Communication tags for pharmaceuticals

Abstract

This invention provides a technology for verifying the configuration of a drug delivery device based on data received from a communication tag placed on the drug delivery device. [Solution] A drug delivery device 102 having a housing with a reservoir large enough to hold the drug, an activation button to start injecting the drug, and a label attached to at least a portion of the housing, wherein the label includes a communication tag that, when accessed by a mobile device 106, causes the mobile device to launch a web browser to access a uniform resource locator (URL) 132. The mobile device receives data from the communication tag placed on the drug delivery device and, based on the received data, verifies and / or authenticates the form of the drug delivery device or tracks ownership of the drug delivery device.

Description

Background Art

[0001] Counterfeiters sell products that are packaged to appear as if they were manufactured by a particular manufacturer, even though they were not actually manufactured. Consuming counterfeit drugs can be unsafe and can prevent patients from receiving the drugs necessary to treat their illness or condition. As a result, such counterfeit products can pose concerns for both patients and manufacturers.

Summary of the Invention

[0002] According to an exemplary embodiment of the present disclosure, a drug delivery device is provided. The drug delivery device includes a housing that includes a reservoir sized to hold a drug. The drug delivery device includes an activation button for initiating injection of the drug. The drug delivery device includes a label affixed to at least a portion of the housing. The label includes a communication tag configured to cause a web browser configured to access a uniform resource locator (URL) to be launched on a mobile device when accessed by the mobile device. In some embodiments, the communication tag can be an RFID tag. In some embodiments, the communication tag can be a Near Field Communication (NFC) tag.

[0003] According to another embodiment of the present disclosure, a computerized method for verifying aspects of a drug delivery device is provided. The method includes receiving data from a communication tag disposed on the drug delivery device. The drug delivery device includes a housing that includes a reservoir sized to hold a drug. The drug delivery device includes an activation button for initiating injection of the drug. The drug delivery device includes a label affixed to at least a portion of the housing. The label includes the tag. The method includes verifying aspects of the drug delivery device by transmitting at least a portion of the received data to a server.

[0004] Another embodiment of this disclosure provides a computerized method for tracking ownership of a drug delivery device. The method includes receiving data from a communication tag placed on the drug delivery device. The drug delivery device includes a housing that includes a reservoir large enough to hold a drug. The drug delivery device includes an activation button for initiating the injection of the drug. The drug delivery device includes a label affixed to at least a portion of the housing. The label includes a tag. The method includes transmitting at least a portion of the received data to a server. The method includes providing user authentication information to the server. The server is configured to log entries based on the received data and user authentication information, the entries indicating that a user owned the drug delivery device at the time the data was received from the tag placed on the drug delivery device. [Brief explanation of the drawing]

[0005] Additional embodiments of the present disclosure, as well as their features and advantages, will become more apparent by referring to the description herein in conjunction with the accompanying drawings. Components in the drawings are not necessarily to scale. Furthermore, in the drawings, similar reference figures indicate corresponding parts throughout different drawings. [Figure 1] This is a block diagram showing an exemplary system 100 for verifying the configuration of a drug delivery device according to some embodiments. [Figure 2] This flowchart shows an exemplary computerized method 200 for verifying the configuration of a drug delivery device according to some embodiments. [Figure 3] This block diagram shows exemplary information displayed on the user interface of a mobile device, according to some embodiments. [Figure 4A] This is an illustrative display on the user interface of a mobile device showing validation data associated with a drug delivery device, according to some embodiments. [Figure 4B]This is an illustrative display on the user interface of a mobile device showing validation data associated with a drug delivery device, according to some embodiments. [Figure 4C] This is an example of a display on the user interface of a mobile device showing a recall notice associated with a drug contained within a drug delivery device, according to some embodiments. [Figure 4D] This is an example of a display on the user interface of a mobile device that shows information indicating the expiration date of a drug contained in a drug delivery device, according to some embodiments. [Figure 5] This block diagram shows an exemplary system 500 for tracking ownership of a drug delivery device, according to one embodiment. [Figure 6] A flowchart shows an exemplary computerized method 600 for tracking ownership of a drug delivery device, according to one embodiment. [Figure 7] This block diagram shows an exemplary system 700 for determining exemplary recommendations associated with a drug delivery device using logged entries according to some embodiments. [Figure 8A] Block diagram of an exemplary system 800a for displaying first information on a user interface based on receiving user authentication information for a first user, according to some embodiments. [Figure 8B] Block diagram of an exemplary system 800b for displaying second information on a user interface based on receiving user authentication information for a second user, according to some embodiments. [Figure 9A] This block diagram shows an exemplary system 900 for determining the average level of adherence using multiple logged entries from multiple users, according to one embodiment. [Figure 9B] Block diagram shows an exemplary system 950 for determining the average level of adherence using multiple logged entries from a single user, according to one embodiment. [Figure 10] This block diagram shows an exemplary system 1000 for tracking product distribution according to one embodiment. [Figure 11] This is a block diagram showing an exemplary system 1100 for detecting counterfeit products according to some embodiments. [Figure 12] This block diagram shows exemplary systems for using patient-specific drug delivery devices and exemplary systems for using healthcare provider (HCP)-specific drug delivery devices, according to some embodiments. [Figure 13] A block diagram showing an exemplary system for configuring a dosing reminder according to some embodiments. [Figure 14A] An exemplary drug delivery device in its initial pre-use configuration according to some embodiments is shown. [Figure 14B] This image shows a drug delivery device after the end cap has been removed, but before the device is activated to deliver the drug. [Figure 14C] This shows a drug delivery device after it has been activated to deliver the drug. [Figure 15A] An exemplary label, including an NFC tag, is shown according to some embodiments. [Figure 15B] An example of the back of a label is shown. [Figure 16] This document illustrates exemplary implementations of computer systems that may be used to implement any of the technologies and embodiments disclosed herein. [Modes for carrying out the invention]

[0006] To facilitate understanding of the principles of this disclosure, embodiments illustrated in the drawings will be described below using specific language. Nevertheless, it will be understood that this does not intend to limit the scope of the invention.

[0007] This specification provides a technique for verifying the characteristics of a drug delivery device. According to some embodiments, the technique verifies the characteristics of a drug delivery device based on data received from a communication tag placed on the drug delivery device. The communication tag may be an RFID tag and / or an NFC tag, or any other type of tag capable of communicating data to a reader device. For example, the data may include data indicating an authentication code generated by the tag. According to some embodiments, the technique transmits at least a portion of the data received from the tag to a server. For example, a portion of the data may include data indicating an authentication code. According to some embodiments, the server is configured to authenticate the authentication code and generate verification information indicating the result of the authentication. For example, the verification information may indicate whether the source of the drug delivery device (e.g., the manufacturer and / or supplier) has been verified, and thus whether the drug delivery device is a verified product and not a counterfeit product.

[0008] Furthermore, this specification provides a technology for tracking ownership of drug delivery devices. According to some embodiments, the technology tracks ownership of a drug delivery device based on the time data is received from a tag placed on the drug delivery device. After receiving data from the tag, the technology launches a website prompting the user to provide user authentication information. For example, the website may prompt the user to provide a username and password, a bearer token, a refresh token (derived from previous authentication, e.g., through the use of a username and password), and / or other user authentication information. According to some embodiments, the technology provides the user authentication information to a server. The server is configured to log entries based on the user authentication information and the data received from the tag. For example, the server may log an entry indicating that the user associated with the provided user authentication information owned the drug delivery device at the time the data was received from the tag placed on the drug delivery device. According to some embodiments, the entry may also indicate the geographical location from which the data was received from the tag, information about the drug contained in the drug delivery device, and / or information about the user associated with the user authentication information. This geographical location can be derived from the IP address from which the server received data from the tag, and / or from location data provided by a mobile device associated with the user (e.g., a smartphone).

[0009] The inventors recognize that product safety and liability concerns arise in the distribution channels of drugs that are not strictly regulated. In particular, counterfeiters may sell drugs that are actually counterfeit products, packaged to appear as if they are from a specific manufacturer. The inventors recognize that such counterfeit products can cause problems. For example, such products may raise safety concerns for end patients who need assurance that the drug they purchased is actually a genuine medicine manufactured by a verified manufacturer. In another embodiment, if a counterfeit product causes one or more problems for an end patient, and the patient is unaware that it is a counterfeit product, it can negatively impact the reputation of the true manufacturer (even if the true manufacturer was not actually involved in any problems caused by the counterfeit product).

[0010] Accordingly, the inventors have developed a technique for verifying the nature of a drug delivery device and tracking its ownership. In some embodiments, the technique can evaluate data received from a communication tag placed on the drug delivery device that displays a unique authentication code. The authentication code changes over time in an unpredictable manner known only to a server configured to authenticate the authentication code. For example, the authentication code may change based on activity, so that the authentication code changes each time a mobile device is brought within range of the drug delivery device to allow the mobile device to communicate with the tag. The inventors have recognized that the use of a tag that generates such an unpredictable authentication code is useful in preventing a forger from successfully counterfeiting at least this nature of a drug delivery device. According to some embodiments, the technique verifies the nature of the drug delivery device (e.g., the source of the drug delivery device) by transmitting at least a portion of the data received from the tag (e.g., the authentication code) to a server.

[0011] The embodiments of the technology described herein verify aspects of a drug delivery device and describe techniques for tracking the ownership of a drug delivery device, but it should be recognized that such techniques can be applied to any suitable type of drug container. For example, the techniques described herein can be used to verify aspects of and track ownership of a pill bottle, a drug vial, a blister pack, or any other suitable type of drug container, but the aspects of the technology are not limited in this regard. According to some embodiments, a tag is disposed on such a drug container and is configured to communicate with a mobile device.

[0012] In some embodiments, the communication tag can comprise any electronic circuit configured to wirelessly communicate with a reader device. For example, the communication tag can be an RFID tag and / or an NFC tag. For ease of explanation, the remainder of this disclosure refers to the communication tag as an NFC tag, but it should be understood that other types of wireless communication tags can also be used.

[0013] Although various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and not the only possible embodiments and implementations. Further, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages are achieved in each embodiment.

[0014] FIG. 1 is a block diagram showing an exemplary system 100 for verifying aspects of a drug delivery device according to some embodiments. The system 100 includes a drug delivery device 102 and a mobile device 106 that communicates with a server 110 and a data store 112 via a network 108. It should be recognized that the system 100 is exemplary and that the system can have one or more components of any suitable type in addition to or instead of the components shown in FIG. 1.

