JP2012232114A - Medical diagnostic apparatus and medical data collection system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical diagnostic apparatus and medical data collection system which easily create TCE.SOLUTION: The medical diagnostic apparatus includes: a workflow acquiring/creating part for acquiring or creating a workflow; a trigger information setting part for setting trigger information to collect TCE object data for research, education or clinical trial from the workflow; an operation execution part for executing the operation of the workflow; a trigger detecting part for detecting whether a state of executing the operation of the workflow to be executed corresponds to the trigger information or not; a TCE creation part for creating TCE files storing TCE information on the basis of the detection result in the trigger detecting part; and a TCE image transfer part for transmitting the TCE information and the TCE object data by anonymizing the medical data designated by the TCE information.

Description

  Embodiments described herein relate generally to a medical data collection system acquired by a medical diagnostic apparatus.

  In recent years, the movement of computerization and sharing of medical information is rapidly progressing. Within each medical institution, electronic medical records (EMR) such as conventional medical records are performed. At the government and local government level, electronic medical information (EHR) collected from multiple facilities is used. Electronic Health Records). By connecting medical information that has been digitized in this way through a network, there is a strong movement to strengthen the cooperative relationship between hospitals and regional hospitals, and to realize advanced medical treatment through the use of medical IT.

  Here, in order to realize smooth operation of EMR and EHR, IHE (Integrating the Healthcare Enterprise), an international organization that promotes the standardization of medical information systems, aims to standardize the digitization of medical information in the radiology department. An integrated profile is provided (http://www.ihe.net/profiles/index.cfm).

  The clinical trial data acquired by the medical diagnostic apparatus is defined by an export protocol of teaching file and clinical trial data (TCE) in the integrated profile of IHE.

The handling of clinical trial data is presented and proposed as an IHE Technical Framework. (http://www.ihe.net/Technical_Framework/index.cfm: Radiology Technical Framework, Vol.I-Vol.IV)
As a general implementation method of clinical trial data collection, there are a method of collecting clinical trial data from routine examinations such as a medical checkup and a medical examination, and a method of collecting clinical trial data by setting a specialized examination. In order to establish collected clinical trial data as evidence for clinical trials, the number of specimens to be tested must satisfy statistical conditions, and in order to do so, it is necessary to collect a large amount of clinical trial data.

  When sample collection using the above-mentioned TCE is performed, the input work necessary for TCE creation is usually performed manually. If the TCE input operation takes time, the throughput of the number of clinical trial data collection is affected. Therefore, the efficiency of TCE preparation is very effective for clinical trial data collection that requires a large number of samples.

Radiology Technical Framework, Vol.I-Vol.IV) URL (http://www.ihe.net/Technical_Framework/index.cfm):

  The problem to be solved by the present invention is to solve the above problems and provide a medical diagnostic apparatus and a medical data collection system that can easily create a TCE.

  To achieve the above object, a medical diagnostic apparatus according to an embodiment includes a workflow acquisition / generation unit that acquires or creates a workflow, and trigger information for collecting TCE object data for research, education, or clinical trial. A trigger information setting unit that is set from: an operation execution unit that performs the operation of the workflow; a trigger detection unit that detects whether an execution state of the workflow executed by the operation matches the trigger information; and the trigger detection A TCE creation unit that creates a TCE file in which TCE information is stored based on a detection result in the unit, and a TCE image transfer unit that transmits TCE object data obtained by anonymizing medical data specified by the TCE information and the TCE information And having.

It is a block block diagram of the whole medical data collection system in 1st Embodiment. It is a figure which shows the example of a workflow selection screen in the same embodiment. It is a figure explaining the activity in the embodiment. It is a figure explaining trigger information setting in the embodiment. It is a flowchart figure of trigger information transmission in the clinical data collection device in the embodiment. It is a flowchart figure explaining the process in the medical diagnostic apparatus in the embodiment. It is TCE input information in the embodiment. It is a flowchart explaining the process in the medical image storage apparatus in the embodiment. It is a flowchart figure which shows image acquisition with the clinical data collection apparatus in the embodiment. It is a block block diagram of the medical diagnostic apparatus in 2nd Embodiment. It is a conceptual diagram of the medical data collection system in 3rd Embodiment. It is a block block diagram of the medical data collection system in the embodiment. It is a block block diagram of the medical diagnostic apparatus in 4th Embodiment.

