Method and system for processing data of an analytical instrument for analyzing a biological sample

Abstract

In one example of the present disclosure, a method for processing data of an analytical instrument for analyzing a biological sample, the method comprising: receiving, at a data processing module communicatively connected with the analytical instrument, instrument data from the analytical instrument; generating, at the data processing module, metadata from the received instrument data; applying, at the data processing module, a first encryption to the instrument data; applying, at the data processing module, a second encryption to the generated metadata; transmitting the encrypted metadata and the encrypted instrument data to a remote server, wherein the remote server and the data processing module are communicatively connected; removing, at the remote server, the second encryption from the metadata; and forwarding the instrument data encrypted by the first encryption from the remote server to a management system of the analytical instrument.

Description

[0001] This invention application is a divisional application of a patent application filed on May 16, 2018, with application number 2018104684342 and invention title "Method and System for Processing Data of Analytical Instruments for Analyzing Biological Samples". Technical Field

[0002] This disclosure relates to methods and systems for processing data from analytical instruments used to analyze biological samples. In particular, methods and systems for encrypted transmission of data are proposed. Background Technology

[0003] Many existing analytical instruments (such as automated analyzers) have been designed to operate as stand-alone units or in closed and controlled network environments with severely restricted access. For example, a network in which some existing analytical instruments operate may be limited to a single cable connection between the instrument and the control unit. Furthermore, these analytical instruments typically serve in the field for extended periods.

[0004] Therefore, it is common to find outdated instruments that lack communication capabilities or have limited communication capabilities. This is especially true for analytical instruments deployed in general practitioner offices, pharmacies, or patients' homes.

[0005] In many cases, it is now beneficial to integrate these analytical instruments into a wider computer network (e.g., a hospital network spanning multiple sites).

[0006] Furthermore, it can be beneficial to allow third parties to be included in the network to provide different services to operators of analytical instruments (e.g., third parties not included in the secure environment of a hospital or general practitioner's office). For example, a supplier of analytical instruments may want to offer different analysis and maintenance services for its instruments deployed at remote sites.

[0007] From a data security perspective, in particular, networking analytical instruments (especially older ones) and transmitting the data provided by those instruments can be challenging. Summary of the Invention

[0008] In a first general aspect, a method for processing data from an analytical instrument used to analyze biological samples includes: receiving instrument data from the analytical instrument at a data processing module communicatively connected to the analytical instrument; generating metadata from the received instrument data at the data processing module; applying a first encryption to the instrument data at the data processing module; applying a second encryption to the generated metadata at the data processing module; transmitting the encrypted metadata and the encrypted instrument data to a remote server, wherein the remote server is communicatively connected to the data processing module; removing the second encryption from the metadata at the remote server; and forwarding the instrument data encrypted with the first encryption from the remote server to a management system of the analytical instrument.

[0009] In a second general aspect, a method for processing data from a management system of an analytical instrument includes: receiving input data at the management system of the analytical instrument; generating metadata based on the input data at the management system of the analytical instrument; applying a first encryption to the input data at the management system; applying a second encryption to the generated metadata at the management system; transmitting the encrypted data from the management system to a remote server, wherein the remote server and the management system are communicatively connected; removing the second encryption from the data at the remote server; transmitting the input data to a data processing module, the data processing module being communicatively connected to an analytical instrument for analyzing biological samples; removing the first encryption from the input data at the data processing module; and forwarding the input data from the data processing module to the analytical instrument.

[0010] In the third overall aspect, a system may be configured to perform methods according to the first and / or second overall aspects.

[0011] Specific implementation schemes of the themes of the first to third overall aspects can be implemented to achieve one or more of the following advantages.

[0012] First, the techniques disclosed herein can be used to ensure that data that should not be accessible outside a secure network (e.g., patient data identifying a patient in a hospital or laboratory network) can be transmitted to and from the management system, even if third-party devices are included in the data transmission portion. In this way, the technique can improve data security in networks that include various third-party network devices.

[0013] Secondly, it may allow third parties to access specific data (e.g., metadata without sensitive patient data) to provide services from outside a secure network (e.g., a hospital or laboratory network). This could facilitate, for example, providing maintenance and quality control services for analytical instruments, as well as analytical services. For instance, the status of analytical instruments could be analyzed or predicted based on metadata, or metadata could be analyzed to provide additional information to the operators of the analytical instruments. Additionally or alternatively, computationally intensive operations could be offloaded to remote servers. The techniques in this disclosure, while allowing these and other actions involving third parties, ensure the maintenance of data security.

[0014] Third, the techniques described in this disclosure can be used to efficiently set up a network comprising one or more analytical instruments, a remote server (e.g., the server of the analytical instrument's supplier), and a management system for the analytical instruments (e.g., a major hospital data center). In particular, the data processing module can provide networking capabilities for the analytical instruments that might otherwise be unable to integrate into such a network (e.g., older analytical instruments with little or no connectivity). For example, the data processing module can be configured with drivers necessary to process data received from the analytical instruments and to enforce predetermined data security policies.

[0015] As used herein, the term "analytical instrument" can refer to any kind of technical device used in laboratory work (e.g., in the fields of clinical, chemical, biological, immunological, or pharmaceutical fields) to test or measure biological samples in vitro or in vivo.

[0016] "Analytical instrument" is not necessarily located in a dedicated laboratory. Rather, the term also includes standalone instruments used to perform analytical procedures, for example, in the fields of clinical, chemical, biological, immunological, or pharmaceutical sciences. For example, a benchtop device in a point-of-care setting (such as a physician's office or pharmacy) or a device used at home can also be an analytical instrument according to this disclosure. In other examples, analytical instruments can be used in mobile and emergency environments (e.g., in the event of an outbreak). For example, an analytical instrument may be present in an ambulance.

[0017] Several possible aspects and implementation methods of the analytical instrument will be discussed in the following paragraphs.

[0018] Examples of such analytical instruments include clinical chemistry analyzers, coagulation chemistry analyzers, immunochemistry analyzers, blood analyzers, urine analyzers, and nucleic acid analyzers, which are used to detect the results of chemical or biological reactions or monitor the progress of chemical or biological reactions.

[0019] Analytical instruments may include components for fluid transfer and metering, fluid homogenization (mixing), temperature control, and measurement of chemical or physical parameters. For example, the apparatus may include fluid dispensing components (e.g., pipettes or valves), stirrers, temperature control devices, shakers, and / or mixers.

[0020] Analytical instruments may include units for assisting in pipetting, quantitative dispensing, and mixing samples and / or reagents. Analytical instruments may include reagent holding units for holding reagents for assays (particularly for confirmatory testing). Reagents may be arranged, for example, in the form of containers or cartridges containing individual reagents or groups of reagents, placed in appropriate receivers or locations within storage compartments or delivery systems. They may include consumable supply units. Analytical instruments may include process and detection systems whose workflows are optimized for certain types of analysis.

[0021] In other examples, analytical instruments may include analytical systems or working units of analytical systems or analyzers.

[0022] As used herein, "analytical instrument" may also include a control unit or controller operatively coupled to control the operation of the analytical instrument. Furthermore, the controller may be operatively used to evaluate and / or process collected analytical data, control the loading, storage, and / or unloading of samples to and / or from any analytical instrument, initialize analysis, or perform hardware or software operations to prepare samples, sample tubes, or reagents for said analysis.

[0023] Analytical instruments can be instruments used to analyze the mechanical, optical, chemical, or biological properties of samples.

