FDA public workshop on cybersecurity

Arlington, Virginia – The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.” FDA, in collaboration with other stakeholders within the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS), seeks broad input from the Healthcare and Public Health (HPH) Sector on medical device and healthcare cybersecurity. The vision for this public workshop is to catalyze collaboration among all HPH stakeholders. Participants will identify barriers to promoting cooperation; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity.

Dates and Times: The public workshop will be held on October 21 and 22, 2014, from 9 a.m. to 5 p.m.

Location: The public workshop will be held at the National Intellectual Property Rights Coordination Center Auditorium, 2451 Crystal Dr., Suite 200, Arlington, VA 22202.

Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m., October 14, 2014. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8:30 a.m.

If you need special accommodations due to a disability, please contact Susan Monahan, 301-796-5661, email: Susan.Monahan@fda.hhs.gov, no later than October 15, 2014.

To register for the public workshop, please visit FDA's Medical Devices News & Events – Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Suzanne Schwartz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993, 301-796-6937, FAX: 301-847-8510, email: Suzanne.Schwartz@fda.hhs.gov.

Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., October 14, 2014. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after October 16, 2014. Most updated browsers will support the Webcast.

Comments: FDA is holding this public workshop to obtain information on medical device cybersecurity. In order to permit the widest possible opportunity to obtain public comment,FDA is soliciting either electronic or written comments on all aspects of the public workshop topics, regardless of attendance at the public workshop. The deadline for submitting comments related to this public workshop is November 24, 2014.

Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section III of this document, please identify the question number you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Source: FDA