Medical Device Sample Provision Program, Medical Device Sample Provision System, and Medical Device Sample Provision Method

Abstract

Provide a program or the like that appropriately determines whether a medical device sample requires a trial form, whether the sample applicant is a doctor, etc., and creates a proper trial form. 【Solution means】The medical device sample providing system 1 determines whether a medical device sample requires a trial form, and whether the user has a doctor's qualification or not. When clinical trial medical devices can be provided, it creates a form in accordance with the rules for providing clinical trial medical devices and transmits it to the medical device business operator together with the application information for the clinical trial medical devices. In addition, the medical device sample providing system 1 has a sample evaluation function etc. that enables a doctor to transmit online to the business operator regarding the use evaluation of clinical trial medical devices.

Description

Technical Field

[0001] The present invention relates to a medical device sample providing program, a medical device sample providing system, and a medical device sample providing method.

Background Art

[0002] The efforts of many people in various fields, such as the technology related to doctors, the technology related to pharmaceuticals and preparations, and the technology related to medical devices, have contributed to the progress of medical technology. Taking medical devices as an example, it can happen daily that in a certain medical institution, when a doctor actually touches, examines, and adopts excellent medical devices, the medical level of that medical institution is improved.

[0003] However, as a problem for medical institutions and doctors, there is a problem of a gap in the medical device information they possess. That is, the information gap of medical devices and the resulting gap in medical levels. This is because there are few means to collect medical device information.

[0004] Medical device manufacturers try to publicize their own products and the like through sales efforts, but there are limitations in human resources. Even if there are exhibitions, not all manufacturers and others providing medical devices can participate in all exhibitions, and also doctors and medical institutions using medical devices do not always have the opportunity to participate in exhibitions.

[0005] Also, even if a medical device that a doctor wants to use is found, in many cases, it may not be adopted for medical devices that have not been actually used.

[0006] For the purpose of doctors and others evaluating the safety and effectiveness of medical devices, medical device operators can provide trial medical devices, so-called samples, to medical staff free of charge. Trial medical devices can be classified into shape samples that are not recognized for clinical use and clinical trial medical devices that can be used clinically.

[0007] Patent Document 1 discloses an orthopedic instrument lending system that streamlines the operations of physicians, medical device dealers, and medical device manufacturers.

Prior Art Document

Patent Document

[0008]

Patent Document 1

[0009] Incidentally, regarding the free provision of trial medical devices, from the perspective of preventing unfair trade inducement acts, industry groups have established fair competition regulations, require a prior written request from physicians, etc., and have defined a "Clinical Trial Medical Device Trial Use Form" (hereinafter sometimes referred to as the "trial use form") as evidence thereof. That is, when providing clinical trial medical devices, physicians, etc. need to create documents in accordance with the standards defined by industry groups, so there is a need for software or the like that automatically creates such documents.

[0010] In addition, although the above regulations also define restrictions on the quantity that can be provided, businesses need to appropriately manage the quantity provided so as not to exceed this limit.

Summary of the Invention

Problems to be Solved by the Invention

[0011] There is no program, system, etc. that appropriately determines whether a medical device sample requires a trial use form and whether the sample applicant is a physician, and creates a proper trial use form with simple operations.

Means for Solving the Problems

[0012] The present invention determines whether a medical device sample requires a trial use form and whether the user has a physician qualification or not (for example, a nurse, a technician, etc.). Determine whether the user has the medical doctor qualification to provide clinical trial medical devices. If the clinical trial medical devices can be provided, it has the most important feature of having a function to create forms in accordance with the rules for providing clinical trial medical devices and a function to transmit the application information of the clinical trial medical devices to the operator. In addition, the present invention has a sample evaluation function and the like that allows a doctor to transmit an online evaluation of the use of the provided clinical trial medical device to the operator.

[0013] The present invention has been made in view of the above problems, and for example, the following means are adopted. That is, the computer is Medical staff information acquisition means for acquiring information of medical staff, Operator information acquisition means for acquiring information of an operator who provides medical devices, Medical device information acquisition means for acquiring medical device information by the operator, Sample application acquisition means for acquiring an application for a medical device sample by medical staff, Form necessity determination means for determining whether a predetermined form is required when the medical device sample is provided, Doctor determination means for determining whether the medical staff is a doctor when the form is required, Form description information acquisition means for acquiring information necessary for creating the form, Completed form creation means for creating a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form, Function as completed form transmission means for transmitting the completed form to the operator, The medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required, and provides a medical device sample provision program.

Effects of the Invention

[0014] The medical device sample providing program of the present invention has the advantage of appropriately determining whether a medical device sample requires a predetermined form (trial use form), whether the sample applicant is a doctor, etc., and creating a proper form (trial use form) with a simple operation. According to the present invention, a doctor can obtain the experience of using a medical device that he / she has never used before. And by promoting the effective and fair use of clinical trial medical devices according to the present invention, social issues such as the information gap of medical devices and the resulting gap in medical standards are solved.

Brief Description of the Drawings

[0015]

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Modes for Carrying Out the Invention

[0016] Embodiments of the present invention will be described with reference to the drawings. In the following embodiments, the same or corresponding parts may be denoted by the same reference numerals and the description thereof may be omitted as appropriate. In addition, the drawings used below are for explaining this embodiment, and may be different from the actual device configuration, user interface (UI), data configuration, etc.

[0017] (Overview of the Embodiment) The overview of this embodiment will be described with reference to FIG. 1. FIG. 1 is a diagram (network diagram) showing an overview of a system (hereinafter referred to as "medical device sample providing system 1") that performs processing by a medical device sample providing program P1 of this embodiment. The medical device sample providing system 1 includes a server 10, a medical staff terminal 20 (hereinafter referred to as "terminal 20"), and a business operator terminal 30 (hereinafter referred to as "terminal 30").

[0018] (Details of the Embodiment) Hereinafter, the medical device sample providing system 1 according to this embodiment will be described in detail. The medical device sample providing system 1 includes a computer (server 10) having a medical device sample providing program P1, and provides an online system that facilitates the provision of medical device samples to medical staff and business operators. That is, in the medical device sample providing system 1, the information processing by the medical device sample providing program P1 is specifically realized using hardware resources. Hereinafter, the 1. user interface, 2. program processing, 3. data, and 4. hardware configuration, which constitute the medical device sample providing system 1, will be described in order.

