WO2015015462A1 - Telematic system for the collection and processing of data and results of self-diagnostic tests in a population of users, corresponding method, and service peripheral electronic device and self-diagnostic kit for use in such a telematic system - Google Patents

Telematic system for the collection and processing of data and results of self-diagnostic tests in a population of users, corresponding method, and service peripheral electronic device and self-diagnostic kit for use in such a telematic system Download PDF

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Publication number
WO2015015462A1
WO2015015462A1 PCT/IB2014/063613 IB2014063613W WO2015015462A1 WO 2015015462 A1 WO2015015462 A1 WO 2015015462A1 IB 2014063613 W IB2014063613 W IB 2014063613W WO 2015015462 A1 WO2015015462 A1 WO 2015015462A1
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WIPO (PCT)
Prior art keywords
self
data
diagnostic
diagnostic test
yes
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PCT/IB2014/063613
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French (fr)
Inventor
Emilia NUNZI
Nicoletta Catteruccia
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Dml-Ablogics Limited
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Publication of WO2015015462A1 publication Critical patent/WO2015015462A1/en

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the present invention relates in general to the sector of telematic systems which use a communication network to monitor and keep under control the state of health and the medical data of a population of users distributed in a certain territory and to diagnose the states of health thereof, and relates more closely to a telematic system, therefore always based on the use of a communication network, for the collection and the analysis and processing of the data and of the results of self-diagnostic tests or assays of the YES/NO type, i.e.
  • diagnostic tests suitable for providing, for the purpose of determining the diagnosis, not a quantitative result but simply either a positive or a negative result, wherein these self- diagnostic tests are performed, and the respective results are read and transmitted to a central unit by the users of a population in a totally autonomous manner without need for the intervention and/or the interpretation and/or the assistance of medical or specialist personnel.
  • the present invention also relates to a special service electronic apparatus or equipment which can be used by the user autonomously, as part of a telematic system, in order to collect the data and the results, to be sent to a central unit of data analysis and control, of self-diagnostic tests or assays of the YES/NO type which are performed by a population of users living in a certain territory in an autonomous manner, i.e. without the intervention of medical or specialist personnel.
  • the present invention also relates to a special kit, formed by a self-diagnostic test of the YES/NO type and by a respective service electronic apparatus or equipment which is provided in order to be used by the single users of a population, as part and in the context of a telematic system, both in order to perform the YES/NO self-diagnostic test autonomously and without the support of medical personnel and in order to send the data and the results of the self- diagnostic test, once performed, to a central unit of data control and analysis.
  • these telematic systems are provided for collecting and handling information and data of the quantitative type, for example obtained by subjecting the users to medical analyses justly of the quantitative type, with results generally consisting of very precise numeric values, such as for example blood tests or others, under the direct control of medical personnel.
  • the data and the results which are obtained with these remote analyses performed on the patients and then sent telematically to the central unit are essentially of the quantitative and numeric type, so as to imply a somewhat rather complex management for recording, analysing and comparing, one with the other, these quantitative data which flow from the peripheral units to the central unit, with the effect also of delaying the responses and the actions to be taken in the case of anomalous health situations.
  • the already known remote medicine systems usually provide for communication of the two-way type in relation to the patient, particularly burdensome and complex to manage by the central unit, wherein this two-way communication involves, among the other things, also preliminary phases of identification and authentication of the patient.
  • the current remote medicine systems are in general aimed at and limited to supporting and managing the diagnosis of the individual patients but do not provide for the integration of the data and of the results obtained with the tests and the analyses with further time and space data relating to the place and to the time wherein the analyses and the tests were performed, in order in particular to determine the dynamic of a disease at population level.
  • both the locations in which the medical analyses are performed physically on the patient and those to which the data and the results of the analyses are subsequently transmitted appear to be constituted by typical medical structures, such as hospitals, consulting rooms or similar structures, that is by a healthcare facility in which therefore medical personnel work and provide assistance.
  • a first object of the present invention is that of proposing and producing a telematic system for the transmission, the collection and the processing of the data and of the results of self-diagnostic tests in a population of users, which innovates and brings tangible advantages with respect to remote medicine systems or in general telematic systems currently known and applied, and in particular is simple, practical to use and does not involve the support of medical staff or specialist personnel, but an active role by the same user, in order to obtain and collect the data and the results to be sent telematically to a central unit where the data are to be analysed and processed together with the respective time-space coordinates, so as to meet in a timely and localised manner the needs of the users and therefore obtain their immediate favour and which at the same time is suitable for both supplying very useful and precise data for monitoring the state of health of the population of users, such as for example information in real time relating to the time-space location of an epidemiological situation.
  • a further object of the present invention is that of proposing and producing a new and innovative telematic system which allows the communication and the collection of the results of self-diagnostic tests performed from home, i.e. tests for the diagnosis of illnesses or even only for the monitoring of special physical conditions such as pregnancy or a particularly state of fatigue, suitable for being performed in their own home autonomously and without the support of medical personnel by the users of this population, so as to achieve a considerable saving in running costs, both direct and indirect, with respect to conventional remote medicine and telematic systems which involve the use of medical personnel for assisting users when they perform the analyses.
  • the present invention also relates to a special service electronic apparatus which has the function, as part of a telematic system, of collecting the data and the results, to be sent to a central control unit, of self- diagnostic tests or assays of the YES/NO type, i.e. suitable for giving solely either a positive or negative result, which are performed by the individual users of a population of a certain territory in an autonomous manner, in which therefore the data and the results of these tests are read and transmitted to the central unit without any intervention and without the need for interpretation by medical or specialist personnel.
  • the present invention also relates to a special package or kit, formed by a self-diagnostic test of the YES/NO type in association with a respective service electronic apparatus, wherein this kit is provided in order to be used by the individual users of a population, as part of a telematic system, in order to perform the self-diagnostic test autonomously and without the support of medical personnel and in order to send the data and the results, obtained in this way, by perfomiing the self-diagnostic test, to a central unit of data control and analysis.
  • the advantages of the telematic system of the invention are many and important, such as those briefly listed here below purely by way of an example, in particular based on the analysis of the useful information and data which this telematic system allows to be obtained simply and in real time on the state of health of a population which lives in a certain territory: - the possibility of promptly reporting the onset and the spread of particular states of health in the population concerned by the telematic system, so as to be able to intervene promptly to circumscribe them and limit the damage thereof;
  • FIG. 1 is a general diagram which shows a telematic system in accordance with the present invention for the collection and the analysis of the data and the results of self-diagnostic tests performed by the individual users of a population;
  • Fig. 2 is a flow diagram which illustrates schematically the various steps of the mode of operation of the telematic system of Fig. 1;
  • Fig. 3 is a diagram of a service electronic apparatus or equipment which can be used by a respective user, as part of the telematic system of Fig. 1, in order to collect the data and the results of the self-diagnostic tests and send them, via a communication network, to a central unit of collection and analysis of data, wherein the self-diagnostic test and the service electronic apparatus are configured as two distinct and separable parts, so as to be suitable to be sold and distributed separately in the population of users;
  • Fig. 4 is a diagram which shows a variant, with respect to the telematic system of the invention of Figs. 1 and 3, in which the service electronic apparatus and the self-diagnostic test are integrated one with the other so as to form a single self-diagnostic kit or package; and
  • Fig. 5 is a diagram which shows a further variant, simplified, of the telematic system of Fig. 1, in which the identification data and the result of the self-diagnostic test, performed by the individual user, are not collected and sent to a central unit via a dedicated service electronic apparatus but by simply using the usual means of communication, available to the same individual user and defined by instructions attached to the self-diagnostic test, such as typically the landline or mobile telephone network or others.
  • a telematic system for the collection, the analysis and the processing of the data and the results of a plurality of self-diagnostic tests S-l, S-2, S-3,....S-n, defined by a first self-diagnostic test S-l and an umpteenth self-diagnostic test S-n, in a population P constituted by a plurality of users U-l, U-2, U-3,.., U-n, in turn defined by a first user U-l and an umpteenth user U-n, is denoted overall by 10.
  • Fig. 1 shows schematically the fundamental parts whereof the telematic system 10 of the invention is composed
  • Fig. 2 is a flow diagram which illustrates, again schematically, the various steps into which the mode of operation of this telematic system 10 is structured.
  • the self-diagnostic tests S-l, S-2, S-3,..., S-n, used as part of the telematic system 10 of the invention, are sold for example in pharmacies or other retail outlets in order to be distributed and available to the population P of users U-l, U-2, U-3, , U-n.
  • these self- diagnostic tests S-l, S-2, S-3,..., S-n are provided to be performed on the basis of appropriate instructions contained in a leaflet I, schematised in Fig. 1, attached to each self-diagnostic test, autonomously, that is without the intervention and/or assistance of medical personnel, by the individual users of this population P.
