regulation | HiTech Service

A medical imaging machine dissolving from left to right into geometric data blocks, illustrating hardware becoming software

How Software Became a Medical Device

The Therac-25 reached the US market in 1983 by declaring itself equivalent to something already on sale. Forty years later, 97% of AI-enabled medical devices get there the same way. How the category was assembled backwards, one definitional crisis at a time.

On August 5, 2026
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An abstract glowing AI network hand offering a golden percentage pie-slice icon toward a distant classical government building

OpenAI Wants to Give the US Government a 5% Stake. The Pitch Compares It to Alaska’s Oil Fund — But AI Isn’t Oil.

A 5% stake in OpenAI would be worth $42.6 billion. Sam Altman is framing it as a sovereign-wealth-fund model borrowed from Alaska's oil dividend — but the analogy breaks down exactly where it matters most.

On June 15, 2026
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A magnifying glass with an EU-star pattern inspecting a grid of data-block icons, with a few blocks highlighted in gold

GDPR Regulators Just Finished Grading Europe on ‘The Right to Be Forgotten.’ Now They’re Grading Honesty.

The EDPB just closed the book on a year-long investigation into how companies handle deletion requests — and immediately opened a new one into whether companies are honest about what they collect in the first place.

On May 9, 2026
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Illustration of a clock and hourglass made of circuit-board patterns in EU flag blue and gold, symbolizing the delayed EU AI Act high-risk compliance deadline

The EU Just Gave AI Companies 16 More Months — Here’s What the AI Act Delay Actually Changes

The EU just pushed its AI Act's high-risk compliance deadline from August 2026 to December 2027 — but GDPR penalties for the same systems never moved, and that gap is where the real risk now sits.

On May 1, 2026
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