Medical Device Cybersecurity Guide

Working Group Chair(s)
Dr Suzanne Schwartz
Food and Drug Administration (FDA)
United States of America
Marc Lamoureux
Health Canada
Canada
Dr Aftin Ross
Food and Drug Administration (FDA)
United States of America
Membership
Regulator and stakeholder membership (membership to be advised)
Status
Current

As medical devices become more connected, there is the potential to impact patient safety. This is evident as cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities worldwide. The purpose of this Work Item is to promote a globally harmonized approach to medical device cybersecurity that at a fundamental level ensures the safety and performance of medical devices while encouraging innovation. The Work Item is thus intended to provide medical device cybersecurity guidance for stakeholders across the device lifecycle.

The working group will develop an IMDRF Technical Document that will provide guidance that includes but is not limited to medical device cybersecurity definitions, stakeholders' shared responsibility, and information sharing.

  • Medical Device Cybersecurity Guide

Participants

Bioing. Carolina Magnatti
National Administration of Drugs, Food and Medical Devices (ANMAT)
Bioing. José Médico Orellano
National Administration of Drugs, Food and Medical Devices (ANMAT)

Alex Bek
Therapeutic Goods Administration (TGA)
Fiona Zhang
Therapeutic Goods Administration (TGA)
Rebecca Moores
Therapeutic Goods Administration (TGA)

Mr Francisco Iran Cartaxo Barbosa
Brazilian Health Regulatory Agency (ANVISA)
Mr Helio Bomfim de Macedo Filho
Brazilian Health Regulatory Agency (ANVISA)

Ian Glasgow
Health Canada
Marc Lamoureux
Health Canada

Mr Liang Hong
Center for Medical Device Evaluation (CMDE), NMPA
Mr Peng Liang
Center for Medical Device Evaluation (CMDE), NMPA

Sophie Nogaret
National Agency for the Safety of Medicines and Health Products (ANSM)
Steffen Buchholz
Germany Federal Ministry of Health (BMG)

Ben Kokx
Philips
Georg Heidenreich
Siemens Healthineers
Joseph Burgoyne
GE Healthcare
Keiichiro Ozawa
FUJIFILM Corporation
Zack Hornberger
Global Diagnostic Imaging, Healthcare ICT, and Radiation Therapy Trade Association (DITTA)

Celestina Bianco
Werfen
Chris Tyberg
Abbott
Mike Pieper
BD
Mr Toshiaki Nakazato
Canon Medical Systems
Rob Suarez
BD

Eri Makino
Ministry of Health, Labour and Welfare (MHLW)
Genki Nishikawa
Ministry of Health, Labour and Welfare (MHLW)
Hidemasa Sekimizu
Pharmaceuticals and Medical Devices Agency (PMDA)
Junichi Ohishi
Pharmaceuticals and Medical Devices Agency (PMDA)
Mariko Ando
Ministry of Health, Labour and Welfare (MHLW)
Masami Saitou
Ministry of Health, Labour and Welfare (MHLW)
Morikazu Seki
Pharmaceuticals and Medical Devices Agency (PMDA)
Mr Kuniki Imagawa
Pharmaceuticals and Medical Devices Agency (PMDA)

Vladimir Kutichev
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Guangyi Zhuang
Health Sciences Authority (HSA)

Mr Hui Sung
Ministry of Food and Drug Safety (MFDS)
Rosa Da-yeong Ryoo (Ms)
Ministry of Food and Drug Safety (MFDS)

Dr Kevin Fu
Food and Drug Administration (FDA)
Dr Suzanne Schwartz
Food and Drug Administration (FDA)
Jessica Wilkerson
Food and Drug Administration (FDA)
Wil Vargas
Food and Drug Administration (FDA)