  • these self-diagnostic tests S-l, S-2, S-3,..., S-n are specifically of the YES/NO type, that is suitable for supplying solely a positive, i.e. YES, or negative, i.e. NO, result.
  • each self-diagnostic test S-l, S-2, S-3,..., S-n comprises a respective label E which has the identification data D l of the same self-diagnostic test, that is the data indicating for example the type of analysis and diagnosis which can be performed, the date of expiry of the test and still other data, and a zone Z suitable for showing the result, that is either YES or NO, of the self-diagnostic test S-l, S-2, S-3, ... S-n, when it is performed by the respective user U-l, U-2, U-3, U-n.
  • these self-diagnostic tests or clinical and immunological tests S-l, S-2, S-3,..., S-n can be of various types and categories and in particular comprise the tests for influenza, tumoural and cardiac markers, the tests for hepatitis in all its variants, the tests for infectious diseases, pregnancy tests, the tests for metabolites of clinical-diagnostic interest.
  • the methods of ascertaining the positive result of the self-diagnostic test or test S-l, S-2, .., S-n can be, for example, the change in colour of the respective zone Z of the self-diagnostic test, but it is clear in any case that other methods are possible, still falling within the sphere of the present invention.
  • the telematic system 10 comprises further:
  • one or more service peripheral electronic apparatuses or devices denoted by 11-1, 1 1-2, 11-3,..., 1 1-n, which are associated with the self-diagnostic tests S-l, S-2, S-3,..., S-n and are available to the population P of users U-l, U-2, U-3,.. .., U-n wherein these one or more service peripheral electronic apparatuses 1 1-1, 11-2, 11-3,..., 11 -n are provided for serving to collect the data and the results of the self-diagnostic tests (S-l, S-2, S-3,..., S-n) which are performed by the users in the telematic system 10;
  • a central unit 20 for collecting and analysing data suitable for receiving, via the communication network (30), the data and the information coming from the service electronic apparatuses 11-1, 1 1-2 , 11-3, 1 1-n which are part of the telematic system 10.
  • a detection unit 12 for reading and detecting the identification data Dl and the data of the YES or NO result of the self-diagnostic test S-l when it is performed by the respective user U-l ;
  • locator or localizer 14 designed to locate, in the territory covered by the telematic system 10 for the collection and the analysis of the data and of the results of self-diagnostic tests, the exact position of the specific user U-l who has performed the self-diagnostic test S-l, S-2, S-n, and
  • a data packaging or packetizing unit 15 which is designed to receive from the detection unit 12 the data D2 relating to the identification data Dl and the YES/NO result of the self-diagnostic test S-l, and from the locator 14 the information D3 on the location of this specific user U-l, and then to form from the data and information received a data packet PD, to be transmitted, via the communication network 30, to the central unit 20 for collecting and analysing data.
  • the data packaging or packetizing unit 15 of each peripheral electronic apparatus 11-1, 1 1-2,.., 1 1-n included in the telematic system 10 is provided, preferably but not exclusively, with a function of encryption and authentication, schematised with a block 15a in Fig. 3, which allows the peripheral electronic apparatus to encrypt and authenticate the data received from the detection unit 12, i.e. the identification data Dl and the YES/NO result of the self-diagnostic test performed, in order to form a data packet PD, encrypted, to be transmitted via the communication network 30 to the central unit 20 for collecting and analysing data.
  • the locator 14 is for example constituted by a satellite locator of the GPS (global positioning system) type or the like, as shown schematically in the drawings, associated with a respective satellite network composed of a plurality of satellites SAT-1, SAT-2, ....SAT-n, as is well known to the persons skilled in the art and schematised in Fig. 1.
  • GPS global positioning system
  • the locator 14 of the position of the user can also be constituted, according to a variant not shown in the drawings, by a locator which uses a usual telephone network and in particular exploits, in order to determine the position of the user, the techniques of locating by triangulation of a mobile network of cellular phones.
  • the communication network 30, placed between the various service electronic apparatuses 1 1-1, 11-2, 11-3,..., 1 1-n and the central unit 20, has substantially known features, and for example can be constituted by the usual landline or mobile telephone network, whether public or private, or by a data network, with these networks suitable for operating according to the communication protocols and the usual standards currently adopted in the communication networks.
  • the information and the data generated by the various service electronic apparatuses 1 1-1, 1 1-2, 1 1-3,..., 1 1-n can also interface and be transmitted via the well-known systems of communication commonly called in English terminology “social networks” such as Twitter and Facebook.
  • the central unit 20 for data collection and analysis is in turn suitable for receiving and authenticating, via a respective authentication unit 20b, the packetized data PD transmitted by the communication network 30, and for analysing them by taking into account the data contained in a database 20a associated with the same central unit 20 and containing data and information related to the self-diagnostic tests S-l, S-2, S-3, S-n distributed in and used by the population P of users U-l, U-2, U-3, U-n.
  • the central unit 20 is able to check whether these data received are truthful, i.e. that they refer to self-diagnostic tests effectively sold and performed as part of the telematic system 10.
  • the essential function of authentication of the data received which is performed by the central unit 20 for collection of data and optionally also by the various peripheral electronic units 1 1-1,11-2, 11-n, can be usefully associated with the use of private keys, for example at the level of peripheral units which detect the data of the self-diagnostic tests performed by the users distributed in the territory, and of a public key at the level of the central unit 20, which receives the data from the various peripheral units, according to techniques which are well known and therefore are not worth further in-depth consideration.
  • the functioning of the telematic system 10 of the invention corresponds to the flow diagram 50 of Fig. 2 and presupposes beforehand a step, denoted by 51 in Fig. 2, wherein the self-diagnostic tests S-l, S-2, S-3,.., S-n are in some way sold, distributed and made available to the users U-l, U-2, U-3, .., U-n of the population P, and a further step 52 wherein the service electronic apparatuses 11-1,1 1-2, 1 1- 3,.., 11-n, associated with the self-diagnostic tests S-l, S-2, S-3,.., S-n, are also supplied and made available to the users U-l, U-2, U-3, .., U-n.
  • the self-diagnostic tests S-l, S-2, S-3,.., S-n sold and distributed as part of the telematic system 10 can be of different types and that therefore a same user U-l, U-2, U-3, .., U-n of the population P can purchase and perform, without the need for the assistance of a doctor or specialist personnel, different types of self-diagnostic tests in order to perform on him or herself different kinds of analysis.
  • a certain user U-l of the population P performs a certain self-diagnostic test S-1 during a step denoted by 53 in Fig. 2, autonomously and without the assistance of medical personnel.
  • the user U-l activates, during a step 54, in particular by means of the pushbutton 13, the service electronic apparatus 1 1-1 which immediately responds by detecting in a totally automatic manner, during a step 56, the identification data which appear on the label E and the either YES or NO result which appears on the zone Z of the self-diagnostic test S-1 which was performed by the user U-l .
  • step 56 the locator 14 included in the service electronic apparatus 11-1 locates, during a step 57, the exact position of the user U-l who has performed the self-diagnostic test S- 1.
  • the packaging unit 15 included in the service electronic apparatus 11-1 performs the packaging and optionally also the encrypting and the authentication of the data relating to the identification data and the either YES or .NO result of the self-diagnostic test S-1 perforaied, and the position of the specific user U-l who has performed this self-diagnostic test so as to form a data package PD.
  • These packaged data PD are then transmitted, during a step 59, via the communication network 30, as indicated by arrows f2 in Fig. 2, by the various service electronic apparatuses associated with the self-diagnostic tests performed by the users of the population P to the central unit 20, where the data received are decrypted, authenticated and analysed in a step 61.
  • the authentication by the central unit 20, of the data received from the various peripheral electronic apparatuses 1 1-1, 11-2, 11-n, has the purpose of ascertaining, using the data and the information contained in the database 20a, whether these data received are not in some way faked, i.e. they refer correctly to the self-diagnostic tests sold and distributed in the population P.
  • the central unit 20 on the basis of the analysis of the data and of the results of the self-diagnostic tests which were performed within the population P and taking account of the effective location of the users who have performed these self-diagnostic tests, produces useful information for the management under the health and medical aspect of the population P included and kept under control with the telematic system 10 of the invention.
  • the telematic system 10, according to the invention achieves in full the objects set to be achieved, and in particular allows the monitoring and the effective keeping under control in real time of the state of health of a population of users in a certain territory, in a manner which is presented as being very convenient and practical for the same users of this population, so as to meet with their immediate favour, and which among other things does not oblige them to travel to specialist medical centres and resort to the assistance of medical personnel.