First, TCE will be described before the description of the embodiment. Specifically, TCE has the following four types of transfer.
(1) Teaching file Export: A form in which interesting data (images) is acquired and the target examination / image is anonymized and transferred to a storage server for later study.
(2) Clinical Trial Export: A form in which the target examination / image is anonymized and transferred to a storage server for use as clinical trial data.
(3) Research Collection Export: A form in which the target examination / image is anonymized and transferred to a storage server for use in research purposes.
(4) Publication Export: A form in which the target examination / image is anonymized and transferred to a storage server for use in publishing applications (paper materials, writing materials).

  The purpose of each form is different, but the basic usage of TCE is the same for any TCE file that specifies the image ID (key object), user (observer), application, etc. to be inspected when transferring. Then, the object (mainly medical image) specified by the key object of the TCE file is temporarily stored in a general medical image storage device (server) connected to a network such as PACS (Picture Archiving and Communication Systems). Forward.

  In the medical image storage device, the target object is anonymized based on the information of the TCE file and transferred to the TCE image storage device (TCE repository). The user takes out the target object from the TCE image storage device and uses it for a specific application such as a clinical test.

  Here, in the present embodiment, a medical data collection system capable of automatically collecting clinical test data will be described with particular attention to the case of collecting clinical test data of (2). Embodiments for carrying out the invention will be described in detail below with reference to the drawings shown in FIGS.

(First embodiment)
The medical data collection system of this embodiment can be constructed on an image storage communication system such as PACS, and can be easily matched with an existing system. The network 11 stores a plurality of medical diagnostic apparatuses 12A, 12B, and 12C such as an ultrasonic diagnostic apparatus, CT (Comuputed Tomography), and MRI (Magnetic Resonance Imaging), and medical images taken by these medical diagnostic apparatuses 12. A medical image storage device 13 that functions as an image server and a clinical test data collection device 14 that functions as a TCE image storage device (TCE repository) are connected. The network 11 is linked to a network such as HIS (Hospital Information System) or RIS (Radiology Information System) (not shown). The medical diagnostic apparatuses 12A, 12B, and 12C have different configurations, but have a common configuration for realizing the present embodiment. Here, the medical diagnostic apparatus 12A will be described using an ultrasonic diagnostic apparatus as an example.

  The clinical test data collection device 14 includes a workflow acquisition / generation unit 141, a trigger information setting unit 142, a trigger information distribution unit 143, a clinical test data reception unit 144, and a clinical test data storage unit 145. The functions of the clinical trial data collection apparatus 14 are broadly divided into a TCE trigger condition setting unit 146 that sets a trigger for creating a TCE file and a TCE repository 147 that stores TCE objects, as indicated by a dotted frame.

  In the workflow acquisition / generation unit 141, an operator such as a doctor or a laboratory technician acquires and edits a workflow for the ultrasonic diagnostic apparatus 12A stored in advance or creates a new workflow. The workflow here refers to an operation sequence of the ultrasonic diagnostic apparatus 12A described in advance. By sequentially executing this workflow and emulating the operation, the operation of the ultrasonic diagnostic apparatus 12A can be semi-automated. In particular, when a routine inspection such as a medical checkup or a medical checkup is performed, the inspection is often performed using such a workflow. Also, although there are some differences in operation procedures depending on the inspection, there are many cases where almost the same workflow is carried out, so one or more workflows created in advance may be acquired and edited, or newly created. May be.

  The trigger information setting unit 142 sets trigger information for TCE creation for an edited or newly created workflow. This trigger information enables the user to set “association” between the workflow and the collected clinical trial data (target image).

  The trigger information distribution unit 143 transmits the trigger information in which the workflow and clinical test data (target image) are “associated” to the ultrasonic diagnostic apparatus 12A.

  As will be described later, each of the medical diagnostic apparatuses 12A, 12B, and 12C detects whether the trigger information for creating the TCE matches the operation procedure executed according to the workflow. When executed, sampling of clinical trial data is automatically performed, and clinical trial data is efficiently collected as a sample.

  The clinical test data receiving unit 144 receives clinical test data based on the trigger information from the medical image storage device 13 and stores it in the clinical test data storage unit 145.

