KR101321406B1 - An examination apparatus and method for authenticating a medical application - Google Patents

Abstract

The present invention discloses an inspection system and method for authenticating a medical application. An inspection apparatus for driving a medical application according to the present invention includes a receiver for receiving measurement information from a medical device, and an analysis for analyzing the received measurement information to determine whether the received measurement information matches a predetermined standard technology. And a transmission unit for transmitting the received measurement information to the medical application if it is determined to match the standard technology by using an analysis result of the analysis unit and the analysis unit, wherein the analysis unit parses a test target among the measurement information. And convert the parsed information into a byte value, and compare the byte value with a value defined in the standard technique.

Description

AN EXAMINATION APPARATUS AND METHOD FOR AUTHENTICATING A MEDICAL APPLICATION}

The present invention relates to an inspection system and an inspection apparatus for medical application certification, and more particularly, to an apparatus and method for examining medical application certification by analyzing whether a mobile medical application conforms to a predefined standard format.

In recent years, medical informatization projects have been actively promoted in an effort to improve the quality of medical services. In addition, as the use of smartphones increases with the development of information and communication technology, it is possible to easily obtain medical information from medical devices (eg, X-ray equipment, CT, MRI, etc.) using a mobile device (eg, smartphone). Can be. In addition, a mobile device embedded with a medical application may be used as a medical device.

Methods of using a mobile device include a method of connecting a mobile device with a medical device to obtain measurement information from the medical device, and a method of directly using the mobile device as a medical device. In this case, the mobile device may include an application, a so-called medical app, and obtain measurement information by being connected to a medical device using the same. In addition, the measurement information may be obtained from the medical device and used by the user as information for medical diagnosis.

Alternatively, the human body can be easily diagnosed by using the mobile device itself as a medical device using an application. For example, a mobile device can be used as a stethoscope or a blood pressure monitor to measure blood pressure or pulse rate.

Medical applications embedded in mobile devices can be used by the public as well as medical professionals. Thus, in the sense that medical applications can be used by the public, medical applications must be clearly certified in advance for their safety and functionality.

In order to certify the stability and functionality of medical applications, discussions have been actively made to establish a standard method for mobile medical applications, and recently, some standard methods for medical applications have been established.

Since medical applications must be certified according to standard methods, there is a need for a simple and accurate method and system for checking the certification of medical applications, despite the need for devices and methods for authenticating and inspecting medical applications. This is being pointed out.

SUMMARY OF THE INVENTION The present invention has been made to solve the above-described problem, and according to the present invention, protocol information of measurement information received from a medical device to check whether a medical application running on a mobile device follows a predefined standard scheme. It is an object of the present invention to provide an inspection apparatus and method for inspecting the certification of medical applications by comparing with the default value of the standard scheme.

According to one embodiment of the invention, the inspection device for medical application authentication, the receiving unit for receiving measurement information from the medical device, the received measurement to determine whether the received measurement information and the predefined standard technology matched An analysis unit for analyzing the information and a transmission unit for transmitting the received measurement information to the medical application if it is determined to match the standard technology by using the analysis result of the analysis unit, and the analysis unit inspects the measurement information. Parsing the object, converting the parsed information into a byte value, and comparing the byte value with a value defined in the standard technique.

In this case, the predefined standard technology is characterized in that the IEEE 11073-20601 standard protocol.

The test result may include protocol data, a description of the protocol data, and an analysis result of the protocol data.

The inspection system may further include an output unit configured to transmit transmission data including the measurement information to a server in a predefined data format.

In this case, the predefined data format is a HL7 message or a PCD-01 profile attached to the HL7 message.

In this case, the HL7 message may include a message header, patient identification information, application information, and measurement data.

On the other hand, the inspection system may further include an authentication unit for identifying individuals, medical personnel and medical institutions.

In this case, the authentication unit is characterized by identifying using a UUID (Uinique User Identidfier).

The inspection system may further include a security audit tracker that records a communication result with the server, wherein the security audit tracker generates a security audit record of the communication result in a data format according to RFC-3881. Characterized in that.

According to another embodiment of the present invention, the test method for medical application authentication, receiving the measurement information from the medical device, the received measurement to determine whether the received measurement information and the predefined standard technology matched Analyzing the information and using the analysis result of the analysis unit to transmit the received measurement information to the medical application if it is determined to match the standard technology, wherein the analyzing comprises: Parsing the object to be inspected, converting the parsed information into a byte value, and comparing the byte value with a value defined in the standard technique.

