Senators push for more frequent medical device cybersecurity guidance from FDA

Cybersecurity threats against health care have skyrocketed in recent years.

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The health data transparency movement is birthing a new generation of startups

The recent movement toward data transparency is birthing a new generation of innovation and startups that could ultimately make healthcare better and more transparent for all of us. Continue reading The health data transparency movement is birthing a new generation of startups

Security ills of health care sector draw senator’s attention

A vocal senator on U.S. cybersecurity matters wrote on Monday to four government agencies, seeking more information about how they are working to mitigate cyber risk in the health care sector. Sen. Mark Warner, D-Va., asked the agencies how they were working to resolve apparent security vulnerabilities and urged them to provide strategic recommendations on how to fend off attacks in the medical sector. Warner’s office wrote to the Food and Drug Administration, the Department of Health and Human Services, the Centers for Medicare and Medicaid Services and National Institute of Standards and Technology. The letter comes amid ongoing scrutiny over an apparent lack of security at many health care organizations. Hackers have haunted the industry for years, leveraging medical devices to steal valuable personal information or launch highly publicized ransomware attacks. The senator last week asked a number of health care organizations how the federal government can more effectively help rectify […]

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Lawmakers want to know how to mitigate cyber risk in medical devices

House lawmakers are calling on stakeholders in the health care industry for tips on how to secure old technology in the medical field. The Committee on Energy and Commerce put out a request for information Friday detailing its concern that outdated equipment and software used in hospitals and other medical organizations pose cybersecurity vulnerabilities that can put patients at risk. “While health care cybersecurity is a complex, nuanced challenge with many different contributing factors, the use of legacy technologies, which are typically more insecure than their modern counterparts, continues to be a root cause of many incidents,” the committee wrote. Fueling the committee’s concern is the WannaCry ransomware attack that paralyzed operations at numerous hospitals and health organizations around the world. The May 2017 attack, which has been widely attributed to North Korea, exploited unpatched versions of Microsoft Windows. In some cases, the machines were being used to run medical devices, such as MRI scanners and […]

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Lawmaker to HHS: Label software in medical devices

The Trump administration should convene a national effort in partnership with the private sector to ensure that the owners and operators of medical devices, hospital IT networks and electronic health records systems can find out what software and other components are in the products they buy, says the chairman of the powerful House Energy and Commerce Committee. In a letter Thursday to acting Health and Human Services Secretary Eric Hargen, committee Chairman Greg Walden, R-Ore., notes a congressionally chartered task force on health care cybersecurity earlier this year recommended such transparency requirements. The congressional report said there should be a “Bill of Materials” (BOM) for medical products because hospital IT managers and network administrators “must first understand what they have on their systems, before they can determine whether these technologies are impacted by a given threat or vulnerability.” “We write today to request that [HHS] convene a sector-wide effort to develop a plan of action for creating, deploying and leveraging BOMs […]

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FDA Demands St. Jude Take Action on Medical Device Security

The FDA sent Abbott Laboratories a warning letter citing that it had inadequately addressed the security of the maligned Merlin@home Transmitter. Continue reading FDA Demands St. Jude Take Action on Medical Device Security

St. Jude Medical Patches Vulnerable Cardiac Devices

St. Jude Medical patched the Merlin@home Transmitter, addressing flaws made public last year in a controversial disclosure by MedSec Holdings and Muddy Waters. Continue reading St. Jude Medical Patches Vulnerable Cardiac Devices

St. Jude Medical Patches Vulnerable Cardiac Devices

St. Jude Medical patched the Merlin@home Transmitter, addressing flaws made public last year in a controversial disclosure by MedSec Holdings and Muddy Waters. Continue reading St. Jude Medical Patches Vulnerable Cardiac Devices