AU2020101208A4

AU2020101208A4 - System And Method For Vaccine Administration Verification

Info

Publication number: AU2020101208A4
Application number: AU2020101208A
Authority: AU
Inventors: Kieran DALY; Jim Joyce; Richard SHATTOCK
Original assignee: Health Beacon Ltd
Current assignee: Health Beacon Ltd
Priority date: 2020-05-01
Filing date: 2020-06-30
Publication date: 2020-08-06
Anticipated expiration: 2028-06-30
Also published as: DE202020103841U1

Abstract

The present application relates generally to a pathogen care management system and method for managing and tracking pathogen care events associated with a patient. [Figure 1] 1/6 100 Supply Chain eDatabase system 11 140 112 PCM platform Processor 110 Health Authority 130 PC Device PC Device PC Device 120-1 120-2 ... 120-n 150-1 150-2 150-n Figure 1A Screen Switch 124 VAV Device . . 121120 Receiving unit 122 Identification Unit 123 --- - -, - / Communication - - L 125 Figure 1B

Description

1/6 100

Supply Chain eDatabase system 11 140 112

PCM platform Processor 110 Health Authority 130

PC Device PC Device PC Device 120-1 120-2 ... 120-n

150-1 150-2 150-n

Figure 1A

Screen Switch 124 VAV Device . . 121120 Receiving unit 122

Identification Unit 123 -- - -, - / Communication - - L 125

Figure 1B

A pathogen care management system and a method thereof

Field

[0001] The present application relates generally to a pathogen care management system and method for managing and tracking pathogen care events associated with a patient. More specifically the present invention relates to a system and method for verifying and validating pathogen care events such as a therapeutic drug administration, a vaccine administration against a pathogen, or an extraction of a medical test sample from the patient to be analysed for the detection of at least one pathogen.

Background

[0002] Vaccination is one of the most effective ways to prevent diseases. A vaccine helps the body's immune system to recognize and fight pathogens like viruses or bacteria, which then keeps us safe from the diseases they cause. Vaccines protect against a range of debilitating and/or life-threatening diseases, including measles, polio, tetanus, diphtheria, meningitis, influenza, tetanus, typhoid and cervical cancer.

[0003] In additional to routine vaccination such as seasonal flu vaccinations, it is particularly important for organizations to have up-to-date record of individuals vaccination statistics when large-scale vaccinations are necessary in order to effectively control the risk of a disease. For example, when an effective vaccine has been developed to battle the current global Covid-19 pandemic, the general public may be encouraged or required to receive vaccinations in order to control the spread and lower the risk of the disease. Given the current Covid 19 pandemic and future such pandemics, it will become a requirement to demonstrate that individuals have been vaccinated so as to have achieved immunity. From the perspective of individuals, patients are generally underinformed as to what immunizations are recommended, or on what schedule they should be received to achieve immunization. Few patients are aware of or understand the spectrum of recommended immunizations. Instead, patients have to rely on medical providers to ensure adherence with recommended immunization schedules. However, it may become challenging for patients to adhere to a recommended vaccine administration course or for administrators to properly manage patient health record by updating their immunization details on a local immunisation register. As a result, it becomes difficult with existing solutions to ensure that patients adhere to recommended vaccination course and further manage the individual health records.

[0004] Therefore, there is a need for providing a pathogen care management system for managing and tracking a pathogen care event such as vaccine administration, the extraction and tracking of a medical test sample, or the administration of a therapeutic drug.

Summary

[0005] An aim of the present invention is to provide a pathogen care management system and method to manage and monitor pathogen care events associated with individual patients. For example, the present invention may be used to manage and monitor vaccine administration events, tracking of medical test samples extracted from a patient and results reporting, therapeutic drug administration, contact tracing, and the like. In general, the present invention provides a centralised system and method for monitoring and tracking pathogen care events associated with individual patients.

[0006] Accordingly, the present invention provides a system and a method as detailed in the independent claims. Advantageous embodiments are provided in the dependent claims.

[0007] According to a first aspect of the present invention, a pathogen care management system (PCM) for managing and tracking pathogen care events associated with a patient is provided, The PCM system comprising: at least one first electronic device running a pathogen care software application configured to at least identify and/or register the patient prior to a pathogen care event, the pathogen care software application configured to generate, during operation, a user identification data record comprising identification information associated with the identified patient; a pathogen care device communicatively coupled to the at least one first electronic device, the pathogen care device configured to detect at least one pathogen care item associated with the pathogen care event, and accordingly generate a pathogen care data record associated with the identified patient; and a pathogen care management, PCM, platform configured to be communicatively coupled to the at least one pathogen care device and at least one first electronic device, the PCM platform comprising a data storage module storing a plurality of digital health records associated with patients, each digital health record comprising pathogen care data and identification data associated with a unique patient, and a processing unit configured to update the digital health record associated with the identified patient with the information received from the pathogen care device and/or at least one first electronic device.

[0008] The PCM platform may act as a centralised management platform communicatively coupled to a plurality of pathogen care devices and electronic devices. For example, the PCM platform may be in the form of a cloud computing platform connected to multiple pathogen care device and electronic devices.

[0009] For example, identification of the user in the first electronic device may be achieved based on biometric ID authentication of the user. The biometric ID of the user may be associated with the digital health record of the patient. The first electronic device may be a mobile phone, table, computer, or any other device capable of running the pathogen care software application. Furthermore, the first electronic device may be part of the pathogen care device. For example, the first electronic device may be a computer device e.g. phone, tablet, computer, communicatively coupled to the pathogen care device, which may be used both by the patient and the healthcare professional.

