Method for managing the risk of distortion of medical information

Abstract

The proposed invention relates to medical automated systems in the field of medicine and computing. The proposed invention defines a method for the implementation of an automated system that executes an algorithm of actions for neutralizing the risks of distortion of medical information in order to ensure the clinical safety of medical information throughout the entire life cycle of a medical record as a medical information carrier. The clinical safety of medical information produces positive practical results at all levels of the healthcare system. The applicability of the present invention is evidenced by the positive practical results produced by the increase in the clinical safety of medical information resulting from implementation of the invention.

Description

[0001] METHOD OF MANAGING THE RISK OF DISTORTION OF MEDICAL INFORMATION

[0002] AREA OF TECHNOLOGY

[0003] This technical solution relates to the field of medicine and computer technology, in particular, to a method of monitoring and ensuring the accuracy and clinical safety of medical information in the process of reading, recording and transmitting a medical record, or recoding the terms of a medical record, as well as to a method of ensuring the accuracy and clinical safety of medical information in the process of creating, copying with subsequent modification and visualization of a medical record.

[0004] LEVEL OF TECHNOLOGY

[0005] A solution selected as the closest analogue is known from the prior art, RU 2748052 (C1), published 19.05.2021. This source of information describes a computer-implemented method for exchanging medical data between a clinic, a patient and an insurance service, comprising the following stages: via an Electronic Health Records server (EHR server), a request for a patient's medical data is made from the clinic's medical information system, wherein when making a request for a patient's medical data, patient identifiers (ID) and patient and clinic indices are used; via a OneTimePassword server (OTP server), the requesting party is checked for authorized access to medical data; patient identifiers (ID) from the original request are replaced with the corresponding identifiers (ID) of data from the clinic's medical information system;send a request to the clinic's medical information system containing only the patient's ID used in the clinic, without the transfer of the patient's personal data; via the EHR server, the requested medical data is extracted from the clinic's medical information system and sent to the requesting party via a secure communication channel.

[0006] The proposed technical solution is aimed at eliminating the shortcomings of the current level of technology and differs from previously known ones in that the proposed solution provides a significant increase in the level of security of medical data. ESSENCE OF THE INVENTION

[0007] The technical problem, which the claimed solution is aimed at solving, is the creation of a method for monitoring and ensuring the accuracy and clinical safety of medical information in the process of reading, recording and transmitting a medical record, or recoding the terms of a medical record, as well as the creation of a method for ensuring the accuracy and safety of medical information in the process of creating, copying with subsequent modification and visualization of a medical record. Additional embodiments of the present invention are presented in the dependent claims of the invention.

[0008] The technical result consists in increasing the level of accuracy and clinical safety of medical records.

[0009] The claimed result is achieved by implementing a method for ensuring the accuracy and clinical safety of medical information in the process of creating, reading, transmitting and storing a medical record, as well as when recoding medical record terms, which includes the following stages: checking the authenticity of a medical record by checking the coincidence of the imitation insert calculated at the time of creating a medical record based on the private key of the medical worker with the imitation insert calculated using the public key of the medical worker upon receipt of the medical record, generating a message about the identified risk of inauthenticity of the medical record; checking the conformity of the field values ​​of the medical record with the corresponding validators of the field values ​​of the reference template of the medical record and, in the event of detection of a conformity error, generating a message about the identified risk of non-conformity of the field values ​​of the medical record;checking the conformity of the values ​​of the scales or dimensions of the fields of the medical record with the corresponding values ​​of the scales or dimensions of the reference template of the medical record and, in the event of detection of a conformity error, generating a message about the identified risk of non-conformity of the values ​​of the scales or dimensions of the medical record; checking the immutability of the data of the medical record by comparing the imitation insert calculated at the time of creation of the medical record based on the private key of the medical worker with the imitation insert calculated at the time of receipt of the medical record based on the public key of the medical worker and, in the event of detection of inequality of the imitation inserts, generating a message about the identified risk of distortion of the medical record;checking the timeliness of a medical record by comparing the timestamp specified in the medical record creation timestamp with the planned time range of the medical record creation and, if a fact of untimeliness is detected, namely, the timestamp goes beyond the planned time range, generating a message about the identified risk of untimeliness of the medical record; checking the consistency of a medical record by comparing the ordinal number specified in the medical record reconciliation timestamp with the ordinal numbers of other medical records and / or by comparing the timestamp specified in the medical record creation timestamp with the timestamps of previous and / or subsequent medical records and, if a failure in reconciling the ordinal numbers or timestamps is detected, generating a message about the identified risk of inconsistency of the medical record;checking the completeness of a medical record using the relevant medical record reference template by checking for unfilled fields that are mandatory to fill in the received medical record and, if such fields are detected, generating a message about the identified risk of incompleteness of the medical record; checking the correspondence of the field types of the received medical record to the corresponding fields of the relevant medical record reference template and, if a discrepancy between the field types is detected, generating a message about the identified risk of substitution of the medical record fields; checking the correspondence of a term using verified term search services and the correspondence of a term class to a given medical record field type.

[0010] In a particular embodiment of the described method, upon receipt of a medical record, a check is made for the continuity of a series of similar medical records by checking the serial number of the received medical record and the previous and / or subsequent medical record and, if an error is detected in checking the serial numbers, a message is generated about the identified risk of a break in the data flow in a series of similar medical records.

[0011] In another particular embodiment of the described method, when receiving a medical record, a check is made for the correct translation of the semantics of the terms, scales and units of measurement of the medical record during automatic recoding of the medical record from one form of presentation to another using the corresponding reference template of the medical record, a service for monitoring the conformity of the term class to a given field of the medical record and a service for searching for verified terms.

