FDA AI Enforcement: Proteus Digital Health’s Backdoor Blunder
A patient monitor with a backdoor isn’t some abstract AI product question. It’s a device oversight failure, the kind of case that defines the entire…
Bias Auditing: From AI Aspiration to Operational Imperative
The talk around AI in healthcare is all about revolutionizing diagnostics, personalizing treatment, and making things more efficient. For those of us on health equity…
AI Chat & PHI: Navigating HIPAA for Cardiac AI Investors
When an AI chatbot talks to a patient about their health, the game changes the instant personal health information (PHI) gets mentioned. For the compliance…
HIPAA 3.7 & Hello Heart: De-risking Cardiac AI for Investors
HIPAA compliance is always a moving target, and if you’re running a distributed care program with AI, keeping up with the changes is foundational to…
23andMe’s Data Readiness: A Billion-Dollar Imperative for AI Scale
The Unmoved Data Readiness Baseline Back in 2022, Innovaccer published research that put a number on what we all knew: chronic data readiness issues were…
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…
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…
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…