[0010] According to embodiments of the present invention, the pathogen care event comprises any one of a therapeutic drug administration, a vaccine administration against a pathogen, or an extraction of a medical test sample from the patient to be analysed for the detection of at least one pathogen.

[0011] According to embodiments of the present invention, the pathogen care device is configured to detect the pathogen care event based on a pathogen care item being placed at a predetermined location of the pathogen care device. For example, the pathogen care device may be configured to detect a disposal of the pathogen care item into a storage bin associated with the pathogen care device. The disposal may be detected for example by capturing an image of the disposed item. Furthermore, the pathogen care device may be configured to detect a pathogen care event by retrieving information form a label attached to the pathogen care item e.g. scanning a bar code, reading an RFID tag, and the like.

[0012] According to embodiments of the present invention, the pathogen care item is any one of a vaccine sharps, a test sample vial. or a therapeutic drug vial.

[0013] According to embodiments of the present invention, the processing unit is configured to update, based on the information associated with the pathogen care data record, a pathogen status parameter of the patient associated with the digital health record, the pathogen status parameter is indicative of the health status of the patient.. For example, the processing unit may assign a health status parameter e.g. healthy or sick, to the patient based on the information contained in the digital health record.

[0014] According to embodiments of the present invention, the processor unit is configured to assign a confidence score to the pathogen status parameters based on a set of criteria comprising any one of the period between pathogen care events, a physical location of the user, or adherence of the patient to a pathogen care medical course. For example, the pathogen status of the patient may be assigned a confidence score, which may indicate the risk of the individual of becoming affected by a particular pathogen. As such the risk associated with a patient being sick with a particular pathogen may be assessed. For example, a patient that has not received a vaccine for a virus, has been present at a virus affected location or in contact with a virus carrying person would be more likely to be carrying the virus, even if the pathogen status indicates that the patient is healthy. Based on the confidence score certain actions may be initiated for the individual patient e.g. take a medical test, vaccine administration, quarantine, and the like. The confidence score may be used by the patients and governmental organisations to manage and prevent spreading of a pathogen to the community.

[0015] A pathogen care management system according to claim 1, wherein the least one first electronic device is configured to identify a patient based on a biometric ID of the patient comprising at least one biometric feature associated with the patient. The biometric features may include but not limited to fingerprints, iris, face, and the like. For example, the electronic device may be a mobile phone comprising a facial recognition or fingerprint recognition software capable of obtaining and optionally validating a user ID.

[0016] According to embodiments of the present invention the processing unit is configured, based on a physical location of patients transmitted from respective first electronic devices during operation of the pathogen care software application, to trace contact and/or exposure of a healthy patient to a non-healthy patient.

[0017] According to embodiments of the present invention, the processing unit is configured to validate the pathogen care event based on a comparison between information contained in the health data record and the information contained in the pathogen care data record and/or user identification record. For example, the information extracted by the pathogen care device during the detection of the pathogen care event about the pathogen care item may be compared to information stored in the digital health data record. For example, in the case of a vaccine administration the digital health record would store information associated with the expected vaccine to be administered, which are compared with the information received from the pathogen care device

[0018] According to embodiments of the present invention, the processing unit is configured to validate the pathogen care event based on proximity information between the at least one first electronic device and the pathogen care device, wherein the proximity information is collected from a proximity module of the pathogen care device and stored in the generated pathogen care data record. For example, the proximity may be established by connecting the first electronic device to the pathogen care device e.g. via a wireless connection such as Bluetooth or NFC,. For example, the electronic device may be a mobile phone or tablet that is configured to be connected via Bluetooth or in any other way to the pathogen care device.

[0019] According to embodiments of the present invention, the processing unit is configured to validate the pathogen care event based on information received from at least one second electronic device associated with an administrator of the pathogen care event. For example, the healthcare professional present at the pathogen care event may use an electronic device, which may be connected to the pathogen care device, to verify that the pathogen care event was administered. For example, the healthcare profession may use his/her mobile phone/tablet to connect to the pathogen care device, in a similar manner as for the patient device. In addition, the first and second electronic devices may be part of the pathogen care device.

[0020] According to embodiments of the present invention, the PCM platform comprises a certification module configured to issue a certificate associated with the health status of the patient based on the information contained in the digital health record. The certificate may be a digital certificate, which may be uploaded to a central database. The certificate may be accessible by the user through the pathogen care application. The certificate may be printed if desired. The certificate may be associated with the biometric ID of the patient. The biometric ID of the patient may be accessed and retrieved by third parties e.g. governmental authorities. For example, a governmental authority e.g. airport security, may be retrieved based on the biometric ID of the patient the certificate to validate the health status of the patient e.g. whether the patient has been vaccinated against a known pathogen such as covid-19.