[0024] Analytical instruments are operable to determine parameter values ​​for a sample or its components via various chemical, biological, physical, optical, or other technical procedures. An analyzer is operable to measure said parameter of a sample or at least one analyte and return the obtained measurement value. A list of possible analytical results returned by the analyzer includes, but is not limited to, the concentration of the analyte in the sample, numerical (e.g., yes or no, or positive or negative) results indicating the presence of the analyte in the sample (corresponding to concentrations above detection levels), optical parameters, images, cell or particle counts, DNA or RNA sequences, data obtained from mass spectrometry of proteins or metabolites, and various types of physical, mechanical, optical, electrical, or chemical parameters.

[0025] Analytical instruments can have different sizes. In one example, the analytical instrument may be a handheld device. In other examples, the analytical instrument may be a benchtop device. In still other examples, the analytical instrument may be a multi-stage automated analyzer.

[0026] In some examples, the analytical instrument may be automatic or semi-automatic. However, in other examples, the analytical instrument may be configured so that some or all steps of the analytical process are performed manually.

[0027] In general, the analytical instruments in this disclosure have the ability to communicate (e.g., using the communication network discussed below) through at least one communication channel.

[0028] The term "biological sample" or "sample" refers to material that may contain an analyte of interest. Samples can be derived from biological sources, such as physiological fluids including whole blood, plasma, serum, saliva, lens fluid, cerebrospinal fluid, sweat, urine, feces, semen, breast milk, ascites, mucus, synovial fluid, peritoneal fluid, amniotic fluid, tissues, cells, etc. Biological samples may be pretreated before use. Pretreatment may involve centrifugation, filtration, dilution, concentration and / or separation of sample components containing the analyte of interest, inactivation of interfering components, and the addition of reagents.

[0029] Samples obtained from the source can be used directly or after pretreatment (which alters the properties of the sample). In some implementations, the initial solid or semi-solid biological material can be dissolved or suspended in a suitable liquid medium to present a liquid form. In some cases, it may be suspected that the sample contains a certain antigen or nucleic acid.

[0030] Samples can be processed before performing analytical tests. For example, blood samples taken from a patient can be centrifuged to obtain serum or treated with an anticoagulant to obtain plasma. However, the techniques of this disclosure are not limited to blood samples or samples derived from blood. In other instances, other biological samples can be used for confirmatory tests (provided that the techniques of this disclosure are applicable to detecting the presence of the corresponding analyte).

[0031] As used in this disclosure, the term "analyte" refers to a substance or component of interest during the analysis.

[0032] The “control unit” or “controller” controls the analytical instrument, enabling it to perform the necessary steps of a processing protocol. This means, for example, that the controller may instruct the analytical instrument to perform certain pipetting steps to mix a liquid biological sample with reagents, or that the controller may control the analytical instrument to incubate a sample mixture for a certain period of time. The control unit may receive information from the data management unit regarding which steps need to be performed with a specific sample. In some implementations, the controller may be integrated with the data management unit or may be implemented using common hardware. For example, the controller may be implemented as a programmable logic controller running a computer-readable program provided with instructions for performing operations according to a process operation plan. The controller may include a processor and memory. The controller may be configured to control, for example, any one or more of the following operations: loading and / or consuming and / or cleaning cuvettes and / or pipette tips, moving and / or opening sample tubes and kits, pipetting of samples and / or reagents, mixing of samples and / or reagents, cleaning of pipettes or tips, cleaning of mixing paddles, control of light sources (e.g., wavelength selection), etc. In particular, the controller may include a scheduler for executing a series of steps within a predefined period of time. The controller can further determine the order of samples to be processed based on factors such as the type of measurement and the urgency level.

[0033] As used herein, the term "communication network" includes any type of wireless network, such as Wi-Fi, GSM, UMTS, LTE, or other wireless networks, or cable-based networks, such as Ethernet. Specifically, a communication network may implement the Internet Protocol (IP). However, in other instances, a communication network may implement proprietary communication protocols. In some instances, a communication network includes a combination of wired and wireless networks.

[0034] The term "metadata" in this disclosure can refer to any type of data generated from or based on instrument data from an analytical instrument. The data generation process may include, for example, selecting data items from the instrument data, modifying instrument data items, combining instrument data items, or other processing steps. Further details regarding the possible characteristics of metadata will be explained below. In any case, "metadata" may include data items from the instrument data (i.e., the term "metadata" does not exclusively refer to data items not included in the instrument data). However, metadata cannot include all data items from the instrument data generated from the metadata (i.e., the metadata cannot be the same as the instrument data).

[0035] Unless otherwise specified, the terms “about,” “approximately,” and “approximately” as used herein may refer to a deviation of + / - 10% from the indicated value. If two values ​​are “approximately” or “about” equal, this may mean that the two values ​​differ by at most 10% (determined starting from the smaller value).

[0036] This invention includes:

[0037] 1. A method for processing data from an analytical instrument used to analyze biological samples, the method comprising:

[0038] The data processing module (2; 2a; 2b) is communicatively connected to the analytical instrument (1a; 1b).

[0039] The instrument receives instrument data (3) from the analytical instrument (1a; 1b);

[0040] Metadata (4) is generated from the received instrument data (3) at the data processing module;

[0041] The first encryption (7) is applied to the instrument data (3) at the data processing module (2; 2a; 2b);

[0042] At the data processing module (2; 2a; 2b), a second encryption (8) is applied to the generated metadata (4);

[0043] The encrypted metadata and encrypted instrument data (11) are transmitted to the remote server (9).

[0044] The remote server and the data processing module are communicatively connected.

[0045] Remove the second encryption (8) from the metadata (4) at the remote server (9); and

[0046] The instrument data, encrypted by the first encryption (10), is forwarded from the remote server to the management system (5) of the analytical instrument.

[0047] 2. The method of item 1, wherein applying the first encryption (7) includes using a first encryption key, and wherein applying the second encryption (8) includes using a second encryption key different from the first encryption key.

[0048] 3. The method of item 2, wherein the first encryption key is a customer-specific key of the user of the analyzer, and wherein the second key is a supplier-specific key of the supplier of the analyzer (1a; 1b).

[0049] 4. The method of either item 2 or 3, further comprising:

[0050] Before applying the first encryption (7), the first encryption key is retrieved at the data processing module (2; 2a; 2b); and

[0051] The first encryption key is deleted after the first encryption (7) is applied.

[0052] 5. The method of any one of items 1 to 4 above, wherein generating metadata (4) includes parsing instrument data (3) received from the analytical instrument (1a; 1b) by using at least one driver dedicated to the analytical instrument (1a; 1b), the at least one driver being stored at the data processing module (2; 2a; 2b).

[0053] 6. The method of any one of items 1 to 5 above, wherein generating the metadata (4) includes removing patient-specific data and / or customer-specific data from instrument data (3) received from the analytical instrument (1a; 1b).

[0054] 7. The method of any one of items 1 to 6 above, further comprising:

[0055] Retrieve the metadata (4) from the remote server (9); and

[0056] The metadata (4) is processed in the remote server (9) by performing at least one analysis operation.

[0057] 8. The method of any one of items 1 to 7 above, further comprising:

[0058] The instrument data (3) is received at the management system (5) of the analytical instrument;

[0059] Remove the first encryption (7) from the received instrument data (3) at the management system;

[0060] as well as

[0061] The instrument data (3), including patient-specific data, is processed in the management system (5).

[0062] 9. The method of any one of items 2 to 8 above, wherein the first encryption key is a first public key of a first customer-specific asymmetric encryption key pair, and / or the second encryption key is a second public key of a second supplier-specific asymmetric encryption key pair.

[0063] 10. The method of item 9, wherein removing the second encryption (8) from the metadata (4) at the remote server (9) includes decrypting the metadata (4) using a second private key of the second asymmetric encryption key pair, and / or removing the first encryption (7) from the received instrument data (3) at the management system (5) includes decrypting the metadata (4) using a first private key of the first asymmetric encryption key pair.