In this case, the predefined standard technology is characterized in that the IEEE 11073-20601 standard protocol.

The test result may include protocol data, a description of the protocol data, and an analysis result of the protocol data.

The inspection method may further include transmitting the transmission data including the measurement information to a server in a predefined data format.

On the other hand, the test method, characterized in that it further comprises an authentication step for identifying individuals, medical personnel and medical institutions.

The inspection method may further include a security audit step of recording a communication result with the server, wherein the security audit step may include generating a security audit record of the communication result in a data format by RFC-3881. It features.

According to the present invention, by simply checking whether the medical application running on the mobile device follows the standard scheme, it provides an effect of ensuring the stability and reliability for the medical application.

1 is a view for explaining a medical network system according to an embodiment of the present invention;
2 is a block diagram of an inspection system for medical application authentication according to an embodiment of the present invention;
3 is a flowchart illustrating a test method for authenticating a medical application according to another embodiment of the present invention;
4 is a timing diagram illustrating an algorithm of data transmission and reception between a medical device and a mobile device according to an embodiment of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS One embodiment of the present invention will be described in detail and its exemplary embodiment is described in conjunction with the accompanying drawings. Wherein like or similar reference numerals designate the same or similar elements throughout the figures. The embodiments are described with reference to the drawings in order to explain the present invention.

1 is a view for explaining the concept of a mobile medical network system according to an embodiment of the present invention. Referring to FIG. 1, a mobile medical network system may include a medical device 110, an inspection system 130, and a server 150.

The mobile medical network system 100 is a network structure interconnecting the medical device 110 and the test system 130 or the test system 130 and the server 150 by wired or wireless communication. Although the transceiver for performing wired and wireless communication is not shown in FIG. 1, a mobile medical network system may be implemented by a generally known wired or wireless communication network. Thus, even if the detailed description is omitted, it is not unreasonable to understand the present invention.

First, the medical apparatus 110 may include all kinds of medical equipment that may be used in medical institutions such as a heart rate monitor and a blood pressure monitor as well as a medical imaging apparatus such as an X-ray imaging apparatus, a CT imaging apparatus, and an MRI.

The examination system 130 may be implemented as a mobile device in which a medical application is embedded. Here, the mobile device refers to various portable electronic devices capable of driving a medical application such as a smart phone, PDA, notebook, smart pad.

The medical application is a kind of application program that can be run in the inspection system, and may include a communication protocol for performing communication between the mobile device and the medical device.

The server 150 receives information data from the inspection system 130, stores the information data, and receives a data read signal from an external device such as the inspection system 130, and transmits the data stored in the storage area to the external device. Function can be performed.

The medical application installed on the inspection system 130 receives the measurement information from the medical device 110 and evaluates whether the received measurement information conforms to the predefined standard format, so that the data format of the measurement information conforms to the standard format. In this case, the received measurement information may be converted into a predetermined data format.

2 is a diagram illustrating an inspection system for authenticating a medical application according to an exemplary embodiment of the present invention. Referring to FIG. 2, the inspection system 200 may include a receiver 210, an analyzer 220, a transmitter 230, an output 240, and an authenticator 250.

The receiver 210 may receive measurement information from the medical device. The receiving unit 210 receives information from the medical device by various wired or wireless methods. Although a detailed description of the communication method is omitted, a description of the communication method will be omitted for clarity of the present invention because a person of ordinary skill in the art will not understand the present invention.

The receiver 210 may receive a measurement signal according to a predefined standard technique. In this case, the predefined standard technology may be an IEEE 11073-20601 PHD protocol. Here, the IEEE 11073-20601 PHD protocol is a standard protocol established by the IEEE 11073 group to ensure interoperability for data transmission of personal health equipment. When the receiver 210 receives measurement information according to a predefined standard technology, the receiver 210 transmits the measured information to the analyzer 220.

The analyzer 220 may perform a function of analyzing whether the measurement information received by the receiver 210 conforms to a predefined standard technology. More specifically, it is as follows.

First, the analysis unit 220 parses the inspection target information by identifying a target to be inspected from the received measurement information. The content inspected by the analysis unit 220 is a script portion of the protocol related to the association request (association request) of the IEEE 11073-20601 PHD protocol described in the left side in Table 1 below.

Referring to Table 1, the left side of Table 1 shows protocol values associated with an association request, and the right side of Table 1 shows descriptions of protocol values.