  • the telematic system 10 of the invention is able to supply data and information, constantly updated, which can be very useful in order to establish correctly and promptly the interventions and the medical policies to be followed in relation to the population.
  • the telematic system in the use for the transmission of the outcome of the test to the central unit for collecting and processing data works in exclusively one-way and not two-way mode, like for example the remote diagnosis system described in the document WO2012/154488 Al, cited previously;
  • this only one-way and not two-way communication allows avoiding of the steps of identification and authentication of the user, as instead often occurs in known remote medicine systems;
  • test is performed by the user in a private place, for example in his or her own home, and not in a dedicated structure such as a hospital structure;
  • the important data collected by the system comprise, as well as the result of the test, also those relating to the location in space and time of the place wherein the test has been performed, so as to allow monitoring to be performed in real time of the development of a medical event, such as the trend of an epidemic;
  • the result of the diagnostic test is read and communicated to the telematic system directly by the user and not by medical staff;
  • the user uses directly and autonomously the biological sample for performing the test on him or herself, while in known remote medicine systems, such as that described by WO2012/154488 Al, the user supplies the remote medicine system with the biological sample;
  • the service peripheral electronic apparatuses supplied to the users as part of the remote medicine system of the invention, are used solely and exclusively for interfacing with the transmission network in order to transmit the data and the results of the self-diagnostic tests to the central unit for collection and processing of these data and results, where the known systems, such as that described by WO2012/154488 A, do not provide corresponding or similar electronic apparatuses to those described above, included in the system of the invention, but electronic apparatuses which perform as a whole very different functions, such as the local storage of the result of the test for a use by the medical centre;
  • every self-diagnostic test performed by a user is associated with one and only one disease or pathogen;
  • the instructions leaflet, associated with each self- diagnostic test and an integral part thereof, can contain, in addition to the instructions for proceeding with the performance and the reading of the test, also those relating to the procedures for transmitting the data and the result of the test to the central unit of data collection;
  • the self-diagnostic test is provided in order to be distributed and sold freely on the market, that is without the restraint of a medical prescription.
  • the self-diagnostic tests consisting in the performing of a test by means of a simple kit following the instructions enclosed with the same kit, are performed in their completeness by the users of the telematic system of the invention in a context which is not that of a hospital or of a healthcare facility and which is moreover very different from a structure or laboratory set up for the diagnostic processing of the result of the test.
  • tests and respective kits are configured in order to give simple and univocal results of the YES/NO type, so as not to require the support of medical personnel also for the purpose of their interpretation.
  • Fig. 4 refers to a first variant, denoted by 110, of the telematic system of the invention, in which the self-diagnostic tests S-l, S-2, S-3,.., S-n and the respective service electronic apparatuses 11-1, 1 1-2, 1 1-3,.., 1 1-n instead of being configured as distinct and separate parts, as in the telematic system 10, therefore provided to be sold and distributed separately in the population of users U-l, U-2, U-3,.., U-n, are integrated and sold together in the form of a single package or kit denoted by K.
  • the self-diagnostic tests S-l, S-2, S-3,.., S-n and the respective service electronic apparatuses 11-1, 1 1-2, 1 1-3,.., 1 1-n instead of being configured as distinct and separate parts, as in the telematic system 10, therefore provided to be sold and distributed separately in the population of users U-l, U-2, U-3,.., U-n, are integrated and sold together in the form of
  • FIG. 4 shows only one of these kits K, wherein the respective parts are denoted by the same reference numerals as the embodiment 10 of the telematic system of the invention.
  • each self-diagnostic test S-l, S-2, S-3,.., S-n is integrated in the structure and in the support 1 1 ' of the respective service electronic apparatus 11-1, 1 1-2, 1 1-3,.., 1 1-n.
  • the user no longer has to enter the self-diagnostic test, after having performed it, in the corresponding service electronic apparatus, but simply has to activate the kit K, for example by pressing a pushbutton 13, in order to perform the analysis with the self-diagnostic test integrated in the kit K, detect the identification data and the YES or NO result of the self-diagnostic test and finally transmit, via the communication network 30, the identification data and the result detected to the central unit 20 in a completely automatic way.
  • Fig. 5 shows schematically a further second variant, denoted in general by 210, in which the parts corresponding to those of the embodiment 10 are again denoted by the same reference numerals.
  • the telematic system 210 of the invention is configured so that the various users U-l, U-2, U-3,.., U-n of the system 110, in order to send to the central unit 20 for data collection and analysis the identification data Dl and the either YES or NO results of the self-diagnostic tests S-l, S-2, S-3,.., S-n performed by the same users, use, instead of the dedicated service electronic apparatuses, associated with the self-diagnostic tests, as in the telematic system 10, the usual devices and means of communication, already available to them, such as cellular phones, landline or mobile telephone network, following in particular the instructions enclosed with each self-diagnostic test or assay S-l, S-2, S-3, ...S-n.
  • the user transmits directly by means of his or her cellular phone or by means of the mobile or landline telephone network, or also via the internet or other similar means of communication, the data and the results detected to the central unit for collection 20, where they will be analysed.
  • a block 40 schematises the interface by means of which the individual user, for example the user U-1, after having detected the data Dl and the YES or NO result of the self-diagnostic test performed by himself or herself without the support of medical personnel and following the instructions indicated in the leaflet enclosed with the self-diagnostic test, transmits via the internet, cellular phones, mobile or landline telephone network or other similar means of communication available thereto, the data and the result detected to the central collection unit 20.
  • This variant 110 of the telematic system of the invention has the advantage of a considerably simplified configuration which does not require, unlike the telematic system 10, the use of several electronic apparatuses, dedicated, associated with the self-diagnostic tests, but is supported by, with a considerable saving in costs, the usual communication means such as the internet, landline phones, cellular phones, i.e. the mobile or landline telephone network, available to the users U-1, U-2, U-3,...U-n, to transmit to the central unit 20 the data and the result of the self-diagnostic test which the user has detected on the self-diagnostic test performed by himself or herself, in a totally automatic manner and without the support and the assistance of medical personnel.
  • the usual communication means such as the internet, landline phones, cellular phones, i.e. the mobile or landline telephone network

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Abstract

A new telematic system (10) for the collection, the analysis and the processing of the data and of the results of self-diagnostic tests in a population (P) of users, comprising: a plurality of self-diagnostic tests or assays (S-1, S-2, S-3,..., S-n) provided in order to be performed in a totally autonomous manner by the individual users (U-1, U-2, U-3,...., U-n) of this population (P), therefore without the need for interpretation by medical or specialist personnel, and one or more service peripheral electronic apparatuses (ll-1, ll-2, ll-3,..ll-n) associated with the self-diagnostic tests and supplied to the users of the population, wherein the self-diagnostic tests (S-1, S-2, S-3,..., S-n) are of the YES/NO type, that is suitable for providing an exclusively either positive or negative (YES/NO) result; and wherein each (ll-1) of the service electronic apparatuses in turn comprises a packetizing unit (15) suitable for receiving, from a detection unit (12), the data (D2) concerning the identification data (D1) and the result (YES/NO) of the self- diagnostic test (S-1), performed by the respective user (U-1), and, from a locator or localizer (14), the information (D3) concerning the location of the specific user (U- 1) who performed the self-diagnostic test(S-1), and then a data package (PD), to be transmitted via a communication network (30) to a central unit (20) for collection and processing of data, so that the results of these self-diagnostic tests are read and transmitted autonomously by the individual users, and wherein the central unit (20) in turn is suitable for authenticating the data (PD) transmitted by the communication network (30) and for processing them, taking account of the data contained in a database (20a) associated with the same central unit (20). The self- diagnostic tests can be sold and distributed, in the population of users, separately from the service electronic apparatuses, or can be packaged and supplied together with these service electronic apparatuses in a single kit.

Description

TELEMATIC SYSTEM FOR THE COLLECTION AND PROCESSING OF DATA AND RESULTS OF SELF-DIAGNOSTIC TESTS IN A POPULATION OF USERS, CORRESPONDING METHOD, AND SERVICE PERIPHERAL ELECTRONIC DEVICE AND SELF-DIAGNOSTIC KIT FOR USE IN SUCH A TELEMATIC SYSTEM
Field of the invention
The present invention relates in general to the sector of telematic systems which use a communication network to monitor and keep under control the state of health and the medical data of a population of users distributed in a certain territory and to diagnose the states of health thereof, and relates more closely to a telematic system, therefore always based on the use of a communication network, for the collection and the analysis and processing of the data and of the results of self-diagnostic tests or assays of the YES/NO type, i.e. of diagnostic tests suitable for providing, for the purpose of determining the diagnosis, not a quantitative result but simply either a positive or a negative result, wherein these self- diagnostic tests are performed, and the respective results are read and transmitted to a central unit by the users of a population in a totally autonomous manner without need for the intervention and/or the interpretation and/or the assistance of medical or specialist personnel.
