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.
Medicine
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 […]
Apple’s Platform for Wellness Arrives | Life as a Healthcare CIO
John Halamka, the CIO of Beth Israel Deaconness Medical Center in Boston has an interesting post on his blog about Apple’s big unveiling yesterday and its implications for connected health applications. With the image of naked Jennifer Lawrence still fresh in our minds, Halamka points out that Apple is taking steps to make sure no such slip-ups happen in the context of protected health information – a promising new market for wearable technology. As Halamka sees it, we’re on the cusp of revolution that will see the consumerization of what he calls “healthcare middleware.” That refers to software and services, like Apple’s recently announced HealthKit, that aggregates data about your body from multiple sensors in your clothing, your body and environment. Unlike the nude selfies that recently made the rounds online, however, health data is protected by Federal legislation – HIPAA. For that reason, Apple keeps that data local to the mobile […]
FDA: Regulators Can’t Scale To Police Mobile Health Apps
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 […]
