KR20200053127A - Transaction method of biomedical data of breast cancer patient - Google Patents

Abstract

According to an embodiment of the present invention, a method of mediating biomedical data of breast cancer patients includes the following steps of: (S110) receiving a first electronic signature from a terminal (P) of a patient; (S120) receiving metadata of clinical data and predetermined pathological data of the patient from a terminal (H) of an institution collecting body derivatives of the patient; (S130) providing the pathological data and the metadata to a researcher terminal (R); (S140) delivering a provision request message of the clinical data to the patient terminal (P) and the institution terminal (H) by receiving the message from the researcher terminal (R); and (S150) receiving a second electronic signature from the terminal (P) of the patient, and transmitting at least some of the raw data of the clinical data to the researcher terminal (R) by receiving the data from the institution terminal (H) when receiving an approval signature from the institution terminal (H). Therefore, the method is capable of performing data mediation between a patient and a researcher while maintaining anonymity.

Description

Transaction method of biomedical data of breast cancer patient

The technical idea of the present disclosure relates to a method for mediating biomedical data for breast cancer patients.

With the development of artificial intelligence-driven data analysis technology, technologies such as diagnosis / prognosis prediction using biomedical data are rapidly developing, and demand for biomedical data essential for technology development is also increasing. However, since biomedical data is sensitive data of an individual, special attention is required in the transmission / intermediary process.

United States Patent Publication No. US20020111833A1

The problem to be solved by the technical idea of the present disclosure is a method of mediating data that enables transmission and / or transaction of data while reducing the risk of identification, particularly a method of mediating biomedical data in breast cancer patients. It is about.

According to an embodiment, a method of mediating biomedical data may include receiving a first electronic signature from a terminal P of a breast cancer patient (S110); Receiving metadata of predetermined pathology data and clinical data of the breast cancer patient from the terminal H of an institution that collects human-derived material of the breast cancer patient (S120); Providing the pathology data and the metadata to a researcher terminal R (S130); Receiving a request message for providing the clinical data from the researcher terminal R and transmitting it to the breast cancer patient terminal P and the institutional terminal H (S140); And when receiving a second electronic signature from the patient's terminal P, and receiving an approval signature from the institutional terminal H, at least a portion of the raw data of the clinical data is the institutional terminal H. It includes; transmitting from the researcher terminal (R) (S150).

According to an embodiment of the present invention, by intervening both breast cancer patients and human body collection agencies, data can be brokered without the problem of personal information infringement. On the other hand, by allowing only the metadata of the pathology data and clinical data to be searched, the risk of personal identification can be reduced while the search can be performed on the intermediary device (server). On the other hand, since personal identification information is not separately stored in an intermediary device, data intermediation between a patient and a researcher can be performed while maintaining anonymity.

On the other hand, by using ER, PR, and Her2 data for breast cancer patients as a search criterion, it is possible to reduce the risk of personally identifiable information leakage while enabling researchers to search for patient's human-derived material through high-value data.

On the other hand, by parsing the pathology data and clinical data provided by the institution terminal in the form of a picture file, the sample collection date and the operation date are arranged in chronological order, so that the researcher who received the data can easily understand the history of breast cancer patients. I can make it possible.

1 and 2 are a flow chart showing a method of mediating biomedical data of a breast cancer patient according to an embodiment of the present invention.
3 and 4 are actual examples of pathology data (original pathology report) of a breast cancer patient.
5 is a real example of clinical data (original surgical record) of a breast cancer patient.
FIG. 6 is an exemplary screen in which sample collection dates and surgical dates of pathology data are arranged over time.

In the present specification, biomedical data should be broadly interpreted as medical data such as medical records of individuals, image data such as MRI, genomic data, dietary data, prescription data, and biometric data. do. Hereinafter, biomedical data will be referred to as 'data'.

In the present specification, the human body (biospecimen) is collected from or collected from the human body during a test / diagnosis / surgery process, such as tissue, cells, blood, and body fluids, and serum, plasma, and chromosomal DNA separated from the human body. It means RNA, protein, etc.

