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EU Lags Behind US In Device Cybersecurity Guidance, But Harmonization On Horizon

The US FDA appears to be ahead of the EU in the effort to issue guidelines specific to medical device cybersecurity. But experts say regulators in the EU are likely to eventually harmonize as part of a global effort to address cybersecurity risks.

The US FDA appears to be ahead of the EU in the effort to issue guidelines specific to medical device cybersecurity. But experts say regulators in the EU are likely to eventually harmonize as part of a global effort to address cybersecurity risks.

FDA has been active in the past few years on cybersecurity, finalizing a guidance on premarket requirements for medical device cybersecurity in 2014 and publishing a draft guidance on postmarket...

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