Optum-Illumina: Data Safety by Design in Genomic Expansion
Payer-funded whole genome sequencing is expanding, which sounds great for diagnosing rare diseases, but it’s blowing up the question of who actually holds on to…
23andMe Breach: The Cost of Genetic Insight and Trust
When a company like 23andMe uses its giant customer genetic database to find a major inherited lung cancer risk, the scientific achievement is obvious. But…
Pear’s Ghost: Click’s Schizophrenia Data Under Investor Scrutiny
The healthcare AI field is a minefield, where a great clinical story often runs straight into a wall of commercial reality. If you’re a health…
Breach Timelines: The True Cost of Health Data Stewardship
The time between a health data incident and its public disclosure is a critical measure of an organization’s stewardship. For privacy counsel and health data…
Post-Clearance Reality: What AI Medical Devices Owe Investors
Getting an AI medical device from concept to a tool doctors actually use is a slog, and that’s true even for the ones that clear…
Cardiac AI: Who Owns Post-Clearance Evidence?
Putting AI into cardiac care is a double-edged sword. The promise is incredible, but the responsibility we take on is just as big. Unlike a…
23andMe Proves: Genetic Data Custody is Your AI’s First Breach Point
How you choose to hold sensitive health data will absolutely dictate the severity of a breach, long before any notification letters get drafted. For anyone…
Why Cleared AI’s “Accuracy” Can Be a Billion Dollar Blind Spot
When an algorithm gets regulatory clearance, people tend to assume its advertised accuracy will just show up in clinical practice. This leap of faith completely…
Regulators’ Enforcement: The New AI Safety Standard
The world of AI in healthcare moves so fast that regulations can’t keep up. For compliance officers and people running telehealth platforms, this creates a…
FDA Clearance: What It Really Means for Cardiac AI Investors
Getting an AI-powered medical device through a regulatory body like the U.S. Food and Drug Administration (FDA) is always treated like the finish line. But…