[0019] (Definition of Terms) Here, some terms will be defined. "Doctor" refers to a doctor or dentist who belongs to a medical institution and has a doctor's qualification to perform medical acts legally. "Medical personnel" refers to those who belong to a medical institution, such as doctors, nurses, or medical technicians (medical technologists), and who are involved in the use, selection, or purchase of medical devices in the course of their duties, regardless of whether they are employees or employers. In the case of doctors, etc., it may refer to medical personnel, or may include medical institutions in addition to medical personnel. "Medical institution" is an organization to which medical personnel belong. For example, it is an organization that provides medical care or conducts research related to medicine, such as a hospital, clinic, or nursing home for the elderly. "Business operator" refers to a corporation that discloses product information through the medical device sample providing system 1 or a natural person such as an employee belonging to the corporation, such as a medical device manufacturer, a medical device seller, and those equivalent to them. "User" is an individual or corporation that uses the medical device sample providing system 1, including at least medical personnel and business operators. "Administrator" is an individual or corporation that manages the medical device sample providing system 1. It has privileges regarding the medical device sample providing system 1 and has higher authority than users. For example, it is an operator, service provider, or maintenance business operator (technician) of the medical device sample providing system 1. "Medical device" is a mechanical instrument (product) that is intended to be used for the diagnosis, treatment, or prevention of diseases of humans or animals, or to affect the structure or function of the body of humans or animals. In the following embodiments, it is a medical device defined in Article 2, Paragraph 4 of the "Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc." (Pharmaceutical and Medical Device Act). "Medical sundries" refers to products used for medical practice other than medical devices. "Product" refers to an article that is being manufactured and sold or an article that is planned to be manufactured and sold. The term "product" includes medical devices, medical sundries, and articles for demonstration. "Sample" is a medical device (especially a clinical trial medical device) or medical sundry that is provided free of charge to a medical institution, etc. for the purpose of clinical trial to contribute to the evaluation of efficacy and safety prior to the use of the medical device by medical personnel. In this specification, the term "medical device sample" may include not only medical devices but also medical supplies or demonstration mechanical instruments. "Documents" are the documents required for the provision of clinical trial medical devices. Here, in particular, it refers to the formats specified in the Fair Competition Rules for the Medical Device Industry. Documents with formats and the like determined by such rules are referred to as "prescribed documents". For example, there is the "Clinical Trial Medical Device Trial Form", which certifies the "request in writing by a doctor or the like" required when providing clinical trial medical devices and has a prescribed format in the Fair Competition Rules for the Medical Device Industry. In the following, the "Clinical Trial Medical Device Trial Form" may sometimes be simply referred to as the "trial form". In addition to the above, there is the Clinical Trial Medical Device Receipt Form, which is a written document certifying that a medical institution or the like has received a clinical trial medical device, and the Fair Competition Rules for the Medical Device Industry oblige business operators to obtain and store it. "Trial amount" is the amount of the (trial) medical device. "Number of use days (times)" is the number of days or times that the medical device is (planned to be) used. "Number of cases" is the number of patients (planned to) use the medical device. "Pressing" means an operation for selection or determination, such as a mouse click or a tap.

[0020] In the following, when it is described as "○○" processing, it means that the computer's processor executes processing based on the "○○" program stored in the program storage unit. In this paragraph, the same word is entered in the "○○" part. That is, the "○○" program is a program that causes the computer to function as "○○" means by executing the "○○" processing. At this time, it also means that the control unit equipped with the processor functions as the "○○" unit (or "○○" device). In this case, the "○○" unit means executing the "○○" processing based on the "○○" program. Also, the "○○" processing may be expressed as an "○○" method including a plurality of steps (or procedures) along the time series.

[0021] For example, the medical device sample providing program P1 is a program that causes a computer to function as a medical device sample providing means by executing a medical device sample providing process. At this time, the control unit 12 of the computer including the processor 122 functions as a medical device sample providing unit 130 (or a medical device sample providing device).

[0022] In the medical device sample providing system 1, each terminal (computer) such as the terminal 20 includes a processor. When simply referring to the processor, it refers to the processor that performs processing by the medical device sample providing program P1, which is the processor 122 of the server 10 in the present embodiment.

[0023] In the following, for simplicity, "the processor 122 of the server 10 receives a request from a terminal and returns data to be displayed on the browser of the terminal" may be described as "the processor 122 displays (causes to display) on the browser of the terminal" or "the processor 122 displays (causes to display)". Similarly, "the processor 122 of the server 10 causes the data storage unit 14b of the storage unit 14 to store data" may be described as "the processor stores (causes to store) (data)".

[0024] 1. User Interface (UI) First, the interface that the medical device sample providing system 1 of the present embodiment causes to be displayed on the terminal 20 will be described with reference to the drawings. The interface described hereinafter is a simplified version of what the processor 122 causes to be displayed on the browser of the terminal 20.

[0025] Also, only icons and the like related to functions necessary for the description are displayed, and other known icons and the like are omitted. For example, a back button for returning to the previously displayed page is omitted. In addition, those having the same name but different functions, such as a "send button", are included.

[0026] Figure 2 is a diagram showing a medical staff registration screen. The medical staff registration screen includes an information registration section UI-11 and a registration button UI-12, and medical staff such as doctors input their own information. In this embodiment, the information registration section UI-11 includes a text box, a radio button, or a pull-down menu.

[0027] After inputting the information, when the medical staff presses the registration button UI-12, the input information is sent to the server 10. Then, the server 10 stores the acquired information.

[0028] As shown in Figure 2, the information registration section UI-11 includes input sections (input fields) for inputting name, date of birth, gender, presence or absence of doctor qualification, doctor registration number, registration date, name of the workplace, address of the workplace (prefecture, etc.), and name of the department / section (department or section) to which the user belongs at the workplace. Note that the term "input section" used in this section of the user interface may be different from the term "input section" used in the hardware section.

[0029] In addition to the above in this embodiment, contact information (such as email address and / or phone number), and areas of interest can also be input. The items that can be input on the medical staff registration screen are not limited to the above, and other items may also be input.

[0030] The differences in permissions when the user is a doctor or other medical staff will be described later (Table 1).

[0031] In addition to the medical staff registration screen, there is also a business operator registration screen as the user interface of this embodiment. Although the registration items are different, the user interface is the same, so the description is omitted.

[0032] Figure 3 is a diagram showing a medical device registration screen. The medical device registration screen includes an information registration section UI-13 and a registration button UI-14, and the operator inputs the information of the medical device (medical device information).

[0033] After the information is input, when the operator presses the registration button UI-14, the input information is sent to the server 10. Then, the server 10 stores the acquired information.

[0034] As shown in FIG. 3, in this embodiment, the information of the medical device (medical device information) includes, for example, information identifying the product such as the product name and / or model number, category, information related to quantity (number of items, quantity per sample provision unit, and sales unit), information related to money such as the list price, information related to the posting status, information on whether it is a new product (within one year from the start of sales), and information related to the provision mode.

[0035] The information related to the provision mode includes information on whether sample provision is possible and information on whether a predetermined form (trial form (clinical trial medical device trial form)) is required for sample provision.

[0036] In this embodiment, it further includes information on whether demonstration (demo) is possible instead of sample provision. In FIG. 3, the operator can select it in the "Conversion Type" column. Details will be described later.

[0037] In FIG. 3, the "Product Name" is the name of the product. That is, it is information identifying the product, and in addition to the product name, it may also be a model number or the like. Also, although the information of the medical device is associated with the operator, when the manufacturer and the seller are different, the information of the manufacturer or the seller may be inputtable.

[0038] The "Category" is a column for selecting or inputting the category of the medical device. In this embodiment, the user (operator) can select multiple categories via a pull-down menu. The categories range from the first category to the third category. The first category is the major classification, the second category is the medium classification, and the third category is the minor classification. For example, the first category is "endoscope", the second category is "endoscope body", and the third category is "nasal use", etc.

[0039] The first categories are set as "liver, gallbladder, and pancreas devices", "gastrointestinal devices", "endoscopes", "peripheral devices", and "others", and the user can select from among these.