The present invention also relates to a special service electronic apparatus or equipment which can be used by the user autonomously, as part of a telematic system, in order to collect the data and the results, to be sent to a central unit of data analysis and control, of self-diagnostic tests or assays of the YES/NO type which are performed by a population of users living in a certain territory in an autonomous manner, i.e. without the intervention of medical or specialist personnel.
Moreover the present invention also relates to a special kit, formed by a self-diagnostic test of the YES/NO type and by a respective service electronic apparatus or equipment which is provided in order to be used by the single users of a population, as part and in the context of a telematic system, both in order to perform the YES/NO self-diagnostic test autonomously and without the support of medical personnel and in order to send the data and the results of the self- diagnostic test, once performed, to a central unit of data control and analysis.
Prior art
Various remote medicine and in general telematic systems are known which are suitable for the collection and for the handling, with the support of a communication network, of the information and the data relating to medical analyses performed on a population of users and/or patients within a certain territory.
Usually these telematic systems are provided for collecting and handling information and data of the quantitative type, for example obtained by subjecting the users to medical analyses justly of the quantitative type, with results generally consisting of very precise numeric values, such as for example blood tests or others, under the direct control of medical personnel.
These quantitative data, which can be obtained by performing the analyses at specialist centres such as medical laboratories, local health units or others, are then sent, via a transmission and communication network, to a central unit, which can be for example a central hospital whereto a certain territory refers, where the data received are appropriately analysed by specialist medical personnel, who if needed will activate the necessary or appropriate measures should the data analysed show anomalous health situations.
These known remote medicine systems, although widespread to a certain extent, are not however free from limits and disadvantages, so as to require further improvement.
For example, as a first observation, it is noted that these known remote medicine systems involve usually high running costs, in part also due to the use of specialist medical personnel in order to perforin remote analyses on patients and therefore obtain the data and the information to be sent via the communication network to the central unit.
Moreover, as mentioned previously, the data and the results which are obtained with these remote analyses performed on the patients and then sent telematically to the central unit are essentially of the quantitative and numeric type, so as to imply a somewhat rather complex management for recording, analysing and comparing, one with the other, these quantitative data which flow from the peripheral units to the central unit, with the effect also of delaying the responses and the actions to be taken in the case of anomalous health situations.
In particular, in this respect, it should be noted that these known systems do not provide for the possibility of entering and recording the results of simple self- diagnostic tests and assays of the YES/NO type, read and supplied directly by the population of users.
Again as part of these known remote medicine systems the users or the patients usually have to travel, with obvious inconvenience of the same, to special specialist centres in order to carry out the medical analyses, the data and results whereof will be sent to the central unit.
Moreover, as further limitation, the already known remote medicine systems usually provide for communication of the two-way type in relation to the patient, particularly burdensome and complex to manage by the central unit, wherein this two-way communication involves, among the other things, also preliminary phases of identification and authentication of the patient.
Finally it is underlined that the current remote medicine systems are in general aimed at and limited to supporting and managing the diagnosis of the individual patients but do not provide for the integration of the data and of the results obtained with the tests and the analyses with further time and space data relating to the place and to the time wherein the analyses and the tests were performed, in order in particular to determine the dynamic of a disease at population level.
Among known remote medicine systems mention is made for example of those described by the following published patent documents: US 2011/0208534 Al, US 4,838,275, US 4,974,607, US 5,421,343, US 5,462,051, US 6,595,918 B2, US 5,785,650, US 5,553,609, US 2013/109927 A, US 2003/0052787 Al, US 2007/073520 Al, WO 2005/101279 A2.
Moreover mention is made in particular of the patent WO 2012/15488 Al which describes a plurality of embodiments of a system of management and evaluation of medical analyses via a data collection centre, wherein the data and the results of the medical analyses are managed and appropriately queued in order to be transmitted via a communication network to the data collection centre.
In any case also in this remote medicine system known from WO 2012/15488 Al the result of the diagnostic analysis or of the test is read, managed and communicated to the telematic system by medical, in particular hospital, staff.
Therefore, in the context of the telematic system described by WO 2012/15488 Al, both the locations in which the medical analyses are performed physically on the patient and those to which the data and the results of the analyses are subsequently transmitted appear to be constituted by typical medical structures, such as hospitals, consulting rooms or similar structures, that is by a healthcare facility in which therefore medical personnel work and provide assistance.
In brief, from the picture outlined above, the need clearly emerges for improvement of the current remote medicine systems, and also the need to integrate self-diagnostic tests of the YES/NO type in a telematic system which allows the transmission, storage and processing in an efficient manner of the data and results of these tests, performed and interpreted autonomously by the users.
The need also emerges to associate the self-diagnostic tests, currently in use, with systems which allow processing of the respective data and results by linking and integrating them with further data relating to the place and to the time in which the tests are performed, in particular in order to control the trend of a pathological condition at population level.
Summary of the invention
Therefore a first object of the present invention is that of proposing and producing a telematic system for the transmission, the collection and the processing of the data and of the results of self-diagnostic tests in a population of users, which innovates and brings tangible advantages with respect to remote medicine systems or in general telematic systems currently known and applied, and in particular is simple, practical to use and does not involve the support of medical staff or specialist personnel, but an active role by the same user, in order to obtain and collect the data and the results to be sent telematically to a central unit where the data are to be analysed and processed together with the respective time-space coordinates, so as to meet in a timely and localised manner the needs of the users and therefore obtain their immediate favour and which at the same time is suitable for both supplying very useful and precise data for monitoring the state of health of the population of users, such as for example information in real time relating to the time-space location of an epidemiological situation.
A further object of the present invention is that of proposing and producing a new and innovative telematic system which allows the communication and the collection of the results of self-diagnostic tests performed from home, i.e. tests for the diagnosis of illnesses or even only for the monitoring of special physical conditions such as pregnancy or a particularly state of fatigue, suitable for being performed in their own home autonomously and without the support of medical personnel by the users of this population, so as to achieve a considerable saving in running costs, both direct and indirect, with respect to conventional remote medicine and telematic systems which involve the use of medical personnel for assisting users when they perform the analyses.
The above objects can be considered to be fully achieved by the new telematic system having the features disclosed by the main independent claim 1.
Particular embodiments of the new telematic system of the invention are moreover defined by the dependent claims.
According to another aspect, the present invention also relates to a special service electronic apparatus which has the function, as part of a telematic system, of collecting the data and the results, to be sent to a central control unit, of self- diagnostic tests or assays of the YES/NO type, i.e. suitable for giving solely either a positive or negative result, which are performed by the individual users of a population of a certain territory in an autonomous manner, in which therefore the data and the results of these tests are read and transmitted to the central unit without any intervention and without the need for interpretation by medical or specialist personnel.
Moreover, according to a further aspect, the present invention also relates to a special package or kit, formed by a self-diagnostic test of the YES/NO type in association with a respective service electronic apparatus, wherein this kit is provided in order to be used by the individual users of a population, as part of a telematic system, in order to perform the self-diagnostic test autonomously and without the support of medical personnel and in order to send the data and the results, obtained in this way, by perfomiing the self-diagnostic test, to a central unit of data control and analysis.
Advantages of the invention
The advantages of the telematic system of the invention are many and important, such as those briefly listed here below purely by way of an example, in particular based on the analysis of the useful information and data which this telematic system allows to be obtained simply and in real time on the state of health of a population which lives in a certain territory: - the possibility of promptly reporting the onset and the spread of particular states of health in the population concerned by the telematic system, so as to be able to intervene promptly to circumscribe them and limit the damage thereof;
- the ability to perform an effective action of prevention in relation to the state of health of a population;
- the ability to provide useful indications on the social impact of a certain illness;
- the possibility of checking with precision the features and the forms of the spread, in the population, of the contagion of a certain disease, so as to be able to define and implement the appropriate and localised countermeasures;
- the ability to provide useful information aimed at guiding the production of certain drugs and vaccines;
- the fact of constituting a useful information base for planning and taking decisions in the public-health sphere, taking account of both qualitative and quantitative indicators;
- the ability to collect systematically the results of self-diagnostic tests performed privately at home by a population, in order to be able to perform the appropriate processing operations and therefore take the most appropriate decisions for improving the well-being and the conditions of health of the same population;
- a considerable reduction in costs both direct, such as those relating to medical personnel, and indirect, such as those due to absences from work and lack of productivity by users, which society has to bear in order to keep under control the medical conditions and the state of health of a population of users.