[0012] In another particular embodiment of the described method, when storing a medical record, the immutability of the storage of the medical record is monitored using data integrity monitoring mechanisms built into the data storage system.

[0013] The claimed technical result is also achieved by a method for ensuring the accuracy and clinical safety of medical information in the process of creating, copying with subsequent modification and visualization of a medical record, which includes a procedure for dynamically creating an automated workstation of a medical worker (AWP) at the request of the user based on the AWP specification required for creating, copying with subsequent modification and / or visualization of a medical record; which includes a procedure for creating an AWP specification for each type of medical record, which includes: a reference sample of a given type of medical record, including an identifier of the type of medical record and a term associated with the type of medical record; a hierarchy of fields of a medical record and terms associated with them; AWP fields - elements of the user interface for entering and / or visualizing data associated with the fields of a medical record;input data validators associated with the fields of the automated workstation for data entry; including a procedure for managing the risk of substitution of medical record fields, namely: monitoring the compliance of the fields of the automated workstation with the corresponding fields of the created medical record using a reference template of the medical record built into the specification of the automated workstation; monitoring the compliance of the fields of the automated workstation with the corresponding fields of the received medical record using a reference template of the medical record built into the specification of the automated workstation; including a procedure for managing the risk of inauthenticity of the medical record, namely: ensuring verification of the authenticity of the medical record by calculating the identity insert calculated at the time of creation of the medical record based on the private key of the medical worker; verification of the authenticity of the medical record by checking the identity insert calculated at the time of creation of the medical record based on the private key of the medical worker using the public key of the medical worker;which includes a procedure for managing the risk of the untimeliness of a medical record, namely: ensuring the verification of the timeliness of a medical record at the time of creation of a medical record using a medical record creation tag; verifying the timeliness of a medical record by comparing the time stamp specified in the medical record creation tag with the planned range of the time of creation of the medical record or the current astronomical time; which includes a procedure for managing the risk of the inconsistency of a medical record, namely: ensuring the verification of the consistency of a medical record at the time of creation of a medical record by adding a reconciliation tag to the medical record, which specifies the value of the integer counters of the patient's medical records and the specified type of medical records, as well as a medical record creation tag, which specifies the creation time stamp;checking the consistency of a medical record by comparing the serial numbers specified in the medical record consistency tag with the serial numbers of other medical records of the patient and the specified type of medical records, and / or by comparing the time stamp specified in the medical record creation tag with the time stamps of previous and / or subsequent medical records; including a procedure for managing the risk of incompleteness of a medical record, namely: ensuring the verification of the completeness of a medical record at the time of creation of a medical record by a medical worker using a reference medical record template built into the ARM specification, by checking for unfilled fields that are mandatory to fill in and, if such fields are detected, issuing a message to the medical worker with relevant information about the need to fill in the mandatory fields;checking the completeness of a medical record using a reference template of a medical record built into the specification of the automated workplace by checking for unfilled fields that are mandatory to fill in the received medical record and, if such fields are detected, issuing a message to the healthcare worker with information about the identified risk of incompleteness of the medical record; including the procedure for managing the risk of incorrect values ​​of the medical record, namely: checking the conformity of the values ​​entered into a given field of the corresponding automated workplace with the corresponding fields of the medical record using user interface elements and the corresponding validators of the automated workplace fields defined in the specification of the automated workplace; checking the conformity of the values ​​of the automated workplace fields with the corresponding values ​​of the fields of the received medical record using a reference template of the medical record built into the specification of the automated workplace;which includes the procedure for managing the risk of violation of scales or dimensions of a medical record, namely: monitoring the compliance of the entered values ​​of scales or dimensions in a given field of the corresponding automated workstation with the corresponding scales and dimensions of the medical record field using user interface elements and the corresponding validators of the automated workstation fields defined in the automated workstation specification; monitoring the compliance of the values ​​of scales or dimensions of the automated workstation fields with the corresponding values ​​of scales or dimensions of the fields of the received medical record using user interface elements and the corresponding values ​​of scales and dimensions of the reference template of the medical record built into the automated workstation specification;which includes the procedure for managing the risk of violation of the semantics of a medical record, namely: checking the compliance of the term entered in the selected field specified by the automated workplace using the verified term substitution services, and the compliance of the class of the entered term with the specified field of the medical record; checking the compliance of the term entered in the automated workplace field with the corresponding field of the medical record when creating it or saving changes using the reference template of the medical record built into the automated workplace specification and the form displayed by the automated workplace specification rendering service; checking the compliance of the term visualized in the automated workplace field using the verified term substitution services and the compliance of the class of the term with the specified field of the medical record.

[0014] DESCRIPTION OF THE DRAWINGS The implementation of the invention will be described further in accordance with the attached drawing, which is presented to explain the essence of the invention and in no way limits the scope of the invention. The following drawing is attached to the application:

[0015] Fig. 1 illustrates a medical information model and mechanisms for managing the model and information.

[0016] Fig. 2 illustrates a model of terms of the claimed invention.

[0017] Fig. 3 illustrates the model of risks of distortion of medical information.

[0018] Fig. 4 illustrates the life cycle model of a medical record.

[0019] Fig. 5 illustrates the access model of the claimed invention.

[0020] Fig. 6 illustrates a model of measures to protect information from the risks of distortion.

[0021] Fig. 7 illustrates a model for visualizing medical information.

[0022] Fig. 8 illustrates scenarios for using the claimed invention.

[0023] Fig. 9 illustrates a diagram of the functional structure of the claimed invention.

[0024] Fig. 10 illustrates the functional structure diagram of the semantics management subsystem.