In the present specification, the "organ that collects human-derived materials" refers to an institution that handles or collects human-derived materials during the examination / diagnosis / surgery process, and may mean a hospital or a biobank, a human-derived material bank, or the like. . Hereinafter, an organ that collects human-derived materials will be referred to as an 'organ'.

In this specification, 'researcher' refers to a person who studies biomedical data and / or human-derived materials, and may mean a pharmaceutical company, a research institute, a bio company, and the like.

1 and 2 is a flow chart showing a method of mediating biomedical data of a breast cancer patient according to an embodiment of the present invention.

The method of mediating data according to an embodiment includes receiving a first electronic signature from a terminal P of a breast cancer patient (S110); Receiving metadata of predetermined pathology data and clinical data of a breast cancer patient from a terminal H of an institution that has collected the patient's human-derived material; Providing pathology data and metadata to the researcher terminal R; Receiving a request message for providing clinical data from the researcher terminal R and transmitting it to the breast cancer patient terminal P and the institution terminal H; When a second electronic signature is received from the terminal P of the breast cancer patient and an approval signature is received from the institution terminal H, at least a portion of the raw data of the clinical data is transferred from the institution terminal H to the researcher And transmitting to the terminal R.

The above-described steps may be performed in the data intermediary device 10. The data intermediary device 10 includes: an electronic signature receiver for receiving a first electronic signature from a terminal P of a breast cancer patient; A data receiving unit receiving metadata of predetermined pathology data and clinical data of breast cancer patients from a terminal H of an institution that has collected a patient's human-derived material; A data providing unit that provides pathology data and metadata to the researcher terminal R; A message transmitting unit receiving a request message for providing clinical data from the researcher terminal R and transmitting it to the patient terminal P and the institution terminal H; And receiving a second electronic signature from the terminal P of the breast cancer patient and receiving an approval signature from the institution terminal H, transmitting at least some of the raw data of the clinical data from the institution terminal H. It may include; a transmitter for receiving and transmitting to the researcher terminal (R).

1 and 2, a step (S110) of receiving a first electronic signature from a terminal P of a breast cancer patient (hereinafter, a patient) is performed. 'Electronic signature' may mean any method of electronically convincing a patient that he or she has consented to a particular content. For example, the electronic signature may be performed by entering a patient's private key to enter a smart contract on a blockchain. The patient may agree to disclose some of his biomedical data to a location other than the institution through a terminal P, such as a smartphone or personal computer (pc). The patient may perform a first electronic signature that allows a third party to search for a part of the biomedical data through the terminal P. If the patient agrees to disclose certain biomedical data, the institution that has examined the patient may provide the data to a third party.

Then, the step (S120) of receiving the metadata of the pathology data and clinical data from the terminal (H) of the institution is performed. Hereinafter, it is assumed that the institution is a 'hospital'. Since the patient's first electronic signature is received, the hospital terminal H can transmit the patient's specific data to the third-party intermediary device 10. The hospital terminal may be an electric medical record (EMR) system for electronically managing medical data or a computer used in a hospital.

Pathological data includes data obtained by examining samples of tissues, cells, organs, etc. using a naked eye or a microscope. Pathology data may be, for example, data relating to cancer tissue. Pathology data may include, for example, data of any one of sample type, tissue collection site, multiplicity, tumor size, histologic type, histologic grade, nuclear grade, Lymph node metastasis, Lymphovascular invasion, Vascular invasion, Extraorgan extension, Resection margin involvement. However, the present invention is not limited thereto.

Pathology data is data that ultimately determines the patient's condition, so it can be provided to a third party in a hospital because of its high importance and low risk of personal identification.

According to one embodiment, the pathology data may include at least ER data, PR data, and Her2 data. The ER, PR, and Her2 data may include data indicating whether the Estrogen Receptor, Progesteron Receptor, or Her2 receptor is positive or negative, respectively.

Particularly in breast cancer, ER, PR, and Her2 data among pathology data are important data that play a decisive role in establishing future treatment policies, but because the risk of personal identification is low, they can be provided to third parties in hospitals. .

Clinical data refers to data related to the clinic besides pathology data. Clinical data may include, for example, epidemiological information, lab information, surgical information, image information, treatment information, and the like.