[0040] The "quantity per package" is the quantity of products contained in one container (such as a box). The "minimum unit" is the unit of the minimum quantity of the product. The "sales unit" is the sales unit of the product. For example, if there are 10 syringes in one box, the "quantity per package" is 10, the minimum unit is 1 syringe, the sales unit is 1 box, etc. If the quantity per package remains the same but it is sold in units of 5 boxes, then the sales unit is 5 boxes.

[0041] The "list price" is the list price of the product.

[0042] The "submission status" is a column for selecting or setting the submission (registration) status to the system. In this embodiment, there are four statuses: "draft", "before publication", "hidden", and "visible", and the operator can select them from a pull-down menu.

[0043] "Draft" and "before publication" are the states before submitting (uploading) to the system. "Draft" is the state during input, and "before publication" is the state where the input is complete but has not been submitted to the system. "Hidden" and "visible" are the states after submitting to the system. "Hidden" is the state where a third party cannot view it, and "visible" is the state where a third party can view it.

[0044] The "New Product Flag" is a field for selecting or entering whether it is a new product or not. In this embodiment, the operator can select the items of "New Product" or "Not a New Product" from a pull-down menu. "New Product" refers to medical devices, etc. that are less than one year from the start of sales, and "Not a New Product" refers to medical devices, etc. that are one year or more from the start of sales.

[0045] "Conversion" is a field for selecting or entering a status according to the nature of medical devices, etc. In this embodiment, the operator can select five statuses of "Sample Application Allowed with Trial Document", "Sample Application Allowed without Trial Document", "Demo Request without Sample Application", "Only Published with Inquiry", and "Only Published without Inquiry" from a pull-down menu. "Only Published" literally means only publishing the product, and it is a product for which sample provision and demonstration are not performed.

[0046]

Table 1

[0047] Table 1 is a privilege table showing the privileges for each user. "○" indicates having the privilege, and "×" indicates not having the privilege.

[0048] The "Top Page" is a page above the "Product Detail Page", for example, a page that displays an overview and list of products.

[0049] In this embodiment, there are two types of products for which "Sample Application" is possible, which are divided into "Medical Devices" that require a trial document and "Medical Sundries" that do not require a trial document.

[0050] "Demo Request" is a request (by a medical staff member) by the operator for a demonstration to medical staff, and no transfer of the product is made and no trial document is required.

[0051] An "inquiry" is an inquiry about a product to a business operator.

[0052] Also, in this embodiment, "member registration" in Table 1 is a state where the administrator has completed the registration of a member through email authentication or the like, and "doctor registration" is a state where, in addition to member registration, the inquiry of the doctor registration number to the Ministry of Health, Labour and Welfare has been completed. An "unregistered person" is a state where the registration of a member has not been completed.

[0053] For example, in Table 1, only doctors who have completed doctor registration can apply for samples that require a trial order form. On the other hand, those other than doctors who have completed doctor registration cannot apply for samples that require a trial order form.

[0054] Figure 4 is a diagram showing a medical device information display screen. Medical staff can select a medical device from a list of medical devices provided by a business operator (for example, a catalog, not shown). When the medical staff selects a medical device, the processor 122 causes the terminal 20 to display a medical device information display screen.

[0055] As shown in Figure 4, on the medical device information display screen, the processor 122 displays the information (image) of the medical device on the medical device image display unit UI-15 and the medical device information on the medical device information display unit UI-16. The medical device image display unit UI-15 can display a plurality of images.

[0056] The medical device information mentioned here is, for example, the provider of the medical device (medical device manufacturer), device name (including model number), cost information, etc. The processor 122 displays at least a part of the medical device information input by the business operator on the medical device registration screen on the medical device information display screen.

[0057] Also, in this embodiment, the medical device information display screen includes a sample application button UI-17. When the medical staff presses the sample application button UI-17, the processor 122 causes the terminal 20 to display a screen for inputting information necessary for sample application.

[0058] Here, a medical device that requires a trial use application form will be used as an example for explanation. That is, the processor 122 receives the pressing of the sample application button UI-17 and displays the next-item trial use application form input screen.

[0059] Although not shown in FIG. 4, the medical staff may be able to select the provision mode of medical devices and the like. For example, in the case of a medical device that enables both sample provision and demo provision, the medical staff may be able to select which of the two provisions they desire.

[0060] FIG. 5 is a diagram showing the trial use application form input screen. As shown in FIG. 5, the trial use application form input screen includes a medical staff information display section UI-18, a medical device information input field UI-19, a signature button UI-20, and a transmission button UI-21.

[0061] In the present embodiment, the processor 122 automatically reflects the content registered on the medical staff registration screen in the medical staff information display section UI-18.

[0062] The medical staff (here, a doctor who has already registered as a doctor) fills in or selects from a pull-down menu the name, specification, trial use amount, number of trial use days (times), and number of cases of the medical device desired as a sample. Note that the processor 122 may automatically input the name and specification.

[0063] After filling in the necessary items, the medical staff presses the signature button UI-20. Upon receiving the pressing of the signature button UI-20, the processor 122 causes the signature input screen of the next item to be displayed on the terminal 20.

[0064] FIG. 6 is a diagram showing the signature input screen. The signature input screen is a screen for the processor 122 to obtain the doctor's personal identification information. In the present embodiment, the personal identification information is signature information. In the present embodiment, the processor 122 displays the signature input screen in a pop-up format.

[0065] As shown in FIG. 6, the processor 122 displays a signature input reception unit UI-22, a signature clear button UI-23, a close button UI-24, and a completion button UI-25 on the signature input screen.

[0066] The signature input reception unit UI-22 is a part for receiving the input of a signature. A medical staff member such as a doctor can sign on the signature input reception unit UI-22 by operating a mouse or a touch pen. The signature clear button UI-23 is a button for erasing the input signature. The close button UI-24 is a button for closing the signature input screen and redisplaying the trial form input screen. The completion button UI-25 is a button for finalizing the input signature. In the present embodiment, when a medical staff member signs on the signature input reception unit UI-22 and presses the completion button UI-25, the processor 122 temporarily stores the information.

[0067] Note that the input to the signature input reception unit UI-22 is, for example, a mouse operation on a PC (such as a stationary type or a notebook type) or a pen input to the touch panel of a tablet, and it varies depending on the hardware of the terminal 20.

[0068] Returning to FIG. 5, when a medical staff member who has input all necessary items presses the send button UI-21, the information input on the trial form input screen and the signature information on the signature input screen are sent to the server 10, and the server 10 stores those information in the storage unit 14. Note that when no signature is input, the medical staff member cannot press the send button UI-21. For example, the processor 122 does not enable the send button UI-21.

[0069] The above is the UI before sample provision. Hereinafter, the UI after sample provision will be described.

[0070] FIG. 7 is a diagram showing a sample evaluation screen. With the sample evaluation screen, medical staff can evaluate the medical devices they have actually used. As shown in FIG. 7, the sample evaluation screen includes, in addition to information on the sample (medical device), an evaluation score input section UI-26, an evaluation comment input field UI-27, and a send button UI-28.

[0071] Medical staff enter the evaluation score (on a 10-point scale) of the sample in the evaluation score input section UI-26 and enter the evaluation comment in the evaluation comment input field UI-27. After the input, when the medical staff presses the send button UI-28, the terminal 20 sends the input content to the server 10.

