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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. No clarification on “placing on the market.”

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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. Cybersecurity risk management and reporting obligations. social networking services platforms.

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The Week in Cyber Security and Data Privacy: 11 – 18 December 2023

IT Governance

We’re also introducing two new categories this week: ‘AI’ and ‘Key dates’. Only 4 definitely haven’t had data breached. GB Coca-Cola Singapore Source (New) Manufacturing Singapore Yes 413.92 GB Coca-Cola Singapore Source (New) Manufacturing Singapore Yes 413.92 Source (New) Manufacturing USA Yes 171.54

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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. Risk-based design, validation, and the CBOM. the significance of the new HDO playbook.

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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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Supply Chain Security 101: An Expert’s View

Krebs on Security

TS: The government still has regular meetings on supply chain risk management, but there are no easy answers to this problem. The attacker in this case has a risk model, too. The attacker in this case has a risk model, too. Yes, he could put something in the circuitry or design, but his risk of exposure also goes up.

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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.