{
  "id": 19114,
  "url": "https://arxiv.org/abs/2608.12360",
  "title": "Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices",
  "summary": "arXiv:2608.12360v1 Announce Type: new Abstract: Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of",
  "authors": "Ahmed M Salih, Oliver D\\'iaz, Alejandro Guzman, Noah Marquez Vara, Fotios Avgoustidis, Rituraj Singh, Saman Barakat, Zahra Raisi-Estabragh, Karim Lekadir",
  "category": "research",
  "topics": "regulation,healthcare",
  "orgs": null,
  "regions": null,
  "published_at": "2026-08-14T04:00:00.000Z",
  "fetched_at": "2026-08-14T05:10:49.168Z",
  "source_slug": "arxiv-cscy",
  "source_name": "arXiv cs.CY",
  "source_homepage": "https://arxiv.org/list/cs.CY/recent",
  "ethics_ai_record_url": "https://ethics.ai/record/19114",
  "original_url": "https://arxiv.org/abs/2608.12360",
  "evidence_status": "source-only",
  "attribution": "via ethics.ai"
}