Initial certification: 11/2023
Robotic Ultrasound System provides customers with a robotic system enabling remote ultrasound exams. It integrates a robotic arm, remote control and ultrasonic imaging technology, which is used for remote ultrasonic diagnosis, and is composed of two independently working endpoints: a doctor-end diagnostic device and a patient-end ultrasound device. Latvia MGI Tech, SIA facilitates the data protection compliant use of Robotic Ultrasound System by providing comprehensive, meaningful, intelligible and up-to-date information to the users of the ToE.
Robotic Ultrasound System
Qualification: IT product
Version of Certification Criteria
29/11/2023 – 30/11/2025
Latvia MGI Tech, SIA
Lidostas Parks A ieeja
Comprehensive, intelligible and up-to-date documentation is in place which informs the users of Robotic Ultrasound System about their responsibilities as controllers when it comes to the processing of personal data.
Robotic Ultrasound System facilitates its privacy compliant use. However, it is the users’ responsibility as controllers to stick to the guidance provided by Latvia MGI Tech and to use the ToE in a way that complies with all relevant provisions of the GDPR.
Robotic Ultrasound System is a hard- and software combination and personal data is processed by both devices individually as well as in exchange between them. Both endpoints are connected through a server. This connection can either be set up through the internet enabling the users to execute exams while being in different regions or by establishing a local connection using the same local area network (LAN). For the subjection of the certification, ToE is not under internet connection.
Robotic Ultrasound System has two main interfaces:
– Ultrasound together with the robotic arm performing the scan as part of the patient-end system and
– Workstation with simulated probe telecontrolling the ultrasound as part of the doctor-end system.
The interface of the patient-end is placed on the control-end of the patient-end and serves the interaction between doctor and patient. Both devices communicate and share data with each other through their interfaces to the signalling server.
Initial Cert 2023/11
The ToE includes:
– The Hardware, containing the patient-end ultrasound device and doctor-end ultrasound keyboard (control panel). doctor-end system: mechanical components, operation control system, and audio-video system and patient-end system: mechanical components, operation execution system, ultrasound device, audio-video system
– The Software, containing Control Software (for doctor-end and patient-end) and Signalling Server Software (information forwarding server) (infrastructure)
– The ToE is set up via the patient-end and doctor-end’s intercommunication with the Signalling Server Software (information forwarding server), which is without internet connection.
The ToE does not include:
– Components needing mandatory internet connection;
– The payment process since this process precedes the use of the product and is self-contained;
– The maintenance process and any related data processing operations.
Dr. Jan Peter Ohrtmann (Lawyer)
PricewaterhouseCoopers Legal AG
B³ | Informationstechnologie