The AI Image Company Plans a Consumer Rollout, With No FDA Clearance Yet
Midjourney, the company best known for generating images from text prompts, has announced its first hardware product: a full-body ultrasound scanner that it plans to deploy in consumer spas.
Health-ISAC pulled quote:
“Innovation in healthcare comes from the most unusual places,” said Phil Englert, vice president of medical device security at Health-ISAC, who nonetheless raised potential data security concerns.
The roughly 800 terabytes a single full-body ultrasound study can produce is about three times what a midsize hospital generates in a day. Because the device is built from thousands of elements that each emit and receive sound, Englert said every element adds to the attack surface. A threat model would have to account for whether the transducers could be manipulated during a scan.
Englert said the spa setting doesn’t relax the device’s affects or regulatory obligations. HIPAA applies only to covered entities – providers that bill insurance, health plans, clearinghouses and their business associates. A spa that charges customers directly, without involving insurance, falls outside those rules. “People using services such as these should understand if they are a customer or a patient,” he said, “and what protections that distinction provides.”
A common mistake in medical-device development, Englert warned, is leaving cybersecurity until it’s too late.
Read the article in Healthcare InfoSecurity. Learn More
