GB2593131A - Wearable device - Google Patents

Abstract

Wearable device for patient in receipt of medication treatment, comprising a medication and monitoring unit comprising a wireless communications unit, a power unit, and a processing unit and a memory unit configured to access remotely and store data relating to a personalised medication treatment program, the data including digitised medication dose and monitoring charts. The medication and monitoring unit comprises an interactive visual display unit or interactive audio platform, configured for bidirectional visual or audio medication and monitoring interaction between the patient and a remote medication monitoring service provider in relation to the charts. The interaction is by means of a medication monitoring centre comprising a local or remote database and which may comprise medication monitoring personnel interfaces. The device comprises a patient attachment for attaching to a body part of the patient or a wearable attachment for attaching to an item of apparel or to a further wearable digital device. The device is adapted for daytime or night-time wearing. The medication and monitoring unit may be detachable from or integral with the attachment. Also provided is a method for interactive bidirectional medication and monitoring.

Description

Wearable Device Introduction

The present invention relates to a personal wireless digital device for supporting a patient in receipt of medication treatment, more particularly for improving a healthcare outcome of said patient, through improved medication adherence; and to a method for the manufacture of said device, and to the use of said device in supporting a patient in receipt of medication treatment.

The present invention relates moreover to a computer implemented method for supporting a patient/citizen with medication treatment, by means of said personal device; and to said personal device programmed to carry out the method for supporting a patient/citizen with medication treatment.

The present invention relates moreover to a data processing system comprising said personal device having a memory and a processor configured for said medication treatment support, or more particularly to carry out said computer implemented method, said system having network communication connectivity.

The present invention relates moreover to a program for said personal device, such as a computer program or an app, comprising instructions which, when executed by said device, cause the device to support a patient with medication treatment, more particularly to carry out the steps of the method; a computer readable data carrier or a data carrier signal comprising instructions which, when executed by said device, cause said device to provide the herein medication treatment support, more particularly to carry out the method, more particularly carrying the program comprising instructions for performing the method thereof; a network communication system comprising a combination of said personal device with one or more additional devices and servers having communication connectivity for communicating via a communications network, being arranged to perform the method.

The present invention relates moreover to a user interface comprised in said personal device, and programmed to operate the method; a subscription or on line account capable of requesting and receiving data packages or data sets from one or more databases to said personal device and/or of transmitting data input in the method; a health information system or medications database, for use with said device and in said method; and the use of any of the foregoing in healthcare The present invention further relates to a computer implemented medication and monitoring service, more particularly a medication and monitoring application service (App), for example provided by an application service provider (ASP), a server or data hosting service or website hosting service provided by a hosting server provider, relating to a medication and monitoring service provided by means of said personal device.

Background

The single most important healthcare intervention for treating and preventing disease conditions is providing medicines, with an annual NHS spend of £17.4B in 16/17. Despite this, up to 50% of people fail to take medications as prescribed (non-adherence) contributing to an estimated £900m in wasted medicines. Also, adverse reactions to medications cause hospital admissions at a cost £530m and are responsible for 700 deaths per year.

This is frequently interpreted as people only taking 50% of their medicines. In reality, reference is to patients taking too little or too much medicine, at incorrect times, or other incorrect behaviours, any of which are potentially unsafe. Of this, 55% unintentional non-adherence has been estimated, with patients simply forgetting to take their medication as prescribed within 10 days of commencing medication.

Non-adherence is a frequent cause of impairment, hospitalisation, higher risk of suicide, longer time to remission, psychiatric emergencies, poor mental performance and low satisfaction with life. Any single one of these outcomes should be considered to be unsafe practice and a failure of effective treatment.

There is a need to support patients in managing medications, and most urgently those with multiple conditions, multiple medications, memory problems, a learning difficulty or age-related challenges. The scale of this problem was reported in a study in 2017 which identified that 49% of older people over 65 years are taking 5 or more medicines a day (20+ doses per day).

We postulate that providing a technological solution to improve adherence can fundamentally support de-prescribing, that is to say reducing or stopping medications that may no longer be of benefit or may be causing harm. A technological solution should provide a clearer treatment picture whilst incorporating adherence as a marker of medicines actually taken.

The MaPPs system (Medicines: A Patient Profile Summary) is used by healthcare to support patients with medication treatment. Healthcare staff register patients onto the system that creates a bespoke patient account together with a list of medicines for the patient. The unique aspect of the system over other patient Records Network systems is the provision of simplified medicines information. However non-adherence remains a challenge.

Treatment monitoring in clinical practice is currently delivered with patients/citizens attending review appointments, taking up clinic, staff and facility time. The current practice is not equipped to identify patients at risk of non-adherence, and patients in need of urgent review, from patients satisfactorily managing appropriate treatment, and simply relies on a rolling review system.

There remains a need to overcome, obviate or mitigate one or more disadvantages of the prior art, whether identified herein or elsewhere, in particular to provide personalised technologies to support patients to live independently as they wish within their own homes and beyond. More particularly to transform care and health pathways (medication review) where digital technology can enable independent living and/or provide support for early intervention that prevents decline.

Brief description

The personal device herein is a wearable device configured to access digitised medication treatment data, including digitised medication dose charts personal to a patient wearing said device, and to provide for visual and/or auditory medication and monitoring interaction by a patient, responsive to said data, with a medication and monitoring centre. Digitised medication dose charts include "on-demand" and "reminder charts" to support patients who self-administer. Alternatively or additionally, digitised medication dose charts include "medicines administration charts" for patients who are given medication by a carer.

The wearable device comprises interactive medication and monitoring function. More particularly, the device comprises an interactive visual display unit and/or interactive audio or audio-visual platform for bidirectional medication and monitoring dose and response function engaging both healthcare professional (HP) and patient. This provides guaranteed delivery of reminder, and patient engagement in the reminder process. The audio platform provides monitoring function, configured to perform voice analysis and to indicate medication error, including over-medication, under-medication, adverse reaction or need for medication review. A device comprising an audio-visual platform, is configured for additional visual analysis facilitating correlation with voice analysis for further enhanced monitoring. Moreover the device herein accesses real time patient biometric data by means of dedicated biometric sensor unit(s) or connectivity with external biometric sensors. The wearable device moreover comprises universal wireless connectivity.

There is moreover provided herein an interactive medication and monitoring application for the device.

There is moreover provided herein a medicines and monitoring service (MAMs) for remote delivery and receipt of interactive medication dose and response by means of the device.

There is moreover provided herein a medicines and monitoring system comprising the device herein and a medicines and monitoring service (MAMs) comprised in one or more computing devices remotely populated by healthcare staff (HP) programmed to provide medicines reminder notifications to a patient via the wearable personal device and to receive patient responses back. Over time the service contributes to supporting medication monitoring, clinical decision making and personalised medicines.

The MAM wearable device is disruptive in that it allows real time monitoring. It identifies patients at risk of non-adherence, and patients in need of urgent review, and directs clinic, staff and facility time to best effect.

Digitised medication reminder charts can be easily updated and displayed on an electronic device such as a smart phone, tablet or personal computer. However we have found that there is no wearable device available having the functionality to issue interactive medication dose data, and receive interactive dose status in real time. Notably, smart phones and watches, GPS devices, fitness trackers and the like each provide some but not all of the technical features of the herein medication and monitoring device.

The herein device in contrast comprises interactive visual display, and/or interactive audio platform, 24/7 connectivity from any point on the globe, in particular satellite connectivity, biometric functionality in the form of pulse rate and sleep monitors, moreover optionally operating with voice recognition features configured to use voice recognition as a health indicator.

In one aspect there is herein provided personal wireless digital medication and monitoring device for a patient in receipt of medication treatment, said device comprising a medication and monitoring unit (MAMu) comprising; a wireless communications unit for accessing at least one wireless communications network; a power unit; and a processing unit and a memory unit configured to access remotely and store, data relating to a personalised medication treatment program, said data including digitised medication dose and monitoring charts; wherein said medication and monitoring unit comprises at least one of an interactive visual display unit and an interactive audio platform, configured for bidirectional visual and/or audio medication and monitoring (MAM) interaction, between said patient and a remote medication monitoring service provider in relation to said digitised charts; wherein said remote medication monitoring service provider interaction is by means of a medication monitoring centre comprising a local or remote database and optionally additionally comprising one or more medication monitoring personnel interfaces, such as one or more healthcare professional interfaces, and combinations thereof; wherein said device is wearable by said patient, comprising at least one attachment selected from a patient-attachment for attaching to a body part of said patient, and a wearable-attachment, for attaching to an item of wearing apparel, or to a further wearable digital device and the like, said device being adapted for daytime wearing and/or night-fime wearing, on or about the person of said patient, wherein said medication and monitoring unit is detachable from or integral with said attachment.

