Danger to public health: medical devices, toxicity, virus and fraud

TY - JOUR

T1 - Danger to public health

T2 - medical devices, toxicity, virus and fraud

AU - Kierkegaard, Sylvia

AU - Kierkegaard, Patrick

PY - 2013/2

Y1 - 2013/2

N2 - The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient’s safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.

AB - The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient’s safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.

U2 - 10.1016/j.clsr.2012.11.006

DO - 10.1016/j.clsr.2012.11.006

M3 - Journal article

SN - 0267-3649

VL - 29

SP - 13

EP - 27

JO - Computer Law and Security Review

JF - Computer Law and Security Review

IS - 1

ER -