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

Research output: Chapter in Book/Report/Conference proceedingConference contribution

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Title of host publication2016 IEEE 18th International Conference on e-Health Networking, Applications and Services, Healthcom 2016
PublisherInstitute of Electrical and Electronics Engineers Inc.
ISBN (Electronic)9781509033706
DOIs
Publication statusPublished - Nov 18 2016
Event18th IEEE International Conference on e-Health Networking, Applications and Services, Healthcom 2016 - Munich, Germany
Duration: Sep 14 2016Sep 17 2016

Other

Other18th IEEE International Conference on e-Health Networking, Applications and Services, Healthcom 2016
CountryGermany
CityMunich
Period9/14/169/17/16

Keywords

  • 510(k)
  • computer-aided detection
  • computer-aided diagnosis
  • legal barriers to entry
  • premarket approval

ASJC Scopus subject areas

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

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  • Cite this

    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. In 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