Advantageously an interactive visual interface and/or interactive audio platform is bidirectional, configured for visual and/or audio communication to patient/citizen, more particularly from a medication monitoring database, centre or HP and by patient/citizen input.

The MAMs wearable device extends the current MaPPs system to allow "real time clinical monitoring" from patients to HP.

More particularly the device herein provides patient interaction including medication dose reporting for on-demand medication dose and for scheduled dose. The device herein enables for the first time real time scheduled dose reporting, on-demand or in response to a dose reminder notification, to a monitoring service with update of medication status. Patient interaction in response to medication reminder notification over time provide markers of adherence from which to support clinical decisions delivering Personalised Digital Care.

Bidirectional communication herein may be simultaneous and is real time.

Accordingly a device herein has universal network communications connectivity. In embodiments a device herein said wireless communications unit is configured for connecting to at least one satellite communications network.

Thereby the device is adapted to receive and transmit medication and monitoring communication, including dose and status response input, in real time.

In embodiments said wireless communications unit comprises dual communication connectivity ports, configured for simultaneously connecting to at least two communications networks, preferably including one or two satellite communications networks, for example comprises at least two slots or apertures each configured to receive a SIM card or the like.

Alternatively or additionally said wireless communications unit provides 5 G connectivity, and may comprise one or two slots or apertures to receive a SIM card or the like. For example a device configured for connectivity via HAPS or CUBEsat satellite systems as herein defined.

In embodiments the device comprises connectivity for radiowave communication.

The MAMs wearable device may also incorporate voice recognition factors for identifying changes that can provide safety alert e.g. drowsiness due to over medication or stroke so provide early warnings of potential fall.

Accordingly, in embodiments said interactive audio platform comprises a speaker unit and a microphone unit, whereby said device is configured to transmit audio medication treatment monitoring communication for the performance of voice recognition analysis, for example detecting changes in voice for determining patient physical or mental wellbeing, and the like.

The wearable device herein may incorporate additional biometric patient data collection for correlation with medication and monitoring data herein. For example this may be to enable home based clinical review. Data may include biomarkers derived from e.g. COPD inhaler use vs distance walked (number of steps).

Accordingly, in embodiments said device is configured to access biometric data by means of one or more integral and/or separate biometric sensors, said device comprising one or more biometric units or comprising wired or wireless data connectivity with one or more biometric devices, and optionally comprising a wearable-attachment for attaching to a separate biometric device. Sensors adapted to monitor patient biometric data, are for example selected from movement sensor, heart rate monitor, body temperature monitor, hydration monitor, oxygen saturation monitor and the like. For example a device herein may attach to a commercially available wearable biometric sensor such as FitBit TM or the like, and may comprise a docking unit or datalink providing for datashaiing.

One or more of said sensors or monitors are adapted to monitor sleep, drowsiness, steps, mood, pulse rate, ECG, hydration, 02/CO2 saturation levels, voice changes and the like. For example a heart rate monitor is configured to alert to falling heart rate as a marker of fall-risk. Biometric data feedback to the monitoring centre facilitates an alert and intervention ahead of adverse event such as a patient fall. The device configured to transmit biometric data and voice data for analysis is moreover competent to indicate the device not being worn or being worn by a person other than the patient.

The wearable device herein is key to facilitating as a final service a remote Medicines and Monitoring Service that is end to end. That is to say a service that is delivered by healthcare and HP to patient, engaging patients back to healthcare.

The MAMs wearable device herein is classed as a Disruptive Technology. It can be programmed to access any Medicines Informations software such as MaPPs from Mistura Informatics, GNCR.

The Key added value provided by the wearable device herein is to primarily a. Reduce admission to hospital due to medicines mis-management b. Reduce waste in medicines c. Reduced visits to the GP or support visits to the home from community nursing teams regarding issues that can be resolved through the online Medicines and Monitoring system and so create capacity within primary care.

Additional Innovative added value include: d. Reduce harm to patients from medicines adverse effects with "real time" monitoring information from the wearable device (e.g. pulse rate, drowsiness, voice changes, ECG etc) e. Relate prescribing decisions to biomarkers of remote monitoring for which the medication is being taken providing a "true" personalised medicines healthcare service.

f. Monitor physical health aspects of social prescribing e.g. (sleep, steps, mood, heart rate, hydration, 02/002 saturation levels, Voice changes) which can be compared with addition of or changes in medication.

g. Enable the clinician to log on to a patient account to access "real time" monitoring information from the wearable that can save a consultation review or appointment. Advantages are manifested in economic, social and environmental benefits.

Economic Benefit: Reduction in cost of medicines to NHS, Reduction in staff time in NHS sorting medicines management issues, Faster time to discharge so releases Hospital Beds, Reduction in GP appointments regarding medicines management issues. Social Benefit: Lower pollution levels from pharmaceutical waste processing, Better health from reduced morbidity, Lower overall healthcare costs per citizen, Improved efficiency of the NHS and A&E services, Increased capacity of GP services, Reduced need for vulnerable people to travel to appointments to sort medication issues, Supports national campaigns e.g. httpliwww.medicinewaste.com, Supports social prescribing initiatives of the NHS.

Environmental Benefit: Reduced medicines wastage processed by community pharmacies, Reduced clinical waste disposal process by specialist waste management companies, Less travelling by patients to consultations when adherence data available online, Less travel needed to collect and remove and process waste of medicines, Reduced plastic pollution from wasted packaging The device herein is configured to enable an "internet of things" in relation to healthcare, i.e.healthcare datasharing between patient and all HP interacting with said patient. More particularly the device facilitates datasharing between patient and HP including patient biometrics, medicine management including monitoring of medicines-taking, response to medicines, and supplies remaining. In embodiments the device identifies by means of a patient identification with a secure access personal account, for example by means of a log-on, patient barcode and the like. The patient account links all data relating to the patient, and is configured for patient and HP access.

Detailed Description

The medications and monitoring device herein is configured for access to digitised medication reminder charts and provision of an interactive dose reminder application. Digitised reminder charts and interactive dose reminder applications are novel. These resources enable HP to set up medication reminder alerts or notifications and patients to respond.

The wearable device herein is configured to display medication reminder alerts or notifications and to receive patient response.

For example: "Dawn Price, your breakfast medication is now due: Name/Form/Strength/Dose/Quantity" Options Y/Taken, N/Not taken, I/Ignore (which prompts a later reminder), E/Stop interaction.

Control over alerts or notifications remains with the patient but with monitoring in place to provide a clinical intervention safety net for patients that stop interaction or routinely reply N. Alerts or notifications may include reminders to cease smoking, take exercise, follow diet etc. Alerts and/or input may also take the form of stock-taking alert or patient-initiated on-demand medication or reorder of a patient's medication reserve. This enables monitoring of on-demand medication, or a "just in time" approach to reorder and dispensing new medication stocks, for addressing reduction in medication waste. This is particularly beneficial in case of medication which is regularly changed, or taken as required, and enables a patient to self-manage medication stocks. For example medications to be taken when symptoms demand, such as sleeping tablets, or salbutamol inhaler in case of patents suffering COPD or bronchiectasis, need only be restocked when needed.

Reminders may take the form of text alert, app notification or pop-up, interactive screen or audio broadcast.

In embodiments the device herein has communication connectivity adapted for communication with a staffed infrastructure to provide, support and maintain the MAMs wearable.

Digital wearables which are currently available include smart watches providing time and notification functions including reminder function, biometric wearable devices for monitoring one or more biometric markers, including fitness wearables comprising sleep quality and heart rate monitors and the like.

We are not aware of any wearable devices intended for daytime and/or nighttime wear, more particularly 24/7 wear, configured for interactive medication dose monitoring function, or additional voice communication and analysis and biometric data assimilation.

