WO2003090150A1

WO2003090150A1 - Managing system of clinical data

Info

Publication number: WO2003090150A1
Application number: PCT/IT2002/000256
Authority: WO
Inventors: Luca Valentinotti
Original assignee: A & L Telemed S.R.L.
Priority date: 2002-04-22
Filing date: 2002-04-22
Publication date: 2003-10-30
Also published as: AU2002307742A1

Abstract

A managing system (1) of clinical data, comprising a plurality of first local electronic patient record means (2), each apt to the storing of clinical data and associated with a local health unit, second integrated electronic patient record means (4), it also apt to the storing of clinical data, and communication means (5), at to the selective exchange of clinical data between each of the first means and the second means, wherein the first means and the second means are apt to the storing of the clinical data in a standarized format apt to the data exchanging via Internet and/or intranet network.

Description

MANAGING SYSTEM OF CLINICAL DATA

DESCRIPTION The present invention refers to a managing system and method of clinical data of at least one patient, and typically of a plurality of patients. In particular, the system of the invention is suitable to the tele-home care of the patients.

The health-care system, in any country, entails a high organizational complexity, requiring high running costs.

Also due to this complexity, significant investments in the field notwithstanding, the health-care system is often affected by scarcities associated with an ineffective managing of the patient clinical data and to a lack of effective coordination among the different health units concerned with the same patient. These scarcities entail a significant social impact on patients, and often result in lengthy waiting times for the carrying out of the medical services, i.e., typically, the hospitalization and the diagnostic and therapeutic interventions, to the apparent detriment of public welfare. The technical problem underlying the present invention is to provide a managing system and method of clinical data enabling to overcome the drawbacks abovementioned with reference to the known art.

This problem is solved by a system according to claim 1.

According to the same inventive concept, the present invention further refers to a method according to claim 25.

The present invention provides several relevant advantages.

The main advantage lies in that the provision of an integrated electronic patient record enables an optimized coordination of the diagnostic, therapeutic and rehabilitative interventions on the same patient and an optimal exploitation of the health operators' competences and availabilities. Concomitantly, the network managing modes of the clinical data provided by the system and the method of the invention make the referencing to the local patient records and to the integrated patient record and the data exchange therebetween extremely simple, rapid, efficient and user-friendly. Hence, it will be understood that the invention, providing a so-called federated management of the local electronic patient records, renders a patient's clinical data immediately available over the entire region, State, and/or World territory. Thus, patient and health operator transfers can be reduced, and useless repetitions of the diagnostic and therapeutic procedures are prevented. In the present context, for 'clinical data' it is intended all the data apt to identify the patient and to trace the clinical history thereof, and in particular: the data and the signals acquired in the course of clinical analysis, inclusive of any biomedical image, even high-resolution ones; the data describing the progress of any activity or clinical, and in particular therapeutic, protocol to which the patient is subjected; the data describing planned or booked clinical protocols or activities; the specialist reports; the data related to the optional tele-home care. Further examples of clinical data manageable by the invention will be provided hereinafter, with reference to preferred embodiments thereof.

Moreover, for 'standardized format' of said data it is intended that they exhibit standardized structure and/or content.

A preferred embodiment of the invention, set forth in claim 10, provides that to the integrated patient record and/or the local patient records also clinical data obtained by patient tele-home care procedures be inputted.

Hence, in this preferred embodiment, the invention enables an advanced integration between hospital and home care, implementing a sort of 'virtual hospitalization' .

In this respect, it should be noted that the foremost state of the art has provided the introduction of systems and protocols for the tele-home care of a patient, typically based on the exchange of information between the latter and a health worker through a communication network. The tele-home care has also been aimed at making the medical sector more effective, as, potentially, the former enables to reduce the number of hospitalizations and the hospital intervention times, and hence also the costs associated therewith. Moreover, tele-home care entails the additional advantage of not taking the patient away from his/her own environment, thereby avoiding the consequences in psychological-affective terms, as well as in loss of working activity, entailed in hospitalization.

However, the abovementioned tele-home care systems of the known art entail several relevant drawbacks. First of all, the above are markedly specific, i.e. each tele-home care apparatus provides the use of a single medical device precisely identified both in terms of typology and of manufacturing company, thereby enabling the tele-home care of a certain type of pathology only. For analogous reasons, only a limited number of pathologies can be monitored. Therefore, in practice a hospital unit needing to monitor for different types of pathologies should provide different monitoring systems for each pathology and/or medical apparatus involved. On the contrary, the invention, providing a selective exchange of data in a standardized format among different health units, is extremely flexible and versatile. Further preferred embodiments of the invention are provided in the dependent claims.

Other advantages, features and the modes of employ of the present invention will be made apparent in the following detailed description of some embodiments thereof, given by way of a non-limiting example. Reference will be made to the figures of the attached drawings, in which:

Figure 1 is a block diagram of an embodiment of the managing system according to the present invention; and

Figure 2 is a generic data diagram referring to tele-home care activities of the system of Figure 1.

With initial reference to Figure 1, a system 1 according to the invention is apt to the managing of clinical data of a plurality of patients.

First of all, the system 1 comprises a plurality of local electronic patient record means 2, each thereof apt just to implement a plurality of local electronic patient records of respective patients and associated with a respective local health unit, like, e.g., a ward or a clinic. For simplicity's sake, hereinafter each of such means 2 will be referred to as local patient record 2.

