CN103761697A - Scientific research data generation and patient privacy protection system based on electronic medical record - Google Patents
Scientific research data generation and patient privacy protection system based on electronic medical record Download PDFInfo
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Abstract
The invention provides a scientific research data generation and patient privacy protection system based on an electronic medical record. The scientific research data generation and patient privacy protection system based on the electronic medical record is used for achieving patient privacy protection based on scientific research data generation of the clinical electronic medical record. According to the scientific research data generation and patient privacy protection system, when a data analytical statement is generated and information is looked up, the patient privacy information such as the name can be hidden (the name is replaced by an ID code in the system); the authorities of research doctors are set, the corresponding level of information can be seen by the research doctor with the corresponding authority, and all research information of a patient can only be accessed by the doctor who obtains enough authorities. The scientific research data generation and patient privacy protection system based on the electronic medical record aims to protect the privacy of the patient, protect the safety of medical data, avoid unnecessary disputes, enable clinical data to be more standard, truer and more reasonable and facilitate exchange and collection of the clinical data when the truthful clinical data are adopted.
Description
Technical field
The present invention is that a kind of scientific research data based on electronic health record generate and patients ' privacy protection system, for realizing patient's secret protection on the basis generating in clinical electronic health record scientific research data, the present invention, can be by patient's privacy information as name concealment (being replaced by ID code in system) when carrying out that generated data analytical statement and information are consulted etc.; Research doctor authority is arranged, and corresponding authority can be seen the information of appropriate level, only has and has obtained enough authority persons, can have access to patient's full-fledged research information.The object of the invention is to protect patient's privacy, the safety of protection medical data, avoids causing unnecessary dispute, makes clinical data standard, true, reasonable more, is convenient to the interchange of clinical data and gathers.
Background technology
Along with management information system for hospitals (hospital management information system, HIS), clinic information system (clinical information system, CIS), electronic medical record system (electronic medical record, EMR) etc. information system management means are in the successful implementation of hospital, and the starting of digital hospital forms.A large amount of clinical data under Information Condition, when providing abundant data for research, patient's privacy is also more easily leaked and is easily caused unnecessary dispute, and the safety problem of data also has much room for improvement.But still lacking ripe direct applying electronic medical record information is at present scientific research data the methods and applications of protecting patients ' privacy according to law.
Under the pattern of existing clinical research, the conclusion that traditional control test draws is not explained situation about occurring under clinical practice condition, is necessary to carry out the real world research based on clinical practice.Real world is studied as a kind of new research form, and the form of its clinical implementation is more complicated, opening Design; intervening measure is unfixing, and study subject is in extensive range, and intervention effect is uncertain; large and the patient's of data volume that research produces secret protection, consultant's authority setting.But what there is no at present that a kind of technology solves scientific research data based on clinical practice obtains, synthesizes, gathers the difficult problem facing.In clinical practice, the data message source of medical treatment is different, as: the data of electronic health record record, hospital HIS system, LIS system, PACS system, in traditional clinical research process, gathering of these data needs people for making a copy of, need cost manpower energetically, also increase the probability of mistake simultaneously.Simultaneously clinical data is because medical institutions are in Samples detection process, may be due to the instrument difference detecting, or same class instrument model difference, the reagent manufacturing enterprise of detecting under same model instrument is not equal, or same reagent adopts not square one of standard.Before and after so can having formed the same class data that different detection methods cause, twice testing result is inconsistent, and the same period, the widely different problem of numerical value detects in different research units.The difference of data, causes research not merge and to contrast, and has affected data Macro or mass analysis, and existing scientific research data are utilized in method can not solve the inconsistent problem of data.