In embodiments in a device herein an audio platform comprises an audio-visual platform, wherein said device further comprises an interactive visual platform, more particularly a camera or videocamera. Visual contact between patient/citizen and monitoring centre further assists with monitoring patient wellbeing.

Indeed wearable devices currently offered do not address any need for 24 hour wear. The present invention providing 24 hour interactive medications and monitoring for a patient poses new requirements for which there is no existing device.

A device herein is sized and shaped to be worn about the person of a patient. It will be apparent that the device is configured to be inconspicuous and non-intrusive. The device is configured so as to not inconvenience or otherwise burden the patient. More particularly the device is sized and shaped to permit of 24 hour wear, and to encourage adherence to wearing of said device.

In embodiments a medications and monitoring unit herein is detachable from said attachment, further comprising cooperating mountings on said monitoring unit and said attachment means. Attachment means may comprise a mounting adapted to receive said monitoring unit, for example said medications and monitoring unit, and said attachment means are mutually engageable, for example comprise by means of push fit mounting and the like.

In embodiments said attachment is selected from a band to encircle a limb or body part or a further wearable device and a clip, clasp or cleat to attach to an item of apparel or a further wearable device and the like, such as a band, strap, wrist bracelet, ankle bracelet, neckband or necklace, tether, buckle, fabric clip, mating cleat attachment for attaching to a cooperating attachment on a further wearable device and the like. For example the device is selected from an ankle or wrist device such as an ankle or wrist band or bracelet, a jewellery item such as a necklace, pin, clip or brooch, fob device such as a button hole fob device or tether-and-pocketdevice such as a watch-fob style, pocket watch-style device and the like.

Preferably units herein are mounted in a MAM unit comprising a flexible polymer mounting, preferably a lightweight slim mounting with combined weight including units as hereinbefore defined of less than or equal to 200 g and profile of less than or equal to 5 to 30mm such as 10 to 20mm. Suitable materials including moulded, extruded or 3-D printed materials including silicone and the like. One or more flexible bands, resiliently deformable such as flexible elastic silicon bands may be secured to the MAM unit, for looping around a further wearable device, body part or item of apparel.

In embodiments said power unit is selected from a power generating unit such as one or more solar power units, battery units for one or more rechargeable batteries and the like, and connections therefor, and combinations thereof, preferably wherein a power generating unit is selected from a solar cell and the like, and a rechargeable battery unit is selected from a unit for battery rechargeable by electric current, magnet, air charging and the like. Two batteries or a combination with another power source may provide for power switching. A device comprising a solar power unit is suited for operating remote from domestic or terrestrial power supplies. A solar power unit may therefore by the main power unit or a reserve or back-up.

The device herein is adapted for daytime and/or night-time wearing, wherein the power unit is configured to power operation of said MAMu for periods in excess of 12 hours weartime, preferably in excess of 24 or 36 or 48 hours weartime, said device including a sleep/power down mode, for example facilitating low power usage.

In embodiments the device herein comprises a timing unit, configured to date and time stamp MAM interaction and to schedule medication dose reminder notifications according to said digitised charts, for operation within and between time zones.

In embodiments the device comprises connectivity for communication with a further device selected from a biometric sensor, medication dispenser and the like, such as a physical docking unit or short wavelength radio wave data transfer unit. Docking may be with a medication dispensing unit providing monitored dosage. In embodiments the wearable device herein provides dose reminder notification and is configured for docking to said medication dispensing unit, which is configured to generating monitoring data. Monitoring data transmission may be by medication dispenser directly or routed via the device herein.

In embodiments the device includes an identification unit, for example configured to recognise a personal QR code and identity stamp MAM interaction or communication. A wearable identifying QR code plate may be provided in the device or in combination with the device, for example the lightweight aluminium or steel QR code bearing "My SOS" plate. The identifier may code to the patient or the SIM(s), and to links to patient health records, health passport and the like.

In embodiments the wearable device meets the contradicting demands of providing microphone and speaker, and being waterproof The device permits showering and other daily activities which pose a risk of contact with water. Such device may be water resistant or waterproof, for example comprising an integral or detachable water resistant or water proof cover or casing.

More particularly a device herein may comprise one or more integral or detachable water resistance shields or water proofing shields, for example selected from membranes, covers, casings and the like and combinations thereof. Any one such detachable shield may shield the interactive audio platform or part thereof, more particularly the speaker. Such shield may be integral with the device, for example a device comprising units mounted in a moulded silicone mounting.

In embodiments herein, a wearable device may comprise detachable audio platform or part thereof, for example detachable speaker. In embodiments a device herein comprises data-share, short wavelength radio wave data transfer unit such as BluetoothIm or other wireless or wired connectivity to a separate portable or wearable audio platform or part thereof, for example which may be worn or carried in or on an item of apparel.

In embodiments, the wearable device herein comprising an interactive audio platform as herein described, is configured to receive interactive voice input for real time transmission of patient audio recording and determination of paralinguistic properties of said patients speech by means of remote signal processing and machine learning, to monitor the wellbeing of said patient.

In embodiments a microphone in an audio platform herein comprises an intelligent voice processing unit. Such unit interprets language, mental state, such as indicated by tone or pitch, fluency, volume, quantity, rhythm, rate and quality of speech. The device may transmit real time voice data as recordings or for remote recording and saving.

Speech as a neuromuscular performance, is affected by the physiological state of the individual which can affect the processes of respiration, voice and articulation as well as motor control and planning that goes into speaking. Monitoring speech as audio input is non-invasive and enables remote monitoring of a patient/citizen. In embodiments, audio response input herein provides an indication of medication error, such as non-adherence or abnormal response to medication, more particularly over-medication, under-medication, adverse reaction or need for medication review, for example in the case that a condition is progressing and there is a need to increase or alter medication. For example slurred speech may be a marker of stroke, monotone voice or slowed speech may be a marker of depression onset.

More particularly detection of drowsy features in voice analysis may be a marker of overmedication by a patient taking medication to slow heart rate, such as beta-blockers.

Accordingly audio response input is an indirect safety marker of patient biometrics such as heart rate. Triangulation of medications taken, voice responses and biometrics enables identifying deviations from normal. Triangulation output may include generating a patient recall for review.

In embodiments the wearable device herein comprising interactive audio platform and satellite communications connectivity, comprises an interactive audio input and voice capture unit, configured for simultaneous capture of voice data and location data, for real time transmission as hereinbefore defined to at least one of a medication monitoring database, medication monitoring centre and healthcare professional. Such transmission may be by satellite or other wireless communication, such as broadband data link.

In embodiments the device herein further comprises a geosensor unit for detecting location data and for stagger/fall alert. In embodiments the device herein further comprises an emergency button or key or trigger or alert or combination of 2 or more thereof, these being interchangeable terms. One or more emergency buttons may be configured to activate the device in low power/sleep mode. In an advantage the device herein configured to access biometric data, for voice analysis and fall alert, is configured to transmit validating data to qualify whether an emergency alert activation and/or a fall alert is genuine.

The device herein comprising dual satellite network connectivity configured for simultaneous connection to two satellite networks permits location determination, for example by triangulation technique as known in the art.

The wearable device herein may comprise a voice analysis unit or processing capacity or may transmit voice recording for remote voice analysis. In embodiments the device herein is configured for transmission of voice recording for remote voice analysis, wherein communications connectivity is by high fidelity communications network, and in particular by satellite communications network.

The wearable device herein provides for medication and monitoring permitting the timely detection of onset of medication error, and intervention with appropriate corrective measures.

Corrective measures may include alerting the patient and instructing remedial action and/or urgent monitoring appointment with HP.

In embodiments said wireless communications system herein comprises satellite communications connectivity. For the wearable device herein to provide 24 hour communication from any location, access is required to a reliable communications network with universal coverage. Many inhabited rural areas lack reliable cell phone coverage. The fact that such areas tend to support a significant proportion of elderly further compounds the problem of providing an effective medication and monitoring service to those in need.

Preferably a device herein comprises dual communication connectivity ports, adapted for simultaneous connectivity to at least two communications networks, for example at least two satellite networks.

