Title of Invention

SYSTEM FOR MANAGING DATA INTEGRATED IN A PROTOCOL

Abstract

The invention concerns a data management method, each information concerning a first entity and having been generated by a second entity. It comprises: means (12) for generating at least one event inseparably assembling in a common elementary data: an information concerning the first entity, an identifier of the first entity, and an identifier of the second entity; and means (44B) for automatically generating, in accordance with the specifications of said protocol, at least one event corresponding to a subsequent operation to be performed depending on the result of an analysis of the or each information contained in at least a prior event in accordance with criteria particular to a predetermined protocol.

Full Text

System for management of information integrated in a protocol The present invention relates to a system for the management of information, and in particular medical information, each item of information concerning a first entity and having been generated by a second entity, the system comprising: at least one database for the storage of the said items of information; and at least one user station comprising means for collecting at least one item of information concerning the first entity. In numerous fields it is necessary to be able to ensure confidential storage and authorised and controlled consultation of validated items of information concerning a person. These items of information may be for example medical information concerning a patient. These items of medical information are generated by one or several medical practitioners subject to the obligations of a professional code of ethics. In particular, these obligations impose upon the practitioners the respect for professional confidentiality, such that practitioners are forbidden to make this information accessible without the authorisation of the patient concerned and the patient must be able to access the information concerning him. The information management systems which are currently known use relational databases in which there are memorised, on the one hand, all the items of information which must be generated by the system, and, on the other hand, identifiers of the patient concerned and/or the practitioner who has generated these items of information. In relational databases, the database is organised as a function of the relationships which exist between the data items. Thus an item of information concerning a patient, the identity of this patient or the identity of the practitioner who generated this item of information is considered as a data item and the links translating the existing relationships between the data items are memorised in the database. This type of database is convenient since it permits modification of the links existing between the data items, which permits the application of new processing operations to already existing items. This reduces the redundancy of data items contained in the database. However, the management of the confidentiality necessary for the limitation of the consultation of the information, imposed in particular by the code of ethics of the persons generating the information, is difficult to ensure, due to the multitude of links which can be created in such a database. Moreover, in the medical field practitioners are often required to apply a medical protocol. This protocol specifies a sequence of operations to be carried out as a function of the results obtained during preceding operations. The subsequent operations to be carried out are defined as a function of criteria specific to the protocol, these criteria concerning the results of the preceding operations. The applicable protocols are very numerous. These are accessible to the practitioners in reference works or in electronic databases. Due to their great variety, it is difficult for practitioners to have an exhaustive knowledge of each protocol and accessing the protocol in a reference work or a database is time-consuming. The object of the invention is to propose a device which permits practitioners easily and reliably to implement complex protocols, and in particular medical protocols. To this end, the invention relates to a system of management of information of the aforementioned type, characterised in that it comprises: means for creating at least one event bringing together in an indissociable manner in one and the same data item: the or each item of information concerning a first entity; an identifier of the first entity; and an identifier of a second entity; means for storing at least one protocol, which protocol specifies a sequence of successive operations to be carried out, in which the subsequent operations depend upon the results obtained in the preceding operations carried out as a function of the criteria specific to the said protocol; means for analysis of the or each item of information contained in at least one preceding event as a function of the criteria specific to a protocol; means for automatic creation, according to the specifications of the said protocol, of at least one event corresponding to a subsequent operation to be carried out as a function of the result of the analysis of the or each item of information contained in at least one preceding event as a fianction of the criteria specific to the said protocol; and means for definitive storage of the content of the or each event created automatically, each by way of a data item in the or each database. According to particular embodiments, the system for management of information comprises one or several of the following characteristics: the said means for automatic creation, according to the specifications of the said protocol, of at least one event corresponding to a subsequent operation to be carried out are adapted for the creation of an incomplete event, and the system includes means for completing the or each incomplete event by at least one second entity from a user station by the addition of at least one item of information in the or each event before its definitive storage; it comprises means for warning at least a