[0015] In some embodiments, the mobile device 106 is configured to receive data 124 from a near-field communication (NFC) tag 104 located on the drug delivery device 102. For example, the mobile device 106 may receive data 124 when it is close to the drug delivery device 102 (e.g., within 10 cm, 6 cm, 4 cm, etc.).

[0016] The drug delivery device 102 may include any suitable drug delivery device, such as an auto-injector or a pre-filled syringe, but aspects of the art are not limited in this respect. An exemplary drug delivery device 20 is described in more detail herein, including at least with respect to Figures 14A to 14C.

[0017] In some embodiments, the drug delivery device 102 optionally includes a sensor 122. For example, the drug delivery device 102 may include a temperature sensor configured to sense temperature. The sensed temperature may be the temperature of the drug delivery device 102, the temperature of the drug contained within the drug delivery device 102, and / or the ambient temperature. The temperature sensor may be a thermistor (e.g., a negative temperature coefficient (NTC) thermistor or a resistance temperature detector (RTD)), a thermocouple, or a semiconductor-based temperature sensor, but can take the form of any suitable sensor for sensing temperature, and is not limited to these.

[0018] Additionally, or alternatively, sensor 122 may include sensors for determining other parameters of the drug delivery device 102, such as the amount of drug remaining in the device's reservoir, the type of drug stored in the device's reservoir, the amount of drug selected for delivery, the amount of drug actually delivered, and whether the drug delivery device is in contact with skin tissue.

[0019] In some embodiments, the NFC tag 104 is placed on a drug delivery device. For example, the NFC tag 104 may be incorporated into a label of the drug delivery device 102. The label may be affixed to, adhered to, or formed as part of the drug delivery device 102. The label may be made of paper, polymer, or any other suitable material, but the embodiments of the technology described herein are not limited in this respect. Exemplary labels incorporating NFC tags are described herein, with at least the reference to Figures 15A and 15B.

[0020] In some embodiments, the NFC tag 104 includes an NFC chip coupled to an NFC antenna. The NFC chip may take any suitable form, but is not limited to an NFC chip manufactured by NXP®. The NFC antenna may take any suitable form, but is not limited to an NFC antenna manufactured by Avery Dennison® or Identiv. However, it should be noted that the aspects of the technology described herein are not limited to any particular NFC tag.

[0021] The NFC tag 104 is configured to communicate data 124 with the mobile device 106 using the NFC radio transmission protocol. The data 124 includes data associated with the NFC tag 104, data associated with the drug delivery device 102, data associated with the drug contained within the drug delivery device 102, and / or data associated with the sensor 122. Thus, the sensor 122 can be communicatively coupled to the NFC tag 104.

[0022] The data associated with the NFC tag 104 includes data indicating an authentication code 124a generated by the NFC tag 104. When a mobile device 106 is placed near the NFC tag, the NFC tag generates an authentication code known only to the server 110. For example, whenever mobile device 106 and / or any other suitable mobile device is placed near the drug delivery device 102, a new authentication code may be generated to enable such mobile device to communicate with the NFC tag 104. In some embodiments, the authentication code is encrypted before being transmitted to the mobile device 106.

[0023] The data associated with sensor 122 includes data indicating the output of sensor 122. For example, if sensor 122 includes a temperature sensor, the data may indicate the temperature of the drug delivery device 102, the temperature of the drug contained within the drug delivery device 102, and / or the ambient temperature.

[0024] According to some embodiments, in response to receiving data 124 from the NFC chip 104, the mobile device determines information indicating an event. “Event,” as used herein, refers to the occurrence of the mobile device being placed near the drug delivery device 102 so that data (e.g., data 124) is transmitted to the mobile device. Information indicating an event may include contextual information such as the time, date, and / or geographical location of the mobile device 106 when the mobile device 106 received data 124 from the drug delivery device 102. According to some embodiments, the mobile device 106 determines such contextual information based on the onboard clock, calendar, and / or GPS chip of the mobile device 106 at the time the data was received from the NFC tag 104.

[0025] The mobile device 106 may include any device that receives, stores, and / or processes data 124 from the NFC tag 104 via a radio signal received by the communication circuit of the mobile device 106. Exemplary mobile devices include smartphones, smartwatches, tablets, and / or laptops. The radio signal may be an active signal in which the mobile device 106 receives a signal transmitted by the communication circuit of the drug delivery device 102, or a passive signal in which the mobile device 106 senses modulation to a signal transmitted by the NFC tag 104. The mobile device 106 may include a separate communication circuit configured to communicate with other devices (e.g., using long-range or cellular transmission protocols).

[0026] The mobile device 106 may further include processing circuits and memory (not shown). The processing circuits may take the form of a processor (e.g., a microprocessor or microcontroller, a field-programmable gate array (FPGA), and / or a digital signal processor (DSP), or any combination thereof) configured to execute logic stored in memory to perform the operations described herein. As used herein, the terms “logic,” “control logic,” “instructions,” or “application” may include software and / or firmware executed on any of the aforementioned processing circuits. The memory may be any suitable computer-readable medium accessible by the processing circuits, including both volatile and non-volatile memory. Exemplary memories include random-access memory (RAM), read-only memory (ROM), and electrically erasable programmable ROM. This includes ROM (ROM, EEPROM), flash memory, magnetic memory devices, optical disc memory devices, or any other suitable medium configured to store data and accessible directly or indirectly by the processing circuit via one or more intermediate devices or wired or wireless communication links. The foregoing description assumes that the memory is separate from the processing circuit but communicatively coupled to it; however, in some embodiments, the memory may also be integrated with the processing circuit. In some embodiments, instead of a processor that executes the logic stored in the memory, the processing circuit may take the form of hardwired logic, for example, a state machine and / or application-specific integrated circuit (ASIC) that performs the functions described herein.

[0027] In some embodiments, the mobile device 106 includes a user interface 130 for displaying data and / or receiving user input. For example, the user interface 130 may include a graphical user interface (GUI) including a touchscreen display. The touchscreen display allows the user to interact with presented information, menus, buttons, and other data in order to provide information to the user or to receive user input from the user. Additionally or alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

[0028] Upon receiving data 124 from the drug delivery device 102, the mobile device 106 launches a web browser 128 configured to access a uniform resource locator (URL) 132 associated with a server 110 via the network 108. In some embodiments, the website associated with URL 132 is displayed on the user interface 130 of the mobile device 106. Additionally, or alternatively, upon receiving data 124, the mobile device searches for and launches a previously downloaded application program (e.g., a mobile app) configured to access URL 132. The received data 124 may then be passed to the mobile app via the server 110. Additionally, or alternatively, data 124 may be sent directly from the drug delivery device 102 to the server 110.

[0029] In some embodiments, server 110 includes one or more computing devices. If server 110 includes multiple computing devices, the devices may be located in the same physical location (e.g., a single room) or distributed across multiple physical locations. In some embodiments, server 110 may be part of a cloud computing infrastructure. In some embodiments, one or more servers 110 may be located in the same location within a facility operated by an entity.

[0030] Network 108 may be, or include, a wide area network (e.g., the Internet), a local area network (e.g., a corporate internet), and / or any other suitable type of network. Any of the devices shown in Figure 1 may connect to Network 108 using one or more wired links, one or more wireless links, and / or any suitable combination thereof. Thus, Network 108 may be, for example, a hardwired network (e.g., a local area network within a healthcare facility), a wireless network (e.g., connected via Wi-Fi and / or a cellular network), a cloud-based computing network, or any combination thereof.

[0031] URL132 may be associated with an authentication code 124a provided by an NFC tag 104 placed on the drug delivery device 102. In some embodiments, server 110 includes an authentication server configured to authenticate the drug delivery device 102 based on the authentication code 124a. For example, the authentication server may authenticate the authentication code 124a to verify whether the NFC tag 104 and the associated drug delivery device 102 are genuine products manufactured and / or provided by a verified source (e.g., a verified manufacturer, provider, etc.). In some embodiments, the authentication server authenticates the authentication code 124a by decrypting it (e.g., when the authentication code 124a is encrypted by the NFC tag 104). The authentication server can then examine the authentication code 124a in the data store 112 to determine whether it is genuine.

[0032] Additionally, or alternatively, the server 110 may query the data store 112 to identify additional information associated with the authentication code 124a, and by extension, the drug delivery device 102 that received the authentication code 124a. For example, the information may include information related to the drug contained in the drug delivery device 102, such as the drug name, drug administration, recall notice, expiration date, and manufacturing lot number. The information may indicate the administration regimen and / or instructions for taking the drug. The information may include information related to one or more preceding events, such as the time and / or location of the preceding event.

[0033] In some embodiments, the data store 112 includes any suitable data store such as a flat file, data store, multifile, or any preferred type of data storage device; however, the embodiments of the technology described herein are not limited to any particular type of data store.

[0034] In some embodiments, the server 110 is configured to evaluate data associated with the sensor 122. The server 110 may determine temperature-based information, such as whether the drug contained in the drug delivery device 102 is warm enough to be administered. Additionally or alternatively, the server 110 may determine dosage-based information, such as the amount of drug dispensed and / or programmed, based on the data detected by the sensor 122.

[0035] In some embodiments, the server 110 transmits verification data 134 to the mobile device 106 (e.g., to a web browser 128 and / or a mobile application). The verification data 134 may include data indicating the authentication of the drug delivery device 102 and / or the NFC tag 104. Additionally or alternatively, the server 110 transmits additional data (not shown) to the mobile device 106. The additional data may include information associated with the sensor 122, and / or information associated with the authentication code 124a and the drug delivery device 102.

[0036] In some embodiments, at least a portion of the verification data 134 and / or additional data may be part of a GUI (e.g., user interface 130) presented to the user. In some embodiments, the GUI may be presented to the user as part of a website displayed by a web browser 128 running on the mobile device 106. In some embodiments, the GUI may be presented to the user using an application program (different from the web browser 128) running on the mobile device 106.

[0037] Figure 2 is a flowchart illustrating an exemplary computerized method 200 for verifying an embodiment of a drug delivery device according to some embodiments. Method 200 can be implemented on one or more of the mobile device 106 and the server 110, whether operating independently or in cooperation with each other.