Secret protection is the cardinal rule that clinical research must be observed.Under clinical practice condition, carry out true world research, the setting of consulting authority of the secret protection to patient, all kinds of clinical datas is new problems that clinical research faces.How, in clinical practice, on to the basis of patients ' privacy protection and data security, carry out real world research, there is no at present effective method and means.Summary of the invention
The present invention is the patients ' privacy protection system generating based on electronic health record scientific research data, for the basic automatic generation that realizes scientific research data at electronic health record, conceals patient's essential information, and arranges and consult accordingly authority and consult.Take the data that record, inscribe disease, physical examination, vital sign, diagnostic message, progress note, MAR and LIS system, PACS system, HIS system in hospital of electronic health record as data source, by extracting, gathering, generate scientific research data, and realize reconstruct data and conceal the synthetic printing of patient's essential information.The present invention meets the requirement of the standardization of clinical research to data, authenticity, reliability, tractability, confidentiality, improved the quality of clinical research, be convenient to the data exchange of similar scientific research and gather, this invention belongs to the method that is extracted and changed by data message and realizes the process of knowledge reorganization.
The present invention seeks to realize electronic health record information and directly generate scientific research data message, solve clinical data because the same class data that different detection methods cause are inconsistent; Real world clinical research patient's secret protection; Consultant's authority setting, data security; The problems such as scientific research data can not dynamically generate, data validity is poor.For erecting the bridge of a perforation between the clinical position the large-scale property practitioner of hospital and research work, also can protect patient's privacy according to law, protect the safety of all kinds of clinical datas.
In order to achieve the above object, the scientific research data that technical scheme of the present invention has been to provide based on electronic health record generate and patients ' privacy protection system, comprising:
Front cover data generation module, has realized scientific research data CRF front cover data and has generated;
Data generation module before treating, treats front data as requirement to write, and has realized the data of course of disease data production scientific research first.
Make a house call and record generation module, with the requirement of making a house call of research approach design, by writing the record of making a house call;
Adverse events generation module, has realized the record of adverse events and has gathered;
MAR generation module, has realized the detailed record of drug combination;
HIS, LIS, PACS system data directly quote module, realized directly quoting and gather of HIS, LIS, PACS system;
Data gather and form production module, with data sheet generate, gather, data-privacy protection and document print;
Patients ' privacy protection module, has realized the concealment (being replaced by ID code in system) to patient critical information (as: name), reaches the object of protection patients ' privacy;
Researcher's authority module, the data that corresponding authority can be consulted appropriate level, only has highest weight limit person just can inquire about whole research information.
First, the present invention is for clinical large-scale medical institutions, can be according to scientific research demand data, with data message and the HIS system of electronic health record, LIS system, PACS system data is source data, as patient's essential information, as the age, sex, national, the information such as wed no, the course of disease first, inscribe disease, past medical history, obsterical history, family history, allergies etc., physical examination, progress note, fox message, the summary of leaving hospital, check detection etc., according to scientific research, require to generate scientific research data, synthetic and gather and generate the scientific research document function that unified standard does not show patient identity information.
Secondly, because the content of clinical research is different with object, the emphasis that data is obtained is variant.The present invention adopts the design of format masterplate in design, according to ICH, WH0 and the requirement of the relevant rules of SFDA to CRF data, in order to meet scientific research data integrity, stipulated the required framework of scientific research data, in the time of these software systems of application, can need to have been adjusted concrete data message according to research.For the data from HIS system, LIS system, PACS system, in the process of Reference source data, record standard value; In order to scientific research data are final, convert and contrast.
Finally, according to the regulation of domestic and international relevant laws and rules, to protect the requirement of patients ' privacy information, when applying electronic case information, need to consider this point.The present invention is when carrying out generated data analytical statement, and the privacy information that conceals patient, as " name " information (being replaced by ID code in system), has been realized the protection of patients ' privacy.Arrange and consult authority simultaneously, the data that corresponding authority researcher can consult appropriate level, only has highest weight limit person just can inquire about whole research information.
Maintenance data of the present invention extracts and conversion method; by knowledge reorganization pattern; realized the automatic generation of the clinical research data based on medical case data; realize sharing of medical treatment and scientific research, save the plenty of time, realized the dynamic generation of scientific research data; improved quality of research; by experimenter's privacy information, send out concealment simultaneously, reached in the time of application scientific research data the object of the experimenter's privacy that adequately protects.
Accompanying drawing explanation
Fig. 1 is the frame diagram that is applicable to computer processing system of the present invention;
Fig. 2 workflow diagram of the present invention.