[0025] Fig. 11 illustrates the functional structure diagram of the risk management subsystem.

[0026] Fig. 12 illustrates the storage subsystem.

[0027] Fig. 13 illustrates a subsystem for implementing measures to protect information from risks of distortion.

[0028] Fig. 14 illustrates the medical decision support subsystem.

[0029] Fig. 15 illustrates the access control subsystem.

[0030] Fig. 16 illustrates the data concentrator subsystem.

[0031] Fig. 17 illustrates an example of a medical record in machine-readable form.

[0032] DETAILED DESCRIPTION OF THE INVENTION

[0033] This technical solution relates to medical automated systems in the field of informatics.

[0034] The relevance of the proposed technical solution is substantiated by positive practical results at all levels of the healthcare system, arising due to the growth of clinical safety of medical information as a result of using the invention due to the reduction of risks of distortion of medical records. In the detailed description of the implementation of the invention given below, numerous implementation details are provided, designed to ensure a clear understanding of the present invention. However, it will be obvious to a specialist skilled in the subject area how the present invention can be used, both with these implementation details and without them. In other cases, well-known methods, procedures and components have not been described in detail, so as not to unnecessarily complicate the understanding of the features of the present invention.

[0035] In addition, it will be clear from the above description that the invention is not limited to the embodiment shown. Numerous possible modifications, changes, variations and substitutions, preserving the essence and form of the present invention, will be obvious to those skilled in the art.

[0036] Terms and definitions used in this technical solution.

[0037] Process: A set of interrelated or interacting activities that uses input data to achieve a desired result.

[0038] Procedure: An established way of carrying out an activity or process.

[0039] Medicine. A substance or mixture of substances of synthetic or natural origin in the form of a medicinal form (tablet, capsule, solution, ointment, etc.), used for the prevention, diagnosis or treatment of diseases, or for maintaining the immunological or metabolic regulatory systems of the human body at a given level.

[0040] Medical activity. Activity of a medical worker aimed at achieving a medical goal.

[0041] Medical goal. The preferred outcome of medical activity.

[0042] Medical device. An instrument, apparatus, device, apparatus, equipment, implant, in vitro reagent, software, material or other similar or related products intended by the manufacturer for use on humans, individually or in combination, for one or more medical purposes, while not achieving their intended effect on the human body through pharmacological, immunological or metabolic means, but whose functions can be supported by such means.

[0043] Benefit. A positive effect or advantageous outcome of the use of a procedure and / or medicinal product and / or medical device on human health or a positive effect on the management and / or clinical outcome of a patient or public health.

[0044] Harm. Injury or damage to health of people, as well as damage to property or the environment.

[0045] Danger. Potential source of harm.

[0046] Severity. The measure of the possible consequences of a hazard.

[0047] Protocol: A logical model that defines the order and rules of interaction to achieve a specific goal.

[0048] Risk: The combination of the likelihood of harm occurring and the severity of that harm.

[0049] Residual risk: The risk remaining after risk management measures have been implemented.

[0050] Safety. No risk.

[0051] Objective evidence: Data that confirms the existence or truth of something.

[0052] Risk management: A protocol-based process that involves making decisions and implementing actions that reduce risks to established levels or maintain them within established levels.

[0053] Medical information. Information directly related to the patient, such as information about health status, body characteristics, past and hereditary diseases, laboratory test results, etc.

[0054] Medical record. A medical document that provides objective evidence of medical activity performed or medical results achieved.

[0055] Life cycle of a medical record. The stages of a medical record's existence from its creation to its removal from archival storage and physical destruction.

[0056] Stages of the life cycle of a medical record.

[0057] 1 . Creation. Creation of a medical record by a medical professional or medical equipment 2. Saving. Saving a medical record in the medical system database

[0058] 3. Retrieval. Retrieval of a medical record from a medical system database or archival system.

[0059] 4. Transfer. Transfer of a medical record between different components of one medical system or different medical systems.

[0060] 5. Visualization. Visualization of a medical record upon request of a healthcare professional or medical equipment.

[0061] 6. Translation. Recoding of terms and / or scales and / or units of measurement of a medical record based on recoding tables for the purpose of importing or exporting a medical record with a different coding system of terms and / or scales and / or units of measurement.

[0062] 7. Storage. Storage of the medical record in the medical system database during the clinical case.

[0063] 8. Archiving. Transferring a medical record from a medical system database to an archival storage facility.

[0064] 9. Archival storage. Storage of medical records in an archival repository for 75 years after the completion of the clinical case.

[0065] 10. Destruction. Irreversible removal of a medical record from archival storage at the expiration of the archival storage period.

[0066] Security of medical records. No risk of medical record distortion.

[0067] Health Information Security Protocol: An agreement that defines how the risk of misrepresentation of health information is managed throughout the life cycle of a health record.

[0068] Change of medical record. Objective evidence that a medical record has been changed since its creation.

[0069] Authenticity of a medical record. Objective evidence that a medical record truly belongs to a specific patient.

[0070] Timeliness of a medical record. Objective evidence of the fact that the time of creation of a medical record corresponds to the time of receipt of the result of medical activity.

[0071] Consistency of the medical record. Objective evidence of the fact that the composition of the medical record complies with the specified risk control protocol. Completeness of the medical record. Objective evidence of the fact that the completed fields of the medical record correspond to the required fields specified in the specified risk control protocol.

[0072] Correctness of medical record terms. Objective evidence of the fact that the meanings of the terms of the filled fields of the medical record correspond to the terms of the corresponding fields that are allowed to be filled in, as specified in a specific protocol for controlling the risks of distortion.