  The ultrasonic diagnostic apparatus 12 </ b> A includes a trigger information reception unit 121, an authentication unit 122, an operation execution unit 123, a trigger detection unit 124, a local image storage unit 125, a TCE creation unit 126, and a TCE image transfer unit 127.

  The trigger information receiving unit 121 receives trigger information sent from the trigger information distribution unit 143. The authentication unit 122 authenticates whether the trigger information can be accepted.

  An operator such as a doctor or a laboratory technician executes a menu called an activity that constitutes a workflow using an operation device connected to the operation execution unit 123. When the activity is executed, the operation execution unit 123 generates the event.

  The trigger detection unit 124 detects whether the event type corresponding to the activity, the occurrence order, the combination, and the like match the conditions of the received trigger information.

  The local image storage unit 125 stores a medical image when an activity corresponding to image storage is executed. However, depending on the workflow conditions, the image may be stored in a medical image storage device via a network.

  The TCE creation unit 126 creates a TCE when an operation that matches the trigger information is performed. At this time, an image ID necessary for TCE creation is acquired as a key object. The TCE image transfer unit 127 transmits a medical image corresponding to the TCE file and the image ID to the medical image storage device 13. Here, the dotted arrow in the figure indicates the movement of the TCE file.

  The medical image storage device 13 includes a TCE image reception unit 131, a server image storage unit 132, an anonymization processing unit 133, and a clinical test data transmission unit 134.

  The TCE image receiving unit 131 receives the TCE file and the medical image corresponding to the image ID from the TCE image transfer unit 127 and stores them in the server image storage unit 132.

  The anonymization processing unit 133 anonymizes privacy data such as personal information based on the received TCE file, and the clinical test data transmission unit 134 transmits the clinical test data together with the TCE file to the clinical test data collection device 14.

  FIG. 2 shows an example of a workflow selection screen operated by the workflow acquisition / generation unit 141. For example, workflows A to G are displayed in advance for examinations often performed by the ultrasonic diagnostic apparatus 12A. Here, it is assumed that “6. Contrast medium inspection” in workflow F is selected. Then, the activity for the workflow F as shown in FIG. 3 is displayed.

  The workflow F includes, for example, four activities 31 of “Peripheral”, “Pre Phase”, “CHI Phase”, and “Initialize”. By selecting each activity 31, the setting window 32 and the subflow windows 33, 34, 35 is displayed.

  The workflow F will be specifically described below. The workflow showing this contrast agent inspection is a workflow in which a contrast agent is administered to a blood vessel and an ultrasound image is collected.

  “Peripheral” is an activity that means implementation of peripheral device settings. When this “Peripheral” is selected, a setting window 32 is displayed. In this example, the output destination of the image is output to an external storage device (local image storage unit 125 in FIG. 1) built in or directly connected to the medical diagnostic apparatus 12A such as MO or HDD, or the network connection destination is an IP address. The output is set in the network image server (for example, the server image storage unit 132 in FIG. 1).

  “Pre Phase” is the activity of the phase before the contrast medium is administered. By selecting “Pre Phase”, the subflow window 33 is displayed. In this example, screening is performed in various display modes performed in a THI (Tissue Harmonic Imaging) imaging mode. “Pre Phase” is expanded into subflows and executed in the order shown in the subflow window 33.

  The “THI” imaging mode is a mode for imaging using harmonic components of ultrasonic waves, and a clear imaging with reduced noise can be obtained. “MMode” means a Motion (M) mode of an ultrasonic image. The M mode refers to a mode in which attention is paid to a certain straight line on the cross section and the change with time of sound wave reflection is imaged there. “Archive” is a flow of collecting a series of data in which images are stored and printed. Specific operations include “Freeze” (operation for stopping the display state), “Still Store” (operation for saving a still image), “Print” (operation for printing a still image), “Unfreeze” (freeze state). Operation).

  “Dual” is a two-screen display mode. “CDI” is a color display (Color Doppler Imaging) mode, which displays the flow velocity and the like in color using the Doppler effect. “PW” is a pulse Doppler display (Pulse Wave imaging) mode in which imaging is performed using the PW method.