Embodiment:
Below in conjunction with example, illustrate the present invention.Should be understood that these examples are only for illustrating of the present invention and being not limited to scope of the present invention.In addition should be understood that reading after the present invention lectures content, those skilled in the art can according to demand, modify or change the present invention, but the change of the equivalent form of value and revising falls within claim and this book limited range described in the application equally.
The scientific research data that the present invention is to provide based on electronic health record generate and patients ' privacy protection software systems.
Take the data of clinical structured electronic patient record, HIS system, LIS system, PACS system as data source, the information such as not no in: age, sex, nationality, wedding in: patient's essential information, first the course of disease, inscribe disease, past medical history, obsterical history, family history, allergies etc., physical examination, doctor's advice information, progress note, leave hospital and sum up and fox message (comprising laboratory examination, PACS systems inspection) etc., by the reconstructing method of knowledge, generate the scientific research document function that unified standard does not show patient identity information.
Be according to the requirement of scientific research scheme, realized the generation of scientific research data Periodical front cover informations;
Be according to the requirement of scientific research scheme, realized the data before electronic health record course of disease Information generation treatment first;
Be according to the requirement of making a house call of research approach design, realized the prompting of make a house call record data production and time window;
Be, according to scientific research requirement, realized the record of adverse events and gathered;
Be, according to HIS system doctor's advice information, to have realized the complete documentation of MAR;
Be according to scientific research data demand, the data that to have realized LIS, PACS system be source data are directly quoted;
Be according to scientific research data demand, realized that data gather, data-privacy protection, form produce and document print.
Be according to scientific research data demand, realized the concealment (being replaced by ID code in system) to patient critical information (as: name), protection patient's privacy.
Be, according to scientific research requirement, to have realized authority setting, the researcher of corresponding authority can consult the data of appropriate level.
Scientific research data based on electronic health record provided by the invention generate and the Data Source of patients ' privacy protection system also comprises the source data from HIS system, PACS system, LIS system, and open system interface is the guarantee of Data Source.Described interface is configurable open interface, and described data pick-up is at electronic health record terminal, by what carry out in LAN (Local Area Network) (hospital internal net), can not directly access internet.
The present invention can realize in the medical institutions that realize information system management, and required hardware is such as application server, HIS system, PACS system, LIS system, electronic medical record system, data storage device, Database Systems, network interface etc.Computer platform also comprises operating system and its instruction code.The instruction code here comprises researcher's username and password.In addition can pass through LAN (Local Area Network) (hospital internal net) by native system and and other system docking.Also can be by peripherals such as printer, data storage device is realized data-printing and derivation.
Fig. 1 is the computer system frame diagram of native system, and this system comprises basal layer 101, as application server, database, memory device, the network equipment; Data Layer 102, as HIS system data, PACS system data, LIS system data, electronic medical record system data; Supporting layer 103, as equipment interface, access controller, storage administration etc.; The application layer 104 i.e. scientific research data based on electronic health record generates and patients ' privacy protection system.Various peripherals is as display device, keyboard and mouse etc.What it should be noted that computer system is that independently LAN (Local Area Network) (hospital internal net) is connected, and the network equipment is connecting Internet directly.Particularly; exactly in the medical institutions that have been equipped with information-based pacing items; take electronic health record, HIS system, LIS system, PACS system data as source data, by supports such as equipment interface, access controllers, the scientific research data of application based on electronic health record generate and patients ' privacy protection system.
The data source of scientific research data as shown in Figure 2, is from electronic health record, LIS system, HIS system, PACS system two parts.The Periodical front cover information of scientific research data generates by front cover data and generates 201 modules realizations, before treatment, data generates by treating front data and generates 202 modules realizations, the record data of making a house call generate by the record of making a house call and generate 203 modules realizations, adverse events data recording generates by adverse events and generates 204 modules realizations, MAR data generate 205 modules by MAR and realize, and synthesizing and gather by data of data synthesized and gathered 206 modules realizations.Wherein treat before data and make a house call record need fox message by LIS system data 101, PACS system data 102 by directly quoting realization; MAR and adverse events need MAR message part by reference HIS system data 103 realize.Patient's secret protection information hiding is realized by secret protection 301 modules; Researcher's authority arranges module 302 by authority and realizes.