In a particular advantage the processing unit and memory unit of a device herein are configured to process medication and monitoring interaction, including medication dose data, to schedule dose reminder notifications and to receive dose status data, input to said visual display interface and/or said audio platform, for real time transmission to said medication and monitoring service provider, and local or remote updating said medication treatment program status responsive to said input data, Remote updating may be performed on a processor in one or more of the medication and monitoring centre database or service personnel, a healthcare institution such as a hospital, GP, clinician or by a pharmacy. In an advantage centralised remote updating may be accessed by all parties.

The wearable device herein is for use in providing to a patient 24 hour medications treatment reminders and receiving interactive medications treatment dose responses. In embodiments said device is for use in providing a medications and monitoring service.

The device herein is of immense significance, indeed is disruptive, in that it allows for the first time real time medications treatment monitoring for patients who self-administer or who are given medication by a carer. The device is moreover disruptive in that it enables for the first time patients in receipt of medication treatment, to live independently as they wish within their own homes and beyond. The device provides reassurance in a medications treatment, with the ability to limit healthcare professional intervention to as and when necessary, and reduces the frequency of, or may replace the need for, monitoring appointments away from the home. This is of great significance for those with impaired mobility or limited access to transport, or simply living at a distance from a treatment centre.

The device moreover supports for the first time a fully informed approach to prescription of a medication. The device supports medications prescription by the provision of monitoring datasets. These datasets aid in determining appropriate medication, treatment plans and the like. The device moreover enables faster prescription or repeat prescription of medication, more relevant prescription of medication, safer medication prescribed, and improved patient behaviour to medication, more particularly the potential for improved patient health outcome, by one or more of correct choice of medication, at the outset as opposed to by trial and error, with patient confidence and empowerment, with resulting optimum adherence.

The act of medication monitoring input lies with a patent which empowers the patient to influence or communicate information which might affect a decision on medication and which can affect a health outcome. The interactive device herein enables improved engagement by a patient. This has been shown to directly change patent behaviour to medication adherence.

Further benefits as hereinbefore defined include reduced wastage and cost of prescribed medication.

The presently claimed device and method offer an efficient way to allow healthcare professionals and patients to make a collaborative informed choice on the correct medication.

Reference herein to wastage of or wasted medication is to medication which is provided to a patient and part or all thereof is unused. Wastage may be for reason of non-adherence or change or correction of prescription, for example because the medication is incorrect, non-optimal or not suitable for reason of any of past response, comorbidity, adverse reaction, and/or lifestyle preference. The herein device provides for "just-in-time" reordering of medication stocks, addressing this issue of wastage.

A patient herein may be an adult or child, having a diagnosis for a medical condition, and who may be assisted by a carer or someone acting on their authority.

A healthcare professional (HP) herein encompasses any healthcare professional such as a clinician or equivalent having direct contact with patients, prescriber or independent prescriber, or any person acting under their authority. Monitoring centre personnel herein may be healthcare professionals of may be specially trained to undertake monitoring and to alert an appropriate healthcare professional as required.

Medication herein is medication prescribed for a diagnosed medical condition, unless indicated otherwise. Medication includes any medicine, therapy or treatment plan requiring signature by a HP as hereinbefore defined.

A medication herein refers to medication indicated to or licensed for a condition and may be any medication available under prescription for the diagnosed condition, including off-label medication or unlicensed medication, and may include over the counter (OTC) medication, and medication available without prescription according to national law in a given country.

Medication herein also includes personalised medicine, such as medication personalised to be taken in a manner considered safe behaviour for a patient, for example in the case that a patient cannot manage evidence-based medication treatment regime. Such personalised medication may be developed using clinical decision support, and may be developed from medication monitoring using the device herein. Off-label or unlicensed medication is medication which is prescribed to treat a medical condition other than that for which its use is authorised. For example an authorisation for a medication prescribed to treat a medical condition does not include authorisation to continue use once the condition is effectively treated, to prevent recurrence of that condition, and is thus considered "off-label" if prescribed for such continued use; medication authorised for treatment of depression which is also effective in treating neuropathic pain is prescribed "off-label" for such treatment of neuropathic pain.

Embodiments herein may be generally applicable in the case of any new or existing medication such as in the case of a decision on a suitable new medication for a patient, in the case of a review of an existing medication taken by said patient, which may be a periodic review or prompted by a change in the patients condition, in case of deciding on a long term medication for a patient progressing from an acute medication A medical condition herein may be any medical condition requiring treatment by medication. A medical condition is for example any condition listed in the International Classification of Diseases. Particularly significant conditions include diabetes, cardiac, cancer, mental health and palliative care, as well as transfer therapy, contraception, neurology and the like.

In a further aspect there is provided a computer implemented method for interactive bidirectional medication and monitoring for a patient in receipt of medication treatment, by means of the wearable personal digital medication and monitoring device herein.

In further aspects, there is herein provided a computer implemented method and system employing the wearable device, a computer program, computer readable data carrier and data carrier signal carrying the computer program, etc. which puts the method into effect in the wearable device, an online patient account as a portal to operate the wearable device and access the data for use by the device and generated by the device herein.

Online accounts of this nature are known, for example as a means for secure online banking. In embodiments the wearable device herein is configured to transmit patient responses for storage in a protected database which is accessible by patient and HP. This enables sharing real-time medication adherence status between patient and HP This facilitates early intervention for non-adherence and promoting HP:patient consultations, to reduce instances of relapse, morbidity and death.

In yet further embodiments, the device readily permits of effective medication treatment reminder and response in a language of choice, and/or with pictures and/or audio facility for children and adults with limited reading skills or hearing impaired and/or with large font text for visually impaired.

In a further aspect there is provided herein a computer implemented method for interactive bidirectional medication and monitoring for a patient in receipt of medication treatment, by means of a wearable personal digital medication and monitoring device comprising a processing unit and a memory unit, an interactive visual display unit and/or interactive audio platform, and a network communications unit, said method comprising: a medication and monitoring step of causing said processing unit to access data locally, such as in a memory unit, or remotely, such as in a medications and monitoring database, or by means of a personalised medications and monitoring account, relating to a personalised medication treatment program and to issue medication dose data together with monitoring status query; a dose status query step of causing said interactive visual display unit and/or said interactive audio platform to display and/or emit said data and query; a patient interaction step of causing said patient to be receptive to said dose status query and causing said interactive visual display unit and/or interactive audio platform to receive patient input dose status data responsive to said query; a treatment program updating step of causing said processor and memory unit or a MAM service provider to update said medication treatment program with said status data; and a transmission step of causing said network communications unit to transmit in real time said status data to said medication and monitoring service provider; wherein the method provides real time day time and/or night time medication and monitoring.

In embodiments said medication and monitoring step is a medication reminder step of causing said processor and memory to schedule a medication dose reminder and issue a reminder notification for display or emission via said visual display unit and/or said audio platform, together with a monitoring status query; wherein said dose status step is responsive to said reminder notification and query.

More particularly the method herein for medication and monitoring for a patient by means of the herein wearable medication and monitoring device, comprises: a medication reminder step of causing a processor comprised in said device to access a medication treatment program, retrieve a medication reminder and display on an interactive visual display unit and/or emit via an interactive audio platform comprised in said device; a medication reminder response step of causing said interface to display one or more fields for input of medication reminder response and receive said response, and/or of causing said interactive platform to be receptive to an audio medication reminder response and to receive said response, or any combination thereof; a medication updating step of causing a processor to update said medication treatment program in view of said response; and a medication monitoring step of causing said processor to transmit said response to at least one of a medication monitoring database, medication monitoring centre and healthcare professional having oversight of said patient/citizen's medication.

In embodiments said medication and monitoring step is an on demand medication step wherein said medication and monitoring step is responsive to a patient on-demand interaction step of causing said interactive visual display unit and/or interactive audio platform to receive a patient on-demand medication dose request.

In embodiments the method comprises a data and/or voice analysis step for indicating patient/citizen medication treatment status performed in a database and processing unit. More particularly the method comprises a patient interaction step via said audio platform, further comprising a voice analysis step of causing said processing unit comprised in said device or said MAM service provider to perform data and/or voice analysis and derive patient medication treatment status and/or markers.

