10.09.14
The U.S. Food and Drug Administration (FDA) is seeking public input on the cybersecurity of medical devices and has scheduled a two-day public workshop in collaboration with the U.S. Department of Homeland Security.
The Collaborative Approaches for Medical Device and Healthcare Cybersecurity workshop will take place Oct. 21 and 22 at the National Intellectual Property Rights Coordination Center Auditorium in Arlington, Va., according to a Federal Register notice. The workshop will last from 9 a.m. to 5 p.m. both days.
The two agencies are asking the Healthcare and Public Health (HPH) industry—including, but not limited to medical device manufacturers; healthcare facilities; personnel, professional, and trade organizations; patient groups; insurance providers; and cybersecurity researchers—or input on medical device and healthcare cybersecurity with hopes to “catalyze collaboration” among the HPH industry.
“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,” according to the notice.
According to the Federal Register, some of the topics the two agencies plan to discuss include:
Since then, the agency has issued draft guidance on the subject, providing recommendations for device makers submitting premarket submissions to reduce the risk of devices being compromised.
“As the industry evolves, we can expect that cybersecurity will be part of new FDA regulatory framework for medical apps and connected devices,” Scott Sheaf, senior software engineer at non-profit research and development organization Battelle, said recently.
The workshop will be webcast, and registration for physical attendance is on a first-come basis. The FDA is taking comment on the workshop, and industry has until Nov. 24 to submit its comments.
The Collaborative Approaches for Medical Device and Healthcare Cybersecurity workshop will take place Oct. 21 and 22 at the National Intellectual Property Rights Coordination Center Auditorium in Arlington, Va., according to a Federal Register notice. The workshop will last from 9 a.m. to 5 p.m. both days.
The two agencies are asking the Healthcare and Public Health (HPH) industry—including, but not limited to medical device manufacturers; healthcare facilities; personnel, professional, and trade organizations; patient groups; insurance providers; and cybersecurity researchers—or input on medical device and healthcare cybersecurity with hopes to “catalyze collaboration” among the HPH industry.
“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,” according to the notice.
According to the Federal Register, some of the topics the two agencies plan to discuss include:
- 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; and
- Gaining situational awareness of the current cyber threats to the HPH sector, especially to medical devices.
Since then, the agency has issued draft guidance on the subject, providing recommendations for device makers submitting premarket submissions to reduce the risk of devices being compromised.
“As the industry evolves, we can expect that cybersecurity will be part of new FDA regulatory framework for medical apps and connected devices,” Scott Sheaf, senior software engineer at non-profit research and development organization Battelle, said recently.
The workshop will be webcast, and registration for physical attendance is on a first-come basis. The FDA is taking comment on the workshop, and industry has until Nov. 24 to submit its comments.