[0073] Correctness of scales and units of measurement of the medical record. Objective evidence of the fact that the values ​​of the assessment scales and / or units of measurement of the filled fields of the medical record correspond to the acceptable values ​​of the assessment scales and / or units of measurement of the corresponding fields specified in a specific protocol for monitoring the risks of distortion.

[0074] Correct visualization of medical record terms. Objective evidence of the fact that the visualized terms and values ​​of the rating scales and / or units of measurement of the filled fields of the medical record correspond to the values ​​of the rating scales and / or units of measurement of the corresponding fields that are allowed to be filled in, as specified in a specific protocol for controlling the risks of distortion.

[0075] Risk of distortion of medical information. A derivative risk from the risks of creation, transmission and storage, visualization and perception of medical records.

[0076] Risk of substitution of medical record fields. Risk of changing the value of fields or attributes of medical record fields after its creation.

[0077] Risk of inauthenticity of the medical record. Risk of error or substitution of the medical record's attribution to a specific patient.

[0078] Risk of untimely medical record. Risk of delay in creation of medical record from the moment of receiving the result of medical activity.

[0079] Medical Record Inconsistency Risk: The risk that the composition of a medical record does not match the specified template specified in a specific misstatement risk control protocol.

[0080] Risk of incompleteness of medical record. Risk of discrepancy between filled fields of medical record and the given template specified in the defined protocol of control of risks of distortion. Risk of incorrectness of medical record. Risk of discrepancy between the used terms for filled fields of medical record and those allowed to be filled in the corresponding fields of the given template specified in the defined protocol of control of risks of distortion.

[0081] Risk of non-compliance with scales or dimensions of a medical record. Risk of non-compliance with scales or dimensions of fields of a medical record and the specified template specified in a specific protocol for controlling the risk of distortion.

[0082] Risk of mismatch of acceptable medical record terms. The risk of mismatch of the visualized terms in the corresponding fields of the medical record with the acceptable terms and fields of the specified template specified in the defined risk control protocol.

[0083] Risk of incomplete visualization of a medical record. The risk that the visualized fields, scales or dimensions of the fields, or parameters of the medical record fields do not match the specified template specified in a specific risk control protocol.

[0084] Risk of creating or altering a medical record. Derived risk from the risks of field substitution, inauthenticity, untimeliness, inconsistency, incompleteness, incorrectness, and violation of scales or dimensions of the medical record.

[0085] Risk of transmission and storage of medical records. Derivative risk from the risks of data corruption during processing or transmission, as well as total or partial loss of data during storage.

[0086] Risk of visualization and perception of the medical record. Derived risk from the risks of violation of scales or dimensions, inconsistency of acceptable terms, incompleteness of visualization of the medical record.

[0087] The objective of this technical solution is to ensure the security of medical information, as well as to significantly increase the level of security of medical information.

[0088] The above task is solved by implementing measures to protect medical information from the risks of distortion of medical information at each stage of the life cycle of a medical record - at the time of creation, visualization, storage, transmission or transformation of a medical record.

[0089] The system of measures to protect medical information from the risks of distortion of medical information consists of: 1. a protocol for managing the risk of distortion when creating, changing and visualizing a medical record, which consists of:

[0090] 1.1. a protocol for managing the risk of substitution of medical record fields that ensures:

[0091] 1.1.1. immutability of medical records;

[0092] 1.1.2. correct perception of the composition and order of fields when visualizing a medical record;

[0093] 1 .2. a protocol for managing the risk of inauthenticity of a medical record that ensures:

[0094] 1 .2.1 . authenticity of the medical record;

[0095] 1 .2.2. correct perception of the authenticity of medical information when visualizing a medical record;

[0096] 1 .3. a protocol for managing the risk of late medical records that ensures:

[0097] 1 .3.1 . timeliness of medical records;

[0098] 1 .3.2. correct perception of the timeliness of medical information when visualizing a medical record;

[0099] 1 .4. a medical record inconsistency risk management protocol that ensures:

[0100] 1 .4.1 . consistency of medical records;

[0101] 1 .4.2. correct perception of the consistency of medical information when visualizing a medical record;

[0102] 1 .5. a protocol for managing the risk of incompleteness of the medical record that ensures:

[0103] 1 .5.1 . completeness of the medical record;

[0104] 1 .5.2. correct perception of the completeness of fields when visualizing a medical record;

[0105] 1 .6. a protocol for managing the risk of medical record inaccuracy that ensures:

[0106] 1 .6.1 . correctness of the terms of the medical record;

[0107] 1 .6.2. correct perception of field values ​​when visualizing a medical record;

[0108] 1 .7. a protocol for managing the risk of violation of scales or dimensions of the medical record that ensures:

[0109] 1 .7.1 . correctness of scales and units of measurement of the medical record; 1 .7.2. correct perception of scales and dimensions of fields when visualizing the medical record;

[0110] 1 .8. a protocol for managing the risk of violation of the semantics of a medical record, which ensures that:

[0111] 1.8.1. the correctness of the terms of the medical record when it is created or modified;

[0112] 1 .8.2. correct perception of terms when visualizing medical records;

[0113] 2. a protocol for managing the risk of distortion during the transmission, storage and transformation of a medical record, which consists of:

[0114] 2.1. a protocol for managing the risk of distortion in the transmission of medical records that ensures:

[0115] 2.1 .1 . immutability of the medical record upon transfer of the medical record;

[0116] 2.2. a protocol for managing the risk of discontinuity in a series of similar medical records that ensures:

[0117] 2.2.1. identifying gaps in records when creating a continuous series of similar medical records;

[0118] 2.3. a protocol for managing the risk of distortion when recoding a medical record, which ensures that:

[0119] 2.3.1. correct translation of the semantics of terms, scales and units of measurement of a medical record during automatic recoding of a medical record from one form of presentation to another;

[0120] 2.4. a protocol for managing the risk of distortion in the storage of medical records that ensures:

[0121] 2.4.1. the immutability of a medical record during storage; the technical result ensured by the given set of features is the security of medical information.