[0021] In general, the present invention enables the management and monitoring/tracking of pathogen care events associated with a patient. Furthermore, the present invention enables patients to create a centralised digital health record, which may store a variety of medical related information e.g. medical history, vaccination log keeping track of the vaccine administration events, upcoming pathogen care events, and the like. Furthermore, the present invention may enable consent and identification of each individual patient, verification and identification of the pathogen care event and corresponding pathogen care item e.g. vaccine (make/batch). For example, the present invention may detect and digitally verify a disposal of a vaccine vial/needle, the placement of a test sample vial in the pathogen care device, and the like. The present invention provides a robust means of patient identification and consent associated with the corresponding pathogen care event through biometric information such as fingerprint scanning obtained through the pathogen care software application running on an electronic device e.g. the mobile phone of the patient. The detection of the pathogen care item provides a pathogen care digital record containing a variety of information. For example, the pathogen care digital record may contain information on the drug administered, time of administration, a verification by healthcare professionals that a drug was administered, information on a test sample via such as type of analysis to be performed, and the like. Furthermore, the present invention enables efficient and accurate confirmation of occurrence of pathogen care events. For example, the present invention may enable effective validation of pathogen care events by means of establishing the physical proximity of the patient, or a device associated with the patient to the pathogen care device during the pathogen care event, so as to enhance accuracy of confirmation and validating of vaccinations. The physical proximity information may be performed by, but not limited to: physical location of the patient established through the geolocation of the electronic device associated with the patient, a connection established between the electronic device associated with the patient with the pathogen care device, the verification by a healthcare professional and the like. The proximity information may be included in the pathogen care digital record transmitted to the pathogen care management platform.

[0022] Further technical advantages of the system and method include but not limited to:

- providing real time data for the uptake and effectiveness of immunization programmes. For example, the PCM platform may provide to information on the uptake of immunization programmes launched by a governmental health authority, based on data contained in the digital health records associated with a patient; - reminding patients when a pathogen care event is due to take place and monitor adherence of the patient to the pathogen care event. For example, the present invention may issue reminders when a vaccine administration is due or when new vaccines are available which provides further protection against new strains of the pathogen. The notifications may be extended to include other type of reminders, e.g. conducting medical test, health authority notifications, and the like. - Managing the availability and stock of the pathogen care items associated with the pathogen care events. Furthermore, the present invention may be configured to manage dispensation of the request pathogen care item based on the credentials of an authorised user. For example, the present invention may manage the stock and dispensation of vaccines or other therapeutic drugs. As a result, the present invention may prevent counterfeiting or incorrect pathogen care item being used in pathogen care events. - Enable the stock management and supply chain monitoring. For example, the present invention may place orders for pathogen care items in an order system when the stock of the pathogen care item reaches a threshold. Furthermore, the present invention may enable to track the pathogen care item along the supply chain channels, from ordering to delivery, based on information received from electronic checkpoints along the supply chain. For example, the PCM platform may be connected to electronic checkpoints associated with different stages along the supply chain e.g. manufacturer, supplier, delivery, and the like. Therefore, it becomes possible to monitor and track the journey of pathogen care items, which may prevent counterfeiting and further enable easy management of mass population immunization. Likewise, with a diagnostic pathogen event, the system may track various stages of the process from scheduling the test procedure, sample extraction, purification, analysis and reporting. - Improving community-based pharmacy administration and reduce record and paperwork keeping. The PCM system may be a portable system that may be used transported and used in a diverse range of locations e.g. a patient's home, a pharmacy, a clinic and the like. Furthermore, the patient may use the pathogen care software application to fill all the necessary information and provide consent prior to pathogen care vaccination event. - Facilitating reporting to users of adverse events associated with the pathogen care event e.g. wrong vaccine administered, possible contact with an individual that tested positive to a particular pathogen, vaccine side effects, and the like; - Facilitating management of large-scale population immunization vaccinations and reporting the results for analysis. - Furthermore, the system may also be used during clinical trials to assist with data collection.

Brief Description of the Drawings

[0023] Figure 1A shows an exemplified implementation of a pathogen care management system in accordance with embodiments of the present invention.

[0024] Figure 1B shows a schematic of an exemplified a pathogen care device according to embodiments of the present invention.

[0025] Figure 2 shows a process flow of an exemplary pathogen care management method for reporting and verifying vaccine administration in accordance with embodiments of the present invention.

[0026] Figure 3 shows a process flow of an exemplary pathogen care method for verifying vaccine administrations in accordance with embodiments of the present invention.

[0027] Figure 4 shows a process flow of an exemplary pathogen care method for managing a pathogen care item supply chain in accordance with embodiments of the present invention.

[0028] Figure 5 shows an example of the system illustrated in figure 1 for monitoring the occurrence of a vaccine administration event at least involving administering a vaccine to a patient according to a prescribed vaccination course.

[0029] Figure 6 shows an exemplified pathogen care method for a vaccine administration event according to embodiments of the present invention.

[0030] Figure 7 shows an exemplified method for verifying the validity of the vaccine administration event according to embodiments of the present invention.

Detailed Description

[0031] The present invention will now be exemplified with reference to the accompanying drawings. While this invention has been shown and described with reference to certain illustrated embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. Furthermore, while the invention has been described with references to a particular system and/or a method for pathogen care management , it should be understood by those skilled in the art that changes in form and details may be made to facilitate other types of method and/or systems used for verifying administration of medicaments, such as injectable medicaments used in chronic conditions, without departing from the scope of the invention encompassed by the appended claims.

[0032] Throughout the following discussion, numerous references will be made regarding servers, services, interfaces, portals, platforms, or other systems formed from computing devices. It should be appreciated that the use of such terms is deemed to represent one or more computing devices having at least one processor configured to execute software instructions stored on a computer readable medium. For example, a server can include one or more computers operating as a web server, database server, or other type of computer server in a manner to fulfil described roles, responsibilities, or functions. One should further appreciate the disclosed computer-based algorithms, processes, methods, or other types of instruction sets can be embodied as a computer program product comprising computer readable media storing instructions that cause a processor to execute the disclosed steps. One should appreciate that the systems and methods described herein involve interconnected networks of hardware devices configured to receive data using receivers, transmit data using transmitters, and transform electronic data signals.