In embodiments the method comprises a clinical monitoring step of causing a healthcare professional (HP) visual display unit and/or audio platform to retrieve and display or emit said response and/or said medication treatment status and/or to display an alert in case of medication treatment status requiring HP review.

In embodiments the method is suitable for realising in a distributed computing environment, comprising said medication and monitoring device together with a medication and monitoring database and optionally one or more personnel interfaces, optionally by means of remote log in facility and/or links to one or more remote databases.

In embodiments the method herein comprises a step of presenting, on said interactive visual display unit provided by said wearable device, input fields for registering, recording or reporting status of medication, such as "medication successfully taken", "yet to be taken" or "not taken".

Patient interactive visual display input herein may be selected from selecting prompts, inputting text response input, moving sliders, ticking or unticking, crossing or uncrossing boxes, highlighting or unhighlighting series of shapes, such as 5 circles or tiles. Dose input may be affirmative or negative, i.e. Taken, Remind me later or Not Taken; and wellbeing monitoring input may be on a scale of high to low, scoring on a numerical scale, which may be a VAS (visual analogue scale) displaying a continuum or continuous scale or a discrete scale, scoring by relative term such as low, moderate or medium, high, or scoring on a colour scale such as a traffic light scale from green through orange to red and the like.

In a further aspect there is provided a medication and monitoring service embodying the device or method of any preceding claim for a patient in receipt of medication treatment, said service being selected from an application service, for example provided by an application service provider (ASP), a server or data hosting service or website hosting service provided by a hosting server provider In a further aspect there is provided herein a data processing system comprising means for carrying out the computer implemented method as hereinbefore and hereinbelow defined and described. In embodiments a data processing system is a medication and monitoring system comprising a combination of a wearable device as claimed in any preceding claims, together with a medication monitoring centre comprising a local or remote database and optionally additionally comprising one or more medication monitoring personnel interfaces, such as one or more healthcare professional interfaces, and combinations thereof More particularly said data processing system comprises a combination of one or more interfaces including the wearable device herein, one or more storage media storing processor-executable instructions, one or more processors for executing said instructions, and means for transmitting a data signal. Said system may be comprised in a single computing device or in a distributed computing environment. Said system may comprise storage media storing generic processor-executable instructions such as selection tools, input fields, alert fields and tools. Said system may be comprised in a single "medication and monitoring system" incorporating all requisite interfaces, storage means, processing means, and databases.

The system may include a memory unit configured to receive and store data relating to a digitised medication treatment program, and optionally relating to one or more medications comprised in said program, or may include one or more local or remote access addresses, configured to indicate the availability of such data stored locally or remotely, and present the option to a patient or a HP, to summon and view such information.

In embodiments said system further comprises transmission means, more particularly data transmission means. Transmission means is configured to transmit input data, receive external input data, and/or to transmit processor output data and or to issue or and/or receive an alert or message to a HP or patient to access the system.

One or more of the components or subcomponents of the system may be located remotely from the other components of the system. In embodiments said system includes communication connectivity, more particularly data transmission and data receiving connectivity. Said system including communication connectivity may operate in a networked environment using logical connections to one or more remote computers, more particularly a networked communication environment. A logical connection may be selected form or include a local or metropolitan area network (LAN or MAN), a wide area network 0/VAN), Internet area network (IAN) also known as the cloud, public switched telephone network (PSTN) and cellular network, in particular in case of mobile networking, and satellite networks, specifically satellite internet, and combinations thereof but may also include other networks. Such networking environments are commonplace or emerging in homes, offices including surgeries, clinics and hospitals, enterprise-wide computer networks, intranets and the Internet. A particular preference is for LAN, WAN, IAN (Cloud) network, or satellite intemet network connectivity and combinations thereof. In a particular advantage the method and system includes satellite communication connectivity, that is to say operates in a networked environment using satellite communication technology. This has particular advantages for patients and HP operating in rural areas, in undeveloped or developing countries or in other areas with limited or no internet provision or with disruption to national or local internet provision.

A satellite network herein may include high altitude satellites such as HAPS (high altitude pseudo satellites, and high altitude platform station. These are e.g. airship networks etc" more particularly high altitude geostationary platform stations, HAPS operate at much lower altitudes than satellites, to cover a small region much more effectively. HAPS as a platform may deliver high-speed connectivity to users, over areas up to 400km. HAPS may deliver bandwidth and capacity similar to a broadband wireless access network (such as WiMAX) while providing a coverage area similar to that of a satellite. Lower altitude also means much lower telecommunications link budget (hence lower power consumption) and smaller round-trip delay compared to satellites. Furthermore, deploying a satellite requires significant time and monetary resources, in terms of development and launch. HAPS, on the other hand, are comparatively less expensive and are rapidly deployable. Another major difference is that a satellite, once launched, cannot be landed for maintenance, while HAPS can.

A satellite network herein may also include nanosatellites such as CubeSat or U-class (University class) satellites, or other small satellite for low Earth orbit (LEO). A CubeSat is a type of minituarised satellite for space research that is made up of multiples of 10 cm 10 cm X 11.35 cm (-4 in x 4 in x 4.5 in) cubic units. CubeSats have a mass of no more than 1.33 kilograms (2.9 lb) per unitPl and often use commercial off-the-shelf (COTS) components for their electronics and structure. SubeSals are commonly put in orbit by deployers on the International Space Station, or launched as secondary payloads on a launch vehicle. They can use radio-communication systems in the VHF, UHF, L-, 5-; C-and X-band.

High earth orbit geo-stationary satellites or low earth orbit ( LEO Cubesat) may be used as backhaul to a HAPS platform, which will provide the service either directly to the wearable device using either NB-10T or possibly 700Mhz spectrum. In the later case acting much like a macro site acts as control plane for the wearable device.

Satellite, such as HAPS can also communicate (using Cu Band) with the terrestrial network: the Satellite access point or either MNO Macro or Micro sites. This enables these endpoints to potentially communicate with the wearable device using 3.5GHz or 26Ghz which can provide very high bandwidth and ultra-low latency when required. This would imply a 5G virtual network slice which could enable switching between the network channels as required.

In embodiments said system comprises additional interfaces, storage means, processors and the like as known in the art.

In a further aspect there is provided herein a program for a device herein or for a method herein, such as a computer program or an app therefor, comprising instructions which, when executed by said device, cause the device to carry out the steps of the computer implemented method as hereinbefore and hereinbelow defined and described.

An app herein may be a patient app as defined, for causing a device herein to carry out the method steps herein., or an HP app for causing a computer to perform an HP medication and monitoring method. In embodiments an HP method comprises in a first mode accessing a patient account comprising healthcare data such as drug history, calendar vs time medicines taking, performance data per medicine, stock management and the like, and in a second mode receiving notifications relating to medications adherence, adverse reaction and the like. An HP app may include compliance steps for progressing a notification before "signed-off' status is assigned.

In a further aspect there is provided herein an algorithm enabling a method or computer program as defined herein.

In a further aspect there is provided herein a device as hereinbefore defined when programmed to carry out the steps of the computer implemented method as defined herein.

In a further aspect there is provided herein a computer-readable storage medium or data carrier comprising instructions which, when executed by a computer, cause the computer to carry out the steps of the computer implemented method as hereinbefore and hereinbelow defined and described.

Any combination of one or more computer-usable or computer-readable media may be utilized.

For example, a computer-readable medium may include one or more of a portable computer diskette, a hard disk, a random access memory (RAM) device, a read-only memory (ROM) device, an erasable programmable read-only memory (EPROM or Flash memory) device, a portable compact disc read-only memory (CDROM), an optical storage device, and a magnetic storage device. Computer readable media may be comprised in any device as hereinbefore defined, notably cellphones or mobile phones, tablets and the like or in private or public servers, including dedicated servers. Computer program code for carrying out operations of the present disclosure may be written in any combination of one or more programming languages.

Embodiments may also be implemented in cloud computing environments, and in satellite communication environments. In this description and the following claims, "cloud computing" may be defined as a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned via virtualizafion and released with minimal management effort or service provider interaction, and then scaled accordingly. A cloud model can be composed of various characteristics (e.g., on-demand self-service, broad network access, resource pooling, rapid elasticity, measured service, etc.), service models (e.g., Software as a Service ("SaaS"), Platform as a Service ("PaaS"), Infrastructure as a Service ("laaS"), and deployment models (e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.).