  “CHI Phase” is an activity in an imaging mode in which imaging is performed in a contrast enhancement (CHI: Contrast Harmonic Imaging) mode so that a contrast agent can be clearly imaged when the contrast agent is administered. By selecting “CHI Phase”, the subflow window 34 is displayed. “CHI Phase” is expanded into subflows and executed in the order shown in the subflow window 34.

  “1.5H” is a CHI mode (contrast-enhanced imaging mode) in which 1.5 Harmonic is a set value. “Annotation” allows characters and marks to be input on the ultrasound screen. For example, an arrow mark is attached to the region of interest.

“VCR REC” is a shooting start operation for a video or a DVD. “Injection” is an operation when a contrast agent is introduced. “Time Start” is a timer start operation for recording how many seconds have passed since the contrast medium was introduced.

“Flash ON” is an operation of flashing the display screen in order to form a clearer image of the contrast agent. “Clip Store” is an operation to save the degree of staining of each tissue in the screen by contrast medium administration as a moving image. “Flash OFF” is an operation to turn off the flash on the display screen.

“Depth Chg” is an operation of increasing or decreasing the depth direction of the display screen.

“VCR Stop” is a video / DVD shooting stop operation. “Time Stop” is a timer stop operation for recording how many seconds have passed since the contrast medium was introduced.

  “Initialize” is an activity that initializes the display state and returns it to the original state for the next CHI inspection. By selecting this “Initialize”, the subflow window 35 is displayed. “Initialize” is expanded into subflows and executed in the order shown in the subflow window 35.

  “ANNO CLR” is an operation for clearing the above “Annotation” (characters or marks on the screen). “BM CLR” is an operation for clearing a body mark (posture mark) displayed on the screen. The workflow described above has no operation for setting a body mark. However, if a body mark has been added in another previous workflow or the like, it is cleared by this operation. “2D” is an operation for setting the 2D display mode. This is an operation to return to the so-called B mode single screen display state.

  Next, trigger setting for a workflow performed by the trigger information setting unit 142 will be described. As for the workflow, the “contrast medium inspection” shown in FIG. 3 is performed. FIG. 4 is a diagram illustrating the trigger setting screen. The trigger setting screen 40 can display a workflow 41 indicating “contrast medium examination” and subflows 42, 43, and 44, respectively, when each activity constituting the workflow 41 has a subflow.

  To the left of each activity, for example, a marking indicated by a black circle or a white circle for setting trigger information is set. In this example, a black circle indicates that all of the activities under control of the activity are marked, and a white circle indicates that a part of the activities under control of the activity is marked. That is, in “Pre Phase”, all subordinate activities are selected, while in “CHI Phase”, a part of the subordinate activities is selected. In addition, when there are further subflows, the same notation is applied to the subflows.

  In this example, since the activity “Pre Phase” of the phase before administration of the contrast agent is fully selected as the trigger condition, the motion mode (“MMode”), the color Doppler mode (“CDI”), and the pulse Doppler mode are selected. The image saved with “PW” is acquired as clinical trial data. Further, a part of “CHI Phase” is selected as a trigger, and a video image in which a flash is turned on at the time of contrast medium administration is acquired as clinical test data.

  Next, a flowchart up to trigger information transmission in the clinical trial data collection device 14 will be described with reference to FIG.

  First, the operator uses the workflow acquisition / generation unit 141 to acquire a workflow of a medical diagnostic apparatus that is to be collected as clinical test data (step ST501). This workflow may be acquired from each medical diagnosis apparatus via the network 11 or may be stored in advance in the clinical test data collection apparatus. These may be used after being edited or newly created (step ST502).

  Next, as shown in FIG. 4, in step ST503, the trigger information setting unit 142 is used to mark an activity to be collected as clinical trial data.

  In step ST504, the trigger logical mode is selected and registered for the marked activity. For example, “order specification” mode that triggers when operations are performed according to the workflow sequence order, “discontinuous” mode that triggers even if other operations are entered during the workflow sequence, and workflow sequence The “combination” mode in which a trigger is generated even if the order is changed is appropriately selected in consideration of inspection contents and workflow. As a result, it is possible to set the optimum collection conditions for the examination contents, so that efficient clinical trial data collection can be performed.

  Next, in step ST505, authentication data such as a user name of a person who collects clinical trial data and a password necessary for authentication are set. Normally, this user name may match the item of the user (observer) specified by TCE. The input items of TCE will be described later.

