Articles about Regulation

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FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device

Quandary Peak’s review of FDA’s final guidance leads us to believe we could see meaningful expansion of the amount of CDSS qualifying as a medical device, which could subject many current and future CDS software applications to FDA oversight.

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An Overview of the Three Google Antitrust Lawsuits

Google is the subject of not one, not two, but three antitrust lawsuits as part of a broader reckoning of technology companies’ power to shape the modern world.

A Closer Look at California’s Data Privacy Law

The notion that data is the property of consumers—and not businesses that collect it—is a relatively new (but impactful) premise. Until national legislation is introduced, California’s CCPA looks to be the standard-setter across the US for the time being.

ACLU vs. Government: Should There Be Rules Governing Hacking?

The ACLU lawsuit claims that what little information exists has been confined to “scattered news accounts”; what they do know is described as “very troubling.”

California’s Sweeping New Privacy Laws

California’s new privacy legislation may not be as comprehensive as its European counterpart, but it’s an important victory for American privacy advocates.