WO2020183470A1

WO2020183470A1 - System and method for identification and verification of authorization of a subject to use a substance delivery device

Info

Publication number: WO2020183470A1
Application number: PCT/IL2020/050292
Authority: WO
Inventors: Perry Davidson; Ianiv Yosef EISENSCHER
Original assignee: Syqe Medical Ltd.
Priority date: 2019-03-12
Filing date: 2020-03-12
Publication date: 2020-09-17
Also published as: EP3937778A4; AU2020234110A1; IL286276A; EP3937710A4; EP3938015A4; CN114206419A; WO2020183478A1; AU2020234112A1; WO2020183476A1; TW202040393A; JP2022526243A; EP3937710A1; US20220151300A1; US20220160047A1; EP3938015A1; EP3937778A1; IL286277A; CA3132948A1; CN113811242A; CA3132930A1

Abstract

System and method for identification and verification of authorization of a subject to use a substance delivery device are disclosed.

Description

SYSTEM AND METHOD FOR IDENTIFICATION AND VERIFICATION OF AUTHORIZATION OF A SUBJECT TO USE A SUBSTANCE DELIVERY DEVICE

BACKGROUND OF THE INVENTION

[0001] Currently, sale of substance delivery devices (e.g., vaping devices, inhalers and e-cigarettes) to individuals can be controlled based on the individual presenting acceptable identification to a seller in order to obtain the device. For example an e-cigarette that delivers nicotine (for example) can be sold to individual in a store upon the individual showing a government or federal issued photo identification document (e.g. and ID card or driver license), to prove that the individual is above a certain age. A controlled substance inhaler, for example, can be sold subject to the presentation of such a government or federal issued photo identification document together with a valid license or prescription for the drug.

[0002] Once an individual has a substance delivery device in their possession, the individual can provide that substance delivery device to any other person or another person can use the substance delivery device without the individual’s permission. This can allow unauthorized persons (e.g., children) to obtain access to controlled substances and/or to begin smoking at an early age.

[0003] Identification can refer to a process of presenting one’s identity to a system. It is typically part of an initial stage of accessing a restricted access system. An identification process usually involves presenting one’s own personal identification data (e.g., providing a username during a login process or using ATM cards).

[0004] Authentication relates to validating an identity provided to a system and is often used to distinguish between authorized and unauthorized individuals or between individuals having different authorizations. Authentication can take place after identification is complete, or concurrently to the identification process. At times, authentication is performed without identification of a unique individual, for example by authenticating that an individual belongs to a defined group of individuals (e.g., one of a group of employees having the same user ID). This can also be considered identification, in the sense that the group is identified.

SUMMARY OF THE INVENTION

[0005] Some embodiments can provide a method of identification of a subject and verification of authorization of the subject to use a substance delivery device, the method can include: connecting a computing device to a substance delivery device; obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; obtaining, by the computing device, individual facial and authorization data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an authorization of the individual; determining, by the computing device, whether the subject is an authorized subject, based on the subject facial data and the individual facial and authorization data; and obtaining, by the substance delivery device, biometric identification data being acquired by the substance delivery device and simultaneously determining by the computing device whether the substance delivery device is being used by the subject.

[0006] In some embodiments, the method includes associating, by the computing device, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device, and registering the association.

[0007] In some embodiments, the method includes associating by the computing device the biometric identification data of the authorized subject with an indication of the authorization of the authorized subject, if the subject is an authorized subject and the substance delivery device was being used by the authorized subject, and registering the association thereof.

[0008] In some embodiments, the method includes obtaining, by the computing device, device-related data of the substance delivery device to the computing device.

[0009] In some embodiments, the method includes obtaining the device-related data includes transfer of data by the substance delivery device to the computing device.

[0010] In some embodiments, determining whether the subject is the authorized subject is based at least partially on the device-related data.

[0011] In some embodiments, obtaining the individual facial and authorization data includes receiving of an image of an authorization document of the individual taken by a camera associated with the computing device.

[0012] In some embodiments, obtaining the individual facial and authorization data includes retrieving data from an identification and authorization database.

[0013] In some embodiments, the identification and authorization database includes a plurality of databases configured to correlate the individual facial data and the authorization data.

[0014] In some embodiments, the method includes obtaining, by the camera, subject facial and device data indicative of a facial image, or at least a portion of the facial image, of the subject simultaneously with an image of the substance delivery device or at least a portion of the substance delivery device when in use by the subject. [0015] In some embodiments, the method includes determining, by the computing device, whether the substance delivery device is being used by the authorized subject is based at least partially on the subject facial and device data.

[0016] In some embodiments, the method includes determining whether the substance delivery device is being used by the subject based on the subject facial and the device data includes determining whether the image of the substance delivery device is within a predefined geometric relation to the facial image of the subject.

[0017] In some embodiments, obtaining the subject facial and the device data is done continuously during obtaining of the biometric data and association of the biometric data with the authorization indication.

[0018] In some embodiments, the method includes tracking a location of the facial image of the subject in the subject facial data.

[0019] In some embodiments, tracking is performed at least over the period of time spanning both the obtaining, by the substance delivery device, biometric identification data and simultaneously determining, by the with the computing device, whether the substance delivery device is being used by the subject, and the obtaining, by the computing device, biometric identification data being acquired by the substance delivery device.

[0020] In some embodiments, the method includes detecting, by the camera, an output signal transmittable by a transmitter of the substance delivery device.

[0021] In some embodiments, the method includes determining whether the substance delivery device is being used by the subject based on the subject facial and device data is based at least partially on determining that an image of the output signal is within a predefined geometric relation to the facial image of the subject.

[0022] In some embodiments, the method includes detecting, by a receiver associated with the computing device, an output signal transmittable by a transmitter of the substance delivery device.

[0023] In some embodiments, the method includes determining, by the computing device, a direction of received output signal; wherein determining whether the substance delivery device is being used by the subject is based at least partially on the determined direction of the received output signal and at least one of: the subject facial data and the subject facial and device data

[0024] In some embodiments, the method includes determining, by the computing device: a real- world location of a face of the subject based on at least one of: the subject data and the subject facial and device data; and a real-world location of the substance delivery device based on the determined direction of received output signal; wherein determining whether the substance delivery device is being used by the subject is based at least partially on determining that the real-world location of the substance delivery device is within a predetermined geometric relation to the real-world location of the face of the subject.

[0025] In some embodiments, the method includes: detecting, by at least one of the camera and a receiver associated with the computing device, an output signal transmittable by a transmitter of the substance delivery device; and defining, by at least one of the computing device and the substance delivery device, at least one output signal property of the output signal.

[0026] In some embodiments, defining an output signal property of the output signal every time is performed when the substance delivery device is connected to the computing device or at predetermined time intervals.

[0027] In some embodiments, the output signal includes biometric identification data encoded therein.

[0028] In some embodiments, the method includes controlling, via a controller of the substance delivery device, the transmitter of the substance delivery device to encode the biometric identification data of the subject using the substance delivery device in the output signal.

[0029] In some embodiments, the method includes issuing a system signal by the computing device to the substance delivery device via the connection between them and wherein defining an output signal property of the output signal includes detecting a temporal correlation between the system signal and the output signal.

[0030] In some embodiments, the method includes receiving the biometric identification data by the computing device and determining by the computing device that the biometric identification data encoded in the output signal corresponds with the received biometric identification data.

[0031] In some embodiments, the registering includes registering one or more limitations on the authorization of the authorized subject.

[0032] In some embodiments, the method includes requiring, by the substance delivery device, a repeat of the registration in order to exceed one or more of the limitations.

[0033] Some embodiments can provide a system for identification of a subject and verification of authorization of the subject to use a substance delivery device, the system can include: a camera to obtain subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; and a processing unit in communication with the camera and configured to connect to the substance delivery device, the processing unit is configured to: obtain individual facial and authorization data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an authorization of the individual; determine whether the subject is an authorized subject, based on the subject facial data and the individual facial and authorization data; and determine whether the substance delivery device is being used by the authorized subject while the substance delivery device is obtaining biometric identification data.

[0034] In some embodiments, the processing unit is configured to: associate the biometric identification data of the authorized subject with an indication of the authorization of the authorized subject, if the subject is an authorized subject and the substance delivery device was being used by the authorized subject, and register the association thereof.

[0035] In some embodiments, the processing unit is configured to: associate, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device; and register the association.

[0036] In some embodiments, the processing unit is configured to obtain device-related data upon the connection of the substance delivery device to the processing unit.

[0037] In some embodiments, the processing unit is configured to determine whether the subject is the authorized subject is based at least partially on the device -related data.

[0038] In some embodiments, the processing unit is configured to obtain the individual facial and authorization data based at least partially on an image of an identification document of the individual taken by the camera.

[0039] In some embodiments, the processing unit is configured to obtain the individual facial and authorization data from an identification and authorization database.

[0040] In some embodiments, the identification and authorization database comprises a plurality of databases configured to correlate the individual facial data and the authorization data.

[0041] In some embodiments, the camera is configured to obtain subject facial and device data indicative of a facial image, or at least a portion of the facial image, of the subject simultaneously with an image of the substance delivery device or at least a portion of the substance delivery device when in use by the subject.

[0042] In some embodiments, the processing unit is configured to determine whether the substance delivery device is being used by the authorized subject based at least partially on the subject facial and device data.

[0043] In some embodiments, the processing unit is configured to determine, based on the subject facial and device data, whether the image of the substance delivery device is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the authorized subject. [0044] In some embodiments, obtaining of the subject facial and the device data is done continuously during obtaining of the biometric data and association of the biometric data with the authorization indication.

[0045] In some embodiments, the processing unit is configured to track a location of the facial image of the subject in the subject facial data.

[0046] In some embodiments, the tracking is performed at least over the period of time spanning both the obtaining, by the substance delivery device, biometric identification data, determining, by the processing unit, whether the substance delivery device is being used by the subject, and the obtaining, by the processing unit, the biometric identification data being acquired by the substance delivery device.

[0047] In some embodiments, the camera is configured to detect an output signal transmittable by a transmitter of the substance delivery device.

[0048] In some embodiments, the processing unit is configured to determine, at least partly based on the subject facial and device data, that an image of the output signal is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the authorized subject.

[0049] In some embodiments, the system includes a receiver associated with the processing unit, the receiver configured to detect an output signal transmittable by a transmitter of the substance delivery device.

[0050] In some embodiments, the processing unit is configured to: determine a direction of a received output signal; and determine, at least partly based on the determined direction of the received output signal and at least one of: the subject facial data and the subject facial and device data, whether the substance delivery device is used by the authorized subject.

[0051 ] In some embodiments, the processing unit is configured to determine whether the substance delivery device is being used by the authorized subject while the substance delivery device is obtaining the biometric identification data by determining: a real-world location of a face of the subject based on at least one of: the subject data and the subject facial and device data; a real-world location of the substance delivery device based on the determined direction of received output signal; and that the real-world location of the substance delivery device is within a predetermined geometric relation to the real-world location of the face of the subject.

[0052] In some embodiments, at least one of the camera and a receiver associated with the processing unit is configured to detect an output signal transmittable by a transmitter of the substance delivery device, and the processing unit is configured to define at least one output signal property of the output signal.

[0053] In some embodiments, the output signal includes biometric identification data encoded therein.

[0054] In some embodiments, the processing unit is configured to determine whether the substance delivery device is used by the authorized subject based at least partially on the biometric identification data encoded in the output signal.

[0055] In some embodiments, the processing unit is configured to issue a system signal to the substance delivery device via the connection between them and wherein defining an output signal property of the output signal by the processing unit includes detecting a temporal correlation between the system signal and the output signal.

[0056] In some embodiments, the camera and the processing unit are implemented on a single computing device.

[0057] Some embodiments can provide a method of identification of a subject and verification of age of the subject to use an electronic pulmonary delivery device, the method can include: connecting a computing device to an electronic pulmonary delivery device; obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; obtaining, by the computing device, individual facial and age data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an indication of the age of the individual; determining, by the computing device, whether the subject is of age, based on the subject facial data and the individual facial and age data; and obtaining, by the electronic pulmonary delivery device, biometric identification data being acquired by the electronic pulmonary delivery device and simultaneously determining by the computing device whether the electronic pulmonary delivery device is being used by the subject. In some embodiments, the method includes: associating by the computing device, the biometric identification data of the subject with an indication of an authorization of the subject to use the electronic pulmonary delivery device, if the subject is of age and the electronic pulmonary delivery device was being used by the authorized subject, and registering the association thereof.

[0058] In some embodiments, the method includes: associating, by the computing device, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device, and registering the association.

[0059] Some embodiments can provide a method of registering a subject in association with a documented property of the subject, the method can include: connecting a computing device to a probe; obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of the subject; obtaining, by the computing device, individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with the documented property of the individual; determining, by the computing device, whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property; obtaining, by the probe, biometric identification data being acquired by the probe and simultaneously determining by the computing device whether the probe is being used by the subject; and registering, by the computing device, the biometric identification data of the subject according to the documented property, based on the determinations.

[0060] Some embodiments can provide a system for registering a subject in association with a property of the subject, the system can include: a camera to obtain subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; and a processing unit in communication with the camera and configured to connect to a probe, the processing unit is configured to: obtain individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with the documented property of the individual; determine whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property; determine whether the probe is being used by the authorized subject while the probe is obtaining biometric identification data; and register the biometric identification data of the subject according to the documented property, based on the determinations.

