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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 […]

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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 […]

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Uncle Sam Makes Mobile, Medical Device Security a Priority in 2014

The U.S. Department of Health and Human Services (HHS) says that it will make the security of mobile devices containing personal health information and networked medical devices areas of intense scrutiny in 2014.   The security of a wide range of devices, from laptops and USB ‘jump drives’ to networked medical devices like dialysis machines and medication dispensing systems will be under review, according to a 2014 Work Plan issued by HHS’s Office of the Inspector General (OIG). (PDF) Among other projects, the  OIG will review hospitals’ plans to protect the loss of protected health information (PHI), as well as similar plans put in place by Medicare and Medicaid contractors in the next year.  OIG will also scrutinize security controls at hospitals that protect networked medical devices. OIG wants to determine if the controls in place are adequate to secure electronic protected health information stored on medical devices. Links between networked […]

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FDA Will Regulate Some Apps As Medical Devices

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 […]

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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 […]

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