US-20260127256-A1 - USER AUTHENTICATION FOR A DRUG DELIVERY DEVICE

US20260127256A1US 20260127256 A1US20260127256 A1US 20260127256A1US-20260127256-A1

Abstract

A method of authenticating a user for using a drug delivery device includes acquiring motion data of the user; comparing acquired motion data with stored motion data of a user-specific data record and generating a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data; and enabling, disabling, triggering, or terminating an execution of a function of the drug delivery device based on the data matching index.

Inventors

Michael Helmer

Assignees

SANOFI

Dates

Publication Date: 20260507
Application Date: 20221102
Priority Date: 20211103

Claims (20)

1 - 19 . (canceled)
20 . A method of authenticating a user for using a drug delivery device, the method comprising: acquiring motion data of the user; comparing acquired motion data with stored motion data of a user-specific data record and generating a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data; and enabling, disabling, triggering, or terminating an execution of a function of the drug delivery device based on the data matching index.
21 . The method according to claim 20 , wherein the motion data of the user is acquired by an electronic circuit comprising at least one of a communication interface and a sensor.
22 . The method according to claim 21 , wherein at least a portion of the acquired motion data is acquired by the sensor.
23 . The method of claim 22 , wherein the sensor comprises at least one of an acceleration sensor, a rotation sensor, a position sensor, a distance sensor, and a physiologic data capturing sensor.
24 . The method according to claim 21 , wherein at least a portion of the acquired motion data is acquired by the communication interface through a wireless communication with at least one of: a satellite-based positioning system, an access point of a communication network, and a counterpart communication interface of at least one of: a supplementary device attachable to the drug delivery device, an electronic unit of the drug delivery device, and a mobile electronic device).
25 . The method according to claim 20 , wherein the acquired motion data comprises at least one of: gesture data being indicative of characteristic gestures of the user, and a motion pattern being indicative of at least one of a position and a motion profile of the user at a specific point of time or during a specific time interval.
26 . The method according to claim 20 , wherein the user-specific data record is obtained by at least one of: deriving and storing the stored motion data from previously acquired motion data of the user; and requesting and receiving at least one of a user-specific motion pattern and user-specific gesture data from a database.
27 . The method according to claim 20 , wherein the execution of the function of the drug delivery device is enabled or triggered when the data matching index is above an upper data matching threshold.
28 . The method according to claim 27 , wherein the execution of the function of the drug delivery device is disabled or terminated when the data matching index is below a lower data matching threshold.
29 . The method according to claim 28 , further comprising: entering into a dialogue with the user; generating and outputting a user request when the data matching index is below the upper data matching threshold and above the lower data matching threshold; and enabling or triggering the function of the drug delivery device in response to the dialogue with the user or in response to a reaction of the user to the user request.
30 . An authentication system for authenticating a user for using a drug delivery device, the authentication system comprising: an electronic circuit integrated into or attachable to the drug delivery device, the electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device; at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record; and at least one processor operable to compare acquired motion data to stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data, wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device.
31 . The authentication system according to claim 30 , wherein the electronic circuit is part of a supplementary device attachable to the drug delivery device, or wherein the electronic circuit is part of an electronic unit integrated into the drug delivery device.
32 . The authentication system according to claim 30 , further comprising a mobile electronic device comprising at least one of the sensor and the communication interface for acquiring at least a portion of the motion data of the user.
33 . The authentication system according to claim 32 , wherein the electronic circuit comprises a circuit communication interface configured to wirelessly communicate with the communication interface of the mobile electronic device.
34 . The authentication system according to claim 33 , wherein the circuit communication interface is operable to receive at least the portion of the motion data acquired by the mobile electronic device.
35 . The authentication system according to claim 30 , wherein the mobile electronic device comprises at least one of an external electronic device, a wearable electronic device, and a wireless tag.
36 . The authentication system according to claim 30 , wherein the at least one processor is operable to enable, disable, trigger, or terminate the execution of the function of the drug delivery device depending on the data matching index.
37 . The authentication system according to claim 30 , wherein at least a portion of the acquired motion data is acquired by the sensor, and wherein the sensor comprises at least one of an acceleration sensor, a rotation sensor, a position sensor, a distance sensor, and a physiologic data capturing sensor.
38 . A computer program that is executable by at least one processor of an authentication system for authenticating a user for using a drug delivery device, wherein the authentication system comprises: an electronic circuit integrated into or attachable to the drug delivery device, the electronic circuit being operable to enable, disable, trigger, or terminate an execution of a function of the drug delivery device; at least one of a sensor and a communication interface operable to acquire motion data of the user; a storage operable to store motion data of a user-specific data record; and at least one processor operable to compare acquired motion data with stored motion data and operable to generate a data matching index being indicative of a degree of matching between the acquired motion data and the stored motion data, wherein the data matching index is configured to effectuate at least one of an enabling, disabling, triggering, or terminating the execution of the function of the drug delivery device; and wherein the computer program product comprises computer readable instructions that, when the computer program product is executed by the at least one processor of the authentication system, causes the at least one processor to: acquire the motion data of the user; compare the acquired motion data to the stored motion data of the user-specific data record; generate the data matching index ; and enable, disable, trigger, or terminate the execution of the function of the drug delivery device based on the data matching index.

