Method for developing digital therapeutics through modular digital therapeutic framework and apparatus using said method

WO2025033583A1PCT designated stage expired Publication Date: 2025-02-13WELT CORP LTD
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Patent Information

Application Number
PCT/KR2023/012019
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-04
Filing Date
2023-08-14
Publication Date
2025-02-13

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Abstract

The present invention relates to a method for developing digital therapeutics through a modular digital therapeutic framework and an apparatus using the method. The method for developing digital therapeutics through a modular digital therapeutic framework may comprise the steps of: a digital therapeutics generation unit receiving digital therapeutics data; and the digital therapeutics generation unit generating digital therapeutics on the basis of the digital therapeutics data.
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Description

Methods for developing digital therapeutics using a modular digital therapeutics framework and devices using such methods

[0001] The present invention relates to a method for developing digital therapeutics using a modular digital therapeutics framework and a device using such a method. More specifically, the present invention relates to a method for developing digital therapeutics using a modular digital therapeutics framework for faster and easier development of digital therapeutics, and a device using such a method.

[0002] The development of various smart technologies has enabled the recording of data on individuals' daily activities, enabling them to manage their lives more efficiently. Among these, health-related data logging is gaining attention due to the growing interest in health. Many users are already generating and utilizing various health-related data, such as exercise, diet, and sleep, through their smartphones and wearable devices. This shift is a shift from the past, when health-related data was solely generated and managed by medical institutions, to users themselves, through their own devices like smartphones and wearables.

[0003] Health-related data logging is often accomplished through wearable devices. Wearable devices are devices worn or attached to the user's body. Thanks to advancements in technologies like the Internet of Things, wearable devices are increasingly being used to collect health-related data. Wearable devices can collect information about the user's physical changes and the environment surrounding them, and based on this data, they can provide necessary health advice.

[0004] A user's health-related data may include user biomarkers, and research is underway on methods to provide more adaptive medical prescriptions to users based on their health-related data.

[0005] Related technology includes Korean registered patent No. 10-2425479.

[0006] The purpose of the present invention is to solve all of the above-described problems.

[0007] In addition, the present invention aims to effectively create digital therapeutics by combining different modules through a modular digital therapeutic framework.

[0008] In addition, the present invention aims to provide a platform for easily creating new digital therapeutics by combining already developed digital therapeutic modules, therapeutic algorithms, and artificial intelligence models.

[0009] A representative configuration of the present invention to achieve the above purpose is as follows.

[0010] According to one embodiment of the present invention, a method for developing a digital therapeutic through a modular digital therapeutic framework may include a step in which a digital therapeutic generation unit receives digital therapeutic data, and a step in which the digital therapeutic generation unit generates a digital therapeutic based on the digital therapeutic data.

[0011] Meanwhile, the digital therapeutic data may include data related to a digital therapeutic module, a therapeutic algorithm, or an artificial intelligence model.

[0012] Additionally, the digital therapeutic may be created based on a combination of digital therapeutic modules, therapeutic algorithms, or artificial intelligence models.

[0013] According to another embodiment of the present invention, a digital therapeutics generation system for developing a digital therapeutics through a modular digital therapeutics framework may include a digital therapeutics generation unit configured to receive digital therapeutics data and generate a digital therapeutics based on the digital therapeutics data.

[0014] Meanwhile, the digital therapeutic data may include data related to a digital therapeutic module, a therapeutic algorithm, or an artificial intelligence model.

[0015] Additionally, the digital therapeutic may be created based on a combination of digital therapeutic modules, therapeutic algorithms, or artificial intelligence models.

[0016] According to the present invention, digital therapeutics can be effectively created by combining different modules through a modular digital therapeutic framework.

[0017] In addition, according to the present invention, a platform can be provided for easily creating a new digital therapeutic by combining already developed digital therapeutic modules, therapeutic algorithms, and artificial intelligence models.

[0018] Figure 1 is a conceptual diagram illustrating a digital therapeutic agent generation system according to an embodiment of the present invention.

[0019] Figure 2 is a conceptual diagram illustrating the operation of a digital therapeutic agent generation unit according to an embodiment of the present invention.

[0020] Figure 3 is a conceptual diagram illustrating the operation of a digital therapeutic agent generation unit according to an embodiment of the present invention.

[0021] Figure 4 is a conceptual diagram illustrating a method for developing a digital therapeutic agent according to an embodiment of the present invention.

[0022] FIG. 5 is a conceptual diagram illustrating a standardization method of a digital treatment component for connecting a digital treatment component according to an embodiment of the present invention.