Brief description of the drawings
These and other objects, features and advantages of the present invention will be made clearer and more evident by the following description of one of its preferred embodiments, with reference to the accompanying drawings, in which: Fig. 1 is a general diagram which shows a telematic system in accordance with the present invention for the collection and the analysis of the data and the results of self-diagnostic tests performed by the individual users of a population;
Fig. 2 is a flow diagram which illustrates schematically the various steps of the mode of operation of the telematic system of Fig. 1;
Fig. 3 is a diagram of a service electronic apparatus or equipment which can be used by a respective user, as part of the telematic system of Fig. 1, in order to collect the data and the results of the self-diagnostic tests and send them, via a communication network, to a central unit of collection and analysis of data, wherein the self-diagnostic test and the service electronic apparatus are configured as two distinct and separable parts, so as to be suitable to be sold and distributed separately in the population of users;
Fig. 4 is a diagram which shows a variant, with respect to the telematic system of the invention of Figs. 1 and 3, in which the service electronic apparatus and the self-diagnostic test are integrated one with the other so as to form a single self-diagnostic kit or package; and
Fig. 5 is a diagram which shows a further variant, simplified, of the telematic system of Fig. 1, in which the identification data and the result of the self-diagnostic test, performed by the individual user, are not collected and sent to a central unit via a dedicated service electronic apparatus but by simply using the usual means of communication, available to the same individual user and defined by instructions attached to the self-diagnostic test, such as typically the landline or mobile telephone network or others.
Description of a first preferred embodiment of the telematic system of the invention
Referring to the drawings, a telematic system, in accordance with the present invention, for the collection, the analysis and the processing of the data and the results of a plurality of self-diagnostic tests S-l, S-2, S-3,....S-n, defined by a first self-diagnostic test S-l and an umpteenth self-diagnostic test S-n, in a population P constituted by a plurality of users U-l, U-2, U-3,.., U-n, in turn defined by a first user U-l and an umpteenth user U-n, is denoted overall by 10.
Fig. 1 shows schematically the fundamental parts whereof the telematic system 10 of the invention is composed, while Fig. 2 is a flow diagram which illustrates, again schematically, the various steps into which the mode of operation of this telematic system 10 is structured.
The self-diagnostic tests S-l, S-2, S-3,..., S-n, used as part of the telematic system 10 of the invention, are sold for example in pharmacies or other retail outlets in order to be distributed and available to the population P of users U-l, U-2, U-3, , U-n.
According to an essential feature of the present invention these self- diagnostic tests S-l, S-2, S-3,..., S-n are provided to be performed on the basis of appropriate instructions contained in a leaflet I, schematised in Fig. 1, attached to each self-diagnostic test, autonomously, that is without the intervention and/or assistance of medical personnel, by the individual users of this population P.
Moreover, again according to an essential feature of the present feature, these self-diagnostic tests S-l, S-2, S-3,..., S-n are specifically of the YES/NO type, that is suitable for supplying solely a positive, i.e. YES, or negative, i.e. NO, result.
In detail, as shown in Fig. 1, each self-diagnostic test S-l, S-2, S-3,..., S-n comprises a respective label E which has the identification data D l of the same self-diagnostic test, that is the data indicating for example the type of analysis and diagnosis which can be performed, the date of expiry of the test and still other data, and a zone Z suitable for showing the result, that is either YES or NO, of the self-diagnostic test S-l, S-2, S-3, ... S-n, when it is performed by the respective user U-l, U-2, U-3, U-n.
For example these self-diagnostic tests or clinical and immunological tests S-l, S-2, S-3,..., S-n can be of various types and categories and in particular comprise the tests for influenza, tumoural and cardiac markers, the tests for hepatitis in all its variants, the tests for infectious diseases, pregnancy tests, the tests for metabolites of clinical-diagnostic interest.
The methods of ascertaining the positive result of the self-diagnostic test or test S-l, S-2, .., S-n can be, for example, the change in colour of the respective zone Z of the self-diagnostic test, but it is clear in any case that other methods are possible, still falling within the sphere of the present invention.
Moreover the telematic system 10 comprises further:
- one or more service peripheral electronic apparatuses or devices, denoted by 11-1, 1 1-2, 11-3,..., 1 1-n, which are associated with the self-diagnostic tests S-l, S-2, S-3,..., S-n and are available to the population P of users U-l, U-2, U-3,.. .., U-n wherein these one or more service peripheral electronic apparatuses 1 1-1, 11-2, 11-3,..., 11 -n are provided for serving to collect the data and the results of the self-diagnostic tests (S-l, S-2, S-3,..., S-n) which are performed by the users in the telematic system 10;
- a communication and transmission network denoted in general by 30, for the transmission of data and information coming from the service electronic apparatuses (11-1, 1 1-2 , 1 1-3, 1 1-n) associated with the self-diagnostic tests S-l, S-2, S-n- and
- a central unit 20 for collecting and analysing data suitable for receiving, via the communication network (30), the data and the information coming from the service electronic apparatuses 11-1, 1 1-2 , 11-3, 1 1-n which are part of the telematic system 10.
Each of the service electronic apparatuses 11-1, 1 1-2, 11-3,. .., 11-n, that are associated with the self-diagnostic tests S-l, S-2, S-3, S-n and are available to the population of users U-l, U-2, U-3, U-n, for example the service electronic apparatus S-l, in turn comprises as shown in Figs. 1 and 3: -a support 1 Γ for receiving and housing the self-diagnostic test S-l with which the electronic apparatus 11-1 is associated and for housing the various parts of the same electronic apparatus 1 1-1;
- a detection unit 12 for reading and detecting the identification data Dl and the data of the YES or NO result of the self-diagnostic test S-l when it is performed by the respective user U-l ;
- a locator or localizer 14 designed to locate, in the territory covered by the telematic system 10 for the collection and the analysis of the data and of the results of self-diagnostic tests, the exact position of the specific user U-l who has performed the self-diagnostic test S-l, S-2, S-n, and
- a data packaging or packetizing unit 15 which is designed to receive from the detection unit 12 the data D2 relating to the identification data Dl and the YES/NO result of the self-diagnostic test S-l, and from the locator 14 the information D3 on the location of this specific user U-l, and then to form from the data and information received a data packet PD, to be transmitted, via the communication network 30, to the central unit 20 for collecting and analysing data.
For the sake of clarity, the association existing between a certain service peripheral electronic apparatus, a respective certain self-diagnostic test and the specific user who performs this certain self-diagnostic test and therefore also uses this certain service electronic apparatus is schematised in Fig. 1 with a dotted and dashed line block for each user of the population P.
The data packaging or packetizing unit 15 of each peripheral electronic apparatus 11-1, 1 1-2,.., 1 1-n included in the telematic system 10 is provided, preferably but not exclusively, with a function of encryption and authentication, schematised with a block 15a in Fig. 3, which allows the peripheral electronic apparatus to encrypt and authenticate the data received from the detection unit 12, i.e. the identification data Dl and the YES/NO result of the self-diagnostic test performed, in order to form a data packet PD, encrypted, to be transmitted via the communication network 30 to the central unit 20 for collecting and analysing data.
The locator 14 is for example constituted by a satellite locator of the GPS (global positioning system) type or the like, as shown schematically in the drawings, associated with a respective satellite network composed of a plurality of satellites SAT-1, SAT-2, ....SAT-n, as is well known to the persons skilled in the art and schematised in Fig. 1.
The locator 14 of the position of the user can also be constituted, according to a variant not shown in the drawings, by a locator which uses a usual telephone network and in particular exploits, in order to determine the position of the user, the techniques of locating by triangulation of a mobile network of cellular phones.
The communication network 30, placed between the various service electronic apparatuses 1 1-1, 11-2, 11-3,..., 1 1-n and the central unit 20, has substantially known features, and for example can be constituted by the usual landline or mobile telephone network, whether public or private, or by a data network, with these networks suitable for operating according to the communication protocols and the usual standards currently adopted in the communication networks.
Purely by way of an example mention is made, among these communication standards, of the following: UMTS (universal mobile telecommunications system) and SMS (short message service).
The information and the data generated by the various service electronic apparatuses 1 1-1, 1 1-2, 1 1-3,..., 1 1-n can also interface and be transmitted via the well-known systems of communication commonly called in English terminology "social networks" such as Twitter and Facebook.
The central unit 20 for data collection and analysis is in turn suitable for receiving and authenticating, via a respective authentication unit 20b, the packetized data PD transmitted by the communication network 30, and for analysing them by taking into account the data contained in a database 20a associated with the same central unit 20 and containing data and information related to the self-diagnostic tests S-l, S-2, S-3, S-n distributed in and used by the population P of users U-l, U-2, U-3, U-n.