[0072] The server 10 stores the acquired information in the storage unit 14. Also, the processor 122 sends the evaluation information to the business operator providing the medical device.

[0073] FIG. 8 is a diagram showing the sample application history screen (for an individual). As shown in FIG. 8 and FIG. 9 in the next section, on the sample application history screen, medical staff can select their own sample application history or the sample application history of the same hospital / department in the sample applicant selection column UI-29 on the left side, and the processor 122 displays specific content in the sample application information display section UI-30 on the right side of the screen based on the selection.

[0074] Medical staff can check the application history of medical device samples through the sample application history screen. In addition, medical staff can also evaluate the medical device samples before evaluation.

[0075] FIG. 9 is a diagram showing the sample application history screen (for an organization). Since the sample applicant selection column UI-29 and the sample application information display section UI-30 are the same as above, the description is omitted.

[0076] Through the sample application history screen (for an organization), medical staff can check the sample application history of the same department / section of the hospital to which they belong. As a result, it is possible to confirm, for example, that another person in the same department is receiving the medical device to be tested. In particular, since the number of clinical trial medical devices that can be provided to the same department free of charge is restricted by the fair competition rules of the medical device industry, the operator can prevent accidentally providing more than this limit.

[0077] Users such as medical staff can view and refer to their own or others' (past) evaluations on the sample application history screen.

[0078] With the above configuration, medical staff can easily create a clinical trial medical device trial form and send it to the operator. Since the medical device sample providing system 1 requires the signature input of a doctor or the like, it is possible to prevent the denial of the sample applicant. In addition, the operator can obtain the evaluation of the medical device by medical staff. Furthermore, medical staff can check the past sample application history. As a result, it is possible to prevent obtaining samples in an amount exceeding the quantity for which samples can be provided. In particular, since the sample application history within the same department as the medical staff can be checked, it is possible to prevent duplicate sample acquisition. In addition to the above, users such as doctors can view the evaluations of other doctors in the same department regarding a certain medical device, and thus can use it as a reference for future medical device selection.

[0079] 2. Program Processing <Medical Device Sample Providing Process> The program processing performed in the medical device sample providing system 1 of the present embodiment will be described.

[0080] In the present embodiment, the processor 122 performs a medical device sample providing process based on the medical device sample providing program P1. The medical device sample providing program P1 includes at least an information registration program P12, a medical device sample application program P14, and a sample application history display program P16. The processor 122 executes information registration processing, medical device sample application processing, and sample application history display processing respectively based on these programs. Also at this time, each program causes the computer to function as an information registration means, a medical device sample application means, and a sample application history display means.

[0081] The information registration program P12 includes a medical staff registration program P122, a business operator registration program P124, and a medical device registration program P126.

[0082] Hereinafter, known processing is omitted. For example, processing such as displaying a login screen to authenticate the user and processing related to forced termination are omitted.

[0083] <2-1. Information registration processing> The information registration processing includes user registration processing (medical staff registration processing and business operator registration processing) and medical device registration processing. In the information registration processing, the processor 122 acquires information of users (medical staff and business operators) and medical devices and stores them in the storage unit 14.

[0084] The medical staff registration processing includes a medical staff information input screen display processing for displaying a medical staff information input screen for inputting medical staff information on the medical staff terminal 20, a medical staff information acquisition processing for acquiring the medical staff information (input on the medical staff information input screen by the medical staff).

[0085] Here, the medical staff information acquisition processing includes a doctor selection display processing in which the processor 122 displays an input unit for inputting information on whether the user (medical staff) is a doctor (refer to the radio button in the information registration unit UI-11 in FIG. 2), The processor 122 performs a doctor declaration acquisition process for acquiring a doctor declaration in which a user (a doctor in charge) is assumed to be a doctor, and a doctor confirmation information acquisition process in which the processor 122 acquires doctor confirmation information related to confirmation that a user (a medical staff) who has made a doctor declaration is a doctor (having a doctor registration number).

[0086] The business operator registration process includes a business operator information input screen display process for displaying a business operator information input screen for inputting business operator information on the business operator terminal 30, and a business operator information acquisition process for acquiring the information of the business operator (input by the business operator on the business operator information input screen).

[0087] The medical device registration process includes a medical device information input screen display process for displaying a medical device information input screen for inputting medical device information on the business operator terminal 30, and a medical device information acquisition process for acquiring medical device information (input by the business operator on the medical device information input screen). The information of the medical device further includes information for specifying a product such as a product name and / or model number, information related to quantities such as category, sample providing unit quantity and / or sales unit, information related to money such as list price, information related to posting status, information on whether it is a new product (within one year from the start of sales), and information related to the providing mode.

[0088] In this embodiment, the information of the medical staff is the name, date of birth, gender, presence or absence of doctor qualification, doctor registration number, registration date, name of the workplace, name of the affiliated department / section at the workplace (e.g., surgery, internal medicine, pediatrics, etc.), address of the workplace (prefecture, etc.), and contact information (e-mail address or telephone number, etc.) of the medical staff (see FIG. 2).

[0089] Due to the nature of this system that is involved in the provision of medical devices, these information are important for confirming the identity of the user. Also, in order to confirm that the user is the doctor himself / herself, particularly detailed personal information is required.

[0090] The information of the business operator refers to the name of the business operator, the name of the representative, the address, the name of the person in charge, and the contact information. These pieces of information, together with the medical device information in the next section, are important for medical staff to correctly understand the information of medical devices. By registering multiple pieces of information, it is possible to identify medical devices even if there are medical devices with similar names.

[0091] The information of medical devices refers to the medical device name (product name), the category of medical devices, information regarding the quantity of medical devices, the submission (upload) status (status), information on whether it is a new product, and conversion (see Figure 3).

[0092] Regarding each of the above-mentioned information (information of medical staff (information of business operators) and medical device information), the details will be described in Section 3. Data below.

[0093] Among the following information registration processes, the medical staff registration process will be taken as an example for explanation. By displaying an information input screen on the terminal (information input screen display process) to obtain information (information acquisition process) and storing it in the storage unit 14, this is common to the user registration process (medical staff registration process and business operator registration process) and the medical device registration process. In the following, the terminal is the medical staff terminal 20, but in the case of the business operator registration process or the medical device registration process, this terminal becomes the business operator terminal 30.

[0094] Figure 10 is a flowchart showing the medical staff registration process. When a medical staff performs an operation for registration on the menu screen (not shown), the processor 122 starts the medical staff registration process.

[0095] As shown in Figure 10, first, the processor 122 displays a screen for inputting the information of the medical staff on the terminal (Step 11 - medical staff information input screen display process) and accepts the input of information by medical personnel (see Figure 2).

[0096] The processor 122 waits for the user to press the registration button (step 12 No). After the user finishes inputting information and presses the registration button (see FIG. 2) (step 12 Yes), the terminal transmits the input information to the server 10. The processor 122 of the server 10 acquires the information and stores it in the storage unit 14 (step 13 - Medical staff information acquisition process), and ends the information registration process.

[0097] In this embodiment, the processor 122 displays radio buttons for the user to input whether the user is a doctor on the information input screen and accepts the input. If the medical staff to be registered is a doctor (has a doctor's qualification), the processor 122 accepts the input of the doctor registration number. If the medical staff to be registered is not a doctor (does not have a doctor's qualification), the processor 122 does not accept the input of the doctor registration number (input is not required).