second entity in order to complete an incomplete event; it comprises means for validating the or each event by the or each second entity before its definitive storage; the said analysis means axe adapted for the analysis of the or each item of information contained in at least two preceding events; it comprises means for automatic searching among the data items stored in the or each database for data items containing information which must be analysed by the analysis means as a function of the criteria specific to the said protocol; it comprises means for archiving the events used during the implementation of the said protocol; and the said means for automatic creation of at least event comprise means for automatic addition in the said event of the identifier of the first entity concerned by the or each item of information. The invention also relates to a method of management of information, each item of information concerning a first entity and having been generated by a second entity, the system comprising at least one database for the storage of the said items of information and at least one user station comprising means for collecting at least one item of information concerning the first entity, the method comprising a step of collecting from a user station at least one item of information concerning the first entity; characterised in that it comprises: a step of creating at least one event bringing together in an indissociable manner in one and the same data item: the or each item of information concerning the first entity; an identifier of the first entity; and an identifier of the second entity; a step of analysis of the or each item of information contained in at least one preceding event as a function of criteria specific to the said protocol, which protocol specifies a sequence of successive operations to be carried out, in which the subsequent operations depend upon the results obtained in the preceding operations carried out as a function of the criteria specific to the said protocol; a step of automatic creation, according to the specifications of the said protocol, of at least one event corresponding to a subsequent operation to be carried out as a function of the result of the analysis of the or each item of information contained in at least one preceding event as a function of the criteria specific to the said protocol; and a step of definitive storage of the content of the or each event created automatically, each by way of a data item in the or each database. The invention will be better understood by reading the description which follows, given solely by way of example and with reference to the drawings, in which: Figure 1 is a schematic view of a system for the management of information according to the invention; Figure 2 is a schematic view illustrating the format of a data item used by the system for the management of information shown in Figure 1; Figure 3 is a flow chart of the principal algorithm implemented in the system according to the invention; Figure 4 is a schematic view of a variant of the system for the management of information according to the invention; and Figure 5 is a flow chart of the algorithm for management by protocol implemented in the system according to the invention. The system for the management of information 10 according to the invention is illustrated schematically in Figure 1. This comprises, on the one hand, a set of user stations designated by the general reference 12, each connected to a collective information transmission network 14 such as the Internet and, on the other hand, a centre 16 for storage and management of information. The system for the management of information 10 is intended, in the example under consideration, for the management of medical information concerning identified patients. These items of information are generated by medical practitioners such as doctors, radiologists or biologists in charge of an analysis laboratory. In particular the management system is adapted to permit the definitive storage of an item of information in the storage centre 16 without it being possible for his item of information to be modified subsequently. Furthermore, at least one identifier of the patient concerned, as well as an identifier of the practitioner who generated the item of information, is preserved, associated with this item of information. The system permits access to a stored item of information to be given solely to the patient concerned and to the practitioner who generated the item of information, as well as, possibly, after the patient"s agreement, to other practitioners. Each entity entering into the system, whether they be a patient or a practitioner, is equipped with or has access to a user station 12. Thus, for example, a first user station 12A serves the consulting-room of a general medical practitioner and a user station 12B serves the home of a patient. Likewise, for example, a medical imaging laboratory is equipped with a user station 12C. Each user station 12A, 12B, 12C has a microcomputer 20 equipped with an adapted Internet navigator, h is connected by an adapted interface to the network 14. Each user station includes means 22 for collection of input data such as a keyboard or a data conversion module. From the keyboard it is possible to input in particular an item of medical information, an identifier of a patient such as his name, as well as an identifier of the practitioner who produced the item of information. Each user station 12 is adapted to implement, from information processing means 24, software means for access to the centre 16 for storage and management of information. According to the invention, each user station 12 has software means in order to create an event bringing together, in an indissociable manner in one and the same data item, items of information collected concerning a patient, an identifier of the patient and an identifier of the practitioner. These means for creation of an event are advantageously downloaded from the centre 16 and consist for example of a page in HTML (Hyper Text Markup Language) format forming a dialogue interface. Certain of these