Roche Diabetes Care, Inc.

F. Hoffmann-la Roche Ag

Thomas Eissenloeffel

Kai-Oliver Schwenker

Carsten Mueglitz

Ralf Schmitz

Kurt Friedli

Stefan Riebel

Wolfgang Heck

Christian-Alexander Luszick

Bimal Thayyil

Volker Zeuner

An inventive method for validating an end user device for use with a medical application. A medical application and a validation application are received in the end user device and the validation application is then executed, which includes: (i) determining the hardware and software environment of the end user device; (ii) providing a validation process compatible with the hardware and software environment; (iii) executing a test mode of the medical application; (iv) running the validation process during the test mode; and (v) determining from running the validation process whether the medical application is compatible with the end user device. When the medical application is determined to be compatible with the end user device, a validation report is generated and stored in the end user device and/or a server. When the medical application is determined to be incompatible with the end user device, the medical application is at least partially blocked.

Method for validating a medical application, end user device and medical system

The invention provides for a medical system comprising a control unit and a medical appliance. The medical appliance comprises: a first processor and a monitoring system for measuring an analyte concentration subcutaneously. The control unit comprises a second processor and a second memory with a persistent partition and an application partition containing a medical application and application data comprising a medical data entry. The medical application backs up the application data as archived data in the persistent partition. The first processor is programmed to: record the analyte concentration, generate the medical data entry using the analyte concentration, and transfer the medical data entry to the control unit. The second memory further contains an operating system operable for de-installing the medical application without deleting the archived data.

Measurement system for measuring the concentration of an analyte with a subcutaneous analyte sensor

The invention provides for method of operating a medical instrument () comprising a battery powered medical appliance () and a control unit (). Both have Bluetooth communication modules. A first memory of the medical appliance contains a onetime password () and of a password-authenticated key agreement algorithm (). The control unit has a second memory () with an implementation of the password-authenticated key agreement algorithm ('). The method comprises entering () the onetime password into the data entry interface () of the control unit. The method further comprises generating () a Bluetooth encryption key () by the medical appliance and the control unit with the onetime password by exchanging data across the wireless communication channel by executing the password-authenticated key agreement algorithm. The method further comprises storing () the Bluetooth encryption key in the first memory. The method further comprises disabling () the password-authenticated key agreement algorithm in the first memory after storing the Bluetooth encryption key in the first memory. The method further comprises storing () the Bluetooth encryption key in the second memory. The method further comprises establishing () an encrypted Bluetooth communication channel using the first Bluetooth communication module and the second Bluetooth communication module. The encrypted Bluetooth communication channel is the wireless communication channel encrypted using the Bluetooth encryption key.

Pairing a medical apparatus with a control unit

The present invention relates to method for generating a monitoring signal by monitoring laboratory values of a patient using a medical app (). The medical app () is executed on a mobile device () of the patient, wherein the execution of the medical app () on the mobile device () of the patient is supervised by a supervising entity or safety module (), the supervising entity or safety module () comprising at least executable program instructions (). The medical app () comprises executable instructions for executing at least one sequence of processes for generating the monitoring signal. The processes comprise safety critical processes. The sequence of processes is triggered by the measurement of the blood glucose level of the patient. The method comprises executing a first process of the sequence of processes, wherein the execution results in the generation of an information, forwarding the information of the executed process to the supervising entity or safety module (), evaluating the received information by the supervising entity or safety module () and executing a second process of the sequence of processes depending on the result of the evaluation.

Method for generating a monitoring signal using a supervising entity or safety module

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Heidelberg, Germany

Thomas Eissenloeffel