LU102750B1 - Printable smart tag - Google Patents

Abstract

A printable electronic tag, a method of configuring the tag for use and a method of tracking tag status in use are disclosed. The tag comprises a flexible data processing substrate layer overlaid by a flexible printable top layer. The substrate layer includes a power source, at least one sensor for monitoring one or more parameter(s) in the environment adjacent the tag, a data interface for receiving calibrating parameter(s), a memory storing a unique tag identifier and the received calibrating parameter(s), a processor and a visual user interface for indicating a status alert or an absence thereof. The processor receives sensed environmental data, compares it with the calibrating parameter(s), and selectively outputs an alert signal to the visual user interface according to the comparison result, wherein the visual user interface is observable through flexible printable top layer in use. The unique tag identifier is recorded in a digital distributed ledger and data exchanged between the tag and a reading terminal is recorded in the ledger against the unique tag identifier.

Description

PRINTABLE SMART TAG LU102750 Field of the Invention

[001] The present invention relates to electronic labels or tags for containers. In particular, the present invention relates to self-powered data processing labels or tags for containers of perishable material and techniques for tracking their status. Background of the Invention

[002] Container monitoring has improved significantly through the reduction in size of data processing architectures and the proliferation of logistic applications requiring real-time or near- real-time monitoring of containers. For instance, self-powered self-locating devices are long known, that are designed for permanent or releasable securing to a shipping container, in order to track its location over time.

[003] In many fields, and in particular the healthcare field, material or substance in a container is perishable, with viability varying according to environmental and/or chronological conditions ambient the container over time. For example, medical samples or vaccines frequently require specific environmental conditions to be maintained and/or not exceeded to remain viable or usable, irrespective of shipping and handling techniques and constraints. Whilst onboard monitoring solutions have been developed as part of temperature-controlling systems for specialized shipping and static containers, these are typically bulky and costly, and therefore uneconomic to use for shipping small sets, or even single instances, of biological samples and the like.

[004] Even for such specialized containers, tracking techniques are still essentially based on locally scanning a barcode or QR code printed on an inert label, or decoding a code from a radio signal broadcast by an active (e.g. RFID) label, then communicating and correlating the scanned data remotely, with no sensing and/or no recording of environmental conditions about the container, prejudicial to the viability or usability of the material or substance therein.

[005] The development of alternatives to the above printed code-based tracking paradigm is severely hindered by the enormous heterogeneity in healthcare labels, from printed or handwritten adhesive labels to, much more recently, electronic paper-based and/or radio frequency-based digital tags, referred to as ‘smart’ tags. This enduring heterogeneity of label types parallels a growing mix of standards for information type and content on labels according to industry or service requirements, and of standards applicable to data formatting, processing and communicating techniques embodied in smart tags. In this context, normative efforts are hindered by thematic or technological silos of competing technologies, wherein both the configuration and the use of -p1 electronic tags get beset by ever more technological points of failure along the information chain iu102750 use.

[006] Currently, these factors cumulate into a loss ratio of between 3 and 7% for biological samples, attributable solely to incorrect sample labeling or label data reconciliation. Beside the time and materials wasted in processing samples not known to be unviable when received, more problematically the corresponding testing results can cause negative patient outcomes, possibly terminal in extreme cases.

[007] There is accordingly a requirement for an alternative electronic tag, apt to mitigate at least some of the shortcomings of the state of the art. Summary of the Invention

[008] Aspects of the invention are set out in the accompanying claims, aimed at various embodiments of a printable electronic tag, a method of configuring same for use and a system for tracking tag status.

[009] In a first aspect, the invention provides a printable electronic tag, comprising a flexible data processing substrate layer and a flexible printable layer atop the substrate layer. The substrate layer comprises an operable combination of a power source, at least one sensor for monitoring one or more environmental parameter(s), a data interface for receiving calibrating parameter(s), a memory storing received calibrating parameter(s) and a unique tag identifier, a visual user interface and a processor connected to the or each sensor. The processor is configured to receive environmental data sensed at the or each sensor, compare the environmental data with the calibrating parameter(s), and selectively output an alert according to the comparison result, and the visual user interface for indicating the alert or an absence thereof, observable through the printable layer in use.

[0010] This minimal configuration according to the invention advantageously indicates the status of the container’s contents to users, irrespectively of any temporary or final break in the information chain between the tag and a relevant tag data-collecting architecture, moreover without any need to connect the tag data processing means, or read printed code thereon, with a terminal. In an example, a biological sample rendered unviable by adverse environmental conditions during its storage in the container equipped with the tag of the invention, can be immediately assessed as unviable from the visual user interface indicating the alert, and so easily and promptly discarded from any further testing and procedures, thus enhancing the accuracy and reliability of the study test data. -p2

[0011] The or each calibrating parameter is preferably user-selectable for configuring the tag, and 192750 selected from a threshold value for an environmental parameter or a range thereof, a time period or a time interval and, generally, from predetermined characteristics against which to measure the status of a material, compound or any other substance stored a container, to which the tag is secured in use.

[0012] The environmental parameter(s) are quantifiable values of characteristics of the environment ambient the tag at any given time, by reference to which the viability of the container’s content is assessed. They preferably comprise one or more selected from a humidity level, a temperature range or threshold, a carbon monoxide concentration, a carbon dioxide concentration, a ethylene concentration, and, generally, measurable characteristics of environments in which a container, to which the tag of the invention is secured, is successively or permanently stored.