user stations, such as the station 12C, have in addition to the microcomputer 20 an interface 30 for connection of the microcomputer to an installation 32 for medical imaging or for collecting medical information capable of producing images or digital items of information in a predefined format such as the format DICOM Hprim HL7. By its nature, this image or digital item of information includes an identifier of the patient concerned. The user station also implements a software module 34 adapted to analyse the digital image produced by the installation 32 and to extract from the latter an identifier of the patient concerned. The centre for storage and management of information 16 includes a set of servers 40 for the management of access to the centre 16. This set of servers 40 includes in particular an authentication server 40A adapted, as is known per se, to identify the origin of a request addressed to the server centre. It also includes one or several servers 40B adapted to the management of the exchange of executable files and of HTML pages according to the HTTP protocol between the centre for storage and management 16 and the user stations. In particular, the or each server 40B includes a software module adapted to ensure the downloading in each requesting user station of HTML pages constituting user interfaces permitting access to the stored information, as well as the saving of new items of information. This set of servers 40 is connected directly to the network 14 via a first security barrier 42 (firewall). The set of servers for management of access 40 is also connected to a set of servers 44 for management of events via a second security barrier 46 (firewall). In particular, the set of servers 44 is adapted to implement a software module 44A for transcription of the digital images received in formats different in particular from the DICOM format into one and the same format, for example the XML format. The set of servers 44 is also adapted to implement a software module 44B for management of the storage of events in a unit 48 for storage and management of access to these events. This storage unit 48 is intended for the permanent memorisation of one or several databases, the data items of which are constituted by events defined by the user stations and include in particular the items of information to be saved. The structure of a data item stored in the database 48 is represented schematically in Figure 2. This data item corresponds to an event. Each event comprises at least one actual item of information 52. This item of information is constituted for example by digital data corresponding to the result of an analysis or by a text corresponding to the opinion of a practitioner on the clinical condition of a patient. An item of information may equally be constituted by a file attached to the event such as a document in HTML format or an image file in DIBCOM format or an attachment in an office administration format. Furthermore, each event includes an identifier 54 of a first entity. This identifier designates the patient concerned by the items of information 52. Likewise, the event includes an identifier 56 of a second entity. This identifier designates the practitioner who produced the item of information. Each event advantageously includes a list of identifiers of additional entities which can have access to the information. The event also includes, advantageously but not obligatorily, other items of information to be filled in by the user such as: a title; a date of creation and/or of supplements to the event; and alist of keywords. For adding an item of information in the storage centre, complementing a pre-existing item of information with a supplementary item of information, modification of the rights of access to an item of information or consulting an item of information, the user connects from a user station 12 to the storage centre 16. The algorithm of Figure 3 is then implemented. The user station can be constituted, for the simplest operations, solely by a microcomputer cormected to the Internet with the aid of a navigator of any adapted type. After connection of the user station, at step 100, the set of servers 40 of the storage centre 16 returns a dialogue interface in HTML format to the user station 12, at step 102. At step 104, the centre 16 proceeds via the dialogue interface implemented by the user station with an authentication of the user. As a function of the identifier input by the user, checks of the actions authorised for this user axe carried out, at step 106, and a check of the access rights of the user is carried out, at step 108. The user is then free to proceed with several operations as a function of the actions which are authorised for him. From the interface made available to him he proceeds, at step 110, with the choice of an operation to carry out. This may be the input of a new item of information into the storage centre 16. The branch 1 lOA of the flow chart is then implemented. It may equally be the addition of a supplementary item of information in order to complete an item of information already present in the storage centre 16. The branch HOB of the flow chart is then implemented. The practitioner user can equally modify the rights of access to the items of information stored by authorising a new practitioner to access the information concerning a patient. The branch 1 IOC of the flow chart is then implemented. Equally, the user can simply gain knowledge of items of information stored in the storage centre by implementation of the branch HOD of the flow chart. When a practitioner wishes to input a new item of information into the centre 16, the algorithm differs according to whether the item of medical information which the practitioner wishes to input can be associated automatically with a patient constituting the first entity or whether the connection with the patient must be effected manually. This choice is effected at step 111. If the item of information does not initially contain the identifier of the patient concerned, the item of information is input by the practitioner, for example at the keyboard, at