[0038] In step 202, the mobile device receives data from a Near Field Communication (NFC) tag (e.g., NFC tag 104) placed on a drug delivery device (e.g., drug delivery device 102). The NFC tag may include an NFC chip and one or more NFC antennas placed on the drug delivery device. For example, the NFC tag may include an NFC chip and one or more NFC antennas incorporated into a label on the drug delivery device. The label may be affixed to, adhered to, or formed as part of the drug delivery device. An exemplary label incorporating an NFC tag is described herein with respect to at least Figures 15A and 15B.

[0039] In some embodiments, a mobile device receives data in response to coming within range of a drug delivery device. This may include coming within 10 cm, 8 cm, 6 cm, 4 cm, 2 cm, 0–10 cm, 2–8 cm, or any preferred distance from the drug delivery device. For example, a user may tap the drug delivery device against the mobile device (or vice versa), resulting in the mobile device receiving data from the drug delivery device. The mobile device may receive data via a radio signal received by the mobile device's communication circuit. The radio signal may be an active or passive signal.

[0040] The received data may include data associated with an NFC tag placed on the drug delivery device, and / or data associated with one or more sensors associated with the drug delivery device. As described herein, with at least the reference to Figure 1, the data associated with the NFC tag may include data indicating an authentication code generated by the NFC tag. In some embodiments, the data indicating the authentication code is encrypted data. In some embodiments, the data associated with one or more sensors may include data indicating the output of one or more sensors, such as the sensors described herein, with at least the reference to Figure 1.

[0041] According to some embodiments, in response to receiving data from an NFC chip, the mobile device determines information indicating an event. Such information may include contextual information such as the time, date, and / or the geographical location of the mobile device when the mobile device received the data from the drug delivery device. According to some embodiments, the mobile device determines the contextual information based on one or more components of the mobile device, such as the mobile device's onboard clock, calendar, and / or GPS chip, at the time the data was received from the NFC tag.

[0042] After receiving data (for example, in response to data reception), the mobile device launches a web browser configured to access the URL associated with the server. Additionally, or alternatively, the mobile device checks for and launches a previously downloaded application program (e.g., a mobile app) configured to access the URL associated with the server.

[0043] In step 204, the mobile device verifies the configuration of the drug delivery device by sending at least a portion (e.g., some, most, or all) of the received data and / or contextual information to the server. In some embodiments, the data sent to the server includes data indicating an authentication code generated by the NFC tag.

[0044] The server may be configured to authenticate an authentication code and generate verification data based on the authentication result. For example, the server may be configured to decrypt data indicating the authentication code (e.g., if the data is encrypted) and query the data store for the (decrypted) authentication code. If the authentication code is found in the data store, the verification data indicates that the drug delivery device configuration has been verified. If the authentication code is not found in the data store, the verification data indicates that the drug delivery device configuration cannot be verified.

[0045] In some embodiments, the authentication code may change over time in such a way that it is predictable to the server but relatively unpredictable to other entities (e.g., eavesdropping attackers). For example, the code may change each time an NFC tag is brought within immediate range of a mobile device so that the mobile device can query the NFC tag. Each time the NFC tag is queried by the mobile device, the mobile device may be configured to alert the server so that the server can track how many times the NFC tag has been queried and how the authentication code is evolving over time. In such embodiments, the server may authenticate the authentication code by determining whether the authentication code matches the expected authentication code at the present time.

[0046] Verifying the nature of a drug delivery device may include verifying the source of the drug delivery device. For example, this may include verifying that a specific manufacturer produced the drug delivery device and / or that a specific supplier supplied the drug delivery device. In some embodiments, if the nature of the drug delivery device cannot be verified, this indicates that the drug delivery device was not received from a verified source (e.g., the drug delivery device is a counterfeit from an unverified manufacturer and / or supplier). If the nature of the drug delivery device can be verified, this indicates that the drug delivery device was received from a verified source (e.g., from the correct manufacturer and / or supplier).

[0047] In some embodiments, the server is further configured to retrieve authentication codes and, by extension, additional data associated with the drug delivery device. For example, the server may look up authentication codes in the data store to identify additional information about the drug delivery device and / or the drug contained within the drug delivery device. This additional information may include information such as the drug name, drug administration, recall notice, expiration date, and manufacturing lot number. The information may indicate the administration regimen and / or instructions for taking the drug. The information may include information related to one or more preceding events, such as the time and / or location of the preceding event.

[0048] A mobile device is configured to receive validation data and / or additional data from a server and to present at least a portion of the received data on a website displayed by a web browser or application running on the mobile device. The mobile device may also be configured to present a GUI as part of the website. Non-limiting examples of information that may be displayed on a mobile device are described herein, including at least those relating to Figures 3 and 4A-4D.

[0049] Figure 3 is a block diagram illustrating exemplary information that may be displayed on the user interface 130 of a mobile device 106 according to some embodiments. As shown, the information is presented as part of a website 300 displayed by the web browser of the mobile device 106 (e.g., web browser 128). However, it should be noted that, although not shown, the information may also be presented using an application program running on the mobile device 106.

[0050] In some embodiments, the information is distributed across one or more pages of the website 300 (or app). The website 300 may include a GUI, and the user may interact with the GUI to navigate the pages of the website 300. For example, the GUI may include one or more buttons, scroll bars, text boxes, or any other suitable elements with which the user can interact. In some embodiments, the information described herein may be presented using one or more audible messages, which may be useful for blind and / or visually impaired users. Such audible messages may be provided in addition to, or as an alternative to, the visual presentation of such information.

[0051] In some embodiments, the information includes information indicating verification data 302i. As described herein, including at least with respect to Figures 1 and 2, the verification data 302i may be obtained from a server (e.g., server 110) and may indicate whether the form of the drug delivery device (e.g., the source of the drug delivery device) has been verified. If the form of the drug delivery device cannot be verified, the verification data 302i may indicate that the drug delivery device is counterfeit. For example, a warning message may be displayed on website 300. If the form of the drug delivery device can be verified additionally or alternatively, the verification data 302i may indicate that the drug delivery device was received from a verified source. For example, a message may be displayed on website 300 indicating to the user that the form of the drug delivery device has been verified.

[0052] In some embodiments, the displayed information includes information associated with the drug delivery device and the drug contained within the drug delivery device. For example, the information includes actual data about the drug, such as the drug name 302a, dose size 302c (e.g., the size of the dose of the drug contained within the drug delivery device), expiration date 302d, dose strength 302l, and / or manufacturing lot number 302f. In some embodiments, the information includes an image of the drug delivery device 302m. In some embodiments, if the drug and / or drug delivery device is recalled after being distributed to the patient, the information includes a recall notice 302e. In some embodiments, the information may indicate an administration regimen 302k and / or provide administration instructions 302g to the patient or caregiver. For example, the information may indicate that the dose of the drug contained within the drug delivery device is part of a multi-dose regimen and indicate the order in which the doses should be taken. The administration instructions may include step-by-step instructions for administering the drug using the drug delivery device. Such instructions are useful to the patient or caregiver administering the drug (e.g., family member, nurse, first responder, etc.).

[0053] In some embodiments, the information includes information related to the output of one or more sensors associated with the drug delivery device. For example, the information includes drug temperature 302b obtained as an output from one or more temperature sensors associated with the drug delivery device. In some embodiments, the information may include temperature-based information, such as whether the drug contained within the drug delivery device is warm enough to be administered. Additionally or alternatively, the information includes activation status 302h obtained as an output from a sensor configured to determine the activation state of the drug delivery device. For example, the activation status may indicate whether the drug delivery device has been activated to dispense the drug, or whether the drug delivery device has dispensed the drug. In some embodiments, the information may include dose-based information (e.g., based on the activation status of the drug delivery device) indicating the amount of drug dispensed and / or programmed to be dispensed.

[0054] In some embodiments, the information includes information related to an NFC tag 104 placed on the drug delivery device 102. For example, the information may indicate a previous event that occurred between the drug delivery device and a mobile device (e.g., any mobile device). As described above, the event refers to the occurrence of the mobile device being placed near the drug delivery device 102 so that data is transmitted from the drug delivery device to the mobile device. The information may include a geographical location 302j associated with the previous event and / or the time of the previous event (not shown). Additionally or alternatively, the information may indicate an NFC tag identifier 302n associated with the NFC tag 104 placed on the drug delivery device 102.

[0055] A user may have access to at least some (e.g., some, most, or all) of the information displayed on website 300. Different users may have access to different parts of the information, as described herein. For example, a user may provide user authentication information to gain access to user-identifiable information.

[0056] Information 302a-n is illustrative, and any suitable information may be obtained and / or displayed, but it should be noted that the aspects of the technology described herein are not limited in this respect.

[0057] Figure 4A is an illustrative display 400 on the user interface of a mobile device showing validation data associated with a drug delivery device according to one embodiment. The illustrative display 400 indicates that the product is validated. Display 400 also provides product-related information (e.g., drug and drug delivery device), such as manufacturing lot number, expiration date, serial number, manufacturer, and dose size.

[0058] Figure 4B shows an illustrative display 440 on the user interface of a mobile device, illustrating verification data associated with a drug delivery device according to one embodiment. The illustrative display 440 indicates, through graphics and text, that the product is unverified. This may indicate that the product is a counterfeit product not manufactured by the expected true manufacturer. The illustrative display 440 also prompts the user to report the product, which may enable counterfeit tracking and help identify the source of the counterfeit product.

[0059] According to some embodiments, in addition to warnings displayed on the user interface of the patient's mobile device (for example, as shown in Figure 4B), warnings may also be sent to the patient's healthcare provider and / or the patient's assistant (e.g., family) when a counterfeit product is detected. For example, the healthcare provider and / or assistant may receive the notification via text message, via a notification on a mobile application, or via any other suitable means of communication, but embodiments of the technology are not limited in this respect. Thus, the healthcare provider can track the patient to ensure that the patient does not use a counterfeit product, track the source of the counterfeit product, replace the medication with a verified product to ensure that the patient adheres to their dosing regimen, and also check other patients to ensure that they have not received a counterfeit product. Similarly, in response to receiving a warning, the patient's assistant can order replacement medication to ensure that the patient does not take the counterfeit medication and that the patient continues to adhere to their dosing regimen.

[0060] Figure 4C shows an illustrative display 460 on the user interface of a mobile device, illustrating a recall notice associated with a drug contained within a drug delivery device, according to one embodiment. The warning message at the top of the screen indicates that the product (e.g., the drug delivery device and the drug contained within it) has been recalled. At the bottom of display 460, interactive buttons are also shown, which, when selected, provide instructions on how to use the drug delivery device.