[0061] Some embodiments can provide a method of identification of a subject and verification of age of the subject to use an electronic pulmonary delivery device, the method can include: connecting a computing device to an electronic pulmonary delivery device; tracking the location of the delivery device by a location sensor; accessing legal data related to the permitted age by law and/or regulations at the location detected; obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; obtaining, by the computing device, individual facial and age data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an indication of the age of the individual; determining, by the computing device, whether the subject is of the legally permitted age at the current device location, based on the subject facial data, the detected location of the device, the legal data and the individual facial and age data; and obtaining, by the electronic pulmonary delivery device, biometric identification data being acquired by the electronic pulmonary delivery device and simultaneously determining by the computing device whether the electronic pulmonary delivery device is being used by the subject; associating, by the computing device, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device, and registering the association.

[0062] In some embodiments the location of the device may be detected by a GPS sensor. In some embodiment the location data is detected by the IP address of the computing device, or can be entered manually.

[0063] In some embodiments the legally permitted age at the detected location is either one of 18 years old, 19 years old, 21 years old, 16 years old or 25 years old.

[0064] These, additional, and/or other aspects and/or advantages of the present invention are set forth in the detailed description which follows; possibly inferable from the detailed description; and/or learnable by practice of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] For a better understanding of embodiments of the invention and to show how the same can be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals designate corresponding elements or sections throughout.

[0066] In the accompanying drawings:

[0067] Figs. 1A, IB, 1C and ID are schematic illustrations of a system for registration of a subject to use a substance delivery device, according to some embodiments of invention;

[0068] Fig. IE depicts an example for preventing registration of an individual who is not authenticated by the system, according to some embodiments of invention.

[0069] Fig. 2 is a flowchart of a method of registration of a subject to use a substance delivery device, according to some embodiments of invention;

[0070] Fig. 3 is a block diagram of a substance delivery device for delivery of a substance to a subject, according to some embodiments;

[0071] Fig. 4A and 4B are schematic diagrams of a substance delivery, according to some embodiments;

[0072] Fig. 4C are graphs showing an example of a received wave without a cover on the wave sensor;

[0073] Fig. 4D are graphs showing an example of the same received waves with a cover on the wave sensor; [0074] Fig. 5 is a flowchart of a method of authenticating a subject for delivery of a substance to the subject, according to some embodiments;

[0075] Fig. 6A and Fig. 6B is a T-distributed Stochastic Neighbor Embedding (t-SNE) graph visualizing a possible distinction between received waves from eight different subjects, wherein Fig. 6B depicts and enlargement of a portion of Fig. 6A, according to some embodiments of an authentication method;

[0076] Fig. 6C and Fig. 6D are graphs showing a reference wave used in determining the values of wave samples shown in graph of Fig. 6A, according to some embodiments of an authentication method; and

[0077] Fig. 7A and Fig. 7B are a T-distributed Stochastic Neighbor Embedding (t-SNE) graph visualizing a possible distinction between adults and children according to received waves, wherein Fig. 7B depicts and enlargement of a portion of Fig. 7 A according to some embodiments of an authentication method.

[0078] It will be appreciated that, for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements can be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals can be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION

[0079] In the following description, various aspects of the present invention are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the present invention. However, it will also be apparent to one skilled in the art that the present invention can be practiced without the specific details presented herein. Furthermore, well known features can have been omitted or simplified in order not to obscure the present invention. With specific reference to the drawings, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention can be embodied in practice. [0080] Before at least one embodiment of the invention is explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is applicable to other embodiments that can be practiced or carried out in various ways as well as to combinations of the disclosed embodiments. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0081] Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as "processing", "computing", "calculating", "determining", “enhancing” or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulates and/or transforms data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices. Any of the disclosed modules or units can be at least partially implemented by a computer processor.

[0082] Reference is now made to Figs. 1A, IB, 1C and ID, which are schematic illustrations of a system 100 for registration of a subject 90 on a substance delivery device 130, according to some embodiments of invention.

[0083] Registration relates to the process of associating and storing authentication data with data of an identified individual and/or with authorization indication. Authentication data allows a system to verify the claimed identity of the subject and/or to verify their authorization based solely on the stored data, without need to obtain external authorization indication. In some embodiments the authentication data is or includes biometric identification data, being data that is indicative of a biometric identifying property of the subject. Authorization indication can include, for example, a permission to access and/or use a device (for example a substance delivery device) or data, permitted usage regime, usage limitations, and/or partial or full restriction. Once registered an individual can be provided with access according to the stored information, solely by providing the biometric indication (e.g., fingerprint, retina scan and/or oral signature etc.). In some embodiments, a substance delivery device is controlled so as not to deliver a substance to a subject who is not registered. In various embodiments, a substance delivery device is controlled to deliver a different substance, a greater amount of substance and/or substance at a greater frequency to a registered individual than to an unregistered subject. [0084] According to some embodiments, system 100 can be capable of identifying a subject 90, verifying that subject 90 is authorized to use a substance delivery device 130 and verifying, optionally in real-time (or substantially in real-time), that authorized subject 90, and not another subject, is using substance delivery device 130. Once such verification is complete, system 100 can store biometric identification data of subject 90 (e.g., biometric identification on substance delivery device 130 thereby enabling the subject to use the device. In some embodiments, biometric identification data is not provided to system 100, but rather once verification is complete, system 100 instructs or permits substance delivery device 130 to store the biometric identification data.

[0085] System 100 can include a camera 110 and a processing unit 120. In some embodiments, camera 110 and processing unit 120 can be implemented on a single computing device (e.g., tablet, cellular phone, desktop computer, smart watch, etc.). In some other embodiments, processing unit 120 can be implemented on a remote device, for example on an associated computing device (e.g., desktop computer, server, cloud, etc.) and camera 110 can be in communication (e.g., wired and/or wireless) with that remote device.

[0086] In some embodiments, system 100 can include a substance delivery device 130. In some other embodiments, substance delivery device 130 can be not a part of system 100 and system 100 can be able to connect with one or more substance delivery devices 130. Substance delivery device 130 can be connectable to processing unit 120. The connection 111 thereof can be wired or wireless (e.g., Bluetooth, etc.). In some embodiments, substance delivery device 130 can be a pulmonary delivery device (e.g. for vaping and/or smoking a substance). In some embodiments, substance delivery device 130 is an electronic device. In some embodiments, substance delivery device 130 can be an inhaler, a vaporizer or an e-cigarette. In some embodiments, substance delivery device 130 can be a medical device, a non-medical device or a combination thereof.

[0087] In some embodiments, processing unit 120 can obtain device-related data upon the connection of sustenance delivery device 130 to processing unit 120. The device-related data can, for example, include a serial number of substance delivery device 130, a type of substance delivery device 130 (e.g., e-cigarette, vaporizer, medical device, non-medical device, etc.), a type of a substance within substance delivery device 130 (e.g., controlled substance or not, type of substance can include a user interface 140. Processing unit 120 can communicate with subject 90 and subject 90 can communicate with processing unit 120 via user interface 140. For example, processing unit can display instructions or feedback to subject 90 via user interface 140. In various embodiments, processing unit 120 can receive input from subject 90 via user interface 140. [0088] In some embodiments, a software application can provide a user interface 140. The software application can be designed to run on processing unit 120, which can include any of personal computer, tablet, cell phone, desktop computer, smart watch and the like. In some embodiments, user interface 140 is integrated in substance delivery device 130 (e.g., as a touch screen, buttons for pressing and/or vocal input and audio output).

[0089] In some embodiments, processing unit 120 can obtain, using a camera 110, subject facial data 112 indicative of a facial image of subject 90 (or with at least a portion of the facial image thereof). In some embodiment, once the facial image is captured, it is tracked via camera 110 to ensure that subject 90 is not replaced before obtaining of all images required for the registration of the subject to substance delivery device was be completed.

[0090] In some embodiments, processing unit 120 can obtain individual facial and authorization data 116 indicative of a facial image of an individual (or with at least a portion of the facial image thereof) in association with an authorization of the individual. The individual can be an arbitrary person having an authorization associated with a facial image of the individual. The authorization can include a condition for using substance delivery device 130. For example, if substance delivery device 130 is an e-cigarette, the authorization can include an age of subject 90 (e.g., at least 18 years old, at least 21 years old, etc.). In some embodiments, if substance delivery device 130 is a medical inhaler, the authorization can include a valid prescription or license for a controlled substance. The authorization thereof can be associated with the facial image of the individual.

[0091] In some embodiments, processing unit 120 can access to two or more distinct databases in order to obtain the authorization data and/or the facial image data. In some embodiment, one or both of the authorization data and the facial image data can be entered to processing unit 120 by the individual. In various embodiments, processing unit 120 can access to two or more distinct databases in order to obtain the authorization data based on the facial image of subject 90 and/or by use of data input via a user interface (e.g. name, ID number or passport number, license number, a password, etc.).

[0092] For example, processing unit 120 can control camera 110 to take an image of a one or more authorization documents 80 of an individual and obtain individual facial and authorization data 116 (e.g., facial image and authorization, e.g., age, etc.) based on the image of authorization document 80 (e.g., identification document) issued by a competent authority (e.g., a government or federal identification document). In some embodiments, the validity of such document is verified against. [0093] In an example, processing unit 120 can obtain individual facial and authorization data 116 from an identification and authorization database 70, for example, identification and authorization database 70 that stores at least facial and authorization data of a plurality of individuals. Some other examples of data stored in identification and authorization database 70 can include a national or regional register, department of motor vehicles database of licensed drivers, ministry of health and/or hospital registry of patients. The information stored in such database 70 can include government issued documents, biometric data, social security numbers, usernames, passwords, licenses for restricted substances, date of birth or age, etc.

[0094] In some embodiments, obtaining individual facial and authorization data 116 can include accessing more than one source, in order to add a layer of certainty and/or prevent fraud. For example, processing unit 120 can obtain identification data of the subject 90 from both their identification document and from an identification database, and determine based on comparison of the two sources, whether the certificate is valid, and the individual indeed physically possess the certificate. In some embodiments, an identification document and/or authorization document is not required, and all the data is obtained remotely from database(s) 70. In some embodiments, a portion of database 70 is stored on system 100 and/or on substance delivery device 130. For example, once data of a given individual is accessed in database 70 (based, for example, on his facial image, authorization document of the individual and/or on data input via user interface 140), an authorization indication of that individual is stored in system 100 and/or on substance delivery device 130.

[0095] In some embodiments, processing unit 120 can control camera 110 to take an image of two or more authorization documents 80 of the individual in one or more images. For example, processing unit 120 can control camera 110 to take an image of an identification document that provide the facial image data as well as personal identification data (e.g., identification number or social security number) and an image of a valid medical prescription (e.g., that has no facial image data but has the name and/or the identification number/social security number). In some embodiments, processing unit 120 can combine the information from the image and possibly and access at least one official database for confirmation of the information.

[0096] In some embodiments, processing unit 120 can determine whether subject 90 is the individual for whom facial and authorization data 116 has been obtained, for example, by using visual algorithm and/or video streaming (e.g., imposing a wireframe mesh and/or the like). Optionally, subject 90 can be instructed to remain in view and facing the camera at all times during imaging and the acquisition of his biometric identification property. The determination can be based on subject facial data 112, facial and authorization data 116 and, optionally, based on the device-related data of substance delivery device 130.

[0097] For example, if substance delivery device 130 is an e-cigarette for the delivery of nicotine (e.g., as indicated in the device-related data), processing unit 120 can compare the facial image of subject 90 (e.g., included in subject facial data 112) with the facial image of the individual (e.g., included in facial and authorization data 116) to determine whether subject 90 is the individual and further determine whether subject 90 has the authorization to use the e-cigarette (e.g., that the age of subject 90 is at least 18 years old, at least 21 years old, etc. as indicated in facial and authorization data 116).

[0098] In an example, if substance delivery device 130 is a medical cannabis inhaler or vaporizer (e.g., as indicated in the device-related data), processing unit 120 can compare the facial image of subject 90 (e.g., included in subject facial data 112) with the facial image of the individual (e.g., included in facial and authorization data 116) to determine whether subject 90 is the individual and further determine whether subject 90 has the authorization to use the medical cannabis vaporizer (e.g., that subject 90 has a valid license or prescription for the medical cannabis as indicated in facial and authorization data 116).

[0099] In various embodiments, if substance delivery device 130 can be used to deliver different substances (e.g. nicotine for non-medical purposes and a controlled substance for medical purposes) processing unit 120 can compare the facial image of subject 90 (e.g., included in subject facial data 112) with the facial image of the individual (e.g., included in facial and authorization data 116) to determine whether subject 90 is the individual. In addition, processing unit 120 will determine: (a) whether subject 90 has the authorization to use the medical cannabis vaporizer (e.g., that subject 90 has a valid license or prescription for the medical cannabis as indicated in facial and authorization data 116), and (b) whether subject 90 has the authorization to use the e-cigarette (e.g., that the age of subject 90 is at least 18 years old, at least 21 years old, etc. as indicated in facial and authorization data 116). Both distinct authorizations can be stored separately and the stored authorization for of each can be accessed by substance delivery device 130 when primed to deliver the respective substance.

[00100] In some embodiments, a service provider can be accessed remotely to determine whether subject 90 is the individual for whom facial and authorization data 116 has been obtained, in place of processing unit 120. For example, in some cases capturing of authorization document80 can prove to be insufficient for machine verification. In such events, a service provider having access to an official database can provide the confirmation. Such service provider can be teleconferenced in, in real time, by system 100 and/or subject 90 to assist in any stage as required, including providing oral instructions to subject 90.