  In step ST506, the trigger information created in steps ST503 to ST505 is transmitted to the ultrasonic diagnostic apparatus 12A.

  Next, processing in the ultrasonic diagnostic apparatus 12A will be described using the flowchart shown in FIG. The trigger information transmitted from the clinical test data collection device 14 is received by the trigger information receiving unit 121 (step ST601). At this time, in the next step ST602, the authentication unit 122 determines whether or not the trigger information is authorized and appropriate. If the authentication is OK (step ST602: Yes), the trigger information is taken into the trigger detection unit 124. If the authentication is NG (step ST602: No), this trigger information is not accepted, and the fact that the authentication is impossible is returned to the clinical trial data collection device 14 (step ST603).

  In step ST604, an operator such as a doctor or a laboratory technician selects a desired workflow as shown in FIG. 2, operates the operation device connected to the operation execution unit 123, and proceeds with the inspection.

  In step ST605, it is detected whether the activity operated according to the workflow matches the trigger information. If it matches the trigger information (step ST605: Yes), it interprets that the desired clinical trial data has been acquired, and acquires the image ID (key object) stored when the workflow is executed.

  Then, the TCE creation unit 126 creates a TCE file. As shown in FIG. 7, the input items of the TCE file are as follows: (1) TCE Title indicating usage such as clinical trial data, (2) Key Object indicating mainly image ID, and (3) Observer indicating users such as doctors. (4) Export Destination indicating a transmission destination.

  This TCE file includes input items for TCE information defined by the standards as described above and input items for TCE information arbitrarily set by the user. An embodiment using informed consent confirmation information added to TCE information arbitrarily set by the user and using this will be described later.

  In step ST607, the medical image read from the created TCE and image ID is transmitted to the medical image storage device 13 via the network 11.

  The process performed by the medical image storage device 13 will be described with reference to FIG. In step ST801, the TCE file and medical image sent from the ultrasound diagnostic apparatus 12A are received. Then, the medical image is temporarily stored in the server image storage unit 132 (step ST802).

  Thereafter, in step ST803, a medical image is acquired from the server image storage unit 132 based on the image ID described in the received TCE file, and the portion corresponding to personal information is anonymized (clinical data). In step ST904, the data is transmitted to the clinical test data collection device 14 together with the TCE file.

  Furthermore, the process in the clinical test data collection device 14 will be described with reference to the flowchart shown in FIG. In step ST <b> 901, the clinical test data receiving unit 144 receives the TCE object data storing the TCE file and clinical test data transmitted from the medical image storage device 13. Thereafter, in step ST902, the TCE file and clinical test data are stored in the clinical test data storage unit 145.

  After the above steps, the clinical trial data collector accesses for the purpose of using and referring to the clinical trial data stored in the clinical trial data storage unit 145.

  As described above, according to the first embodiment, for an image desired to be acquired as clinical test data, the marking for the activities constituting the workflow used in the medical diagnostic apparatus is performed to acquire the clinical test data. Trigger information can be set. A TCE file is automatically generated based on this trigger information, and anonymized clinical trial data can be acquired based on the TCE file.

  As a result, the time required for input to the TCE file, which is normally performed manually, is shortened, and the operator automatically saves clinical trial data without spending time for image classification and selection for TCE. It can be collected. This makes it easy to obtain large numbers of specimens to establish clinical trial evidence.

(Second Embodiment)
In the present embodiment, workflow acquisition / generation and trigger information can be set also in the medical diagnostic apparatuses 12A, 12B, and 12C.

  FIG. 10 is a block configuration diagram of the medical diagnostic apparatus 12. The difference from the medical diagnostic apparatus 12A of FIG. 1 is that a workflow acquisition / generation unit 141 and a trigger information setting unit 142 are provided in the medical diagnostic apparatus 12. In some cases, an anonymization processing unit for the TCE object is provided in the TCE image transfer unit 127.

  With such a configuration, trigger information can be set independently for each medical diagnostic apparatus as well as the clinical test data collection apparatus 14, so that detailed trigger settings can be made by the doctor in charge.

  Further, if the anonymization process is performed by the TCE image transfer unit 127, the clinical test data can be directly transmitted to the clinical test data collection device 14 at a remote location without going through the medical image storage device 13.