[0061] Figure 4D is an illustrative display on the user interface of a mobile device showing information indicating the expiration of a drug contained in a drug delivery device, according to one embodiment. A warning message at the top of the screen indicates that the drug has expired and instructs the user to tap the message for additional information. Again, this warning message instructs the user to tap the message for additional details regarding a recall notice.

[0062] Figure 5 is a block diagram showing an exemplary system 500 for tracking ownership of a drug delivery device, according to one embodiment. Similar to system 100, system 500 includes a drug delivery device 102 and a mobile device 106 that communicates with a server 110 and a data store 112 via a network 108.

[0063] However, unlike system 100, system 500 is additionally or alternatively configured to track ownership of the drug delivery device 102. In some embodiments, a mobile device 106 of system 500 is configured to receive data 124 from the drug delivery device 102, as described herein with respect to Figure 1. After receiving the data (for example, in response to receiving the data), the mobile device launches a web browser configured to access a URL 132 associated with server 110. Additionally or alternatively, the mobile device 106 checks for and launches a previously downloaded application program (e.g., a mobile app) configured to access a URL 132 associated with server 110.

[0064] The mobile device 106 transmits at least a portion (e.g., some, most, or all) of the data 124 to the server 110. In some embodiments, the portion of the data 124 includes data indicating an authentication code generated by the NFC tag 104 and / or data indicating the output of the sensor 122. In some embodiments, the mobile device 106 also transmits contextual information to the server 110, such as the time, date, and / or the geographical location of the mobile device 106, when the data 124 is received from the NFC tag 104 located on the drug delivery device 102.

[0065] In response, the website 300 is displayed on the user interface 130 of the mobile device. The website 300 is configured to prompt the user for user authentication information 554. For example, the user may provide a username and password through one or more text boxes presented on the user interface 130. Additionally or alternatively, the user authentication information may include a bearer token, a refresh token (for example, derived from previous authentication using the username and password), and / or other user authentication information.

[0066] The mobile device 106 transmits user authentication information to the server 110. The server 110 is configured to log an entry 556 in the data store 112 based on the user authentication information 554 and a portion 124 of the data transmitted by the mobile device 106. The entry 556 may indicate the user (e.g., the user who provided the user authentication information 554), the time the data 124 from the drug delivery device 102 was received by the mobile device 106, the date the data 124 was received by the mobile device 106, and / or the geographical location of the mobile device 106 when it received the data 124 from the drug delivery device 102. However, the entry 556 may contain less information, different information, and / or additional information, but it should be noted that aspects of the technology are not limited in this respect.

[0067] In some embodiments, logged entries 556 may be accessed by one or more users to track patient adherence, detect potential fraud, determine the timing of the next dose, collect data from clinical trials, track device distribution, and / or perform any other suitable use cases, but the embodiments of the technology described herein are not limited in this respect. For example, a user may access the information via a website configured to access this data.

[0068] In some embodiments, the server 110 may also examine the received user authentication information 554 in the data store 112 to identify additional user-specific information associated with the user authentication information 554. For example, the server 110 may access user-specific dosing regimens, past doses administered to the user, patient information associated with the user, or any other suitable user-specific information, but the embodiments of the technology described herein are not limited in this respect.

[0069] Server 110 may provide the mobile device 106 with patient-specific information and / or other information described herein, including information described with respect to Figures 1 to 4D. The mobile device 106 may display the information on a website displayed by a web browser and / or on an application program running on the mobile device 106. In some embodiments, certain information may be displayed to only some users (for example, based on user authentication information 554), while the same information is not displayed to other users.

[0070] Figure 6 is a flowchart illustrating an exemplary computerized method 600 for tracking ownership of a drug delivery device, according to some embodiments. Method 600 may be implemented on one or more of the mobile device 106 and the server 110, whether operating independently or in cooperation with each other.

[0071] In step 602, the mobile device receives data from a Near Field Communication (NFC) tag placed on the drug delivery device. The NFC tag may include an NFC chip and one or more NFC antennas placed on the drug delivery device. For example, the NFC tag may include an NFC chip and one or more NFC antennas incorporated into a label on the drug delivery device. The label may be affixed to, adhered to, or formed as part of the drug delivery device. An exemplary label incorporating an NFC tag is described herein with respect to at least Figures 15A and 15B.

[0072] In some embodiments, a mobile device receives data in response to coming within range of a drug delivery device. This may include coming within 10 cm, 8 cm, 6 cm, 4 cm, 2 cm, 0-10 cm, 2-8 cm, or any preferred distance from the drug delivery device. For example, a user may tap the drug delivery device against the mobile device (or vice versa), resulting in the mobile device receiving data from the drug delivery device. The mobile device may receive data via a radio signal received by the mobile device's communication circuit. The radio signal may be an active or passive signal.

[0073] The received data may include data associated with an NFC tag placed on the drug delivery device, and / or data associated with one or more sensors associated with the drug delivery device. As described herein, with at least the reference to Figure 1, the data associated with the NFC tag may include data indicating an authentication code generated by the NFC tag. In some embodiments, the data indicating the authentication code is encrypted data. In some embodiments, the data associated with one or more sensors may include data indicating the output of one or more sensors, such as the sensors described herein, with at least the reference to Figure 1.

[0074] According to some embodiments, in response to receiving data from an NFC chip, the mobile device determines information indicating an event. Such information may include contextual information such as the time, date, and / or the geographical location of the mobile device when it received the data from the drug delivery device. According to some embodiments, the mobile device determines the contextual information based on the onboard clock, calendar, and / or GPS chip at the time the data was received from the NFC tag.

[0075] In step 604, the mobile device transmits at least a portion of the received data to the server. For example, the mobile device may transmit some, most, or all of the received data to the server via any preferred network. In some embodiments, the mobile device also transmits to the server some of the contextual information, such as the time, date, and / or geographical location of the mobile device when it received the data from the drug delivery device.

[0076] In some embodiments, the server is configured to launch a website on the mobile device in response to receiving at least a portion of the data from the mobile device. The website is configured to prompt the user to provide user authentication information using the mobile device's user interface. For example, the user may provide a username and password using one or more text boxes displayed on the user interface. Additionally or alternatively, the user authentication information may include bearer tokens, refresh tokens, and / or other user authentication information as described herein.

[0077] In step 606, the mobile device provides user authentication information to the server. The server is configured to log entries based on the user authentication information and a portion of the received data (e.g., sent to the server in step 602). For example, the server may be configured to log entries to a data store associated with the server. The entries indicate that the user possessed the drug delivery device at the time the data was received from the NFC tag placed on the drug delivery device. For example, the entries may include user authentication information, the user associated with the user authentication information, geographical location, time, date, and / or any other suitable information, but aspects of the art are not limited in this respect.

[0078] Application of the example As described above, including at least with respect to Figures 1 to 6, exemplary applications of systems and methods for verifying the characteristics of drug delivery devices and for tracking the ownership of drug delivery devices are described here. However, it should be noted that the following examples are non-limiting, and the systems and methods described herein may have many other suitable applications.

[0079] Figure 7 is a block diagram showing an exemplary system 700 for determining exemplary recommendations associated with a drug delivery device using logged entries, according to one embodiment.

[0080] In this embodiment, a server (e.g., server 110) can access a stored entry 556 indicating when a patient (e.g., user 1) was administered a certain dose of medication (e.g., an event). The server can also access additional information stored along with the entry 556 related to the event and / or the patient. For example, the entry 556 may store data indicating the dose of the delivered medication, the name of the medication, the patient's administration regimen, information related to the timing of other past administration events, and / or any other suitable information.

[0081] In some embodiments, the server uses entry 556 and / or information stored with entry 556 to track when the patient takes or receives medication. Using this information, the server may provide assistance to the patient or the patient's caregiver (e.g., healthcare provider, family, etc.). For example, the server may detect a potential missed dose 702. The server may detect a potential missed dose if no data is received from the mobile device during a time window in which the patient is expected to have taken a medication dose. The server may also suggest a time for the next medication dose 704, suggest a dosage for the next medication dose 706, and / or order a replacement medication 708.

[0082] The server may transmit data related to these options 702-708 to the mobile device, and information indicating the data may be displayed on a website on the mobile device's user interface. For example, the website may provide the patient with messages such as a message warning the patient that they may have missed a dose, a message suggesting the time for the next dose, a message suggesting the amount for the next dose, and / or a message indicating that a replacement medication has been ordered.

[0083] By providing user authentication information, users should be aware that they may have access to patient-specific information that enables them to track their dosing regimens, receive communications from healthcare providers, and maintain their prescriptions. As shown in Figures 8A and 8B, a first user may provide first user authentication information 856a that is unique to the first user, while a second user may provide second user authentication information 856b that is unique to the second user.

[0084] In response to receiving user authentication information, the server is configured to provide user-specific data to the mobile device 106. Thus, the website 300 displays first information 858a specific to the first user when first user authentication information 856a is provided, and displays second information 858b specific to the second user when second user authentication information 856b is provided.

[0085] Research studies and / or clinical trials may seek to determine how well a group of patients adhere to a therapy. Relatedly, insurance companies may seek to track population-level health outcomes. The level of adherence for a group of patients can be determined using the techniques described herein by automatically logging entries associated with administration events.

[0086] For example, as shown in Figure 9A, the server and / or user (e.g., a researcher and / or an insurance company) may access logged entries 926 that show administration events for multiple patients (e.g., users 1-N). The server and / or user may use logged entries 926 to determine the average level 940 of adherence to the administration regimen for those patients. Additionally or alternatively, the user and / or server may access individual entries 926a-d to assess the adherence of individual patients to individual administration regimens.

[0087] In some embodiments, healthcare providers may seek to determine how well individual patients adhere to their therapy. In particular, healthcare providers may want to track when patients take their medications and whether they are following their medication regimens. By automatically logging entries associated with administration events, the techniques described herein can be used to provide healthcare providers with patient adherence information.

[0088] For example, as shown in Figure 9B, the server and / or user (e.g., healthcare provider) may access logged entries 956 that show the administration events for a single patient (e.g., user 1). The server and / or user may use logged entries 956 to determine the average level of patient adherence 960 to the patient's own administration regimen. Additionally or alternatively, the user and / or server may access individual entries 956a-d to evaluate the timing and / or dosage administered to the user.

[0089] Therefore, healthcare providers can provide better care to their patients by identifying and addressing problems that arise when patients do not adhere to their medication regimens and by developing effective treatment plans.

