TIC Council is organising a webinar entitled“TIC Sector and the Cybersecurity of Medical Devices in North Americas”. The webinar will discuss the challenges presented by cybersecurity of medical devices and the recommended best practices to address issues in this field.
The virtual panel will bring together speakers from the , U.S. Food and Drug Administration (FDA), the medical device industry and the TIC sector, who will share their expertise and knowledge in addressing how medical devices can remain reliable against cybersecurity threats. It will focus on the following aspects:
The webinar will take place on Wednesday, 30th September 2020 at 11:00-12:30 U.S. Eastern Time.
Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience.
Confirmed speakers:
Suzanne B. Schwartz, MD, MBA
Director - Office of Strategic Partnerships & Technology Innovation
Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration
Suzanne B. Schwartz, MD, MBA is the Director of the Office of Strategic Partnerships and Technology Innovation (OST) at FDA’s Center for Devices & Radiological Health (CDRH).
Suzanne’s work in medical device cybersecurity includes raising awareness, educating, outreach, partnering and coalition-building within the Healthcare and Public Health Sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Suzanne has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in Medical Device Cybersecurity.
Together with Health Canada, Suzanne has represented FDA in co-chairing the International Medical Device Regulators Forum (IMDRF) Work Group on Medical Device Cybersecurity leading to its first international guidance publication in March 2020. She chairs CDRH’s Cybersecurity Working Group, tasked with formulating FDA’s medical device cybersecurity policy and has additionally served as co-chair of the Government Coordinating Council (GCC) for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cybersecurity initiatives.
Suzanne earned an MD from Albert Einstein College of Medicine; an executive MBA from NYU Stern School of Business, completed Cohort X of the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government executive education, and earned in September 2018 a certificate of mastery for completion of requirements at the Federal Executive Institute – Leadership for a Democratic Society.
Michelle Jump
Global Regulatory Advisor – Medical Device Security
MedSec
Michelle Jump is the Global Regulatory Advisor -Medical Device Cybersecurity at MedSec , where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management. Ms. Jump has a passion for bringing technology-based solutions to healthcare, actively participating in a variety of domestic and international standards, as well as relevant industry and governmental initiatives to support security within the healthcare industry. As a dedicated contributor to overall industry engagement, she serves in numerous leadership roles globally, including ISO/TC 215 Convenor for WG4 Security, Safety, Privacy, Project lead for ISO/IEC 81001-1, Task group lead for NTIA Software Transparency Framing group, and HSCC End-of-Life Legacy Cybersecurity Task Group lead. Ms. Jump holds a Master of Science in Regulatory Science from the University of Southern California and a Master of Science in Biotechnology from California State University. She is also RAC certified and a Certified HIPAA Administrator.
George Strom
Director of IOT
Intertek
George Strom is the Business Development Director of IOT at Intertek, a FTSE 100 Company. He has worked in the assurance, testing, inspection, and certification industry for over 25 years and has an in-depth knowledge of product cyber security across multiple industry verticals including, but not limited to medical, governmental, consumer, and electrical. He currently sits on the board of the Global Life Safety Alliance . George is based out of one of Intertek’s largest U.S. Medical Electrical laboratory in Boxborough, MA.
Further details
The microphone function will be disabled for participants during the webinar but all questions for the presenter can be submitted through Webex via the chat function.
For further questions, please do not hesitate to contact secretariat@tic-council.org
We look forward to welcoming you and/or your colleagues.
Best regards,
TIC Council
Hanane Taidi
Director-General
The virtual panel will bring together speakers from the , U.S. Food and Drug Administration (FDA), the medical device industry and the TIC sector, who will share their expertise and knowledge in addressing how medical devices can remain reliable against cybersecurity threats. It will focus on the following aspects:
- Regulators expectations from industry
- Best practices manufacturers should take into consideration for mitigating risks
- Threat models and SBOMs
- IMDRF guidance and trends and more
The webinar will take place on Wednesday, 30th September 2020 at 11:00-12:30 U.S. Eastern Time.
Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience.
Confirmed speakers:
- Suzanne Schwartz, Director, Office of Strategic Partnerships & Technology Innovation, U.S. Food and Drug Administration (FDA)
- Michelle Jump, Global Regulatory Advisor, Medical Device Security, MedSec
- George Strom, Director of IOT at Intertek
Suzanne B. Schwartz, MD, MBA
Director - Office of Strategic Partnerships & Technology Innovation
Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration
Suzanne B. Schwartz, MD, MBA is the Director of the Office of Strategic Partnerships and Technology Innovation (OST) at FDA’s Center for Devices & Radiological Health (CDRH).
Suzanne’s work in medical device cybersecurity includes raising awareness, educating, outreach, partnering and coalition-building within the Healthcare and Public Health Sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Suzanne has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in Medical Device Cybersecurity.
Together with Health Canada, Suzanne has represented FDA in co-chairing the International Medical Device Regulators Forum (IMDRF) Work Group on Medical Device Cybersecurity leading to its first international guidance publication in March 2020. She chairs CDRH’s Cybersecurity Working Group, tasked with formulating FDA’s medical device cybersecurity policy and has additionally served as co-chair of the Government Coordinating Council (GCC) for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cybersecurity initiatives.
Suzanne earned an MD from Albert Einstein College of Medicine; an executive MBA from NYU Stern School of Business, completed Cohort X of the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government executive education, and earned in September 2018 a certificate of mastery for completion of requirements at the Federal Executive Institute – Leadership for a Democratic Society.
Michelle Jump
Global Regulatory Advisor – Medical Device Security
MedSec
Michelle Jump is the Global Regulatory Advisor -Medical Device Cybersecurity at MedSec , where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management. Ms. Jump has a passion for bringing technology-based solutions to healthcare, actively participating in a variety of domestic and international standards, as well as relevant industry and governmental initiatives to support security within the healthcare industry. As a dedicated contributor to overall industry engagement, she serves in numerous leadership roles globally, including ISO/TC 215 Convenor for WG4 Security, Safety, Privacy, Project lead for ISO/IEC 81001-1, Task group lead for NTIA Software Transparency Framing group, and HSCC End-of-Life Legacy Cybersecurity Task Group lead. Ms. Jump holds a Master of Science in Regulatory Science from the University of Southern California and a Master of Science in Biotechnology from California State University. She is also RAC certified and a Certified HIPAA Administrator.
George Strom
Director of IOT
Intertek
George Strom is the Business Development Director of IOT at Intertek, a FTSE 100 Company. He has worked in the assurance, testing, inspection, and certification industry for over 25 years and has an in-depth knowledge of product cyber security across multiple industry verticals including, but not limited to medical, governmental, consumer, and electrical. He currently sits on the board of the Global Life Safety Alliance . George is based out of one of Intertek’s largest U.S. Medical Electrical laboratory in Boxborough, MA.
Further details
The microphone function will be disabled for participants during the webinar but all questions for the presenter can be submitted through Webex via the chat function.
For further questions, please do not hesitate to contact secretariat@tic-council.org
We look forward to welcoming you and/or your colleagues.
Best regards,
TIC Council
Hanane Taidi
Director-General