The flowchart and block diagrams in the flow diagrams illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It will also be noted that each block of the block diagrams and/or flowchart illustrations, and combinations of blocks in the block diagrams and/or flowchart illustrations, may be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

These computer program instructions may also be stored in a computer-readable medium that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instruction means which implement the function/act specified in the flowchart and/or block diagram block or blocks.

In a further aspect there is provided herein a data carrier signal carrying the computer program as hereinbefore and hereinbelow defined and described.

In a further aspect there is provided herein a computer-readable storage medium or data carrier or data carrier signal as defined herein having stored thereon the computer program herein.

In further aspects there are provided herein a network communication system comprising a combination of the device herein and a medication and monitoring database having communication connectivity capable of communicating via a communications network arranged to perform the method herein; a user interface comprised in a wearable device herein, when programmed to operate the method herein; a subscription or on line account comprising instructions which, when executed by a computer, or a wearable device herein, cause the computer or device to request and receive data packages or data sets from one or more databases and/or to transmit and receive data input by means of the device herein.

a health information system or medications database, capable of, or for, use with the device or in the method herein.

a digitised medication treatment program generated by the method, service, system, or program, device or computer, storage medium or data carrier or signal, interface, account or database herein.

In a further aspect there is provided herein a hosting service for a patient account operating the method, service or with use of the system, program, device or computer, storage medium or data carrier or signal, interface, or database herein, comprising: a server capable of executing, or configured to execute, an instance of a patient medication treatment application with a patient wearable device over a network using a first secure communication channel established between the server and the patient device by the hosting service; optionally additionally capable of executing, or configured to execute, an instance of a medication and monitoring centre (MAM) application with a MAM centre computing device over a network using a second secure communication channel established between the sewer and a MAM centre computing device by the hosting service; a module that is capable of querying, or configured to query, one or more databases and of retrieving, or to retrieve, data sets relating to medication, patient decision aids and/or patient medical records, and of transmission, or to transmit, to a patient account associated with the patient operating the patient device, wherein said communication channels are capable of being established by an account login procedure.

In a further aspect there is provided herein a method, system, computer program, computer-readable storage medium or data carrier comprising instructions or a data signal as hereinbefore or hereinbelow defined or described for use in healthcare, more particularly in monitoring medication treatment.

Description of preferred embodiments

An visual display unit herein may be a text interface, touch screen or any other suitable interface.

An HP interface or monitoring centre interface may be provided on any suitable computing system environment or configuration, device or unit such as a mobile device or stationary device, for example a mobile phone, smart phone, tablet or laptop device, personal computer, desktop computer, server computer, multiprocessor system, microprocessor based system, set top box, programmable consumer electronic device, network PC, minicomputer, mainframe computer, public access terminal, or distributed computing environment containing any of these systems or devices, and the like.

The computing environment may execute computer executable instructions, such as program modules, including routines, programs, objects, components, data structures and the like that perform particular tasks or implement particular data types. Embodiments may be practiced in distributed computing environments in which tasks are performed by remote processing devices that are linked through a communication network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.

In embodiments a wearable device, method, system, computer program and computer readable data carrier and/or data carrier signal herein is suitable for realising in a distributed computing environment. For example the wearable device may comprise a remote log in facility and/or may comprise links to one or more remote databases.

A remote log-in facility may be as known in the art, comprising a log in created by a patient or issued to a patient to access a remotely hosted computing environment.

A link to a remote database may operate in one direction, configured for reference by said patient to supporting information on medications or side effects provided on a database. A database may be public or private. A link may operate in two directions, additionally configured to transmit information comprised on said database to said interface.

A viewable account document herein may be user protected against any changes, and/or may be edited with HP notes or patient comments.

A viewable account document herein may include information on patient input and/or information relevant to said digitised medication treatment program.

Patient access as hereinbefore defined may be any form of local or remote access as known in the art, for example selected from password access to a protected data package, secure log in code to a remote database and the like.

A wearable device and system herein may be for use in shared decision making in relation to medication.

A medication and monitoring system herein may comprise means to issue an alert or message to a HP to access the system and acquire medication status responses. HP access may be by means of log-on link, which may be auto generated or generated by patient consent, e.g. by completion of a patient consent field.

A medication and monitoring system herein may comprise means to store data on medications and their associated indicators.

A wearable device herein may provide connectivity to remote documents, websites or databases providing information on medications Educational material may comprise digital reference resource selected from any information or supporting data which might assist a patient or HP, for example selected from data sheets, educational content on medical conditions, medications by class such as by mode of action or active ingredient, individual medications, side effects, dosing, formulation categories and the like.

Digital reference resource may be accessed by any means for summoning digital information as known in the art including data link, embedded data and the like. Digital reference resources may be comprised in digital documents such as pdfs, websites and the like. Digital reference resources may be comprised on an interrogable database, such as a public database, subscription database or a database constructed for the purposes of the present medication and monitoring.

In preferred embodiments the wearable device herein comprises: 1. Simple interface, i.e. amenable for use by patients of all ages and abilities 2. Competent to deliver the intended function -ie. Remind patients and track medicines taking inputs over time already programmed in a list, for example provided within the MaPPs software system.

2.1 Reminder for individual medicines at particular scheduled times during the day and then input response horn the patient as taken/not taken/remind me later together with a dose amount (1 -2 -3 etc) 2.2 Allows an additional "on demand" input of a selection "when required" medicines and take input response from the patient as above 2.3. Allows "on demand" emergency alert to be sent via the device (Activity based) 3. Waterproof 4, Connected 24/7 5. Global connection, i.e. rather than national 6. Voice interlace element to give patient the names of the medicines on the list and select each medicine to respond as taken not Laken remind me later / low battery etc 7. Voice interface element to request response from patient regarding mood.

The voice analysis interaction can pick up side effects of medication; overmedication, potential problems e.g. stroke, depression, drowsiness.

The monitoring device, method and system allows correlation of voice and medicines taking to flag up challenges for safety (potential falls) and key patients for urgent review 8. Biometric integration May be integral or separate, i.e. additional wearable device access for biometrics that can provide side effects of medication, overmedication, potential problems e.g. heart rhythm, bradycardias, eco disturbance and complications with medications such as beta-bloc:kers and a ntipsychotics such as clozapine.

9. The monitoring device, method and system allows triangulation of biometrics; voice and medicines taking to flag up challenges for safety (potential falls) and key patients for urgent review 10. Long battery low power usage 11. Simple charging 12. Robust 13. Lightweight The system is now illustrated in non-limiting manner with reference to the figures, wherein: Figure 1 demonstrates a problem in current practice among self-administering patients; Figures 2a and 2b are illustrations of a wearable device herein; Figures 3a and 3b illustrate embodiments of the wearable device herein with inset interactive visual display; Figures 4a and 4b illustrate an embodiment of the wearable device herein with inset interactive audio platform; Figure 5 illustrates the units comprised in a MAMs herein; Figures 6a and 6b illustrate a data processing system for medication optimisation herein; Figure 7a and 7b illustrate a distributed computing environment capable of operating the method herein; Figures 8 illustrates a patient id for use with a device herein.

Figure 1 demonstrates hospitalisation rate by gap in therapy in a study of patients prescribed anfipsychotic medication. Statistical significance, P, was 0.004. The hospitalisation rate illustrates that even small gaps in anfipsychotic medication usage increase the risk of hospitalisation. Patients with a maximum therapy gap of 1 to 10 days within one year had almost a 2-fold increase in risk of hospitalisation.

Figure 2a illustrates the wearable device (1) herein, comprising medication and monitoring unit (MaM) and wearable attachment (VV), as a medication and monitoring bracelet worn on patient (P). Device (1) is envisaged for day and night wear. It is important for the efficacy of device (1), as a medication aid and as a monitoring device, that it should be non-intrusive for continuous wear by patient (P). Figure 2b illustrates an alternative embodiment of a wearable device comprising medication and monitoring unit la and attachment lb in the form of two elastic loops suitable for securing about a body part, an item of apparel, or a further wearable device, typically a wearable biometric sensor having data connectivity with the medication and monitoring unit la. Interactive visual display unit (2) and interactive audio platform (3) are illustrated, together with short wave data communications unit (16) configured to communicate with an external biometric sensor.