[0090] Distributors who distribute drug samples (for example, contained within drug delivery devices) to healthcare provider offices have a regulatory obligation to record which drug samples were distributed to whom. Typically, distributors log information about the samples, such as the drug product, manufacturing lot number, visit date, and the clinic where the sample was provided. This process is manual and time-consuming.

[0091] The efficiency of this process can be improved by using the techniques described herein. As shown in Figure 10, the sales agent may tap the drug delivery device onto a mobile device 106. The website 300 prompts the sales agent to enter authentication information 1056, and once the authentication information is provided, the system logs that information. For example, the system logs the visit date 1058a, manufacturing lot number 1058b, drug name 1058c, and hospital 1058d. However, any suitable information may be logged, and it should be noted that the embodiments of this technique are not limited in this respect.

[0092] The sales agent may later access the logged information by providing their authentication information 1056, and the website 300 will display the logged information via the user interface 130 on the mobile device 106.

[0093] In some embodiments, customs and border agents may check drug delivery devices to determine whether they are counterfeit. Figure 11 is a block diagram showing an exemplary system 1100 for detecting counterfeit products according to some embodiments of the present technology.

[0094] The agent may tap the drug delivery device on a mobile device 106, which launches a website 300 prompting the agent for their authentication information 1156. After the authentication information is provided, the website 300 may display information about a previous event 1158. For example, this information may include previous geolocations 1158a and 1158b (determined, for example, from an IP address) where the NFC tag was previously tapped. Such information may not be generally available to the public.

[0095] Customs and border agents may use geolocation information to determine if a drug delivery device is likely to be counterfeit. For example, if the information indicates that the NFC tag has been previously tapped on another counterfeit device and that only a short time has passed since the NFC tag was tapped, the drug delivery device is likely to be counterfeit.

[0096] In some embodiments, customs and border agents may provide information to website 300, such as information reporting counterfeit goods. This information may be used to track the origin of counterfeit goods.

[0097] In clinical trials, researchers often provide the drug under test to a first subset of a patient population and a placebo to a second subset. This allows researchers to measure the drug's effectiveness in treating a condition compared to a placebo. To prevent potential bias, researchers "double-blind" the distribution of the drug and placebo; that is, neither the patients nor the healthcare providers distributing the product to the patients know whether the product being administered to a particular patient is the drug or a placebo. In such double-blind drug trials, all external labels for the distributed drug containers may appear identical regardless of whether the container contains the drug or a placebo.

[0098] Despite identical external container labeling, NFC tags can be integrated into the label of each drug container, allowing patients to maintain individual serialization of their drug containers. By tapping a mobile device on the drug container before administering the product (e.g., drug or placebo), an entry is logged that stores patient information and information identifying the product contained in the container. Thus, backend researchers can track which patients took the drug being tested and which patients took the placebo. In other words, once data from clinical trials are unblinded, researchers can determine which patients took the placebo and which patients took the active ingredient based on the logged entries that store patient information and information identifying the product contained in the container.

[0099] Additionally, or alternatively, researchers can easily communicate with patients participating in clinical trials by updating a website accessed by the patients. Specifically, when a patient taps their medication container on a mobile device (or vice versa), a website displaying information about updates to the clinical trial is launched.

[0100] According to some embodiments, the drug delivery device may be configured for use by a patient. For example, as shown in Figure 12, the patient drug delivery device 1202 of the exemplary system 1200 includes a patient NFC tag 1204. When a mobile device 106 is placed near the patient drug delivery device 1202, the website 300 is launched on the user interface 130 of the mobile device 106.

[0101] According to some embodiments, in response to receiving data from a patient NFC tag 1204, the website 300 displays patient information 1206. Patient information 1206 may include any other suitable general or patient-specific information, such as information relating to a patient drug delivery device, information relating to drugs contained within the patient drug delivery device, instructions on how to use the patient drug delivery device, the patient's administration schedule, the patient's medical history information, or information described herein, including at least that relating to Figure 3.

[0102] Additionally, or alternatively, drug delivery devices may be configured for use by healthcare providers (HCPs). For example, as shown in Figure 12, the HCP drug delivery device 1222 in the exemplary system 1220 includes an HCP NFC tag 1224. When a mobile device 106 is placed near the HCP drug delivery device 1222, the website 300 is launched on the user interface 130 of the mobile device 106.

[0103] According to some embodiments, in response to receiving data from the HCP NFC tag 1224, the website 300 displays HCP information 1226. The HCP information 1226 may include, for example, medical literature 1226a, prescription information 1226b, patient demo 1226c, or any other suitable general or HCP-specific information described herein, including at least that relating to Figure 3. In some embodiments, prescription information 1226b includes information explaining how and when to prescribe to the patient. In some embodiments, patient demo 1226c includes features that enable the HCP to demonstrate to the patient how something should be done medically or electronically. For example, patient demo 1226c may include features that enable the HCP to show the patient how to electronically sign a Health Insurance Portability and Accountability Act (HIPAA) form. Alternatively or additionally, patient demo 1226c may facilitate the HCP and the patient finding the appropriate HIPAA form and actually signing it electronically. Next, the electronically signed form can be stored in an appropriate electronic repository, such as an Electronic Health Record (EHR) system.

[0104] Patients may recognize receiving reminders to take their medication. For example, some medications need to be stored in a refrigerator to prevent spoilage. When it is time to take a certain dose of medication, the patient is instructed to remove the medication (e.g., a medication delivery device) from the refrigerator and leave it at room temperature for a specified duration (e.g., 15, 20, 30, 40, 50, 60 minutes, or any other preferred duration). Some patients may recognize receiving a reminder that their medication is ready to take after the specified duration. Additionally, or alternatively, some patients may recognize general reminders to take their medication according to their medication regimen (e.g., multiple times a day, daily, weekly, etc.).

[0105] Figure 13 shows an exemplary system 1300 for configuring a dosing reminder according to the technology described herein. According to some embodiments as described herein, after a mobile device 106 is placed near a drug delivery device 102, a website 300 is launched on the user interface 130 of the mobile device 106.

[0106] According to some embodiments, the website 300 is configured to prompt the user to enter contact information 1302 for configuring a dosing reminder. For example, the website 300 may display options for configuring a dosing reminder 1314 via one or more communication platforms 1312. The user can then enter their own contact information 1302 for each communication platform 1312. For example, the user may provide a telephone number for receiving dosing reminders via short message service (SMS) text, an email address for receiving dosing reminders via email, a username for receiving dosing reminders via a messaging platform, or any preferred contact information for any preferred communication platform, but the embodiments of the technology described herein are not limited in this respect.

[0107] After the user provides contact information, according to some embodiments, the server (e.g., server 110) provides the user with a code via a communication platform 1312. For example, if the user provides a phone number, the user may receive the code via text message. The website 300 may prompt the user to enter a code via the user interface 130 to verify that the patient possesses a communication platform 1312 (e.g., an email account, phone number, messaging platform) associated with the provided contact information.

[0108] According to some embodiments, after a dosing reminder is configured, the user receives a dosing reminder 1314 via a communication platform 1312. The dosing reminder 1314 reminds the user to take their medication at the appropriate time. For example, the user may receive a dosing reminder after a certain period of time (e.g., 30 minutes) has elapsed since the medication was removed from the refrigerator. In this case, the dosing reminder may indicate that the medication has warmed up and is ready for use. Additionally, or alternatively, the user may receive dosing reminders at a specific time each day or at a specific time each week. Such dosing reminders may help the user adhere to their medication regimen.

[0109] Additionally, or alternatively, when setting a dose reminder for the first time via the website 300, or when receiving a dose reminder via the communication platform 1312, the user may be provided with the option to enter the injection site used in their most recent injection. For example, when setting a dose reminder for the first time via the website 300, the website may include a user input field that allows the user to select from several options for injection sites, such as the left arm, right arm, left abdomen, right abdomen, left thigh, and / or right thigh. Additionally, or alternatively, the website 300 may allow the user to type free text indicating the injection site used in their most recent injection. When receiving a dose reminder via the communication platform 1312, the dose reminder may include a similar user input field, or the dose reminder may include a link to a website that includes a similar user input field. When a user provides information about the injection sites they have used in their most recent injections, this information may be stored by the server (e.g., server 110) in a log of previously used injection sites, potentially associated with other injection-related data such as the date and / or time of the previous injection associated with the previous injection site, the type of medication injected, and / or the amount of medication injected. This logged information may be accessed by the user upon request or presented to the user along with each medication reminder to remind the user about which injection sites they have used in their most recent injections. In this way, the logged information may help the user effectively rotate injection sites and avoid overusing any particular site, because overuse of a particular injection site may increase the risk of complications (e.g., infection or scarring) and / or reduce the effectiveness of the injected medication.

[0110] An exemplary drug delivery device 20 is illustrated in various operating states in Figures 14A–14C. Examples of such devices and their operation are described in U.S. Patent No. 8,734,394(B2) issued to Adams et al. on 27 May 2014, and U.S. Patent Application Publication No. 2021 / 0093784(A1) published to Adams et al. on 1 April 2021, and the entirety of each of these disclosures is incorporated herein by reference. The device 20 includes a syringe assembly 22, a drive mechanism 24, and a retraction mechanism 26. The syringe assembly 22 includes a barrel 30 forming a reservoir for holding the drug and a piston 32 disposed within the barrel 30 to drive the drug out of the barrel. The syringe assembly 22 also includes a needle assembly 33 having a hollow syringe needle 34 and a needle hub 35 for mounting the needle 34 to the syringe barrel 30. The lower body support member 29, which is coupled to the device housing 38, surrounds the needle 34. Moving the piston 32 in the barrel 30 forward toward the needle 34 dispenses the drug through the needle 34.

[0111] Devices described herein, such as device 20, may further include a drug, for example, in a syringe barrel 30. In another embodiment, the system may include one or more devices, including device 20, and a drug. The term "pharmaceutical" or "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tilzepatide, oxytomodulin analogs, oxytomodulin derivatives, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, therapeutic agents for pain-related treatment such as galcanezumab and rasmiditan, and any therapeutic agents that can be delivered by the devices described herein. Pharmaceuticals used in devices may be formulated with one or more excipients. The device is operated by a user, caregiver, or healthcare professional in generally the manner described above to deliver medication to a patient. As used herein, the term “user” may refer to the operator of the device described herein, and the term “patient” may refer to the person receiving the medication. In some cases, the user and the patient may be the same person (for example, the patient is operating the device described herein to administer an injection to themselves). In other cases, the user and the patient may be different people (for example, the user may be a person providing care to the patient).