Metadata of clinical data corresponds to the 'name' of the data. For example, Table 1 below exemplarily shows clinical data of breast cancer patient A and some of its metadata. The left column of <Table 1> corresponds to 'metadata', and the right column corresponds to the actual 'raw data' of metadata.

Metadata Data Age 30 Sex F Ethnicity Asian Name of disease Breast Cancer Chemotherapy AC-docetaxel

The intermediary device 10 may receive the original data of the pathology data and the metadata of the clinical data from the terminal H of the institution. That is, at least a portion of the raw data of clinical data may not be received from the institution terminal H. When receiving only metadata, it is possible to know only what data a specific patient has.

Thereafter, step S130 of providing pathology data and metadata to the researcher terminal R is performed. The intermediary device 10 may serve as a server that enables the researcher terminal R to search for pathology data and metadata. For example, the researcher can access the server of the intermediary device 10 and set and search the desired data criteria.

According to an embodiment, the step of providing pathology data and metadata to the researcher terminal includes: parsing a sample collection date of the pathology data received from the terminal R of the institution; Parsing the surgical date of clinical data received from the terminal R of the institution; And arranging and providing the sample collection date and the operation date of the pathology data according to time.

In one embodiment, the intermediary device 10 may receive pathology data in the form of a scanned pathology report, ie, a picture file format. In this case, in order to extract the desired information from the picture file, the text must be optically read and parsed.

In an embodiment of the present invention, the scanned pathology report file is optically read (OCR) to parse the sample collection date. The 'sample collection date' is the date when a tissue sample is actually removed from a breast cancer patient, and becomes a standard for determining when the corresponding tissue sample was made in the study of the human body.

3 and 4 are actual examples of pathology data (original pathology report) of a breast cancer patient. To prevent the leakage of personally identifiable information, part of the report was covered, and the date information was corrected. 3 and 4, the 'request date' of the pathology data appears. Since the format of the pathology report is different for each hospital, in one embodiment of the present invention, {sample collection date, collection date, request date, request date, request date, inspection date, inspection date, inspection date, reception date, reception date, reception date } Extract all the dates corresponding to} and identify the earliest date as 'sample collection date'. That is, in the case of FIGS. 3 and 4, the sample collection dates are '20170127' and '20170901', respectively.

Meanwhile, in one embodiment of the present invention, the scanned pathology report file is optically read (OCR) to parse ER, PR, and Her2 data.

In one embodiment, ER data may extract {positive, +} as a positive value and {negative,-} as a negative value among {ER, Estrogen Receptor}.

In one embodiment, PR data is among the values corresponding to {PR, Progesteron Receptor}

{positive, +} can be extracted as positive and {negative,-} can be extracted as negative.

In one embodiment, Her2 data is {positive, 2+, +2, 3 among values corresponding to {Her2, Her-2, Her2 / neu, human epidermal growth factor receptor 2, ErbB-2, c-erb B2} You can extract +, +3} as positive and {negative, 0, +1, 1+} as negative.

3 and 4, when the original report is parsed according to the criteria according to the above embodiment, the corresponding breast cancer patient may be classified as a patient of ER +, PR +, Her2-. That is, when the institution terminal H transmits the original report to the intermediary device 10, the intermediary device 10 may extract ER, PR, and Her2 information of the corresponding breast cancer patient through the parsing process described above. The intermediary device 10 may extract information of various breast cancer patients and provide it to the researcher terminal R in a form of filtering (searching).

Meanwhile, in an embodiment of the present invention, the scanned pathology report file is optically read (OCR) to parse the surgical date. In one embodiment, the operation date may be extracted from values corresponding to {operation day, operation date, operation day, operation date, operation date, date of operation}.

5 is a real example of clinical data (original surgical record) of a breast cancer patient. To prevent the leakage of personally identifiable information, part of the report was covered, and the date information was corrected. Referring to part A of FIG. 5, the original picture file of the surgical record was parsed after OCR and the surgical date was parsed as '20180901'.