[0098] That is, the processor 122 acquires whether the medical staff is a doctor (selection or input), and if the medical staff is a doctor, acquires the doctor registration number (doctor declaration acquisition process).

[0099] However, it is not limited to the above aspect. For example, the processor 122 may be configured to output an error when a doctor is selected but no doctor registration number is input.

[0100] Furthermore, in this embodiment, the processor 122 acquires doctor confirmation information related to the confirmation of being a doctor (having a doctor registration number) (doctor confirmation information acquisition process).

[0101] Specifically, after the medical staff (doctor) is registered as a member, the administrator inquires with the Ministry of Health, Labour and Welfare about the information (doctor registration number) acquired in the doctor declaration acquisition process, and after confirming that the doctor is a registered doctor, the processor 122 acquires the information to that effect. In this embodiment, the processor 122 manages this information with a flag.

[0102] Note that the method for obtaining the doctor confirmation information is not limited to this. For example, a database that stores, as data, the doctor registration numbers and doctor names of all doctors at a certain point in time may be prepared, and the processor 122 may access the database and (automatically) confirm them. Also, it may access a predetermined (external) database that contains the necessary information through a network to obtain the information.

[0103] <2-2. Medical Device Sample Application Process> In the medical device sample application process, the processor 122 creates a trial form based on a predetermined standard and sends the sample application to the business operator.

[0104] The medical device sample application process includes a sample application acquisition process for acquiring an application for a medical device sample by a user (especially a medical staff), an invoice requirement determination process for determining whether a predetermined form (trial form (clinical trial medical device trial form)) is required when the medical device sample is provided, a doctor determination process for determining whether the user (medical staff) is a doctor when the (predetermined) form is required (based on the doctor confirmation information described above), an invoice description information acquisition process for acquiring information necessary for creating the (predetermined) form (information for identifying the product (such as product name), trial amount, trial date, and number of cases), (Display an input section for identity verification and) an identity verification information reception process for receiving the input of identity verification information (signature) by the doctor, a completed invoice creation process for creating a completed invoice (trial form with necessary items described) in which information for identifying the product, trial amount, trial date, and number of cases (necessary items) are described based on the information necessary for creating the (predetermined) form, an identity verification information addition process for adding the identity verification information (signature) to the completed invoice, and a completed invoice sending process for sending the completed invoice to the business operator (along with the sample application). The following describes each process.

[0105] Figure 11 is a flowchart showing the medical device sample application process. Hereinafter, the user is a medical professional in principle. In this embodiment, when a person among the users who has the right to access the product detail page accesses the product detail page, the processor 122 starts the medical device sample application process.

[0106] For the product being displayed, if an application for a sample or a demo (such as a sample) can be made (step 21 Yes), the processor 122 displays a sample application button (see FIG. 4) (step 22). On the other hand, if an application for a sample or the like cannot be made (step 21 No), the processor 122 ends the process.

[0107] Here, the case where an application for a sample or the like cannot be made means that the product is a product for which an application for a sample or a demo (such as a sample) cannot be made, or the user is a user without the right such as a user other than a medical professional (see Table 1).

[0108] The processor 122 waits for the user to press the application button (step 23 No), and if the button is pressed (step 23 Yes - sample application acquisition process), the processor 122 starts the next process (step 24).

[0109] The processor 122 determines whether a trial form (clinical trial medical device trial form) is required for the sample provision of the (displayed) device (step 24 - form requirement determination process).

[0110] In the case of a product (medical device) that requires a trial form (step 24 Yes), the processor 122 determines whether the user is a doctor (step 25 - doctor determination process). Whether the user is a doctor means whether the server 10 can obtain the above-mentioned doctor confirmation information.

[0111] If the user is not a doctor (No in step 25), the processor 122 does not proceed to the next process and returns to the product details page. Also, at this time, the processor 122 may display a warning message or an error.

[0112] On the other hand, if the user is a doctor (Yes in step 25), the processor 122 displays a screen (see the trial form input screen in Fig. 5) for the user to input the items required for the trial form and other items (step 26). The items required for the trial form are, as described above, the product name, specifications (information for identifying the product), the trial dose, the trial date (number of times), and the number of cases.

[0113] Although not shown in Fig. 11, at this time, the processor 122 displays an input section for identity verification (a signature input screen in this embodiment) according to the user's operation and accepts the input of identity verification information (signature information) (identity verification information reception process).

[0114] Returning to step 24, for equipment that does not require a trial form, that is, when the product is a medical sundry or a demo application (No in step 24), the processor 122 displays an input screen for the user to input items other than those required for the trial form, for example, the number of samples if it is a medical sundry, the implementation date if it is a demo, etc. (step 27).

[0115] Both input screens in steps 26 and 27 are provided with a send button, and the processor 122 waits for the user to press the button (No in step 28). Then, when the send button is pressed (Yes in step 28), the processor 122 acquires various information and stores (or stores the various information that has been acquired) in the storage unit 14 (step 29 - form entry information acquisition process).

[0116] Particularly, for medical devices that require a trial form, the processor 122 stores the trial form and the signature in the storage unit 14.

[0117] In addition, when the send button is pressed, the processor 122 may display a confirmation screen for confirming the input content.

[0118] The processor 122 creates documents related to the application (such as sample application information, filled-out forms, etc.) (step 30 - filled-out form creation process). Here, the term "document" includes not only paper media but also electronic data such as pdf (the same applies hereinafter).

[0119] In this embodiment, the personal identification information is a signature, and the signature is added to the name field of the filled-out form (personal identification information addition process) (refer to the medical staff information display section UI-18 in FIG. 5 for an image).

[0120] Then, the processor 122 transmits the documents (such as sample application information, filled-out forms, etc.) to the business operator providing the medical device (step 31 - filled-out form transmission process), and ends the medical device sample application process.

[0121] Although omitted in FIG. 11, the processor 122 determines whether a trial form is required before creating the application documents (step 30), and creates a trial form if a trial form is required. Then, the processor 122 transmits the signed trial form and other data to the business operator providing the medical device (step 31) and ends the medical device sample application process.

[0122] To summarize briefly, in the medical device sample application process, the processor 122 automatically determines whether the medical device, etc. is a product for which sample provision is possible, whether the medical device requires a trial form, etc. In addition, the processor 122 determines whether the user is a doctor and requests the doctor's signature. And whether the user is a doctor is strictly determined based on the above-mentioned doctor confirmation information, etc. The processor 122 acquires information in such a multi-stage manner and strictly determines whether the user is a doctor, so that it is possible to prevent a person who is not a doctor from making a sample application. In addition to the above, since the user can input through the GUI (Graphical User Interface), intuitive operations are possible, and the labor for creating and sending trial documents can be significantly reduced.

[0123] <2-3. Sample Application History Display Process> In the sample application history display process, the processor 122 displays a list of sample application histories from the medical department or section to which the medical staff belongs on the medical staff terminal.

[0124] The processor 122 starts the sample application history display process by receiving an operation of the UI by the medical staff, for example, an operation to display the sample application history screen from the menu screen.

[0125] When the sample application history screen (individual) as shown in FIG. 8 is selected, the processor 122 acquires the sample application history information of the medical staff of the individual using the medical device sample supply system 1 and displays the information. The sample application history information referred to here includes, in addition to the information of the medical device, the sample application date, etc.

