Medical devices today are becoming more and more connected to the internet, hospital networks and other devices. While these features often improve the ability to provide quality health care, they also increase vulnerability to security breaches and cybersecurity threats. On 18 October 2018, the Food and Drug Administration (FDA) issued a draft guidance, Content of Premarket Submission for Management of Cybersecurity in Medical Devices, which provided updated recommendations on cybersecurity considerations for device design, labeling and documentation. In December of 2018, Health Canada also produced a draft guidance, Pre-market Requirements for Medical Device Cybersecurity, to provide assistance on this topic as well.
During this workshop, attendees will learn from a diverse panel of leading experts, FDA and Health Canada regulators and product end users how to incorporate cybersecurity into product design, assess changes for regulatory impact and how to best present it in a health authority submission. Panelists include the co-chair of CDRH’s Cybersecurity Working Group, Seth Carmody, and Health Canada’s Digital Health Division senior evaluator, Ian Glasgow. This workshop will explore cybersecurity consideration in the medical device industry and the impact on regulatory professionals and attendees will gain a deeper understanding of the challenges, as well as strategies to address them.
Speakers will address a variety of topics including:
- How to incorporate cybersecurity into your product design
- Assessing changes for regulatory impact
- How to present it in a health authority submission
Featured presentations will included:
- Building Cybersecurity into Medical Device Development
- Medical Device Cybersecurity: A Health Canada Perspective
- Safety Considerations for Apps, Devices and Platforms in the Integrated Clinical Environment
- Regulatory Pre-submission Using a Concept Device to Elaborate Safety Considerations
- Medical Device Cybersecurity
This workshop is brought to you by the RAPS Boston chapter and is intended to encourage professional development and networking among regulatory and quality professionals in the region. Attendees can claim six continuing education RAC recertification credits.
Seth D. Carmody, PhD, cybersecurity program manager, CDRH, FDA, Co-chair of CDRH’s Cybersecurity Working Group
Stephanie Domas, vice president of research and development, MedSec
Ian Glasgow, BASc, MSc., senior evaluator, Digital Health Division, Medical Devices Bureau, Health Canada
Julian M. Goldman, MD, attending anesthesiologist, MGH, medical director, partners healthcare biomedical engineering, director, program on medical device interoperability and cybersecurity (MD PnP)
Scott Thiel, MT(ASCP), MBA, RAC, director of life sciences, Navigant