Description

CROSS REFERENCE TO RELATED APPLICATIONS The present application is the national stage entry of International Patent Application No. PCT/EP2022/080594, filed on Nov. 2, 2022, and claims priority to EP Application No. 21315204.4, filed on Nov. 3, 2021, the disclosures of which are incorporated herein by reference. TECHNICAL FIELD The present disclosure relates to a method of authenticating a user to use a drug delivery device, to an authentication system to authenticate the user, to a computer program for user authentication, and to a mobile electronic device for providing user authentication. BACKGROUND Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe. SUMMARY Drug delivery devices, e.g. injection devices and needle based injection system (NIS) devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous. A patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe or infused via a pump. Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time. Needle based injection to be conducted with a variety of injection devices is more and more associated with measuring and logging data regarding the amount of medicament set and set or dispensed or injected at a particular date or time. For this, injection devices may be provided with an electronic circuit providing data acquisition and/or data logging as well as communication of collected or measured dispensing related data. Such electronic circuits or electronic units may be either implemented or integrated into the injection device itself. Alternatively, such electronic circuits or electronic units may be provided by a supplementary device or an add-on device configured for releasable attachment to the injection device and being operable to log injection-related data during use of the injection device. Moreover, electronic circuits for data logging may be also provided with a communication interface so as to transmit previously stored injection-related data to an external electronic device for further data processing. Some users or patients may need to administer different medicaments by using different drug delivery devices, where the devices may, at first glance, look similar. Also, devices may be kept in households, where not only a single but a plurality of persons is in theory able to access the device. It is therefore desirable to provide an improved method and a system to authenticate a user to use a particular drug delivery device. It is further desirable to provide a computer program and to provide respective hardware components to enhance patient safety and to prevent unauthorized use of a drug delivery device by a user not authorized to make use of the drug delivery device. SUMMARY According to one aspect the present disclosure relates to a method of authenticating a user to use a drug delivery device, such as an injection device. The method includes the steps of acquiring of motion data of the user and comparing the acquired motion data with stored motion data of a user specific data record. Based on this comparison there is generated a data matching index. The data matching index is indicative of a degree of matching or similarity between the acquired motion data and the stored motion data. Furthermore, a function, e.g. an electronically implemented function of the drug delivery device is either enabled, disabled, triggered or terminated on the basis of the data matching index. Typically, a user authorized to use the drug delivery device is identified by its motion data. The motion data is typically acquired or collected either by the drug delivery device itself or by a mobile electronic device, e.g. carried along with the user or attached to the user. Typically, motion data of the user is acquired over a predefine