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U.S. Commerce Department Issues Interim Regulations Establishing Review Process for Information and Communications Technology and Services Supply Chains

Data Matters

The new review mechanism focuses on transactions involving any acquisition, importation, transfer, installation, dealing in, or use of ICTS that has been designed, developed, manufactured, or supplied by parties owned by, controlled by, or subject to the jurisdiction or direction of “foreign adversaries.”. The definition is very broad.

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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.

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CCPA: “Attorney General Amendment” Likely Dead

Data Protection Report

561, the “Attorney General amendment” to the California Consumer Privacy Act (“CCPA”). It would have deleted the 30-day cure period that enables a company to remedy an issue prior to Attorney General enforcement. It would have changed a provision relating to Attorney General opinions. 10-word summary. 5/8 – vote to pass.

Retail 40
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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. Department of Homeland Security (DHS) earlier this month. Consistent with the U.S.

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What Is an Insider Threat? Definition, Types, and Examples

IT Governance

Insider threats fall into two categories: malicious or negligent. As with crime generally, the two biggest obstacles that prevent people from doing this are their moral compass and their fear of being caught. The risks presented by negligent insiders are, by definition, harder to define. Examples of insider threats 1.

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Nevada, New York and other states follow California’s CCPA

Data Protection Report

Although the concept of providing consumers certain privacy rights is similar, the law has some significant differences from the CCPA, including the definition of “sale”. Excludes “employees” from definition of “consumer”. Expands definition of “de-identified” data, narrows definition of “personal information”.

Sales 40
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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.”

B2B 40