step 112. An identification of the patient concerned is entered, at step 114, particularly by selection of an identifier of the patient from among a list of identifiers of patients or by key strokes. By contrast, and in the case of a user station such as the station 12C, the recognition of the identifier of the patient concerned can be achieved automatically at the time of input of the item of information. Thus, the item of information containing the identifier of the patient concerned is input, at step 122, for example via the interface 30. This information is constituted for example by a medical image in DICOM format. At step 124, the software module 36 proceeds to an analysis of the image and a recognition of the identifier of the patient in the image transmitted. At step 130, the practitioner defines the list of identifiers of the supplementary entities authorised to access the items of information contained in the event. This step consists of defining the list 58 of identifiers of the practitioners authorised to have access. At step 132, the practitioner validates by entry of a signature code all of the elements constituting the event, namely the actual item of medical information, the identifier of the patient concerned, his own identifier and the list of identifiers of the supplementary entities authorised to have access. At the end of this step, the elements constituting the event can no longer be modified and the event can only be completed. At step 134, the user station 12 ensures the creation of a data item including the different elements of the event. This data item is encrypted by any suitable process and is addressed by the dialogue interface to the centre 16 for storage and management of information. Upon its reception, the data item is processed by the servers for management of events 44, at step 136. If the data item contains digital images in formats different from XML format, these images are automatically converted to XML format, at step 138, and the data item is completed by image data in XML format in addition to the image data in another format. The data item thus reprocessed is saved definitively in the storage unit 48, at step 140. When the user wishes to complete an event by adding a supplementary item of information, the steps of the branch HOB are implemented after step 110. At step 150, the event to be completed is selected. The data item corresponding to the event selected is transmitted by the centre 16 to the user station, at step 152. The data item is only transmitted if the identifier of the user is included in the event in question, whether it be the patient concerned, the practitioner who originated the item of information or a supplementary practitioner whose identifier appears in the list 58. The supplementary item of information is input at step 154, either manually from the keyboard or by resumption of an already existing file. In this later case the supplementary item of information constitutes a new attached file. At step 156, the user validates the addition of information by input of a signature code. The supplementary item of information is added at step 158 to form a new data element constituting the modified event. Furthermore, the date and the identifier of the user who added the item of information, as well as a link to the item of information are added in the data item in order to follow through the modifications. The new data element thus constituted is then processed in accordance with steps 136 and following. When the user wishes to modify a right of access, he can solely add new user identifiers authorised to access a given item of information. To this end, the event for which the accesses are to be completed is selected at step 200. The data item corresponding to the selected event is then transmitted to the user station at step 202. The data item is only transmitted if the identifier of the user is included in the event in question, whether it be the patient concerned, the practitioner who originated the item of information or an additional practitioner whose identifier appears in the list 58. At step 204, the user selects or enters at the keyboard one or several additional identifiers of users authorised to access the item of information then, at step 206, he validates the new identifiers. The supplementary identifiers are added in the data item constituting the event at step 208. Furthermore, the date and the identifier of the user who added the item of information, as well as a link to the item of information are added in the data item in order to follow through the modifications. The steps 136 and following are then implemented again. For consultation of the items of information stored in the centre 16, and from any user station whatsoever, the steps of the branch 1 lOD are implemented. At step 250, a request is formulated by the user from the user station. This is taken into account by the servers for management of the events 44, at step 252. As a function of the rights of access contained in the event in question in the request, and as a function of the rights of the user, the content of the data item is transmitted from the storage centre 16 to the user station 12, at step 254. In particular, the data item is only transmitted if the identifier of the user is included in the event in question in the request, whether it be the patient concerned, the practitioner who originated the item of information or an additional practitioner whose identifier appears in the list 58. The item of information is then made available to the user at step 256, for example by display, or by saving the content of the data item on the hard disk of the user station. At step 258 a log of the accesses is updated in the centre 16 in order to record the identifier of the user, the nature of the information made available, the date of access provided by the system and any other useful information. It will be understood that with such a system for the management of information the reliability of access to the items of information is increased since the actual item of information is associated, in one and the same data item, with