[0064] 11. The method of any of the preceding items, wherein the second encryption (8) is applied to the instrument data (3) at the data processing module (2; 2a; 2b).

[0065] 12. A method for processing data from a management system for analytical instruments, comprising:

[0066] Input data is received at the management system (5) of the analytical instrument;

[0067] Metadata (4) is generated based on the input data in the management system (5) of the analytical instrument;

[0068] The input data is encrypted (7) at the management system (5);

[0069] The generated metadata (4) is subjected to a second encryption (8) at the management system (5);

[0070] The encrypted data is transmitted from the management system to a remote server (9), wherein the remote server and the management system are communicatively connected;

[0071] Remove the second encryption (8) from the data at the remote server (9);

[0072] The input data is transmitted to a data processing module (2; 2a; 2b), which is communicatively connected to an analytical instrument (1a; 1b) used to analyze biological samples.

[0073] The first encryption (7) is removed from the input data at the data processing module (2; 2a; 2b);

[0074] as well as

[0075] The input data is forwarded from the data processing module to the analytical instrument (1a; 1b).

[0076] 13. A system for processing data from an analytical instrument used to analyze biological samples, the system comprising:

[0077] The data processing module (2; 2a; 2b) is communicatively connected to the analytical instrument (1a; 1b), and is configured to:

[0078] Receive instrument data from the analyzer (3);

[0079] Metadata (4) is generated from the received instrument data (3);

[0080] The instrument data (3) is encrypted using the first encryption method (7);

[0081] Apply a second encryption (8) to the generated metadata (4);

[0082] The encrypted metadata and encrypted instrument data (11) are transmitted from the data processing module to the remote server (9).

[0083] 14. A system for processing data from a management system for analytical instruments, comprising:

[0084] The management system (5) for the analytical instrument is configured to:

[0085] Receive input data;

[0086] Based on this input data, metadata (4) is generated; and

[0087] Apply the first encryption to the input data (7);

[0088] Apply a second encryption (8) to the generated metadata; and

[0089] The encrypted data is transmitted to a remote server (9);

[0090] The remote server (9) is configured to be used for:

[0091] Remove the second encryption from the metadata (4); and

[0092] The input data is transmitted from the remote server to the data processing module (2; 2a; 2b) connected to the analyzer via a communication link; and

[0093] The data processing module (2; 2a; 2b) is communicatively connected to the analytical instrument (1a; 1b).

[0094] This data processing module is configured to be used for:

[0095] Remove the first encryption (7) from the input data; and

[0096] The input data is forwarded to the analytical instrument (1a; 1b).

[0097] 15. A computer-readable medium having instructions stored thereon, which, when executed by a computer system, cause the computer system to perform the steps of any one of methods 1 to 12. Attached Figure Description

[0098] Figure 1 A schematic diagram illustrating a data processing module according to this disclosure is shown.

[0099] Figure 2 A schematic diagram is shown, illustrating a network configured using a data processing module according to this disclosure.

[0100] Figure 3 A swimlane diagram illustrating a method for transferring data from an analytical instrument to an instrument management system according to this disclosure is shown.

[0101] Figure 4 A swimlane diagram illustrating a method for transferring data from an instrument management system to an analytical instrument, according to this disclosure, is shown. Detailed Implementation

[0102] The methods and systems for processing data from analytical instruments used to analyze biological samples, according to this disclosure, will then be discussed in more detail.

[0103] First, combine Figure 1 and Figure 2 An overview of the methods and systems disclosed herein is given. Subsequently, [the following will be discussed in conjunction with...] Figure 3 and Figure 4 Let us discuss some additional aspects of this public text.

[0104] Overall operation of the data processing module

[0105] Figure 1 This includes a schematic diagram illustrating data processing module 2 according to this disclosure. Figure 1 In the example, two analytical instruments 1a and 1b (e.g., handheld device 1b and automated in vitro analyzer 1a) provide instrument data 3 (abbreviated as "ID" in some paragraphs of the specification and figures) to the data processing module 2 described below.

[0106] Data processing module 2 can be configured in many different ways.

[0107] In one example, the data processing module 2 is a standalone hardware module configured to connect to the analytical instruments 1a and 1b (e.g., via a communication network or via a direct cable or wireless connection).

[0108] The standalone hardware module may include a housing 100 that contains all the components required for the data processing module 2. In some examples, the data processing module 2 may be a standalone hardware module with a shape factor of less than 20cm x 20cm x 20cm (length x height x width).

[0109] For example, the data processing module 2 may have a form factor suitable for connecting to the analytical instruments 1a and 1b via their data communication ports (wired or wireless) (e.g., similar to a WIFI router).

[0110] In other examples, the data processing module 2 is a plug-in hardware module configured to be inserted into the housing of a different device. In one example, the plug-in hardware module may be adapted to be disposed in analytical instruments 1a, 1b or another device connected to analytical instruments 1a, 1b (e.g., in the form of a slide-in module). The plug-in module can then be communicatively coupled to analytical instruments 1a, 1b via an interface (e.g., an external communication port or an internal interface).

[0111] In addition to the functional units required to perform the operations described herein, the data processing module 2 may also be equipped with different functional units. In some examples, the data processing module 2 may include a dedicated power supply. For example, the data processing module 2 may include one or more batteries or capacitors to power the different functions of the data processing module 2.

[0112] Alternatively, the data processing module 2 may include a transceiver to provide wired or wireless communication capabilities. In one example, the data processing module 2 may be configured to communicate over a wired or wireless public telephone network. Alternatively, the data processing module 2 may be configured to establish a wired or wireless Internet connection.

[0113] In the above example, data processing module 2 is configured as a single hardware unit. However, in other examples, data processing module 2 may be implemented as multiple hardware units (e.g., a main body and an antenna unit).

[0114] In other examples, data processing module 2 can be configured as a software module.

[0115] For example, data processing module 2 may be a software module residing on or at least controlled by a remote server. In some examples, data processing module 2 may be configured to operate as Infrastructure as a Service (“IaaS”) or Software as a Service (“SaaS”).

[0116] In other examples, data processing module 2 may be provided by a combination of hardware and software modules (e.g., hardware modules using software modules running on a remote server).

[0117] Regardless of the specific configuration (e.g., hardware or software), the data processing module 2 can be configured to perform techniques according to this disclosure for processing data from analytical instruments 1a, 1b used for analyzing biological samples.

[0118] In this disclosure, we will distinguish between instrument data 3 and metadata 4 (data metadata is generated based on instrument data 3) provided by analytical instruments 1a and 1b. Instrument data 3 may include any data generated by analytical instruments 1a and 1b (e.g., data generated by any of the analytical instruments discussed above). Typically, instrument data 3 may include any data generated by the instrument during normal operation (e.g., when testing a sample), setup, maintenance, or other operating modes of the analytical instrument.

[0119] In one example, instrument data 3 may include data relating to measurements or tests performed by or using analytical instruments 1a and 1b. In other examples, instrument data 3 may include data relating to the state of analytical instruments 1a and 1b (e.g., data generated by sensors monitoring the analytical instruments). In still other examples, instrument data 3 may include data related to the environment of analytical instruments 1a and 1b collected by the analytical instruments 1a and 1b (e.g., data generated by sensors in the analytical instruments, such as temperature or humidity data).

[0120] Typically, instrument data 3 may include two types of data—a first type of data and a second type of data. The first type of data may include information that should not be accessible to parties outside the predetermined secure network environment in which the analytical instrument resides (e.g., a hospital, laboratory, or pharmacy network, or a doctor's office network).

