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FDA Issues Guidance on Security of Medical Devices

October 1, 2014 Paul Roberts

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

September 24, 2014 Paul Roberts

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: Community Health Hack Linked To Heartbleed OpenSSL Hole

August 20, 2014 Paul Roberts

The security firm TrustedSec said in a blog post on Tuesday that a recent hack of the healthcare network Community Health Services was the result of an attack on the so-called “Heartbleed” vulnerability in OpenSSL. According to TrustedSec, attackers targeted vulnerable VPN (virtual private network) software from Juniper networks in a breach that affected an estimated 4.5 million patients. TrustedSec cited a “trusted and anonymous source close to the CHS investigation” in its blog post. It said attackers were able to glean user credentials from memory on a CHS Juniper device by exploiting the Heartbleed vulnerability. Those credentials were used to login via the VPN to CHS’s network, then move laterally to the servers containing the patient data. [Read more Security Ledger coverage of the Heartbleed vulnerability here.] A separate report by Bloomberg attributed the attack to hackers in China, though it did not provide any evidence linking the attackers to a specific Chinese […]

Report: Hospital network hacked, 4.5 million records stolen

August 19, 2014 Paul Roberts

News today that Community Health Systems, a national hospital network that operates 206 hospitals across the United States, was the victim of a cyber attack that resulted in the theft of 4.5 million patients. According to CNN Money, hackers gained access to patient names, Social Security numbers, physical addresses, birthdays and telephone numbers. The breach affects anyone who received treatment from a physician’s office tied to a Community Health Systems network-owned hospital in the last five years. The FBI is investigating the breach. Community Health Systems’ hospitals operate in 28 states but have their most significant presence in Alabama, Florida, Mississippi, Oklahoma, Pennsylvania, Tennessee and Texas. Help Net Security has a panel of experts comment. The consensus is that the healthcare sector is more in the cross hairs for sophisticated attacks that are intended to steal personal information that can be used for identity theft scams. Read more over at CNN Money: Hospital network hacked, 4.5 million […]

FDA: Regulators Can’t Scale To Police Mobile Health Apps

July 2, 2014 Paul Roberts

A senior advisor to the U.S. Food and Drug Administration (FDA) tossed cold water on speculation that the Agency might try to police mobile health and wellness applications, saying the FDA couldn’t possibly scale up to meet the challenge of policing the hundreds of new apps appearing every month. Correction: The article was changed to clarify Mr. Patel’s comments. He was not responding to a direct question about the FDA setting up an office to regulate mobile health applications. He was commenting on the possibility of creating a platform to evaluate and rate mobile health applications. Also, he said “It’s not do-able,” not “it’s not possible.” We apologize for any confusion created by the article. – PFR July 10, 2014. The sheer pace of innovation in the mobile health application space and the numbers of such applications already available on mobile marketplaces like the iTunes App Store and Google Play mean that many mobile health applications will escape scrutiny by federal […]