FIG. 6 is an exemplary screen in which sample collection dates and surgical dates of pathology data are arranged over time. Referring to FIG. 6, dates are displayed on the time axis, and major events are arranged by date. First, ER, PR, and Her2 data among the parsed pathology data 611 and 612 may be provided to the researcher terminal R. In the researcher terminal (R), since 2017.02 and September are each sample collection days, it is possible to grasp that a biopsy was performed at this time, and it can be seen that the institution stores the corresponding human-derived materials.

According to an embodiment, the intermediary device 10 may provide metadata 613 regarding chemotherapy among clinical data to the researcher terminal R. Referring to FIG. 6, only 'metadata' called chemotherapy (613) is shown, and raw data regarding what chemotherapy was specifically used is not shown.

According to an embodiment, the intermediary device 10 may transmit the operation date 614 to the researcher terminal R. In the case of the breast cancer patient, the biopsy was performed immediately on the surgery date, so the surgery and sample collection date appear on the same day.

According to an embodiment, the intermediary device 10 may provide metadata 613 regarding radiation therapy data or antihormonal therapy data among clinical data to the researcher terminal R. Referring to FIG. 6, only 'metadata' of radiotherapy / hormonal therapy (RT-HT, 615) is shown, and raw data regarding which treatment method is specifically used is not shown.

In this case, suppose that there is a researcher who wants to statistically analyze the prognosis of breast cancer patients, such as ER +, PR +, and Her2-, through human-derived and pathological / clinical data. The researcher can find a list of patients whose ER, PR, and Her2 status corresponding to pathology data are {+, +,-}, respectively, through the intermediary device 10. Suppose, on the other hand, that a researcher needs information about chemotherapy in breast cancer patients for statistical analysis. In this case, referring to FIG. 6 and <Table 1>, the intermediary device 10 has received only metadata such as <Chemotherapy> of patient A, and 'AC-docetaxel' corresponding to each original data has not been received. State. Therefore, the researcher knows that patient A or the organ has data on <Chemotherapy>, but does not know the raw data. Therefore, in order for the researcher to receive and receive the original data of <Chemotherapy>, the patient A and the institution must request it.

Thereafter, a step (S140) of receiving a request message for providing clinical data from the researcher terminal R and transmitting it to the patient terminal P and the institution terminal H is performed. The researcher may request the transmission and / or sale of raw data to the patient A or the institution having the original data of the clinical data through the intermediary device 10 (server). According to one embodiment, the intermediary device 10 may receive information regarding the research purpose, the type of data required, or the expected risk and benefit to the research subject from the researcher terminal R.

Subsequently, when a second electronic signature is received from the patient's terminal P and an approval signature is received from the institution terminal H, at least some of the raw data of the clinical data is transmitted from the institution terminal H Step (S150) of receiving and transmitting to the researcher terminal R is performed. When the researcher requests the transmission / disclosure of patient's surgical information or treatment information, such as raw data of <Chemotherapy>, the patient agrees to provide raw data of such clinical data through the terminal P The second electronic signature can be performed. On the other hand, the institution may perform an approval signature to agree to the study using the raw data of the clinical data through the terminal (H). According to an embodiment, the intermediary device 10 receives at least some of the original data of the clinical data only when the second electronic signature from the patient terminal P and the approval signature from the institution terminal H are received. ), And transmit to the researcher terminal R. The second electronic signature and the approval signature may be recorded on a blockchain, and the intermediary device 10 may confirm whether the second electronic signature and the approval signature are authentic through a blockchain.

For example, patient A may agree to disclose the original data of <Chemotherapy> requested through the terminal P, and if the institution also approves its transmission through the terminal H, the intermediary device 10 may transmit the 'AC -docetaxel 'can be received and transmitted to the researcher terminal (R).

The mediation method of biomedical data according to an embodiment is After the transmission step (S150), receiving the upload message of the patient generated data from the researcher terminal (R) and passing it to the patient terminal (P) and from the patient terminal (P), only when a third electronic signature is received The method may further include transmitting patient-generated data to the researcher terminal R.

The researcher may need additional data in addition to the pathology data and clinical data received in the above-described process. For example, the researcher may need information about what foods the patient is taking, what medications he is taking, and how much he is exercising. Hereinafter, in addition to the pathology data and clinical data generated in the hospital, the data generated and uploaded by the patient will be referred to as 'Patient-Generated Health Data (PGHD)'.