In this way, i.e. by authenticating in co-operation with the database 20a the data which flow from the various peripheral electronic apparatuses 1 1-1, 11-2, .., 11-n via the transmission network 30, the central unit 20 is able to check whether these data received are truthful, i.e. that they refer to self-diagnostic tests effectively sold and performed as part of the telematic system 10.
The essential function of authentication of the data received, which is performed by the central unit 20 for collection of data and optionally also by the various peripheral electronic units 1 1-1,11-2, 11-n, can be usefully associated with the use of private keys, for example at the level of peripheral units which detect the data of the self-diagnostic tests performed by the users distributed in the territory, and of a public key at the level of the central unit 20, which receives the data from the various peripheral units, according to techniques which are well known and therefore are not worth further in-depth consideration.
Modes of operation of the telematic system of the invention
The functioning of the telematic system 10 of the invention corresponds to the flow diagram 50 of Fig. 2 and presupposes beforehand a step, denoted by 51 in Fig. 2, wherein the self-diagnostic tests S-l, S-2, S-3,.., S-n are in some way sold, distributed and made available to the users U-l, U-2, U-3, .., U-n of the population P, and a further step 52 wherein the service electronic apparatuses 11-1,1 1-2, 1 1- 3,.., 11-n, associated with the self-diagnostic tests S-l, S-2, S-3,.., S-n, are also supplied and made available to the users U-l, U-2, U-3, .., U-n.
It is clear that the self-diagnostic tests S-l, S-2, S-3,.., S-n sold and distributed as part of the telematic system 10 can be of different types and that therefore a same user U-l, U-2, U-3, .., U-n of the population P can purchase and perform, without the need for the assistance of a doctor or specialist personnel, different types of self-diagnostic tests in order to perform on him or herself different kinds of analysis.
In the actual functioning of the telematic system 10 a certain user U-l of the population P performs a certain self-diagnostic test S-1 during a step denoted by 53 in Fig. 2, autonomously and without the assistance of medical personnel.
Then the same user U-l introduces, as indicated by an arrow fl in Fig. 1, the self-diagnostic test S-1, once performed, in the service apparatus 1 1-1 associated with the self-diagnostic test S- 1.
At this point the user U-l activates, during a step 54, in particular by means of the pushbutton 13, the service electronic apparatus 1 1-1 which immediately responds by detecting in a totally automatic manner, during a step 56, the identification data which appear on the label E and the either YES or NO result which appears on the zone Z of the self-diagnostic test S-1 which was performed by the user U-l .
At the same time as step 56 the locator 14 included in the service electronic apparatus 11-1 locates, during a step 57, the exact position of the user U-l who has performed the self-diagnostic test S- 1.
Therefore during a step 58 the packaging unit 15 included in the service electronic apparatus 11-1 performs the packaging and optionally also the encrypting and the authentication of the data relating to the identification data and the either YES or .NO result of the self-diagnostic test S-1 perforaied, and the position of the specific user U-l who has performed this self-diagnostic test so as to form a data package PD.
These packaged data PD are then transmitted, during a step 59, via the communication network 30, as indicated by arrows f2 in Fig. 2, by the various service electronic apparatuses associated with the self-diagnostic tests performed by the users of the population P to the central unit 20, where the data received are decrypted, authenticated and analysed in a step 61. In particular the authentication, by the central unit 20, of the data received from the various peripheral electronic apparatuses 1 1-1, 11-2, 11-n, has the purpose of ascertaining, using the data and the information contained in the database 20a, whether these data received are not in some way faked, i.e. they refer correctly to the self-diagnostic tests sold and distributed in the population P.
Finally in a step 62 the central unit 20, on the basis of the analysis of the data and of the results of the self-diagnostic tests which were performed within the population P and taking account of the effective location of the users who have performed these self-diagnostic tests, produces useful information for the management under the health and medical aspect of the population P included and kept under control with the telematic system 10 of the invention.
It is therefore clear, from the description given, that the telematic system 10, according to the invention, achieves in full the objects set to be achieved, and in particular allows the monitoring and the effective keeping under control in real time of the state of health of a population of users in a certain territory, in a manner which is presented as being very convenient and practical for the same users of this population, so as to meet with their immediate favour, and which among other things does not oblige them to travel to specialist medical centres and resort to the assistance of medical personnel.
Moreover the telematic system 10 of the invention is able to supply data and information, constantly updated, which can be very useful in order to establish correctly and promptly the interventions and the medical policies to be followed in relation to the population.
For the sake of completeness the features and the performances which distinguish the remote medicine system of the invention from those known and currently in use are underlined and reiterated:
- the telematic system, in the use for the transmission of the outcome of the test to the central unit for collecting and processing data works in exclusively one-way and not two-way mode, like for example the remote diagnosis system described in the document WO2012/154488 Al, cited previously;
- in particular this only one-way and not two-way communication allows avoiding of the steps of identification and authentication of the user, as instead often occurs in known remote medicine systems;
- the test is performed by the user in a private place, for example in his or her own home, and not in a dedicated structure such as a hospital structure;
- the important data collected by the system comprise, as well as the result of the test, also those relating to the location in space and time of the place wherein the test has been performed, so as to allow monitoring to be performed in real time of the development of a medical event, such as the trend of an epidemic;
- the result of the diagnostic test is read and communicated to the telematic system directly by the user and not by medical staff;
- the user uses directly and autonomously the biological sample for performing the test on him or herself, while in known remote medicine systems, such as that described by WO2012/154488 Al, the user supplies the remote medicine system with the biological sample;
- the service peripheral electronic apparatuses, supplied to the users as part of the remote medicine system of the invention, are used solely and exclusively for interfacing with the transmission network in order to transmit the data and the results of the self-diagnostic tests to the central unit for collection and processing of these data and results, where the known systems, such as that described by WO2012/154488 A, do not provide corresponding or similar electronic apparatuses to those described above, included in the system of the invention, but electronic apparatuses which perform as a whole very different functions, such as the local storage of the result of the test for a use by the medical centre;
- every self-diagnostic test performed by a user is associated with one and only one disease or pathogen; - advantageously the instructions leaflet, associated with each self- diagnostic test and an integral part thereof, can contain, in addition to the instructions for proceeding with the performance and the reading of the test, also those relating to the procedures for transmitting the data and the result of the test to the central unit of data collection;
- the self-diagnostic test is provided in order to be distributed and sold freely on the market, that is without the restraint of a medical prescription.
In brief the self-diagnostic tests, consisting in the performing of a test by means of a simple kit following the instructions enclosed with the same kit, are performed in their completeness by the users of the telematic system of the invention in a context which is not that of a hospital or of a healthcare facility and which is moreover very different from a structure or laboratory set up for the diagnostic processing of the result of the test.
Moreover the tests and respective kits are configured in order to give simple and univocal results of the YES/NO type, so as not to require the support of medical personnel also for the purpose of their interpretation.
Further aspects and variants of the invention
Naturally, without prejudice to the basic concepts and principle of the present invention, the embodiments and the details of manufacture of the telematic system for the collection and the analysis of the data and of the results of self-diagnostic tests in a population of users and of the respective service electronic apparatus used in this telematic system, may be widely varied and be the subject of further improvements with respect to what has hitherto been described and illustrated, without thereby departing from the sphere of the same invention.
Variant 1
Fig. 4 refers to a first variant, denoted by 110, of the telematic system of the invention, in which the self-diagnostic tests S-l, S-2, S-3,.., S-n and the respective service electronic apparatuses 11-1, 1 1-2, 1 1-3,.., 1 1-n instead of being configured as distinct and separate parts, as in the telematic system 10, therefore provided to be sold and distributed separately in the population of users U-l, U-2, U-3,.., U-n, are integrated and sold together in the form of a single package or kit denoted by K.
For reasons of briefness, Fig. 4 shows only one of these kits K, wherein the respective parts are denoted by the same reference numerals as the embodiment 10 of the telematic system of the invention.
As can be seen from Fig. 4, each self-diagnostic test S-l, S-2, S-3,.., S-n is integrated in the structure and in the support 1 1 ' of the respective service electronic apparatus 11-1, 1 1-2, 1 1-3,.., 1 1-n.
Therefore in this variant 110 the user no longer has to enter the self-diagnostic test, after having performed it, in the corresponding service electronic apparatus, but simply has to activate the kit K, for example by pressing a pushbutton 13, in order to perform the analysis with the self-diagnostic test integrated in the kit K, detect the identification data and the YES or NO result of the self-diagnostic test and finally transmit, via the communication network 30, the identification data and the result detected to the central unit 20 in a completely automatic way.
Variant 2
Fig. 5 shows schematically a further second variant, denoted in general by 210, in which the parts corresponding to those of the embodiment 10 are again denoted by the same reference numerals.
