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How the #FDA #Pushes #Medical Device #Cybersecurity

Source: National Cyber Security – Produced By Gregory Evans

How the #FDA #Pushes #Medical Device #Cybersecurity

A phony myth might be fun on Halloween, but spooky is no good in the medical device industry. Still, quite a few legends surrounding the FDA’s role in promoting the cybersecurity of medical devices have bounced around the healthcare-technology sphere. Today, a higher-up in the agency made clear what exactly the regulator does to encourage strong digital defenses—and why that goal is crucial.

Suzanne B. Schwartz, MD, MBA, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health, wrote a blog post championing a thorough approach to device security, from a project’s early days to long after it enters the market.

“With so many devices dependent on software and internet access today, having a plan in place to address cybersecurity risks is as essential to the device development process as coming up with a novel new product,” Schwartz wrote. “Working with the medical device industry and other federal agencies, FDA will continue its work to ensure the safety and effectiveness of medical devices at all stages of their lifecycles against potential cyber threats.”

For one, the regulator has published guidances encouraging device manufacturers to track cybersecurity risks throughout a product’s life, she noted. The agency “incentivizes industry” to update marketed and distributed devices to reduce cyberattack risks, she said.

The recommendations are meant to help companies navigate the complex nature of “critical safety systems,” requiring a “collaborative approach to finding solutions,” Schwartz wrote.

Released in late 2016, the guidance for post-market management is a 30-page document that lists specific vulnerabilities that companies should test, how they should go about doing that, threat reporting recommendations, and more. For instance, the document notes that changes to a medical device made solely to boost security—like a patch—are considered enhancements and don’t need to be reported.

The FDA also aims to work with manufacturers and the public to dispel myths. Some common bogus claims?
The FDA is the only federal body responsible for medical device cybersecurity. (It’s not.)
Cybersecurity for medical devices is optional. (Federal regulations require risks to be addressed.)
Medical manufacturers can’t update devices for security. (They always can.)
Healthcare organizations can’t patch devices to beef up their cyber defenses. (The FDA recommends they “work closely” with manufacturers.)
The FDA validates security software changes. (That’s up to the manufacturer.)
The FDA tests the cybersecurity of medical devices. (Again, that task falls on the company.)
Developers of off-the-shelf software used in medical devices must ensure the code is secure for healthcare uses. (Yet another responsibility of the device maker.)
The regulator considers cybersecurity efforts in this area important not just due to the potential loss or theft of patient medical data, but also because the health implications, Schwartz wrote. “A breach that potentially impacts the safety and effectiveness of a medical device can threaten the health and safety of an individual or patients using the device,” she explained.

She pointed to cyberattacks, like WannaCry and Petya, which have exposed vulnerabilities in healthcare across the globe in 2017. If healthcare is to stay on top of these “constant” threats, hospitals, device makers, and other organizations must team up, Schwartz wrote.

The post How the #FDA #Pushes #Medical Device #Cybersecurity appeared first on National Cyber Security Ventures.

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How healthcare providers can curb medical identity theft

Source: National Cyber Security – Produced By Gregory Evans

Medical records are valued at 20 to 50 times more than financial identities on the black market. Medical identity theft is on the rise. Medical records are a hot target for hackers because, according to the FBI, medical identities are valued at 20 to 50 times more than financial identities…

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Siemens to update medical scanner software amid Homeland Security warning machines could be hacked

Source: National Cyber Security – Produced By Gregory Evans

German industrial group Siemens expects to update software in some of its medical scanners by the end of the month to deal with vulnerabilities that could, in theory, allow some of this equipment to be hacked, a company spokesman said on Monday. Last week, the U.S. Department of Homeland Security…

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CYBERSECURITY BILL TAKES AIM AT VULNERABILITIES IN MEDICAL DEVICES

Source: National Cyber Security – Produced By Gregory Evans

On July 27, U.S. Senator Richard Blumenthal (D-CT) introduced the Medical Device Cybersecurity Act of 2017, a bill that CHIME supports. The legislation, S.1656, would make the cybersecurity capabilities of medical devices more transparent to providers, clarifies expectations concerning security enhancements and maintenance of medical devices and establishes a cybersecurity…

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Stolen medical records uncovered in identity theft scheme

Source: National Cyber Security – Produced By Gregory Evans

MARIETTA, Okla. (KXII)– Authorities confirmed Thursday that medical records were stolen in addition to mail, in two identity theft arrests made last month. “We’ve been violated as a hospital, the community’s been violated, and we suffered the theft of some records that was inappropriate, and will not happen again.” Mercy…

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UA grads battle medical hacking

Source: National Cyber Security – Produced By Gregory Evans

TUCSON (KGUN9-TV) – Two University of Arizona grads are working to educate healthcare providers to stop hackers from taking control of medical devices in peoples’ bodies. Dr. Christian Dameff and Dr. Jeff Tully recently participated in the first CyberMed Summit, which simulated what would happen if a hospital or a…

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Mother accused of trying to smother child has medical background

To Purchase This Product/Services, Go To The Store Link Above Or Go To http://www.become007.com/store/ CHARLOTTE, N.C. – A mother who is accused of trying to smother her 1-year-old son with her hands and a pillow while at Levine Children’s Hospital made her first appearance in …

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NEET: Medical entrance server was hacked, two held, say cops

To Purchase This Product/Services, Go To The Store Link Above Or Go To http://www.become007.com/store/ Source: National Cyber Security – Produced By Gregory Evans With the arrest of two people, Delhi Police have cracked a case wherein computer servers were allegedly hacked during the National Eligibility …

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FDA threatens action against medical device-maker over poor cybersecurity

Source: National Cyber Security – Produced By Gregory Evans

The Food and Drug Administration (FDA) is threatening action if Abbott Labs fails to address safety and security issues in certain medical devices. The company recently purchased St. Jude Medical, which makes implanted cardiac devices that have been the subject …

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Montefiore Medical Center identity theft ringleader pleads guilty

Source: National Cyber Security – Produced By Gregory Evans

Your ads will be inserted here byEasy Plugin for AdSense.Please go to the plugin admin page toPaste your ad code OR Suppress this ad slot. The head of an identity theft ring that used information stolen from 12,000 Montefiore Medical Center patients pleaded guilty to the scam Monday. Fernando Salazar, 28, the crew’s ringleader, admitted […]

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