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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). No clarification on “placing on the market.” This could have a significant impact for many software manufacturers.

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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

Department of Labor’s regulations expanding the definition of the term “fiduciary” (Fiduciary Rule), the Annuity Suitability (A) Working Group (ASWG) is proceeding with developing proposed amendments to the NAIC’s Suitability in Annuity Transactions Model Regulation (SAT). and the EU in September 2017. territory (i.e.,