[0126] When the sample application history screen (organization) as shown in FIG. 9 is selected, the processor 122 acquires the sample application history information in the organization to which the medical staff belongs and displays the information. The sample application history information referred to here includes, in addition to the information of the medical device and the sample application date, the billing history of the sample by other doctors in the same medical department or section of the facility to which one belongs and the evaluation of the medical device.

[0127] 3. Data Hereinafter, the data handled by the medical device sample supply system 1 of the present embodiment will be described with reference to the drawings. The medical device sample supply system 1 includes a medical device sample supply data table D1 in the storage unit 14 (data storage unit 14b) of the server 10. The medical device sample provision data table D1 of this embodiment includes a user data table D10, a medical institution data table D20, a medical department / section data table D30, a medical device data table D40, and a provision sample data table D50. This will be described below.

[0128] The user data table D10 is a data table that includes data related to users (user data). Note that there are data tables for medical staff and business operators in the user data table D10. Here, an example of the medical staff data table is shown, and an example of the business operator data table including a business operator ID and the like is omitted.

[0129] The data included in the medical staff data table is mainly information input by medical staff on the medical staff registration screen (Figure 2). That is, it includes information acquired by the processor in the medical staff information acquisition process and information otherwise.

[0130]

Table 2

[0131] Table 2 exemplifies the data included in the user data table D10. As shown in Table 2, in addition to a unique user ID, the user data table D10 includes, as items, name, date of birth, gender, presence or absence of a doctor's qualification, doctor registration number, registration date, presence or absence of confirmation (only described as "confirmation" in Table 2), the medical institution ID of the workplace (described later), and the medical department / section ID of the workplace (described later).

[0132] These pieces of information are mainly the contents input by the user on the information registration screen (medical staff registration screen).

[0133] Here, the "presence or absence of confirmation" indicates whether the server 10 has acquired doctor confirmation information (if it is "○", it has been confirmed).

[0134] In addition, when the name of the medical institution and the name of the department / section have already been registered in the medical device sample provision data table D1, the processor 122 stores the name of the medical institution and the name of the department / section as IDs.

[0135] The medical institution data table D20 is a data table that stores data related to medical institutions such as hospitals (medical institution data).

[0136]

Table 3

[0137] Table 3 illustrates the data included in the medical institution data table D20. As shown in Table 3, in addition to a unique medical institution ID, the medical institution data table D20 includes, as items, the name of the medical institution, the address of the medical institution (address after prefecture and municipality), and the ID of the department / section belonging to the medical institution (department / section ID, to be described later).

[0138] Note that although Table 3 describes that multiple IDs are included in the department / section ID, different departments / sections may have different medical institution IDs. In this case, although the number of IDs increases, there is an advantage that data can be easily updated when there is a change in the department / section.

[0139] The department / section data table D30 is a data table that stores data related to departments / sections (data of departments or sections).

[0140]

Table 4

[0141] Table 4 illustrates the data included in the department / section data table D30. As shown in Table 4, in addition to a unique department / section ID, the department / section data table D30 includes, as an item, the name of the department / section.

[0142] The medical device data table D40 is a data table that stores data related to medical devices (medical device information and medical device data). The data included in the medical device data table D40 mainly consists of information entered by the operator on the medical device registration screen (Figure 3). That is, it includes information obtained by the processor in the medical device information acquisition process and information otherwise.

[0143] That is, the medical device information includes information identifying the product such as the product name and / or model number, information related to the operator, category, information related to quantity (number of items, quantity per sample provided unit, and sales unit), information related to money such as the list price, information related to the submission status, information on whether it is a new product (within one year from the start of sales), and information related to the provision mode.

[0144] The information on whether it is a new product may be automatically determined by the processor 122 from the data acquisition date.

[0145] In this embodiment, it is named the medical device data table D40, but data related to medical supplies (medical supply data) and data related to demonstration products (demo data) are also included as information related to the provision mode.

[0146] In addition, the medical device data table D40 includes information related to the system such as the registration date, the upper limit number of samples provided, images (image file names), and so on.

[0147]

Table 5

[0148] Table 5 is an example of the data included in the medical device data table D40. As shown in Table 5, the medical device data table D40 includes, for example, as items, in addition to a unique medical device ID, the name of the medical device, the model number of the medical device, the operator, the operator address, the registration date in the database, the sample providing unit (number provided), the upper limit number of samples provided, the sample image (file name), and the list price of the medical device, etc. The operator information may be replaced with the operator ID.

[0149] The data related to medical devices is not limited to the above, and may include information other than the above. For example, the release date of the medical device, the presence or absence of continuous production, or the warranty period, etc. Furthermore, the medical device data table D40 may include information (name, address, etc.) related to the agents and / or retailers handling it.

[0150] The provided sample data table D50 is a data table that includes data related to the provided samples (provided sample data).

[0151]

Table 6

[0152] Table 6 illustrates the data included in the provided sample data table D50. As shown in Table 6, the provided sample data table D50 includes, as items, in addition to a unique provided sample ID, the medical device ID, sample applicant information (user ID, medical institution ID, and department / section ID), the sample application date, and the number of samples provided.

[0153] In addition to the above, the provided sample data table D50 may further include information on the sample provider. Here, the sample provider referred to here is not the operator but an agent or the like.

[0154] The provided sample data table D50 may include data related to the demo. In this case, for example, the item of the number of samples provided is not present, while data items such as the demo implementation date are included. Alternatively, the medical device sample provision data table D1 may separately include a data table for data related to the demonstration.

[0155] With the above configuration, the medical device sample provision data table D1 includes information related to medical devices and information related to users, and the processor 122 uses this data for medical device sample application processing.

[0156] 4. Hardware Configuration As shown in FIG. 1, the medical device sample provision system 1 in the present embodiment includes a server 10, a medical staff terminal 20, and a business operator terminal 30. Further, each of these devices is connected via a network N. The network N is, for example, the Internet or the like. Hereinafter, each piece of hardware will be described.

[0157] <Server 10> The server 10 is a computer for executing the medical device sample provision program P1. That is, software (application software including the medical device sample provision program P1) for operating the medical device sample provision system 1 according to the present embodiment is installed in the server 10, and the processor 122 executes various processes by the functions of the software.

[0158] In FIG. 1, only one server 10 is illustrated, but the number is not limited to one, and it may be realized by a plurality of servers. For example, from the viewpoints of load distribution, function separation, availability, or security, a plurality of servers may be used. The server 10 may use a computer of a cloud service provider, or a user may prepare a computer.

[0159] FIG. 12 is a hardware configuration diagram of the server 10. As shown in FIG. 12, the server 10 includes a control unit 12, a storage unit 14, and a communication control unit 16. The control unit 12 includes a processor 122, a ROM 124, a RAM 126, and a timer unit 128. The basic functions of each will be summarized and described later.

[0160] The control unit 12 including the processor 122 also functions as a medical device sample providing unit 130 in the server 10 (not shown). The medical device sample providing unit executes a medical device sample providing program P1 to perform a medical device sample providing process. In the present embodiment, the processor 122 is a CPU (Central Processing Unit).

[0161] Also, one program may include another program. For example, in the present embodiment, the medical device sample providing program P1 includes an information registration program P12, a medical device sample application program P14, a sample application history display program P16, and the like.