Each local patient record 2 is apt to store clinical data, according to the above- provided definition of the latter, just implementing an informatic dossier for each patient registered at the respective local health unit. In particular, each local patient record 2 resides in, or is anyhow associated with, said respective local health unit, comprising both the clinical data acquired thereat and, potentially, those of the other local health units afferent to the system 1, according to modes that will be illustrated hereinafter. In the present embodiment, each local patient record 2 consists of a mere local database 31 and of a respective interface 32 for the reading/writing of clinical data from/on the database.

As it will be made apparent hereinafter, each of said interfaces 32, jointly to the respective database 31, forms a local patient unit implementing a so-called 'legacy' system.

Moreover, the system 1 comprises integrated electronic patient record means 4, apt just to implement an integrated patient record for each patient of said plurality, i.e. for each patient whose clinical data be contained in one or more local patient record 2. Always for simplicity's sake, hereinafter said means 4 will be referred to as integrated patient record 4. Both the local patient records 2 and the integrated patient record 4 enable the storing and the structured presentation of clinical data in a standardized format apt to the data exchanging via Internet and/or intranet network.

In the present embodiment, the integrated patient record 4 is implemented by an interactive computer archive 41 managed by a remote server. The integrated patient record 4 further provides a related interface 42 for the direct querying of said archive 41.

The archive 41 can consist of plural sub-units, each referring to the clinical data of a patient or of a patient group and residing in the local health unit primarily responsible of the care for said patient or patient group. Hence, it will be understood that in Figure 1 the integrated patient record 4 has been depicted as unitary body and separated from the local patient records 2 purely by way of example.

Preferably, the integrated patient record 4 also comprises automatic processing means, apt to produce a summary document of the clinical data of each patient, that appears as initial document to any worker querying the integrated record 4.

According to the invention, the system 1 further comprises communication means 5, apt to the selective exchange of clinical data between the integrated patient record 4 and each local patient record 2 on Internet and/or intranet network. This data exchange between the integrated patient record 4 and the local patient records 2 can be selective according to the type of data and of patient. Moreover, it can take place automatically or in response to specific queries carried out via the interfaces 32 or the interface 42 via Internet and/or intranet network.

In particular, the communication means 5 in turn comprises means 51 for selectively extracting clinical data from each local patient record 2 and for the temporary or permanent writing of said data in the integrated patient record 4. As abovementioned, this writing can take place automatically or upon a specific querying.

The communication means 5 also comprises means 52 for transmitting the clinical data stored in the integrated patient record 4 to each of the interfaces 32. i this case as well, this transmitting can take place automatically or in response to a corresponding querying carried out via the interface 32 itself.

Of course, the communication means 5 can also comprise means 53 for the direct, rather than mediated via the integrated patient record 4, connecting of the various local patient records 2. Said connecting can also be selective for the various patients whose clinical data are contained in a certain set of local patient records 2. The communication means 5 is apt to the transmitting of data on Internet and/or intranet network, and preferably enables a protected connection, in order to safeguard the safety and the confidential nature of the clinical data.

Hence, the integrated patient record 4 can be queried either via its own interface 42 or via the interface 32 of a local patient record 2 by a traditional-type Internet browser.

As aboveillustrated, both the local patient records 2 and the integrated patient record 4 provide the storing and the managing of clinical data of different nature, both descriptive of the state of health of each patient and related to the advancement stage of the clinical protocols and of the managing activities associated thereto, implementing multifunction and multimedia systems. In particular, said patient records 2 and 4 bear, for each patient, information related to the clinical activities suggested, planned and carried out, as well as information on the clinical protocol that the person in charge of a certain activity intends to follow, in order to ensure coherence to the various interventions onto the same patient. Moreover, the patient records can also keep track of the flow of clinical data thereto and therefrom, i.e., of the type and of the times of data exchange from the integrated patient record 4 to the local patient records 2, and vice versa.

In particular, each patient is matched by a respective 'record' in a local patient record 2 as well as in an integrated patient record 4. The local patient records 2 and the integrated patient record 4 are substantially implementable by cooperative informative systems, with the option of a different use of same clinical data.

In the present embodiment, the clinical data are stored both in the integrated patient record 4 and in the local patient records 2 in form of documents in the so-called XML (extensible mark-up language) format. As it will be detailed hereinafter, the information exchange takes place through the transforming of the clinical data in XML tags. In particular, for the standardizing of the format of the clinical data managed by the system 1, there was defined the XML scheme, and therefore the related tags and the structure of the managed documents, as well as a so-called 'Document Definition Type (DTD)' related to the adopted data scheme.

To exchange clinical data, the system 1 uses a single Multisource XML Publisher. As it is known, the XML enables the sharing and the transmitting in an open frame of the clinical data, ensuring the protection (integrity, safety, confidentiality) of the latter. Furthermore, a person skilled in the art will appreciate that the use of the XML language for the managing of clinical data entails the following additional advantages:

- the option of treating said clinical data extremely smoothly via a universal common platform, even in case said data be organized at a local level on different platforms, and optionally with a different obsolescence level; - the option of compressing the transmitted data;

- the option to establish a standard for the managing and the exchanging of medical information of any type, nature and provenance;

- the simple interpretability of the language at issue, also associated with the self- defining capability thereof; - the option of managing bi- and tridimensional biomedical signals as a single tag.