  This produces an effect that the TCE object can be generated even in a relatively small hospital that does not have a network such as PACS, so that clinical test data can be transmitted to the remote clinical test data collection device 14.

(Third embodiment)
In this embodiment, informed consent indicating whether or not patient medical data can be widely used as anonymized clinical trial data is obtained, and when the propriety is “Yes”, the anonymized clinical trial is obtained. An embodiment for transmitting data to the clinical trial data collection device 14 will be described. The clinical trial data collection device 14 is connected to a WAN (Wide Area Network), and is used not only in Japan but also from multiple facilities (hospitals) around the world for TCE object data (for clinical trial data, education and research). Medical information).

  FIG. 11 is a conceptual diagram of the medical data collection system of this embodiment. A plurality of facilities (here, hospital A, hospital B, and hospital C) are connected to the WAN 16. In hospitals A, B, and C, a medical diagnostic device 12, a medical image storage device 13, a medical chart system 15, and the like are connected to the hospital network, and TCE object data collected by the medical diagnostic device 12 of each hospital is clinically used. The data is transmitted to the test data collection device 14. Thereby, the clinical test data collection device 14 connected to the WAN 16 collects anonymized TCE object data (clinical test data) from a plurality of facilities.

  Further, not only the clinical trial data collection device 14 but also the TCE object data collection device corresponding to each transfer form according to the TCE Title and Export Destination indicated in the TCE information in the TCE file. In the example of FIG. 11, research TCE object data is collected in the research data collecting device 17, and educational TCE object data is collected in the educational data collecting device 18. The WAN 16 functions as a cloud, and an Observer terminal 19 connected to the WAN 16 can access TCE object data stored in the clinical trial data collection device 14.

  Further, as described above, the TCE object data is anonymized and, in principle, with a limited number of viewers, but is collected from a plurality of facilities around the world and released for education, research, or clinical trials. For this reason, it is considered preferable to obtain a patient's consent form (informed consent) regarding whether or not the patient's own medical image may be disclosed.

  FIG. 12 is a block diagram of a medical data collection system according to the third embodiment. Note that the clinical test data collection device 14, the research data collection device 17, and the education data collection device 18 in FIG. 11 are referred to herein as TCE object data collection devices.

  Accordingly, in FIG. 12, the clinical test data collection device 14 is the TCE object data collection device 14b, the clinical test data transmission unit 134 is the TCE object data transmission unit 134b, the clinical test data reception unit 144 is the TCE object data reception unit 144b, and the clinical The test data storage unit 145 will be described by changing it to a common name with the TCE object data storage unit 145b.

  As shown in FIG. 12, in addition to the block configuration diagram of FIG. 1, a standard condition setting unit 148 is added to the TCE trigger condition setting unit 146 of the TCE object data collection device 14b (clinical trial data collection device 14 of FIG. 1). The Further, an inquiry unit 128 for informed consent is added to the medical diagnostic apparatus 12. Furthermore, an informed consent determination unit 135 is added to the medical image storage device 13. A chart system 15 that manages chart information including informed consent is connected to the network 11.

  The standard condition setting unit 148 can determine the trigger information in consideration of differences in standards and regulations depending on the facility and country. By setting the trigger information based on the international standard in the standard condition setting unit 148, the TCE object data collection device 14b (clinical test data collection device 14) allows the TCE object data in accordance with the integrated profile based on the international standard. (Clinical trial data) can be collected. For example, in a radiological examination apparatus such as a CT apparatus, it is possible to collect medical data in which irradiation dose and related information are handled in an integrated manner.

  When the trigger detection unit 124 detects a match with the trigger information for generating the TCE object file, the trigger detection unit 124 transmits a detection signal to the inquiry unit 128.

  Then, the inquiry unit 128 transmits information indicating that acquisition of informed consent is necessary to the medical chart system 15 via the network 11.

  In this embodiment, informed consent confirmation information corresponding to an image ID (key object) acquired during execution of a workflow is added to the TCE file as new TCE information.

  As the confirmation information of the informed consent, “unacquired” information is input until “inhibition” of the informed consent is obtained. This is to cope with a case where informed consent is not obtained at the examination stage in which the workflow is executed. Even if the confirmation information of the informed consent is “not acquired”, the TCE file and the TCE object data as the target are generated.