[0121] The second category of data may be data that does not include the information described above. This data may be accessible to parties outside the intended secure network environment. In this disclosure, the first category of data will also be referred to as "sensitive data" or "confidential data." Therefore, the second category of data will be referred to as "non-sensitive data" or "non-confidential data" in this disclosure.

[0122] The first category of data may include patient data that may be suitable for identifying a particular patient (e.g., name, address, date of birth, or other data items that may be suitable for identifying a particular patient). Additionally or alternatively, the first category of data may include private patient data (e.g., data related to medical history, test results, or a set of test results and other private data). Both categories of data (i.e., patient-specific data and patient-private data) are also referred to as “patient-specific data” in this publication. Whether a data item falls into one of these categories may be determined by law or other regulations.

[0123] Alternatively, the first type of data may include data suitable for identifying the specific entity in which the corresponding analytical instrument is located (e.g., data identifying a hospital, laboratory, or doctor's office). Alternatively, the first type of data may include proprietary data of the organization operating the corresponding analytical instruments 1a, 1b (e.g., billing data or data identifying the operator of analytical instruments 1a, 1b). Both types of data (i.e., proprietary data and dedicated data of the entities operating analytical instruments 1a, 1b) are also referred to in this disclosure as "customer-specific data".

[0124] On the other hand, the second category of data can be any data that does not possess the aforementioned characteristics. For example, the second category of data may include data that is not suitable for identifying a specific patient (e.g., year of birth, postal code, city of residence, or other data that is not suitable for identifying a specific patient).

[0125] like Figure 1 As shown, data processing module 2 also processes metadata 4 generated from instrument data 3. Typically, metadata 4 may include data generated from the analytical instrument or data generated based on instrument data 3 from the analytical instrument. For example, metadata 4 may be the second type of data discussed above.

[0126] The generation process of metadata 4 may include one or more of the following process steps. In one example, metadata 4 may be a sub-selection of data items contained in instrument data 3. For example, the metadata generation process may include selecting one or more data items contained in instrument data 3. For example, measurement or test data may be selected from a dataset that includes measurement or test data and data identifying patients to whom the corresponding tests or measurements were performed.

[0127] In these examples, metadata 4 may include data items that are also included in instrument data 3 (so that the metadata generation process can also be seen as a filtering operation of instrument data).

[0128] In other examples, metadata 4 can be a sub-selection of data items contained in instrument data 3 that are further processed. For example, a data item in instrument data 3 may include a patient's date of birth, which is then processed to produce only the year of birth as metadata 4. In another example, instrument data 3 may include measurements used for a specific test. Processing this data may involve classifying the measurements into one of several categories (e.g., "normal," "low," or "high"). Metadata 4 could then include only the category to which the measurement belongs.

[0129] In other examples, metadata 4 is generated based on data items contained in instrument data 3 and other data. For example, metadata 4 may be generated based on data from different patients or data from different analytical instruments, or both.

[0130] In one example, the metadata generation process may include removing all data from the first category of data discussed above. For instance, the generation of metadata 4 may include removing patient-specific or customer-specific data received from analytical instruments 1a and 1b.

[0131] In the following sections, we will sometimes refer to metadata 4 as “generation” and sometimes as “selection”. As can be seen from the explanation above, these two terms refer to the extraction of data from instrument data 3 with or without additional processing steps.

[0132] Typically, the data processing module 2 can apply different types of encryption to the instrument data 3 and metadata 4 (in this disclosure, the expressions “apply encryption to data” and “encrypt data” are synonymous).

[0133] The first encryption 7 is applied to the instrument data 3 and the second encryption 8 is applied to the metadata 4. In this publication, when discussing "first encryption," we sometimes refer to it as "first-level encryption"; correspondingly, when discussing "second encryption," we sometimes refer to it as "second-level encryption." These expressions are synonymous.

[0134] The first encryption 7 and the second encryption 8 are different. This means that an entity or device capable of decrypting data encrypted with one encryption by a specific means (e.g., using a specific key) cannot encrypt data encrypted with a corresponding other encryption by the same means.

[0135] Typically, metadata 4 is not encrypted with the first encryption 7. Figure 1 In the example, metadata 4 is also not encrypted with the second encryption 8. However, in other examples, both instrument data 3 and metadata 4 can be encrypted with the second encryption 8.

[0136] The first encryption 7 and the second encryption 8 can be any encryption suitable for encrypting electronic data. The following will combine... Figure 2 The discussion covers exemplary encryption techniques that can be used to generate the first encryption 7 and the second encryption 8.

[0137] In addition to the metadata generation and encryption processes, data processing module 2 is configured to be used via a communication network ( Figure 1 (Not shown in the image) to transmit encrypted data. The communication network can be any wired or wireless communication network (e.g., any of the communication networks discussed above). The transmitted data can then be further processed at a remote location. Now, we will combine... Figure 2 Let's discuss this operation in more detail.

[0138] Network including data processing module

[0139] Figure 2Two data processing modules, 2a and 2b, are shown in a network environment. Similar to... Figure 1 , Figure 2 Analytical instruments 1a and 1b are shown connected to data processing module 2a. In some examples, a particular data processing module may be connected to only a single analytical instrument to serve that single instrument. In other examples, a data processing module may be connected to multiple analytical instruments and serve each of those instruments. Data processing modules may be statically or dynamically assigned to analytical instruments.

[0140] exist Figure 2 In the example above, data processing module 2a is a standalone hardware module. However, in other examples, data processing module 2a can be a combination of the above. Figure 1 Any data processing module 2 discussed.

[0141] As described, data processing module 2a receives instrument data 3 from analytical instruments 1a and 1b and processes this data using the techniques described above. The processed data 11 is then transmitted to remote server 9. Figure 2 As depicted, data 11 is encrypted. In some examples, data 11 includes instrument data 3 encrypted with a first encryption 7 and metadata 4 encrypted with a second encryption 8 (e.g., both types of data are "single-encrypted"). In other examples, data 11 includes instrument data 3 encrypted with both the first encryption 7 and the second encryption 8, and metadata 4 encrypted only with the second encryption 8 (e.g., instrument data 3 is "double-encrypted" and metadata 4 is "single-encrypted").

[0142] Data processing module 2a can connect to remote server 9 via any direct or indirect network connection. In one example, data processing module 2a is connected to the Internet to establish a connection with remote server 9.

[0143] In some examples, remote server 9 may be a server operated by the vendor of analytical instruments 1a and 1b. However, in other examples, remote server 9 may be a server operated by a different third-party operator (e.g., a provider of analytical services for the entity operating analytical instruments 1a and 1b). In some examples, remote server 9 may be located outside the secure network of the entity operating analytical instruments 1a and 1b.

[0144] Further data processing steps will be discussed. At remote server 9, the second encryption 8 is removed. Therefore, metadata 4 can be accessed and processed at remote server 9. The following will combine... Figure 3 and Figure 4 Let's discuss an example of how metadata 4 can be processed at remote server 9. However, in some cases, remote server 9 only removes the second encryption 8 and does not process metadata 4.

[0145] Regardless of the processing steps performed on data 11 by remote server 9, remote server 9 will forward the instrument data 10 encrypted by the first encryption 7 to the management system 5 of analytical instruments 1a and 1b used for analyzing biological samples.

[0146] For example, the management system 5 for analytical instruments 1a and 1b used to analyze biological samples can be a data center for the operators of analytical instruments 1a and 1b. As mentioned above, the operators of analytical instruments 1a and 1b can be hospitals, pharmacies, laboratories, doctors' offices, or other entities. Therefore, the instrument management system 5 can be a hospital management system, a pharmacy management system, a doctor's office or laboratory management system, or a management system of another entity. In some examples, the instrument management system 5 can be part of a laboratory information system (“LIS”) or a hospital information system (“HIS”).