Since the institutional terminal H does not have such patient-generated data, the researcher may directly request the patient to provide such data. Therefore, in this case, if there is only consent by the patient's third electronic signature, data may be transmitted to the researcher terminal R even if there is no approval signature of the institution terminal H.

The mediation method of biomedical data according to an embodiment is When the subsequent data is uploaded from the institution terminal (H) or the patient terminal (P) after the transmission step (S150), it may further include the step of notifying the researcher terminal (R).

Subsequent data refers to data generated about the patient at the institution terminal H after the researcher terminal R has obtained pathology data and clinical data for the first time. For example, the follow-up data may include follow-up data, such as whether the patient has recurrence, has metastasis, has other diseases, or has died.

Suppose that a researcher wants to analyze the prognosis of a breast cancer patient through, for example, human body material and data analysis. In this case, the researcher needs to continuously understand the patient's condition after the acquisition of the pathology / clinical data. At this time, if the patient terminal (P) or institutional terminal (H) to update the subsequent data, the intermediary device 10 may notify the researcher terminal (R).

According to one embodiment, when the institution requests the provision / purchase of such subsequent data and the patient and / or the institution agree, the intermediary device 10 may transmit the original data of the subsequent data to the researcher terminal R have. According to one embodiment, the subsequent data include a disease-free survival period (Disease Free Survival, DFS), a progression-free survival (PFS) Distant Metastasis Free Survival (DMFS), and a local recurrence period ( locoregional progression free survival (LRPFS), or overall survival (OS).

According to an embodiment of the present invention, the mediation of data can be performed without the problem of personal information protection by involving both the patient and the human body collection agency. On the other hand, by allowing only the metadata of the pathology data and clinical data to be searched, the risk of personal identification can be reduced while the search can be performed on the intermediary device 10 (server). Meanwhile, since the personal identification information is not separately stored in the intermediary device 10, it is possible to perform data intermediary between the patient and the researcher while maintaining anonymity.

The data transmission method according to an embodiment of the present invention may be executed in the form of a computer program or application recorded on a computer-readable recording medium. Computers that can record and store computer programs or applications are not only ordinary PCs such as desktops or laptops, but also smart devices, smartphones, tablet PCs, PDAs (Personal Digital Assistants), and It should be interpreted as a mobile terminal such as a mobile communication terminal and all devices capable of computing.

As described above, exemplary embodiments have been disclosed in the drawings and the specification. Although the embodiments have been described using specific terminology in this specification, they are used only for the purpose of describing the technical spirit of the present disclosure and are not used to limit the scope of the present disclosure as defined in the claims or the claims. . Therefore, those skilled in the art will understand that various modifications and other equivalent embodiments are possible therefrom. Therefore, the true technical protection scope of the present disclosure should be defined by the technical spirit of the appended claims.

Claims (4)

Receiving a first electronic signature from a terminal of a breast cancer patient;
Receiving metadata of pathological data and clinical data of the breast cancer patient from a terminal of an institution that collects human-derived material of the breast cancer patient;
Providing the pathology data and the metadata to a researcher terminal;
Receiving a request message for providing the clinical data from the researcher terminal and transmitting it to the breast cancer patient terminal and the institution terminal;
When a second electronic signature is received from the terminal of the breast cancer patient and an approval signature is received from the institution terminal, at least a portion of the raw data of the clinical data is transmitted from the institution terminal and transmitted to the researcher terminal A method of mediating biomedical data for a patient with breast cancer, comprising a step .
According to claim 1,
The pathology data comprises at least ER data, PR data, Her2 data, mediating method of breast cancer patient biomedical data .
According to claim 1,
Providing the pathology data and the metadata to the researcher terminal,
Parsing a sample collection date of the pathology data received from the terminal of the institution;
Parsing a surgical date of the clinical data received from the terminal of the institution;
And arranging and providing the sample collection date and the operation date according to the time of the pathology data .
A method that allows a processor to perform the method of claim 1.
A computer program stored on a computer readable recording medium.

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