In the present embodiment, the system 1 further comprises at least one tele-home care unit 10, for the self-assisted tele-home care of a patient. This tele-home care unit 10 comprises a tele-home care kit provided to the patient, e.g. at the discharge thereof from a local health unit. Always in the present example, the kit consists of a portable network-connectable processor 11, typically a PC, apt to be connected to a medical device 12, like, e.g., an electrocardiograph, a spirometer or an electronic sphygmomanometer. This medical device is digital, or anyhow associated with an analog/digital converter. The unit 10 further comprises means for connecting to the integrated patient record 4 and/or to the local patient records 2, that in the present embodiment consists of the

PC modem unit. Variant embodiments instead provide different connecting means, like, e.g. a mobile phone or other means for connecting to the ISDN network.

The processor 11, the medical device 12, the local patient records 2 and/or the integrated patient record 4 provide means for translating the clinical data acquired by the device 12 itself into said standardized format.

The kit can further comprise a videocamera, for transmitting images of the patient or of a body district thereof.

The activation of the connection between the unit 10 and the integrated patient record 4 or a local patient record 2 can take place according to a frequency set in the pre- operative (optional) and in the patient discharge stages, continuously or interactively upon request both of the patient and the medical doctor.

In general, the unit 10 can enable the exchanging of clinical data of any kind and nature, like, e.g., sounds, signals, images and/or texts, with the remaimng components of the system 1. In particular, the unit 10 can enable to transmit said data to the integrated 4 and/or to the local 2 patient records by two types of outputs, i.e. :

- texts, and in general data not requiring reporting, that are directly sent, via home communication means in all analogous to the abovedescribed means 5, directly to the integrated patient record 4; and signals (e.g., ECG, spirometry, pressure) which are sent, always via said home communication means, to the local patient record 2 of a specialist health unit, and therefrom reported and sent to the integrated patient record 4 according to a message thus structured:

^■ 'payload', i.e. signal accompanied by structured heading data (e.g., patient name, physician name, date); and

■ interpretation and conclusions of the specialist center on the signal, preferably in form of a document in pdf format;

Moreover, said report and signal can be structured in hypertext format.

According to a further preferred embodiment, the unit 10 provides the option of acquiring and transmitting the four basic vital signals, i.e. ECG, SpO , NiBP and Breath. Moreover, the system 1 also provides means for controlling the vital signals acquired, and means for sending an automatic warning to at least one preselected local patient record 2 and/or to the integrated patient record 4 upon detection of an alteration thereof.

In Figure 2, a generic data scheme for storing the clinical data related to a tele-home care activity is provided. With reference to this latter Figure, in the data scheme advanced solely three data categories, or 'concepts', are used to describe a general tele-home care session: the patient, the tele-home care event and the tele-home care result. The one-to-many relationships among these concepts indicate that each patient can be subjected to one or more tele-home care events, even of different types, and that to each event one or more possible tele-home care results can correspond. Moreover, both the concept of tele-home care event and that of tele- home care result can be nested. In fact, a tele-home care event can in turn induce one or more tele-home care sub-events, and likewise a tele-home care result can generate one or more viable sub-results.

Hereinafter, the standardized data format provided in the managing system 1 of clinical data of patients will be detailed. This standardized format is suitable to be employed both for the clinical data acquired at local health unit level, and, especially, for the clinical data acquired in the tele-home care sessions. Variant embodiments could instead provide that the format described hereinafter be used solely for one type of clinical data. The general data scheme advanced can be implemented in several ways in a relational database. Preferably, on the basis of a simplified embodiment, each concept can be represented, for each patient, by a table of a generic database implementing a local patient record or the integrated patient record.

By way of example, hereinafter this data format will be illustrated with reference to a case of asthma tele-home care and of the Holter ECG device.

In particular, considering the case of clinical data managing by the data scheme of Figure 2, a first table is associated with the 'patient' data category. This table contains all the patient general information, like, e.g., personal data, current pharmacological therapy, worker in charge of the cure, diagnosis, therapeutic protocol, etc.

A second table, reported hereinafter as Table 1, is associated with the tele-home care event, and it stores the information related to the procedures or the tests carried out on the patient during the tele-home care session at issue. The headings of each column of Table 1 are substantially self-explanatory. In particular, the 'code' column identifies the session and the test type, and the 'group' column identifies the session and the test type, and the 'group' column enables to unify thereamong a plurality of repetitive clinical tests carried out in the same session.

Then, a third table, reported hereinafter as Table 2, is associated with the tele-home care result, and it provides detailed information on the outcome of the procedure or of the corresponding test indicated in the 'code' column of Table 1. Also the column headings of Table 2 are substantially self-explanatory. In particular, column 'seq#' reports a sequence number associated with the same patient with regard to a certain clinical analysis session, and columns 'num', 'char', 'coded value' and 'signal' are preset to encode a clinical data descriptive of the outcome of the test of the procedure, a numerical value (e.g., the body temperature), a char (e.g., a glycemia data), a further data, in a specific format, of a certain medical instrument, and a plotting (e.g., an ECG), respectively.