[0147] It should be noted that the instrument management system 5 can take various forms. For example, in medical practice, the instrument management system 5 can be a data processing system residing on a personal computer or local server. In other examples, the instrument management system 5 can be a management system for a large entity, such as a hospital network comprising many sites.

[0148] In some examples, the instrument management system 5 is located locally on analytical instruments 1a and 1b. In other examples, the instrument management system 5 is a remote instrument management system.

[0149] In other words, the analytical instruments 1a and 1b, which are connected to the instrument management system 5 via data processing modules 2a and 2b, can be located anywhere. In one example, the analytical instruments 1a and 1b may be located in the patient's home or may be non-stationary (e.g., in an ambulance) and can be connected to the instrument management system 5 via data processing module 2a.

[0150] At the instrument management system 5, the first encryption 7 can be removed and instrument data 3 can be processed. In this way, the data processing module 2a can allow data to be securely transmitted from the analytical instruments 1a and 1b to the data processing module 2a via the remote server 9. In particular, the operator of the remote server 9 cannot access sensitive patient or customer data. However, this data can be received and processed at the instrument management system 5.

[0151] The following will combine Figure 4 The data processing module 2 can also be used to transfer data from the instrument management system 5 to the analytical instruments 1a and 1b. However, several aspects of the encryption methods that can be employed in the technology disclosed herein will be discussed first.

[0152] All aspects of encryption and decryption technologies

[0153] As discussed above, generally, any encryption technology can be used to provide first encryption 7 and second encryption 8 to instrument data 3 and / or metadata 4.

[0154] In one example, applying first encryption 7 to instrument data 3 includes using a first encryption key, and applying second encryption 8 to metadata 4 includes using a second encryption key different from the first encryption key. In some examples, the first encryption key may be a customer-specific key of the operator of analytical instruments 1a and 1b, and the second key may be a supplier-specific key of analytical instruments 1a and 1b. However, in other examples, the second key may be a key of a third party providing services by processing the metadata 4 generated from instrument data 3. Typically, the second key may be a key of any party operating a remote server 9 (through which the encrypted data will be sent).

[0155] The key used for the first / second encryption can be a public key of a public-key encryption scheme. In other examples, the key used for the first / second encryption can be a private key of a private-key encryption scheme.

[0156] In one example, the first encryption key may be the first public key of a first customer-specific asymmetric encryption key pair. Alternatively, the second encryption key may be the second public key of a second vendor-specific asymmetric encryption key pair. Furthermore, "customer" may be any entity operating the analytical instruments 1a, 1b described herein. Similarly, "vendor" may be any entity operating the remote server 9.

[0157] In this example, removing the second encryption 8 from metadata 4 at remote server 9 includes decrypting metadata 4 using the second private key of the second asymmetric encryption key pair, and / or removing the first encryption 7 from received instrument data 3 at management system 5 includes decrypting metadata 4 using the first private key of the first asymmetric encryption key pair.

[0158] As discussed above, data processing module 2 can apply first encryption 7 and second encryption 8 to the data received from analysis instruments 1a and 1b. If this encryption uses keys, these keys can be managed in different ways.

[0159] In one example, data processing module 2 can be configured to temporarily store either the first encryption key or the second encryption key. For instance, data processing module 2 can be configured to retrieve the first encryption key before applying the first encryption and delete the first encryption key after applying the first encryption. In this way, the first encryption key does not need to be permanently stored on data processing modules 2a and 2b.

[0160] In other examples, data processing module 2a may be configured to receive a second key (e.g., a vendor key) from remote server 9 for the second encryption 8. For example, the second key may be a dynamic key used only for a predetermined period or for a specific purpose. In one example, the second key may be a temporary session key or a key used only for a single message.

[0161] However, in some cases, the data processing module 2 can also be configured to permanently store the first and / or second keys used in different encryption steps.

[0162] In some cases, the second key may be the key of the operator of the remote server 9, which is private to the operator (e.g., the customer) of the analytical instruments 1a and 1b.

[0163] In this disclosure, a first encryption 7 and a second encryption 8 for instrument data 3 and / or metadata 4 are discussed. In some examples, different additional encryption layers may be applied at different stages of the data transmission process. For example, in some examples, additional encryption layers may be used to encrypt messages sent from data processing module 2a to remote server 9 via the Internet.

[0164] In already combined Figure 1 and Figure 2 After a general discussion of the different aspects of instrument data communication via data processing modules 2a and 2b, the following will be discussed... Figure 3 and Figure 4 The following two examples illustrate other aspects of the techniques used to explain this disclosure.

[0165] Transmitting data from the analytical instrument to the instrument management system

[0166] Figure 3 A swimlane diagram illustrating the method of transferring data 3 from analytical instruments 1a and 1b to instrument management system 5 according to this disclosure is shown.

[0167] As discussed above, the process begins with the analytical instrument generating instrument data (“ID”). For example, instrument data may include test results from in vitro assays, as well as patient and billing data associated with the test results and assays.

[0168] In the next step, the instrument data is transmitted 12 to the data processing module. The data processing module then processes 21 the instrument data. As mentioned above, this includes generating metadata 4. Figure 3 In this context, the metadata generation process may include extracting all non-sensitive data from instrument data 3. In the example above, this may include test results from in vitro assays, but not patient and billing data associated with those test results and assays.

[0169] The processing also includes encrypting instrument data and metadata at first and second encryption levels. Figure 3 In this example, encrypting the data involves using a vendor key from a remote server and a customer key received from the analysis instrument. Furthermore, in... Figure 3 In the example, the instrument data is double-encrypted using a first (customer) and a second (supplier) key. However, any other encryption techniques described in this disclosure may also be used.

[0170] In addition to the steps of generating metadata and encryption, the data processing module can also parse instrument data. This process will be discussed below.

[0171] Typically, the parsing process involves receiving instrument data in a first instrument format and identifying the data items contained within the instrument format data. In some examples, the data processing module may use one or more instrument drivers during the parsing process. In some examples, the instrument drivers may be provided by a remote server.

[0172] One reason for the parsing step is that the instrument data received from the analytical instrument may be in a format that is unsuitable or unsuitable for further processing. In particular, in some cases, the metadata generation process (e.g., the identification process of sensitive and non-sensitive data) may require a parsing process.

[0173] This may be because many analytical instruments have outdated control systems that output instrument data in obsolete and / or proprietary formats. These formats may not be digestible by later-generation devices or management systems. Therefore, it can be difficult to identify the information contained in the instrument data (e.g., it may be difficult to determine whether the information is sensitive or non-sensitive).

[0174] For example, an analytical instrument can output the results of in vitro measurements, along with patient and billing data associated with those test results and measurements, as a single string. In this example, the parsing process may include identifying which data items are included in the string.

[0175] In one example, the parsing process may include transforming instrument data into a second format for further processing or transmission. Additionally, an instrument driver may be used in this process.

[0176] In some examples, the transformation process may include standardizing instrument data using instrument drivers. The data processing module can transform instrument data into a data format specified at the instrument management system of the entity operating the analytical instrument. However, the data processing module can also transform instrument data into any other standardized data format (e.g., industry standards for data generated by a particular analytical instrument).

[0177] In a further step 22, the encrypted (and possibly standardized) data is transmitted to a remote server. In one example, the remote server is the server of the analytical instrument supplier. Figure 3 As highlighted, instrument data is encrypted using a first encryption method, and both instrument data and metadata are encrypted using a second encryption method. In other examples, any other encryption techniques described above may be used.

[0178] The following discussion will cover the operations that may occur on the remote server. As discussed above, the remote server can be operated by any third party. However, in this example, for demonstration purposes, the remote server could be the remote server of the analytical instrument vendor.