In particular, in this variant, the telematic system 210 of the invention is configured so that the various users U-l, U-2, U-3,.., U-n of the system 110, in order to send to the central unit 20 for data collection and analysis the identification data Dl and the either YES or NO results of the self-diagnostic tests S-l, S-2, S-3,.., S-n performed by the same users, use, instead of the dedicated service electronic apparatuses, associated with the self-diagnostic tests, as in the telematic system 10, the usual devices and means of communication, already available to them, such as cellular phones, landline or mobile telephone network, following in particular the instructions enclosed with each self-diagnostic test or assay S-l, S-2, S-3, ...S-n.
Therefore, in this variant 210, in a certain sense simplified with respect to the embodiments 10 and 110, the individual user him or herself takes, directly from the label E and from the zone Z of the self-diagnostic test which he or she has performed, the respective identification data D 1 and the YES or NO result.
Therefore, following the instructions given on the instructions leaflet I enclosed with each self-diagnostic test, the user transmits directly by means of his or her cellular phone or by means of the mobile or landline telephone network, or also via the internet or other similar means of communication, the data and the results detected to the central unit for collection 20, where they will be analysed.
In particular, in Fig. 5, a block 40 schematises the interface by means of which the individual user, for example the user U-1, after having detected the data Dl and the YES or NO result of the self-diagnostic test performed by himself or herself without the support of medical personnel and following the instructions indicated in the leaflet enclosed with the self-diagnostic test, transmits via the internet, cellular phones, mobile or landline telephone network or other similar means of communication available thereto, the data and the result detected to the central collection unit 20.
This variant 110 of the telematic system of the invention has the advantage of a considerably simplified configuration which does not require, unlike the telematic system 10, the use of several electronic apparatuses, dedicated, associated with the self-diagnostic tests, but is supported by, with a considerable saving in costs, the usual communication means such as the internet, landline phones, cellular phones, i.e. the mobile or landline telephone network, available to the users U-1, U-2, U-3,...U-n, to transmit to the central unit 20 the data and the result of the self-diagnostic test which the user has detected on the self-diagnostic test performed by himself or herself, in a totally automatic manner and without the support and the assistance of medical personnel.

Claims

1 Telematic system (10; 110) for the collection and analysis of data and results of self-diagnostic tests in a population of users, comprising:
- a plurality of self-diagnostic tests or assays (S-l, S-2, S-3, S-n), sold and distributed in said population of users (U-l, U-2, U-3, U-n), to be performed, on the basis of appropriate instructions (I) attached to each self- diagnostic test, autonomously, that is without the intervention and/or assistance of medical personnel, by the individual users of said population;
- one or more service peripheral electronic apparatuses (1 1-1, 1 1-2, 11-3,..., 11-n) associated with said self-diagnostic tests (S-l, S-2, S-3,..., S-n) and available to the users (U-l, U-2, U-3,...., U-n) of said population , said one or more service peripheral electronic apparatuses (1 1-1, 1 1-2, 11-3,..., 11-n) being suitable for serving to collect and transmit the data and results of the self-diagnostic tests (S-l, S-2, S-3,..., S-n) which are performed by the users in said telematic system (10; 110);
- a communication and transmission network (30) for the transmission of data and information coming from said one or more peripheral electronic apparatuses (11-1, 1 1-2, 1 1-3, .., 11-n), and
-a data collecting and analysing central unit (20) suitable for receiving, through said communication network (30), the data and the information coming from said one or more peripheral electronic apparatuses (1 1-1, 1 1-2, 11 - 3, .., 1 1- n);
wherein said self-diagnostic tests (S-l, S-2, S-3, S-n), sold and distributed in said population of users (U-l, U-2, U-3, , U-n), are of the
YES/NO type, that is suitable for giving solely a positive or negative result (YES/NO), and each comprises a label (E) with the identification data (Dl) of the self-diagnostic test and a zone (Z) suitable for showing the positive (YES) or negative (NO) result of the same self-diagnostic test (S-1, S-2, S-3, ...S-(n-l),S-n), when it is performed by the user (U-1, U-2, U-3, U-n);
wherein each (1 1-1) of said peripheral electronic apparatuses (11-1, 11-2, 11-3, 1 1-n), associated with said self-diagnostic tests (S-1, S-2, S -3, S-n) and available to the users (U-1, U-2, U-3, U-n) of said population, in turn comprises:
- a support (1 ) to accommodate the self-diagnostic test (S-1) with which the electronic apparatus (1 1-1) is associated and the various parts of the same electronic apparatus (1 1-1);
- a detection unit (12) for detecting the identification data (Dl) and the data of the result (YES/NO) of the self-diagnostic test (S-1), once performed by the user (U-1);
- a locator designed to locate, in the territory covered by the system (10) for the collection and analysis of the data and of the results of self-diagnostic tests, the position of the specific user (U-1) who has performed the self-diagnostic test (S-1, S-2, S-n), and
- a packaging or packetizing unit (15) designed to receive from said detection unit (12) the data (D2) relating to the identification data (Dl) and the result (YES/NO) of the self-diagnostic test (S-1), and from said locator (14) the information (D3) on the location of said specific user (U-1), and then to form from the data and from the information received a data packet (PD), to be transmitted, via said communication network (30), to said central unit (20) for collecting and analysing data,
wherein said central unit (20) for data collection and analysis is suitable for receiving and authenticating, via a respective authentication unit (20b), the packetized data (PD) coming from said one or more peripheral electronic apparatuses and transmitted by said communication network (30), so as to check that they refer to a self-diagnostic test actually sold and performed, by taking into account the data contained in a database (20a) associated with the same central unit (20) and containing data and information related to the self-diagnostic tests (S-l, S-2, S-3, S-n) distributed in and used by said population of users (U-l, U-2, U- 3, ...., U-n).
2. Telematic system (10; 110) according to claim 1, wherein the packetizing unit (15) included in each peripheral electronic apparatus (1 1-1, 1 1-2, .., 1 1-n) is also suitable for encrypting and authenticating (15a) the data concerning the identification data (Dl) and the result (YES/NO), of the self-diagnostic test (S-l) performed, to be transmitted through said communication network (30) to said central unit (20) for collection and analysis of data.
3. Telematic system (10; 110) according to claim 1 or 2, wherein said locator is a satellite locator (14), for example of the GPS type or the like, co-operating with a respective satellite network (SAT-1, SAT-2, SAT-n), or it is constituted by a locator that uses a usual telephone network and in particular the methods of locating, based on triangulation, of a mobile network of cellular phones.
4. Telematic system (10; 110) according to any one of the preceding claims, wherein the zone (Z), of each self-diagnostic test (S-l, S-2, S-3, S-n), which shows the respective result (YES/NO), is suitable for changing or otherwise colour or in general chromatic tonality when the self-diagnostic test is performed, as a function of its either YES or NO result.
5. Telematic system (10; 1 10) according to any one of the preceding claims, wherein each of said service peripheral electronic apparatuses (11-1, 11-2, 11-3,
1 1-n) is associated with appropriate instructions aimed at instructing the user (U-l, U-2, U-3, U-n) on how to use the same service peripheral electronic apparatus (11-1, 1 1-2, 1 1-3, 1 1-n ) to transmit, to the central unit (20) for the collection and analysis of data, the identification data and the result (YES/NO) of the self- diagnostic test(S-l, S-2, S-3, S-n) which was performed.
6. Telematic system (10; 1 10) according to any one of the preceding claims, wherein the detection unit (12) of each service electronic apparatus can be activated manually by the respective user with a pushbutton (13) or a similar device.
7. Telematic system (10) according to any one of the preceding claims, wherein said self-diagnostic tests (S-l, S-2, S-3, S-n) and said one or more service electronic apparatuses (11-1, 1 1 - 2, 11-3, 11-n) are separable and distinct from each other, so that the self-diagnostic tests (S- l, S-2, -S3, S-(n-l) and the service electronic apparatuses (1 1- 1, 11-2, 11-3, .., 11-n) are sold and distributed separately in said population of users (U-l, U-2, U-3, .... , U-n), and therefore the self-diagnostic tests (S-l) are provided to be inserted (fl), by the users, in the service electronic apparatuses (1 1-1) which serve to collect the data (Dl) and the results (YES/NO), of the self-diagnostic tests (S-l) to be transmitted and sent to the central unit (20) for collecting and analysing data.
8. Telematic system (110) according to any one of the preceding claims, wherein the self-diagnostic tests (S-l, S-2, S-3, S-n) and said one or more service electronic apparatuses (1 1-1, 11 - 2, 1 1-3, 1 1-n) are not separate and distinct but are integrated one with the other, so that the self-diagnostic tests (S-l, S-2, S-3, S-n) and the service electronic apparatuses (11-1, 11-2, 1 1-3, .., 11-n) are sold and distributed together in the form of a unique kit comprising the self- diagnostic test (S-l) and the service electronic apparatus (11-1) associated with the same self-diagnostic test.