[0122] The medical information model consists of the following submodels (Fig. 1): a term model that defines the mechanism for managing the semantics of the subject area (for a detailed description, see Fig. 2); a risk model that defines the risks of medical information distortion (for a detailed description, see Fig. 3); a medical record lifecycle model that defines the lifecycle of a medical record (for a detailed description, see Fig. 4); an access rights model that defines the mechanism for managing access rights to medical records, protocols for managing the risks of medical information distortion, terms and functions for their creation and visualization (for a detailed description, see Fig. 5); an information security measures model that defines the system of measures for protecting information from the risks of distortion (for a detailed description, see Fig. 6); a visualization model that defines the mechanism for visualizing medical information (for a detailed description, see Fig.7); a use case model that defines the use case scenarios for the automated system (for a detailed description, see Fig. 8);

[0123] Description of the mechanisms for creating, storing, visualizing and maintaining the model and medical information in an up-to-date state (for a detailed description, see Fig. 9);

[0124] Semantics management subsystem that executes the mechanism that implements the logic defined in the term model (for a detailed description, see Fig. 10);

[0125] A protocol management subsystem that executes the mechanism that implements the logic for creating, modifying, and decommissioning risk management protocols defined in the risk model (for a detailed description, see Fig. 1 1 );

[0126] A storage subsystem that executes a mechanism that implements the logic of operational and archival storage of medical records and other data of the automated system (for a detailed description, see Fig. 12);

[0127] A subsystem for executing measures to protect information from risks of distortion, executing a mechanism that implements the logic defined in the model of protection measures (for a detailed description, see Fig. 13);

[0128] A medical decision support subsystem that executes a mechanism that implements the logic defined in the visualization model (for a detailed description, see Fig. 14);

[0129] A subsystem for managing access to the functions of an automated system and data, executing a mechanism that implements the logic defined in the access model (for a detailed description, see Fig. 15);

[0130] A data concentrator subsystem that executes a mechanism implementing the logic defined in the medical record life cycle model in terms of automatic creation of medical records (for a detailed description, see Fig. 16); An approximate composition of a medical record in machine-readable form that implements the logic of the required level of accuracy and clinical safety of medical information (for a detailed description, see Fig. 17).

[0131] Fig. 2 illustrates the term model of the claimed invention. Description of the term model, depicted in the form of a conceptual data model

[0132] The model of risks of distortion of medical information is illustrated in Figure 3. Description of the model of risks and consequences of the realization of risks of distortion of medical information.

[0133] The life cycle model of a medical record is illustrated in Figure 4. The life cycle model of a medical record is a cyclic directed graph consisting of nodes - states, and edges - transitions between states. The states are needed to associate them with a certain job - measures to protect information from the risks of distortion. One or more protection measures are executed as soon as the medical record gets to the corresponding state. Transitions are needed to organize the model. Two nodes are special: the initial state ("S") and the final state ("E"). No edges enter the initial state, and only one edge exits it. Only one edge enters the final state, but no edges exit it.

[0134] Description of the Medical Record Life Cycle Model

[0135] The access model of the claimed invention is illustrated in Figure 5. The access model is a role model of access to resources and consists of lists of role groups, resource groups, and role access rights to resources. Roles are created within role groups, inherit or override the group access rights, and are assigned to specific users. Resources are created within resource groups, inherit or override the group access rights, and access rights are assigned to specific role groups or roles.

[0136] Description of role groups

[0137] Description of resource groups

[0138] Description of role access rights to resources

[0139] The model of measures for protecting information from the risks of distortion is illustrated in Figure 6. The model of measures for protecting information from the risks of distortion is a matrix, the rows of which are a list of stages of the life cycle of a medical record, and the columns are a list of measures for protecting information from the risks of distortion. At the intersection of a column and a row there is a mark that indicates the flag of the mandatory execution of the measure for protecting information when the medical record is in this stage of the life cycle. Measures for managing the risks of distortion of medical information are organized into a system of measures in such a way as to achieve the target effect - a guarantee of protecting medical information from the risks of distortion. Each measure is determined by the method and the result of the execution of the method of protecting information. Description of the model of measures for managing the risks of distortion of medical information:

[0140] Method 1 .

[0141] A systematic approach to ensuring the security of health information when creating and / or visualizing a health record.

[0142] Method 1.1.

[0143] A systematic approach that includes the following procedure for managing a medical record field substitution claim: Method 1.2.

[0144] A systematic approach that includes the following procedures for managing a medical record inauthenticity claim:

[0145]

[0146] Method 1.4.

[0147] A systematic approach that includes the following procedure for managing a medical record inconsistency claim:

[0148] Method 1.5.

[0149] A systematic approach to managing the risk of incompleteness in medical records includes the following:

[0150] Method 1.6.

[0151] A systematic approach that includes the following steps to manage the risk of incorrect values ​​in a medical record:

[0152] Method 1.7.

[0153] A systematic approach that involves the following procedure for managing claims of violation of scales or dimensions of a medical record:

[0154] Method 1.8.

[0155] A systematic approach that includes the following procedure for managing a medical record semantic violation claim:

[0156] Method 2 A systematic approach that provides control and security for health information during the process of reading, writing, transmitting, or recoding terms in a medical record. Method 2.1.