[0112] Figure 14A illustrates the device 20 in its initial pre-use configuration. Here, the end cap 36 is fixed to the lower body support member 29 (the lower body support member 29 is coupled to the device housing 38). The end cap 36 covers the proximal end opening 40 of the housing 38. As used herein, distal and proximal refer to the axial location relative to the injection site when the device is oriented for use at the injection site; therefore, for example, the proximal end of the housing refers to the housing end closest to such an injection site, and the distal end of the housing refers to the housing end furthest from such an injection site. Also as used herein, “injection site” may refer to the exact spot on the patient’s body to be injected by the needle, as well as the surrounding body tissue (e.g., within 1-5 cm or 1-10 cm of the spot where the needle punctures the patient’s skin). The housing 38 may be formed from a plastic material and is shown to extend generally longitudinally along the longitudinal axis 48, between the distal end immediately near the actuation button 52 and the proximal end immediately near the proximal end opening 40. As shown in Figure 14B, the housing 38 may include a user-graspable portion 37 configured to be grasped by the user's hand, the user-graspable portion 37 extending radially outward from the longitudinal axis 48 by a distance 41. In some embodiments, the radial distance 41 may be 5 to 10 mm in length (for example, in some embodiments, 5 to 8 mm may be a preferred length). Also, as shown in Figure 14B, the housing 38 may also include an end portion 39 that extends outward from the proximal end of the housing, adjacent to the proximal opening 40.

[0113] The needle guard 42 is mounted on the syringe assembly 22 and covers and surrounds the needle 34. The end cap 36 and needle guard 42 protect the user from accidental needle prick and also protect the needle 34 from damage. When dispensing medication using the device 20, for example, when injecting medication into a patient, the end cap 36 and needle guard 42 are removed first. Figure 14B illustrates the device 20 after the end cap 36 and needle guard 42 have been removed from the syringe assembly 22, the syringe assembly is in its storage position, and the device 20 is ready for a dispensing event.

[0114] The syringe assembly 22 is movable relative to the drug delivery device 20 between a storage position and an injection position. Figure 14C illustrates the device 20 after the syringe assembly 22 has been moved relative to the device 20 from its storage position, as shown in Figure 14B, to the injection position. In the storage position (Figures 14A and 14B), the needle 34 is retracted to a position where the needle 34 is positioned within the housing 38 of the device 20. In the injection position (Figure 14C), the needle 34 protrudes outward from the housing 38 beyond the proximal opening 40 in a proximal direction parallel to the longitudinal axis 48, thereby allowing the needle 34 to be inserted into the patient.

[0115] The drive mechanism 24 includes a plunger 44 that engages with the piston 32. The drive mechanism 24 includes a spring 46 that drives the plunger 44 in translational motion. In the illustrated embodiment, the spring 46 advances the plunger 44 along a linear path defined by the longitudinal axis 48 of the device 20. As the plunger 44 advances, the foot 50 of the plunger 44 contacts the piston 32. As the plunger 44 advances further, the syringe assembly 22 advances along the axis 48 from its stowed position to its injection position. After the syringe assembly 22 has advanced to its injection position, the continued proximal advance of the plunger 44, at the time of a dispensing event, advances the piston 32 proximal within the barrel 30 from its initial piston position (shown in Figures 14A and 14B) to its final piston position (shown in Figure 14C) to dispense the drug from the needle 34. Before any dispensing of the drug, and while the syringe barrel 30 holds the full volume of the original drug, the piston 32 is in its initial piston position. After the piston 32 has advanced its entire length toward the needle assembly 33, the piston 32 is in its final piston position, close to the needle assembly 33, and the drug from within the barrel 30 has been released. In some embodiments, the syringe assembly 22 holds a single dose of the drug to be delivered in a single injection event, and the piston 32 advances from its initial piston position to its final piston position during that single injection event, thereby delivering the entire single-dose contents of the syringe assembly 22. Although the device is shown as a single-use device, the device 20 may also be configured as a multi-use device with appropriate modifications.

[0116] The forward movement of the plunger 44 will generally not result in the dispensing of drug from the syringe assembly 22 until the syringe assembly 22 has advanced to the injection position. Factors exist that may prevent the drug from being dispensed before the syringe has advanced to the injection position. These factors may include friction between the piston 32 and the barrel 30. Typically, the piston 32 should be made of rubber material and the barrel 30 should be glass. The frictional resistance between these two components may be sufficient to prevent the piston 32 from advancing within the barrel 30 until the syringe assembly 22 has advanced to its injection position and engagement with a suitable stopper prevents further advancement of the syringe assembly 22. Additionally, the drug in the syringe may be somewhat viscous, thereby providing some resistance to leakage from the needle 34. If necessary, modifications to the piston 32 and syringe barrel 30 to change the frictional resistance of the dispensing motion of the engaging member 32 against the syringe barrel 30 may limit or prevent premature dispensing of drug before the container 22 reaches its injection position.

[0117] To activate the drive mechanism 24, the user presses the actuation button 52 on the distal end of the device 20. Pressing the button 52 disengages one or two elongated projections 54 on the plunger 44 from the shuttle assembly 60, thereby allowing the spring 46 to expand and advance the plunger 44 axially. The spring 46 has a helical shape and surrounds the projections 54. The proximal end of the spring 46 biasively engages with the flange on the plunger 44.

[0118] The shuttle assembly 60 may include an upper shuttle member 62 and a lower shuttle member 64. The shuttle members 62 and 64 are fixed together in the final assembly. In the final assembly, the upper shuttle member 62 captures the button 52 and the spring 46 to restrict the axial movement of these parts distally. The projection 54 engages with the surface on the upper shuttle 62 when the device is in the state shown in Figures 14A and 14B. Pressing the button 52 engages the tab on the button 52 with the inclination (not shown) of the projection 54, biasing the projection 54 inward and disengaging it from the upper shuttle member 62. After the projection 54 is disengaged, the spring 46 exerts a biasing force on the flange of the plunger 44, moving the plunger 44 forward from the position shown in Figure 14B to the position shown in Figure 14C as the spring 46 transitions from a compressed state to an expanded state. As the plunger 44 moves forward, it moves the syringe assembly 22 to the injection position, and then moves the piston 32 forward to dispense the drug as discussed above.

[0119] After the dispensing event is complete, the retraction mechanism 26 optionally moves the syringe assembly 22 back from the injection position shown in Figure 14C to the retracted position. More specifically, the retraction mechanism is adapted to move the drug container from the injection position to the retracted position in a retraction motion. The retracted position may be similar to the stowed position in that the syringe assembly is pulled back into the housing 38, thereby the needle 34 no longer protruding proximally from the proximal opening 40 and being fully disposed within the housing 38. In some embodiments, the retracted position may be the same as the stowed position. However, in other embodiments, the syringe assembly 22 in the retracted position may be slightly proximal or distal to the syringe assembly in the stowed position. In the exemplary embodiment, the retraction mechanism includes a spring 66, a syringe carrier, and a rotating member 70 acting as a driven member. In yet another embodiment, the device 20 may not include the retraction mechanism 26 so that the syringe assembly remains indefinitely in its injection position after the drug has been dispensed until the syringe assembly is manually removed or repositioned by the user.

[0120] The plunger 44 may include an outrigger (not shown) that disengages the rotating member 70 as the plunger 44 approaches the end of its proximal movement. The rotating member 70 is rotatably fixed to the lower shuttle member 64 by engagement between a latch and a latch recess in the lower shuttle member 64. The outrigger disengages the member 70 by pressing the latch. The spring 66 is torsionally preloaded and has one end engaged with the member 70 and the opposite end engaged with the shuttle assembly 60. When the latch is pressed, the spring 66 rotates the member 70.

[0121] Member 70 is rotatable within the housing 38 but not axially movable relative to the housing 38. Other embodiments may also include a member 70 that is axially movable. The rotation of member 70 acts as a delay mechanism, preventing the retraction mechanism 26 from retracting the syringe assembly 22 until the syringe assembly has finished delivering its dose of medication. The rotational speed of member 70 can be adjusted by adjusting the viscosity of the grease disposed on or around the surface of member 70 in contact with the housing 38; higher viscosity grease results in slower rotation, and lower viscosity grease results in faster rotation. The radial flange of the rotating member 70 may engage with an overhang within the housing member 38 to restrict the proximal movement of member 70. The spring 66 may also be preloaded to compress initially. In this compressed state, the spring 66 exerts an axial force, a torsional force, or both on the member 70, thereby biasing the member 70 in a proximal position, and thereby maintaining the member 70 in an axial position where its radial flange engages with the internal protrusion of the housing member 38.

[0122] The shuttle assembly 60 may include axially extending channels or ribs that engage with corresponding features on the housing member 38, allowing the shuttle assembly 60 to move axially within the housing 38 but preventing relative rotation of the shuttle assembly 60 with respect to the housing member 38. The shuttle assembly 60 is biased distally by a spring 66, but is prevented from moving distally by the engagement of a latch (not shown) before the activation of the drive mechanism 24. When the rotating member 70 completes its rotation, it disengages the aforementioned latch, thus allowing the shuttle assembly 60 to move distally under the biasing force of the spring 66.

[0123] As the shuttle assembly 60 moves distally, it transports the syringe assembly 22 distally and returns the syringe assembly 22 to its retracted position. Also, as the shuttle assembly 60 moves, the spring 66 transitions from its compressed state to its extended state. The spring 66 biases the retraction mechanism 26 distally, thereby maintaining the syringe assembly 22 in its retracted position after the injection event. In some embodiments, as the shuttle assembly 60 moves distally, the spring 46 of the drive mechanism 24 may also transition from its extended state to its compressed state. Locking mechanisms, such as a stopper on the shuttle assembly 60 and a recess on the housing 38 member, additionally provide locking engagements to fix the syringe assembly 22 in the retracted position together with the needle 34 disposed within the housing 38 after the injection event, thereby allowing the user to then safely dispose of or otherwise handle the device 20.

