CN112863623A - Systematic fusion of clinical trial business and routine clinical business - Google Patents
Systematic fusion of clinical trial business and routine clinical business Download PDFInfo
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- CN112863623A CN112863623A CN202110191975.7A CN202110191975A CN112863623A CN 112863623 A CN112863623 A CN 112863623A CN 202110191975 A CN202110191975 A CN 202110191975A CN 112863623 A CN112863623 A CN 112863623A
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H70/00—ICT specially adapted for the handling or processing of medical references
- G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
Abstract
The invention discloses a clinical test and routine clinical integrated service system, which comprises: a registration function module and a medical advice setting function module; the registration function module comprises: the system comprises a self-service unit, an HIS unit, a clinical test management unit and an expense management unit; the expense management unit interacts with the HIS unit through a clinical test expense interface; the HIS unit collects the clinical test expense data and sends the data to the expense management unit and the clinical test management unit; the open function module includes: an electronic medical record unit and a clinical medicine research management unit; the electronic medical record unit is interacted with the clinical medicine research management unit through a clinical medicine research interface; the registration function module interacts with the medical advice provision function module through the electronic medical record interface. The invention meets the requirements of the national drug administration on the originality and the authenticity of the tested data in the clinical test data check; accurate and detailed inspection statistics of relevant tests related to clinical tests are realized.
Description
Technical Field
The invention relates to the technical field of medical systems, in particular to a system fusion of clinical trial business and conventional clinical business.
Background
In 2019, the national drug administration (GCP) updates and issues a new GCP version, which is the first update of GCP in the last two decades.
First, it is clear in the national medical insurance regulations that clinical trials must not occupy medical insurance costs. In actual conditions, clinical test projects of hospitals are many, and the number of clinical test participants accounts for one tenth of that of common clinical patients. The number of the participating testees is large, the expenditure management is in the manual reimbursement stage, the clinical trial office is often lack of hands, and the expenses of the clinical trial cannot be accurately reimbursed, so that the condition that the testees occupy the medical insurance expenses often occurs.
Secondly, the new GCP requires "clinical trial with patient as the subject, and the relevant medical record should be loaded into the outpatient or inpatient medical record system", but in the actual situation, the medical institution has adopted the form that the subject applies for free laboratory sheet examination from each project, so the subject, especially the healthy subject, can not enter the clinical diagnosis and treatment system of the hospital. At present, in order to meet new regulations, all hospitals basically adopt a medical record system which allows a subject to register for self-fees and enter the hospitals, but the measure often causes the situation that the subject is not checked and checked out in time, which is contrary to the policy of medical insurance.
Therefore, how to provide a systematic fusion of clinical trial services and conventional clinical services is a problem that needs to be solved urgently by those skilled in the art.
Disclosure of Invention
In view of the above, the present invention provides a system fusion of clinical trial business and conventional clinical business. The national medical insurance regulations require that the subject is not paid additionally in clinical tests, so that the trial is allowed to pay registration cost additionally and is contrary to GCP regulations; the national regulation takes a patient as a clinical test to be tested, and related medical records are loaded into an outpatient service or inpatient medical record system, so that the identity of the clinical test to be tested is set, the traceability problem of the test is thoroughly solved, a virtual identity is set, all inspection and inspection work is integrated with clinical routine work, index statistics enters a code scanning system, the workload is greatly reduced, and accurate statistics can be realized.
In order to achieve the purpose, the invention adopts the following technical scheme:
a clinical trial and routine clinical integrated business system, comprising: a registration function module and a medical advice setting function module;
the registration function module comprises: the system comprises a self-service unit, an HIS unit, a clinical test management unit and an expense management unit;
the self-service unit interacts with the clinical test management unit through a clinical test information interface;
the self-service unit interacts with the HIS unit through an HIS unit registration interface;
the clinical trial management unit interacts with the HIS unit through a patient basic information interface;
the expense management unit interacts with the HIS unit through a clinical trial expense interface; the HIS unit collects clinical test cost data and sends the data to the expense management unit and the clinical test management unit;
the open function module includes: an electronic medical record unit and a clinical medicine research management unit;
the electronic medical record unit interacts with the clinical medicine research management unit through the clinical medicine research interface;
the registration function module interacts with the medical advice provision function module through an electronic medical record interface.