[0023] Figure 6 is a conceptual diagram showing the connection relationship between digital treatment components according to an embodiment of the present invention.

[0024] The following detailed description of the present invention refers to the accompanying drawings, which illustrate specific embodiments in which the present invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present invention. It should be understood that the various embodiments of the present invention, while different from each other, are not necessarily mutually exclusive. For example, specific shapes, structures, and characteristics described herein may be modified and implemented from one embodiment to another without departing from the spirit and scope of the present invention. Furthermore, it should be understood that the positions or arrangements of individual components within each embodiment may also be modified without departing from the spirit and scope of the present invention. Accordingly, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is to be construed to encompass the scope of the claims and all equivalents thereof. Like reference numerals in the drawings represent the same or similar elements throughout the several aspects.

[0025] Hereinafter, various preferred embodiments of the present invention will be described in detail with reference to the attached drawings so that a person having ordinary skill in the art to which the present invention pertains can easily practice the present invention.

[0026]

[0027] Figure 1 is a conceptual diagram illustrating a digital therapeutic agent generation system according to an embodiment of the present invention.

[0028] In FIG. 1, a digital therapeutics creation system is disclosed to provide a digital therapeutics creation framework for creating digital therapeutics more quickly and easily.

[0029] Referring to FIG. 1, the digital therapeutic agent creation system may include a digital therapeutic agent module library (100), a digital therapeutic agent creation unit (120), and a digital therapeutic agent testing unit (140).

[0030] The digital treatment module library (100), digital treatment generation unit (120), and digital treatment test unit (140) may be individual hardware devices or integrated hardware devices.

[0031] A digital therapy module library (100) may be implemented to provide digital therapy modules that can be used in digital therapy. The digital therapy module may be a module usable in multiple different digital therapy applications. For example, the digital therapy module may be a module that can be utilized for digital therapy services in various digital therapy applications, such as a sleep time monitoring module, a dietary habit monitoring module, a heart rate monitoring module, etc.

[0032] The digital therapeutics generation unit (120) can be implemented to generate digital therapeutics based on digital therapeutic modules. Digital therapeutics can be generated not only from the digital therapeutics module library, but also through a combination of various other separately developed modules.

[0033] The digital therapeutic agent creation unit (120) may include a database (123) for creating a digital therapeutic agent, a digital therapeutic agent data provision unit (126), etc.

[0034] The database (123) may include disease-related data. For example, in the case of migraine, the database (123) may include patient data necessary for the creation of digital therapeutics, such as biometric data of migraine patients, treatment data for migraine patients, and other patient treatment data.

[0035] Additionally, the database (120) includes previous digital treatment history data accumulated through previous digital treatment procedures, and the previous digital treatment history data can be provided to the digital treatment generation unit.

[0036] The digital therapeutic data provider (126) can provide data on digital therapeutic modules, digital therapeutic algorithms, and AI engines for digital therapeutics, which constitute existing digital therapeutics, as digital therapeutic data. Digital therapeutic module data may include data on modules for disease management and / or analysis. For example, digital therapeutic module data may provide information on existing AI models used for disease diagnosis and management, and digital therapeutic modules used in digital therapeutics.

[0037] Development of new digital therapeutics can be performed through the database (123) provided by the digital therapeutics creation unit (120) and the digital therapeutics data provision unit (126).

[0038] The digital therapeutics testing unit (140) can be implemented to test the generated digital therapeutics. If a specific digital therapeutic application is developed, testing can be conducted on multiple users. The test results can include performance comparison data based on comparisons with existing digital therapeutic applications. For example, suppose there is an existing digital therapeutic application for insomnia and a new digital therapeutic application for insomnia treatment. In this case, the digital therapeutics testing unit (140) can test the therapeutic effects of the existing digital therapeutic application and the new digital therapeutic application, and deliver the test results to the developer of the new digital therapeutic application.

[0039]

[0040] Figure 2 is a conceptual diagram illustrating the operation of a digital therapeutic agent generation unit according to an embodiment of the present invention.

[0041] In Fig. 2, the operation of creating a digital therapeutic agent through the workspace of the digital therapeutic agent creation unit is initiated.

[0042] Referring to Figure 2, the digital therapeutics generation unit can develop new digital therapeutics and new digital therapeutic modules based on data stored in the database (210). For example, a user, as a developer, may be developing a digital therapeutic application for insomnia treatment.

[0043] To develop a digital treatment application for insomnia, existing insomnia patient data (symptom data, treatment data, etc.) may be provided in a database (210).