  The chart system 15 uses the inquiry signal sent from the inquiry unit 128 as a trigger to search whether there is an informed consent of the patient for each corresponding examination order. Then, the result of whether the informed consent is “not acquired” or “acquired” is transmitted to the informed consent determination unit 135 of the medical image storage device 13. Further, when the informed consent is “acquired”, the information about “possibility” of the informed consent is also transmitted.

  Then, the informed consent determination unit 135 of the medical image storage device 13 generates a TCE object (clinical test data) as a TCE object data collecting device only when the informed consent is “acquired” and the content is “possible”. 14b. At this time, the confirmation information of the informed consent for the key object of the TCE file is transmitted as “OK”.

  Further, when the informed consent is “not acquired”, the informed consent determination unit 135 performs polling at a predetermined time interval and a predetermined number of times until “informed consent” is obtained.

  As described above, according to the third embodiment, the TCE object data collection device 14b can handle only medical data for which informed consent is obtained. Further, since medical data can be collected according to the integrated profile based on the international standard, anonymous medical data can be handled in an integrated manner.

(Fourth embodiment)
Further, as shown in FIG. 13, a standard condition setting unit 148b, an inquiry unit 128b, and an informed consent determination unit 135b may be provided in the medical diagnostic apparatus 12. The operation of each part is the same as in the third embodiment.

  However, this embodiment is an embodiment applicable to a small hospital or the like that does not have an electronic medical chart system. When there is no medical chart system 15, the inquiry unit 128 b displays a message such as “Please obtain an informed consent” on a monitor (not shown) of the medical diagnostic apparatus 12.

  The operator explains “informed consent” to the patient during or after diagnosis, and if the patient approves, the operator can enter the information on the informed consent input screen displayed on the monitor (not shown) of the medical diagnostic apparatus 12. Enter “Yes / No” for the form consent.

  The informed consent determination unit 135b transmits the anonymized TCE object data to the TCE object data collecting device 14b based on the input “confirmation” of the informed consent.

  With such a configuration, in addition to the effects of the second and third embodiments, an anonymous informed consent is made directly to the remote TCE object data collection device 14b without going through the medical image storage device 13. Medical data can be transmitted.

  According to the medical diagnostic apparatus and the medical data collection system of the present embodiment, marking of activities constituting a workflow used in the medical diagnostic apparatus is given to medical data such as education, research, or clinical trial data to be acquired. Thus, trigger information for acquiring medical data including clinical trial data can be set. A TCE file is automatically generated by this trigger information, and anonymized medical data can be acquired. As a result, the time required for the input operation to the TCE file, which is normally performed manually, is reduced, and the operator is automatically anonymized without spending time for image classification and selection for TCE. Medical data can be collected. This makes it easy to obtain large numbers of specimens to establish evidence for education, research, or clinical trials.

  In this embodiment, for the sake of explanation, clinical trial data has been mainly described. However, TCE objects for education and research can also be applied. Further, although medical image data has been described as an example of the TCE object, medical records, diagnosis result reports, and the like can be handled in the same embodiment.

  In addition, this embodiment can be easily matched with existing systems such as PACS, and can also be applied to networks that do not have PACS or the like.

  The present invention is not limited to the above embodiment, and various modifications are possible. For example, the workflow in the ultrasonic diagnostic apparatus shown in the above embodiment is merely an example, and can be applied to other workflows such as a CT apparatus and an MRI apparatus.

  Further, although the embodiment has been described in a form conforming to TCE, the effect of the present embodiment can be exhibited without necessarily conforming to TCE.

  Although several embodiments of the present invention have been described, these embodiments are presented by way of example and are not intended to limit the scope of the invention. These novel embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the scope of the invention. These embodiments and modifications thereof are included in the scope and gist of the invention, and are included in the invention described in the claims and the equivalents thereof.

