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EU Court of Justice rules indiscriminate data retention illegal

JURIST

The European Court of Justice (ECJ) Tuesday ruled that Germany’s data retention statute is not compatible with EU law. The TGK law imposed an obligation on telecom operators to retain customers’ traffic data for 10 weeks and location data for four weeks. .”

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Google, Apple Beat Video Data Retention Fight At 9th Circ.

Law 360

The Ninth Circuit refused Wednesday to revive allegations that Google and Apple violated state privacy laws in New York and Minnesota by retaining data about consumers' streaming video rentals, finding that the state statutes don't create a private right of action for the purported data-retention violations.

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Fraud-on-the-FDA As A Basis for A False Claims Act Lawsuit: Is It Dead Or Just Resting?

FDA Law Blog

established by statute and case law. The increased number of reports would likely swamp FDA’s data systems, creating even more signal to noise than already exists. This fraudulent inducement theory is well?established Note the vagueness of the regulatory standard in the first place.

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP.

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Get Ready for the Investigators

InHouseOps

We only share information with internal authorization as our investigations are confidential under our governing statute,” said a securities regulator in North America. “We The definitions ranged from better data mapping and improved remote access to increased automation and effective data management.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

The statute achieves this through disclosure of information by the software manufacturer about the “basis for” the recommendations made by the software. FDA’s novel reading of Criterion 3 may dramatically affect the regulatory status of CDS software that includes risk probabilities or risk scores as outputs.