[0033] The following discussion provides many exemplary embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0034] For simplicity and clarity of illustration, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. Numerous details are set forth to provide an understanding of the examples described herein. The examples may be practiced without these details. In other instances, well-known methods, procedures, and components are not described in detail to avoid obscuring the examples described. The description is not to be considered as limited to the scope of the examples described herein.

[0035] Figure 1A shows an exemplified implementation of a pathogen care management system according to embodiments of the present invention. The PCM system may be configured for managing and tracking pathogen care events associated with a patient. For example, the pathogen care system may be used to track and a manage a vaccine administration event, the administration of a therapeutic drug, or a medical test sample. The system comprises at least one pathogen care (PC) devices 120 1-n configured for detecting the use of pathogen care item associated with the pathogen care event. For example, the pathogen care device may be configured for recording deposits of vaccine sharps i.e. spent vaccine vials after administration of the vaccine, sharps/vials associated with a therapeutic drug, or a medical test sample. Each device may be associated with an authorised user and/or an authorised organisation. For example, each PC device 120 1-n may be associated with a hospital, a clinic, a health authority official, a doctor, nurse, or any other user with the credentials for operating the device. Each PC device 120 1-n may be associated with pathogen care software application that may be used to authenticate the credentials of the user before operating the PC device. The pathogen care software application may authenticate the credentials of the user based on a password, a biometric feature of the user e.g. fingerprint, an electronic signature, or any other known means that can be used for user authentication. For example, the pathogen care software application may be configured to identify a user based on a biometric ID. The software application may be running on the PC device, and/or running on an electronic device 150 1-n communicatively coupled to the VAV device 120 1-n e.g. a computer, mobile phone, and the like.

[0036] The pathogen care software application may be configured to identify and/or register a user e.g. a patient, prior to a pathogen care event based on the biometric information of the user. For example, the biometric information may be stored as part of the user data record stored either in the electronic device 150 1-n and/or the pathogen care management (PCM) platform. For example, the biometric ID of a patient may be stored and/or associated with the digital health record of the patient. A patient may further use the pathogen care software application to consent to the pathogen care event. For example, the patient may consent to the vaccination by for example completing a digital consent form via the pathogen care software application. The electronic device

150 1-n may be configured to connect to the PC device 120 1-n to enable the exchange of data. For example, the electronic device 150 may be connected to the PC device 120 via a wireless connection, a Bluetooth, Near Field Communication (NFC), one or more wireless personal area network (WPAN), Wireless local area network (WLAN) or another suitable device-to-device network. The pathogen care device 120 may comprise a proximity module configured to detect when an electronic device 150 is connected/paired with the PC device 120. For example, a patient and/or a healthcare professional may be asked when opening the pathogen care software application to allow a connection to a PC device 120. For example, the geolocation information of the user may be collected via geolocation API. The proximity information collected from the proximity module may be added to the PC data record.

[0037] The pathogen care (PC) device 120 may be configured to detect a pathogen care item associated with the pathogen care event. For example, the pathogen care (PC) device 120 may be configured to detect the deposit of pathogen care items to a storage/collection bin of the pathogen care (PC) device. The pathogen care items may include, but not limited to, vaccine sharps, medical/therapeutic drug vials, test samples and the like. Furthermore, the PC device 120 may be configured to detect the pathogen care items by reading or scanning a label or another device on the pathogen care item. For example, the PC device 120 may comprise an identification device such as a Bluetooth device, GPS device, near field communications module (NFC), bar code scanner, QR code scanner, RFID tag reader and the like. The identification device may be capable of reading and/or obtaining information from a corresponding identification element attached to the pathogen care item. The identification element may be in the form of communication labels: radio/electronic inlays - single or dual frequency NFC/UHF, barcodes, QR codes, digital watermarks, and RFID. The communication labels may provide short- and long-range tracking. For example, short range (e.g., 1- 4 cm) may be used to track consumer engagement, while long range( 1 meter) may be used for prescription management/stock control.

[0038] For example, the pathogen care (PC) device 120 may be a smart medical storage bin such as the ones described in one of the following patent applications : US 14/307,002, US 29/595,646, US 29/595,655, PCT/US2019/039269, PCT/IB2018/000993, EP19217751 or any other similar device configured to receive pathogen care item deposits. Furthermore, the device 120 may be configured to store and/or dispense pathogen care items e.g. vaccines or associated items (e.g. vaccines, syringes, and the like) for administration to the user as part of a pathogen care event. The PC device 120 may be configured to generate a pathogen care (PC) data record, which may be transmitted to the Pathogen Care Management (PCM) platform for storage and further processing. The PC data record may contain a range of information associated with the pathogen care event. For example, the PC data record may contain information associated with the pathogen care item detected by the identification device such as type of the pathogen care item, timestamping of the deposit, patient details, healthcare professional details, and the like. Furthermore, the PC data record may contain information associated with a dispensation of a pathogen care item. For example, it may contain details of the user requesting the dispensation, a timestamping of the dispensation event, the type of pathogen care item, and the like. As such, data obtained during dispensation of a requested pathogen care item may be compared to the data retrieved from the deposited pathogen care item.