11 ... Network 12, 12A, 12B, 12C ... Medical diagnostic equipment (12A ultrasonic diagnostic equipment)
DESCRIPTION OF SYMBOLS 13 ... Medical image storage apparatus 14 ... Clinical test data collection apparatus 121 ... Trigger information receiving part 122 ... Authentication part 123 ... Operation execution part 124 ... Trigger detection part 125 ... Local image storage part 126 ... TCE preparation part 127 ... TCE image transfer part 128 ... inquiry unit 131 ... TCE image reception unit 132 ... server image storage unit 133 ... anonymization processing unit 134 ... clinical trial data transmission unit 135 ... informed consent determination unit 141 ... workflow acquisition / generation unit 142 ... trigger information setting unit 143 ... trigger information distribution unit 144 ... clinical test data receiving unit 145 ... clinical test data storage unit 146 ... TCE trigger condition setting unit 147 ... TCE repository 148 ... standard condition setting unit

Claims (11)

A workflow acquisition / generation unit that acquires or creates a workflow,
A trigger information setting unit for setting trigger information for collecting TCE object data for research, education or clinical trial from the workflow;
An operation execution unit for performing the operation of the workflow;
A trigger detection unit for detecting whether or not an execution state of the workflow to be executed is identical to the trigger information;
A TCE creation unit that creates a TCE file in which TCE information is stored based on a detection result in the trigger detection unit;
A TCE image transfer unit that transmits TCE object data obtained by anonymizing medical data specified by the TCE information and the TCE information;
A medical diagnostic apparatus.   The medical diagnosis apparatus according to claim 1, wherein the trigger information setting unit determines trigger information according to an order and a combination of execution states of activities.   The medical diagnostic apparatus according to claim 2, wherein the trigger information setting unit sets the trigger information by marking a corresponding activity in the workflow.   The medical diagnostic apparatus according to claim 3, further comprising an inquiry unit that confirms an informed consent of a patient based on a detection result of the trigger detection unit.   The medical diagnostic apparatus according to claim 4, wherein the TCE object data is transmitted to a TCE object data collection apparatus when a patient's informed consent is possible. A workflow acquisition / generation unit for acquiring or creating a workflow of a medical diagnostic apparatus;
A trigger information setting unit for setting trigger information for collecting TCE object data for research, education or clinical trial from the workflow;
A trigger information distribution unit for transmitting the trigger information to the medical diagnostic device;
A TCE object data receiving unit for receiving TCE object data collected by the trigger information;
A TCE object data storage unit for storing the TCE object data;
A medical data collection system. A medical data collection system comprising a TCE object data collection device, a medical diagnosis device, and a medical image storage device,
The TCE object data collection device
A workflow acquisition / generation unit for acquiring or creating a workflow of the medical diagnostic apparatus;
A trigger information setting unit for setting trigger information for collecting TCE object data for research, education or clinical trial from the workflow;
A trigger information distribution unit for transmitting the trigger information to the medical diagnostic device;
A TCE object data receiving unit for receiving TCE object data collected by the trigger information;
And a TCE object data storage unit for storing the TCE object data;
Have
The medical diagnostic apparatus comprises:
A trigger information receiving unit for receiving the trigger information;
An operation execution unit for operating the workflow;
A trigger detection unit for detecting whether the operation-executed workflow matches the trigger information;
A TCE creation unit that creates a TCE file in which TCE information is stored based on a detection result in the trigger detection unit;
A TCE image transfer unit that transmits the TCE information and medical data specified by the TCE information;
Have
The medical image storage device includes:
A TCE image receiving unit for receiving the TCE file and the medical data;
A server image storage unit for storing the TCE file and the medical data;
Based on the TCE information, anonymization processing is performed on the medical data and converted into the TCE object data;
A TCE object data transmission unit for transmitting the TCE object data to the TCE object data collection device;
A medical data collection system.   The medical data collection system according to claim 6 or 7, wherein the trigger information setting unit determines trigger information according to an order and a combination of execution states of the activities.   The medical data collection system according to claim 8, wherein the trigger information setting unit sets the trigger information by marking a corresponding activity in the workflow. A workflow acquisition / generation unit that acquires or creates a workflow,
A trigger information setting unit for setting trigger information for collecting medical data for research, education or clinical trial from the workflow;
The workflow is operated using an operation device, whereby an operation execution unit for collecting medical data;
A trigger detection unit for detecting whether or not an execution state of the workflow to be executed is identical to the trigger information;
A collection information creation unit for creating medical data collection information based on a detection result in the trigger detection unit;
A medical diagnostic apparatus.   The medical diagnostic apparatus according to claim 10, further comprising: a data transfer unit configured to anonymize medical data designated by the medical data collection information and to transmit the anonymized medical data when informed consent is possible.

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