an identifier of the patient concerned, an identifier of the practitioner who generated the item of information and, possibly, the identifiers of other entities likely to access the actual item of information. The system for the management of information illustrated in Figure 4 has the characteristics of the system of management illustrated in Figure 1. However, it also comprises means for management of medical protocols. To this end, the centre 16 for storage and management of information comprises an additional storage unit 402 in which a set of medical protocols is memorised permanently. Each protocol specifies a sequence of successive operations to be carried out by a practitioner in the case of the diagnosis and/or treatment of a patient, or in the case of an epidemiological study or a study of the effects of a treatment. In particular, each protocol defines decision¬making criteria concerning the items of information collected during preceding operations. The subsequent operations of the protocol are chosen from amongst a set of possible operations as a function of the criteria specific to the protocol. Furthermore, the set of servers 44 for management of events, and more particularly the software module 44B for management of the storage of events is adapted to the implementation of an algorithm for management of the protocols. The algorithm for management of the protocols is illustrated in Figure 5. This algorithm is implemented over a long period of time corresponding the to the entire duration of the implementation of the protocol. In the case of the diagnosis and/or treatment of a serious illness, the protocol can be implemented over a period ranging from one week to several months. At step 502, the user, that is to say a practitioner, selects a protocol to apply from a user station. To this end, the user has recourse to a user interface downloaded from the centre for storage and management 16. This interface permits the selection of the protocol from among the protocols memorised in the storage unit 402. The following example concerns a protocol for diagnosis or treatment of a patient. The additional items of information, such as the patient to whom the protocol is applied, are entered at step 502. At step 504, the software module 44B effects a search of the existing events which can be exploited by the protocol. These existing events are searched in the storage unit 48 among the data items including the identifier of the first entity selected at step 502. Each of the events which can be exploited is attached to the protocol, at step 506, in order that the items of information which it contains may be taken into account by the protocol. At step 508, the software module 44B effects an analysis of the items of information contained in the events attached to step 106. This analysis of the items of information is effected by application of the criteria specific to the selected protocol. At step 510, a test is carried out in order to determine whether or not the protocol is concluded. As long as the protocol is not concluded, the software module 44B creates, at step 512, one or several events. Each event created corresponds to a subsequent operation of the protocol to be carried out. The events created depend upon the result of the analysis made of the items of information contained in the preceding events corresponding to preceding operations of the protocol. These events are generally incomplete since they correspond, for example, as a function of the selected protocol, to an examination to be effected on the patient, or to a therapeutic action which must be carried out on the patient. The items of information contained in the event then consist either of the result of the analysis or of a report made by the practitioner who carried out the therapeutic action. The incomplete event created automatically at step 512 contains for example only the identifier of the patient, an identifier of the protocol in progress, and the identifier of one or several entities authorised to access the item of information which will subsequently appear in the event. Other items of information such as the date of creation of the event can also be specified automatically from the moment of creation of the incomplete event. The incomplete event is stored temporarily in the storage unit 48. At step 514, the software module 44B advantageously ensures that a warning is sent to the practitioner concerned by the incomplete event, that is to say to the practitioner who has to effect the associated operation. Step 514 is optional and, in the absence of a warning, the practitioner in charge of an operation of the protocol for which the incomplete event has already been created accesses the incomplete event from a user station after the patient has given access to the practitioner to this incomplete event under the conditions described previously. The practitioner carrying out the operation provided by the protocol undertakes, at step 516, from a user station, the entry of the or each item of information in the corresponding, initially incomplete event. This entry of items of information is effected either manually or from an interface 30 for connection of the microcomputer to an installation for imaging or for collecting medical information. At step 518, the practitioner proceeds with the definition of the rights of access by input of the identifiers of the entities which can subsequently access the entered items of information. At step 520, by entering a signature code the practitioner validates the set of items constituting the event, that is to say in particular the actual item medical information, the identifier of the patient concerned already contained therein since the creation of the event, his ovm identifier and the list of identifiers of additional entities authorised to have access. The following steps 522, 524, 526 and 528 are absolutely identical to the steps 134 to 140 of the algorithm illustrated in Figure 3. In particular, these latter consist of the creation of a data item adapted to be stored, the processing of the data item and the possible conversion of an