CDRH Industry: FDA Public Workshop; Collaborative Approaches for Medical Device and Healthcare Cybersecurity; October 21-22, 2014

FDA Public Workshop October 21-22, 2014 –

Arlington, VA

Collaborative Approaches for Medical Device and Healthcare Cybersecurity

  

In recognition of National Cybersecurity Awareness Month, the Food and Drug Administration (FDA) in collaboration with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) is announcing a public workshop on medical device and healthcare cybersecurity.

FDA and its workshop partners strive to engage all stakeholders in the healthcare and public health (HPH) Sector in order to identify HPH cybersecurity challenges and ways the Sector can work together to address these challenges. This is accomplished via discussion of the following general themes:

(1) Envisioning a collaborative environment for information sharing and developing a shared risk-assessment framework using a common lexicon; overcoming barriers (perceived and real) to create a community of “shared ownership and shared responsibility” within the HPH Sector to increase medical device cybersecurity;

(2) Gaining situational awareness of the current cyber threats to the HPH Sector including those that impact medical devices;

(3) Identifying cybersecurity gaps and challenges, especially end-of-life support for legacy devices and interconnectivity of medical devices;

(4) Adapting and implementing the “Framework for Improving Critical Infrastructure Cybersecurity” to support management of cybersecurity risks involving medical devices;

(5) Developing tools and standards to build a comprehensive cybersecurity program to meet the unique needs of the sector’s critical infrastructure including medical devices;

(6) How to leverage the technical subject matter expertise of the cybersecurity researcher community working with HPH stakeholders to identify, assess, and mitigate vulnerabilities; and

(7) Building potential solutions: Exploring collaborative models to gather diverse experts and establish medical device security benchmarks which are continuously validated.

Registration: Is free and now open for both on-site and remote access. Please register online athttp://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm

Registration to attend in person is available on a first-come, first served basis. Registration for both in person and remote access closes October 14, 2014.

Inquiries can be directed to Dr. Suzanne Schwartz – Suzanne.Schwartz@fda.hhs.gov.

Federal Register Notice: https://www.federalregister.gov/articles/2014/09/23/2014-22515/collaborative-approaches-for-medical-device-and-healthcare-cybersecurity-public-workshop-request-for

You can also visit the FDA Cybersecurity page at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/ucm373213.htm for more information on FDA’s cybersecurity activities.

Thank you for your interest in and support of FDA and its mission.

Center for Devices and Radiological Health

Food and Drug Administration