Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems

Ting Wei Lin, Po Yu Huang, Claire Wan Chiung Cheng

研究成果: 書貢獻/報告類型會議貢獻

1 引文 斯高帕斯(Scopus)

摘要

The goal of this paper is to explore whether the premarket regulatory system of the United States functions ideally in facing the emergence of commercial computer-aided diagnosis (CAD) systems for medical imaging. To outline the commercial CAD systems available in the United States, clinical trials published in PubMed and EMBASE from 2012 to 2016 that investigated the clinical competence of commercial CAD products were obtained, and the product information provided in these studies was searched in the Establishment Registration & Device Listing database, the Releasable 510(k) Premarket Notification database, and the Premarket Approval (PMA) database of the FDA to trace the processes through which such CAD systems entered the healthcare market. A review of current premarket regulatory system for medical devices, and the potential problems that may hinder the social and clinical integration of CAD systems are presented. We noticed expansion of regulatory definition and variation of device classes and product codes among CAD systems with similar clinical uses, which may compromise the efficacy of such regulatory controls. The results suggested ineffectiveness of current premarket regulatory controls for CAD systems in the United States.

原文英語
主出版物標題2016 IEEE 18th International Conference on e-Health Networking, Applications and Services, Healthcom 2016
發行者Institute of Electrical and Electronics Engineers Inc.
ISBN(電子)9781509033706
DOIs
出版狀態已發佈 - 十一月 18 2016
事件18th IEEE International Conference on e-Health Networking, Applications and Services, Healthcom 2016 - Munich, 德国
持續時間: 九月 14 2016九月 17 2016

其他

其他18th IEEE International Conference on e-Health Networking, Applications and Services, Healthcom 2016
國家德国
城市Munich
期間9/14/169/17/16

    指紋

ASJC Scopus subject areas

  • Computer Science Applications
  • Computer Networks and Communications
  • Health(social science)
  • Health Informatics

引用此

Lin, T. W., Huang, P. Y., & Cheng, C. W. C. (2016). Computer-aided diagnosis in medical imaging: Review of legal barriers to entry for the commercial systems. 於 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services, Healthcom 2016 [7749517] Institute of Electrical and Electronics Engineers Inc.. https://doi.org/10.1109/HealthCom.2016.7749517