The protocol value related to the connection request can be expressed in the following format in XML format.

<PHDStandardProtocol>

<AssociationRequest>

<Protocol>

E2 00 00 32 80 00 00 00 00 01 00 2A 50 79 00 26 80 00 00 00

A0 00 80 00 00 00 00 00 00 00 00 80 00 00 00 08 11 22 33 44

55 66 77 07 02 BC 00 01 01 00 00 00 00 00

</ Protocol>

</ AssociationRequest>

</ PHDStandardProtocol>

In this case, the protocol value may be included in the protocol item in XML format in the form of a string.

The analyzer 220 may parse content to be inspected among the received measurement information. The parsed information is protocol information among the information described in Table 1 below. The protocol information may be expressed in the above-described XML format.

The analyzer 220 may convert data including protocol information expressed in XML format into a byte value. The protocol information converted into the byte value may be compared with a default value of the IEEE 11073-20601 PHD protocol to determine whether the received measurement information matches the standard format.

The result analyzed by the analysis unit 220 may be expressed as shown in Table 2 below.

Referring to Table 2, 0 in the first column of the first line of Table 2 means the number of the script line. 'e2 00' means a protocol value, "APDU CHOICE Type (AarqAp)" is a description of the protocol value, and "Result = Okay" indicates an analysis result of whether or not conforming to the standard format.

The analysis unit 220 calculates an analysis result by sequentially comparing the protocol value of the measurement information with the default value of the IEEE 11073-20601 PHD protocol. The result of the analysis is whether the received measurement information conforms to the standard format of the IEEE 11073-20601 PHD protocol.

If the received measurement information conforms to the standard format of the IEEE 11073-20601 PHD protocol, the delivery unit 230 may transmit the received measurement information to the medical application using the analysis result of the analysis unit 220.

The test apparatus 200 may be implemented in a mobile device (not shown) in which a medical application is driven, but may be implemented independently from the outside. Or it may be included in a storage medium including a program for performing a step for checking the authentication of the medical application.

The output unit 240 may output the test result in the format described in Table 2 including the analysis result of the analysis unit 220. The output unit 240 may display the test result through the user interface. Alternatively, the output unit 240 may transmit the test result to the server in a wired / wireless manner.

The output unit 240 may transmit a test result including measurement information in a predefined data format. In this case, the predefined data format may be a HL7 message or a PCD-01 profile attached to the HL7 message.

Table 3 below is an example script that shows the contents that make up HL7 messaging.

Referring to Table 3, MSH represents a message header, PID represents a patient ID, OBR represents a program description in a gateway, and OBX represents an actual measurement information value.

The messaging content of Table 3 can be designed into the following XML structure to be included in the HL7 messaging content.

More specifically, an exemplary XML script implemented may be expressed as follows.

This Health Level 7 (HL7) is a set of rules that allow information to be compatible between software applications in different healthcare sectors. This allows access to all kinds of health care services, regardless of the type or size of the medical institution. In other words, HL7 refers to a network standard that can share patient care information.

The HL7 protocol specifies elements such as message structures, coding rules, trigger events, etc., where the message structure refers to the abstract definition of a message. Coding rule refers to a message representation method for transmission, and a trigger event refers to an application event for generating a message.

In HL7, when an event occurs by a trigger event, the event causes a path through the network between two or more systems to perform data exchange. Then, when data in the form of a message is transmitted from one system to another system, one cycle is completed by sending a response message confirming whether the message is received from the system that received the message to the system that sent the message.

As described above, the HL7 message may consider terms and codes based on XML (eXtensible Markup Language). However, HL7 messages are suitable for the way in which various independent systems should be linked, but they are not very useful in integrated systems centered on databases.

However, the database-driven order communication system (OCS) is also effective to use HL7 messages to link with independent systems such as picture archiving communication system (PACS).

Here, OCS refers to a system that delivers orders from doctors, and PACS refers to a system that supports image sharing by storing and delivering images.

Modern medical device systems are designed to provide test and measurement results in HL7 messages or to link test request information to HL7 messages. When introducing the latest devices, it is necessary to use HL7 messages for easy and quick system integration. In addition, there is a demand for the construction of a real-time emergency computer network that shares patient information while transferring emergency patients, and the use of HL7 messages for information exchange.

The HL7 message server is a method for generating HL7 messages with minimal changes to existing medical information systems. This method is to share information by delivering a message to a message server when each developed system shares information. It is easy to link between systems because each system only needs to process messages without affecting the environment of other systems. There is one advantage.