9. Telematic system (10; 110) according to any one of the preceding claims, wherein the self-diagnostic tests included and provided to be performed as part of the system can be selected from a group of self-diagnostic tests or clinical and immunological tests constituted, by way of an example, by: tests for influenza, cancer and cardiac markers, tests for hepatitis in all its variations, epidemiological tests for infectious diseases, pregnancy testing, testing for metabolites of clinical- diagnostic interest.
10. Method (50) to monitor and keep under control the state of health of a population (P) of users (U-l, U-2, U-3, .., U-n), comprising the following steps:
- providing (51) in said population of users (U-l, U-2, U-3,..., U-n) a plurality of self-diagnostic tests or assays (S-1, S-2, S-3, S-n ) of the YES/NO type, i.e. capable of providing simply a positive or negative result (YES/NO), and suitable for being performed, on the basis of appropriate instructions attached to each self-diagnostic test, autonomously, that is without the intervention and/or the assistance of medical personnel, by the individual users of said population (P);
- providing and making available (52) in said population (P) of users (U-l, U-2, U-3, U-n) one or more service peripheral electronic apparatuses (11-1, 11- 2 , 11-3, 11-n) associated with said self-diagnostic tests (S-1, S-2, S-3, S-n) available to said population (P), said one or more service peripheral electronic apparatuses (1 1-1, 1 1-2, 11-3, 11-n) being suitable for serving to collect the data and the results of the self-diagnostic tests (S-1, S-2, S-3 , S-n) performed by said population (P) of users;
- performing of the self-diagnostic tests (S-1, S-2, S-3, S-n) by the users (U-l, U-2, U-3, U-n) of said population (P ), so as to obtain for each self- diagnostic test performed a positive (YES) or negative (NO) result;
- detecting, via the service electronic apparatus (11-1) associated with each self-diagnostic test (S-1) which was performed, the identification data (Dl) and the result (YES/NO) of the self-diagnostic tests (S-1, S-2, S-n) performed;
- locating, via a locator (14) included in the service peripheral electronic apparatus (11-1) associated with each self-diagnostic test (S-1) that was performed, the specific users (U-l, U-2 , U-3, U-n) who performed the self-diagnostic tests (S-1, S-2, S-n);
- packetizing, again via the service electronic apparatus (11-1) associated with the self-diagnostic test (S-1) which was performed, both the identification data (Dl) and the result (YES/NO) of the self-diagnostic test (S-1) performed, and the information (D3), given by the locator (14), on the location of the specific user (U-l) who performed the self-diagnostic test (S-l);
- transmitting (f2), via a communication network (30), to a central unit (20) for collecting and analysing data, the packetized data and information (PD) generated by the service electronic apparatuses (11-1, 11-2 , 1 1-3, 11-n) associated with the self-diagnostic tests (S-l, S-2, S-n) that were performed; and
- authenticating and analysing, in said central unit (20) for collecting and analysing data, the information and data received from the various service electronic apparatuses (11-1, 11-2, 11-3, .., 11-n), taking into account the data contained in a database (20a) associated with said central unit (20) and containing data and information related to the self-diagnostic tests (S-l, S-2, S-3, S-n) used by said population of users (U-l, U-2, U-3, U-n).
11. Service electronic apparatus (11-1, 1 1-2, 11-3, .., 11-n) for use in a telematic system (10) for the collection and analysis of data and results of self- diagnostic tests (S-l, S-2, S-3, ... S-n), suitable for being performed, on the basis of appropriate instructions attached to each self-diagnostic test, by a population (P) of users (U-l, U-2, U-3, U-n) in an autonomous way, that is without the intervention and/or the assistance of medical personnel, said self-diagnostic tests (S-l, S-2, S-3, S-n ) being of the YES/NO type, that is suitable to give solely a positive or negative result (YES/NO), and each comprising a label (E) with the identification data (Dl) of the self-diagnostic test and a zone (Z ) suitable for showing the results (YES/NO) of the same self-diagnostic test (S-l, S-2, S-3, ... S- n), when it is performed by the respective user (U-l, U-2, U -3, U-n);
wherein said service electronic apparatus (1 1-1, 1 1-2, 11-3, .. 1 1-n) comprises:
- a support (1 Γ) which houses the various parts of the service electronic apparatus and is suitable for receiving (fl) a self-diagnostic test (S-l); - a detection unit (12) suitable for reading and detecting the identification data (Dl) and the result (YES/NO) of the self-diagnostic test (S-l), once performed by the relative user (U-1), respectively from said label (E) and said zone (Z) of the self-diagnostic test (S-l);
- a locator (14) designed to locate, in the territory covered by the system (10) for the collection and analysis of the data and results of self-diagnostic tests, the specific user (U-1) who performed the self-diagnostic test (S-l), and
- a data packaging and packetizing unit (15) suitable for receiving from said detection unit (12) the data (D2) concerning the identification data (Dl) and the result (YES/NO) of the self-diagnostic test (S-l), and from said locator (14) the information (D3) on the location of the specific user (U-1) who performed the self- diagnostic test, and then form from the received data (D2, D3) a data packet (PD) to be transmitted, through a communication network (30), to a central unit (20) for the collection and analysis of data, where the transmitted data will be suitably analysed.
12. Self-diagnostic kit (K) for use in a telematic system (1 10) for the collection and analysis of data and of the results of self-diagnostic tests in a population of users, comprising:
- a self-diagnostic test (S-l) suitable for being performed by a respective user (U-1) on the basis of appropriate instructions attached to the self-diagnostic test, in an autonomous way, that is without the intervention and/or the assistance of medical personnel, and
- a service electronic apparatus (1 1-1),
wherein said self-diagnostic test (S-l) and said service electronic apparatus (1 1-1) are not separable and are incorporated in a single package;
wherein said self-diagnostic test (S-l) is of the YES/NO type, that is suitable to give either a positive or negative (YES/NO) result, and comprises a label (E) with the identification data (Dl) of the self-diagnostic test and a zone (Z) suitable for showing the results (YES/NO) of the same self-diagnostic test (S-l, S- 2, S-3, ... S-n), when it is performed by the user (U-1, U-2, U-3, U-n), and
wherein said service apparatus in turn comprises:
- a support (1 ) for housing the respective self-diagnostic test (S-l) and the various parts of the electronic apparatus;
- a detection unit (12) for reading and detecting the identification data (Dl) and the data of the result (YES/NO) of the self-diagnostic test (S-l) when it is performed by the user (U-1);
- a locator (14) designed to locate, in the territory covered by the telematic system (10) for the collection and analysis of the data and the results of medical self-diagnostic tests, the specific user (U- 1) who performed the medical self- diagnostic test (S-l, S-2, S-n), and
- a data packetizing unit (15) for receiving from said detection unit (12) the data (D2) concerning the identification data (Dl) and the result (YES/NO) of the self- diagnostic test (S-l) performed, and from said locator (14) the information (D3) on the location of the specific user (U-1), and then forming a data packet (PD), to be sent to said communication network (30) in order to be transmitted to said central unit (20) for the collection and analysis of data.
13. Self-diagnostic kit (K) according to claim 12, wherein the packetizing unit (15) of said service electronic apparatus (11-1) is designed to encrypt and authenticate (15a) the data concerning the identification data (Dl) and the result (YES/NO) of the self-diagnostic test (S-l), performed, to be transmitted, via said communication network (30), to said central unit (20) for data collection and analysis.
14. Self-diagnostic kit (K) according to claim 12 or 13, wherein said locator is a satellite locator (14), for example of the GPS type or the like, co-operating with a respective satellite network (SAT-1, SAT-2, SAT-n), or is constituted by a locator that uses a usual telephone network and in particular the methods of locating by triangulation of a mobile network of cellular phones.
15. Telematic system (210) for the collection and the analysis of the data and of the results (YES/NO) of self-diagnostic tests (S-l, S-2, S-3, ... S-n), in a population of users (U-l, U-2, U-3,..., U-n), according to claim 1, comprising, as an alternative to said one or more service electronic apparatuses, data communication and collection means, of the internet, landline or mobile telephone network type and others, available to the individual user and as defined by the instructions attached to each self-diagnostic test or assay (S-l, S-2, S3 ...S-(n-l), S-n), for the sending of the data and of the results of the self-diagnostic test to said central unit (20) for collecting and analysing data.
PCT/IB2014/063613 2013-08-02 2014-08-01 Telematic system for the collection and processing of data and results of self-diagnostic tests in a population of users, corresponding method, and service peripheral electronic device and self-diagnostic kit for use in such a telematic system WO2015015462A1 (en)

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