[0039] Furthermore, the PC device 120 may be configured to identify and classify the pathogen care items received. For example, the PC device may be configured to collect the used pathogen care item e.g. vaccine sharps, and accordingly identify the content of the storage container for downstream recycling processes, to aid in the recovery of material from this waste product. For example, in the case where the deposited pathogen care items in the storage container are of similar type or coming from same manufacturer, the PC device may accordingly label the storage containers, e.g. when replaced, so that the content of the storage container may be processed together with other like type container thus importing downstream recycling process. For example, the PC device may be associated with a specific pathogen care item type, and as such configured to store a predetermined type of pathogen care item e.g. used vaccine sharps, or therapeutic drug sharps, and the like. Furthermore, the PC device 120 may be provided with a plurality of containers, each configured to store a predetermined type of pathogen care items. The PC device 120 may be provided with a classification device, for directing the deposited products to the corresponding storage container. The PC device 120 of the present invention may be used in environmental waste management applications, improving circular economy, product stewardship and Extended Producer responsibility. The PC device 120 may further provide real time data on waste disposal, identifying, quantifying and measuring consumption during vaccine administration or therapeutic consumption as well as providing the data figures for recycling, re-using during waste recovery/processing activities. For example, the information regarding to the identification of the content of the storage containers/bin of the PC device 120 may be transmitted to the PCM platform 110 or another suitable system for processing. For example, the identification content information may be part of the pathogen care data record or may be transmitted as a separate data record. For example, based on the detection of the pathogen care items in the at least one storage bin of the pathogen care device 120, it may be possible to reconcile the pathogen care items when storage bin is emptied. The pathogen care items that may be disposed in the storage bin may include but not limited to the any one of or combination thereof of the following items: medical and electronic apparatus, equipment, instruments and devices, namely, medical and electronic devices used in self injectable medication procedures to collect waste materials; electronic medical apparatus, equipment, instruments and devices, namely; containers for medical waste; containers especially made for medical waste; boxes adapted for medical waste products; containers specially adapted for the disposal of medical instruments, syringes, and other contaminated medical waste; receptacles for applying for medicines, namely, cannulas for anaesthetics with receptacles; medical waste container, namely, sharps container for disposing of injectable medication; injection needles and syringes for medical use; drug delivery devices, namely, drug delivery systems; medical delivery apparatus, equipment, instruments, devices and systems for delivering medicaments, pharmaceuticals, vaccines and other substances intradermally, transdermally, subcutaneously or otherwise through the skin; electronic analysers for medical purposes, namely, skin moisture analysers for medical purposes, analysers for bacterial identification; electronic medical apparatus, equipment, instruments and devices for monitoring, detecting, measuring and recording data relating to the behaviour of humans taking medication; electronic monitoring instruments for medical use, namely, medical instruments for monitoring oximetry, gas analysis and vital signs; measuring apparatus, namely, electronic drop counters for medical use; inhalers for medical use; medical inhalers, namely, anaesthetic inhalers sold empty, hydrogen inhalers for medical use, sold empty; pumps for medical use to dispense pharmaceuticals from containers; medical apparatus, equipment, instruments and devices containing medicaments, pharmaceuticals, vaccines and drugs, namely, automatic vaccination apparatus, electromagnetic drug delivery apparatus for medical use, injection device for pharmaceuticals; medical delivery apparatus, equipment, instruments, devices and systems containing medicaments, pharmaceuticals, vaccines and drugs for delivery thereof intradermally, transdermally, subcutaneously or otherwise through the skin; parts and fittings for all the aforesaid goods. Unused medications or packaging for therapeutics, treatments or drugs.

[0040] An exemplified pathogen care device 120 is shown in Figure 1B.. The PC device 120 comprises for example a switch 121, a storage container 122, also referred to as a receiving unit, an identification unit 123, and a screen 124.

When a user deposits a pathogen care item into the receiving unit 121, the disposal or deposit may trigger the operation of the item identification unit 122. The identification unit 122 may comprise one or more sensors configured to detect, recognize and/or identify received Pathogen care items associated with a pathogen care event, e.g. an injection of a specific vaccine. According to some embodiments, the identification unit 122 may be configured to analyse an image obtained from the detected pathogen care item. The identification unit 122 may be configured for scanning a one-dimensional or two-dimensional identification code attached to the pathogen care item, as previously described. For example, the pathogen care item identification unit 122 may comprise an RFID reader configured to read information form an RFID tag attached to the VAV item.

[0041] According to some embodiments of the invention, the pathogen care item may be a vaccine syringe. The item identification unit 123 may be configured to detect a state of the syringe received in storage container 123 of the PC device 120. The state of the syringe may indicate whether the vaccine has been properly or validly administered. For example, a fully compressed syringe may indicate that the syringe is empty, thus indicating that the full dose of the vaccine has been administered. The compression level may be detected based on the position of the syringe piston in the syringe tube. The information related to the detected state of the pathogen care item may be added to the PC data record, which is transmitted to the PC platform for further processing and validation. For example, the state of the pathogen care item may be used by the PC platform to verify that the pathogen care event was validly performed. For example, if the identification unity 122 detects that the syringe is in a compressed state, the processor 114 may consider that the vaccine has been validly administered, otherwise the processor may indicate an invalid administration of the vaccine or another related pathogen care item e.g. therapeutic drug.

[0042] The VAV device 120 may be configured for transmitting the generated pathogen care (PC) data record to the PC platform based associated via a communication module 125 such as a known cellular/wireless module. The identification unit 123 may comprise a processing unit in communication with a timer configured to timestamp the pathogen care items deposited in the storage container 123. The time-stamped information may be transmitted to as part of the pathogen care data record to the PC platform for storage in the database module 112 and processing by the processing unit 114.