On the other hand, when converting, storing, retrieving, and storing HL7 messages into XML, one can also consider how to save storage space by eliminating duplicate data.

These methods focus on generating HL7 messages while operating in the form of a server in large systems such as hospital information systems. If the data type can be specially determined in such a server type of operation, a method in which the server operates independently of a heterogeneous database by generating a common view can also be used.

Here, the HL7 message may include a message header, patient identification information, application information, and measurement data.

The authentication unit 250 performs a function of identifying an individual, a medical person, and a medical institution. The authentication unit 250 may identify between an individual and an individual, a medical person, and a medical person using a Uinique User Identidfier (UUID).

Standards such as ISO 27527 Health Informatics-Provider Identificiation, ISO 22220 Health Informatics-Subject of Care Identification, and ISO 18232-Messages and communication can be applied for examinations conducted to identify individuals, health care providers or medical institutions.

The following Table 4 is a table showing the essential items and recommended items of the standard method for identifying the individual (patient) and explaining the test method.

Referring to Table 4, mandatory items among the individual (patient) test items include an identifier (UUID) and a name. Other test items (date of birth, address, contact, gender, etc.) are only recommendations.

Table 5 below shows the essential and recommended items of the standard method for identifying medical personnel and describes the test methods.

Referring to Table 5, mandatory items among medical test items are identifier, name, registration information, and registration number. Other test items (date of birth, address, contact information) are only recommendations.

Table 6 below shows the essential and recommended items of the standard method for identifying medical institutions and describes the test methods.

Referring to Table 6, the mandatory items among the test items of the medical institution are identifier, name, service start date, and registration number. Other test items (name, date of birth, address, contact information, etc.) are only recommendations.

Essential items and test items for identifying the above-mentioned individuals, medical personnel, medical institutions are merely illustrative to illustrate the present invention, and may include various items in addition thereto.

If the above-described value is designed in XML format, it is shown in Table 7 below.

Referring to Table 7, an XML script for identifying a user may be configured to include each test item in a person, a doctor, and an organization item.

For example, an XML script containing the following personal information is input to the inspection system.

Based on this, the result of authenticating the user is compared.

Algorithm for identifying a user by UUID does not correspond to the technical features of the present invention, which corresponds to a technique well known in the art, so even if omitted for the sake of brevity of the present invention, it will be difficult for a person skilled in the art to understand the present invention. I will not.

In addition, the inspection apparatus 200 may further include a security audit tracker (not shown) for recording a communication result with the server. The security audit tracker may generate a security audit record of the communication result in a data format by RFC-3881.

ISO 27789-Health informatics: Audit trails for electronic health records describe situations or conditions under which audit trails will be implemented for privacy. That is, every time a user connects through the system, an information system including personal medical information is required to create, generate, update, or provide personal health information in the archive.

RFC-3881 describes what XML format the content defined in ISO 27789 should leave.

Table 8 below shows the inspection XML presented in RFC-3881.

For example, using the inspection XML represented in Table 8, the "stored registry query" audit used in the standard medical information system in the IHE is represented as follows.

3 is a flowchart illustrating a test method for authenticating a medical application according to another embodiment of the present invention.

Referring to FIG. 3, a test method for medical application authentication includes receiving measurement information (S310), analyzing received measurement information (S330), and outputting a test result (S350).

Receiving the measurement information (S310), the medical device may measure the biometric information of the patient, and temporarily store the measured biometric information, or may transmit to the mobile device around the medical device. An algorithm of data transmission and reception between the medical apparatus and the mobile apparatus will be described later, and the receiver may receive measurement information from the medical apparatus based on the algorithm described later.

Analyzing the received measurement information (S330) is a step in which data analysis on the received measurement information is performed in order to confirm whether the received measurement information conforms to a predefined standard method. In more detail, the received information including the measurement information received from the medical device may be in XML format.

The target to be inspected is parsed to determine the target of the received measurement information in XML format. The parsed test target contains protocol information in the form of a string, so the string is converted into a byte value. By comparing the modified byte value with the default value of a protocol of a predefined standard format, it is possible to analyze whether the protocol format of the received measurement information conforms to the standard format.

The outputting of the test result (S350) performs a function of outputting the result analyzed in the previous step (S330) to a display device or an external server. The output analysis result may include a result of determining whether the standard format is met. The result of this determination is a visual confirmation of all the items whether the medical application conforms to the standard format, so that the medical application can be easily verified.