[00101] In this manner, system 100 can identify subject 90 and verify that subject 90 is authorized to use substance delivery device 130. In some embodiments, processing unit 120 can register authorized subject 90 in memory 150 (e.g., in a list of registered authorized subjects).

[00102] In various embodiments, substance delivery device 130 can acquire biometric identification data of subject 90 before and/or during a use of substance delivery device 130. For example, the biometric identification data can include a fingerprint.

[00103] In some embodiments, the biometric identification data can include an oral signature. For example, substance delivery device 130 can include an oral sampling probe. At a first mode, the oral sampling probe can be used for registration. At a second mode, the oral sampling probe can be used for authentication, for example to control the delivery of the substance. The oral sampling probe can include a wave generator and a wave sensor. The wave generator is configured to transmit waves into or in a vicinity of an oral space of subject 90., The wave sensor is configured to receive at least a portion of waves reflected from subject 90. A transducer, typically incorporating wave sensor, can convert the reflected signal to electronic data and store the data in memory 150. Optionally, the wave can be or includes a sound wave and/or electromagnetic wave. In some embodiments, the oral sampling probe is incorporated within substance delivery device 130. In various embodiments, the oral sampling probe is a separate unit and can be coupled to substance delivery device 130, and/or to other devices, upon need and/or be used independently, solely for registering an oral signature of an individual in association with an indication of authorization of the same individual. In some embodiments, the oral signature of a subject or individual includes data indicative of at least a portion of the reflections of the waves received by the wave sensor and/or a derivation and/or result of analysis thereof.

[00104] In some embodiments, processing unit 120 is configured to determine in real-time (or substantially in real-time) that subject 90 is the individual whose oral signature is being taken in real time during the registration process. In some embodiments, camera 110 can image subject 90 having the probe in their mouth. The image data can then be stored in memory 150.

[00105] Optionally, the oral sampling probe includes a transmitter (e.g., like transmitter 132 described below with respect to Figs. 1C and ID) capable of transmitting an output signal (e.g., like output signal 133 described below with respect to Figs. 1C and ID) to system 100. In some embodiments, processing unit 120 can control the transmitter 132 to transmit the output signal. The output signal can, for example, include one or more electromagnetic waves.

[00106] An output signal receiver, optionally camera 110 and/or an antenna (e.g., like a receiver 160 described below with respect to Figs. 1C and ID), is configured to receive the output signal. A transducer, typically incorporated in the signal receiver, can convert the reflected signal to electronic data and store the data in memory 150. In some embodiments, processing unit 120 is operative to determine, based on comparison of the direction of the output signal and the direction of the second image, whether the oral sampling probe is indeed positioned within the mouth of the subject 90 during the registration process. In some embodiments, processing unit 120 is operative to prevent the determination in the event that the subject 90 moves or changes position to such extent as his facial image is no longer captured or is capture but not recognized with a defined minimal confidence level by system 100. In some embodiments, once a facial image of subject 90 is captured and identified, any change in posture and/or position that might enable switching subject 90 with another subject will cause processing unit 120 not to complete the determination. System 100 can, in some embodiments, thereby avoid or reduce the possibility of oral signature being taken from a second individual being nearby the subject 90 during the registration and/or subject 90 being replaced by a second individual.

[00107] In some embodiments, system 100 can be capable of associating the biometric identification data of subject 90 with an identity and/or an authorization indication of authorized subject 90. In some embodiments, system 100 can be capable of instructing or permitting an association, by substance delivery device 130, of the biometric identification data of subject 90 with an identity and/or an authorization indication of authorized subject 90. Such association can include storing an indication of the biometric identification data stored in a database of authorized individuals and/or using encoding unique to the authorization. In some embodiments, the association includes storing an indication of the biometric identification data together with an indication of authorization. Examples for such indication can include an indication of the individual’s age (e.g. date of birth), and indication that the individual is above a threshold age without necessarily specifying their age, an indication that the individual holds a valid prescription for a controlled substance, etc. In some embodiments, the indication is stored in association with a limitation of authorization, such as the type and/or dosage and/or regimen of a controlled substance, maximal daily delivery of a substance, time of day when delivery is authorized, date of expiration of the authorization etc. In some embodiments, the biometric identification data stored in association with details of the process that had led to such storing, including for example indications of the basis of the authorization (for example an image of the presented authorization document(s) and/or a database from which information was retrieved) and/or timing and/or location and/or system on which the process was conducted.

[00108] In various embodiments, processing unit 120 can obtain the biometric identification data of authorized subject 90 being acquired by substance delivery device 130 or by the oral sampling probe associated therewith and simultaneously (or substantially simultaneously) verify that substance delivery device 130 is being used by authorized subject 90 and not by another unauthorized subject (e.g., as described hereinafter). Upon the verification thereof, processing unit 120 can associate the biometric identification data with the identity and the authorization of authorized subject 90 and/or with an authorization indication and register the association thereof. Processing unit 120 can store the registration thereof in memory 150 or in a memory of substance delivery device 130. In some embodiments, processing unit 120 can verify that substance delivery device 130 is being used by authorized subject 90 and (e.g., as described hereinafter) while the substance delivery device 130 is acquiring the biometric identification data of subject 90 without the biometric identification data itself being provided to processing unit 120.

[00109] The registration of the biometric identification data of authorized subject 90 with the identity and the authorization of authorized subject 90 can be performed only once, for example, during or prior to the first use of substance delivery device 130 by subject 90. This can, for example, eliminate a need in accessing external databases, e.g., identification and authorization database 70, during subsequent uses of substance delivery device 130. For example, once registered, the authorized subject 90 can be authenticated based on the biometric identification data of authorized subject 90 being acquired by substance delivery device 130.

[00110] In some embodiments, processing unit 120 can set one or more limitations on the authorization of authorized subject 90, when registering the biometric identification data of authorized subject 90 with the authorization thereof. For example, the limitation(s) can include an expiration term on the authorization, a maximal usage of a substance within a given timeframe, etc. In some embodiments, processing unit 120 can require a repeat of the registration upon in order to exceed the registered limitation(s). In some embodiments, system 100 and/or substance delivery device 130 issues a notification indicating that a term of registration has expired, and a new registration is required to allow further substance delivery.

[00111] In some embodiments, substance delivery device 130 includes age sorting. In some embodiments, once an individual or subject is registered, age sorting is no longer operative. This can be beneficial when a subject of age is not identified as such by the age sorter, and the device will not be useful for any person who is not registered. In some embodiments, once an individual or a subject is registered, age sorting is performed only in the event that a subject trying to use substance delivery device 130 is registered. This can be beneficial when an individual of age is not identified as such by the age sorter, such that whoever is registered can use the device but if it is taken by another subject, that subject will not able to use it if not identified by the age sorter as being of age.

[00112] In some embodiments, processing unit 120 can control camera 110 to obtain subject facial and device data 114. Subject facial and device data 114 can be indicative of a facial image of subject 90 (or at least a portion thereof) and an image of substance delivery device 130 (or at least a portion thereof) while in use by subject 90 can acquire the biometric identification data of subject 90.

[00113] Processing unit 120 can determine, based on subject facial and device data 114, whether the image of substance delivery device 130 is within a predefined geometric relation to the facial image of subject 90 to confirm that substance delivery device 130 is used by authorized subject 90. For example, when substance delivery device is capable of performing the oral authentication, processing unit 120 can lock on and track a location of the facial image of subject 90 in subject facial and device data 114.

[00114] In some embodiments, substance delivery device 130 can include a transmitter 132 capable of transmitting an output signal 133 (e.g., as shown in Figs. 1C and ID). In some embodiments, processing unit 120 may control transmitter 132 of substance delivery device 130 to transmit output signal 133. Output signal 133 may, for example, include one or more electromagnetic waves.

[00115] In some embodiments, output signal 133 can be in a visible light wavelength range. In this case, output signal 133 can be detectable by camera 110 (e.g., as shown in Fig. 1C). In some embodiments, processing unit 120 can determine, based on subject facial and device data 114, whether that substance delivery device 130 is used by authorized subject 90. For example, processing unit 120 can determine, based on subject facial and device data 114, that an image and/or direction of output signal 133 is within a predefined geometric relation to the facial image of subject 90 to confirm that substance delivery device 130 is used by authorized subject 90.

[00116] In some other embodiments, output signal 133 can be not in the visible light wavelength range. In this case, system 100 can include a receiver 160 capable of receiving output signal 133 (e.g., as shown in Fig. ID). In some embodiments, processing unit 120 can determine a direction of received output signal 133. Processing unit 120 can further determine, based on the determined direction of received output signal 133 and subject facial data 112/subject facial and device data 114, whether substance delivery device 130 is used by authorized subject 90. For example, processing unit 120 can determine a real-world location of a face of subject 90 based on at least one of: subject facial data 112 and subject facial and device data 114, determine a real-world location of substance delivery device 130 based on the determined direction of received output signal 133 and determine that the real-world location of substance delivery device 130 is within a predetermined geometric relation to the real- world location of the face of subject 90 to confirm that substance delivery device 130 is used by authorized subject 90.

[00117] Output signal 133 transmittable by transmitter 132 can have at least one output signal property. Examples for output signals and their property include visible light, infrared light, radio frequency transmission and any combination thereof in any spatial and/or temporal pattern. For example, output signal 133 can include a pattern or variations of output signal properties. The output signal property can, for example, include wavelength, color (e.g., in the case of output signal 133 within the visible light wavelength range of the electromagnetic spectrum), timing, duration, number of signal sources in transmitter 132, intensity, frequency, etc. Optionally, the signal may include one or more signals with partial or complete overlaps.

[00118] In some embodiments, the at least one output signal property of output signal 133 can be unique to substance delivery device 130. In some embodiments, the at least one unique output signal property of output signal 133 can be defined by processing unit 120 when substance delivery device 130 is connected thereto. In various embodiments, the at least one unique output signal property of output signal 133 can be selected and/or changed by processing unit 120 every time when substance delivery device 130 is connected thereto or at predetermined time intervals (e.g., every week, month, etc.). In some embodiments, detection of the at least one unique signal property of output signal 133 is included in the determination that substance delivery device 130 is used by authorized subject 90.

[00119] For example, the unique signal property of output signal 133 may include a timing (e.g., a temporal correlation) of transmission of output signal 133, or a portion thereof, by substance delivery device 130. The timing may be defined by processing unit 120 relative to the timing of communication/connection 111 between substance delivery device 130 and processing unit 120 (e.g., via wired communication or wireless communication, such as via Wi-Fi and/or Bluetooth). The wired or wireless communication/connection 111 can be provided by processing unit 120 to substance delivery device 130, thereby prompting the substance delivery device 130 to obtain the biometric identification data and transmit the output signal 133 at a defined time. The wired or wireless communication can be provided to processing unit 120 by substance delivery device 130 at the defined temporal correlation with the transmitting of the output signal 133 and obtaining the biometric identification data. Detection of transmission of output signal 133 according to the preset timing may be part of the determination that substance delivery device 130 is used by authorized subject 90. For example, a timing of a detected output signal that differs from the preset timing may indicate that the detected output signal has been transmitted by different substance delivery device and not by substance delivery device 130 that is communication/connection 111 with processing unit 120.

[00120] In some embodiments, a controller of substance delivery device 130 can encode the biometric identification data of subject 90 in output signal 133 transmittable by transmitter 132. For example, processing unit 120 or a controller of substance delivery device 130 can define the at least one output signal property or the pattern thereof to encode the biometric identification data of subject 90. In some embodiments, processing unit 120 can determine whether substance delivery device 130 is used by authorized subject 90 further based on the biometric identification data encoded in output signal 133 and comparison thereof to the biometric identification data being registered by system 100 on substance delivery device 130. For example, processing unit 120 can receive biometric identification data from substance delivery device 130 by communication/connection 111 (e.g. by wireless or wired communication) and compare it to the detected output signal 133. Only in the event that there is a match, system 100 will authorize substance delivery device 130 to register subject 90. For example, system 100 can transmit to the controller of substance delivery device 130 the detected output signal and the controller will compare it with the acquired biometric identification data and will perform the registration only in the event that there is a match between them.

[00121] Reference is now made to Fig. IE, depicting an example for preventing registration of an individual who is not authenticated by system 100, according to some embodiments of the invention.

[00122] In example depicted in Fig. IE, subject 90 has been identified as an authorized individual by system 100, essentially as described above with respect to Figs. 1A and IB and subject 91 has not been identified (for any reason). For example, subject 90 may be of age (e.g., older than 18 or 21 years) and subject 91 may be underage (e.g., younger than 18 or 21 years) or simply not authorized by the system for any other reason (including, for example due, to a system limitation or to not providing ready documentation).

[00123] In Fig. IE, oral sampling probe or device 130 is held by unauthorized subject 91 and is in communication 111 with system 100, while the authorized individual (subject 90) uses a sampling probe or device 1300. In this example, system 100 may identify via imaging that authorized subject 90 is in contact with a sampling probe or device. However, system 100 cannot confirm that subject 90 is using probe or device 130, and therefore registration cannot be completed. In some examples output signal 1330 may be received by system 100 but not have a unique property associated with device 130. In some examples, output signal 133 is not received by system 100. In some examples, output signal 133 is received by the system but is not identified as being collocated with the authorized individual (subject 90).