In a typical tele-home care session for asthma, the patient carries out, e.g., three FVC tests. Each test records the blood flow volume and other pulmonary indexes. Table 1 indicates that the patient identified with 1 has carried out three FVC tests on 11/12/01 in a tele-home care session for asthma. This session comprises three consecutive FVC tests. In Table 1, all three tests have the same date in the 'group' column, to indicate that all three belong to the same session identified by the 'date and time' column. The patient ID and the 'date and time' column are the primary access keys to this Table; the patient ID is the secondary key, that points, i.e., correlates, Table 1 to the table associated with the 'patient' category. As abovementioned, the detailed information about each individual test are stored in Table 2. The patient ID, the 'date and time' column, and the 'Seq#' column are the primary access keys of Table 2; the patient ID and the 'date and time' also form the external key with which to aim at Table 1. The hereto introduced tables enable the storing of a broad variety of data, inclusive of numbers, characters, encoded values and binary strings or of signals in general.

The hereto described embodiment provides high flexibility to the data format, as the scheme requires no modification when novel attributes are added to the tables.

Moreover, the standardized format of the present embodiment of the invention provides the definition of a 'Dictionary of the entities', i.e. of a managing semantics of clinical data. The entities forming the dictionary are those contained in the integrated and in the local patient records, like, e.g., the diagnosis, the therapy, the prognosis, the diagnostic examination, the diagnostic report, the sign, the symptom, etc. This dictionary implements a simple sorting of the information to be managed, and it provides an instrument to describe the semantics of all that could be useful in the managing of a patient, regardless of the data scheme used to organize the entities. It will be appreciated that when said entities are connected according to a cause- effect connection, they originate medical knowledge grounding. This knowledge grounding should be construed as a set of multimedia information when it is used as a guide for navigating the clinical record of a patient in order to analyze the latter' s state of health.

In the light of the above, it will presently be appreciated that the system 1 enables the extraction of the health data from the integrated patient record 4 according to the existing standards (DICOM3, HL7, Active-X for healthcare, CorbaMed, XML) in partially structured documents, and exclusively of the patient information required, at a determined instant, to define the diagnostic and therapeutic protocol of interest.

Since the hereto described various components of the system 1 can be implemented by hardware and/or software means well-known to a person skilled in the art, a further description thereof will be omitted. The modes of employ of the system of the invention will hereinafter be illustrated with reference to the specific embodiment disclosed.

A health worker, e.g., a physician, a nurse, a laboratory technician, etc. can create at a local level, i.e. in a local health unit, a clinical record 2 for a new patient, using the interface 32 to store into the database 31 the clinical data available up to then. This new creation can automatically be stored in the integrated patient record 4 as well, provided the system 1 be thus configured. Alternatively, the storing of the data at issue in a suitable record of the integrated patient record 4 can be carried out only on explicit instruction by the worker that has created the corresponding local patient record 2, or further in response to the first querying of the integrated patient record 4 requiring the clinical data of the patient at issue. Any subsequent creation, in another local patient record 2, of a record related to the same patient, could immediately, and optionally automatically, generate a connection to the corresponding record in the integrated patient record 4 and an optional exchange of clinical data therebetween.

Of course, the clinical data stored in a local patient record 2 and/or in the integrated patient record 4 can derive from tele-home care sessions. The operation modes of the tele-home care unit 10 will already be apparent to a person skilled in the art. In particular, the patient, autonomously or aided by a home care health worker or by another person, employs the medical device 12 to acquire a biomedical signal, in the hereto advanced examples an ECG, a heart rate, a blood pressure plotting, the mimmum and the maximum values thereof and/or a spirometer plotting, or the four basic vital signals.

The patient, connecting his/her PC to the network, sends said data to the integrated patient record 4 and/or to a local patient record 2. In particular, in case of connection to a patient record 2, the transmitted data can be reported prior to the inputting thereof in the integrated clinical patient record 4.

As abovementioned, each clinical data inputted in a local patient record 2 is accessible to the other local health units as XML document. In electronic format, said XML documents consist of messages comprising one or more respective attachments. Said messages circulate in the system 1 by the communication means 5 and are stored into the integrated patient record 4. In the present embodiment, a message, and therefore the data set packed thereby consists of:

'envelope' i.e. data element list by format of message header (e.g., sender ID and receiver ID, the latter typically being the integrated patient record 4);

'directory entry', i.e. data element list by entry in the directory for the XML documents (e.g., physician name, patient name, recording date, document type, event type, event date);

- 'payload', that is the useful content of the message, i.e., in the present embodiment, two typologies of clinical data produced and/or used by each local health unit: ^■ structured (minimum) data set (onto which structured researches, tables and calculations can be carried out), i.e. the lists of the structured data elements contained in the different document types (a list for each type of event and of pathology);

^■ attached documents - for display only, and optionally for free-text research - under the entry of the directory there is inserted the standard name of the document (e.g.: 'visit account', 'laboratory result, Operation report') and the event described (e.g. 'dermatological visit', 'pacemaker implant')

The data present in the message are interpreted by the local interface 32 and suitably stored in the respective local patient record 2. Instead, for the attached documents, merely the structured entry of the directory is interpreted. The actual attached document is stored in the local patient record 2, or anyhow URL-linked to an always on-line server, and it is passed to a dedicated software, depending on the type of file. Therefore, the local interface 32 manages the directory entry, yet not attempting to enter the latter nor to extract information therefrom: only the option of a visualization thereof subsists.

It will be understood that the system of the invention is susceptible of several variants with respect to the above disclosed. In particular, the system can provide many additional features, some of which are summarily illustrated hereinafter.

First of all, the fact that the clinical data be stored and transmitted in a standardized format enables to provide, at the level of local patient records 2 and/or of integrated patient record 4, further automatic processing means thereof, e.g. to support clinical decisions and/or for statistical, scientific ends, etc.