[0044] In addition, digital therapeutic data for existing insomnia treatment may be provided through the digital therapeutic data provider (230). For example, data on digital therapeutic modules (e.g., artificial intelligence modules, sleep time determination modules, etc.) and treatment algorithms (e.g., insomnia treatment algorithms, eating disorder treatment algorithms, migraine treatment algorithms), artificial intelligence models (insomnia treatment artificial intelligence models, eating disorder treatment artificial intelligence models, migraine treatment artificial intelligence models), etc. used in digital therapeutics used for existing insomnia treatment may be provided through the digital therapeutic data provider (230).

[0045] In addition, specific development information such as source code and learning data for individual modules (e.g., artificial intelligence module, sleep time determination module, etc.) may be provided through the digital treatment data provision unit (230).

[0046] Users can develop new digital therapeutics and new digital therapeutic modules based on previous digital therapeutic history data and digital therapeutic data through the workspace (220).

[0047] Additionally, according to an embodiment of the present invention, the digital therapeutics generator may provide previous digital therapeutic history data and digital therapeutic data for developing digital therapeutics based on keyword or tag information. For example, if a developer user wishes to develop a digital therapeutic for migraine, a search function using the keyword "migraine" may be provided, and search results for previous digital therapeutic history data and digital therapeutic data may be provided to the user.

[0048]

[0049] Figure 3 is a conceptual diagram illustrating the operation of a digital therapeutic agent generation unit according to an embodiment of the present invention.

[0050] In Figure 3, the process of creating a digital therapeutic is initiated through the workspace of the digital therapeutic creation unit. While only the digital therapeutic module library for the digital therapeutic module is disclosed in Figure 3, a therapeutic algorithm library, an artificial intelligence model library, a digital therapeutic data library, and other libraries may also be present.

[0051] Referring to FIG. 3, a digital treatment module can be selected through a digital treatment module library (300) included in the digital treatment module data provider. The digital treatment module library (300) can provide information on digital treatment modules used in digital treatment in a library format in association with digital treatment data.

[0052] Digital treatment modules can be selected from the digital treatment module library (300) and combined in the workspace. Furthermore, newly developed digital treatment modules can be combined with existing digital treatment modules in the user workspace, enabling the development of new digital therapeutics.

[0053] Additionally, existing digital therapeutics associated with the updated digital therapeutic module may be updated according to performance updates of the digital therapeutic module on the digital therapeutic module library (300).

[0054]

[0055] Figure 4 is a conceptual diagram illustrating a method for developing a digital therapeutic agent according to an embodiment of the present invention.

[0056] In FIG. 4, a method for developing a digital therapeutic by considering user input data is disclosed.

[0057] Referring to FIG. 4, a method for developing a digital therapeutic is disclosed, taking into account user-input data that can be input by the user. Hereinafter, for convenience of explanation, modules, artificial intelligence models, and algorithms for developing digital therapeutics, such as digital therapeutic modules, artificial intelligence models, and treatment algorithms, may be referred to as "digital therapeutic components."

[0058] Each digital treatment component can include input information and output information, and a connection relationship between the digital treatment components can be established through matching between the input information and output information.

[0059] A configuration can be performed for a digital therapeutic component that receives the earliest data based on input user input data. In the digital therapeutic component, required input information can be configured, and it can be determined whether the user input data includes required input information for the initial digital therapeutic component that receives the user input data.

[0060] The input data and output data may be set as extended input data (400) and extended output data (410) even if they are not of the same format, taking into account whether conversion between data is possible and whether they are replaceable.

[0061] In order to set extended input data (400) and extended output data (410), a judgment can be made on the possibility of conversion between input data and other input data and the possibility of conversion between input data and other input data.

[0062] The feasibility of data conversion (input / output data) can be determined by considering the accuracy of data conversion based on the relationships between the data. Data conversion accuracy can be determined by considering the relationships between the data, such as when the relationship between two sets of data is already established in a database based on a specific mathematical relationship or existing data. Data conversion accuracy can be determined by considering the error probability and error range during data conversion.

[0063] In this way, if the data transformation accuracy is above a threshold, it can be set as extended data for the input data.

[0064] First connection option (450): Can be set as a digital treatment component that can be connected only when input data and output data match.

[0065] Second connection option (460): Even if the input data and output data do not match, it can be set as a connectable digital treatment component through the setting of extended input data / extended output data.

[0066] Third connection option (470): The digital therapeutic component may be configured to be connected by a combination of a partial first connection option (partial first connection option) and a partial second connection option (partial second connection option).