[0043] The system 100 may comprise a Pathogen Care Management platform 110. The PCM platform 110 may be configured for receiving, via a communication link, the PC data records collected from the one or more PC devices 120 e.g. during retrieval and/or disposal of the vaccine vial and/or identification information collected and transmitted from the electronic device 150 1-n.

[0044] The PCM platform 110 may comprise a database storage module 112 configured for storing data records associated with registered users. The data storage module 112 may be a computer database and/or a decentralised database e.g. blockchain. For example, the database storage module 112 may be configured to store the digital health data records of registered patients. The health data records may include a range of information relating to the individual patients, such as medical information, personal information, identification credentials, and the like. The PCM platform 110 may further store digital data records associated with administration users e.g. the practitioners administering the vaccine, which may contain similar information with the ones associated with the patient digital data records.

[0045] The PCM platform 110 may be running on a cloud platform thus allowing each user to access and manage their corresponding digital data records via a pathogen care software application, which may be downloaded and operated on an electronic device of a user e.g. patient, healthcare professional, or another authorised user. The pathogen care software application may enable the user, depending on their credentials, to access and manage their digital health data records, updated information, receive and access information regarding a pathogen care event e.g. vaccination schedule, access vaccination aid and assistance resources, review vaccination history and status, modify vaccination schedule, consent to the vaccination schedule, and the like. Furthermore, the pathogen care software application may be used to authenticate users for operating the PC device 120, as previously described. The software application may be configured to generate for each individual patient a pathogen care event schedule and plan based on certain information obtained directly from the patient and/or patient's health record. For example, the pathogen care event schedule may be based on the patient's health status, medical history, vaccination history, recommendation and/or policies of an authorized health authority etc. The pathogen care software application may be further configured for providing notifications and reminders to assist each patient to timely and effectively adhere to a scheduled pathogen care event e.g. a vaccination event.

[0046] The PCM platform 110 further comprises a processing unit 114 configured for processing the information received from the PC device 120, e.g. the PC data record, and/or the identification data received from the electronic device 150. The processing unit 114 may be configured to verifying the validity of the vaccine administration event based on the comparison of the information received from the VAV device 120 and/or electronic device 150 with the information stored in the digital health data records stored in the VAV registry. For example, the processing unit 114 may compare the type of vaccine administered to the individual patient with the expected vaccine information stored in the digital health data record. The processing unit 114 may be configured to update the digital data health record of each patient with information received from the PC device 120. For example, in response to a valid verification of the vaccination event, i.e. the vaccination of the individual was successful, the processing unit may be configured to update the vaccination status of patient in the corresponding digital health data record. Furthermore, the processing unit 114 may update a health status of the patient according to the information contained in the corresponding digital health record. Furthermore, the processing unit 114 may be configured to assign a confidence/risk score to the health status of the patient. For example, the processing unit, based on the physical location of the patient, which may be shared via the software application, may adjust the confidence score of the health status of the patient indicating whether for example a healthy patient is likely to become sick. For example, in the case, where the patient travels to a country with high level of infectious diseases, then the confidence score of the health status of the patient may be lowered. As such an corresponding action may be issued by the PCM platform directly or from a third party such as that the patient needs to stay in quarantine for a number of days, a vaccine/drug needs to be administered, a test sample needs to be taken, schedule a visit to the doctor and the like.

[0047] The PCM platform 110 may comprise a certification module configured to generate a medical certificate to the patient, in response for example to a valid pathogen care event being detected e.g. verification of a valid vaccination.

[0048] As shown in Figure 1A, the PCM platform 110 may be linked to a centralized registry of a health authority 130, wherein certificates may be registered with an authorised health authority and may also be associated with the ID of the patient e.g. the biometric ID. The PCM platform 110 may be linked to a supply chain system 140 configured to manage the supply and/or production of pathogen care items. For example, in the case of a vaccine, the PCM platform may provide information to the supply system of a vaccine manufacturer/distributer of the vaccine product stock levels.

[0049] An exemplified method 200 for tracking and managing pathogen care events is shown in Figure 2. According to some embodiments of the invention, the PC device detects 202 one or more deposits of pathogen care items e.g. vaccine sharps deposits. Each of the pathogen care item may be associated with an administration of an injectable medicament e.g. a vaccine. Based on the detected pathogen care items, at step 204, the PC device 120 generates a pathogen care data record. The PC data record may comprise information associated with the deposit of the pathogen care item e.g. type of vaccine, date and time, a VAV item identification data e.g. photo, electronic device connected to the VAV device 120, and the like. The generated data record is transmitted, at step 206, to the PCM platform 110, where it is processed at step 208 by the processing unit 114. The processing unit 114 may be configured for updating at step 210 the information in the patient's digital health data record with information contained at least in the PC data record. For example, in the case of a valid vaccine administration event the processor is configured for updating the vaccine information in the corresponding digital health data record in the data storage module.

[0050] It should be noted that the processing unit 114 may update the digital health record of the patient with information from the PC data record irrespective of the validity of the vaccine administration event.

