Is Enough Being Done About Cybersecurity In The EU? Contradictory Views Raise Regulatory Questions
A recent report from the UK Royal Academy of Engineering suggests that more efforts are needed to ensure cybersecurity protections for medical devices. But a key European industry trade association says that cybersecurity is adequately addressed from a regulatory standpoint in the EU.
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An expert from the European Union Agency for Cybersecurity (ENISA) has told Medtech Insight that although the new EU Medical Device and IVD Regulations will push developers to make more secure products, regulation is not enough to prevent cyberattacks on devices and digital health systems.
The medtech cybersecurity group MDISS says it will adopt the ISA/IEC 62443 cybersecurity standard that has been widely used in an array of industries for the medical device industry. This comes following news from the European medtech group COCIR that it was also considering adopting the standard.
Medtech and biopharma are among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.