[0013] An embodiment of the printable electronic tag may comprise at least a second sensor, namely a geographical positioning system (GPS) module for monitoring a geographical location of the tag, wherein the calibrating parameters and the environmental parameters include geographical data. Beside the expected function of tracking of the container geographically, this embodiment advantageously provides a means to geo-fence the container through the provision of geographical boundaries as calibrating parameters wherein, pursuant to the principles herein, a breach is indicated by the visual user interface.

[0014] In embodiments of the printable electronic tag for applications requiring enhanced data processing security and integrity, the processor may usefully implement a trusted execution environment (TEE), wherein at least the unique tag identifier is recorded in a digital distributed ledger.

[0015] In embodiments of the printable electronic tag, connectors of the power source are preferably insulated by a user-removable non-conducting member before tag use, to avoid discharging the power source prematurely.

[0016] The data interface is preferably an input/output interface, configured for outputting calibrating parameter data and/or environmental data and/or alert data selectively in answer to a data query by a local device.

[0017] An embodiment of the data interface may be a wireless communications module, configured for outputting calibrating parameter data and/or environmental data and/or alert data wirelessly selectively in answer to a data query by a local device, such as a tag reader-scanner or -p3 a personal communication device, or a remote device such as a user computer in a distant officeU102750 Embodiment of the wireless communications module may implement one or more of a low power wide area network (LPWAN) and/or radio-frequency identification-based (RFID) and/or near-field communication (NFC) and/or Bluetooth Low Energy (BLE) data communication standard.

[0018] In embodiments of the printable electronic tag with a wireless communications module, the data interface may be further configured to communicate data selectively according to the calibrating parameters, wherein the calibrating parameters include an authentication key or code and/or a communicating interval value, respectively in order to avoid disclosing tag data to an unauthorised terminal and/or discharging the power source prematurely.

[0019] In another aspect, the invention provides a method of configuring a printable electronic tag for use, comprising the steps of assembling an operable combination of a power source, a memory, a processor, a data input interface for receiving user-selected calibrating parameter(s), at least one sensor suitable for monitoring one or more parameter(s) in the environment adjacent the tag, and a user interface for indicating an alert or an absence thereof, on a flexible substrate layer, securing a flexible printable layer atop the substrate layer, through which the visual user interface is observable in use ; generating a unique tag identifier for the tag ; and storing the unique tag identifier in the memory and in a digital distributed ledger.

[0020] The configuration method advantageously instantiates each physical tag of the invention in a block chain individually, by way of mitigating tag and/or tag data tampering or loss in use, as container contents-respective data physically printed on a tag will always be reconcilable with at least that tag’s unique tag identifier recorded in the block chain for purposes of verification, irrespectively of the situation wherein the data processing layer of the tag fails or gets compromised.

[0021] In an embodiment of the method, the step of assembling may further comprise receiving a user selection from a remote terminal over a network, the selection identifying the or each sensor in the combination to be assembled. This embodiment of the method advantageously provides users with a modular tag architecture, wherein tags of the invention can be configured according to the container application and in numbers deemed sufficient for same, reducing the potential wastage in producing redundant tags.

[0022] Embodiment of the method may comprise the further steps of receiving the calibrating parameter(s) from the remote user terminal over a network, and storing the received calibrating parameter(s) in the memory via the data input interface. A variant may comprise the further steps - p4 of storing the received calibrating parameter(s) in the digital distributed ledger, and associating th&J102750 stored calibrating parameter(s) with the respective unique tag identifier in the digital distributed ledger.

[0023] When the printable electronic tag is configurable for healthcare use, the method, preferably comprise the further steps of receiving healthcare data from a remote terminal over a network, and printing at least a subset of the received healthcare data on the printable layer. A variant may comprise the further steps of storing at least the subset of received healthcare data in the digital distributed ledger, and associating the stored healthcare data with the respective unique tag identifier in the digital distributed ledger.

[0024] In a further aspect, the invention provides a distributed system for tracking a status of a printable electronic tag, comprising at least one printable electronic tag according to any embodiment wherein the data interface is an input/output interface ; at least a first network- connected terminal configured, as a validation sensor, to establish a data connection with the or each tag, to determine an alert status therefrom and to relay tag-respective alert status to a second network-connected terminal ; and the second network-connected terminal configured to encode relayed alert status with the respective unique identifier of the or each tag in the digital distributed ledger.

[0025] In embodiments of the system, the first network-connected terminal may be further adapted to read environmental data from the or each tag and/or from environment ambient the or each tag, and to relay the environmental data to the second network-connected terminal, and the second network-connected terminal may be further configured to encode relayed environmental data with the respective unique tag identifier of the or each tag in the digital distributed ledger.

[0026] In embodiment of the system, the first network-connected terminal preferably implements one or more of a low power wide area network (LPWAN) and/or radio-frequency identification- based (RFID) and/or near-field communication (NFC) and/orBluetooth Low Energy (BLE) data communication standard.

[0027] In still another aspect, the invention provides a data processing method for tracking a status of a printable electronic tag, comprising the steps of providing at least one printable electronic tag according to any embodiment wherein the data interface is an input/output interface and wherein the unique tag identifier of the or each tag is stored in the digital distributed ledger ; establishing a data connection between the tag data interface and a network-connected terminal ; communicating -p5 an alert from the tag to the terminal or reading the alert from the tag with the terminal ; and causingJ102750 the terminal to associate the alert with the respective unique tag identifier of the connected tag in the digital distributed ledger.

[0028] An embodiment of this method may comprise the further steps of reading environmental data from the tag with the terminal or sensing environmental data with the terminal or a sensor connected thereto; and causing the terminal to associate the environmental data with the respective unique tag identifier of the connected tag in the digital distributed ledger.