[0179] At the remote server, the received data can be prepared for further processing. In the first step, (e.g., by using a vendor key) the second encryption can be removed. Therefore, metadata becomes accessible. Figure 3 In the example, metadata is extracted from a remote server.

[0180] The metadata extracted in this way can then be processed in different ways at a remote server. Several exemplary processing operations will be discussed in the following sections.

[0181] In one example, one or more analytical operations can be applied to the metadata. In this way, analytical data about one or more patients can be generated. For example, the analytical data may include information related to the test results (or multiple test results) of a specific determination contained in the metadata.

[0182] Alternatively, processing at the remote server may include statistical analysis of metadata received from one or more analytical instruments. For example, statistical data may be calculated for multiple test results or measurements from one or more analytical instruments.

[0183] In other examples, metadata processing can generate data for monitoring analytical instruments. For instance, measurement data included in the metadata may help assess the condition of an analytical instrument (or a component of an analytical instrument). In one illustrative example, metadata might reveal that an analytical instrument's illumination unit has low light output. This could be interpreted as an indication that the illumination unit is nearing the end of its lifespan. Similarly, the condition of other components can be assessed.

[0184] In another example, metadata can be used for quality control purposes. For many analytical instruments, quality control measurements may need to be performed at predetermined points in time to assess whether the instrument is functioning correctly. The results of these measurements can be included in metadata and processed on a remote server.

[0185] In some examples (in) Figure 3(Not shown in the image), data obtained at a remote server through metadata processing can be transferred to the instrument management system. Additionally or alternatively, in some examples (in...), Figure 3 (Not shown in the image), data generated at a remote server by processing metadata can be transmitted to the analysis instrument.

[0186] Regardless of the nature of the analysis operation, the encrypted instrument data (encrypted by the first encryption) is forwarded to the instrument management system.

[0187] In the data management system, the first encryption is removed from the instrument data (e.g., including sensitive data). The instrument data can then be processed in any suitable manner.

[0188] from Figure 3 As can be seen from the examples, the technology of this disclosure, including the use of data processing modules as described herein, allows analytical instruments (including older instruments) to be connected to a network for transmitting data to a (central) data management system. Furthermore, this technology allows third parties to be included in the transmission loop. Simultaneously, it protects sensitive data from unauthorized access.

[0189] Transmit data from the instrument management system to the analytical instrument.

[0190] In the preceding sections, the techniques of this disclosure have been described for transmitting instrument data to the data management system 5. However, the techniques of this disclosure can also be used to transmit data in the opposite direction (i.e., from the data management system 5 to the analytical instruments 1a, 1b). Aspects of this technique will be combined... Figure 4 This will be discussed in the following paragraphs.

[0191] Figure 4 A swimlane diagram is shown illustrating the method of transferring data from the instrument management system 5 to the analytical instruments 1a and 1b according to this disclosure.

[0192] In the first step, instrument data 83 is generated at the instrument management system (the instrument data generated at the instrument management system is also referred to as "input data" in this disclosure). Typically, instrument data may include any data that exists in the instrument management system and should be transferred to the analytical instrument.

[0193] For example, instrument data may include a list of patients (e.g., a list of patients who will be tested using the analytical instrument). In other examples, instrument data may include an ordered list of tests or measurements to be performed at the analytical instrument. Typically, instrument data may include patient- or customer-specific information (i.e., sensitive data).

[0194] In a further step 84, the instrument data is processed in the data management system. This processing may include generating metadata and applying first and second encryption. These steps may include any aspects described in the first and second encryption steps for the instrument data derived from the analytical instruments discussed above, in conjunction with the generation of metadata. Naturally, in some cases, the nature of the instrument data and metadata may differ on the instrument management system side.

[0195] In some cases, the generation and encryption of metadata can be performed by a data processing module as described herein. On the instrument management side, the data processing module can be a software module (e.g., a SaaS module).

[0196] In any case, the data processing module can generate a double-encrypted message. This message can be transmitted to the remote server in a further step 85. At the remote server, the received message can be processed. Processing steps 94 to 96 may include steps in conjunction with the above. Figure 3 The processing steps described are the same as those described (unless the corresponding processing steps become meaningful only when combined with data received from the analytical instrument and not with data received from the data management system).

[0197] This process may include removing the second encryption and extracting the metadata contained in the message. The processed data can then be forwarded to the data processing module.

[0198] The data processing module can further process the received data. This may involve decrypting the received data to remove the first level of encryption. Additionally, the data processing module can transform the data into a format suitable for processing by the analytical instrument. As discussed above in the section on "Other Transmission Directions," this may involve using instrument drivers stored at the data processing module. In some examples, instrument drivers may be received from a remote server at the data processing module. In this way, instrument data can be transformed into a format that the analytical instrument can digest (e.g., legacy data formats used by the analytical instrument's controller).

[0199] In a further step 26, the data processing module can transmit the decrypted (and possibly reformatized) data to the analysis instrument. At the analysis instrument, the data can be used in various ways to facilitate its operation.

[0200] Similar to the combination above Figure 3 The described exemplary process for securely transferring data from an analytical instrument to an instrument management system also allows for the secure transfer of instrument data in the opposite direction. It can be seen that neither the operator of the analytical instrument nor the instrument management system needs to replace or update the software or firmware of the corresponding devices to facilitate this secure communication. One or more data processing modules capable of enabling secure communication may suffice.

[0201] In particular, this technology can be used to connect one or more older instruments that are widely distributed in different locations (e.g., a patient's home). Furthermore, small entities such as doctors' offices can network their analytical instruments and instrument management systems in a relatively simple and straightforward manner.

[0202] In addition, the data processing module allows third parties to be included in the transmission loop, which enables the provision of additional services to the operators and management systems of analytical instruments.

[0203] Additional aspects

[0204] In the preceding detailed description, several examples of methods and systems for processing data from analytical instruments used to analyze biological samples have been discussed. However, methods and systems for processing data from analytical instruments used to analyze biological samples can also be configured as described in the following aspects:

[0205] 1. A method for processing data from an analytical instrument used to analyze biological samples, the method comprising:

[0206] The data processing module, which is connected in communication with the analytical instrument, receives instrument data from the analytical instrument; and generates metadata from the received instrument data at the data processing module.

[0207] The instrument data is encrypted using the first encryption method at the data processing module.

[0208] The generated metadata is then subjected to a second encryption at the data processing module.

[0209] The encrypted metadata and encrypted instrument data are transmitted to a remote server, which is communicatively connected to the data processing module.

[0210] Remove the second encryption from the metadata at the remote server; and

[0211] The instrument data, encrypted using the first encryption, is forwarded from the remote server to the management system of the analytical instrument.

[0212] 2. The method of aspect 1, wherein applying the first encryption includes using a first encryption key, and wherein applying the second encryption includes using a second encryption key different from the first encryption key.

[0213] 3. The method of aspect 2, wherein the first encryption key is a customer-specific key of the user of the analyzer, and wherein the second key is a supplier-specific key of the supplier of the analyzer.

[0214] 4. The method of either aspect 2 or 3, further comprising:

[0215] Before applying the first encryption, the first encryption key is retrieved at the data processing module; and after applying the first encryption, the first encryption key is deleted.

[0216] 5. The method of any one of aspects 1 to 4 above, wherein generating metadata includes parsing instrument data received from the analytical instrument by using one or more drivers dedicated to the analytical instrument, the one or more drivers being stored at the data processing module.

[0217] 6. The method of aspect 5, which further includes receiving the one or more drivers from the remote server.

[0218] 7. The method of any one of aspects 1 to 6 above, wherein generating the metadata includes removing patient-specific data and / or customer-specific data from instrument data received from the analytical instrument.