[00124] While Fig. IE was depicted such that the output signal 133 is detectible by camera 110 (as depicted in Fig. 1C), the same may be obtainable with an output signal 133 being detectible with receiver 160 (as depicted in Fig. ID). It is also noted that unauthorized subject 91 may be imaged by camera 100 together with subject 90, but using image processing, system 100 can be capable of focusing on subject 90 and ignoring other individuals in its frame. Optionally, if more than one individual is detected in a frame of camera 110, system 100 can instruct subject 90 to reposition one or more of the camera, subject 90 and other subjects such that only subject 90 would be recognizable within the frame.

[00125] Some embodiments may provide a system for registering a subject in association with a documented property of the subject using an oral sampling probe. The system may be similar to system 100 described above with respect to Figs. 1 A, IB, 1C, ID and IE, with probe replacing the substance delivery device 130 depicted in these figures. The system may include a camera (e.g., similar to camera 110 described above with respect to Figs. 1A, IB, 1C and ID), a computing device and a processing unit (e.g., similar to processing unit 120 described Figs. 1A, IB, 1C and ID) connected with the computing device.

[00126] The camera can obtain subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject.

[00127] The computing device may be configured to connect to the oral sampling probe. In some embodiments, the oral sampling probe can be included in a substance delivery device (e.g., substance delivery device 130 described above with respect to Figs. 1A, IB, 1C and ID). In some embodiments, the oral sampling probe may be any oral probe capable of obtaining an oral signature of the subject. For example, the oral sampling probe may be similar to the oral sampling probe described above with respect to Figs. 1A, IB, 1C and ID. In some embodiments, the oral sampling probe can be associated with at least one of: a personal device, fluid delivery device, substance delivery device, personal digital assistant (PDA), an electronic device, or breath testing device, etc.

[00128] The processing unit may be configured to obtain individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with the documented property of the individual (e.g., as described above with respect to Figs. 1A, IB, 1C and ID).

[00129] The documented property can be any property that is documented on an official record (e.g., federal, organizational, DMV, etc.) in association with a facial image data (or data that allows derivation of the facial image. For example, the documented property can be a license to drive, license to use a drug, age, name, identification/social security/passport number, certification, etc. The documented property is not necessarily indicative of an authorization.

[00130] The processing unit may be configured to determine whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property (e.g., as described above with respect to Figs. 1A, IB, 1C and ID).

[00131] The processing unit may be configured to determine whether a probe is being used by the authorized subject while the probe is obtaining biometric identification data (e.g., as described above with respect to Figs. 1 A, IB, 1C and ID). For example, the probe can include a transmitter (e.g., such as transmitter 132 described above with respect to Figs. 1C and ID) capable of transmitting an output signal (e.g., such as output signal 133 described above with respect to Figs. 1C and ID). In some embodiments, the processing unit may control the transmitter of the probe to transmit the output signal. The output signal may, for example, include one or more electromagnetic waves. In some embodiments, the processing unit can determine, based on subject facial and device data, whether that probe is used by the authorized subject. For example, the processing unit can determine, based on subject facial and device data, that an image and/or direction of the output signal is within a predefined geometric relation to the facial image of the subject to confirm that the probe is used by the authorized subject. Optionally, the output signal includes a unique signal property. In some embodiments, detection of the at least one unique signal property of the output signal is included in the determination that the probe is used by the authorized subject.

[00132] The processing unit may be configured to register the biometric identification data of the subject according to the documented property based on the determinations (e.g., as described above with respect to Figs. 1A, IB, 1C and ID).

[00133] The system may be used for, for example, registering the biometric identification data in database of individuals (e.g., age, license, etc.). Optionally, the database is a databased on authorized individuals only, and inclusion of an oral signature is such database is sufficient indication of the authorization of the individual to which the oral signature belongs. Optionally, the oral signature is registered in a database in association with at least one documented property, and authorization is based on the documented property (e.g. if a registered date of birth indicates that the individual is above a defined age which is required for authorization).

[00134] Optionally, the system may be used for registering the biometric identification data on a device (e.g., a substance delivery device or breath testing device, for example to determined blood alcohol levels) only if the user is authorized, wherein the authorization is determined based on the documented property. In various examples, the system may be used for registering the documented property with the biometric ID for later retrieval (the next login may be with the bio ID and no camera). In some embodiments, the system may be used for registering the biometric identification data with the documented property that is an instruction for operation of the device (e.g., a treatment regimen, etc.).

[00135] Reference is now made to Fig. 2, which is a flowchart of a method of registration of a subject to use a substance delivery device, according to some embodiments of invention.

[00136] The method can be implemented by system 100, which can be configured to implement the method. It is noted that the method is not limited to the flowchart illustrated in Fig. 2 and to the corresponding description. For example, in various embodiments, the method needs not move through each illustrated box, or in exactly the same order as illustrated and described.

[00137] Some embodiments can include connecting a computing device to a substance delivery device (202). The connection can be wired or wireless (e.g. using WiFi and/or Bluetooth). For example, a subject can be instructed to use an application on the computing device (and possible download the application). Once downloaded, the application can provide a user interface to instruct the subject and/or obtain input from the subject. In some embodiments the user interface and/or the computing device are included in substance delivery device. The computing device can, for example, include processing unit 120 and the substance delivery device can be substance delivery device 130 described above with respect to Figs. 1A, IB, 1C, ID and IE.

[00138] Some embodiments can include obtaining, by the computing device, device -related data upon the connection of the substance delivery device to the computing device. The device -related data can, for example, include a serial number of substance delivery device, a type of substance delivery device (e.g., e-cigarette, vaporizer, medical device, non-medical device, etc.), a type of a substance within substance delivery device (e.g., controlled substance or not, type of substance, etc.), etc. In some embodiments some or all of the device-related data is input by the user via the user interface and is optionally confirmed based on the data received via the substance delivery device. [00139] Some embodiments can include obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject (204). For example, subject facial data 112 as described above with respect to Figs. 1A, IB, 1C and ID.

[00140] Some embodiments can include obtaining, by the computing device, individual facial and authorization data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an authorization of the individual (206). For example, individual facial and authorization data 116 as described above with respect to Figs. 1A, IB, 1C and ID.

[00141] Some embodiments can include obtaining the individual facial and authorization data based on an image of an authorization document of an individual taken by the camera. For example, as described above with respect to Figs. 1A, IB, 1C and ID.

[00142] Some embodiments can include obtaining the individual facial and authorization data from an identification and authorization database. For example, identification and authorization database 70 as described above with respect to Figs. 1 A, IB, 1C and ID. In some embodiments, the database or a portion thereof is stored locally in the system and/or on the substance delivery device. For example, once data is retrieved from a remote database, it is stored locally so that the system will no longer depend on communication, and the registration method can proceed regardless of the connection or even at a later day.

[00143] In some embodiments, the subject is instructed to input personal identification data (e.g. an ID number or social security number) before presenting an authorization document to the camera. In some embodiments, identification and/or authorization data is obtained directly from a remote database, based only on the facial image of the subject, as captured by the camera, and the subject is instructed to confirm or deny the identification. In some embodiments, both data from an official database and a captured authorization document are used to establish the data indicative of the facial image or part thereof and/or authorization of the authorized individual.

[00144] Some embodiments can include determining, by the computing device, whether the subject is an authorized subject, based on the subject facial data, the facial and authorization data and, optionally, based on the device-related data (208). For example, as described above with respect to Figs. 1A, IB, 1C and ID. In the event that the subject is not determined to be the authorized individual, the registration is rejected (213). [00145] Some embodiments can include repeating 204 if the subject is not the individual and/or if the subject changes position and/or location to an extent that might allow replacement or misidentification of the subject.

[00146] Some embodiments can include obtaining biometric identification data being acquired by the substance delivery device and simultaneously (or substantially simultaneously) receiving an output signal from the substance delivery device (210). In some embodiments, once the subject’s facial image is captured, it must remain in full view of the camera at all times (continuously or whenever checked, if checked periodically) until 210 is completed.

[00147] Various embodiments include determining whether the substance delivery device was being used by the subject while the biometric identification data was obtained (211) based on biometric identification data obtained and output signal received in 210. For example, as described above with respect to Figs. 1A, IB, 1C and ID. In the event that the subject is not determined that the substance delivery device was being used by the subject while the biometric identification data was obtained the registration is rejected (213).

[00148] In some embodiments, 208 is performed after 210, such that the subject is identified as being an authorized individual only after or concomitantly with the determination whether the substance delivery device was being used by the subject while the biometric identification data was obtained.

[00149] Some embodiments can include obtaining, by the camera, subject facial and device data indicative of a facial image, or at least a portion of the facial image, of the subject and an image of the substance delivery device or at least a portion of the substance delivery device. For example, subject facial and device data 114 described above with respect to Figs. IB, 1C and ID. Some embodiments can include determining whether the substance delivery device is being used by the subject based on the subject facial and device data. Some embodiments can include determining, by the computing device, based on the subject facial and device data, whether the image of the substance delivery device is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the subject. Some embodiments can include tracking a location of the facial image of the subject in the subject facial data. In some embodiments, such tracking covers the entire span of time covering both 204 and 210. In such embodiments, if tracking is interrupted for any reason, the method is either terminated without registration and/or the tracking period 204 and 210 are repeated. For example, as described above with respect to Figs. IB, 1C and ID. In various embodiments if tracking interruptions are repeated above a predefined number of times, the registration is rejected. [00150] In some embodiments, if registration is rejected more than a predefined number of times (e.g. more than 5) the system locks down for a predefined period (e.g. 15 minutes) before the method can be repeated. In some embodiments, if registration is rejected more than a predefined number of times (e.g. more than 5 or more than 10) an alarm (215) or notification is issued by the system and/or the controller of substance delivery device. In some embodiments, if registration is rejected more than a predefined number of times (e.g. more than 5 or more than 10) the substance delivery device and/or the system is locked down such that performing the method again necessitates involvement of a service provider with license and/or tools to override the lock down.

[00151] In some embodiments, if the determination that the subject is authorized (208) fails more than a predefined number of times (e.g. more than 5) the system opens a communication channel or recommends to the subject to involve a remote service provider. The service provider can be contacted via teleconference to perform 208 in real time, while the subject’s facial image is being tracked.

[00152] Various embodiments can include detecting, by the camera or by a receiver associated with the computing device, an output signal transmittable by the substance delivery device. For example, output signal 133 transmittable by transmitter 132 as described above with respect to Figs. 1C and ID.

[00153] In some embodiments, the output signal can include one or more electromagnetic waves in a visible light wavelength range (as described above with respect to Fig. 1C) or any other frequency. Some embodiments can include detecting, by the camera, an output signal transmittable by the substance delivery device. Some embodiments can include determining, by the computing device, based on the subject facial and device data, that an image of the output signal is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the subject. For example, as described above with respect to Fig. 1C.

[00154] In some embodiments, the output signal can be not in visible light wavelength range. Some embodiments can include receiving, by a receiver associated with the computing device, the output signal. In some embodiments the output signal is a narrow beam and the system instructs the subject to assume a position such that the signal is directed at the receiver and the user’ s face and the substance delivery device are captured by the camera.

[00155] Some embodiments can include determining, by the computing device, a direction of received output signal. Some embodiments can include determining, based on the determined direction of the received output signal and at least one of: the subject facial data and the subject facial and device data, whether the substance delivery device is used by the subject. For example, the computing device can a real-world location of a face of the subject based on at least one of: the subject data and the subject facial and device data, a real-world location of the substance delivery device based on the determined direction of received output signal and determine that the real-world location of the substance delivery device is within a predetermined geometric relation to the real-world location of the face of the subject to confirm that the substance delivery device is used by the subject. For example, as described above with respect to Fig. ID.

[00156] The output signal transmittable by the transmitter can have at least one output signal property. For example, the output signal can include a pattern or variations of output signal properties. The output signal property can, for example, include color (e.g., in the case the output signal is within the visible light wavelength range of the electromagnetic spectrum), timing, duration, number of signal sources in the transmitter, intercity, frequency, etc. In some embodiments, the at least one output signal property of the output signal can be unique to the substance delivery device. For example, as described above with respect to Figs. 1C and ID.

[00157] Some embodiments can include controlling, by the computing device, the transmitter of the substance delivery device to transmit the output signal. Some embodiments can include defining, by the computing device, the at least one output signal property of the output signal, when the substance delivery device is connected thereto. Various embodiments can include changing, by the computing device, the at least one output signal property of the output signal every time when the substance delivery device is connected thereto or at predetermined time intervals (e.g., every week, month, etc.). For example, as described above with respect to Figs. 1C and ID.

[00158] Some embodiments can include determining, by the computing device, whether the substance delivery device is used by the subject further based on the biometric identification data encoded in the output signal. Some embodiments can include controlling, by the computing device, the transmitter of the substance delivery device to encode the biometric identification data of the subject using the substance delivery device in the output signal. For example, as described above with respect to Figs. 1C and ID.

[00159] Some embodiments can include repeating 210, 206, and/or204, if the device is rejected. Some embodiments include issuing an alarm (215), and/or other notification in the event that the method or part thereof is repeated more than a predefined number of times (e.g. 5 or 10). Some embodiments include locking the system and/or the substance delivery device for a predefined period of time or indefinitely, in the event that the method or part thereof is repeated more than a predefined number of times (e.g. 5 or 10). In some embodiments if the method or art thereof is repeated more than a predefined number of times (e.g. more than 5 or more than 10) the substance delivery device and/or the system is locked down such that performing the method again necessitates involvement of a service provider with license and/or tools to override the lock down.

