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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). This is a broad category of software and the Guidance sets out that image optimizing means can be medical software.

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European Commission proposes reinforcement of EU Cybersecurity rules

DLA Piper Privacy Matters

Annex II includes entities in the following sectors: energy, transport, banking, financial market infrastructures, health, drinking water supply and distribution and digital infrastructure. A DSP is an information society service that is an online marketplace, an online search engine or a cloud computing service.

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Panasonic to Offer EPEAT® Registered Document Scanners for Businesses

Info Source

The rating differentiates Panasonic’s solutions from others on the market, giving government and commercial customers the option to select high-performance electronics that effectively focus on functionality, features and sustainability without limiting product selection. Used by the U.S. Used by the U.S.

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And then there were five: CCPA amendments pass legislature

Data Protection Report

Changes range from clarifications to definitions and new exemptions to technical corrections. Section (a)(2) is amended to permit the consumer to request that the business notifies a consumer of the categories of personal information sold for “each category of third party”, rather than “each third party.” Medical staff member.

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Proposed Changes to FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: What you Should Know

HL Chronicle of Data Protection

The new draft premarket cybersecurity guidance provides information designed to aid manufacturers in determining how to meet the agency’s expectations during premarket review of medical devices. This is the first time that FDA has been clear as to its expectation that it be created by manufacturers and provided to customers.

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The NewCo-BigCo Shift or, These Nine Things Will Change Business Forever

John Battelle's Searchblog

but NewCos — even the very largest ones like Google — most definitely are. Regardless of good intent or excellent marketing, if your business makes people unhealthy, or depends on exploitation of vulnerable workers, or can be laddered to climate change, it’s at risk of mass consumer migration to businesses with better narratives.

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Supply Chain Security 101: An Expert’s View

Krebs on Security

In the past, it’s been much more lucrative for the attacker to attack the supply chain on the distribution side, to go after targeted machines in targeted markets to lessen the exposure of this activity. It’s a hard problem category. TS: We’re definitely going through this now in thinking about the election devices.

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