image contained therein and, finally, the saving of the data item in the storage unit 48. At the end of the saving of the data item corresponding to the event thus completed, the steps 506 and following are implemented again. In particular, the new event produced and saved is attached, at step 506, to the other events and then a new analysis of the items of information contained in the different events, and in particular in the new event saved, is effected at step 508 according to the criteria specific to the protocol. If the protocol is not concluded, one or several new incomplete events are created at step 512 according to the specifications of the protocol initially selected. It will be understood that the implementation of the algorithm of Figure 5 permits a linking, within the framework of a protocol, of the events which already exist and the automatic creation of new events corresponding to operations which must be implemented subsequently within the framework of the selected protocol. Thus the items of information coming from the different entities intervening in the protocol are linked to one another and taken into account for the following operations which have to be implemented in the protocol. Thus, each entity can be guided in its intervention by the creation of incomplete events. Furthermore, the exploitation which is undertaken of the items of information communicated by each entity is likewise assisted by the analysis effected at step 508 and the automatic creation of incomplete events which result therefrom at step 512. Such a system for the management of information can be applied in fields other than the medical field and in particular in the legal field. In this case, the second entity is an attorney or counsel, the first entity being the client of the attorney or counsel. Equally, this system of management can be applied to the management of complex projects. In this case the first entity is the project itself, whilst the second entities are the different participants in the project. SWE CLAIM : 1. Method for the management of infonnation, and in particular medical information, each item of information concerning a first entity and having been generated by a second entity, comprising the steps of: storing of the said items of information in at least one database (48); and collecting (12, 22, 34, 36) at least one item of information (52) concerning the first entity in at least one user station (12); characterized in that it comprises further the step of: creating by means (12) at least one event bringing together in an indissociable manner in one and the same data item (50): the or each item of information (52) concerning the first entity; an identifier (54) of the first entity; and an identifier (56) of the second entity, storing by means (402) at least one protocol, which protocol specifies a sequence of successive operations to be carried out, in which the subsequent operations depend upon the results obtained in the preceding operations carried out as a function of the criteria specific to the said protocol; analysing by means (44B) the or each item of information contained in at least one preceding event as a function of the criteria specific to a protocol; automatic by creating by means (44B), according to the specifications of the said protocol, at least one event corresponding to a subsequent operation to be carried out as a function of the resuh of the analysis of the or each item of information contained in at least one preceding event as a function of the criteria specific to the said protocol; and definitively storing by means (12, 44, 48) the content of the or each event created automatically, each by way of a data item (50) in the or each database (48). 2. Method for management as claimed in claim 1, wherein the step of automatic creation, according to the specifications of the said protocol, of at least one event corresponding to a subsequent operation to be carried out creates an incomplete event, and the method comprising the step of completing the or each incomplete event by at least one second entity from a user station by the addition of at least one item of information in the or each event before its definitive storage. 3. Method for management as claimed in claim 2, comprising the step of warning at least a second entity in order to complete an incomplete event. 4. Method for management as claimed in any one of the preceding claims, wherein it comprises the step of validating the or each event by the or each second entity before its definitive storage. 5. Method for management as claimed in any one of the preceding claims, wherein the analysis step is adapted for the analysis of the or each item of information contained in at least two preceding events. 6. Method for management as claimed in any one of the preceding claims, wherein it comprises the step of automatically searching among the data items stored in the or each database for data items containing information which must be analysed by the analysis means as function of the criteria specific to the said protocol. 7. Method for management as claimed in any one of the preceding claims, wherein it comprises the step of archiving the events used during the implementation of the said protocol. 8. Method for management as claimed in any one of the preceding claims, wherein the step of automatically creating at least one event comprise the step of automatically adding in the said event the identifier of the first entity concerned by the or each item of information.

Documents:

2451-chenp-2004 abstract.jpg

2451-chenp-2004 abstract.pdf

2451-chenp-2004 claims-duplicate.pdf

2451-chenp-2004 claims.pdf

2451-chenp-2004 correspondences-others.pdf

2451-chenp-2004 correspondences-po.pdf

2451-chenp-2004 description (complete)-duplicate.pdf

2451-chenp-2004 description (complete).pdf

2451-chenp-2004 drawings.pdf

2451-chenp-2004 form-1.pdf

2451-chenp-2004 form-19.pdf

2451-chenp-2004 form-26.pdf

2451-chenp-2004 form-3.pdf

2451-chenp-2004 form-5.pdf

2451-chenp-2004 others.pdf

2451-chenp-2004 pct search report.pdf

2451-chenp-2004 pct.pdf

2451-chenp-2004 petition.pdf