Preferably, the HIS unit is configured to register and register information of the identity card of the subject, and the self-service unit is configured to acquire registration authority information of the subject of the clinical trial management unit; the self-service unit completes registration through the HIS unit; the self-service unit solely provides a registration function for the subject.
Preferably, the clinical trial management unit acquires the identity information of the subject in the HIS unit, and the clinical trial management unit is configured to review the identity registration application information of the subject; the clinical test management unit is also used for managing and inquiring the cost data of the tested clinical test; the clinical trial management unit displays and saves the personal information of the testee.
Preferably, the clinical drug research management unit includes: a process management subunit and a tested management subunit; the flow management subunit judges whether the tested person is registered with the clinical medicine research identity of the diagnosis day; and the electronic medical record unit acquires the visit data of the clinical medicine research management unit.
Preferably, the clinical trial management unit provides an access plan for the electronic medical record.
Preferably, the electronic medical record unit is provided with a tested functional subunit, and the tested functional subunit is used for displaying the examination of the visit data and the examination medical order set.
A method of fusing a clinical trial business with a conventional clinical business, comprising:
step a, registering and registering: the HIS unit provides a registration information function for the patient, after registration is completed, the identity information of the patient is confirmed in the clinical test management unit through clinical test management personnel, and the patient is enrolled by using the patient visit card;
step b, confirming identity information: after the patient is successfully registered, the self-service unit provides a registration function, acquires patient registration authority information from the clinical test management unit by using the patient number, further judges whether the patient is tested, and then opens a registration operation by the self-service unit;
step c, the consultation is examined: the electronic medical record obtains the data of the interview plan of the patient in a clinical medicine research management unit for carrying out inspection and examination type assembly; the clinical medicine research advice function in the electronic medical record unit provides an interview plan and progress condition for the tested patient; wherein the HIS unit also counts the cost of clinical trials;
step d, medical advice is set up: after the test receiving the consultation of doctors, the clinical test management unit confirms.
Preferably, the method for fusing the clinical trial service with the conventional clinical service, the prerequisite that the registration function is used in step b comprises:
step b 1: the subject holds a conventional patient card and has registered an identification number in the HIS system;
step b 2: the subject is registered with the clinical trial management unit, and the manager registers the subject with the information related to participation in the clinical trial.
Preferably, in the method for fusing the clinical trial service with the conventional clinical service, the prerequisite for the clinical medicine prescribing function in step c includes:
step c 1: the date of the medical advice is the same as the date of the clinical medicine registration of the subject;
step c 2: the doctor orders to start the day, and the identity of the tested clinical medicine continues to be effective;
step c 3: the visit plan of the clinical trial project in which the subject participated was maintained and effective.
According to the technical scheme, compared with the prior art, the invention discloses and provides the system fusion of the clinical test service and the conventional clinical service, and the requirements of the national drug administration on the originality and the authenticity of the tested data in the clinical test data check are realized; accurate and detailed inspection statistics of relevant tests related to clinical tests are realized. The medical insurance cost of the test patient is avoided, and the flow is simplified. Meanwhile, the medical research identity is used in the test, so that the medical system of the hospital is entered, and the condition that the medical record is not taken when the test is carried out in the medical system is avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a schematic diagram of interaction between a bed testing service and a conventional clinical service function module provided by the invention;
FIG. 2 is a flow chart of a method for fusing clinical trial services with conventional clinical services provided by the present invention;
FIG. 3 is a general flow chart of the system integration of clinical trial business and conventional clinical business provided by the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the invention discloses a system fusion of clinical trial business and conventional clinical business, which comprises the following steps: a registration function module and a medical advice setting function module;
the registration function module comprises: the system comprises a self-service unit, an HIS unit, a clinical test management unit and an expense management unit;
the self-service unit interacts with the clinical test management unit through a clinical test information interface;
the self-service unit interacts with the HIS unit through an HIS unit registration interface;
the clinical trial management unit interacts with the HIS unit through a patient basic information interface;
the expense management unit interacts with the HIS unit through a clinical trial expense interface; the HIS unit collects clinical test cost data and sends the data to the expense management unit and the clinical test management unit;
the open function module includes: an electronic medical record unit and a clinical medicine research management unit;
the electronic medical record unit interacts with the clinical medicine research management unit through the clinical medicine research interface;
the registration function module interacts with the medical advice provision function module through an electronic medical record interface.