[0029] In a variant of this method, subject to the tag embodiment used, the environmental data may include at least one selected from a geographical position, a relative humidity level, a temperature, a carbon monoxide concentration, a carbon dioxide concentration and an ethylene concentration.

[0030] Other aspects are as set out in the claims herein.

Brief Description of the Drawings

[0031] For a better understanding of the invention and to show how the same may be carried into effect, there will now be described by way of example only, specific embodiments, methods and processes according to the present invention with reference to the accompanying drawings in which:

[0032] Figure 1 is a top view of an embodiment of a flexible substrate layer for a printable electronic tag according to the invention.

[0033] Figure 2 is a functional representation of the data processing arrangement on the substrate layer of Figure 1.

[0034] Figure 3 provides top and lateral views of an embodiment of a flexible printable layer for a printable electronic tag according to the invention, securable to the substrate layer of Figure 1.

[0035] Figure 4 provides a detail view of the assembled printable electronic tag of Figure 3.

[0036] Figure 5 shows an example of a networked system for configuring and tracking printable electronic tags according to the invention.

[0037] Figure 6 is a functional representation of the system shown in Figure 5.

[0038] Figure 7 details steps of a method of configuring printable electronic tags according to the invention in the system of Figures 5 and 6.

[0039] Figure 8 shows the processing logic of each printable electronic tag in use with the system of Figures 5 to 7.

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[0040] Figure 9 details steps of a method of tracking printable electronic tags with the system pf102750 Figures 5 to 8 in use.

[0041] Figure 10 provides a graphical depiction of the tracking method of Figure 9 with a healthcare example.

Detailed Description of the Embodiments

[0042] There will now be described by way of example a specific mode contemplated by the inventors. In the following description numerous specific details are set forth in order to provide a thorough understanding. It will be apparent however, to one skilled in the art, that the present invention may be practiced without limitation to these specific details. In other instances, well known methods and structures have not been described in detail so as not to unnecessarily obscure the description.

[0043] Referring now to the Figures and initially Figures 1 to 4, wherein like numerals reference like features, a printable electronic tag 100 according to the invention comprises a flexible data processing substrate layer 110 and a flexible printable layer 190 secured atop the substrate. The tag of the example is rectangular, a form factor particularly suitable for cylindrical containers like biological sample glass vials, but other shapes are considered subject to application requirements, in particular the configuration of the container to which a tag should be secured for use.

[0044] The flexible data processing substrate layer 110 is a thin layer of plastic material, for instance polyvinyl chloride. The data processing architecture assembled onto the substrate layer may be a system on a chip (SoC) and comprises a variety of components operably connected to each other by circuitry embodying a power bus 112 and a data bus 114. The example configuration shown in Figures 1 and 2 is a milliwatt-consuming wireless sensing architecture, powered by a battery with limited lifetime.

[0045] Accordingly, a first component is a power source for the remaining components, in the example a flexible thin film battery 116 that connected to the power bus 112 and is isolatable from the circuitry with a user-removable pull tab 118. The thin-film battery is preferably a low-profile flexible unit, capable of application to a curved surface with a bend radius of 25 mm or greater, and disposable, with a chemical composition of zinc, manganese dioxide and zinc chloride excluding heavy metals. In a specific example, the battery 116 has a capacity of substantially 0,7 mAh and supplies substantially 3V, having a thickness of substantially 0.25 mm or less, and an operating temperature range of -80°C to +50°C. -p7

[0046] The next components are a microprocessor 120 and a memory 122. The memory 122 islaJ102750 non-volatile flash-type random access memory. At least a portion of the memory may be, or may be configured as, a read-only memory, for instance for storing set(s) of instructions for the microprocessor, and non-sensing components included in the architecture by default that are application- and environment-independent, in order to enhance the tag’s data processing security.

[0047] The microprocessor 120 provides data processing functionality, including data reading, writing and routing between the memory 122, an input interface 124 and an output interface 126 such as a pair of input and output pads, a radiofrequency (RFID) and self-locating (GPS) module 128, a low-power wide area network (LPWAN) adapter 130 and a variety of environmental sensors, according to instructions recorded in the memory 122, including calibrating parameters that will be further described hereinafter. Alternative or additional wireless data communication modules considered for inclusion in the substrate architecture include near-field communication (NFC) and Bluetooth Low Energy (BLE) network adapters.

[0048] The microprocessor 120 further provides digital and analogue signal conversion and conditioning, although such signal data conversion and processing tasks may instead be performed by the LPWAN module 130, or by discrete units in the architecture.

[0049] The next components are environmental sensors. The number and respective types of sensors used in the tag data processing architecture vary according to the application requirements, per the tag configuration method that will be further described hereinafter. In the example, the sensors include a relative humidity (RH) sensor 140, a temperature sensor 142 and a carbon monoxide/dioxide — oxygen — ethylene (CO-CO2-O2-C2H4) concentration sensor 144, a sensing combination desirable for packaging and transportation of perishables such as biological samples. Many different types of sensors may be used in alternative to, or complementarily with, the 3 sensors of the embodiment shown, with the doted lines in Figure 1 denoting vacant sensor emplacements available for alternative tag configurations. For example, an additional three-axis acceleration sensor may be desirable for detecting a container impact prejudicial to the container contents.