[0157] A systematic approach that includes the following procedures for managing claims of misrepresentation in the transmission of a medical record:

[0158] Method 2.2.

[0159] A systematic approach that involves the following procedure for managing the occurrence of a break in a series of similar medical records:

[0160] Method 2.3.

[0161] A systematic approach that includes the following procedure for managing the risk of distortion when recoding a medical record:

[0162] Method 2.4.

[0163] A systematic approach that includes the following procedures for managing the risk of misrepresentation in the storage of medical records:

[0164] The model for visualizing medical information of the claimed invention is illustrated in Figure 8.

[0165] Composition of the interface elements library

[0166] The use scenarios of the claimed invention are illustrated in Figure 8. The use scenarios of the claimed invention are grouped into the following groups: semantic management, risk management of medical information distortion, creation and visualization of medical records, archiving and exchange of medical records, access rights management.

[0167] Description of scenarios for using the claimed invention. Scenario group "semantics management" Scenario group "managing the risks of distortion of medical information"

[0168] group of scenarios "creation and visualization of medical records"

[0169] a group of scenarios "archiving and sharing medical records" group of scripts "manage access rights" The diagram of the functional structure of the automated system of the claimed invention is illustrated in Figure 9. The diagram of the functional structure of the automated system (AS) is an idealized general diagram of the organization of the AS, including a description of the elements of the functional structure of the AS (AS subsystems) and data flows between the elements of the functional structure of the AS.

[0170] Description of the elements of the functional structure of the AS and the connections between them

[0171] The functional structure diagram of the semantics management subsystem is illustrated in Figure 10. The semantics management subsystem is designed to manage the knowledge base of terms - the basis of the unified semantic layer of the automated system.

[0172] Description of the elements of the functional structure of the semantics management subsystem and the connections between them

[0173] The functional structure diagram of the semantics management subsystem is illustrated in Figure 10.

[0174] The semantics management subsystem provides management of the knowledge base of terms that underlies and defines the unified semantics of medical records and the automated system.

[0175] Description of the elements of the functional structure of the semantics management subsystem and the connections between them

[0176] The functional structure diagram of the protocol management subsystem is illustrated in Figure 1 1 .

[0177] Risk management of medical information distortion is carried out by creating and executing protocols for controlling the risks of medical information distortion. Each risk from the risk model is mitigated by the corresponding protocol. When creating a new type of medical record, a corresponding protocol for controlling the risks of medical information distortion is created. In this case, the new type of medical record is created simultaneously with the protocol for creating and visualizing the medical record and is rigidly associated with it. The composition of the medical record and the corresponding protocol for controlling the risks of medical information distortion are created in the designer of the automated workplace of a medical worker (Client).

[0178] The procedure for creating a new type of medical record and the corresponding protocol for monitoring the risks of distortion of medical information:

[0179] • A description of the medical record is created in an Excel table. • Terms are specified in the cells of the Excel table. Terms can be organized into hierarchies. If necessary, 4 levels of term hierarchy are available, which allows for the description of complex medical records.

[0180] • The Excel table is loaded into the Designer, then the table contents are interpreted and the form is automatically filled in

[0181] Designer for interactive data entry or automatic creation of medical records.

[0182] • Next, the user can validate the contents of the medical record form, if necessary, defining two selection forms - parent medical records and created medical records.

[0183] • After this, the user sends the form for compilation, as a result of this procedure the following are created: a protocol (AWP specification), an automated workstation (AWP) and a database object (data source), which will store medical records of the corresponding type.

[0184] Description of the functional components of the protocol management subsystem The conceptual data model of the storage subsystem is illustrated in Figure 12.

[0185] The storage subsystem ensures management of risks of medical information distortion during storage of medical records. A relational DBMS that supports storage of encrypted medical records as large binary objects (BLOB) in relational table fields can be used for data storage. Modern DBMS have built-in mechanisms to guarantee data integrity during storage. The storage subsystem uses these mechanisms. An example of a suitable DBMS is the open source Postgres 15 system.

[0186] The storage subsystem contains two databases with an identical structure - an operational database and an archive database. The operational database solves the problem of reliable storage and fast processing of user or external system requests. The recommended depth of the medical records storage history in the operational database is up to three years from the date of completion of the clinical case. After the clinical case archiving date, the medical records of the specified clinical case are transferred to the archive database, where they are stored for at least 75 years in accordance with the regulatory documentation of the Regulator. The transfer of medical records that make up a specified clinical case is carried out either automatically, if the policy of transferring clinical cases to the archive is configured, or "manually" at the request of the administrator. After the medical records are transferred to archival storage, they continue to be available for viewing in a special automated workplace, which is connected to the archive database.

[0187] Description of the conceptual data model

[0188] Structure of DB objects

[0189] The subsystem for implementing measures to protect information from risks of distortion is illustrated in Figure 13.

[0190] The subsystem for implementing measures to protect information from risks of distortion ensures management of risks of distortion of medical information after the creation or import of medical records.

[0191] Description of the functional components of the subsystem for implementing measures to protect information from risks of distortion

[0192] The medical decision support subsystem is illustrated in Figure 14. The medical decision support subsystem ensures management of the risks of medical information distortion during the creation and visualization of medical records.

[0193] Description of the functional components of the medical decision support subsystem

[0194] Composition of the interface elements library

[0195] The subsystem for controlling access to the functions of the automated system and data is illustrated in Figure 15.

[0196] The access control subsystem ensures management of the risks of distortion of medical information when accessing the functions and data of the automated system.

[0197] The access control subsystem is based on the role model of access to resources. The subsystem defines: a role group, a resource group, and role access rights to resources. Roles are created within role groups, inherit or override the group's access rights, and are assigned to specific users. Resources are created within resource groups, inherit or override the group's access rights, while access rights are assigned to specific role groups or roles.