[00160] Some embodiments can include associating, by the computing device, the biometric identification data of the subject being acquired by the substance delivery device with an identity and/or an authorization of the subject and registering the association thereof, if the substance delivery device is being used by the subject (212). For example, as described above with respect to Figs. 1A, IB, 1C and ID.

[00161] Some embodiments can include setting, by the computing device, one or more limitations on the authorization of the subject when registering the biometric identification data of the subject with the authorization thereof. For example, the limitation(s) can include an expiration term on the authorization, a maximal usage of a substance within a given timeframe, etc.). Some embodiments can include requiring, by the computing device, a repeat of the registration upon restriction of the one or more limitations. For example, as described above with respect to Figs. 1 A, IB, 1C and ID.

[00162] Some embodiments may provide a method of registering a subject in association with a documented property of the subject using an oral sampling probe. The method may be performed by, for example, system 100 described above with respect to Figs. 1A, IB, 1C and ID.

[00163] Some embodiments may include connecting a computing device to an oral sampling probe (e.g., as described above with respect to Figs. 1A, IB, 1C and ID). In some embodiments, the oral sampling probe can be connectable to a substance delivery device (e.g., substance delivery device 130 described above with respect to Figs. 1A, IB, 1C and ID). In some embodiments, the oral sampling probe may be any oral probe capable of obtaining an oral signature of the subject. For example, the oral sampling probe may be similar to the oral sampling probe described above with respect to Figs. 1A, IB, 1C and ID. In some embodiments, the oral sampling probe can be associated with at least one of: an oral signature database, a personal device, fluid delivery device, substance delivery device, inhaler, e-cigarette, PDA, an electronic device, breath testing device, etc. In some embodiment, the probe may be used for registration only and may not be associate with any device once the registration is completed, the data comprising a property of an individual in association with their oral signature is stored on a distinct memory, which can be accessed upon need.

[00164] Some embodiments may include obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of the subject (e.g., as described above with respect to Figs. 1A, IB, 1C and ID). [00165] Some embodiments may include obtaining, by the computing device, individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with a documented property of the individual (e.g., as described above with respect to Figs. 1 A, IB, 1C and ID). The documented property can be any property that is documented on an official record (e.g., federal, organizational, DMV, etc.) in association with a facial image data (or data that allows derivation of the facial image. For example, the documented property can be a license to drive, license to use a drug, age, name, identification/social security/passport number, certification, etc. The documented property is not necessarily indicative of an authorization.

[00166] Some embodiments may include determining, by the computing device, whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property (e.g., as described above with respect to Figs. 1A, IB, 1C and ID).

[00167] Some embodiments may include obtaining, by the probe, biometric identification data being acquired by the probe and simultaneously determining by the computing device whether the probe is being used by the subject (e.g., as described above with respect to Figs. 1A, IB, 1C and ID). For example, the probe can include a transmitter (e.g., transmitter 132 described above with respect to Figs. 1C and ID) capable of transmitting an output signal (e.g., output signal 133 described above with respect to Figs. 1C and ID). In some embodiments, the computing device may control the transmitter of the probe to transmit the output signal. The output signal may, for example, include one or more electromagnetic waves. In some embodiments, the computing device can determine, based on subject facial and device data, whether that probe is used by the authorized subject. For example, the computing device can determine, based on subject facial and device data, that an image and/or direction of the output signal is within a predefined geometric relation to the facial image of the subject to confirm that the probe is used by the authorized subject. Optionally, the output signal includes a unique signal property. In some embodiments, detection of the at least one unique signal property of the output signal is included in the determination that the probe is used by the authorized subject.

[00168] Some embodiments may include registering by the computing device the biometric identification data of the subject according to the documented property based on the determinations (e.g., as described above with respect to Figs. 1A, IB, 1C and ID).

[00169] The method may be used for, for example, registering the biometric identification data in database of individuals (e.g., age, license, etc.). Optionally the database is a databased on authorized individuals only, and inclusion of an oral signature is such database is sufficient indication of the authorization of the individual to which the oral signature belongs. Optionally, the oral signature is registered in a database in association with at least one documented property, and authorization is based on the documented property (e.g. if a registered date of birth indicates that the individual is above a defined age which is required for authorization).

[00170] In various examples, the method may be used for registering the biometric identification data on a device (e.g., a substance delivery device or breath testing device, for example to determined blood alcohol levels) only if the user is authorized, wherein the authorization is determined based on the documented property. In some embodiments, the method may be used for registering the documented property with the biometric ID for later retrieval (the next login may be with the bio ID and no camera). In various embodiments, the method may be used for registering the biometric identification data with the documented property that is an instruction for operation of the device (e.g., a treatment regimen, etc.).

[00171] Reference is now made to Fig. 3, which is a block diagram of a substance delivery device 300 for delivery of a substance to a subject, according to some embodiments.

[00172] The substance delivery device 300 includes a substance delivery portion 314, an authentication module 312, an opening 326. In some embodiments, the substance delivery device is a device that may deliver to a subject a fluid (e.g., a gas, such as air and/or a liquid), optionally via the subject’s mouth. In some embodiments, the substance delivery device may deliver a fluid into a subject’s lungs. The delivered fluid may serve as a carrier of a substance. In the case of pulmonary delivery, the gas (optionally air) can serve as a carrier for the substance. The substance may be inhaled in any form, including for example vapor, powder and/or aerosol. Optionally, the devices may be electronically controlled. In some embodiments, the substance delivery device may be a medical device. Examples for substance delivery devices for pulmonary delivery may include e-cigarettes, vaping devices and inhalers, used for medical and/or non-medical purposes. In some embodiments, the substance delivery device may be a device though which a subject may inhale air solely for the operation of authentication module 312.

[00173] The substance delivery portion 314 includes a reservoir 318, an actuator 316, conduit

320 (e.g., dispensing duct) and a valve 323. The authentication module 312 includes a processor 334, memory 331, storage 332, communication module 330 and a display 328.

[00174] The reservoir 318 can be coupled to the actuator 316 and the opening 326 via a conduit 320 (e.g., a dispensing duct). The actuator 316 can be coupled to the valve 323 positioned within the conduit 320 or at any other position that can regulate flow of the fluid within the substance delivery device. The processor 334 can be coupled to the wave generator 322, the wave sensor 324, the memory 331, the storage 332, the communication module 330, and/or the display 328.

[00175] The wave generator 322 can be an air pressure wave generator (e.g., generating audio waves, ultrasound waves). The wave generator 322 can be a low frequency buzzer. The wave generator 322 can be a MEMS based component. The wave generator 322 can transmit sound waves or electromagnetic waves. The wave generator 322 can transmit a single pulse wave and/or a plurality of pulsed waves.

[00176] In some embodiments, the wave generator 322 may by a speaker. In some embodiments wave generator 322 is a or includes a passive structure positioned in a substance delivery device such that it produces noise as air flows through or next to it (e.g. plurality of flapping sheets or a fan). In some embodiment a passive wave generator is breath actuated.

[00177] In some embodiments, the wave generator 322 transmits electromagnetic waves having one or more frequencies of visible light, ultra-violet light, infra-red light, and radiofrequency. In some embodiments, other ranges of electromagnetic waves may also be applicable. In some embodiments, the wave generator 322 transmits sound waves. In some embodiments, the transmitted sound waves are in the ultrasound frequency range. In some embodiments, the transmitted waves are or include waves at a range of 20 kilohertz to 1 gigahertz. In some embodiments, the transmitted waves are or include waves at a range of 1 gigahertz to 3 gigahertz, or higher. In some embodiments, the transmitted sound waves are in the frequency range of human hearing, e.g., have a frequency between 20 hertz to 20 kilohertz. In some embodiments, transmitted soundwaves have a frequency below 400Hz. In some embodiments, the sound waves have a frequency range that may be annoying for subjects below a threshold age but inaudible for older ones. For example, sound waves between 15-20 kilohertz are typically only heard by children. Thus, the device can transmit sound waves in this range to cause children to be unable and/or reluctant to use the substance delivery device 300. In some embodiments, the sound waves are inaudible to the human ear (e.g., to avoid causing mental or physical harm).

[00178] The wave sensor 324 can be a sound sensor (e.g., e.g., microphone, directional microphone array). The sensor 324 can be a piezoelectric microphone. The sensor 324 can be a MEMS based component. The sensor 324 can comprise a noise dumper, in order to reduce the recorded background noise and increase the portion of recorded data typical to the subject. The sensor 324 can comprise a transducer, operative to convert received waves into electrical signals. Alternatively (not shown) the sensor and the converter can be separate components, each of them may be either analog or digital. [00179] The authentication module 312 (or processor 334) can be configured to communicate with a remote device (e.g., a network server, a cloud based server, etc., medical service provider, etc.), for example, to update an operating system, to obtain and/or update, authentication data relating to an authorized subject or subjects, a list with details of one or more authorized subjects, and/or administration scheme or schemes associated with the authorized subject or subjects. Authentication module 312 may be distributed in more than one location. For example, the display 328 and/or storage 332 may be in a smartphone. In various embodiments, one or more elements of the authentication module 312 are housed on a computing device that is in wired or wireless communication with the substance delivery device 300.

[00180] The display 328 can display information relating to the use of substance delivery device 300 and/or to the subject/s, or to a care worker, or others. The memory 331 can store use information, authentication information, registration information or any combination thereof. In various embodiments, the substance delivery device 300 includes a plurality of wave generators and/or a plurality of sensors. In various embodiments, one or more wave generators and one or more sensors are in the same housing.

[00181] In some embodiments, the valve 323 is a pressure dependent flow valve such that the substance only flows through the valve during inhalation, for example, when a generated inhalation pressure exceeds a threshold. In some embodiments, the wave generator 322 transmits only partially or only as long as the valve 323 is closed. In various embodiments, the valve is electrical and/or mechanical.

[00182] In some embodiments, the substance delivery device 300 does not include the authentication module 312 and only includes a processor. In some embodiments, the substance delivery device 300 does not include the valve 323. In various embodiments, one or more of the elements of the authentication module 312 are excluded from the substance delivery device 300.

[00183] The components of the substance delivery device 300 as shown in Fig. 3 can be housed in a single housing or in multiple housings. In various embodiments, reservoir 318 can house one or more substances of one or more cannabis derived substances, cannabinoids, prescribed drugs, medicine, pharmaceuticals, nicotine, tobacco, any substance known for smoking or smoking alternative, substances to cause various flavors and/or scents, controlled substances and substances derived from cannabis, substances derived from tobacco, or any substance as is known in the art.

[00184] The substance delivery device 300 can be an electronic substance delivery device and/or be battery/solar powered. [00185] In some embodiments, the substance delivery device 300 includes a notification module (e.g. an alarm). The notification module can be issue audio notification, a visual notification or both (one or more of which may include an alarm). The notification can be triggered if the subject is identified as being below an age threshold and/or is identified as not being an authorized subject. In some embodiments, the alarm is located on a remote device (e.g., a smartphone and/or other computer in communication with the authentication module).

[00186] During operation the authentication module 312 can instruct the wave generator 322 to transmit waves when the opening 326 (e.g., mouthpiece) is positioned towards a mouth 32 (e.g., lips, tissue surrounding the lips, and/or oral cavity) of a subject, and the wave generator can transmit waves 34 towards the subject. This can take place, for example, upon request (e.g., pressing on a button, inhaling through a substance delivery device, placing the mouthpiece in one’s mouth, providing an activation authorization, for example via software or by inputting a code etc.) and/or upon use (first use and/or other uses). As shown in Fig. 3, the opening 326 is positioned within the oral cavity 30, however, the opening 326 can be positioned in any position that allows the waves generated by the wave generator to impinge upon the mouth 32.

[00187] At least a portion of the waves can reflect from the mouth 32 of the subject causing reflections 36 that are detected by the sensor 324. In some embodiments, at least a portion of the waves 34 are absorbed by the oral cavity 30. In some embodiments, a sensor (not shown) is positioned a location that allows the sensor to detect absorption of the waves by the oral cavity 30 and/or mouth 32.

[00188] In some embodiments at least one of wave generator 322 and sensor 324 is positioned in direct physical contact with the mouth during the wave transmittal. In some embodiments, at least one of wave generator 322 and sensor 324 is positioned between the lips and in direct physical contact with one or both of the lips. In some embodiments at least one of wave generator 322 and sensor 324 is positioned in direct physical contact with one or more teeth. In some embodiments at least one of wave generator 322 and sensor 324 is positioned in direct physical contact with one or more of the tongues, and/or inner part of the mouth. In some embodiments wave generator 322 and sensor 324 are positioned within the subject’s oral cavity and are not in contact with any organs (e.g. lips, teeth, inner part of mouth, and/or tongue).

[00189] In some of the embodiments where at least one of wave generator 322 and sensor 324 is enclosed within an enclosure, at least one enclosure is positioned in direct physical contact with a part of the mouth during the wave transmittal. In some embodiments, at least one enclosure is positioned between the lips and in direct physical contact with one or both of the lips. In some embodiments at least one enclosure is positioned in direct physical contact with one or more teeth. In some embodiments at least one enclosure is positioned in direct physical contact with one or more of the tongues, and/or inner part of the mouth. In some embodiments wave all enclosures are positioned within the subject’s oral cavity and are not in contact with any organs (e.g. lips, teeth, inner part of mouth, and/or tongue).

