/record/8293",
  "original_url": "https://doi.org/10.1007/s13244-018-0645-y",
  "evidence_status": "source-only",
  "attribution": "via ethics.ai"
}