The system 1 can also comprise, again both at the level of the integrated patient record 4 and of the individual local patient records 2, means for enabling or authorizing access, in particular to the data writing and/or reading, in order to safeguard the safety and the confidentiality of the patient clinical data.

Moreover, the system 1 can provide, at the level of the integrated patient record 4 and/or of the local patient record 2, a health worker archive containing ID information of all the workers authorized to said access. Advantageously, the local 2 and/or the integrated 4 patient records also provide suitable means, typically an informatic archive, for storing the health worker and the technical instrument and the venues allocated to the local health unit or units availability, in order to allow an optimum allocation of the medical resources even in emergency situations. Furthermore, the system 1 could comprise means apt to send a warning signal to each local interface 32 upon modification of the clinical data of one of the other local patient record 2. Said means can provide the indiscriminate warning of all the local patient records 2 or solely of those that had activated this type of service. Likewise, the warning can be selective depending on the type of modified medical data and/or of patient.

Moreover, the system 1 could provide means for deleting the clinical data contained in the archive 41 of the integrated patient record 4 and/or in the individual database 31 of the local patient records 2, optionally managed by a health worker. In general, this deleting step actually provides the insertion of a flag associated with the individual information to be eliminated, so as to make it obsolete. In fact, for legal reasons, the system does not enable a physical deleting.

According to a further variant embodiment, the system of the invention provides that one of the local health units network-connected to the integrated patient record, and therefore to the local patient records, be a listening center. The listening center, which can be national or regional and is preferably active round the clock, intervenes, generally for an emergency, when the other local health units are not available. To this end, the listening center provides, alike other local health units, its own interface and associated communication means in order to accede to the health data of the integrated patient record and to insert a document summarizing its intervention therein.

The listening center is preferably apt to carry out telematically the following steps:

- periodic checking of the patient conditions;

- suggestions to the patient - via phone and/or e-mail - and checking thereof; - booking of tests or interventions via the integrated patient record and the connection thereof to the local health units; and

- managing the emergencies with phone availability of the workers.

In the case of presence of the listening center, the health data sent via the home unit can transit therethrough, and therefrom be sent to the integrated patient record. Also the components of the abovedisclosed variant embodiments can be implemented by hardware and/or software means well-known to a person skilled in the art, therefore a further description thereof will be omitted.

It will be appreciated that the system of the invention enables to overcome the drawbacks of the patient managing systems known to the art, in which each health unit has its own archive not accessible to the other health units. On the contrary, the system of the invention enables each health worker, regardless of the health unit of appartenance, to avail him/herself of a full and integrated case history of the patient, to the apparent advantage of the quality, times, and effectiveness of the therapeutic interventions on the latter.

As abovementioned, in practice the system enables to implement, in particular when it provides a tele-home care unit, an actual 'virtual hospitalization'. hi fact:

- each health worker afferent to a local health unit comprised in the system of the invention has an up-to-date notion of the patient's state of health and of the past, present and future 'actions' (diagnostic exams, therapeutic and rehabilitative protocols, etc.) and moreover knows the units involved in said activities; - the worker, in order to intervene on the patient, utilizes all the health units present on the territory (surgeries, laboratories, car hospitals, etc.), minimizing the patient transfer and waiting time, and maximizing the information transfer; and

- in chronic situations, the patient can be tele-home monitored and cured according to proper home care modes. All this entails the continuous availability of specialist advice for the minor health units, an improved health assistance to the communities scattered on the territory (mountains, islands, etc.), the option to meet the pressures deriving from the demographic changes (and the entailed change of the hospital size and structure), the option to follow the novel diagnostic, therapeutic and rehabilitative protocols in an improved and more widespread way, the adjustment of the medical assistance to the temporary variations of the population (due to tourism, large events, etc.), the reduction of patient hospitalization and of home-hospital commuting times, and, in short, the efficiency increase and the concomitant reduction of the public and private cost of medical assistance. Moreover, it will be appreciated that the system of the invention enables to optimize the quality of the cure provided to the patient, hi particular, the patient can be followed by an individual physician in charge of the cure, typically a physician of the health unit at which the respective record of the integrated patient record resides. By virtue of the system of the invention, said person in charge can avail him/herself in real-time of the required diagnostic and therapeutic services. Said services are selected in a short time among those available in the medical unit (at an individual hospital or hospital pool level) and interacting (on-line or off-line) with the specialists (local, national and international) in order to solve more complex aspects via the use of network services of the system of the invention. hi the light of the above, it will further be appreciated that the system of the invention implements an integrated system, in which the health worker can navigate, that merges the data stored in a certain local patient record to the data of the other local health units. Thus, the system enables a greater control on the information about each patient inserted in the individual patient record, and also a well-defined boundary to be drawn in the responsibility and in the quality of the information contained therein.

In particular, the system of the invention implements a federation of the clinical data contained in each local patient record by a document system that is coherently network-navigable, enabling an optimized interfaceability and cooperation between the different clinical units.

Moreover, the system of the invention enables to implement a network of local health units that cooperate in order to carry out the clinical protocol selected for the patient and for the 'virtual hospitalization' of the latter. This network emerges as a federation of autonomous services, each having its own decision process and its own working organization, interconnected thereamong so as to have their interaction enabling to carry out an integrated managing of the patient. Hence, each local health unit is based on its own organization-information system implementing a respective local patient record. Therefore, the latter shall contain, besides said plurality of patient records, also a database of managerial clinical data, related e.g., to the staff, the equipment, the premises etc., as abovementioned.