FIG. 1 is a schematic diagram illustrating bed testing services interacting with a conventional clinical services function module according to an exemplary embodiment; the HIS unit is used for registering and registering the identity card information of the tested person, and the self-service unit is used for acquiring the registration authority information of the tested person of the clinical test management unit; the self-service unit completes registration through the HIS unit; the self-service unit solely provides the registration function for the testee.
The clinical trial management unit obtains the identity information of the testee in the HIS unit, is used for auditing the identity registration application information of the testee, and displays and stores the personal information of the testee.
The clinical medicine research management unit comprises: a process management subunit and a tested management subunit; the flow management subunit judges whether the tested person is registered with the clinical medicine research identity of the diagnosis day; the electronic medical record unit acquires access data of the clinical medicine research management unit. The clinical trial management unit provides an access plan for the electronic medical record. The electronic medical record unit is provided with a tested functional subunit, and the tested functional subunit is used for displaying examination of the visit data and examination of the medical advice suite. The electronic medical record unit is provided with a tested functional subunit, and the tested functional subunit is used for displaying examination of the visit data and examination of the medical advice suite.
FIG. 2 is a flow diagram illustrating a method of fusing a clinical trial business with a conventional clinical business in accordance with an exemplary embodiment; also disclosed is a method for fusing clinical trial business with conventional clinical business, comprising:
step a, registering and registering: the HIS unit provides a registration information function for the patient, after registration is completed, the identity information of the patient is confirmed in the clinical test management unit through clinical test management personnel, and the patient is enrolled by using the patient visit card;
step b, confirming identity information: after the patient is successfully registered, the self-service unit provides a registration function, acquires patient registration authority information from the clinical test management unit by using the patient number, further judges whether the patient is tested, and then opens a registration operation by the self-service unit;
step c, the consultation is examined: the electronic medical record obtains the data of the interview plan of the patient in a clinical medicine research management unit for carrying out inspection and examination type assembly; the clinical medicine research advice function in the electronic medical record unit provides an interview plan and progress condition for the tested patient; wherein the HIS unit also counts the cost of clinical trials;
step d, medical advice is set up: after the test receiving the consultation of doctors, the clinical test management unit confirms.
The prerequisites for the use of the registration function in step b include:
step b 1: the subject holds a conventional patient card and has registered an identification number in the HIS system;
step b 2: the subject is registered with the clinical trial management unit, and the manager registers the subject with the information related to participation in the clinical trial.
The prerequisite condition of the clinical medicine research advice establishing function in the step c comprises the following steps:
step c 1: the date of the medical advice is the same as the date of the clinical medicine registration of the subject;
step c 2: the doctor orders to start the day, and the identity of the tested clinical medicine continues to be effective;
step c 3: the visit plan of the clinical trial project in which the subject participated was maintained and effective.