[0067] Among the multiple digital therapeutic components that constitute the digital therapeutic, a core digital therapeutic component that is set to have a relatively high importance may be connected using a partial first connection option, and among the multiple digital therapeutic components that constitute the digital therapeutic, a non-core digital therapeutic component that is set to have a relatively low importance may be connected using a partial second connection option.

[0068] Additionally, according to embodiments of the present invention, the possibility of conversion between data (input data / output data) may be determined based on auxiliary data. For example, it may be assumed that conversion of first input data into second input data is required. Even when converting the first input data into the second input data by adding auxiliary data, if the data conversion accuracy exceeds a threshold, a digital treatment component may be recommended based on the possibility of securing the auxiliary data.

[0069]

[0070] FIG. 5 is a conceptual diagram illustrating a standardization method of a digital treatment component for connecting a digital treatment component according to an embodiment of the present invention.

[0071] In FIG. 5, a method for standardizing and defining digital treatment components for connection between digital treatment components is disclosed.

[0072] Referring to FIG. 5, the digital treatment component can define and set input data and output data by taking into account the characteristics of the digital treatment component.

[0073] The input data of the digital treatment component can be defined based on the definition of input data or input data groups that can be input into the digital treatment component, and information on the reliability of output data upon input according to the input data or input data group. Hereinafter, for convenience of explanation, a group including at least one input data input into the digital treatment component is defined as an input data group.

[0074] For example, a digital treatment component may be a digital treatment module, and various data groups capable of generating output data for the digital treatment module may be set. For example, input data groups may be set as input data group 1, input data group 2, and input data group 3, and the reliability of output data may be set for each of input data group 1, input data group 2, and input data group 3.

[0075] In addition, for the digital treatment component, the generation time of input data included in the input data group can be set. For example, for input data 1 to input data n included in the input data group, an input data validity cycle for each input data can be defined, which can form one input data group as multiple input data. The input data included within the input data validity cycle for each input data can form one input data group. The input data validity cycle can be defined to be relatively short as the change in input data becomes relatively rapid.

[0076] When using input data that is out of the validity cycle of the input data for each digital treatment component, an input data cycle-by-cycle reliability adjustment value can be set to adjust the reliability of the output data by considering the degree of deviation of the validity time cycle of the input data (e.g., 1 cycle deviation) (hereinafter, cycle-by-cycle validity score). The validity time cycle is defined differently for each input data, and the cycle-by-cycle validity score is set differently for each input data, so that the reliability of the output data can be adjusted.

[0077] In addition, the timing score of the input data may be determined based on how closely multiple input data are generated within the input data validity cycle, and a reliability adjustment value of the output data according to the timing score of the input data may be defined. The higher the simultaneity of the input data, the higher the timing score of the input data, and the higher the timing score of the input data, the higher the reliability of the output data may be set, so that the reliability of the output data may be adjusted. Timing-centric input data for determining the timing score may be determined, and the timing-centric input data may be input data that has the greatest influence on the reliability of the output data.

[0078] Additionally, an output data validity cycle may be defined for the output data of the digital treatment component. The output data validity cycle is defined based on the input data validity cycle, but the faster the change in the output data, the shorter the output data validity cycle may be defined.

[0079] There may be cases where the output data of a digital therapy component is used as input data of another digital therapy component, and such output data may be defined as input data (output). The input data validity cycle of the input data (output) used as input data may be determined based on the output data validity cycle. In this case, the input data validity cycle of the input data (output) input to another digital therapy component may be adjusted based on the input data validity cycle of other input data input to another digital therapy component.

[0080] If the average of other input data valid cycles is relatively shorter than the input data valid cycle of the input data (output), the input data valid cycle of the input data (output) can be adjusted to be relatively shorter based on the average of other input data valid cycles. Conversely, if the average of other input data valid cycles is relatively longer than the input data valid cycle of the input data (output), the input data valid cycle of the input data (output) can be adjusted to be relatively longer based on the average of other input data valid cycles. In this way, the impact on the reliability of the output data can be minimized by adjusting the time difference between input data.

[0081] As described above, extended input data and extended output data for the digital therapeutic component can be defined, and these extended input data and extended output data can change according to changes in the relationships between the data. Additionally, auxiliary data other than the input data can be defined, and settings for changes in reliability when additional auxiliary data is input can also be defined.

[0082]

[0083] Figure 6 is a conceptual diagram showing the connection relationship between digital treatment components according to an embodiment of the present invention.

[0084] In FIG. 6, a connection algorithm for connecting digital therapeutic components to implement a digital therapeutic is disclosed.

[0085] Referring to FIG. 6, a user creating a digital therapeutic on the workspace for connection between digital therapeutic components can select possible input data and enter information about desired output data.