4 is a timing diagram illustrating an algorithm of data transmission and reception between a medical device and a mobile device according to an embodiment of the present invention.

Referring to Figure 4, look at the overall operation flow in the inspection method for medical application authentication as follows.

First, the medical device transmits an association request to the surrounding mobile device (S401). In response to the connection request, when a specific mobile device transmits an association response to the medical device (S402), the medical device transmits a data reporting request to the mobile device that has transmitted the connection response (S403). . In response to the data report request, when a specific mobile device transmits a data reporting request (S404), the medical device transmits predetermined measurement information to the mobile device (S405).

If the medical device determines that the transmission of the measurement information is finished, the medical device transmits a disassociation request to the specific mobile device (S406). When a specific mobile device transmits a disassociation response to the medical device in response to the connection termination request (S407), the connection between the medical device and the mobile device is terminated.

The process of authenticating a user between the server and the inspection system will now be described with reference to FIG. 4.

First, the server makes a user authentication request to the inspection system (S410). In FIG. 4, the server requests user authentication from the inspection system, but the inspection system may request user authentication from the server.

The inspection system requests data transmission in order to transmit data to the server (S412). At this time, the server responds to the data transmission request of the inspection system (S413), and in response to the response of the server, the inspection system transmits the corresponding data (S414).

Although illustrative embodiments and applications of the present invention have been shown and described, many changes and modifications may be made without departing from the scope of the present invention, and such modifications may be made by one of ordinary skill in the art to which the present invention pertains It can be clearly understood. Accordingly, the described embodiments are illustrative and not restrictive, and the invention is not limited by the accompanying detailed description, but is capable of modifications within the scope of the claims.

Claims (15)

An inspection apparatus for driving a medical application,
Receiving unit for receiving the measurement information from the medical device;
An analysis unit analyzing the received measurement information to determine whether the received measurement information matches a predefined standard technology; And
And a delivery unit which transmits the received measurement information to the medical application if it is determined that the standard technology is matched using the analysis result of the analysis unit.
The analysis unit parses a test object among the measurement information, converts the parsed information into a byte value, and compares the byte value with a value defined in the standard technology. Inspection device. The method of claim 1,
The predefined standard technology is an inspection apparatus for medical application authentication, characterized in that the IEEE 11073-20601 standard protocol. 3. The method of claim 2,
The analysis result of the analysis unit, the test device for a medical application, characterized in that the protocol data, the description of the protocol data and the analysis results for the 'protocol data'. The method of claim 1,
The inspection apparatus further comprises an output unit for transmitting the transmission data including the measurement information to a server in a predefined data format. 5. The method of claim 4,
And said predefined data format is a HL7 message or a PCD-01 profile attached to said HL7 message. The method of claim 5,
The HL7 message includes a message header, patient identification information, application information and measurement result data. The method of claim 1,
The inspection apparatus further comprises an authentication unit for identifying an individual, a medical person and a medical institution. The method of claim 7, wherein
The authentication unit, the inspection device for medical applications, characterized in that to identify the user using a UUID (Uinique User Identidfier). 5. The method of claim 4,
The inspection apparatus further includes a security audit tracker for recording a communication result with the server,
And the security audit tracker generates a security audit record of the communication result in a data format according to RFC-3881. In the inspection method for medical application certification,
Receiving measurement information from a medical device;
Analyzing the received measurement information to determine whether the received measurement information matches a predefined standard technology; And
And transmitting the received measurement information to the medical application if it is determined to match the standard technology using the result analyzed in the analyzing step.
The analyzing may include parsing a test object among the measurement information, convert the parsed information into a byte value, and compare the byte value with a value defined in the standard technology. Inspection method for The method of claim 10,
The predefined standard technology is a test method for medical application authentication, characterized in that the IEEE 11073-20601 standard protocol. 12. The method of claim 11,
The result analyzed in the analyzing step, the protocol data, a description of the protocol data and the test results for the medical application, characterized in that the analysis results for the 'protocol data'. The method of claim 10,
The inspection method further comprises the step of transmitting the transmission data including the measurement information to a server in a predefined data format. The method of claim 10,
The testing method further comprises an authentication step for identifying an individual, a medical person, and a medical institution. The method of claim 13,
The inspection method may further include a security audit step of recording a communication result with the server.
And the security audit step generates a security audit record of the communication result in a data format according to RFC-3881.

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