Moreover, the system of the invention also implements a cooperative informative system, apt to interconnect the informative systems of the individual local health units in order to enable the coordination of the activities carried out with regard to a same patient.

The interaction between the different clinical, organizational and communication activities manageable by the system of the invention generates the interaction among specific and coordinated workflows, for simplicity's sake hereinafter referred to as WF. The invention also provides a model enabling the dynamic connection of different WF types, and in particular:

- clinical WFs, describing the flow of the clinical events (e.g., signs and symptoms) and of the activities (e.g., diagnostic exams and therapies) and the activities resulting in a positive development of the illness;

- managerial WFs, describing the event flow, the planning and the control of clinical activities (e.g., resource availability and diagnostic exam booking).

The model uses:

- a graphic representation, modeling the activities and the events activating the latter;

- a textual representation, describing information related to: the set of the conditions used to control the carrying out of the activities; the actors carrying out the latter; the resources and the instruments involved; the clinical and the managerial data generated or utilized during the performance;

- a state diagram, enabling the control of the carrying out of an activity and managing the exceptions.

With the model, the WF can be constructed through a refining process. The cure protocol of a new patient makes reference to guidelines described by a highly generic WF scheme (so-called template WF). This scheme is gradually detailed taking into account both the patient features and the managerial issues (available resources and actors, costs and time limits). Hence, the definition of the WF scheme is based on WF that are predefined and stored in a library, or on specifically designed WFs. The libraries, besides facilitating and speeding up the WF construction process, receive the protocols and the descriptions of standardized and unit-specific processes. A greater adherence to the actual case is provided by the option available to each user of modifying the library-stored WFs. This is made possible by virtue of the modularity of the model, enabling to structure the activities from a set of primitives, and of the possibility provided thereby to operate a so-called top-down development of the activity description. The model is based on an algebra for the handling of the different WF types combining the operators of:

- writing off activities and events;

- inserting activities and events;

- replacing a WF portion; - comparing two WFs therebetween in order to delete the portions in common;

- defining a novel WF obtained combining two different WFs therebetween. The different interaction modes among WFs can be classified in three types: suspending - the calling WF is suspended over the entire duration of the called WF - e.g., a radiological exam with preliminary tests;

- synchronizing - the two WFs have different interaction instants during their execution and there is no other interaction therebetween - such is the case of the ecographic exam with taking of biological material to be subjected to cytological exam (at the starting of the ultrasound examination the cytological examination WF is activated).

Let us introduce the operators used to define a WF from existent activities and/or WFs. Let us distinguish two groups of operators: ^■ operators applying to a single WF (insert and delete), and

^■ operators applying to two or more WFs (difference, replace, join). Hereinafter, a synthetic description of the different operators is provided:

^■ deletion of an event - disconnecting two activities Al and A2 means deleting the event (and therefore the corresponding arc in the graphic representation) that, starting from Al, activates A2;

■ deletion of an activity - deleting an activity Al means eliminating the latter, and all the events linking it to other activities from the WF;

■ insertion of an event - the insert operator enables to add into a WF a new event linking two activities therebetween and connecting them in a direct causality relationship;

■ difference - the difference operator enables to define a new WF starting from the comparison of two existant WF;

■ replacement - the replace operator enables to insert into a WF, in place of one or more activities, another WF already defined (and stored in a WF library);

■ join - the join operator enables to define a new WF integrating two existant WFs. As aboveillustrated with reference to a preferred embodiment of the invention, all the clinical, organizational and communication activities and the related steps underlying a WF can be managed by the system of the invention by an exchange of messages, and in particular of XML documents.

Finally, purely by way of example, hereinafter two possible scenarios of application of the invention will be given.

Scenario A: early-discharged hospitalized patient The features of this scenario are: • the patient is discharged and remains under the hospital supervision, yet, via the system of the invention:

- the general medical doctor (MMG) is appointed to follow a 'suggested follow- up plan';

- the MMG receives the advised cure plan and the summary of the hospital patient record, plus the update related to any hospital contact;

- the MMG reports unexpected events and related decisions to the hospital;

• the main patient record resides at the hospital, that therefore will manage it as an integrated patient record, receiving data related to: - tele-home care, and

- MMG reports;

• the starting and the ending of the therapy are incumbent on the hospital; • the decisions incumbent on the medical unit in the managing of clinical data stored in the integrated patient record:

- Responsibility of the cure, with particular regard to the legal responsibility of the patient and to the role and freedom of action of the MMG;

- Optional active role of the patient, relatives thereof, and/or of volunteers in the carrying out of the tele-home care sessions and in the sending of the related data.