[0162] As shown in FIG. 12, the storage unit 14 includes a program storage unit 14a and a data storage unit 14b, and stores programs and data necessary for various processes. For example, in the program storage unit 14a, in addition to the medical device sample providing program P1 according to the present embodiment, a control program for controlling devices connected to the server 10, such as a communication control program for controlling the communication control unit 16, is stored.

[0163] As shown in FIG. 12, the communication control unit 16 is a device that communicates between the server 10 and an external terminal, such as the terminal 20 described later. As shown in FIG. 1, the communication control unit 16 connects the server 10 to the network N.

[0164] In addition to the above, the server 10 may also include an input unit (e.g., a keyboard) for inputting commands and data, an output unit (e.g., a voice output device) for outputting information in some form, etc. (not shown). Further, it may include devices that are additionally necessary for the purposes of this embodiment, or devices for improving convenience with respect to the purposes of this embodiment.

[0165] <Medical staff terminal 20 (Terminal 20)> The medical staff terminal 20 (Terminal 20) is an information processing device for medical staff to use the medical device sample providing system 1. The medical staff accesses the server 10 using the terminal 20 to utilize the medical device sample providing system 1.

[0166] FIG. 13 is a hardware configuration diagram of the terminal 20. As shown in FIG. 13, the terminal 20 includes a control unit 22, a storage unit 24, a communication control unit 26, and an input / output unit 28 (input unit 282, output unit 284, display unit 284a). The control unit 22 further includes a processor 222, a ROM, a RAM, and a timing unit. Descriptions of those that overlap with the described content and those related to basic functions to be described later will be omitted.

[0167] In this embodiment, the terminal 20 is a desktop PC. However, the terminal 20 is not limited to this, and may be a portable terminal such as a smartphone or a tablet.

[0168] The user does not need to install a specific application on the terminal 20, and can utilize the medical device sample providing system 1 by accessing the server 10 etc. through the Internet.

[0169] <Business operator terminal 30 (Terminal 30)> The business operator terminal 30 (Terminal 30) is an information processing device for business operators to use the medical device sample providing system 1. The business operator accesses the server 10 using the terminal 30 to utilize the medical device sample providing system 1.

[0170] In this embodiment, the terminal 30 is a desktop PC. However, the terminal 30 is not limited to this, and may be a portable terminal such as a smartphone or a tablet. Descriptions that overlap with the content already described, such as the hardware configuration, and descriptions regarding the basic functions to be described later are omitted.

[0171] (Description regarding the basic functions of the computer) Hereinafter, the control unit (processor, ROM, RAM, timer unit), storage unit, communication control unit, input unit, and output unit will be described. Note that, in any of the terminals of this embodiment, the connection mode (network topology) between the functional units is not particularly limited. For example, it may be a bus type, or a star type, a mesh type, or the like.

[0172] The processor performs information processing and control of various devices according to programs stored in the ROM, storage unit, and the like. In this embodiment, the processor is a CPU.

[0173] However, the processor is not limited to the CPU. Various processors such as a CPU, a DSP (Digital Signal Unit), a GPU (Graphics Processing Unit), a GPGPU (General Purpose computing on GPU), a TPU (Tensor Processing Unit), or an ASIC (Application Specific Integrated Circuit) may be used alone or in combination. For example, a processor integrating a CPU and a GPU is called an APU (Accelerated Processing Unit), and such a processor may be used.

[0174] The ROM is a read-only memory in which various programs and data for the processor to perform various controls and operations are stored in advance.

[0175] The RAM is a random access memory used as working memory by the processor. Various areas for performing various processes of this embodiment can be secured in this RAM.

[0176] The timing unit performs timing processes related to acquisition of time information etc. When the computer includes a communication control unit, time information may be acquired from the outside by NTP (Network Time Protocol).

[0177] The storage unit is a device for storing information such as programs and data. The storage unit is also referred to as storage. The storage unit may be of an internal type or an external type.

[0178] The storage unit includes a storage medium capable of reading and writing data, and a drive for reading and writing to the storage medium. Examples of the storage medium include internal type and external type, such as HD (hard disk), CD-ROM, flash memory, etc. Examples of the drive include HDD (hard disk drive), SSD (solid state drive), etc.

[0179] The storage unit includes a program storage unit and a data storage unit as functional units. The program storage unit stores control programs for controlling various devices, such as a communication control program for controlling communication.

[0180] The communication control unit is a device for performing communication between terminals etc. The communication control unit connects the terminal including the communication control unit to the network N.

[0181] The communication method of the communication control unit is a known method, and a wired method or a wireless method is applied according to the device. For example, if the terminal is a desktop PC, both wired and wireless cases are conceivable, and if the terminal is a smartphone, a wireless communication method is conceivable.

[0182] In the case of wired communication, for example, a communication method defined by IEEE802.3 (such as a bus-type or star-type wired LAN) can be preferably used. However, in addition to this, a communication method defined by IEEE802.5 (such as a ring-type wired LAN) or the like can also be used.

[0183] In the case of wireless communication, for example, a communication method defined by IEEE802.11 (such as Wi-Fi) can be preferably used. However, in addition to this, a communication method defined by IEEE802.15 (such as Bluetooth (registered trademark), BLE (Bluetooth (registered trademark) Low Energy), etc.), IEEE802.16 (such as WiMAX), ZigBee (registered trademark), 920MHz band wireless (such as Wi-SUN), or an optical communication such as infrared communication can also be used.

[0184] The input unit and the output unit are devices that respectively handle input to and output from the terminal. The input unit and the output unit may be collectively referred to as the input / output unit. The input unit is a device that receives input from the user. Examples of such an input unit include a keyboard, a mouse as a pointing device, a trackpad, a tablet, or a touch panel.

[0185] When the terminal is a tablet, a smartphone, or the like, and the input unit is a touch panel, the input unit is arranged on the surface of a display unit such as a touch screen that displays an image or the like. In this case, the input unit identifies the touch position of the user corresponding to various operation icons displayed on the display unit and receives the input from the user.

[0186] The output unit is, for example, a device for outputting an image, sound, a document, or the like. Examples of the output unit include a display device such as a touch screen or a display (liquid crystal display or organic EL display), a sound output device such as a speaker, and a document output device such as a printer.

[0187] With the above configuration, information such as medical device information, trial use documents, or signatures can be exchanged between medical staff and businesses through the medical device sample provision system 1. As a result, the administrative burden of creating various documents, etc., which were previously created and sent manually, can be significantly reduced, and medical staff such as doctors can focus on their original work.

[0188] (Modification example) The present invention is not limited to the above-described embodiments, and includes those obtained by making various modifications to the above-described embodiments without departing from the gist of the present invention.

[0189] For example, in the above-described embodiment, the processor 122 performs the signature in the medical device sample application process, but it is not limited thereto. For example, a signature may be obtained at the stage of information registration processing. In the medical staff registration process, the processor 122 may display a signature entry section for a doctor to sign and store the signature in the storage unit 14 (``personal identification information pre-registration process''). Note that as long as personal identification can be performed, it is not limited to the above-described method. Instead of a signature by an entry operation, an electronic signature or an electronic seal, etc. may be used.