[0219] 8. The method of any one of aspects 1 to 7 above, further comprising:

[0220] The metadata is extracted from the remote server and processed on the remote server by performing one or more analysis operations.

[0221] 9. The method of any one of aspects 1 to 8 above, further comprising:

[0222] Receive instrument data from the management system of the analytical instrument;

[0223] Remove the first encryption from the received instrument data at the management system level; and

[0224] The management system processes the instrument's data, including patient-specific data.

[0225] 10. The method of any one of aspects 2 to 9 above, wherein the first encryption key is a first public key of a first customer-specific asymmetric encryption key pair, and / or the second encryption key is a second public key of a second supplier-specific asymmetric encryption key pair.

[0226] 11. The method of aspect 10, wherein removing the second encryption from the metadata at the remote server includes decrypting the metadata using a second private key of the second asymmetric encryption key pair, and / or removing the first encryption from the received instrument data at the management system includes decrypting the metadata using a first private key of the first asymmetric encryption key pair.

[0227] 12. The method of any of the foregoing aspects, wherein the second encryption is further applied to the instrument data at the data processing module.

[0228] 13. A method for processing data from a management system for analytical instruments, comprising:

[0229] The system receives input data from the management system of the analytical instrument.

[0230] Metadata is generated based on this input data at the management system of the analytical instrument;

[0231] The input data is encrypted using the management system.

[0232] The generated metadata is subject to a second encryption within the management system.

[0233] The encrypted data is transmitted from the management system to a remote server, wherein the remote server and the management system are communicatively connected.

[0234] Remove the second encryption from the data at the remote server;

[0235] The input data is transmitted to a data processing module, which is communicatively connected to an analytical instrument used to analyze biological samples.

[0236] The first encryption is removed from the input data at the data processing module; and

[0237] The input data is forwarded from the data processing module to the analysis instrument.

[0238] 14. The method of aspect 13, wherein applying the first encryption includes using a first encryption key, and wherein applying the second encryption includes using a second encryption key different from the first encryption key.

[0239] 15. The method of aspect 14, wherein the first encryption key is a customer-specific key of the user of the analyzer, and wherein the second key is a supplier-specific key of the supplier of the analyzer.

[0240] 16. The method of any one of aspects 14 or 15, further comprising:

[0241] Before removing the first encryption from the input data, the first encryption key is retrieved at the data processing module; and

[0242] Delete the first encryption key after removing the first encryption.

[0243] 17. The method of any one of aspects 13 to 16 above, wherein forwarding the input data to an analytical instrument for analyzing biological samples includes using one or more drivers dedicated to the analytical instrument, the one or more drivers being stored at the data processing module.

[0244] 18. The method of aspect 17, which further includes receiving the one or more drivers from the remote server.

[0245] 19. The method of any one of aspects 13 to 18 above, further comprising:

[0246] The metadata is extracted from the remote server and processed on the remote server by performing one or more analysis operations.

[0247] 20. The method of any one of aspects 13 to 19 above, further comprising:

[0248] The input data is received at the analytical instrument used to analyze biological samples;

[0249] The input data is analyzed at the analytical instrument used to analyze biological samples.

[0250] 21. The method of any one of aspects 14 to 19 above, wherein the first encryption key is a first public key of a first customer-specific asymmetric encryption key pair, and / or the second encryption key is a second public key of a second supplier-specific asymmetric encryption key pair, optionally wherein removing the second encryption from the metadata at the remote server includes decrypting the metadata using the second private key of the second asymmetric encryption key pair, and / or removing the first encryption from the received instrument data at the management system includes decrypting the metadata using the first private key of the first asymmetric encryption key pair.

[0251] 22. The method of any of the foregoing aspects, wherein the second encryption is further applied to the input data at the data processing module.

[0252] 23. The method of any one of aspects 1 to 22 above, wherein the data processing module is a hardware module.

[0253] 24. The method of aspect 23, wherein the hardware module is an independent hardware module.

[0254] 25. The method of aspect 23 or aspect 24, wherein the hardware module includes a dedicated power supply configured to supply power to the data processing module.

[0255] 26. The method of aspect 25, wherein the power source comprises one or more batteries, or wherein the power source comprises one or more capacitors, or both.

[0256] 27. The method of any one of aspects 1 to 26, wherein the data processing module operates as a platform as a service or infrastructure as a service.

[0257] 28. The method of any of the foregoing aspects, wherein the data processing module provides the ability to connect the analytical instrument to a communication network.

[0258] 29. The method of aspect 28, wherein the communication network is a wireless communication network.

[0259] 30. A system for processing data from an analytical instrument used to analyze biological samples, the system comprising:

[0260] The data processing module, which is communicatively connected to the analytical instrument, is configured to:

[0261] Receive instrument data from the analytical instrument used to analyze biological samples;

[0262] Generate metadata from the received instrument data;

[0263] Apply first encryption to the instrument data but not to the metadata;

[0264] Apply a second encryption to the generated metadata;

[0265] The encrypted metadata and the encrypted instrument data are transmitted to a remote server.

[0266] 31. The system of aspect 30, further comprising the remote server, the remote server being configured to:

[0267] Remove the second encryption from the metadata at the remote server; and

[0268] The instrument data encrypted using this first encryption is forwarded to the management system of the analytical instruments used to analyze biological samples.

[0269] 32. The system of aspect 31, further comprising an analytical instrument for analyzing biological samples and / or a management system for the analytical instrument.

[0270] 33. A system of any one of aspects 30 to 32, further configured to perform the method steps of any one of aspects 2 to 12.

[0271] 34. A system for processing data from the management system of an analytical instrument, comprising:

[0272] A management system for analytical instruments, configured to:

[0273] Receive input data;

[0274] Metadata is generated based on this input data; and

[0275] Apply the first encryption to the input data;

[0276] A second encryption is applied to the generated metadata; and

[0277] The encrypted data is then transmitted to a remote server.

[0278] The remote server is configured to be used for:

[0279] Remove the second encryption from the data; and

[0280] The input data is transmitted to a data processing module, which is communicatively connected to an analytical instrument used to analyze biological samples.

[0281] A data processing module communicatively connected to an analytical instrument used for analyzing biological samples, the data processing module being configured to:

[0282] Remove the first encryption from the input data; and

[0283] The input data is forwarded to the analytical instrument used to analyze the biological sample.

[0284] 35. The system of aspect 34, which is further configured to perform the steps of the method of any one of aspects 13 to 29.

[0285] 36. The system of any one of aspects 30 to 35 above, wherein the data processing module is a hardware module.

[0286] 37. The system of aspect 36, wherein the hardware module is an independent hardware module.

[0287] 38. The system of aspect 36 or aspect 37, wherein the hardware module includes a dedicated power supply configured to supply power to the data processing module.

[0288] 39. The system of aspect 38, wherein the power source comprises one or more batteries, or wherein the power source comprises one or more capacitors, or both.

[0289] 40. A system of any one of aspects 30 to 35, wherein the data processing module operates as a platform as a service or infrastructure as a service.

[0290] 41. The system of any of the foregoing aspects, wherein the data processing module provides the ability to connect the analytical instrument to a communication network.

[0291] 42. The system of aspect 41, wherein the communication network is a wireless communication network.

[0292] 43. A computer-readable medium having instructions stored thereon, which, when executed by a computer system, cause the computer system to perform the steps of any one of methods 1 to 29.

[0293] Computer implementation

[0294] A computer program is further disclosed and proposed, comprising computer-executable instructions for performing the methods according to this disclosure in one or more embodiments appended herein when executed on a computer or computer network. Specifically, the computer program may be stored on a computer-readable data carrier. Thus, specifically, one, more, or all of the method steps disclosed herein can be performed by using a computer or computer network, preferably by using a computer program.