[0124] Figure 15A shows an exemplary label 1500 including an NFC tag 1504. In some embodiments, the label 1500 is wrapped around the outer surface of a drug delivery device. For example, the exemplary label may be wrapped around the outer surface of a user-graspable portion 37 of a drug delivery device 20. The label 1500 may include a flexible paper and / or plastic material that can be attached to the outer surface of the device 20. The label 1500 may be attached using any of a variety of methods, including but not limited to using adhesives, adhesive films (e.g., polyurethane films), magnetic attachments, clip-on attachments, ultrasonic bonding / welding, injection molding / in-mold labeling, laser bonding / welding, etc. The label 1500 may be printed with information about the device 20 and / or the drug stored in the device 20, such as the drug name, manufacturer name, manufacturing batch / lot number, expiration date, use and / or storage instructions, and the amount of drug stored therein.

[0125] In some embodiments, the NFC tag 1504 is incorporated into the label 1500. As described above, the mobile device may be placed near the NFC tag 1504 to receive data from it. The label 1500 may include a graphic 1502 indicating the location of the NFC tag 1504 within the label 1500. For example, a user can query the NFC tag 1504 by tapping the mobile device near the graphic 1502 on a drug delivery device.

[0126] Figure 15B shows a diagram of the back of label 1500. As shown, label 1500 comprises an NFC tag 1504. According to some embodiments, the NFC tag 1504 comprises a chip 1510 and an antenna 1512. According to some embodiments, the NFC tag 1504 may have any preferred dimensions. For example, the NFC tag 1504 may have a width (and / or length) of at least 8 mm, at least 10 mm, at least 12 mm, at least 14 mm, at least 16 mm, at least 18 mm, at least 20 mm, at least 22 mm, at least 24 mm, at least 26 mm, at least 28 mm, at least 30 mm, 8 mm to 30 mm, 10 mm to 24 mm, or 12 mm to 22 mm.

[0127] According to some embodiments, the NFC chip 1510 may include a processing circuit. The processing circuit 1510 may take the form of a processor (e.g., a microprocessor or microcontroller, a field-programmable gate array (FPGA) and / or a digital signal processor (DSP), or any combination thereof) configured to execute logic stored in memory (not shown) to perform the operations described herein. The terms “logic,” “control logic,” “instructions,” or “applications” as used herein may include software and / or firmware executed on any of the aforementioned processing circuits.

[0128] In some embodiments, the NFC chip 1510 may include an onboard temperature sensor and does not need to be mounted on a flexible substrate that allows the chip to bend. The NFC chip may have any preferred thickness, such as about 1 mm or more.

[0129] Label 1500 also includes an NFC antenna 1512 which is communicatively coupled to an NFC chip 1510. In addition to communicating data to an external device, the NFC antenna 1512 may also be used to inductively and wirelessly collect power from the external device.

[0130] Figure 16 shows an exemplary implementation of a computer system 1600 that may be used to carry out any aspect of the technology and embodiments disclosed herein. The computer system 1600 may include one or more processors 1610, one or more non-temporary computer-readable storage media (e.g., memory 1620 and one or more non-volatile storage media 1630), and a display 1640. Since the aspects of the invention described herein are not limited in this respect, the processor 1610 may control write and read data to and from the memory 1620 and the non-volatile storage devices 1630 in any preferred manner. To carry out the functions and / or technologies described herein, the processor 1610 may execute one or more instructions stored in one or more computer-readable storage media (e.g., memory 1620, storage media, etc.), the computer-readable storage media may function as non-temporary computer-readable storage media storing instructions for execution by the processor 1610.

[0131] With respect to the techniques described herein, for example, a code used to identify patients to be included in a clinical trial may be stored on one or more computer-readable storage media of the computer system 1600. The processor 1610 may execute such code to provide any techniques for recognizing the objects described herein. Any other software, programs, or instructions described herein may also be stored and executed by the computer system 1600. It will be understood that computer code may be applied to any aspect of the methods and techniques described herein. For example, computer code may be applied to interact with an operating system and recognize an object through conventional operating system processes.

[0132] The various methods or processes outlined herein may be coded as software executable on one or more processors using any one of a variety of operating systems or platforms. Additionally, such software may be written using a number of suitable programming languages ​​and / or programming tools or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a virtual machine or a suitable framework.

[0133] In this regard, various inventive concepts may be embodied as at least one non-temporary computer-readable storage medium (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, field-programmable gate arrays, or circuit configurations in other semiconductor devices, etc.) encoded in one or more programs that, when executed on one or more computers or other processors, implement various embodiments of the present invention. The non-temporary computer-readable medium or multiple mediums may be portable, and as a result, one or more programs stored therein can be loaded onto any computer resource to implement various aspects of the present invention as considered above.

[0134] The terms “program,” “software,” and / or “application” are used herein in a general sense and refer to any type of computer code or set of computer executable instructions employed to program a computer or other processor to implement various aspects of the embodiments discussed above. Additionally, it should be understood that, according to one embodiment, one or more computer programs that, when executed, implement the methods of the present invention do not need to reside on a single computer or processor, but can be distributed modularly between different computers or processors to implement various aspects of the present invention.

[0135] Computer executable instructions can take many forms, such as program modules, that are executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc., that perform a specific task or implement a specific abstract data type. Typically, the functions of a program module may be combined or distributed as desired in various embodiments.

[0136] Furthermore, data structures can be stored in a non-temporary computer-readable storage medium in any preferred form. A data structure may have related fields through locations within that data structure. Such relationships can also be achieved by allocating storage to fields that have locations in a non-temporary computer-readable medium that communicate relationships between fields. However, any preferred mechanism may be used to establish relationships between information within the fields of a data structure, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0137] Various inventive concepts may be embodied in one or more methods, and examples are provided. The actions performed as part of a method may be ordered in any preferred manner. Thus, while they are shown as sequential actions in the exemplary embodiments, embodiments can be constructed in which the actions are performed in a different order than those exemplified, which may include performing several actions simultaneously.

[0138] In this specification and in the claims, the indefinite articles "a" and "an" as used herein should be understood to mean "at least one" unless explicitly stated otherwise. When used in this specification and in the claims, the phrase "at least one" relating to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, and not necessarily including at least one of each element specifically listed in the list of elements, nor excluding any combination of elements in the list of elements. This allows for the optional presence of elements other than those specifically identified in the list of elements referred to by the phrase "at least one," whether related to these specifically identified elements or not.

[0139] As used herein and in the claims, the phrase “and / or” should be understood to mean “either or both” of the elements thus combined, i.e., elements that exist as a combination in some cases and separately in others. Multiple elements listed using “and / or” must be interpreted in the same way, i.e., “one or more” of the elements thus combined. Other elements other than those specifically identified by the “and / or” clause may exist optionally, whether related to those specifically identified elements or not. Thus, as a non-restrictive example, a reference to “A and / or B” when used in conjunction with open-ended language such as “comprising” may, in one embodiment, refer to A only (optionally including elements other than B), in another embodiment, refer to B only (optionally including elements other than A), in yet another embodiment, refer to both A and B (optionally including other elements), and so on.

[0140] Where used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” should be interpreted as inclusive; that is, including not just one but two or more of a group of elements or a list of elements, and optionally including additional items not listed. Only terms that are explicitly indicated in the opposite way, such as “only one of” or “exactly one of,” or, where used in the claims, “consisting of,” should be interpreted as including exactly one element of a group of elements or a list of elements. In general, where used herein, the term “or” should be interpreted as indicating an exclusive choice (i.e., “one or the other but not both”) when followed by an exclusive term such as “either,” “one of,” “only one of,” or “exactly one of.” When used in patent claims, "consisting essentially of" shall have the ordinary meaning as it has in the field of patent law.

[0141] In the claims, the use of ordinal terms such as “first,” “second,” and “third” to modify elements of a claim does not, by itself, imply any priority, precedence, or order of one element of a claim relative to another, or any chronological order in which the actions of a method are performed. Such terms are used solely as identifiers to distinguish one element of a claim having a particular name from another element having the same name (in the absence of ordinal terms).

[0142] The terminology and grammar used herein are for illustrative purposes only and should not be considered limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof means to include the items and additional items listed thereafter.

[0143] While several embodiments of the present invention have been described in detail, those skilled in the art will readily conceive of various modifications and improvements. Such modifications and improvements are intended to fall within the spirit and scope of the present invention. Therefore, the foregoing description is merely illustrative and not intended to be limiting.