Scenario B: chronic home patient The features of this scenario are:

• The patient is cared for via a tele-home care unit of the system of the invention as the abovedefined one;

• The main responsibility of the assistance is entrusted to the general medical doctor (MMG), who therefore manages the integrated patient record; • The hospital acts as supervisor, and it manages a respective local patient record, automatically receiving a copy of the data modified in the integrated patient record according to agreed-upon sentinel parameters, intervening with 'interrupt' and 'proactive warnings' exchanged via the system of the invention;

• The hospital also intervenes with structured notifications, in particular predefined data indicating the importance/urgency level, always transmitted via the system of the invention;

• decisions incumbent on the medical unit in the managing of clinical data stored in the integrated patient record:

Also in the light of the abovedisclosed exemplary scenarios, it will presently be understood that the dispensing of the cure carried out by the system of the invention, especially during the so-called 'virtual hospitalization', involves the following actors:

- the patient (subject of the cure),

- the party in charge of the cure (a physician or a team of physicians), that follows the entire process of patient diagnosis and cure,

- the provider of the cure (the party in charge of the cure, a specialist, a nurse, the actual patient, a patient's relative), carrying out the diagnostic, therapeutic and rehabilitative activities, and

- the specialist (a physician or a team of physicians), providing consulence in the evaluation of the results of the diagnostic examinations, in the definition of the diagnostic and therapeutic protocol. Preferably, as abovementioned, the exchange of clinical data among the various actors is implemented by accessing the information stored in the patient record inserted in the integrated patient record. Said data are inputted by all the actors, according to data protecting and safeguarding procedures. A further option of interaction among actors, and especially between the party in charge of the cure and the specialist is that of the tele-consultation, enabling the long-distance discussion of the results of diagnostic analysis and the definition of subsequent therapeutic interventions.

It will be understood that the present invention further provides a managing method of clinical data, comprising the steps of: - providing a plurality of local electronic patient records as abovedisclosed, each apt to the storing of clinical data of at least one patient and associated with a local health unit;

- providing an integrated electronic patient record, it also abovedescribed and apt to the storing of clinical data of the patient; and - selectively exchanging clinical data of the patient between one or more local patient records and the integrated patient record, wherein the clinical data are stored in the local patient records and in the integrated patient record in a standardized format apt to exchange data via Internet and/or intranet network. The preferred features of the method at issue have already been illustrated hereto, hence a further description thereof will be omitted.

Finally, it will be understood that in principle the invention is also apt to manage clinical data of a single patient.

Hereto, the present invention has been described with reference to preferred embodiments thereof. It is understood that there could be other embodiments thereof, all however encompassed by the protective scope of the claims set forth hereinafter.

Claims

CLAΓMS

1. A managing system (1) of clinical data, comprising:

- a plurality of first local electronic patient record means (2), each apt to the storing of clinical data of at least one patient and associated with a local health unit; - second integrated electronic patient record means (4), it also apt to the storing of clinical data of the at least one patient; and

- communication means (5), apt to the selective exchange of clinical data of the at least one patient between each of said first means and said second means, wherein said first means of said plurality and said second means are apt to the storing of the clinical data in a standardized format apt to the data exchanging via Internet and/or intranet network.

2. The system (1) according to claim 1, wherem each of said first means (2) and said second means (4) provide a plurality of records, each record being apt to the storing of clinical data of a respective patient.

3. The system (1) according to claim 1 or 2, wherem said standardized format is based on the use of the XML language, said first means (2) of said plurality and said second means (4) being apt to store and to present the clinical data in form of XML documents.

4. The system (1) according to the preceding claim, comprising, to exchange the clinical data, a single ultisource XML publisher.

5. The system (1) according to any one of the preceding claims, wherein said communication means (5) comprises means for the automatic transferring of clinical data from each of said first means (2) to said second means (4).

6. The system (1) according to any one of the preceding claims, wherein said communication means (5) comprises means (51) for selectively extracting clinical data from each of said first means (2) in response to a corresponding querying carried out via Internet or intranet network and for the temporary and/or permanent writing of the extracted clinical data in said second means (4).

7. The system (1) according to any one of the preceding claims, wherein said communication means (5) comprises means (52) for transmitting clinical data stored in said second means (4) to one of said first means (2) in response to a corresponding querying carried out via Internet or intranet network.

8. The system (1) according to any one of the preceding claims, wherein said communication means (5) comprises means (53) for the direct exchanging of clinical data between different first means (2) of said plurality.

9. The system (1) according to any one of the preceding claims, wherein said first (2) and/or second (4) means comprises a relational database for the storing of the clinical data.

10. The system (1) according to any one of the preceding claims, comprising at least one tele-home care unit (10), apt to transmit clinical data of the at least one patient to said second means (4) and/or to at least one of said first means (2).

11. The system (1) according to the preceding claim, wherein said second means (4) and/or said at least one of said first means (2) comprises means for translating in said standardized format the clinical data transmitted from said tele-home care unit (10).

12. The system (1) according to claim 10 or 11, wherein said tele-home care unit (10) comprises means for translating in said standardized format the clinical data to be transmitted to said second means (4) and/or to said at least one of said first means (2).

13. The system (1) according to any one of claims 10 to 12, wherein said tele-home care unit (10) comprises a portable intranet and/or Internet network -connectable processor (11) and a medical device (12) apt to be connected to said processor.

14. The system (1) according to the preceding claim, wherein said tele-home care unit (10) comprises a medical device (12) selected from a group comprising an electrocardiograph, a spirometer and a sphygmomanometer.

15. The system (1) according to claim 13 or 14, wherein said tele-home care unit (10) comprises one or more medical devices (12) apt to acquire four basic vital signals of the patient (ECG, SpO₂, NiBP and Breathing).

16. The system (1) according to the preceding claim, wherein said tele-home care unit (10) comprises means for controlling the vital signals acquired and means for sending an automatic warning to at least one of said first means (2) and/or to said second means (4) upon detection of an alteration of the vital signals themselves.