[0198] Description of the functional components of the medical decision support subsystem

[0199] The Data Concentrator subsystem is illustrated in Figure 16.

[0200] The data hub provides risk management for health information distortion during the automatic creation of health records.

[0201] Description of the functional components of the Data Concentrator subsystem An approximate composition of an electronic medical record in machine-readable form is illustrated in Figure 17.

[0202] The electronic medical record consists of two parts

[0203] ~!The “object of accounting” is understood as a “term-value” pair, where

[0204] Nesting order of "emr.data" The "emr.data" section may contain the following nesting order

[0205] Description of a medical record in machine-readable form Practical results of applying this technical solution.

[0206] Clinical security of medical information ensures the achievement of positive practical results at all levels of the healthcare system.

[0207] 1. Regulatory level. This level ensures quality control of medical care at the state level. Two federal agencies and an off-budget fund operate at this level: the Ministry of Health of the Russian Federation issues orders that regulate the procedure for all lower authorities and the criteria for assessing quality; Roszdravnadzor performs the supervisory function for the execution of orders; the Compulsory Medical Insurance Fund, through authorized insurance companies, conducts its own departmental quality control.

[0208] 2. Manufacturer level. This is the level of suppliers of scientific and technical support for medical care: research teams, pharmaceutical companies, manufacturers of medical equipment, devices and consumables, start-ups.

[0209] 3. Healthcare provider level. This is the level of health care providers: inpatient or outpatient health care facilities, telemedicine services, and private practice physicians.

[0210] 4. Level of recipient of medical care. Recipients of medical care are citizens and stateless persons.

[0211] The result of applying the proposed invention at the regulator level:

[0212] 1. Improving the quality of medical records in a single electronic medical record;

[0213] 2. Improving the quality of medical care;

[0214] 3. Improving the quality of mandatory medical reporting;

[0215] 4. Reducing delays in processing medical information;

[0216] 5. Increasing public confidence in the healthcare system as a whole.

[0217] The result of applying the proposed invention at the manufacturer level:

[0218] 1. Improving the quality of medical records in a single electronic medical record;

[0219] 2. Improving the quality of mandatory medical reporting; 3. Reducing the complexity of obtaining consolidated reporting for statistical analysis;

[0220] 4. Reducing delays in processing medical information;

[0221] 5. Reducing the diversity of medical record formats and structures;

[0222] 6. Reducing the risk of unreliable clinical data;

[0223] 7. Systematization of medical information;

[0224] 8. Reducing the complexity of verifying medical information;

[0225] 9. Increased trust in clinical data providers;

[0226] 10. Reducing the cost and timeframe of clinical trials.

[0227] The result of applying the proposed invention at the level of the healthcare provider:

[0228] 1. Reducing the number of errors in medical records;

[0229] 2. Reduce the complexity of comparing medical records;

[0230] 3. Improving the accuracy of medical records;

[0231] 4. Reducing the cost of providing medical care;

[0232] 5. Improving the quality of mandatory medical reporting for medical care provided;

[0233] 6. Improving the quality of medical care;

[0234] 7. Reduction of payment delays by the regulator;

[0235] 8. Increasing trust among consumers of medical information;

[0236] 9. Increase in extra-budgetary income due to acceleration of clinical research.

[0237] The result of applying the proposed invention at the level of the recipient of medical care:

[0238] 1. Reducing the risk of medical errors in diagnosis and treatment;

[0239] 2. Correspondence of medical records to the actual state of health;

[0240] 3. Improving the quality of medical care.

[0241] The present application materials present a preferred disclosure of the implementation of the claimed technical solution, which should not be used as limiting other, particular embodiments of its implementation that do not go beyond the scope of the requested scope of legal protection and are obvious to specialists in the relevant field of technology.

Claims

FORMULA 1. A method for monitoring and ensuring the accuracy and clinical security of medical information during the process of reading, writing, or transmitting a medical record, as well as recoding the terms of a medical record, which includes the following stages: checking the authenticity of a medical record by checking the match of the identification insert calculated at the time of creating the medical record based on the private key of the medical worker with the identification insert calculated using the public key of the medical worker upon receipt of the medical record, generating a message about the identified risk of inauthenticity of the medical record; checking the conformity of the field values ​​of the medical record with the corresponding validators of the field values ​​of the reference template of the medical record and, in the event of detection of a conformity error, generating a message about the identified risk of inconsistency of the field values ​​of the medical record;checking the conformity of the values ​​of the scales or dimensions of the fields of the medical record with the corresponding values ​​of the scales or dimensions of the reference template of the medical record and, in the event of a conformity error being detected, generating a message about the identified risk of inconsistency of the values ​​of the scales or dimensions of the medical record; checking the immutability of the data of the medical record by comparing the imitation insert calculated at the time of creation of the medical record based on the private key of the medical worker with the imitation insert calculated at the time of receipt of the medical record based on the public key of the medical worker and, in the event of an inequality of the imitation inserts being detected, generating a message about the identified risk of distortion of the medical record;checking the timeliness of a medical record by comparing the timestamp specified in the medical record creation time stamp with the planned time range of the medical record creation and, in the event of detection of a fact of untimeliness, namely, the timestamp going beyond the planned time range, generating a message about the identified risk of untimeliness of the medical record; checking the consistency of a medical record by comparing the serial number specified in the medical record consistency tag with the serial numbers of other medical records, and / or by comparison; the timestamp specified in the medical record creation time stamp with the timestamps of previous and / or subsequent medical records and, if a failure to match serial numbers or timestamps is detected, generating a message about the identified risk of inconsistency of the medical record; checking the completeness of the medical record using the corresponding reference medical record template by checking for unfilled fields that are mandatory to fill in the received medical record and, if such fields are detected, generating a message about the identified risk of incompleteness of the medical record; checking the correspondence of the field types of the received medical record with the corresponding fields of the corresponding reference medical record template and, if a discrepancy in the field types is detected, generating a message about the identified risk of substitution of the fields of the medical record;checking the compliance of a term using verified term search services and the compliance of a term class with a given medical record field type.

