A certified quality system, from deployment to documentation.
Rho is a regulated medical device. Rho Enterprise is deployed inside your environment. Here is how it handles data, where it is authorized, and how it is built.
Patient identities stay with you.
Rho Enterprise: your images stay on your servers
On-premise deployment
Rho runs on a virtual machine provisioned by your team, inside your network. This applies to production use and to any retrospective review.
No PHI leaves your site
Images and protected health information are processed locally and are not sent to 16 Bit or a third-party cloud.
You keep control
Your team controls the environment, access, and routing. 16 Bit services and updates Rho remotely through the access you provide. That narrows the scope of security and privacy review.
Rho Direct: identifiers are encrypted on your device
Sealed with your key
Before upload, Rho Direct de-identifies each case on your device. Patient identifiers are sealed with a key you choose, and the key never leaves your device.
Only de-identified inputs are sent
Age, sex, and pixel data, an encrypted identifier blob that 16 Bit cannot read, and a random correlation token not derived from the file.
De-identified under HIPAA
An independent expert has determined that what Rho Direct sends is de-identified under HIPAA (45 CFR 164.514(b)(1)). 16 Bit never receives unencrypted identifiers or your key.
A certified quality system.
16 Bit maintains a quality management system certified by Intertek to ISO 13485:2016 under MDSAP, and under Annex IX of the EU MDR (Regulation (EU) 2017/745).
Rho is physician-founded and radiologist-led, developed and validated to clinical standards, and supported by peer-reviewed independent validation.
See the evidence →Authorized for clinical use in six jurisdictions.
Product features and outputs vary by jurisdiction.
Hover over or tap a highlighted region, or select a jurisdiction, to see its status and year.
Bring your security and regulatory questions.
We will share deployment requirements, regulatory documentation, and instructions for use for your market.