In an important move, the U.S. Food And Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on devices like the iPhone and Android mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices.* The statement is the final word from the FDA on the approach it will take when enforcing federal regulations regarding the safety of medical devices to the large and fast-growing category of medical applications. The agency said on Monday that, while it doesn’t see the need to vet “the majority of mobile apps,” because they pose “minimal risk to consumers,” it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed “using the same […]
DHS
Emergency Alert System: Vulnerable Systems Double, Despite Zombie Hoax
You’d think that the prospect of a zombie invasion would prompt our nation’s broadcasters and others who participate in the Emergency Alert System (EAS). Just the opposite is true. Months after a bogus EAS message warning about a zombie uprising startled residents in Michigan, Montana and New Mexico, the number of vulnerable EAS devices accessible from the Internet has increased, rather than decreased, according to data from the security firm IOActive. In a blog post Thursday, Mike Davis, principal research scientist at IOActive said that a scan of the public Internet for systems running versions of the Monroe Electronics software found almost double the number of vulnerable systems in July – 412 – as were found in April, when an IOActive scan of the public Internet using the Shodan search engine found only 222 vulnerable systems. IOActive first notified Monroe Electronics about vulnerabilities in its DASDECS product in January of […]
Homeland Security: Hack Attempts On Energy, Manufacturing Way Up in 2013
Attempted cyber attacks on critical infrastructure in the U.S., including energy and critical manufacturing jumped sharply in the first half of 2013, according to a just-released report from the Department of Homeland Security’s Industrial Control System Cyber Emergency Response Team (ICS-CERT). ICS-CERT said that cyber incidents across all critical infrastructure in the U.S. are on pace to double in 2013. The agency has responded to 200 such incidents so far in fiscal year 2013 (October of 2012 to May of 2013), compared to 198 incidents for all of fiscal year 2012. A majority of those incidents – 53% – were against organizations in the energy sector, ICS-CERT reported. The report is just the latest from DHS about threats to the energy sector. The agency warned energy firms after seeing a sharp jump in attacks during 2012, when attacks on energy firms accounted for around 40% of the malicious activity directed […]
FDA: Medical Device Makers, Hospitals Need To Boost Cyber Security
The U.S. Food and Drug Administration (FDA) has issued guidance to medical device makers and hospitals that use their products to pay more attention to cyber security and the potential for cyber attacks on vulnerable medical instruments. The FDA released its “Safety Communication for Cybersecurity for Medical Devices and Hospital Networks” on Thursday – the same day that the Department of Homeland Security’s ICS (Industrial Control System) CERT issued a warning about the discovery of hard coded “back door” passwords in some 300 medical devices from 40 separate vendors, including drug infusion pumps, ventilators and patient monitoring systems. The FDA said it expects device makers to “review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device. Hospitals were instructed to harden […]
Homeland Security Warns Of Expanding Medical Device Attacks
A bulletin published by the Department of Homeland Security has warned that the increasing use of wireless networking technology to enable medical devices expands the ways that those devices could be hacked. The bulletin, published May 4 by DHS’ National Cybersecurity and Communications Integration Center, warns that advances in medical devices, including Internet connectivity and the use of smartphones, tablets and other mobile devices in patient care “expands the attack surface” of medical devices. “Smartphones and tablets are mini computers with instant access to the internet or linked directly to a hospital’s network. The device or the network could be infected with malware designed to steal medical information if not upgraded with the latest anti-virus and spy-ware software,” DHS said. Advances in medical device technology have already greatly improved medical care, especially in areas like medical health records and remote monitoring of patients with implantable medical devices. However, too little […]