[0144] Various embodiments are described in this disclosure, including, but not limited to, the following embodiments. 1. A drug delivery device comprising: a housing having a reservoir large enough to hold a drug; an activation button for initiating drug injection; and a label affixed to at least a portion of the housing, the label having a communication tag configured to cause a mobile device to launch a web browser configured to access a uniform resource locator (URL) when accessed by a mobile device. 2. A drug delivery device according to embodiment 1, wherein the label comprises at least one of paper and polymer. 3. A drug delivery device according to embodiment 1 or 2, wherein the tag comprises an antenna and an NFC chip. 4. A drug delivery device according to any one of embodiments 1 to 3, wherein the URL is associated with an authentication server and includes an authentication code provided by a tag. 5. The drug delivery device according to embodiment 4, wherein the authentication server authenticates the authentication code of the URL in order to authenticate the drug delivery device. 6. A drug delivery device according to any one of embodiments 1 to 5, further comprising a drug held in a reservoir. 7. A drug delivery device according to any one of embodiments 1 to 6, wherein the drug delivery device includes a single-use drug delivery device. 8. A drug delivery device according to any one of embodiments 1 to 6, wherein the drug delivery device includes a drug delivery device for multiple uses. 9. A drug delivery device according to embodiment 8, wherein the operating button is rotatable relative to the housing for selecting a dose size of drug for injection. 10. A computerized method for verifying the configuration of a drug delivery device, comprising receiving data from a communication tag placed on the drug delivery device, wherein the drug delivery device comprises a housing having a reservoir of sufficient size to hold a drug, an activation button for initiating drug injection, and a label affixed to at least a portion of the housing, the label comprising a tag, and transmitting at least a portion of the received data to a server to verify the configuration of the drug delivery device. 11. The computerized method according to embodiment 10, wherein the data received from the tag includes an encrypted code. 12. A computerized method according to embodiment 10 or 11, wherein verifying the form of a drug delivery device includes verifying the source of the drug delivery device. 13. A computerized method according to any one of embodiments 10 to 12, further comprising receiving verification data from a server, wherein the verification data indicates that the drug delivery device is authentic. 14. The computerized method according to embodiment 13, further comprising presenting information indicating verification data via a user interface. 15. The computerized method according to embodiment 14, further comprising presenting additional information associated with at least one of a drug and a drug delivery device via a user interface. 16. The computerized method according to embodiment 15, wherein additional information includes at least one of the following: drug name, drug temperature, dose size, dose strength, image of drug delivery device, unique identifier associated with a tag, drug expiration date, manufacturing lot number, recall notice, instructions for administering drug, previous geographical location of drug delivery device, and activation status of drug delivery device. 17. A computerized method according to any one of embodiments 14 to 16, further comprising receiving data from a tag and launching a web browser configured to access a uniform resource locator (URL) associated with a server, wherein the URL includes at least one of information indicating validation data and additional information. 18. A computerized method according to any one of embodiments 15 to 17, wherein the drug delivery device further comprises a sensor configured to acquire a drug and at least a portion of information associated with at least one of the drug delivery devices, and the method further comprises receiving information associated with a drug and at least one of the drug delivery devices. 19. A non-temporary computer-readable storage medium containing instructions, wherein the instructions are operable to cause one or more processors on a computing device to perform the computerized method described in any one of embodiments 10 to 18 when the instructions are executed by one or more processors on the computing device. 20. A system comprising: a memory for storing instructions; and a processor configured to execute instructions in order to carry out the computerized method described in any one of embodiments 10 to 18. 21. A computerized method for tracking ownership of a drug delivery device, comprising receiving data from a communication tag placed on the drug delivery device, wherein the drug delivery device comprises a housing having a reservoir large enough to hold a drug, an activation button for initiating drug injection, and a label affixed to at least a portion of the housing, the label comprising a tag, transmitting at least a portion of the received data to a server, and providing user authentication information to the server, wherein the server is configured to log entries based on the received data and user authentication information, the entries indicating that a user owned the drug delivery device at the time the data was received from the tag placed on the drug delivery device. 22. The computerized method according to embodiment 21, wherein the entry further indicates the geographical location of the user at the time the data was received from a tag placed on a drug delivery device. 23. The computerized method according to embodiment 21 or 22, further comprising detecting a potential missed medication dose when data is not received from a tag within a predicted time. 24. The computerized method according to embodiment 21 or 22, wherein the server is configured to detect a potential missed medication when an entry is not logged within a predicted time. 25. A computerized method according to any one of embodiments 21 to 24, further comprising suggesting at least one of the following timings and amounts of drug administration based on logged entries. 26. A computerized method according to any one of embodiments 21 to 24, wherein the server is configured to detect at least one of timing and the next drug administration based on logged entries. 27. A computerized method according to any one of embodiments 21 to 26, further comprising ordering replacement medication or reminding the user to order replacement medication based on logged entries. 28. A computerized method according to any one of embodiments 21 to 26, wherein the server is configured to order replacement medication and to remind the user to order replacement medication based on logged entries. 29. A computerized method according to any one of embodiments 21 to 28, wherein the server is configured to log multiple entries relating to multiple users and to provide a report on the average level of adherence to a drug regimen among multiple users. 30. A computerized method according to any one of embodiments 21 to 29, further comprising launching a website configured to prompt a user to provide user authentication information before providing user authentication information to a server. 31. The computerized method according to embodiment 30, further comprising the computerized method providing reminders to the user for taking medication dosages via the communication platform, wherein the website is further configured to prompt the user to provide contact information associated with a communication platform. 32. A computerized method according to any one of embodiments 21 to 31, further comprising receiving first user authentication information relating to a first user, and providing first information to the first user based on the first user authentication information. 33. The computerized method according to aspect 32, further comprising receiving second user authentication information relating to a second user, and providing second information to the second user based on the second user authentication information, wherein the second information is different from the first information. 34. The computerized method according to embodiment 33, wherein the first information includes a first instruction for using a drug delivery device, and the second information includes a second instruction for using a drug delivery device, and the first instruction is different from the second instruction. 35. A non-temporary computer-readable storage medium containing instructions, wherein the instructions are operable to cause one or more processors on a computing device to perform the computerized method described in any one of embodiments 21 to 34 when the instructions are executed by one or more processors on the computing device. 36. A system comprising: a memory for storing instructions; and a processor configured to execute instructions in order to carry out the computerized method described in any one of embodiments 21 to 34.

Claims

1. A drug delivery device, A housing with a reservoir large enough to hold the medication, An activation button for initiating the injection of the aforementioned drug, A drug delivery device comprising: a label affixed to at least a portion of the housing, the label having a communication tag configured to cause a mobile device to launch a web browser configured to access a uniform resource locator (URL) when the label is accessed by a mobile device.

2. The drug delivery device according to claim 1, wherein the label comprises at least one of paper and polymer.

3. The drug delivery device according to claim 1 or 2, wherein the tag comprises an antenna and an NFC chip.

4. The drug delivery device according to any one of claims 1 to 3, wherein the URL is associated with an authentication server and includes an authentication code provided by the tag.

5. The drug delivery device according to claim 4, wherein the authentication server authenticates the authentication code of the URL in order to authenticate the drug delivery device.

6. The drug delivery device according to any one of claims 1 to 5, further comprising a drug held in the reservoir.

7. The drug delivery device according to any one of claims 1 to 6, wherein the drug delivery device includes a single-use drug delivery device.

8. The drug delivery device according to any one of claims 1 to 6, wherein the drug delivery device includes a drug delivery device for multiple uses.

9. The drug delivery device according to claim 8, wherein the operating button is rotatable relative to the housing for selecting a dose size of the drug for injection.

10. A computerized method for verifying the configuration of a drug delivery device, Receiving data from a communication tag placed on the drug delivery device, wherein the drug delivery device A housing with a reservoir large enough to hold the medication, An activation button for initiating the injection of the aforementioned drug, A label affixed to at least a portion of the housing, wherein the label comprises the tag, and is for receiving, A method comprising verifying the embodiment of the drug delivery device by transmitting at least a portion of the received data to a server.

11. The computerized method according to claim 10, wherein the data received from the tag includes an encrypted code.

12. The computerized method according to claim 10 or 11, wherein verifying the embodiment of the drug delivery device includes verifying the source of the drug delivery device.

13. A computerized method according to any one of claims 10 to 12, further comprising receiving verification data from the server, wherein the verification data indicates that the drug delivery device is authenticated.

14. The computerized method according to claim 13, further comprising presenting information indicating the verification data via a user interface.

15. The computerized method according to claim 14, further comprising presenting additional information associated with at least one of the drug and the drug delivery device via the user interface.

16. The computerized method according to claim 15, wherein the additional information includes at least one of the following: the name of the drug, the temperature of the drug, the dose size, the dose strength, an image of the drug delivery device, a unique identifier associated with the tag, the expiration date of the drug, the manufacturing lot number, a recall notice, an instruction to administer the drug, the previous geographical location of the drug delivery device, and the activation status of the drug delivery device.

17. The computerized method according to any one of claims 14 to 16, further comprising receiving the data from the tag and launching a web browser configured to access a uniform resource locator (URL) associated with the server, wherein the URL includes at least one of the information indicating the verification data and the additional information.

18. The drug delivery device further comprises a sensor configured to acquire the drug and at least a portion of the information associated with at least one of the drug delivery devices, The computerized method according to any one of claims 15 to 17, further comprising receiving the information relating to at least one of the drug and the drug delivery device.

19. A non-temporary computer-readable storage medium containing instructions, wherein, when the instructions are executed by one or more processors on a computing device, the instructions are operable to cause one or more processors to perform the computerized method according to any one of claims 10 to 18.

20. A system comprising: a memory for storing instructions; and a processor configured to execute the instructions in order to carry out the computerized method described in any one of claims 10 to 18.

21. A computerized method for tracking ownership of drug delivery devices, Receiving data from a communication tag placed on the drug delivery device, wherein the drug delivery device A housing with a reservoir large enough to hold the medication, An activation button for initiating the injection of the aforementioned drug, A label affixed to at least a portion of the housing, wherein the label comprises the tag, and is for receiving, Sending at least a portion of the received data to the server, A computerized method comprising providing user authentication information to the server, wherein the server is configured to log entries based on the received data and the user authentication information, the entries indicating that the user possessed the drug delivery device at the time the data was received from the tag placed on the drug delivery device.

22. The computerized method according to claim 21, wherein the entry further indicates the geographical location of the user at the time the data was received from the tag placed on the drug delivery device.

23. The computerized method according to claim 21 or 22, further comprising detecting a potential missed dose when data is not received from the tag within a predicted time.

24. The computerized method according to claim 21 or 22, wherein the server is configured to detect a potential missed medication when an entry is not logged within a predicted time.

25. The computerized method according to any one of claims 21 to 24, further comprising suggesting at least one of the timing and amount of the next drug administration based on the logged entries.

26. The computerized method according to any one of claims 21 to 24, wherein the server is configured to detect at least one of the timing and the next drug administration based on the logged entries.

27. A computerized method according to any one of claims 21 to 26, further comprising ordering a replacement drug based on the logged entry, or reminding the user to order the replacement drug.

28. The computerized method according to any one of claims 21 to 26, wherein the server is configured to order the replacement drug and to remind the user to order the replacement drug based on the logged entries.

29. The computerized method according to any one of claims 21 to 28, wherein the server is configured to log multiple entries relating to multiple users and to provide a report relating to the average level of adherence to a drug regimen among the multiple users.

30. The computerized method according to any one of claims 21 to 29, further comprising launching a website configured to prompt a user to provide user authentication information before providing the user authentication information to the server.

31. The website is further configured to prompt the user to provide contact information associated with the communication platform, The computerized method according to claim 30, further comprising providing the user with a reminder via the communication platform for taking the dosage of the drug.

32. Receiving first user authentication information for the first user, A computerized method according to any one of claims 21 to 31, further comprising providing first information to the first user based on the first user authentication information.

33. Receiving second user authentication information for a second user, The computerized method according to claim 32, further comprising providing a second information to a second user based on the second user authentication information, wherein the second information is different from the first information.

34. The computerized method according to claim 33, wherein the first information includes a first instruction for using the drug delivery device, and the second information includes a second instruction for using the drug delivery device, and the first instruction is different from the second instruction.

35. A non-temporary computer-readable storage medium containing instructions, wherein, when the instructions are executed by one or more processors on a computing device, the instructions are operable to cause one or more processors to perform the computerized method according to any one of claims 21 to 34.

36. A system comprising: a memory for storing instructions; and a processor configured to execute the instructions in order to carry out the computerized method described in any one of claims 21 to 34.

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