In-brief: The Department of Homeland Security warned that drug infusion pump management software sold by Hospira contains serious and exploitable vulnerabilities that could be used to remotely take control of the devices.
FDA
Intel: New Approach Needed to Secure Connected Health Devices
In-brief: connected medical devices pose a number of risks to patients, including the threat of “targeted killings,” according to a report by Intel Security. The fix: better application design and more public-private sector cooperation.
Wireless Infusion Pump is Test Case for Securing Medical Devices
A National Institute of Standards and Technology (NIST) reference document is providing some of the clearest guidance from the U.S. government for securing connected medical devices, but may be setting too low a bar for securing wireless communications, according to a security expert. NIST, working with the University of Minnesota’s Technological Leadership Institute, released a draft Use Case document (PDF) on December 18 to help health care providers “secure their medical devices on an enterprise networks.” However, in the area of communications security, the document suggests the use of WEP (Wired Equivalent Privacy), a legacy wireless security technology that can easily be cracked. NIST released the draft security use case document and is seeking feedback from the public. The drug infusion pump case study is described as the “first of a series” of similar use cases that will focus on medical device security, NIST wrote. The draft document presents a technical description of the security challenges […]
FDA Issues Guidance on Security of Medical Devices
The U.S. Food and Drug Administration (FDA) issued final guidance on Wednesday that are designed to strengthen the safety of medical devices. The FDA called on medical device manufacturers to consider cyber security risks as part of the design and development of devices. The document, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” asks device makers to submit documentation to the FDA about any “risks identified and controls in place to mitigate those risks” in medical devices. The guidance also recommends that manufacturers submit documentation of plans for patching and updating the operating systems and medical software that devices run. The document, which will be released on Thursday, does not contain specific requirements. Rather, it describes the kinds of things that medical device manufacturers should consider when preparing pre-market submissions for medical devices in areas such as information confidentiality, integrity, and availability, the FDA said. The release of the document follows the […]
FDA Seeks Collaboration on Medical Device Security
The U.S. Food and Drug Administration (FDA) on Tuesday put out a call for ideas and input on how best to secure medical devices and the healthcare system from cyber attack. In a federal notice, the FDA announced that it will hold an October workshop entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.” It also solicited input from stakeholders within the government and from the public health sector on medical device and healthcare cyber security. The workshop is scheduled for October 21 and 22 and will run from 9:00 AM to 5:00PM at the National Intellectual Property Rights Coordination Center Auditorium in Arlington, Virginia. [Read more Security Ledger coverage of connected medical devices here.] The Department of Health and Human Services (HHS) is looking for ideas about how best to implement aspects of both Executive Order 13636 for“Improving Critical Infrastructure” and follow-on guidance like the National Institute of Standards and Technology’s (NIST’s) “Framework for Improving […]
