Sep 3, 2019
Europe
The Federal Institute for Drugs and Medical Devices (BfArM), a special medical device regulating agency in Germany, issued warning on vulnerabilities detected in one of the most widely used operating systems for medical devices. Medical Device Cybersecurity Issue...
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Jun 28, 2019
North America
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to cybersecurity threats. In accordance with applicable...
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Jun 26, 2019
North America
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA published a draft guidance about cybersecurity and it...
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Mar 28, 2019
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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Jul 12, 2016
North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
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