FIG. 3 is a system fusion overview flow diagram illustrating a clinical trial business with a routine clinical business, according to an exemplary embodiment:
more specifically, a hospital received a clinical trial project a initiated by a sponsor and was intended to recruit 5 subjects. When project A is planned to be started in a hospital, a worker performs scheme configuration on project A in a hospital clinical test management system, and all examination fees are paid in project A. After a subject is recruited into the group A project according with the scheme, the identity of 'drug research registration' is selected on a self-help registration machine of a hospital, the identity of the subject is matched with the project A, and a doctor can select to open a bill according to the scheme group in an HIS system of the hospital. The statistics of the business volume of 'drug research identity' of the whole hospital every day are summarized into financial statements, and the settlement is automatically carried out from the project. The subject of 'medicine research identity' can trace the source according to the flow, and can more accurately settle the expenses in real time by the system, thereby reducing the manpower input and avoiding the inaccuracy caused by the recurrence of the ending of the expense project and the medical insurance expense occupied by the clinical trial patient.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The device disclosed by the embodiment corresponds to the method disclosed by the embodiment, so that the description is simple, and the relevant points can be referred to the method part for description.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (9)
1. A clinical trial and routine clinical integrated business system, comprising: a registration function module and a medical advice setting function module;
the registration function module comprises: the system comprises a self-service unit, an HIS unit, a clinical test management unit and an expense management unit;
the self-service unit interacts with the clinical test management unit through a clinical test information interface;
the self-service unit interacts with the HIS unit through an HIS unit registration interface;
the clinical trial management unit interacts with the HIS unit through a patient basic information interface;
the expense management unit interacts with the HIS unit through a clinical trial expense interface; the HIS unit collects clinical test cost data and sends the data to the expense management unit and the clinical test management unit;
the open function module includes: an electronic medical record unit and a clinical medicine research management unit;
the electronic medical record unit interacts with the clinical medicine research management unit through the clinical medicine research interface;
the registration function module interacts with the medical advice provision function module through an electronic medical record interface.
2. The system of claim 1, wherein the HIS unit is configured to register and register identity card information of a subject, and the self-service unit is configured to obtain registration authority information of the subject of the clinical trial management unit; the self-service unit completes registration through the HIS unit; the self-service unit solely provides a registration function for the subject.
3. The system of claim 1, wherein the clinical trial management unit obtains identity information of a subject in the HIS unit, and the clinical trial management unit is configured to review identity registration application information of the subject; the clinical test management unit is also used for managing and inquiring the cost data of the tested clinical test; the clinical trial management unit displays and saves the personal information of the testee.
4. The system of claim 1, wherein the clinical research administration unit comprises: a process management subunit and a tested management subunit; the flow management subunit judges whether the tested person is registered with the clinical medicine research identity of the diagnosis day; and the electronic medical record unit acquires the visit data of the clinical medicine research management unit.
5. The system of claim 1, wherein the clinical trial management unit provides an interview plan for the electronic medical record.
6. The system of claim 1, wherein the electronic medical record unit is provided with a functional sub-unit for examination, which is used to display the examination of the visit data and the medical order package.
7. A method of fusing clinical trial services with conventional clinical services, comprising:
step a, registering and registering: the HIS unit provides a registration information function for the patient, after registration is completed, the identity information of the patient is confirmed in the clinical test management unit through clinical test management personnel, and the patient is enrolled by using the patient visit card;
step b, confirming identity information: after the patient is successfully registered, the self-service unit provides a registration function, acquires patient registration authority information from the clinical test management unit by using the patient number, further judges whether the patient is tested, and then opens a registration operation by the self-service unit;
step c, the consultation is examined: the electronic medical record obtains the data of the interview plan of the patient in a clinical medicine research management unit for carrying out inspection and examination type assembly; the clinical medicine research advice function in the electronic medical record unit provides an interview plan and progress condition for the tested patient; wherein the HIS unit counts the cost of the clinical trial;
step d, medical advice is set up: after the test receiving the consultation of doctors, the clinical test management unit confirms.
8. A method for fusing a clinical trial service with a conventional clinical service, wherein the prerequisite for trying to use a registration function in step b comprises:
step b 1: the subject holds a conventional patient card and has registered an identification number in the HIS system;
step b 2: the subject is registered with the clinical trial management unit, and the manager registers the subject with the information related to participation in the clinical trial.
9. A method for fusing clinical trial services with conventional clinical services, wherein the preconditions for the clinical medication order function in step c comprise:
step c 1: the date of the medical advice is the same as the date of the clinical medicine registration of the subject;
step c 2: the doctor orders to start the day, and the identity of the tested clinical medicine continues to be effective;
step c 3: the visit plan of the clinical trial project in which the subject participated was maintained and effective.
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