Post Tagged with: "medical devices"

Wireless Infusion Pump is Test Case for Securing Medical Devices

December 29, 2014 11:210 comments
A NIST document provides a test case for securing connected medical devices, starting with wireless infusion pumps.

A National Institute of Standards and Technology (NIST) reference document is providing some of the clearest guidance from the U.S. government for securing connected medical devices, but may be setting too low a bar for securing wireless communications, according to a security expert. NIST, working with the University of Minnesota’s Technological Leadership Institute, released a draft Use Case document  (PDF) on December 18 to help health care providers “secure their medical devices on an enterprise networks.” However, in the area of communications security, the document suggests the use of WEP (Wired Equivalent Privacy), a legacy wireless security technology that can easily be cracked. NIST released the draft security use case document and is seeking feedback from the public. The drug infusion pump case study is described as the “first of a series” of similar use cases that will focus on medical device security, NIST wrote. The draft document presents a technical description of the security challenges […]

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FDA Issues Guidance on Security of Medical Devices

October 1, 2014 20:55Comments Off
The FDA issued guidance for manufacturers to address cyber security issues in the design of connected 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

September 24, 2014 11:38Comments Off
The FDA is calling for private and public sector collaboration to address 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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Apple’s Platform for Wellness Arrives | Life as a Healthcare CIO

September 10, 2014 11:51Comments Off
Wearables like Apple's new watch will combine with health middleware to expand the market for connected health products, says one prominent 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 […]

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Home Depot Acknowledges Breach of Payment Systems

September 8, 2014 19:05Comments Off
Home Depot issued a statement Monday acknowledging a hack of its payment systems. The breach dates to April, 2014, and affects stores in the US and Canada, Home Depot said.

Almost a week after public reports named Home Depot as a possible victim of a sophisticated cyber attack, the home improvement giant has acknowledged that it was hacked.   In a statement on Monday, Home Depot said that an internal investigation confirmed a “breach of our payment data systems” took place. The breach affects the company’s U.S. and Canadian stores, though not its Mexican locations or online transactions, the company said. The incident also appears to have been long-lived. Home Depot estimates that the breach dates to April, 2014. The company did not say when it was finally shut down – though that date could be as late as July. Home Depot has been investigating the incident since it was first disclosed by Brian Krebs at the blog Krebsonsecurity. Krebs was alerted to the incident after large quantities of stolen credit cards began appearing on cyber criminal forums. Sources at […]

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