[00190] The wave sensor 324 can transmit the detected reflections to the processor 334. The processor 334 can process the detected reflections to determine whether the subject has permission to use the substance delivery device 300. If the subject has permission to use the substance delivery device 300, the subject can be authenticated.

[00191] Upon a successful authentication of the subject, the actuator 316 can activate the delivery of a substance housed within the reservoir 318 and/or control the valve 323 to a particular position, for example, fully open or partially open. The actuator 316 can activate a heating element (not shown) that heats the substance housed within the reservoir 318. The heated substance can flow through the conduit 320 into the oral cavity 30 of the subject. Optionally, the heated substance can undergo a chemical and/or structural change as a result of temperature its heating and/cooling. Optionally, the substance in the reservoir is liquid form and is optionally released by one or more of heating and pressure release. In some embodiments, the substance in the reservoir is in powder form and is released by heating and/or by extracting (or dispensing) powder away from the reservoir. In some embodiments the substance is in plant material is optionally released by heating or vaporization. In some embodiments, the substance is association with an air permeable structure (e.g., a pallet) from which it is extracted by allowing airflow through the structure and/or heating the structure. In some embodiments, the processor 334 controls the valve 323.

[00192] As is understood in the art, the substance delivery device 300 can have a reservoir that is empty and filled/refilled with one or more substances. Optionally, the reservoir is replaceable. For example, in some embodiments the reservoir is in the form of distinct substance carrying units each configured for one or several substance deliveries events (e.g., capsules, chips, cannister, etc.). Such reservoirs can be stored in a magazine for automatic replacing by the substance delivery device, or are replaceable manually.

[00193] In some embodiments, the substance delivery device 300 can require once or several (n number) authentications prior to delivering the substance, where n is an integer value. In various embodiments, during operation, the subject is repeatedly authenticated during use of the substance delivery device 300. The repeated authentication can occur by the processor 334 causing the wave generator 322 to transmit waves according to the desired authentication. The authentication can occur at a predefined time interval, after a triggering event, once or a predetermined number of times, with a periodicity over a predefined duration, or any combination thereof. The predefined duration and/or the periodicity can be input by a subject and/or be based on a type of the substance delivery device 300 and/or the type of substance to be delivered. For example, for a substance delivery device of a tobacco or nicotine e-cigarette the predefined interval can be 3 -5 pulses per second. In some embodiments, for a substance delivery device of a pharmaceutical or controlled substance, the predefined interval can be 5-10 pulses per second. The predetermined time interval can be constant (e.g., every predetermined number of milliseconds, for example, in any of the following ranges: 5-50 milliseconds, 50-200 milliseconds, 200-1000 milliseconds, every 1 second, every 5 seconds or every 10 seconds). In some embodiments, the predetermined time interval varies. For example, as substance delivery or inhalation (or exhalation) progresses, the periodicity may drop (e.g., from a periodicity of reiterating the authentication module every 30 milliseconds to reiterating it every 60 milliseconds, etc.). Optionally, for authentication that barely passes (e.g., a very young adult is identified) periodicity of the authentication process can increase (e.g., from a periodicity of reiterating the authentication module every 30 milliseconds to reiterating it every 10 milliseconds, etc.).

[00194] In some embodiments, the substance delivery device 300 can require several (n number) transmission to authenticate, where n is an integer value. For example, the substance delivery device 300 can require that the wave generator transmit the wave 5 times and receive the wave 5 times, before making a determination of authentication. The determination can then be based on combined analysis of the received waves. In this manner, the authentication of a subject can be more accurate.

[00195] The triggering event can be actuation of the device by a subject. For example, by turning the device on, by releasing a substance from a storage location (reservoir or magazine holding reservoirs) into a use location, and/or by sensing that inhalation through the device has commenced (e.g., sensing a drop in air pressure by a sensor in the device, such as in breath actuated inhalers or by sensing a change in temperature, such as a thermometer being put in a individual’s mouth).

[00196] The triggering event can be that the substance delivery device 300 has changed its position or moved a distance greater than a predefined minimal range from a location or position where an authorization occurred. For example, a subject, during a single inhalation is typically not supposed to move more than a minimal range of movement typical of inhalation (e.g., unless an inhalation device is passed on to another subject after authentication, which it may be desired to prevent). After the subject is authenticated, if the authentication module 312 determines that the substance delivery device has changed its position significantly (e.g., vertical displacement from a mouth elevation of the authorized subject to a waist elevation, or horizontal displacement, and/or tilting by more than 30 degrees, indicative of passing the inhalation device to another subject) delivery of the substance can stop.

[00197] The substance delivery device 300 can include a motion detection sensor (not shown).

The motion detection sensor can detect movement of the substance delivery device 300. In some embodiments, the motion detection sensor includes a processor to process waves detected by the sensor and transmit to the processor 334 if the predefined minimal range is exceeded. In some embodiments, the motion detection sensor can be in communication with the processor 334 and the processor 334 can determine if the predefined minimal range is exceeded.

[00198] In some embodiments, exceeding the predefined minimal range can cause the substance delivery device 300 to cease delivery of the substance (e.g., by closing the valve 323, shutting off power and/or causing a heating element to cool down) and/or cause the substance delivery device 300 to reset authentication (e.g., behave as if the subject had not been previously authenticated).

[00199] The authentication module 312 can be preprogrammed with one or more threshold values defining predefined minimal range. Optionally, once a person is registered and uses a substance delivery device, the threshold values are updated in view of the specific subject’s typical motion in use. The authentication may be repeated for each inhalation. This can prevent transfer of the substance delivery device from an authorized subject to one who is not authorized after the first inhalation while allowing the authorized subject to be in ordinary motion during use (e.g. taking a series of inhalations from an e-cigarette).

[00200] In some embodiments, the triggering event is inhalation of the subject. In some embodiments, each time inhalation of the subject is sensed, the substance delivery device 300 authenticates the subject.

[00201] In some embodiments, the substance delivery device 300 authenticates a subject at least once before delivery and at least once during delivery of the substance. In some embodiments, authentication by the substance delivery device 300 begins before delivery and overlaps a part of delivery.

[00202] The predefined minimal range can be an amount of movement that is typical during inhalation/exhalation. The predefined minimal range can be input by a subject. The predetermined number of times can be input by a subject. The predefined period of time can be based on an amount of time that the substance delivery device 300 typically takes to deliver the substance. One or more of the predefined period of time, the predefined minimal range, and the predetermined number of times can be based on substance type. [00203] In various embodiments, when the substance delivery device 300 includes a heating element, the heating element can be prevented from heating above a predefined threshold until authentication is performed. The predefined threshold can be a temperature slightly (e.g., 5-50 deg. C) lower than the substance vaporization temperature, to speed up the delivery time in the event that the subject is authenticated. In some embodiments heating commences only after the subject is authenticated.

[00204] In some embodiments, the wave generator 322 may be triggered to transmit waves in a specific manner. For example, wave transmission may be triggered upon initiation of inhalation by a current subject. Such initiation may be supervised, for example by an authorized subject (e.g., a medical doctor or a medical care worker, a seller at a point of sale, verifying authorization for a transaction, a welfare officer, a policeman, a pharmacist, a parent, etc.). Supervision may be most useful for wave transmission during a process of registration.

[00205] The substance delivery device 300 can be a medical inhaler, a vaporizer, or an e- cigarette.

[00206] Reference is now made to Fig. 4A and 4B, which are schematic diagrams of a substance delivery device 400 (e.g., substance delivery device 300 as described above in Fig. 3) according to some embodiments of the invention.

[00207] The substance delivery device 400 includes a housing 410. The housing 410 includes a LED light 412, an airflow aperture 414, a wave sensor aperture 416 and a wave generator aperture 418. During operation, waves exit the wave generator aperture 418, the wave sensor aperture 416 can detect reflected waves, and the airflow aperture 414 can permit a fluid to flow out of the device.

[00208] Fig. 4B shows some of the elements housed within the housing 410 of the substance delivery device 400. Electronics and control panel 420, a power unit 422, a wave sensor enclosure 424, an airflow conduit 426, a wave generator enclosure 428, a flexible seal 430 are shown positioned within the housing 410. The electronics and control panel 420 can include any of the elements as described above in Fig. 3. Flexible seal 430 can be made of a flexible material, such as silicon rubber, rubber of other kind, or flexible polymer material. In some embodiments the flexible seal is being in direct contact with the wave generator without having an enclosure therebetween. In some embodiments wave generator enclosure is made of a flexible material, such as silicon rubber or rubber of other kind or flexible polymer material. In some embodiments the wave generator is exposed to the sampled space (e.g., the mouth) via conduit. In some embodiments wave generator is a sound generator, e.g., a speaker, or buzzer and wave sensor is sound wave sensor, e.g., a microphone. In some embodiments, the sound wave sensor can comprise a noise dumper, in order to reduce the recorded background noise and increase the portion of recorded data typical to the subject. In some embodiments, the sound wave sensor is contact microphone, such as a piezoceramic microphone, which can be less sensitive to air vibrations than an air microphone. Each of the wave sensor enclosure 424 and wave generator enclosure 428 can have an open end in the direction of the subject’s mouth. The shape of each of enclosures 424, 428 may be tubular, have a conical tube shape, or otherwise cylindrical or irregular. Each of the enclosures 424, 428 can be hollow and have substantially the wave generator or the wave sensor completely enclosed therein. In some embodiments, each of the enclosures 424, 428 may contain a medium, within which the wave generator and/or the wave sensor are disposed.

[00209] The wave sensor enclosure 424 houses a wave sensor and has an end that terminates at or near the wave sensor aperture 416. The airflow conduit 426 connected to an interior portion of the substance delivery device 400 that out of which the fluid flows to the subject (e.g., the reservoir 318 as described above in Fig. 3). The wave generator enclosure 428 houses a wave generator (e.g., generator 322 as described above in Fig. 3) and terminates at wave generator cover 430 (e.g., a flexible seal). The flexible seal 430 can cover the wave sensor positioned within the wave generator enclosure 428 to prevent or reduce acoustic interruptions (e.g., noise) caused by friction. In some embodiments, the flexible seal 430 is not present. In some embodiments, the wave generator enclosure 428 and thus the wave sensor is positioned at a distance away from the wave sensor aperture 416 to, for example, prevent or minimize noise. The distance can be determined based on noise level, sensor sensitivity and wave generator power.

[00210] In various embodiments, the substance delivery device 400 includes a plurality of wave generators and/or a plurality of wave sensors. The plurality of wave generators can include or be an array of wave generators. The plurality of wave sensors can include or be an array of wave sensors. In various embodiments, some of the plurality of wave generators or all of the plurality of wave generators are enclosed. In various embodiments, the plurality of wave generators that are enclosed are in a single enclosure or multiple enclosures. In various embodiments, some of the plurality of wave sensors or all of the plurality of wave sensors are enclosed. In various embodiments, the plurality of wave sensors that are enclosed are in a single enclosure or multiple enclosures.

[00211] In some embodiments, each enclosure has the same media or different media. In some embodiments, the enclosures have a medium of air.

[00212] During operation, in some embodiments, with a plurality of wave generators, the plurality wave generators can be used simultaneous, sequentially or any combination thereof. In some embodiments, the plurality of wave generators transmit the same waves, different waves, or any combination thereof. In some embodiments, the plurality of wave sensors receive the same waves, different waves, or any combination thereof.

[00213] Reference is now made to Fig. 4C and Fig. 4D, Fig. 4C are graphs showing an example of a received wave without a cover on the wave sensor and Fig. 4D are graphs showing an example of the same received waves with a cover on the wave sensor. As shown, the received waves in Fig. 4C have noise that is not present in the received waves in Fig. 4D.

[00214] Reference is now made to Fig. 5, which is a flowchart of a method of authenticating a subject for delivery of a substance to the subject, according to some embodiments.

[00215] Some embodiments may include transmitting waves (e.g., generated via wave generator 322 as described above in Fig. 3) towards at least a portion of the subject’s mouth (510).

[00216] Some embodiments may include receiving reflected waves (e.g., via sensor 324 as described above in Fig. 3) that include at least a portion of reflections of the waves from the subject, at least a portion of absorption of the waves by the subject, or both (520). For example, transmitting (510) may be continuous, with receiving (520) being performed intermittently for only a portion of the received waves. In some such embodiments, transmitting may include repeated transmission of the same wave pattern a plurality of times, and optionally, receiving is timed to occur at the same time in each repetition.

[00217] Some embodiments may include processing the reflected waves (530). In some embodiments all of the waves received in 520 are used in the processing. In some embodiments, only a portion of the waves received in 520 are used in the processing. For example, transmitting (510) and receiving (520) may be continuous, with processing (530) being performed intermittently for only a portion of the received waves. In some such embodiments, transmitting may include repeated transmission of the same wave pattern a plurality of times, and optionally, processing is performed only for waves that were received at the same time in each repetition.

[00218] Processing the reflected waves can involve determining a signature of the subject and/or personal data associated with the subject (e.g., identification of nasal or tympanic cavity). In some embodiments, the processed waves can be analyzed by comparison against stored signatures of subjects who were previously registered and/or or registered as authorized to receive the substance (e.g., registered at a pharmacy database after a physician transmits a prescription to the pharmacy and/or age of date of birth previously verified, identification information stored in a database of subject).