[0190] The aspect of the present invention including this embodiment has the following features in other words. The following corresponds to the claims at the time of filing of the present application. However, it may differ from the description of the claims after amendment of the claims after filing. (1) In the first aspect, a computer is provided with a medical staff information acquisition means for acquiring information of medical staff, a business information acquisition means for acquiring information of a business that provides medical devices, and a medical device information acquisition means for acquiring medical device information by the business. Function as a sample application acquisition means for acquiring an application for a medical device sample by a medical professional, a form requirement determination means for determining whether a predetermined form is required when providing the medical device sample, a doctor determination means for determining whether the medical professional is a doctor when the form is required, a form description information acquisition means for acquiring information necessary for creating the form, a completed form creation means for creating a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form, and a completed form transmission means for transmitting the completed form to a business operator. Provide a medical device sample providing program, wherein the medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required. (2) In a second aspect, further function the computer as a personal identification information reception means for receiving input of personal identification information by a doctor and a personal identification information addition means for adding the personal identification information to the completed form, to provide the medical device sample providing program according to the first aspect. In this case, it prevents denial of those who have input personal identification information by signature or the like. (3) In a third aspect, further, the information of the medical professional includes information on the department or section to which the medical professional belongs, and function the computer as a sample application history display means for displaying a list of sample application histories from the department or section to which the medical professional belongs on a medical professional terminal, to provide the medical device sample providing program according to the first aspect. In this case, a user such as a doctor can view the evaluation, etc. of another doctor in the same department for a certain medical device, and thus can use it as a reference for future medical device selection. (4) In a fourth aspect, a medical professional information acquisition unit for acquiring information of a medical professional, a business operator information acquisition unit for acquiring information of a business operator providing a medical device, and a medical device information acquisition unit for acquiring medical device information by the business operator. A sample application acquisition unit that acquires an application for a medical device sample by a medical professional, a form necessity determination unit that determines whether a predetermined form is required when providing the medical device sample, a doctor determination unit that determines whether the medical professional is a doctor when the form is required, a form description information acquisition unit that acquires information necessary for creating the form, a completed form creation unit that creates a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form, and a completed form transmission unit that transmits the completed form to a business operator. The medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required, and provides a medical device sample provision system. (5) In a fifth aspect, a processor has a medical professional information acquisition step of acquiring information on a medical professional, a business operator information acquisition step of acquiring information on a business operator that provides a medical device, and a medical device information acquisition step of acquiring medical device information by the business operator. The processor includes a sample application acquisition step of acquiring an application for a medical device sample by a medical professional, a form necessity determination step of determining whether a predetermined form is required when providing the medical device sample, a doctor determination step of determining whether the medical professional is a doctor when the form is required, a form description information acquisition step of acquiring information necessary for creating the form, a completed form creation step of creating a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form, and a completed form transmission step of causing the communication control unit to transmit the completed form to the business operator. The medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required, and provides a medical device sample provision method.

Industrial Applicability

[0191] It can also be applied to the purpose of creating documents related to the provision of medical device samples not limited to the trial use form.

Explanation of Signs

[0192] 1 Medical device sample provision system 10 Server 12 Control unit 122 Processor 124 ROM 126 RAM 128 Timing unit 130 Medical device sample provision unit 14 Storage unit 14a Program storage unit 14b Data storage unit 16 Communication control unit 18 Input / output unit 20 Medical staff terminal 22 Control unit 222 Processor 24 Storage unit 26 Communication control unit 28 Input / output unit 282 Input unit 284 Output unit 284a Display unit 30 Business operator terminal UI-11 Information registration unit UI-12 Registration button UI-13 Information registration unit UI-14 Registration button UI-15 Medical device image display unit UI-16 Medical device information display unit UI-17 Sample application button UI-18 Medical staff information display unit UI-19 Medical device information input field UI-20 Signature button UI-21 Transmission button UI-22 Signature input reception unit UI-23 Signature clear button UI-24 Close button UI-25 Completion button UI-26 Evaluation point input unit UI-27 Evaluation Comment Input Field UI-28 Send Button UI-29 Sample Applicant Selection Field UI-30 Sample Application Information Display Section P1 Medical Device Sample Provision Program P12 Information Registration Program P122 Medical Staff Registration Program P124 Business Operator Registration Program P14 Medical Device Sample Application Program P16 Sample Application History Display Program D1 Medical Device Sample Provision Data Table D10 User Data Table D20 Medical Institution Data Table D30 Department / Unit Data Table D40 Medical Device Data Table D50 Provided Sample Data Table

Claims

1. A computer, a healthcare provider information acquisition means for acquiring information of healthcare providers, a vendor information acquisition means for acquiring information of vendors providing medical devices, a medical device information acquisition means for acquiring medical device information input by the vendor, a sample application acquisition means for acquiring applications for medical device samples by healthcare providers, a form requirement determination means for determining whether a predetermined form is required when providing the medical device sample, a doctor determination means for determining whether the healthcare provider is a doctor when the form is required, a form description information acquisition means for acquiring information necessary for creating the form when the healthcare provider is a doctor, a completed form creation means for creating a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form when the healthcare provider is a doctor, a completed form transmission means for transmitting the completed form to the vendor, functioning as, wherein the medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required, a medical device sample provision program.

2. Furthermore, the computer, an identity verification information reception means for receiving input of identity verification information by a doctor, and an identity verification information addition means for adding the identity verification information to the completed form, characterized by functioning as, the medical device sample provision program according to claim 1.

3. Furthermore, the information of the healthcare provider includes information on the department or section to which the healthcare provider belongs, the computer, functioning as a sample application history display means for displaying a list of sample application histories from the department or section to which the healthcare provider belongs on the healthcare provider terminal, the medical device sample provision program according to claim 1.

4. a healthcare provider information acquisition unit for acquiring information of healthcare providers, a vendor information acquisition unit for acquiring information of vendors providing medical devices, a medical device information acquisition unit for acquiring medical device information input by the vendor, a sample application acquisition unit for acquiring applications for medical device samples by healthcare providers, a form requirement determination unit for determining whether a predetermined form is required when providing the medical device sample, a doctor determination unit for determining whether the healthcare provider is a doctor when the form is required, When the medical staff is a doctor, a form description information acquisition unit that acquires information necessary for creating the form; When the medical staff is a doctor, a completed form creation unit that creates a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form; A completed form transmission unit that transmits the completed form to the business operator; Comprising; The medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required. A medical device sample provision system characterized by this.

5. A processor information acquisition step for acquiring information on medical staff; A business operator information acquisition step for acquiring information on a business operator that provides medical devices; A medical device information acquisition step for acquiring medical device information input by the business operator; A sample application acquisition step for acquiring an application for a medical device sample by a medical staff; A form necessity determination step for determining whether a predetermined form is required when providing the medical device sample; A doctor determination step for determining whether the medical staff is a doctor when the form is required; A form description information acquisition step for acquiring information necessary for creating the form when the medical staff is a doctor; A completed form creation step for creating a completed form in which information for specifying a product, a trial dose, a trial date, and the number of cases are described based on the information necessary for creating the form when the medical staff is a doctor, and; A completed form transmission step for causing the communication control unit to transmit the completed form to the business operator; Composed of; The medical device information includes information on whether sample provision is possible and information on whether a predetermined form is required. A medical device sample provision method characterized by this.

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