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 […]
Privacy
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 […]
Report: Home Depot Fallout Reveals History of Lax Security, Hiring
Its a truism in cyber security that behind every great hack often lies a string of bad decisions and missed opportunities. Its also true that when you dig into the details of damaging cyber incidents, the root causes are personal and psychological as often as they are technical in nature. Organizations -even sophisticated and wealthy organizations – end up making bad decisions for all the wrong reason: failing to properly assess their risk, or pursuing short term savings when long term investment is needed. Home Depot learned via law enforcement that a breach of transaction data exposed as many as 52 million credit card transactions, the largest retail credit card breach to date. But as more comes out about the breach at home improvement giant Home Depot, it starts to look a lot more like the root causes there may have started in the HR department rather than the data center. The […]
The Key to Security in the Internet of Things – IEEE Spectrum
IEEE Spectrum has an article that provides a nice overview of security and privacy issues on the Internet of Things. The article by Mark Anderson highlights a number of the issues that have cropped up on these pages as well, namely: the rush to market in the consumer IoT space (much of it driven by crowd funding sites like IndieGoGo and Kickstarter) the lack of a strong business case for (consumer) manufacturers to build security into IoT products the tendency of large manufacturers to pursue siloed security standards that thwart efforts to build devices interconnect with other IoT infrastructure (other devices, routers, etc.) So far efforts to coordinate IoT development around a single platform or set of standards have been reduced to predictable turf battles: Google’s Thread versus multi-vendor efforts like TheAllSeen Alliance, The Open Interconnect Consortium, The Industrial Internet Consortium versus Apple HomeKit and HealthKit and others. In the […]
Consumers Embrace IoT And Wearables, Worry About Security Consequences
A new survey of consumer attitudes and expectations about technology finds that a strong majority of Americans expect wearable technology and biometric security to be common within the next decade. The survey, sponsored by the security company McAfee, asked 1,500 U.S. consumers about lifestyle and technology trends in the home and workplace. The results suggest that consumers are already adjusting their expectations about the future to include pervasive connectivity, a wealth of intelligent devices – and some of the problems that come with both. More than 60% of those surveyed by McAfee said they anticipate having connected appliances like refrigerators that will “automatically add food to a running grocery list if the product is running low.” A strong majority of those polled – 84% – said they were convinced their home security systems will be connected to their mobile device. “As technology, especially the Internet of Things, continues to rapidly advance and […]