[0050] Importantly, a further component of the architecture on the substrate layer 110 is a visual user interface 150, in the example a light emitting diode, interfaced with the microprocessor through the data bus. This visual user interface 150 outputs an alert signal selectively as instructed by the microprocessor 120, conditionally according to the outcome of a comparison of the sensors’ environmental data output, for example a temperature ambient a container to which the tag is secured, against the calibrating parameters that provide one or more alert thresholds, for example -p8 still a temperature range deemed non-prejudicial to the viability for the container’s content, beyond)102750 which the content is deemed to be rendered unviable.

[0051] In a specific embodiment, the visual user interface 150 is switched off by default, representative of a condition wherein sensed environment data remains within the calibrating parameters of the tag, and the visual user interface 150 is selectively switched on, either permanently or intermittently for minimising power draw, representative of an alert condition wherein sensed environment data exceeds the calibrating parameters of the tag.

[0052] Preferred alert-signalling logic schemes are expected to seek to minimise power draw by the visual user interface 150, so as to maximise the alert status indication to a user, by reference to the depletion rate of the battery 116. However alternative schemes are considered, subject to discrete alert-signalling logic for a particular application. For example, in an application wherein power draw is a lesser constraint due to short logistic chains, the visual user interface may instead indicate a satisfactory condition, again permanently or intermittently, wherein the alert status is indicated by switching the LED off or, alternatively still, through respective semantic colours like green for a satisfactory status and red for an alert status. Other types of visual user interfaces are also considered, that may be used in alternative to a LED, for example a diode-sized electronic paper (“e-ink”) unit.

[0053] The flexible printable layer 190 is a thin layer of paper or paper-like laminate material, having a complementary shape with the substrate layer 110 and, in the example shown, is likewise rectangular. A topside section 192 of the flexible printable layer 190 that is distal the battery 116 of the underlying substrate layer 110 is reserved for printing data thereon, leaving the remaining section 194 of the flexible printable layer 190 overlying the battery 116 blank in use.

[0054] With reference to the example shown in Figure 4, data printable on the topside section 192 may conventionally include user and/or container addressee data, container routing codes and container contents data 200, but it should preferably also include, when available to the printer, the unique tag identifier 300 and one or more calibrating parameters 400, in the example a tolerable temperature range and a best before date.

[0055] Importantly, a portion 196 of the printable section 192 that is located and dimensioned in correspondence to the visual user interface 150 on the underlying substrate layer 110 is configured to maintain the visibility of the user interface 150 through the flexible printable layer 190. Many techniques can be considered for implementing this feature, from simply punching the area of the - p9 flexible printable layer 190 corresponding to the portion 196, to using a substantially transparent102750 material for the whole flexible printable layer 190 or, in the case of a laminate material for the printable layer comprising at least one transparent sheet, reserving the area of the flexible printable layer 190 corresponding to the portion 196 from coverage by opaque sheet(s) during its manufacture.

[0056] With reference to Figures 5 and 6 now, wherein like numerals reference like features, the printable electronic tag 100 is configured and used within a distributed data processing system 500 comprising a plurality of data processing terminals in data communication with each other. In use, the tag is conventionally secured to a container 502, for instance by applying an adhesive compound to the underside of the substrate layer 110 and affixing same to a surface of the container 502.

[0057] In the system 500, regardless of whether a container 502 carrying a printable electronic tag 100 is stored statically, or in transit through a logistical chain, so long as the tag 100 enters the operable range of a third party data-acquiring terminal, then tag data such as the unique tag identifier 300, tag status data and environmental data sensed by the tag can be acquired through a bilateral wireless network data communication 504 by a RFID or LPWAN data-reading device 506, or through a unilateral data communication 506, for instance the optical recognition of a barcode encoding the unique tag identifier 300 printed on the tag 100, by an optical scanning device 508. Such third party devices 504, 506 are typically configured with a respective wireless data connection 512 to a router device 514 implementing a wireless local area network (WLAN) and interfacing them with a wide area network (WAN) 520 such as the Internet. The LPWAN module 130 of the tag 100 can establish its own wireless data connection 512 with the router device 514 or directly with the WAN 520.

[0058] The system 500 also comprises a server terminal 530 implementing both a tag configuring method and a tag status tracking method further described hereinafter. The server terminal 530 is configured with a high-bandwidth wired data connection 512 to a router device 514 implementing a local area network (LAN), which interfaces the server with the WAN 520. Accordingly, data can be communicated between the server terminal 530 and the LPWAN module 130 of each tag 100 and/or third party data-acquiring devices 504, 506 across the WAN 120. The server terminal 530 receives tag-respective data with a tag data acquiring and preprocessing routine 610, the output of which is received by a tag data storing and verifying routine 620 configured to cross-reference each tag's unique tag identifier 300, tag status data and optionally environment data against a tag- respective record of a database 630 and update same over the useful life of the tag 100. -p10

[0059] The server terminal 530 further receives user tag configurations, i.e. user selections of sensors 140-144 and/or calibrating parameters 400 for same, for causing printable electronic tags 100 to be assembled according to same, either locally by the operator of the server terminal or remotely by a printing supplier. These user tag configurations and calibrating parameters, as well as tag status enquiries, are received from user terminals 540, with the example of a personal communication device shown in the Figure, that are interfaced with the server terminal 530 through a user and user data authenticating routine 650.

[0060] Each such personal communication device 540 conventionally receives or emits voice, text, audio and/or image data encoded as a digital signal over a wireless data transmission 542, wherein the signal is relayed respectively to or from the handset by the geographically-closest communication link relay 544 of a plurality thereof. The plurality of communication link relays 544 allows digital signals to be routed between each handset 540 and their destination by means of a remote gateway 546 via a MSC or base station. The gateway 546 is for instance a communication network switch, which couples digital signal traffic between wireless telecommunication networks, such as the cellular network within which wireless data transmissions 542 take place, and the Wide Area Network 520.

