Hacking Threat Merits Closer Look, Industry Acknowledges
This article was originally published in The Gray Sheet
Executive SummaryMedical device makers, software engineers and mobile application developers must do a better job building data security into their products, according to several speakers appearing at a recent FDA public meeting on mobile medical technology.
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Chinese hackers recently broke into Community Health Systems’ IT system and stole patient data. Although they did not take device data in this instance, the hackers might have been after that, experts suggest, highlighting vulnerabilities for industry.
The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.
Tighter standards are needed to guard against wireless attacks of implantable or body-worn medical devices, but the attack risk should be weighed against potential adverse effects that may arise from security measures meant to address them, according to the Government Accountability Office.