Figures 3a and 3b illustrate interactive visual display unit (2) of wearable device (1) herein. Interactive visual display unit (2) is readily viewed by the patient, and sized and shaped to display a medication reminder (21), together with dosage type and amount (22) and, simultaneously or subsequently, prompts or input fields (5) for response, more particularly medication dose response. Exemplary input prompts or fields (23) are illustrated: Taken, Ask me later, Not taken. Exemplary input prompts or fields (23) are also illustrated as a traffic light system: Taken -green, Ask me later -yellow, Not taken -red. Input response may be by selecting the appropriate response, or by text input.

Figures 4a and 4b illustrate interactive audio platform (3) of wearable device (1) herein.

Interactive audio platform (3) includes speaker (31) and microphone (32). Speaker (31) is configured to communicate a monitoring communication inviting a response by patient (P), received by microphone (32) for voice analysis. In Figure 4b is illustrated satellite connectivity (4) with monitoring centre (5). In Figure 4b is depicted audio reminder communicated by speaker (31) and audio medication dose response by patient (P), received by microphone (32) and communicated by satellite connectivity (4) to monitoring centre (5).

Figure 5 illustrates units comprised in medication and monitoring unit (MaM): processor (61), memory (62), timer unit (63), wireless communications unit (64), interactive audio platform (3), interactive visual display unit (2), biometric sensor(s) (65), and geosensor (66).

Figure 6a illustrates the Medical and Monitoring service, provided by wearable device herein, in flowscheme. In step i) Medication reminder is retrieved from Digital Medication Treatment Program. In step H) reminder is displayed and/or emitted on interactive visual display unit and/or via interactive audio platform, together with prompt for response input. In step iii), response input is a) Remind me later. Service loops back to step i) or ii). Alternatively response input is b) Taken. Service proceeds to step iv), Digital Medication Treatment Program updated and next reminder retrieved and scheduled, the service loops back to step i). Alternatively there is no response input or response input is Not taken. Service proceeds to step iv), Digital Medication Treatment Program updated: Response/Dose missed, and service proceeds to step v), Alert issued to HP, intervention escalated or initiated, for example monitoring voice communication initiated, review consultation with HP scheduled; service proceeds to step vi) Remedial action, such as patient reassured on any concerns over medication, medication changed etc. Service then loops back to step ii) or iii).

Figure 6b illustrates the corresponding On-Demand Medication and Monitoring Service. In step i) patient inputs a demand for medication options and data; processing unit retrieves and displays or emits (via audio platform) medication options and data, for example as drop down box, or audio menu. Patient selection prompts step ii) medication data displayed and/or emitted on interactive visual display unit and/or via interactive audio platform, together with prompt for response input. In step iii), response input is a) Stocks low/finished, reorder. Input transmitted to Pharmacy reorder and Treatment Program update. Alternatively or additionally response input is b) Taken. Service proceeds to step iv), Digital Medication Treatment Program updated with dose and date and time stamp, the service loops back to step i).

Figure 7a illustrates a Medication and Monitoring system configured to carry out the method of Figure 6, comprising wearable device (1) comprising wireless communications unit (64) in satellite communication connectivity (4, one or two satellites) with monitoring centre (5) and broadband communication (7) with HP interface (8). Broadband Comms mast (7) relays communication between device (1), monitoring centre (5), HP interface (8) and satellites (4).

Communication with satellite(s) (4) is optionally via HAPS satellite (41) and/or Cube satellite (42).

Illustrated in Figure 7b, in normal mode HAPS acts as NB-10T transport from wearable to monitoring centre. In ALERT mode a 5G slice may be instantiated to make use of available small cell and /or macro site coverage to provide real 20 time feedback.

HAPS communicates with terrestrial segment using Cu Band or possibly 700Mhz -using multiple Software Defined Radio links to provide >1Gb downlink if required. HAPS uses High Earth Orbit Satellite for geopositioning and/or backhaul to the satellite groundstation which will normally sit on high speed fibre backbone, The HP in a Healthcentre may also have a Fibre link or, if mobile, connect to 4G LTE network.

Figure 8 illustrates a patient identification tag (70), bearing a code (71) such as a bar code, QR code or other code identifying the patient, device and or patient healthcare account.

In further aspects herein, said system components as hereinbefore defined comprising said one or more interfaces, memories and processors may comprise any local or distributed computing environment, which may be configured by means of a computer program, computer-readable storage medium or data carrier or data carrier signal storing or carrying said program, as known in the art, said program comprising instructions which, when executed by a computer or a distributed computing environment, cause the computer or environment to carry out the steps of the computer implemented method herein.

The invention has been described above in relation to its use for mental health care and mental health conditions. However, the very same principles may be used for any health disorder.

Although a few preferred embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope of the invention, as defined in the appended claims. Attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features. The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

EXAMPLES

Example I -Health outcome change of a commercial health information system, in terms of medication-taking behaviour or adherence, determined by Motivation to take Medication/MAR (Medication Adherence Rating Scale) The impact of a commercial health information system on health outcome change was measured by a post interaction outcome (questionnaires). It clarified that improved knowledge, understanding, confidence and empowerment were characteristics of a positive patient experience that led to a post intervention outcome (positive health outcome change = motivation to take medication).

The Choice and Medication website h[ths://www.choiceandmedication.orq/ provides information on medication side effects and on condition symptoms to help people make informed choices in medication. A key aim of the website is to promote medicines-taking behaviour or adherence, i.e. the degree to which patients comply with advice on how to take their medication correctly.

Patients' knowledge on dose mode and regime of prescribed medication, understanding of medications being taken and the effects of taking the medication improved confidence in discussing options to treatment, different medication alternatives, including dose mode and regimes, side effects and the like, with HPs, fostering patient empowerment.

This example observed impact of the system as a change of motivation to take medication as intended (adherence). A statistically significant improvement in medicines taking was observed, as evidenced by questionnaires completed by users of the website, Improved adherence was indicated by a clinically significant change in medicines adherence rating scale (MARS). Evidence included movement from "rarely complied to "sometimes" complied with treatment, which showed a positive change in adherence. Any improvement was considered clinically beneficial, no matter how small, because the consequences of not adhering, in this case to mental health medication, was increased morbidity and mortality.

The example concluded that a positive user experience was an antecedent to a health behaviour change. A health information system provided in the form of a website that provided high quality credible information was essential to the positive user experience. This had a direct result in more engaging and meaningful consultations between HP and patients, reduced in time as a direct result of not having to explain information already explored on the website, with the added advantage that limited patient time was extended beyond the clinical consultation as the website was open all hours.

Comparative Example -Medication error in patient not subject to monitoring A safety benefit that a clear treatment picture can bring can be seen from an example of nonadherence with respect to Clozapine. This important agent is effective in PWS, with usual doses 4 ranging from 200mg to 450mg (maximum of 900mg daily), yet the manufacturer's summaries of product characteristics states that if the medication is not taken for 2 days it must be restarted at 12.5mg with a maximum dose titration of 50mg. The speed of titration is dictated by preventing adverse effects including hypotension, tachycardia and seizures and so requires close monitoring. This raises two issues: firstly, a patient who is unsupervised could stop and restart Clozapine at any point during periods of unsupervised care, with an increased risk of potentially fatal adverse drug reactions including neutropenia, agranulocytosis and myocarditis. When a two day break is observed by a healthcare professional, a re-titration of the medication is initiated with small incremental increases and more regular blood monitoring requiring additional contact time for the patient.

Example 2 -Improving healthcare outcome by means of patient input in monitoring medication treatment via wearable device Patient is provided with wearable device herein, that enables an intervention to be made before a two day break due to monitoring adherence, providing reminders and notification of missed doses to the healthcare professionals, this ultimately leads to prevention of a re-titration in both supervised and unsupervised PWS and the associated time and costs from healthcare to support this. The ability to incorporate adherence as a marker of medicines actually taken can, therefore, improve safety.

