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…
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…
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…
The collapse of Babylon Health in 2023, once valued at $4.2 billion, with its UK assets eventually sold for £500,000, serves as a stark reminder…
The promise of artificial intelligence in healthcare is vast, yet the chasm between general-purpose AI and clinically validated solutions remains dangerously wide. A critical incident,…
The healthcare artificial intelligence landscape, brimming with promise and investment, has also become a graveyard for ventures that prioritized hype over evidence. The cautionary tales…
The narrative of AI in healthcare is often painted with broad strokes of transformative potential, yet the critical examination of clinical evidence frequently lags behind…
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…
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…
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…
We’re all chasing the promise of autonomous AI in our revenue cycles, especially with the constant coder shortages and relentless pressure to improve financial performance.…
The hype around AI in healthcare is deafening, particularly when a major platform gives a new tool a megaphone. But for the leaders actually trying…
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…
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…
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…
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…
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…
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…
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…
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…
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…