[0051] As shown in figure 3, the step 210 of updating the digital health record may comprise a series of additional steps. For example, at step 301 the verify the validity of the pathogen care event. For example, the processing unit 114 may compare the information received from the PC device 120 and/or electronic device 150 with the information stored in the digital data record of the patient. At step 302, the processing unit 114 may be configured to evaluate based on information in the digital health data record, whether a prescribed pathogen care event course has been completed e.g. vaccination event. In step 304, a medical certificate may be issued following valid and completed pathogen care event course. The certificate may be registered with an authorised authority e.g. a governmental authority and may further be associated with the ID of the patient e.g. biometric ID, at step 306. For example, the certificate may be transmitted to a computer device 150 associated with the individual. The certificate may also be available for download or viewing via the pathogen care software application. This certificate may be issued as a softcopy or a hardcopy. The patient may for example use the certificate at a border control e.g. a port or an airport, where based on the presentation of the biometric features of the patient, through a scanner may retrieve an individual's validated digital certificate allowing entry into the that territory.

[0052] As previously discussed, the PC device 120 may be configured to also dispense pathogen care items e.g. vaccine vials. As such, the PC device 120 may be configured to register the pathogen care items dispensed and accordingly determine, based on information obtained during the detection of a pathogen care item deposit, if the correct pathogen care item has been deposited. In this way, the system 100 of the present invention enables tracking of the pathogen care item. For example, certain vaccines may need to be used within a certain time frame otherwise their effectiveness may be compromised. Furthermore, in this way, misappropriate and counterfeiting of the pathogen care items may be prevented.

[0053] The PCM platform 110 may issue one or more notifications to at least one authorised user of the PCM system 100. For example, the PCM platform 110 may issue a notification to a user indicating the vaccination state of an individual, or that the vaccine was administered within the specified time frame, whether any dispensed vaccines were not used, and or issue a vaccine stock notification indicating the number of vaccines remaining/used and whether a new vaccine order needs to be placed.

[0054] The PCM platform 110 may reconcile at step 402 supply chain information of the vaccine by aggregating pathogen care item supply chain information collected from a plurality of electronic checking points from different stages along the supply journey of the pathogen care item. The supply chain information may comprise information collected during manufacturing, and/or transportation, and/or delivery, and/or administration. An authorised user may re-order the vaccine through the software application. Alternatively, the application or the service can automatically place an order a vaccine based on the reconciled supply chain information.

[0055] An example of a Pathogen care management system 100 used in tracking and managing vaccine administration events according to embodiments of the present invention is shown in Figure 5. The PC system 100 of figure 5 may be used for monitoring and verifying the occurrence of a vaccine administration event at least involving administering a vaccine to a patient according to a prescribed vaccination course. The PCM system 100 may be provided with at least one PC device 120 configured to detect sharps deposits of administered vaccines, and accordingly generate for each vaccine sharp deposit a PC data record comprising information associated with the vaccine administration event. As previously mentioned with reference to figure 1, the PC device 120 may be communicatively coupled to at least one first electronic device 150-1 configured to run a PC software application configured to identify and/or register a patient prior to the vaccine administration event. The PC software application, as previously indicated, may be operated by a patient to access and manage their unique health data record, as well as completing any necessary documentations prior to the vaccination e.g. consent forms, and the like. The health care professional (HPC) administering the vaccine may be provided with a second electronic device 150-2 running a corresponding software application associated with the PCM system 100. For example, the software application may be configured differently depending on the credentials of the user. The first and second electronic devices 150-1 and 150-2 are communicatively coupled to the PC device 120 via a wireless communication network. For example, the electronic device of the patients and/or the vaccine administrator may be connected with the PC device 120 using a Bluetooth connection. A software application may be running on the PC device 120 and electronic device 150 that may initiate the connection/pairing of the device, e.g. by alerting the user when the PC device 120 is within a connection range and accordingly prompting the user to connect to the PC device 120. Information generated by the PC device during the vaccine administration event is transmitted to the PCM Platform 110. As previously indicated, the information received are processed and collated/compared with information stored in the digital health record of the patient to determine validity of the vaccine administration event. It should be noted that depending on the use of the PCM system 100 more or less devices from the ones shown in figure 5 may be required. According to some other embodiments of the invention, the patient may complete a vaccination event using the PC device 120 in conjunction with the patient electronic device 150-1. In the event of clinic vaccination, according to some embodiment, a vaccination event may be completed with the presence of only the VAV device 120 and the HCP electronic device 150-2. For example, there may be situations where the patient has left his/her electronic device at home. Further information regarding the process for carrying out these various embodiments of the invention will be described in further detail in later sections.

[0056] Figure 6 shows an example of a process flow for administering a vaccine to an individual at a healthcare facility e.g. a clinic, a pharmacy, and the like. Prior to the vaccination at step 601, the patient downloads the pathogen care software application on his/her electronic device 150 such a mobile phone. The individual patient may register or create a profile in the PCM system 100 and completes the necessary documentation such as providing consent. At step 601 the patient identity is also confirmed using biometric authentication e.g. a fingerprint obtained from a biometric sensor of the electronic device, or similar. The patient may further use the software application to request vaccination appointment on his/her own initiative or according to vaccination policies of the relevant heath authorities.