2. The method according to paragraph 1, in which, upon receipt of a medical record, a check is made for the continuity of a series of similar medical records by checking the serial number of the received medical record and the previous and / or subsequent medical record and, in the event of detection of an error in checking the serial numbers, a message is generated about the identified risk of a break in the data flow in a series of similar medical records.

3. The method according to paragraph 1, in which, upon receipt of a medical record, a check is performed for the correct translation of the semantics of terms, scales and units of measurement of the medical record during the automatic recoding of the medical record from one form of presentation to another using the corresponding reference template of the medical record, a service for monitoring the conformity of the term class with a given field of the medical record and a service for searching for verified terms.

4. The method according to paragraph 1, in which, when storing a medical record, control is exercised over the immutability of the storage of the medical record when with the help of data integrity control mechanisms built into the data storage system.

5. A method for ensuring the accuracy and clinical security of medical information in the process of creating, copying with subsequent modification and visualization of a medical record, including a procedure for dynamically creating an automated workstation of a medical worker (AWP) upon user request based on the specification of the AWP necessary for creating, copying with subsequent modification and / or visualization of a medical record; including a procedure for creating a specification of the AWP for each type of medical record, which includes: a reference sample of a given type of medical record, including an identifier of the type of medical record and a term associated with the type of medical record; a hierarchy of fields of a medical record and terms associated with them; AWP fields - user interface elements for entering and / or visualizing data, associated with the fields of a medical record; validators of input data, associated with the fields of the AWP for entering data;which includes a procedure for managing the risk of substitution of medical record fields, namely: monitoring the compliance of the ARM fields with the corresponding fields of the created medical record using the reference medical record template built into the ARM specification; monitoring the compliance of the ARM fields with the corresponding fields of the received medical record using the reference medical record template built into the ARM specification; which includes a procedure for managing the risk of inauthenticity of a medical record, namely: ensuring verification of the authenticity of a medical record by calculating the identification insert calculated at the time of creation of a medical record based on the private key of a medical worker; verification of the authenticity of a medical record by checking the identification insert calculated at the time of creation of a medical record based on the private key of a medical worker using the public key of a medical worker;which includes the procedure for managing the risk of untimeliness of a medical record, namely: ensuring the timeliness of a medical record is checked at the time of creation of a medical record using the medical record creation mark; checking the timeliness of a medical record when; assistance in comparing the time stamp specified in the medical record creation time stamp with the planned range of the medical record creation time or the current astronomical time; including the procedure for managing the risk of inconsistency of the medical record, namely: ensuring the consistency check of the medical record at the time of creation of the medical record by adding to the medical record a reconciliation mark, which indicates the value of the integer counters of the patient's medical records and the specified type of medical records, as well as a medical record creation mark, which indicates the creation time stamp;checking the consistency of a medical record by comparing the sequence numbers specified in the medical record consistency tag with the sequence numbers of other medical records of the patient and the specified type of medical records, and / or by comparing the timestamp specified in the medical record creation tag with the timestamps of previous and / or subsequent medical records; including a procedure for managing the risk of incompleteness of a medical record, namely: ensuring the verification of the completeness of a medical record at the time of creation of a medical record by a healthcare professional using a reference medical record template built into the ARM specification, by checking for unfilled fields that are mandatory to fill in and, if such fields are detected, issuing a message to the healthcare professional with relevant information about the need to fill in the mandatory fields;checking the completeness of a medical record using a medical record reference template built into the ARM specification by checking for unfilled fields that are mandatory to fill in the received medical record and, if such fields are detected, issuing a message to the healthcare professional with information about the identified risk of incompleteness of the medical record; including a procedure for managing the risk of incorrect values ​​of a medical record, namely: checking the conformity of the values ​​entered into a given field in the corresponding ARM with the corresponding fields of the medical record using user interface elements and the corresponding ARM field validators defined in the ARM specification; checking the conformity of the ARM field values ​​with the corresponding field values ​​of the received medical record using a medical record reference template built into the ARM specification; which includes a procedure for managing the risk of violation of the scales or dimensions of a medical record, namely: monitoring the compliance of the entered values ​​of scales or dimensions in a given field of the corresponding automated workstation with the corresponding scales and dimensions of the medical record field using user interface elements and the corresponding validators of the automated workstation fields defined in the automated workstation specification; monitoring the compliance of the values ​​of scales or dimensions of the automated workstation fields with the corresponding values ​​of scales or dimensions of the fields of the received medical record using user interface elements and the corresponding values ​​of scales and dimensions of the reference template of the medical record built into the automated workstation specification; including a procedure for managing the risk of violation of the semantics of a medical record, namely: monitoring the compliance of the entered term in the selected field of a given automated workstation using verified term substitution services, and the compliance of the class of the entered term with the specified field of the medical record;control of the correspondence of the entered term in the ARM field with the corresponding field of the medical record when creating it or saving changes using the reference template of the medical record built into the ARM specification and the form displayed by the ARM specification rendering service; verification of the correspondence of the term visualized in the ARM field using the services of substitution of the verified term and the correspondence of the term class to the specified field of the medical record.

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