[00219] In some embodiments, the reflected waves are analyzed to determine if the subject is a child or adult. In these embodiments, there is an intermediate gap of ages, around a threshold age, which may not be determined by wave reflection analysis, namely that the system may reach an ambiguous determination or otherwise that an adult is identified by the system as a child (or not identified as an adult) or vice versa - a child is identified as an adult (or is not identified as a child). In such cases, if mis identification prevents use by a subject that should have been authorized (e.g., an adult prevented from smoking tobacco as he is not identified as being an adult) the subject may revert to alternative methods of identification. For example, the subject may be registered on his device in such conditions that allow overriding the child/adult identification, for example, at a point of sale by showing valid identification documentation and proof of age. In such cases the seller can have the authority and/or tools (software, hardware, and/or password) required to enable registration of any subject. In some embodiments, the subject’s age and/or authorization and his oral signature are recorded on a mobile device (e.g., a token) that can be used for registration on devices as an override of child/adult identification, for example by way of wireless transfer of information (e.g., Bluetooth, Wi-Fi and/or RFID, etc.) between the mobile device and a controller associated with the device or purpose for which age identification is required. Storing these data and/or the communication can be encrypted to prevent ease of unauthorized override of the age identification.

[00220] An oral signature may be obtained in advance in a registration process, in which the authorized subject uses an authentication module (e.g., authentication module 312 of the same device) and data indicative of the wave reflection that are received and recorded from the subject’s mouth is saved as the wave signature for future comparison with obtained wave reflections during use of a device associated with the stored data or having access to the data. During the registration, the oral signature of the subject may be associated with an authorization indication and/or with an identity of the authorized subject and recorded in a memory. In some embodiments, a security token is required during the registration process. In some embodiments, the registration process only occurs once. In various embodiments, the reflected waves can be influenced by one or more features of the current subject’s parts of the mouth (e.g., oral cavity, larynx, pharynx, vocal cords, throat, tongue and/or other part of the oral cavity, as well as instantaneous conditions, such as, for example, having something in the mouth, such as a chewing gum, food leftover, retainer, throat lozenge and/or candy). The reflected waves can be influenced by the position of the tongue, or the position and orientation of the substance delivery device, and in particular the wave generator and/or the wave sensor, the current subject’s current activity (e.g. inhalation, exhalation, physical activity, rest, etc.). When used during inhalation, acquired reflections can be associated with specific points of time during the inhalation, which can correlate with changes within the oral cavity that normally occur during use of an inhalation device, and the analysis can take such timing into account. When used during exhalation, acquired reflections can be associated with specific points of time during the exhalation, which can correlate with changes within the oral cavity that normally occur during exhalation, and the analysis can take such timing into account.

[00221] In some embodiments, the reflected waves are normalized with respect predetermined reference wave signal of the sound of the environment. In some embodiments, noise is filtered (or substantially filtered), canceled (or substantially cancelled) or any combination thereof from the reflected waves. In some embodiments, the noise is environmental noise. In some embodiments, the portions of the received waves that are below a predefined threshold are filtered out. In some embodiments, the predefined threshold is between -6 and -14 Decibels. In some embodiments, the predefined threshold is between -7 and -12 Decibels and even between -9 and -12. In some embodiments, the predefined threshold is between -6 and -8 Decibels.

[00222] Some embodiments may include determining if the subject is an authorized subject

(540). In some embodiments the subject is determined to be an authorized based on the processed reflected waves. In some embodiments, additional identification data is used along with the received waves to determine if the subject is an authorized subject. For example, fingerprints, inhalation pattern, voice, retinal scan, breathing pattern, face recognition, and/or any biometric data. The biometric data can include gender, ethnicity, geographical origin, or any combination thereof. In some embodiments, the additional identification information includes historical use of the subject, a password and/or response to one or more security questions. In some embodiments, a likely age of the subject is determined based on the received waves to determine if the subject is authorized. For example, it can be desirable to restrict access of the substance delivery device to subjects above an age threshold. The determination can, for example, include determining that the subject is above a first threshold and/or that the subject is not below a second threshold. In some embodiments the first threshold and the second threshold are the same. In some embodiments, machine learning algorithms are used for authentication. In some embodiments, machine learning sorting algorithms are used for age determination.

[00223] In some embodiments, if the authentication is valid, then some embodiments may include determining if the subject complies with an age limitation based on the analysis of the reflected waves (570). The age limitation can be input by a user, set by a pharmacist, set by a manufacturer, determined based on a type of the device that is used or otherwise set.

[00224] If the subject doesn’t comply with the age limitation, then Some embodiments may include rejecting the subject (560). If the subject does comply with the age limitation, then Some embodiments may include permitting the subject (580). Each of the authentication of this method may occur more than once during a use event, for example in order to increase the protection and/or prevent passing the device subsequent to authentication to a non-authorized user.

[00225] In some embodiments, the method shown in Fig. 5 provides an additional layer of protection, against age related abuse of the device. Accordingly, even if a false identity authorization is issued, the subject is checked again for their age, and a subject who does not meet the age limitation is rejected or stopped.

[00226] In some embodiments of an authentication method, a wave reflection data sampled from the mouth of a subject is analyzed compared to a database comprising data of restricted subjects. The subject can be permitted only if they were found non-restricted.

[00227] In some embodiments, determining if the subject is a restricted subject is done subsequent to authenticating their identity. In some embodiments, the determination whether a subject is restricted can be additional to the identity authentication. Once a subject is authorized, the system analyses their wave reflection data compared to the restricted subjects’ database. If the subject was found non-restricted, they are being permitted.

[00228] In some embodiments, the determination whether a subject is restricted can be alternative to the identity authentication. In some embodiments, the system may determine that the identity of a subject is not authenticated. An alternative permission path may be checking whether or not this subject is restricted, and if they were found not restricted, the subject is permitted.

[00229] Optionally, a database of restricted and/or permitted users is created by collecting oral signatures of subjects and storing them in association with restriction and/or permission data, respectively. For example, a parent may have their child’s oral signature stored on the parent’s substance delivery device as a restricted subject to ensure that the child will not be able to use the parent’s device, even if the child is misidentified as an adult. In some embodiments, young adults may opt to register as being of age on a database so that in the event that their oral signatures will not be properly identified by age authentication, they will be identified as permitted subjects via the data base and their presence in the database will override an oral authentication of age. In some embodiments, a young adult may register as such by presenting proof of age at a point of sale.

[00230] In some embodiments a device, such as device 300 in Fig. 3, includes a communication unit for retrieving data from a permitted and/or restricted subject database. In some embodiments, a database, or a part thereof (e.g. based on geographic relevance), is stored locally, in the device. In method such as exemplified in Fig. 5, the database may be used to override any other form of authentication. [00231] Reference is now made to Figs. 6A and 6B, which depict a T-distributed Stochastic Neighbor Embedding (t-SNE) graph visualizing a possible distinction between received waves from eight different subjects, wherein Fig. 6B depicts and enlargement of a portion of Fig. 6A, according to some embodiments of an authentication method.

[00232] Reference is also made to Fig. 6C and 6D, which depict graphs showing a reference wave used in determining the values of wave samples shown in graph of Fig. 6A, according to some embodiments of an authentication method.

[00233] Sound wave signal samples were taken from eight (8) different individuals. The individuals were told to insert a probe into their mouth and avoid movement. The probe included a wave generator and a wave sensor, which received the reflected waves. The wave generator was a 46 Ohms Receiver, Balanced Armature Speaker 20Hz ~ 8.8kHz Top Round 105dB. The wave sensor was a I2S MEMS Microphone, Omnidirectional, -26dB @ 94dB SPF.

[00234] A chirp of 3200-9200 Hz Finear Frequency Modulated (FFM) sound waves was transmitted into the mouth of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween the entire chirp was therefore 250 milliseconds. 20 chirps, hence 60 samples were taken from each of the eight individuals.

[00235] A processor recorded the received wave reflections and encoded the received weaves by Digital Signal Processing (DSP) algorithm and stored in a database. A reference chirp of 3200- 9200 Hz FFM sound wave samples was transmitted to the surrounding and recorded adjacent to and at the same location of the sampling of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween. One of the three reference samples is shown in plots 6C and 6D, and represents the ambient sound.

[00236] During processing the data, samples were cleaned and normalized with respect to the reference wave. The data was entered to an artificial intelligence (AI) algorithm of the Random Tree kind. The system analyzed the data, compared between the samples and gave each sample a multi dimensional value that reflects the sample’s difference degree with respect to the other samples. The algorithm visualized its analysis using T-distributed Stochastic Neighbor Embedding (t-SNE) on the graph shown in Fig. 6A.

[00237] Each of the marks shown on the graph of Fig. 6A represent a single sample after receiving the result, each sample on the graph was given a symbol with respect to the individual to whom it belongs. For example, the circled symbols represent wave reflections that was received during transmission to the mouth of individual A_0, the square symbols represent wave reflections received from individual A_l, and so forth. As can be seen in Fig. 6A, the AI algorithm arranged the received waves in distinct clusters, each of which comprising samples of the same individual. The results show that the system can distinguish between individuals based on wave reflections received from their mouth. An enlarged portion of Fig. 6A, marked by dashed line 601 is depicted in Fig. 6B to show part of the results at higher resolution. As seen, two clusters 600 of circle symbols represent wave reflections taken from the mouth of individual A_0 and three clusters 610 of inverted triangles represent wave reflections that were taken from the mouth of individual A_5. This two-dimensional representation represents a portion of the data points that were analyzed by the system in this example, and shows that different individuals manifest differently one from the other to a degree significantly greater than the variation between samples taken from the same individual.

[00238] Reference is now made to Figs. 7A and 7B, which depict a T-distributed Stochastic Neighbor Embedding (t-SNE) graph, visualizing a possible distinction between adults and children according to received wave reflections, wherein FIG. 7B is an enlarged portion 701 marked by dashed rectangle a of FIG. 7A. The results shown were collected in an experiment that was conducted in order to test some embodiments of an authentication system, and its ability to distinguish between adults and children based on reflections of waves transmitted to their mouth.

[00239] Sound wave signal samples were taken from 66 subjects, that included 28 adults and 38 children. Adults were defined by ages above 25. Children were defined by ages of below 15. The subjects were told to insert a probe into their mouth and avoid movement during sampling.

[00240] The probe included a sound wave generator and a sensor that received the reflected waves. The wave generator was 46 Ohms Receiver, Balanced Armature Speaker 20Hz ~ 8.8kHz Top Round 105dB. The wave sensor was I2S MEMS Microphone, Omnidirectional, -26dB @ 94dB SPL.

[00241] A chirp of 3200-9200 Hz Linear Frequency Modulated (LFM) sound waves was transmitted into the mouth of the individuals. The chirp included three wave samples, each of which lasted 50 milliseconds with breaks of 50 milliseconds each therebetween the entire chirp was therefore 250 milliseconds. 5 chirps, hence 15 samples were taken from each of the individuals.

[00242] A processor recorded the received wave reflections and encoded the received weaves by Digital Signal Processing (DSP) algorithm and stored in a database. A reference wave represents the ambient sound and was recorded adjacent to sampling the mouth of the individual, in a manner similar to recording the reference chirp as detailed in the description of the experiment of Figs. 6A, 6B, 6C, and 6D.

[00243] During processing the data, samples were cleaned and normalized with respect to the reference wave. As an initial training phase, data relating to 49 of the subjects that were randomly selected was entered to the system. Each of the subject was indicated to the system as an adult/child. [00244] At a next phase, the system analyzed the remaining 17 samples, which were not given an indication. The algorithm was set to determine whether each of the samples belong to an adult or a child. The system analyzed the data, compared between the samples and gave each sample a multi dimensional value that reflects the sample’s difference degree with respect to the other samples. The algorithm visualized its analysis using T-distributed Stochastic Neighbor Embedding (t-SNE) on the graph shown in Fig. 7 A.

[00245] Each of the marks shown on the graph of Fig. 7A represents a single sample the algorithm classified each of the samples as an adult or a junior (child). Sample was marked twice. The star was used to mark reflections taken from a junior (child) and a square for an adult. The performance symbols were marked around the classification symbols. A circle marked for a success, i.e., the algorithm classified a child as a child or an adult as an adult. An X shaped symbol marked for failure, i.e., the algorithm classified a child as an adult or an adult as a child. A portion of Fig. 7 A shows the region 701 marked by dashed rectangle a at higher resolution in Fig. 7B. As seen, 700 marks a sample taken from a junior (star) that was correctly identified as such (circled) and 702 marks a sample taken from an adult (square) that was correctly identified as such (circled). A misidentification by the algorithm is depicted at 704, where an adult (square) was not identified as an adult (marked by an X). In the example shown in FIG. 7 A, the model was able to distinguish between a child and an adult with an accuracy of 76.3%. When using a learning algorithm, as the number of samples will increase so the accuracy expected to increase. In addition, by changing the cutoff value, it is possible to decrease the number of false positives at the expense of an increase in false negatives, and vice versa.

[00246] As described above, in some embodiments, the determination of an adult or child can be provided by a likelihood of accuracy, for example, the determination of the system can be that a subject is a child by a likelihood of 75%, according to the percentage level (%) of wave trends and properties that are recorded in the system as characterizing a child or an adult.

[00247] In some embodiments, a machine learning algorithm can be trained to increase accuracy and efficiency of age and/or other identity criteria recognition. Useful examples of age restriction criteria may be helpful in prevention of tobacco, nicotine, cannabis and/or cannabinoid smoking or vaping by children, as well as prevention of minors or children making use of a medical device.