[0061] The server terminal 530 further encodes tag-respective data, including at least each tag’s unique tag identifier 300 and received tag status data in a distributed ledger 550, which may be a public or private block chain, with a tag data encoding and decoding routine 640 implementing for instance a hashing function. The tag-respective data includes at least at least each unique tag identifier 300 issued to a manufactured tag 100, effectively instantiating a non-falsifiable and — independently-verifiable digital equivalent of each physical tag 100 manufactured. In a preferable embodiment, the tag-respective data further includes at least tag status data acquired by RFID or LPWAN data-reading devices 506 and optical scanning device 508. The server terminal 530 may further encode the calibrating parameters 400, and environmental data sensed by the data-reading devices 506, 508 in the distributed ledger 550.

[0062] The server terminal 530 communicates tag-respective data stored in the database 630 in reply to tag-respective status requests of authenticated user terminal 540 with a data retrieval routine 660. The server terminal 530 further optionally certifies the communicated tag-respective data with a data certification routine 670, which invoked the tag data encoding and decoding routine 640 to match the tag-respective data retrieved by the data retrieval routine 660 with its corresponding instantiation in the block chain 550.

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[0063] With reference to Figure 7 now, an embodiment of the method of configuring a printable electronic tag 100 in the system 500 starts with a question at step 701 about whether the server terminal 503 has received a user sensor selection from a remote user terminal 540. If the question of step 701 is answered negatively a default selection of sensor(s) e.g. 140, 142, 144 is set at step

702. Alternatively if the question at step 701 is answered positively, likewise subsequently to step 702, a second question is asked at step 703, about whether user calibrating parameters 400, e.g. temperature and relatively humidity ranges specific to the intended contents of a container 502, have been received for the user- or default sensor selection from the user terminal 540.

[0064] If the question of step 703 is answered negatively, a default set of calibration parameters for the user- or default sensor selection is set at step 704, e.g. sensor manufacturer-specified tolerances of temperature and relatively humidity for normal operation of the selected (/default) sensors. At step 705, components 110 to 150 are physically assembled on the substrate layer 110 according to the user or default sensor selection.

[0065] The logic of server terminal 530 issues a unique tag identifier 300 at step 706 then stores the unique tag identifier and the user or default calibrating parameters 400 in the tag memory 122 at step 707. At step 708, the logic of server terminal 503 encodes the unique tag identifier 300, and optionally the user-provided or default calibrating parameters 400, in the distributed ledger 550. The printable layer 190 is then secured atop the assembled substrate layer 1110 at step 709. A printable electronic tag 100 is accordingly manufactured according to user-selected sensor(s) 701, 702 and/or user-specified calibrating parameters for the sensor selection 703, 704.

[0066] A user may configure a single tag for a single application in this manner, but in the specific field of healthcare, applications are expected to involve hundreds or even thousands of samples requiring sample-respective tags 100. Accordingly when the user requires a batch of identical tags, a third question is asked at step 710, about whether another tag needs to be manufactured with the sensor selections and calibrating parameters for same. The logic returns to the sensor selection-determining question 701 while ever the last tag of the batch has not been processed and, when the question of step 710 is eventually answered negatively, control proceeds to a waiting loop polling for a next tag configuration.

[0067] Advantageously with this configuring method, as each manufactured tag is individually recorded as a respective and non-falsifiable entry in the block chain 550, the configuration of each tag can always be certified, likewise —subject to the granularity of safety and certification desired by -p12 an application—characteristics such as its date, time and location of manufacture, its specifying)102750 user, its calibrating parameters and more.

[0068] With reference to Figure 8 now, sample-respective data is printed on the topside printable section 192 of the tag 100 at the point of use or before and, in the example case of a healthcare application, preferably according to an interoperable electronic health record standard. In preferred healthcare uses for the system 500, all sample-respective data received by the server terminal 530 from a remote user terminal 540 complies with, else gets translated according to, the HL7 Fast Healthcare Interoperability Resources (FHIR) standard, preferably still in an eXtended Mark-up Language (XML) format ; likewise all sample-respective data temporarily stored by the server terminal 530 in the database 630 and output to a tag printer (not shown) for printing the data thereon. The HL7 FHIR specification is preferred for the semantic depth which it provides, given its low degree of complexity.

[0069] In preferred embodiments, this sample-respective data is encoded in the distributed ledger 550 against that tag’s respective unique tag identifier 300, for example with a corresponding hashing function at step 802. Upon storing the sample in the container 502, the tag 100 is activated at step 103, for instance with removing the battery pull tab 118 from its default short-circuiting position. The tag 100 may be secured to the container 502 at step 804 before or after the tag is activated, according to safe and/or best practice.

[0070] As the battery 110 powers-up the circuitry and tag components 110 to 150, an operating system for the tag is loaded and run at step 805, including data processing and networking communication routines. The tag modules and the sensors 140, 142, 144 are accordingly initialized at step 806, then the sensors begin to sense characteristics of the environment ambient the tag 100 at step 807. In the example, the relative humidity sensor 140 detects the ambient humidity level, the temperature sensor 142 detects the ambient temperature, the RFID-GPS module 128 determines its geographical position and the microprocessor determines the current date. The microprocessor stores the sensed environment data in the memory 122 at step 808, which may be structured as a first-in-first out buffer in order to reduce memory size requirements, and of a capacity sufficient to store several days’ worth of periodically-sensed data, subject to the expected duration of use of the tag.