17. The system (1) according to any one of claims 10 to 16, wherein said tele-home care unit (10) comprises a videocamera.

18. The system (1) according to any one of the preceding claims, comprising means for sending an automatic warning of input and/or modification of the clinical data contained in each of said first means (2) to said second means (4).

19. The system (1) according to any one of the preceding claims, comprising means for sending an automatic warning to one or more of said first means (2) of said plurality upon modification of the clinical data contained in one of the other first means (2).

20. The system (1) according to any one of the preceding claims, comprising automatic processing means of the clinical data in standardized format stored in said second means (4), apt to produce, for each patient, a summary document of said data.

21. The system (1) according to any one of the preceding claims, wherein said first (2) and second (4) means are apt to store clinical data selected from a group comprising: ID data of the patient and of his/her case history, biomedical signals, biomedical images, high-definition biomedical images, clinical protocols, examination bookings and specialist reports.

22. The system (1) according to any one of the preceding claims, wherein said first (2) and/or second (4) means comprises an archive for storing the availability of the health workers and/or of the technical instruments and/or of the venues allocated to each local health unit.

23. The system (1) according to any one of the preceding claims, comprising means for authorizing access to the data contained in said first (2) and/or second (4) means.

24. The system (1) according to any one of the preceding claims, comprising a listening center communicating with one or more first means (2) and/or to said second means (4).

25. A managing method of clinical data, comprising the steps of:

- providing a plurality of local electronic patient records (2), each apt to the storing of clinical data of at least one patient and associated with a local health unit;

- providing an integrated electronic patient record (4), it also apt to the storing of clinical data of the at least one patient; and

- selectively exchanging clinical data of the at least one patient between one or more of said local patient records and said integrated patient record, wherein the clinical data are stored in said local patient records and in said integrated patient record in a standardized format apt to exchange data via Internet and/or intranet network.

26. The method according to claim 25, wherein each of said local patient record (2) and said integrated patient record (4) are apt to the storing of clinical data of a plurality of patients.

27. The method according to claim 25 or 26, wherein said standardized format is based on the use of the XML language, said local patient records (2) and said integrated patient record (4) being apt to store and to present the clinical data in form of XML documents.

28. The method according to any one of claims 25 to 27, wherein said exchanging step provides the automatic transferring of clinical data from each of said local patient records (2) to said integrated patient record (4).

29. The method according to any one of claims 25 to 28, wherein said exchanging step provides the selective extraction of clinical data from each local patient record (2) in response to a corresponding querying carried out via Internet or intranet network and the temporary and/or permanent writing of the extracted clinical data in said integrated patient record (4).

30. The method according to any one of claims 25 to 29, wherein said exchanging step provides the transmission of clinical data stored in said integrated patient record (4) to one of said local patient records (2) in response to a corresponding querying carried out via Internet or intranet network.

31. The method according to any one of claims 25 to 30, wherein said exchanging step provides the direct exchanging of clinical data between different local patient records (2) of said plurality.

32. The method according to any one of claims 25 to 31, comprising a step of tele- home care of a patient and a step of transmitting the clinical data acquired in said tele-home care step to said integrated patient record (4) and/or to at least one of said local patient records (2).

33. The method according to the preceding claim, wherein said tele-home care step comprises a step of translating in said standardized format the acquired clinical data, carried out at home level, at the level of said at least one local patient record (2) and/or at the level of said integrated patient record (4).

34. The method according to claim 32 or 33, wherein said tele-home care step comprises a step of transmitting via intranet and/or Internet network of the acquired clinical data.

35. The method according to any one of the claims 32 to 34, wherein said tele-home care step comprises a step of acquiring a biomedical signal by a medical device (12) selected from a group comprising an electrocardiograph, a spirometer and a sphygmomanometer.

36. The method according to any one of claims 32 to 35, wherein said tele-home care step comprises a step of acquiring four basic vital signals of the patient (ECG, SpO₂, NiBP and Breath).

37. The method according to the preceding claim, wherein said tele-home care step comprises a step of controlling the vital signals acquired and a step of automatically sending a warning to at least one of said local patient records (2) and/or to said integrated patient record (4) upon detection of an alteration of the vital signals themselves.

38. The method according to any one of claims 32 to 37, wherein said tele-home care step comprises a step of taking images of the patient and/or of a body district thereof by a videocamera.

39. The method according to any one of claims 25 to 38, comprising a step of sending an automatic warning of input and/or modification of the clinical data contained in each of said local patient records (2) to said integrated patient record (4).

40. The method according to any one of claims 25 to 39, comprising a step of sending an automatic warning to one or more of said local patient records (2) of said plurality upon modification of the clinical data contained in one of the other local patient records (2).

41. The method according to any one of claims 25 to 40, comprising a step of automatically processing the clinical data in standardized format stored in said integrated patient record (4), wherein, for a certain patient, a summary document of said data is produced.

42. The method according to any one of claims 25 to 41, wherein said clinical data stored in said local patient records (2) and in said integrated patient record (4) are selected from a group comprising: ID data of the patient and of the case history thereof, biomedical signals, biomedical images, high-definition biomedical images, clinical protocols, examination bookings and specialist reports.

43. The method according to any one of claims 25 to 42, comprising a step of authorizing access to the data contained in said local (2) and/or integrated (4) patient records.

44. The method according to any one of claims 25 to 43, comprising a step of data exchanging between a listening center and one or more of said local (2) and/or integrated (4) patient records.