The U.S. Food and Drug Administration and Departments of Health and Human Services and Homeland Security will host a public workshop on Oct. 21-22 to develop a collaborative approach to medical device cybersecurity.
The purpose of the meeting is to catalyze collaboration in the healthcare and public health sector to more fully address medical device cybersecurity, writes Suzanne Schwartz, M.D., director of emergency preparedness/operations and medical countermeasures at FDAs Center for Devices and Radiological Health, in an Oct. 8 blog. The meeting will bring together medical device manufacturers; healthcare providers; biomedical engineers; IT system administrators; professional and trade organizations; insurance providers; cybersecurity researchers; local, state and federal government staffs; and representatives of information security firms.
According to Schwartz, medical devices that contain computer hardware or software or that connect to computer networks are subject to the same types of cyber vulnerabilities as consumer devices. However, the healthcare industry is particularly vulnerable to cyber attacks. In April, the FBI's Cyber Division issued a notice warning that healthcare systems and medical devices are at risk for increased cyber intrusions for financial gain.
To combat vulnerabilities, the FDA is partnering with the National Health-Information Sharing and Analysis Center (NH-ISAC), a non-profit organization that closely cooperates with government agencies, and numerous healthcare and public health organizations. The partnership will enable FDA and NH-ISAC to share information about medical device cybersecurity threats among healthcare and public health stakeholders.
In addition, the FDA recently issued guidance identifying cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices to maintain information confidentiality, integrity and availability.
Online registration to attend the Oct. 21-22 meeting at the National Intellectual Property Rights Coordination Center in Arlington, Va., is available here.The workshop also will be webcast.
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