[0071] A question is then asked at step 809, about whether at least one of the sensed environment variables exceeds the calibrating parameters 400 at step 809, e.g. whether the ambient temperature detected by the temperature sensor 142 exceeds the temperature range of - p13 the calibration parameters 400. If the question of step 809 is answered positively, th&)102750 microprocessor sets the tag status to an alert and outputs a corresponding alert signal to the visual user interface 150 at step 810. In the example embodiment, the signal switches the LED 150 for permanent or intermittent illumination.

[0072] Alternatively, if the question of step 809 is answered negatively, else subsequently to the tag alert status setting of step 810, a next question is asked at step 811, about whether a network or radio data connection has been established, for instance according to a calibration parameter pre-setting a data signaling schedule for the LPWAN module 130 or according to a data-polling query by a RFID device 510 nearby. If the question of step 811 is answered positively, the microprocessor outputs the sensed environment data stored in the memory 122, including data corresponding to the tag alert status if same was set at an earlier instance of step 810, to a remote terminal, for instance the server terminal 530 via the LPWAN module 130, or the RFID device 510. Alternatively, when the question of step 811 is answered negatively, else subsequently to the data communication of step 812, control returns to the environment data-sensing of step 807.

[0073] Accordingly, the data sensing, processing and communicating loop of steps 807 to 812 continues until the battery 110 becomes fully depleted, or until the tag 100 gets disassembled after use. Importantly, once the alert status should be set for the tag per step 810, the configuration of the tag and the data processing logic for the microprocessor 120 prevent its resetting. Thus, should environmental conditions about the container 502 become prejudicial to the material or substance of the sample therein, by reference to the calibrating parameters 400 defining viability thresholds for same, the tag 100 indicates this situation through the visual user interface 150, independently and irrespectively of any data communication ever getting established after the initial activation of the tag 100 at step 803, until the container 502 is next inspected, e.g. received by a sample- processing laboratory after transit ; likewise irrespectively of environmental conditions alternating in and out of viability thresholds within that same time interval.

[0074] With reference to Figure 9 now, a logic configuring data processing at the server terminal 530 is next described, discrete steps of which implement a method of tracking the printable electronic tags 100 in use. Users of the system 500 intending to obtain status information for a container 502 equipped with a tag 100 must initially authenticate with the server terminal 130 at step 901. Those users typically include users providing tag configurations in the context of commissioning applications that involve the containers 502, third party recipients of containers 502 in logistics chains, and patients whose samples are stored in containers 502 and whose personal sensitive data is partly or fully encoded in the HL7 FHIR information printed on the tag 100. -p14

[0075] In accordance with the principles described hereinbefore, a step 902 is shown, of th&J102750 server terminal 530 receiving user configurations for configuring tags 100, per the configuring method described with reference to Figure 7, and a step 903 is then shown, of the server terminal 530 recording the respective unique tag identifier 300 of each manufactured tag 100 in the database 630 and in the distributed ledger 550.

[0076] A next step 904 is shown, of the server terminal 530 recording a tag’s first activation in the database 630 and in the distributed ledger 550, for example shortly after the removal of the battery pull tab 118 of step 803 remotely of the server terminal 530, as the LPWAN module 130 or a third party device 506, 510 first communicates with the server terminal 530 across the WAN 120.

[0077] A next step 905 is shown, of the server terminal 530 receiving first or next tag status data, and optionally environmental data, for a given tag 100, on every instance of a data communication by that tag’s LPWAN module 130 per step 812. A next step 906 is shown, of the server terminal 530 receiving of first or next tag status data, and optionally environmental data, for a given tag 100, on every instance of a data communication by a third party device or sensor 506, 510 interacting with that tag 100 and which, when received, is data that effectively cross-validates the tag status data and optional environmental data communicated by that tag 100 and received at the previous step 905.

[0078] At step 907, the server terminal 530 records the tag-communicated status and environmental data of step 905, and/or the tag status and environmental data sensed by a third party device 506, 510 of step 906 in the database 630 and in the distributed ledger 550.

[0079] At step 908, the server terminal 530 verifies the data stored at step 907 for a tag, including at least tag status data, against that tag's previous data record in the database 630, for consistency. Such verification may for instance include a simple hashing and comparison of the tag’s unique tag identifier 300, as recorded at step 903 in the tag’s initial record and as later encoded in the tag data stored at step 907. At step 909, the server terminal 530 performs, or causes to be performed, a verification similar to step 908, against the tag’s previous data record in the distributed ledger 550, for certifying the tag status as of the time of verification.

[0080] A next step 910 is shown, of the server terminal 530 receiving a first or next tag status request from a remote user terminal 540, including authenticating the request according to login details as created at step 901 in order to authorise its processing and a reply. A next step 911 is - p15 shown, of the server terminal 530 responding to an authenticated tag status request with databaset)102750 stored tag status data, and optionally with database-stored environmental data.

[0081] . When a containers usage eventually ends, at step 912 the server terminal 530 prevents that tag’s record from getting further updated in the database 630 and in the distributed ledger 550. This step effectively ends that tag’s status tracking and the server terminal 530 preferably encodes a corresponding tag termination message in the distributed ledger 550. Each tag 100 is then eventually removed from the discarded container 502 and recycled at step 913.

