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European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations

Data Matters

The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification). 6, 2 most software devices are classified as low risk. Key Points to Highlight. No change in qualification.

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China’s First Data Protection Measures Lifting Its Veils

HL Chronicle of Data Protection

The draft Data Security Measures appear to mainly target the data processing activities of “network operators,” which under these draft measures has the same definition as is used in the Cyber Security Law , namely, including the owner or administrator of a network or a network service provider. credit information companies).

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Regulatory Update: NAIC Summer 2018 National Meeting

Data Matters

While it has been determined that the GCC will utilize a risk-based capital (RBC) aggregation approach in order to leverage existing legal capital requirements, it is not clear which entities within any group will be subject to the GCC or how the GCC will apply to those entities within a group that do not have existing capital requirements.

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NIST Cybersecurity Framework: IoT and PKI Security

Thales Cloud Protection & Licensing

In order to talk about any specialized field of knowledge, you need a common language with agreed upon terms, definitions and some level of accepted industry standards. The proliferation of connected devices offers enormous business benefit, across industries as diverse as manufacturing, healthcare and automotive.

IoT 97