As Fig. 2 illustrated scientific research data based on electronic health record source, reconstruct and protection, now as an example of " clinical research of therapy of combing traditional Chinese and Western medicine Treating Stable Angina Pectoris of Coronary Artery Disease " example, its application process is described.
Data take electronic health record data as data source generate: as: patient's electronic health record is diagnosed as " coronary disease and angina pectoris ", researcher enables the scientific research data generation system based on electronic health record, according to patient be in hospital the large medical record information of case history enable front cover data generate 201, automatically generate the required front cover data message of scientific research data as patient's name, patient's numbering, researcher's name, research unit etc.
As: after scientific research Periodical front cover information completes, according to the large medical record information of being in hospital of electronic health record, as: name, sex, age while being admitted to hospital, national, marital status, native place, occupation, morbidity solar term, admission date and and course of disease information first, as: main suit is (as uncomfortable in chest in symptom, 7 years duration, breathe hard, continue 4 days), present illness history is (uncomfortable in chest, degree uncomfortable in chest, breathe hard, the degree of breathing hard etc.), physical examination, past medical history, personal history, family history, traditional Chinese medical science four methods of diagnosis information, as: corpulent tongue is large, small and wiry pulse, vital sign is as body temperature, pulse, breathe, blood pressure, Western medicine diagnose is as coronary disease and angina pectoris, tcm diagnosis is as the obstruction of qi in the chest, Qi deficiency blood stasis type etc., data information before the automatic generation treatment of data generation 202 before treating by startup.
As: after before treating, data completes, according to the requirement of making a house call of scientific research scheme, obtain the corresponding record data of being in hospital of electronic health record, as: cardinal symptom is as " uncomfortable in chest ", " breathing hard " and degree thereof, " the tongue picture " of the traditional Chinese medical science four methods of diagnosis, " pulse condition " information is as data source, by the startup record of making a house call, generated 203 and automatically generated the record data of making a house call.
As: as there being adverse events to occur in research process, as there is " diarrhoea " in patient's diagnosis and treatment process, poor starting event generates 204 separately, by record " diarrhoea " time of origin, processing mode, medication information, finally go through transition and filled in adverse events record and fill in, realized the generation of adverse events data.
If: the doctor's advice information of HIS system data 103 is as the data source of MAR, start MAR and generate 205, quote the medicine name of doctor's advice information, dosage, route of administration, doctor's advice time and fill in medication reason and realize the generation of MAR data.
As: before treating, data generation 202 and the record of making a house call generate 203 and need to quote LIS system data 101, PACS system data 102, as " routine blood test " can select to study the data that need by sql statement, as " white blood cell count(WBC) ", " red blood cell count(RBC) ", " haemoglobin ", " platelet count ", treats front data and makes a house call and look record data by selecting and being cited as, and realizes the automatic selection of LIS system data 101 and PACS system data 102 and quotes and gather.
Data are synthesized and gathered is after data generates, log-on data is synthetic and gather 206, by the front cover data of scientific research document, treat before data, the record of making a house call, adverse events, MAR, fox message be aggregated into the forms such as WORD, PDF, EXCEL, and realize and print item by item and gather printing.
As: in the time of consulting patient's data or generated data analytical statement, the privacy information that secret protection 301 conceals patient as: " name " (being replaced by ID code in system), realized the protection of patients ' privacy.Authority arranges 302 simultaneously, and the data that makes corresponding authority researcher can consult appropriate level, only has highest weight limit person just can inquire about whole research information.
The present invention has realized under clinical practice condition, the automatic generation of the scientific research data based on electronic health record, improve standardization, authenticity, reliability, the tractability of clinical research to data, solve the problem that the clinical data that causes due to data difference can not exchange and gather simultaneously, for coordinating to provide condition between clinician's clinical and scientific research, to carrying out real world clinical research, provide technical support, also for the conversion of clinical research pattern provides the foundation.