[0082] The tracking method of steps 903 to 912 is illustrated in a healthcare context in Figure 10, wherein a printable electronic tag 100 has been configured by a user with a user terminal 540, and eventually manufactured as described hereinbefore. Accordingly its unique tag identifier 300 and calibrating parameters 400 are recorded in its memory 122, and at least the unique tag identifier 300 is encoded as a first tag-respective entry 552 in the block chain 550 at an initial time 1010.

[0083] A biological sample is eventually taken from a patient and stored inside a container 502. The tag 100 is printed with the tag unique identifier 300 or a coded representation of same, optionally with calibrating parameters 400, and with HL7 FHIR-formatted sample- and/or intended testing-respective data; secured to the container 502; and activated as described with reference to steps 801 to 804, whereby the tag begins the environmental data sensing and recording according to step 805 to 812.

[0084] In the example the container 502 is sent to a remote laboratory for testing the sample therein, wherein the container 502 is picked up by a first courier vehicle 1012 and tag data stored inthe tag memory 122 is read by a courier scanning device 506, including the unique tag identifier 300 and tag-sensed environment data. Pursuant to steps 905, 906, 907, the tag data read by the courier device 506 is relayed to the server terminal 530 and eventually encoded as a next tag- respective entry 554 in the block chain 550 at a time 1014, that is either substantially in real-time relative to the time of scanning the tag 100 at the courier vehicle 1012, or asynchronously.

[0085] The container 502 is passed to a next courier vehicle 1016, within which environmental conditions come to exceed the calibrating parameters 400 for the tag 100, for instance a cargo heating system fails unexpectedly and the temperature ambient container 502 inside the cargo area falls below a minimum temperature threshold. Pursuant to steps 807 to 810, upon the microprocessor 120 comparing the ambient temperature sensed by the temperature sensor 142 with the temperature range 400 and detecting a breach of the lower threshold, the microprocessor 120 sets the tag 100 to an alert status, record the date and time of alert 1018 in the memory 122, - p16 and triggers the visual user interface 150. In the example, the tag 100 is located inside an102750 aeroplane 1016 wherein data communication functionalities of the tag via tag modules 128, 130 is disabled for considerations of flight safety, therefore the tag alert status is not communicated to the server terminal 530, nor to any other third party device 506, 510.

[0086] The container 502 is next passed to a final courier vehicle 1020 at the end of the logistic chain, within which environmental conditions resume compliance with the calibrating parameters 400 for the tag 100. The tag’s alert status and time of alert 1018 is still recorded in the tag memory 122 and the tag visual user interface 150 is still switched on to indicate the alert.

[0087] When the container 502 is picked up by the last courier vehicle 1020 for last-mile delivery to the destination laboratory, tag data either printed on the tag 100 (192) or stored in the tag memory 122 is again read by a courier scanning device 506 (510), including at least the unique tag identifier

300. If the courier device 506 is an optical scanner reading the code(s) printed on the tag 100, the tag alert status is not read by the courier device wherein, potentially, only the unique tag identifier 300 is read and relayed to the server terminal 530, to be eventually encoded as a next tag- respective entry 556 in the block chain 550 at a time 1022, separated from the earlier time of alert 1018 by a period 1024 of, potentially, several hours or days. Conversely, if the courier device 510 is a wireless data processing device querying the tag 100 for data stored in its memory 122, the tag alert status is read by the courier device, wherein the unique tag identifier 300 and at least the alert status is read and relayed to the server terminal 530, to be eventually encoded as the next tag- respective entry 556 in the block chain 550 at 1022.

[0088] Irrespectively of the type of scanning device 506, 510 used by the final courier 1020, irrespectively of a tag reading instance at a time 1022 intermediate the tag alert status 1018 and the time 1026 of final delivery of the container 502 to the destination laboratory, and irrespectively of a WAN network connection between the tag LPWAN module 130 and the server terminal 530 in that same post-alert time interval, the recipient user at the destination delivery is immediately made aware of the prejudiced condition of the biological sample within the container 506 by the visual user interface 150, and can immediately discard the sample from further tests and processes. Moreover, and advantageously, the chain of tag-respective entries 552, 554, 556 that exist in the block chain 550 can then be investigated to determine the approximate or actual time at which the sample was compromised ; likewise the location and environmental cause of prejudice, subject to the granularity of tag data recorded in the block chain 550.

[0089] The skilled ready will appreciate from the foregoing that an important advantage of the system solution is that environmental data is recorded discretely and independently by tags 100 of -p17 the invention but aggregated and cross-referenced through a secure portal embodied by the serveu102750 terminal 530, which certifies it by encoding data transactions in a secured ledger. This system advantageously allows third party data, from applications and use cases that lie outside the scope of the present disclosure but which involve containers 502 with tracking requirements and susceptible to environmental variations, for instance clinical trials and other small-to-large scale healthcare projects, to be easily cross-reference with data and logs obtained from the tags. Through relevant APIs this tag data can be securely exported to the subscriber of a trial, or the user who needs to track a medical sample, a vaccine or some other compound.

[0090] In the specification the terms "comprise, comprises, comprised and comprising” or any variation thereof and the terms include, includes, included and including" or any variation thereof are considered to be totally interchangeable and they should all be afforded the widest possible interpretation and vice versa.

[0091] The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail.

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Claims (22)

Claims LU102750

1. À printable electronic tag, comprising a flexible data processing substrate layer, comprising an operable combination of a power source, at least one sensor for monitoring one or more parameter(s) in the environment adjacent the tag, a data interface for receiving calibrating parameter(s), a memory storing received calibrating parameter(s) and a unique tag identifier, a processor connected to the or each sensor and configured to- receive environmental data sensed at the or each sensor, compare the environmental data with the calibrating parameter(s), and selectively output an alert according to the comparison result ; and a visual user interface for indicating the alert or an absence thereof ; and a flexible printable layer atop the substrate layer, through which the visual user interface is observable in use.