[0295] A computer program product is further disclosed and proposed, having program code for performing the methods according to this disclosure in one or more embodiments appended herein when the program is executed on a computer or computer network. Specifically, the program code may be stored on a computer-readable data carrier.

[0296] Further disclosure and proposal include a data carrier storing the data structure described above, which, after being loaded into a computer or computer network, such as into the working memory or main memory of the computer or computer network, can execute methods according to one or more embodiments disclosed herein.

[0297] A computer program product is further disclosed and proposed, having program code stored on a machine-readable medium to perform methods according to one or more embodiments disclosed herein when the program is executed on a computer or computer network. As used herein, the computer program product refers to the program as a tradable product. This product can generally exist in any format (such as paper format) or on a computer-readable data medium. Specifically, the computer program product can be distributed on a data network.

[0298] A modulated data signal is further disclosed and proposed, which contains instructions readable by a computer system or computer network for performing a method according to one or more embodiments disclosed herein.

[0299] Referring to the computer implementation aspects of this disclosure, one or more method steps, or even all method steps, of the methods according to one or more embodiments disclosed herein can be performed using a computer or computer network. Therefore, generally, any method step, including providing and / or manipulating data, can be performed using a computer or computer network. In general, these method steps can include any method steps that typically require no manual work (such as providing samples and / or performing certain measurements).

[0300] Further disclosure and proposal include a computer or computer network comprising at least one processor, wherein the processor is adapted to perform a method according to an embodiment described in this specification.

[0301] A computer-loadable data structure is further disclosed and proposed, which is adapted to perform a method according to an embodiment described herein while the data structure is executed on a computer.

[0302] A storage medium is further disclosed and proposed, wherein a data structure is stored on the storage medium, and wherein the data structure is adapted to be used in a method according to an embodiment described herein after being loaded into the main storage device and / or working storage device of a computer or computer network.

Claims

1. A method for processing data from more than one analytical instrument used to analyze biological samples, the method comprising: The data processing module (2; 2a; 2b) is communicatively connected to the more than one analytical instrument (1a; 1b) to receive instrument data (3) from the more than one analytical instrument (1a; 1b); Metadata (4) is generated from the received instrument data (3) at the data processing module; The instrument data (3) is encrypted using a first encryption (7) at the data processing module (2; 2a; 2b); The generated metadata (4) is subjected to a second encryption (8) at the data processing module (2; 2a; 2b); The application of the first encryption (7) includes using a first encryption key, and the application of the second encryption (8) includes using a second encryption key that is different from the first encryption key; The encrypted metadata and encrypted instrument data (11) are transmitted to a remote server (9), wherein the remote server and the data processing module are communicatively connected; Remove the second encryption (8) from the metadata (4) at the remote server (9); as well as The instrument data, encrypted by the first encryption (10), is forwarded from the remote server to the management system (5) of the more than one analytical instrument. The generation of this metadata (4) includes removing patient-specific data and / or customer-specific data from the instrument data (3) received from the analytical instruments (1a; 1b). The metadata (4) is used to provide maintenance and quality control services and analysis services for analytical instruments.

2. The method of claim 1, wherein the instrument data (3) includes data generated by the more than one analytical instrument (1a; 1b) during setup or maintenance.

3. The method according to claim 1 or 2, further comprising: The evaluation of more than one analytical instrument (1a) is based on the metadata (4) at the remote server (9); The state of 1b).

4. The method according to any one of claims 1-2, further comprising: At the remote server (9), more than one analytical instrument (1a) is used. 1b) Statistical analysis of received metadata (4).

5. The method according to any one of claims 1-2, further comprising: Before applying the first encryption (7), in the data processing module (2; 2a; Retrieve the first encryption key at point 2b); as well as The first encryption key is deleted after the first encryption (7) is applied.

6. The method according to any one of claims 1 to 2, further comprising: Retrieve the metadata (4) from the remote server (9); as well as The metadata (4) is processed in the remote server (9) by performing at least one analysis operation.

7. The method according to any one of claims 1 to 2, further comprising: The instrument data (3) is received at the management system (5) of the analytical instrument. The first encryption (7) is removed from the received instrument data (3) at the management system; and The instrument data (3), including patient-specific data, is processed in the management system (5).

8. The method according to any one of claims 1 to 2, wherein the first encryption key is a first public key of a first customer-specific asymmetric encryption key pair, and / or the second encryption key is a second public key of a second supplier-specific asymmetric encryption key pair, optionally wherein removing the second encryption (8) from the metadata (4) at the remote server (9) includes decrypting the metadata (4) using the second private key of the second supplier-specific asymmetric encryption key pair, and / or removing the first encryption (7) from the received instrument data (3) at the management system (5) includes decrypting the instrument data (3) using the first private key of the first customer-specific asymmetric encryption key pair.

9. The method according to any one of claims 1-2, wherein the second encryption (8) is applied to the instrument data (3) at the data processing module (2; 2a; 2b).

10. The method according to any one of claims 1 to 2, further comprising: Remove the first encryption in the management system to process the instrument data.

11. The method according to any one of claims 1-2, wherein the metadata (4) does not include billing data associated with the test results of the more than one analytical instrument (1a; 1b).

12. A system for processing data from more than one analytical instrument (1a; 1b) used for analyzing biological samples, the system comprising: The data processing module (2; 2a; 1b) is communicatively connected to more than one analytical instrument (1a; 1b). 2b) A remote server (9) and a management system (5) configured to perform the steps of the method according to any one of claims 1-11.

13. A method for processing data from a management system for analytical instruments, comprising: Input data is received at the management system (5) of the analytical instrument; Metadata (4) is generated based on the input data in the management system (5) of the analytical instrument; The input data is encrypted (7) at the management system (5); The generated metadata (4) is encrypted (8) at the management system (5); The application of the first encryption (7) includes using a first encryption key, and the application of the second encryption (8) includes using a second encryption key that is different from the first encryption key; The encrypted data is transmitted from the management system to a remote server (9), wherein the remote server and the management system are communicatively connected; Remove the second encryption (8) from the metadata at the remote server (9); The input data is transmitted to a data processing module (2; 2a; 2b), which is communicatively connected to more than one analytical instrument (1a; 1b) for analyzing biological samples. The first encryption (7) is removed from the input data at the data processing module (2; 2a; 2b); and The input data is forwarded from the data processing module to more than one analytical instrument (1a); 1b）, The generation of this metadata (4) includes removing patient-specific data and / or customer-specific data from the input data received from the management system (5) of the analyzer. The metadata (4) is used to provide maintenance and quality control services and analysis services for analytical instruments.

14. A system for processing data from a management system for analytical instruments, comprising: The management system (5) for the analytical instruments is configured to: Receive input data; Based on this input data, generate metadata (4); and Apply the first encryption (7) to the input data; Apply a second encryption to the generated metadata (8); The application of the first encryption (7) includes using a first encryption key, and the application of the second encryption (8) includes using a second encryption key different from the first encryption key; and The encrypted data is transmitted to a remote server (9); The remote server (9) is configured to be used for: Remove the second encryption from the metadata (4); and The input data is transmitted from the remote server to a data processing module (2; 2a; 2b) that is connected to more than one analytical instrument. and The data processing module (2; 2a; 2b) is communicatively connected to more than one analytical instrument (1a; 1b), and is configured to: Remove the first encryption (7) from the input data; and The input data is forwarded to more than one analytical instrument (1a; 1b). The generation of this metadata (4) includes removing patient-specific data and / or customer-specific data from the input data received from the management system (5). The metadata (4) is used to provide maintenance and quality control services and analysis services for analytical instruments.

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