[00248] In some embodiments, a group of people can be allowed to use the same device (e.g., a fluid delivery device such as substance delivery device 300 as described above in Fig. 3) or a set of devices (e.g., patients’ devices in a hospital setting or a few members of the same family). A processor can be configured to allow monitoring of each subject’s use. In some embodiments, the same device, based on input from the device can establish a use regime (e.g., substance administration) associated with each authorized subject. In some embodiments the same device may be configured, based on input from the authentication module, to facilitate administration of the same or different substance(s) to a group of authorized subjects, in parallel or at different times and/or dosages. In some embodiments the same device may be used by a group of people, for example by a few members of a family; in a hospital by a few patients.

[00249] Aspects of the present invention are described above with reference to flowchart illustrations and/or portion diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each portion of the flowchart illustrations and/or portion diagrams, and combinations of portions in the flowchart illustrations and/or portion diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or portion diagram or portions thereof.

[00250] These computer program instructions can also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or portion diagram portion or portions thereof. The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or portion diagram portion or portions thereof.

[00251] The aforementioned flowchart and diagrams illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each portion in the flowchart or portion diagrams can represent a module, segment, or portion of code, which includes one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the portion can occur out of the order noted in the figures. For example, two portions shown in succession can, in fact, be executed substantially concurrently, or the portions can sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each portion of the portion diagrams and/or flowchart illustration, and combinations of portions in the portion diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

[00252] In the above description, an embodiment is an example or implementation of the invention. The various appearances of“one embodiment”,“an embodiment”,“certain embodiments” or“some embodiments” do not necessarily all refer to the same embodiments. Although various features of the invention can be described in the context of a single embodiment, the features can also be provided separately or in any suitable combination. Conversely, although the invention can be described herein in the context of separate embodiments for clarity, the invention can also be implemented in a single embodiment. Certain embodiments of the invention can include features from different embodiments disclosed above, and certain embodiments can incorporate elements from other embodiments disclosed above. The disclosure of elements of the invention in the context of a specific embodiment is not to be taken as limiting their use in the specific embodiment alone. Furthermore, it is to be understood that the invention can be carried out or practiced in various ways and that the invention can be implemented in certain embodiments other than the ones outlined in the description above.

[00253] The invention is not limited to those diagrams or to the corresponding descriptions. For example, flow need not move through each illustrated box or state, or in exactly the same order as illustrated and described. Meanings of technical and scientific terms used herein are to be commonly understood as by one of ordinary skill in the art to which the invention belongs, unless otherwise defined. While the invention has been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of some of the preferred embodiments. Other possible variations, modifications, and applications are also within the scope of the invention. Accordingly, the scope of the invention should not be limited by what has thus far been described, but by the appended claims and their legal equivalents.

Claims

P-591872-PC CLAIMS

1. A method of identification of a subject and verification of authorization of the subject to use a substance delivery device, the method comprising:

connecting a computing device to a substance delivery device;

obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject;

obtaining, by the computing device, individual facial and authorization data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an authorization of the individual;

determining, by the computing device, whether the subject is an authorized subject, based on the subject facial data and the individual facial and authorization data;

obtaining, by the substance delivery device, biometric identification data being acquired by the substance delivery device and simultaneously determining by the computing device whether the substance delivery device is being used by the subject; and

associating, by the computing device, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device, and

registering the association.

2. The method of claim 1, comprising obtaining, by the computing device, device-related data of the substance delivery device to the computing device.

3. The method of claim 2, wherein obtaining the device-related data includes transfer of data by the substance delivery device to the computing device.

4. The method of any one of claims 2 and 3, wherein determining whether the subject is the authorized subject is based at least partially on the device -related data. P-591872-PC

5. The method of any one of claims 1-4, wherein obtaining the individual facial and authorization data includes receiving an image of an authorization document of the individual taken by a camera associated with the computing device.

6. The method any one of claims 1-5, wherein obtaining the individual facial and authorization data includes retrieving data from at least one identification and authorization database.

7. The method of any one of claims 1-6, comprising obtaining, by the camera, subject facial and device data indicative of a facial image, or at least a portion of the facial image, of the subject simultaneously with an image of the substance delivery device or at least a portion of the substance delivery device when in use by the subject.

8. The method of claim 7, wherein determining, by the computing device, whether the substance delivery device is being used by the authorized subject is based at least partially on the subject facial and the device data.

9. The method of claim 8, wherein determining whether the substance delivery device is being used by the subject based on the subject facial and the device data includes determining whether the image of the substance delivery device is within a predefined geometric relation to the facial image of the subject.

10. The method of any one of claims 7-9, wherein obtaining the subject facial and the device data is done continuously during obtaining of the biometric data and association of the biometric data with the authorization indication.

11. The method of any one of claims 1-10, comprising tracking a location of the facial image of the subject in the subject facial data.

12. The method of claim 11, wherein tracking is performed at least over the period of time spanning both the obtaining, by the substance delivery device, biometric identification data and simultaneously determining, by the computing device, whether the substance delivery device is being used by the subject and the obtaining, by the computing device, biometric identification data being acquired by the substance delivery device. P-591872-PC

13. The method of any one of claims 1-12, comprising detecting, by the camera, an output signal transmittable by a transmitter of the substance delivery device.

14. The method of claim 13, wherein determining whether the substance delivery device is being used by the subject based on the subject facial and device data is based at least partially on determining that an image of the output signal is within a predefined geometric relation to the facial image of the subject.

15. The method of any one of claims 1-14, comprising detecting, by a receiver associated with the computing device, an output signal transmittable by a transmitter of the substance delivery device.

16. The method of claim 15, comprising:

determining, by the computing device, a direction of received output signal;

wherein determining whether the substance delivery device is being used by the subject is based at least partially on the determined direction of the received output signal and at least one of: the subject facial data and the subject facial and device data.

17. The method of claim 16, comprising determining, by the computing device:

a real-world location of a face of the subject based on at least one of: the subject data and the subject facial and device data; and

a real-world location of the substance delivery device based on the determined direction of received output signal;

wherein determining whether the substance delivery device is being used by the subject is based at least partially on determining that the real-world location of the substance delivery device is within a predetermined geometric relation to the real-world location of the face of the subject.

18. The method of any one of claims 1-17, comprising:

detecting, by at least one of the camera and a receiver associated with the computing device, an output signal transmittable by a transmitter of the substance delivery device; and P-591872-PC

defining, by at least one of the computing device and the substance delivery device, at least one output signal property of the output signal.

19. The method of claim 18, wherein defining an output signal property of the output signal is performed when the substance delivery device is connected to the computing device or at predetermined time intervals.

20. The method of any one of claims 18-19, wherein output signal includes biometric identification data encoded therein.

21. The method of claim 20, comprising controlling via a controller of the substance delivery device, the transmitter of the substance delivery device to encode the biometric identification data of the subject using the substance delivery device in the output signal.

22. The method of any one of claims 18-21, comprising issuing a system signal by the computing device to the substance delivery device via the connection between them and wherein defining an output signal property of the output signal includes detecting a temporal correlation between the system signal and the output signal.

23. The method of any one of claims 18-22, comprising receiving the biometric identification data by the computing device and determining by the computing device that the biometric identification data encoded in the output signal corresponds with the received biometric identification data.

24. The method of any one of claims 1-23, wherein the registering comprises registering one or more limitations on the authorization of the authorized subject.

25. The method of claim 24, further comprising requiring, by the substance delivery device, a repeat of the registration in order to exceed one or more of the limitations.

26. A system for identification of a subject and verification of authorization of the subject to use a substance delivery device, the system comprising:

a camera to obtain subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; and P-591872-PC

a processing unit in communication with the camera and configured to connect to the substance delivery device, the processing unit is configured to:

obtain individual facial and authorization data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an authorization of the individual; determine whether the subject is an authorized subject, based on the subject facial data and the individual facial and authorization data;

determine whether the substance delivery device is being used by the authorized subject while the substance delivery device is obtaining biometric identification data;

associate, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device; and register the association.

27. The system of claim 26, wherein processing unit is configured to obtain device -related data upon the connection of the substance delivery device to the processing unit.

28. The system of claim 27, wherein the processing unit is configured to determine whether the subject is the authorized subject is based at least partially on the device-related data.

29. The system of any one of claims 26-28, wherein the processing unit is configured to obtain the individual facial and authorization data based at least partially on an image of an identification document of the individual taken by the camera.

30. The system of any one of claims 26-29, wherein the processing unit is configured to obtain the individual facial and authorization data from at least one identification and authorization database.

31. The system of any one of claims 26-30, wherein the camera is configured to obtain subject facial and device data indicative of a facial image, or at least a portion of the facial image, of the subject simultaneously with an image of the substance delivery device or at least a portion of the substance delivery device when in use by the subject.

32. The system of claim 31, wherein the processing unit is configured to determine whether the substance delivery device is being used by the authorized subject based at least partially on the subject facial and device data. P-591872-PC

33. The system of claim 32, wherein the processing unit is configured to determine, based on the subject facial and device data, whether the image of the substance delivery device is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the authorized subject.

34. The system of claim 27-33, wherein obtaining of the subject facial and the device data is done continuously during obtaining of the biometric data and association of the biometric data with the authorization indication.

35. The system of any one of claims 26-34, wherein the processing unit is configured to track a location of the facial image of the subject in the subject facial data.

36. The system of claim 35, wherein the tracking is performed at least over the period of time spanning both the obtaining, by the substance delivery device, biometric identification data, determining, by the processing unit, whether the substance delivery device is being used by the subject, and the obtaining, by the processing unit, the biometric identification data being acquired by the substance delivery device.

37. The system of any one of claims 26-36, wherein the camera is configured to detect an output signal transmittable by a transmitter of the substance delivery device.

38. The system of claim 37, wherein the processing unit is configured to determine, at least partly based on the subject facial and device data, that an image of the output signal is within a predefined geometric relation to the facial image of the subject to confirm that the substance delivery device is used by the authorized subject.

39. The system of any one of claims 26-38, comprising a receiver associated with the processing unit, the receiver configured to detect an output signal transmittable by a transmitter of the substance delivery device.

40. The system of any one of claims 26-39, wherein the processing unit is configured to:

determine a direction of a received output signal; and P-591872-PC

determine, at least partly based on the determined direction of the received output signal and at least one of: the subject facial data and the subject facial and device data, whether the substance delivery device is used by the authorized subject.

41. The system of any one of claims 26-40, wherein the processing unit is configured to determine whether the substance delivery device is being used by the authorized subject while the substance delivery device is obtaining the biometric identification data by determining:

a real-world location of a face of the subject based on at least one of: the subject data and the subject facial and device data;

a real-world location of the substance delivery device based on the determined direction of received output signal; and

that the real-world location of the substance delivery device is within a predetermined geometric relation to the real-world location of the face of the subject

42. The system of any one of claims 26-41, wherein:

at least one of the camera and a receiver associated with the processing unit is configured to detect an output signal transmittable by a transmitter of the substance delivery device; and

the processing unit is configured to define at least one output signal property of the output signal.

43. The system of claim 42, wherein the output signal includes biometric identification data encoded therein.

44. The system of claim 43, wherein the processing unit is configured to determine whether the substance delivery device is used by the authorized subject based at least partially on the biometric identification data encoded in the output signal.

45. The system of any one of claims 42-44, wherein the processing unit is configured to issue a system signal to the substance delivery device via the connection between them and wherein defining an output signal property of the output signal by the processing unit includes detecting a temporal correlation between the system signal and the output signal. P-591872-PC

46. The system of any one of claims 26-45, wherein the camera and the processing unit are implemented on a single computing device.

47. A method of identification of a subject and verification of age of the subject to use an electronic pulmonary delivery device, the method comprising:

connecting a computing device to an electronic pulmonary delivery device;

obtaining, by the computing device, individual facial and age data indicative of a facial image, or at least a portion of the facial image, of an individual in association with an indication of the age of the individual;

determining, by the computing device, whether the subject is of age, based on the subject facial data and the individual facial and age data;

obtaining, by the electronic pulmonary delivery device, biometric identification data being acquired by the electronic pulmonary delivery device and simultaneously determining by the computing device whether the electronic pulmonary delivery device is being used by the subject; and

associating, by the computing device, based on the determinations, an authorization indication with the biometric data of the authorized user acquired while the user has been using the substance delivery device, and registering the association.

48. A method of registering a subject in association with a documented property of the subject, the method comprising:

connecting a computing device to a probe;

obtaining, by a camera associated with the computing device, subject facial data indicative of a facial image, or at least a portion of the facial image, of the subject;

obtaining, by the computing device, individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with the documented property of the individual; P-591872-PC

determining, by the computing device, whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property;

obtaining, by the probe, biometric identification data being acquired by the probe and simultaneously determining by the computing device whether the probe is being used by the subject; and

registering, by the computing device, the biometric identification data of the subject according to the documented property, based on the determinations.

49. A system for registering a subject in association with a property of the subject, the system comprising:

a camera to obtain subject facial data indicative of a facial image, or at least a portion of the facial image, of a subject; and

a processing unit in communication with the camera and configured to connect to a probe, the processing unit is configured to:

obtain individual facial data and identification data indicative of a facial image, or at least a portion of the facial image, of an individual in association with the documented property of the individual;

determine whether the subject is a subject having the documented property, based on the subject facial data and the individual facial data and individual documented property;

determine whether the probe is being used by the authorized subject while the probe is obtaining biometric identification data; and

register the biometric identification data of the subject according to the documented property, based on the determinations.