Claims (25)

1. CLAIMS1. A personal wireless digital medication and monitoring device for a patient in receipt of medication treatment, said device comprising a medication and monitoring unit (MAMu) comprising; a wireless communications unit for accessing at least one wireless communications network; a power unit, and a processing unit and a memory unit configured to access remotely and store, data relating to a personalised medication treatment program, said data including digitised medication dose and monitoring charts; wherein said medication and monitoring unit comprises at least one of an interactive visual display unit and an interactive audio platform, configured for bidirectional visual and/or audio medication and monitoring (MAM) interaction, between said patient and a remote medication monitoring service provider in relation to said digitised charts; wherein said remote medication monitoring service provider interaction is by means of a medication monitoring centre comprising a local or remote database and optionally additionally comprising one or more medication monitoring personnel interfaces, such as one or more healthcare professional interfaces, and combinations thereof; wherein said device is wearable by said patient, comprising at least one attachment selected from a patient-attachment for attaching to a body part of said patient, and a wearable--attachment, for attaching to an item of wearing apparel, or to a further wearable digital device and the like, said device being adapted for daytime wearing and/or night-time wearing, on or about the person of said patient, wherein said medication and monitoring unit is detachable from or integral with said attachment.
2. 2. A device as claimed in Claim 1 wherein said wireless communications unit is configured for connecting to at least one satellite communications network, which may include HAPS, Cubesat and other satellite networks and combinations thereof.
3. 3. A device as claimed in any of Claims 1 and 2 wherein said wireless communications unit comprises dual communication connectivity ports, configured for simultaneously connecting to at least two communications networks, preferably to at least two satellite communications networks, for example comprises at least two slots for receiving a SIM card.
4. 4. A device as claimed in any of Claims 1 to 3 wherein said interactive audio platform comprises a speaker unit and a microphone unit, whereby said device is configured to transmit audio medication and monitoring communication for the performance of voice recognition analysis, for example for the detection of changes in voice, for determining patient physical or mental wellbeing, and the like.
5. 5. A device as claimed in any of Claims 1 to 4 which is configured to receive patient biometric data from one or more integral or separate biometric sensor units, for example selected from a movement sensor unit, heart rate monitor unit, body temperature monitor unit, hydration monitor unit, oxygen saturation monitor unit and the like, said device comprising one or more biometric units or comprising wired or wireless data connectivity with one or more biometric devices, and optionally comprising a wearable-attachment for attaching to a separate biometric device.
6. 6. A device as claimed in any of Claims 1 to 5 wherein an audio platform comprises an audio-visual platform, said device further comprising an interactive visual image platform, such as a camera or video camera.
7. 7. A device as claimed in any of Claims 1 to 6 wherein said attachment is selected from a band to encircle a limb or body part or a further wearable device and a clip, clasp or cleat to attach to an item of apparel or a further wearable device and the like, such as a band, strap, wrist bracelet, ankle bracelet, neckband or necklace, tether, buckle, fabric clip, mating cleat attachment for attaching to a cooperating attachment on a further wearable device and the like.
8. 8. A device as claimed in any of claims 1 to 7 which is selected from an ankle or wrist device such as an ankle or wrist band or bracelet, a jewellery item such as a necklace, pin, clip or brooch, fob device such as a button hole fob device or tether-and-pocket-device such as a watch-fob style, pocket watch-style device and the like.9. A device as claimed in any of claims 1 to 8 wherein said units are mounted in a moulded flexible plastics mounting, preferably a lightweight slim mounting with combined weight including units as hereinbefore defined of less than or equal to 200 g and profile of less than or equal to 5 to 30mm such as 10 to 20mm.
9. 9. A device as claimed in any of claims 1 to 8 wherein said power unit is selected from a power generating unit such as a solar power unit, a battery unit for a rechargeable battery and the like, and connections therefor, and combinations thereof, preferably wherein a power generating unit is selected from a solar cell and the like, and a rechargeable battery unit is selected from a unit for battery rechargeable by electric current, magnet, air charging and the like.
10. 10. A device as claimed in any of claims 1 to 9 which is adapted for daytime and/or night-time wearing, wherein the power unit is configured to power operation of said MAMu for periods in excess of 12 hours weartime, preferably in excess of 24 or 36 or 48 hours weartime, said device including a sleep/power down mode, for example facilitating low power usage.
11. 11. A device as claimed in any of claims 1 to 10 which comprises a timing unit, configured to date and time stamp MAM interaction and to schedule medication dose reminder notifications according to said digitised charts, for operation within and between time zones.
12. 12. A device as claimed in any of claims 1 to 11 which comprises connectivity for communication with a further device selected from a biometric sensor, medication dispenser and the like, such as a physical docking unit or short wavelength radio wave data transfer unit.
13. 13. A device as claimed in any of claims 1 to 12 which includes an identification unit, for example configured to recognise a personal QR code and identity stamp MAM interaction or communication.
14. 14. A device as claimed in any of Claims 1 to 13 which is water resistant, comprising an integral or detachable water resistant or water proof cover or 10 casing.
15. 15. A device as claimed in any of Claims 1 to 14 wherein the MAM unit is detachable from the attachment, further comprising a releasably engageable coupling for said MAM unit and said attachment, such as a band, mutually engageable coupling, for example a push fit coupling or the like.
16. 16. A device as claimed in any of Claims 1 to 15 further comprising a geosensor unit for detecting location data and /or stagger/fall alert.
17. 17. A device as claimed in any of Claims 1 to 16 wherein said processing unit and memory unit are configured to process medication and monitoring interaction, including medication dose data, to schedule dose reminder notifications and to receive dose status data, input to said visual display interface and/or said audio platform, to update said medication treatment program status responsive to said input data, for real time transmission to said medication and monitoring service provider.
18. 18. A device as claimed in any of Claims 1 to 17 for use in a medication and monitoring service.
19. 19. A computer implemented method for interactive bidirectional medication and monitoring for a patient in receipt of medication treatment, by means of the wearable personal digital medication and monitoring device according to any of Claims 1 to 18.
20. 20. A medication and monitoring system including the wearable personal digital medication and monitoring device according to any of Claims 1 to 18, or a computer program, computer readable data carrier and data carrier signal carrying the computer program, for the wearable personal digital medication and monitoring device according to any of Claims 1 to 18.
21. 21. A computer implemented method for interactive bidirectional medication and monitoring for a patient in receipt of medication treatment, by means of a wearable personal digital medication and monitoring device comprising a processing unit and a memory unit, an interactive visual display unit and/or interactive audio platform, and a network communications unit, said method comprising: a medication and monitoring step of causing said processing unit to access data locally, such as in a memory unit, or remotely, such as in a medications and monitoring database, or by means of a personalised medications and monitoring account, relating to a personalised medication treatment program and to issue medication dose data together with monitoring status query; a dose status query step of causing said interactive visual display unit and/or said interactive audio platform to display and/or emit said data and query; a patient interaction step of causing said patient to be receptive to said dose status query and causing said interactive visual display unit and/or interactive audio platform to receive patient input dose status data responsive to said query; a treatment program updating step of causing said processor and memory unit or a MAM service provider to update said medication treatment program with 25 said status data; and a transmission step of causing said network communications unit to transmit in real time said status data to said medication and monitoring service provider; wherein the method provides real time day time and/or night time medication and monitoring.
22. 22. Method as claimed in Claim 21 wherein said medication and monitoring step is a medication reminder step of causing said processor and memory to schedule a medication dose reminder and issue a reminder notification for display or emission via said visual display unit and/or said audio platform, together with a monitoring status query; wherein said dose status step is responsive to said reminder notification and query.
23. 23. Method as claimed in Claim 21 or 22 wherein said medication and monitoring step is an on demand medication step wherein said medication and monitoring step is responsive to a patient on-demand interaction step of causing said interactive visual display unit and/or interactive audio platform to receive a patient on-demand medication dose request.
24. 24. Method as claimed in any of Claims 21 to 23 comprising a patient interaction step via said audio platform, further comprising a voice analysis step of causing said processing unit comprised in said device or said MAM service provider to perform data and/or voice analysis and derive patient medication treatment status and/or markers.
25. 25. A method as claimed in any of Claims 21 to 24 which is suitable for realising in a distributed computing environment, comprising said medication and monitoring device together with a medication and monitoring database and optionally one or more personnel interfaces, optionally by means of remote log in facility and/or links to one or more remote databases.