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
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

Fiona Zhang
Therapeutic Goods Administration (TGA)
Mrs Olivia Reeves
Therapeutic Goods Administration (TGA)

Mr Anderson de Almeida Pereira
Brazilian Health Regulatory Agency (ANVISA)
Mr Helio Bomfim de Macedo Filho
Brazilian Health Regulatory Agency (ANVISA)

Marc Lamoureux
Health Canada

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

Nada Alkhayat
European Commission
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 cooperation
Rob Suarez
BD

Akimasa Takeuchi
Ministry of Health, Labour and Welfare (MHLW)
Arisa Nakamura
Ministry of Health, Labour and Welfare (MHLW)
Hidemasa Sekimizu
Pharmaceuticals and Medical Devices Agency (PMDA)
Junichi Ohishi
Pharmaceuticals and Medical Devices Agency (PMDA)
Kanako Sasaki
Ministry of Health, Labour and Welfare (MHLW)
Katsuya Sawadaishi
Ministry of Health, Labour and Welfare (MHLW)
Koutarou Tomita
Ministry of Health, Labour and Welfare (MHLW)
Masahito Ogawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Yasuyuki Sakurai
Pharmaceuticals and Medical Devices Agency (PMDA)
Yutaku Kaneta
Pharmaceuticals and Medical Devices Agency (PMDA)

Vladimir Kutichev
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Guangyi Zhuang
Health Sciences Authority (HSA)

Mr Hyun-soo Kim
Ministry of Food and Drug Safety (MFDS)
Mr Kyoung-taek Lim
Ministry of Food and Drug Safety (MFDS)

Dr Aftin Ross
Food and Drug Administration (FDA)
Dr Kevin Fu
Food and Drug Administration (FDA)
Dr Suzanne Schwartz
Food and Drug Administration (FDA)
Jessica Wilkerson
Food and Drug Administration (FDA)