[0086] In such cases, a target digital therapeutic component that can be connected based on input data and output data can be recommended.

[0087] For the recommendation of the target digital treatment component, the digital treatment component can be defined by layers. The layers can be composed of an input layer (610), a middle layer (620) (the first middle layer to the nth middle layer), and an output layer (630). The input layer (610) is a layer that receives input data, the middle layer (620) is a layer used to connect the input data and output data (or the input layer and the output layer), and the output layer (630) can be a layer that outputs output data.

[0088] In the present invention, the target digital treatment component can be recommended based on different configurations, such as a maximum reliability configuration (650), a minimum path configuration (660), and a minimum cost configuration (670).

[0089] The maximum reliability configuration (650) may be based on connections between target digital therapeutic components whose output data can have the highest reliability. Combinations of digital therapeutic components that maximize the reliability of output data based on various combinations of digital therapeutic components may be included in the maximum reliability configuration.

[0090] The minimum path configuration (660) may be a configuration using the fewest number of target digital therapeutic components.

[0091] The minimum cost configuration (670) may be a configuration for outputting output data at the lowest cost. The cost may be calculated based on various costs, such as the cost of using the digital treatment component (e.g., license fee), the cost of using computing resources used to use the digital treatment component, etc.

[0092] The present invention recommends the configuration of various digital therapeutic components, and allows a user to selectively select a digital therapeutic component to generate a digital therapeutic.

[0093] In addition, in the embodiment of the present invention, through selection of optional extended input data and extended output data, an extended extended maximum reliability configuration, an extended minimum path configuration, and an extended minimum cost configuration for a maximum reliability configuration (650), a minimum path configuration (660), and a minimum cost configuration (670) may be newly defined, and a target digital treatment configuration part may be newly set accordingly.

[0094] Or more specifically, the user may additionally input information about the validity cycle of possible input data, the possibility of inputting additional auxiliary data, and the reliability of the input data, based on which recommendations for target digital therapeutic components may be made.

[0095]

[0096] The embodiments of the present invention described above may be implemented in the form of program commands that can be executed through various computer components and recorded on a computer-readable recording medium. The computer-readable recording medium may include program commands, data files, data structures, etc., either singly or in combination. The program commands recorded on the computer-readable recording medium may be specially designed and configured for the present invention or may be known and available to those skilled in the art of computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes, optical recording media such as CD-ROMs and DVDs, magneto-optical media such as floptical disks, and hardware devices specifically configured to store and execute program commands, such as ROMs, RAMs, and flash memories. Examples of program commands include not only machine language codes generated by a compiler, but also high-level language codes that can be executed by a computer using an interpreter, etc. Hardware devices may be changed into one or more software modules to perform processing according to the present invention, and vice versa.

[0097] Although the present invention has been described above with specific details such as specific components and limited examples and drawings, these are provided only to help a more general understanding of the present invention, and the present invention is not limited to the above examples, and those with ordinary knowledge in the technical field to which the present invention pertains can make various modifications and changes based on this description.

[0098] Therefore, the idea of ​​the present invention should not be limited to the embodiments described above, and not only the scope of the patent claims described below but also all scopes equivalent to or equivalently modified from the scope of the patent claims are considered to fall within the scope of the idea of ​​the present invention.

Claims

1. How to develop digital therapeutics through a modular digital therapeutic framework: A step in which the digital therapeutics generation unit receives digital therapeutics data; and A method characterized in that the digital therapeutic agent generation unit comprises a step of generating a digital therapeutic agent based on the digital therapeutic agent data.

2. In paragraph 1, A method characterized in that the above digital therapeutic data includes data related to a digital therapeutic module, a therapeutic algorithm, or an artificial intelligence model.

3. In paragraph 2, A method characterized in that the above digital therapeutic agent is generated based on a combination of a digital therapeutic module, a therapeutic algorithm, or an artificial intelligence model.

4. A digital therapeutics creation system for developing digital therapeutics through a modular digital therapeutics framework. A digital therapeutic agent generation system, characterized by including a digital therapeutic agent generation unit configured to receive digital therapeutic agent data and generate a digital therapeutic agent based on the digital therapeutic agent data.

5. In paragraph 4, A digital therapeutics generation system characterized in that the above digital therapeutics data includes data related to a digital therapeutics module, a therapeutic algorithm, or an artificial intelligence model.

6. In paragraph 5, A digital therapeutic agent generation system characterized in that the above digital therapeutic agent is generated based on a combination of a digital therapeutic agent module, a therapeutic algorithm, or an artificial intelligence model.

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