Claims (2)
1. the scientific research data based on electronic health record generate and a patients ' privacy protection system, it is characterized in that, system comprises:
(1) front cover data generation module, has realized scientific research data CRF front cover data and has generated;
(2) treat front data generation module, to write, treat front data as requirement, realized the data of course of disease data production scientific research first;
(3) make a house call and record generation module, with the requirement of making a house call of research approach design, by writing the record of making a house call;
(4) adverse events generation module, has realized the record of adverse events and has gathered;
(5) MAR generation module, has realized the detailed record of drug combination;
(6) HIS, LIS, PACS system data are directly quoted module, have realized directly quoting and gather of HIS, LIS, PACS system;
(7) data gather and form production module, with data sheet, generate, gather and document print;
(8) patients ' privacy protection module, has realized the concealment to patient critical information, reaches the object of protection patients ' privacy;
(9) researcher's authority module, the data that corresponding authority can be consulted appropriate level, only has highest weight limit person just can inquire about whole research information.
2. a kind of scientific research data based on electronic health record as claimed in claim 1 generate and patients ' privacy protection system, it is characterized in that, this system is take clinical electronic health record as basis, merged LIS system, HIS system, PACS system data is source data, can extract the age in electronic health record, sex, national, the no patient essential information of waiting of wedding, and the course of disease first, inscribe disease, past medical history, obsterical history, family history, allergies etc., physical examination, diagnosis, MAR, progress note, fox message, the summary of leaving hospital, patients ' privacy protection module has been realized the concealment to patient's name's information, reach the object of protection patients ' privacy.
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| CN105760667A (en) * | 2016-02-05 | 2016-07-13 | 西部天使（北京）健康科技有限公司 | Clinical observation table filling method and system |
| CN106529177A (en) * | 2016-11-12 | 2017-03-22 | 杭州电子科技大学 | Patient portrait drawing method and device based on medical big data |
| CN106778026A (en) * | 2017-01-05 | 2017-05-31 | 张传钊 | A kind of case history processes follow-up system |
| CN111739594A (en) * | 2020-04-09 | 2020-10-02 | 卫宁健康科技集团股份有限公司 | Method and system for acquiring clinical scientific research data |
| WO2021000230A1 (en) * | 2019-07-01 | 2021-01-07 | 深圳迈瑞生物医疗电子股份有限公司 | Central monitoring system, monitoring device, mobile terminal, and patient monitoring method |
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| CN114741438A (en) * | 2022-03-03 | 2022-07-12 | 清华大学 | Multi-center research data extraction method and device, electronic equipment and storage medium |
| CN117912624A (en) * | 2024-03-15 | 2024-04-19 | 江西曼荼罗软件有限公司 | Electronic medical record sharing method and system |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105760667A (en) * | 2016-02-05 | 2016-07-13 | 西部天使（北京）健康科技有限公司 | Clinical observation table filling method and system |
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| CN106529177A (en) * | 2016-11-12 | 2017-03-22 | 杭州电子科技大学 | Patient portrait drawing method and device based on medical big data |
| CN106529177B (en) * | 2016-11-12 | 2019-05-03 | 杭州电子科技大学 | A kind of patient's portrait method and device based on medical big data |
| CN106778026A (en) * | 2017-01-05 | 2017-05-31 | 张传钊 | A kind of case history processes follow-up system |
| WO2021000230A1 (en) * | 2019-07-01 | 2021-01-07 | 深圳迈瑞生物医疗电子股份有限公司 | Central monitoring system, monitoring device, mobile terminal, and patient monitoring method |
| CN111739594A (en) * | 2020-04-09 | 2020-10-02 | 卫宁健康科技集团股份有限公司 | Method and system for acquiring clinical scientific research data |
| CN111739594B (en) * | 2020-04-09 | 2021-06-04 | 卫宁健康科技集团股份有限公司 | Method and system for acquiring clinical scientific research data |
| CN113722379A (en) * | 2021-09-02 | 2021-11-30 | 上海国际人类表型组研究院 | Medical data aggregation statistical analysis system and method |
| CN114741438A (en) * | 2022-03-03 | 2022-07-12 | 清华大学 | Multi-center research data extraction method and device, electronic equipment and storage medium |
| CN117912624A (en) * | 2024-03-15 | 2024-04-19 | 江西曼荼罗软件有限公司 | Electronic medical record sharing method and system |
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