2. The printable electronic tag of claim 1, wherein the or each calibrating parameter is user- selectable for configuring the tag, and is selected from a threshold value for an environmental parameter or a range thereof, a time period and a time interval.

3. The printable electronic tag of claim 2, wherein the environmental parameter(s) comprise one or more selected from relative humidity level, ambient temperature, carbon monoxide concentration, carbon dioxide concentration, ethylene concentration.

4 The printable electronic tag of any of claims 1 to 3, wherein at least a second sensor is a geographical positioning system (GPS) module for monitoring a geographical location of the tag, wherein the calibrating parameters and the environmental parameters include geographical data.

5. The printable electronic tag of any of claims 1 to 4, wherein the processor implements a trusted execution environment (TEE) and wherein at least the unique tag identifier is recorded in a digital distributed ledger.

6. The printable electronic tag of any of claims 1 to 5 wherein, before tag use, connectors of the power source are insulated by a user-removable non-conducting member.

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7. The printable electronic tag of any of claims 1 to 6, wherein the data interface is an102750 input/output interface, configured for outputting calibrating parameter data and/or environmental data and/or alert data selectively in answer to a data query by a local device.

8. The printable electronic tag of claim 7, wherein the data interface is a wireless communications module, configured for outputting calibrating parameter data and/or environmental data and/or alert data wirelessly selectively in answer to a data query by a local or remote device.

9. The printable electronic tag of claim 8, wherein the wireless communications module implements a low power wide area network (LPWAN) and/or radio-frequency identification-based (RFID) and/or near-field communication (NFC) and/or Bluetooth Low Energy (BLE) data communication standard.

10. The printable electronic tag of claim 8 or 9, wherein the data interface is further configured to communicate data selectively according to the calibrating parameters, and wherein the calibrating parameters include an authentication key or code and/or a communicating interval value.

11. A method of configuring a printable electronic tag for use, comprising the steps of- assembling an operable combination of a power source, a memory, a processor, a data input interface for receiving user-selected calibrating parameter(s), at least one sensor suitable for monitoring one or more parameter(s) in the environment adjacent the tag, and a user interface for indicating an alert or an absence thereof, on a flexible substrate layer, securing a flexible printable layer atop the substrate layer, through which the visual user interface is observable in use, generating a unique tag identifier for the tag, and storing the unique tag identifier in the memory and in a digital distributed ledger.

12. The method according to claim 11, wherein the step of assembling further comprises- receiving a user selection from a remote terminal over a network, the selection identifying the or each sensor in the combination to be assembled.

13. The method according to claim 11 or 12, comprising the further steps of- receiving the calibrating parameter(s) from the remote user terminal over a network, and storing the received calibrating parameter(s) in the memory via the data input interface.

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14. The method according to claim 13, comprising the further steps of- LU102750 storing the received calibrating parameter(s) in the digital distributed ledger, and associating the stored calibrating parameter(s) with the respective unique tag identifier in the digital distributed ledger.

15. The method according to any of claims 11 to 14, wherein the printable electronic tag is configurable for use with a healthcare container, the method comprising the further steps of- receiving healthcare data from a remote terminal over a network, and printing at least a subset of the received healthcare data on the printable layer.

16. The method according to claim 15, comprising the further steps of- storing at least the subset of received healthcare data in the digital distributed ledger, and associating the stored healthcare data with the respective unique tag identifier in the digital distributed ledger.

17. A distributed system for tracking a status of a printable electronic tag, comprising at least one printable electronic tag configured according to any of claims 7 to 10, at least a first network-connected terminal configured, as a validation sensor, to establish a data connection with the or each tag, to determine an alert status therefrom and to relay tag- respective alert status to a second network-connected terminal ; and the second network-connected terminal configured to encode relayed alert status with the respective unique identifier of the or each tag in the digital distributed ledger.

18. The system according to claim 17, wherein the first network-connected terminal is further configured to read environmental data from the or each tag and/or from environment ambient the or each tag, and to relay the environmental data to the second network-connected terminal, and wherein the second network-connected terminal is further configured to encode relayed environmental data with the respective unique tag identifier of the or each tag in the digital distributed ledger.

19. The system according to claim 17 or 18, wherein the first network-connected terminal implements a low power wide area network (LPWAN) and/or radio-frequency identification-based (RFID) and/or near-field communication (NFC) and/or Bluetooth Low Energy (BLE) data communication standard.

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20. A data processing method for tracking a status of a printable electronic tag, comprising th&J102750 steps of- providing at least one printable electronic tag configured according to any of claims 7 to 10, wherein the unique tag identifier of the or each tag is storing in the digital distributed ledger ; establishing a data connection between the tag data interface and a network-connected terminal ; communicating an alert from the tag to the terminal or reading the alert from the tag with the terminal ; and causing the terminal to associate the alert with the respective unique tag identifier of the connected tag in the digital distributed ledger.

21. The method according to claim 20, comprising the further steps of- reading environmental data from the tag with the terminal or sensing environmental data with the terminal or a sensor connected thereto ; and causing the terminal to associate the environmental data with the respective unique tag identifier of the connected tag in the digital distributed ledger.

22. The method according to claim 21, wherein the environmental data includes at least one selected from a geographical position, a relative humidity level, a temperature, a carbon monoxide concentration, a carbon dioxide concentration, an ethylene concentration. - p22