[0057] When the patient attends the vaccine clinic and presents their fingerprint, the patient health data record may be reviewed through an administrator software application. A photo of the individual's ID may be taken. The photo may be uploaded to the database through the administrator application. The healthcare professional and the patient proceed to scan and administer the vaccine. The healthcare professional may scan the vaccine box or enter the unit ID on a computer system connected to or being part of the PC device 120. The administered vaccine may be validated by the PCM system 100. The administered vaccine sharp is disposed into the PC device 120 as previously described. The PC device 120 detects, at step 602, the vaccine sharp deposit and generates, at step 603, a PC data record containing a range information e.g. vaccine type, a vaccine image, timestamping information, proximity detection information, and the like. The PC data record, along with other information (e.g. identification data generated from a connected electronic device 150) are received and processed at the PCM platform 110 to verify the validity of the vaccine administration event at step 604. In response to a valid vaccination, the vaccine status of the digital health record is updated accordingly, at step 607. In the case where the vaccine administration is deemed invalid or further conformation is needed, a notification may be issued to a corresponding user e.g. patient, doctor, health authority, and the like, at step 606. At step 608, vaccine certificate may be generated for a valid vaccine administration event, which is associated with the corresponding digital health record of the patient. A confirmation of administration may be sent to both the individual and the clinic through the individual and the administrator applications to update the corresponding records. The individual's vaccine record is created or updated with the specific vaccination event. Based on the updated record that the specific vaccine has been consumed, the service 110 may update to reconcile the vaccine supply chain. The vaccine may be re-ordered to ensure sufficient supply of vaccines for future administration.

[0058] Figure 7 shows an example of a steps taken by the processing unit 114 to verify the validity of the vaccine administration at step 604 of figure 6. At step 6041, the processing unit may compare the information received by the PC device 120 and/or a connected electronic device associated with an HPC user and/or patient with information contained in the digital health data record. For example, the processing unit 114 may determine based on the comparison that the correct vaccine and/or vaccine dose was given to the patient. If there is match between the information compared in step 6041, then a notification is issuer at step 6403. For example, a notification may be issued to the patient and/or vaccine administrator via the pathogen care software application. If there is a match, at step 6402, then the processing unit may use the proximity information received from the PC device 120 to determine whether the electronic device of the user was connected to the PC device during the vaccine administration event, as previously explained. If the proximity information indicate that the connection was not made, then a notification may be issued requesting additional confirmation by the patient and/or vaccine administrator, at step 6044. Otherwise, the processing unit 114 may further request a vaccine conformation from the vaccine administrator to confirm that the vaccine was administered according to predetermined set of standards associated with the prescribed vaccination course.

[0059] Although the above process is described in a context of a clinical setting for vaccine administration, it is understood that setting for administration could be a hospital, clinic or home setting. The vaccine may be administered by a nurse in a clinic or self-administered by the individual.

[0060] As previously described, once the patient has successfully completed one or more administrations of vaccines required to be considered vaccinated so as to achieve immunity against a specific pathogen or disease, a digital vaccine certificate may be generated 304 and issued to the patient through the patient application. The certificate may be registered 306 with the corresponding health authority. The patient may download or retrieve the vaccine certificate when needed. For example, relevant authorities may require an individual to show a specific vaccine certificate in order to allow the individual to travel or enter a premise. The vaccine certificate may be signed or encrypted such that the authority can verify the validity of the vaccine certificate to ensure authenticity. The certificate may have an expiry date depending on the specific type of vaccine, i.e. whether the vaccine is life-long, effective for a specific number of years, or seasonal.

[0061] The PCM system 100 of the present invention may also be used for tracking and monitoring a clinical/medical diagnostic test. For example, the following steps may be involved: - a screening test is scheduled, and the patient is notified via the software application; - the patient attends the event at a clinic/pharmacy and identifies through an electronic device using his/her biometric ID. - a blood sample, swab or another sample taken; - the sample is sealed and dropped into the storage container of the PC device 120. - PC data record is generated, which is transmitted to the PCM platform for storage and processing. - The storage container may be configured to keep the medical test sample cold; - the sample is removed from the storage box for processing in the medical lab - The lab may be connected to the PCM platform to determine the required diagnostic analysis on the sample - Sample is processed and the results are transmitted to the PCM platform; - patient and/or doctor receives notification of the results;

- the PCM platform updates the health status of the patient and assigns a confidence score; - patient is notified and may follow-up with a doctor.

Claims

1. A pathogen care management system for managing and tracking pathogen care events associated with a patient, the system comprising: at least one first electronic device running a pathogen care software application configured to at least identify and/or register the patient prior to a pathogen care event, the pathogen care software application configured to generate, during operation, a user identification data record comprising identification information associated with the identified patient, at least one pathogen care device communicatively coupled to the at least one first electronic device, the pathogen care device configured to detect at least one pathogen care item associated with the pathogen care event, and accordingly generate a pathogen care data record associated with the identified patient; and a pathogen care management, PCM, platform configured to be communicatively coupled to the at least one pathogen care device and at least one first electronic device, the PCM platform comprising a data storage module storing a plurality of digital health records associated with patients, each digital health record comprising pathogen care data and identification data associated with a unique patient, and a processing unit configured to update the digital health record associated with the identified patient with the information received from the pathogen care device and/or at least one first electronic device.

2. A pathogen care management system according to claim 1, wherein the least one first electronic device is configured to identify a patient based on a biometric ID of the patient comprising at least one biometric feature associated with the patient.

3. A pathogen care management system according to any one of the preceding claims, wherein the PCM platform comprises a certification module configured to issue a certificate associated with a health status of the patient based on the information contained in the digital health record, the certificate being associated with the biometric ID of the patient.

4. A pathogen care management system according to any one of the preceding claims, wherein the pathogen care event comprises any one of a therapeutic drug administration, a vaccine administration against a pathogen, or an extraction of a medical test sample from the patient to be analysed for the detection of at least one pathogen.

5. A pathogen care management system according to any one of the preceding claims, wherein the pathogen care device is configured to detect the pathogen care event based on a pathogen care item being placed at a predetermined location of the pathogen care device.