regulation | HiTech Service

A brass stamp and a broken wax seal resting on printed legal paper on top of a rack-mounted server

Your Infrastructure Choice Is a Governance Decision Now

Terraform, Redis, LibreOffice and a 3D printer company: four license disputes between 2023 and 2026, one mechanism. Picking a dependency now means betting on who owns it - and what to check before it is expensive to remove.

On September 21, 2026
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Technical schematic of a medical instrument in which one internal component is an opaque black sphere the callout lines never reach

When the Model Is the Vendor: What Happens to Compliance When You Don’t Own the Weights

The FDA cleared its first LLM-based device in December 2025 and the public record does not say which model it runs. Every regulated-software regime assumes you can describe, pin and reproduce what you shipped — a manufacturer building on someone else's foundation model can do none of the three reliably.

On September 3, 2026
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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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Two wax certification seals beside two unsealed scrolls, illustrating that only SOC 2 and ISO 27001 produce an artifact while GDPR and HIPAA do not

Compliant With What? A Working Map of GDPR, HIPAA, SOC 2 and ISO 27001

Two of the four are laws you can only be found in violation of; two are attestations you can buy. A practical map of what each framework actually asks, where the control sets genuinely overlap, and why the published overlap figures range from 43% to 85%.

On August 2, 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 dominant teal radiology pie slice with an X-ray icon, next to smaller but rapidly growing slices for cardiology, neurology, and pathology with upward arrows

FDA’s AI Medical Device Approvals Aren’t Just Growing — They’re Finally Breaking Out of Radiology

Six AI medical devices got FDA clearance in 2015. Two hundred ninety-five got cleared in 2025. But the real story in the 2026 numbers isn't the growth rate — it's that radiology, which has dominated for a decade, is finally losing share.

On May 31, 2026
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A wearable smartwatch crossing a glowing dividing line on the ground, from a red regulated medical zone to a teal open wellness zone

FDA Just Redrew the Line for What Counts as a Medical Device — and a Lot of AI Health Products Just Landed on the Free Side

A blood glucose wearable can now be marketed as a general wellness product instead of a regulated medical device — the FDA's January 2026 guidance moves the line for AI health software further than most coverage let on.

On May 24, 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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Category: regulation