Computer implemented method of configuring a data transfer application on a patient's mobile device

Abstract

According to a first aspect of the present invention, a computer implemented method of configuring a consent application on a patient's mobile device is presented. The method comprises the steps of providing the patient's mobile device with the consent application (step S1), wherein the consent application is capable of sending to a computing device a consent of said patient for a usage of health data of said patient in a research study. Further, the method comprises the step of providing a code to the consent application, which code is specific for at least one individual research study (step S2). The code is processable by the patient's mobile device and / or the consent application. Upon processing the provided code by the consent application, the consent application is automatically pre-configured such that a consent subsequently generated with said pre-configured consent application complies with consent criteria of said at least one individual research study (step S3). The invention also relates to a network (200) for configuring a consent application on a patient's mobile device.

Description

[0001] COMPUTER IMPLEMENTED METHOD OF CONFIGURING A DATA TRANSFER APPLICATION ON A PATIENT’S MOBILE DEVICE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a computer implemented method of configuring a consent application on a patient’s mobile device, a computer program, non-transitory program storage medium storing such a program, and to a network comprising the patient’s mobile device with the consent application and a computing device.

[0004] TECHNICAL BACKGROUND

[0005] Every day, the amount of health data in patient care and clinical research grows exponentially. Patients are also generating more data every day through health and wellness apps that feed into their medical care. This data has great potential: by integrating and analysing it in research studies, medical care and products can be improved and lives can be saved. Digital health applications, telemedicine, wearables and innovative technologies such as Al and loT can only realise their full potential with comprehensive and structured health data, which, however, need to be accessible for researchers conducting research studies.

[0006] Nowadays the collection of health data of patients for use in a research study disadvantageously involves a lot of time intensive communication and data transmission. Moreover, this time intensive communication and data transmission takes place between several parties, e.g., the involved researcher or research institution, the hospitals, in which the health data of patients are stored in data storages or repositories, that are typically embedded in mixed digital and analog hospital information systems (his), and the patients themselves. The patients typically provide health data to the hospitals and fill out paper-based forms, which they have to physically sign with their handwritten signature for giving their consent to the use of their health data in research studies. Not only are these approaches time-intensive, involve huge data transmissions, but they are also error prone. Moreover, since the health data of patients used by researchers for their studies are often collected by the hospitals, the compliance of the collected data with the data requirements or data criteria defined by the underlying research study is often less than optimal. In other words, the reliability of the health data often provided by hospitals could be improved. Furthermore, the current process of collecting the consent from the patient for a particular and individual use of his / her data is technically cumbersome, and no fast and reliable solution exists to collect such consents from the patient. Particularly, no technical solution exists when the need arises to amend, supplement or exchange the consent requirements or consent criteria set by a research study and to which a patient had already agreed or consented in the past. The time-consuming and data-consuming paper-based process via the hospitals nowadays has to begin from the beginning.

[0007] The inventors of the present invention have identified these drawbacks of the current situation of health data generation and of the current collection of consents from patients. In particular, the inventors have identified the need for a technical solution, which allows for a reliable and adaptable consent collection, and which allows for the generation and collection of health data in a timeliness and reliable manner. The present invention addresses these technical drawbacks, as will be explained in detail hereinafter.

[0008] Aspects of the present invention, examples and exemplary steps and their embodiments are disclosed in the following. Different exemplary features of the invention can be combined in accordance with the invention wherever technically expedient and feasible.

[0009] GENERAL DESCRIPTION OF THE INVENTION

[0010] In this section, a description of the general features of the present invention is given for example by referring to possible embodiments of the invention.

[0011] The described embodiments similarly pertain to the computer implemented method of configuring a consent application on a patient’s mobile device, the computer program, the non-transitory program storage medium, and to the network. Synergetic effects may arise from different combinations of the embodiments although they might not be described in detail.

[0012] Further, it shall be noted that all embodiments of the present invention concerning a method, might be carried out in the order of the steps as described, nevertheless this has not to be the only and essential order of the steps of the method. The herein presented methods can be carried out in another order of the disclosed steps without departing from the respective method embodiment, unless explicitly mentioned to the contrary hereinafter.

[0013] According to a first aspect of the present invention, a computer implemented method of configuring a consent application on a patient’s mobile device is presented. The method comprises the steps of providing the patient’s mobile device with the consent application (step S1 ), wherein the consent application is capable of sending to a computing device a consent of said patient for a usage of health data of said patient in a research study. Further, the method comprises the step of providing a code to the consent application, which code is specific for at least one individual research study (step S2). The code is processable by the patient’s mobile device and / or the consent application. Upon processing the provided code by the consent application, the consent application is automatically pre-configured such that a consent subsequently generated with said pre-configured consent application complies with consent criteria of said at least one individual research study (step S3).

[0014] In an exemplary study, researchers could compare patient cohorts that underwent knee replacement surgery, where one group received an implant during a robot- assisted surgery and others with a non-robot-assisted surgery. They were invited by the researchers to take part in an outcome-study and reported regularly e.g., on their walking or movements patterns, pain. The study is focussed on short-term recovery and the input has to happen in this time frame. The presented method allows a less error prone consent and data collection and allow to reliable transmit consent data and measurement data from a patient’s mobile device to the computing device used by the researcher running the study. This will be explained in more detail hereinafter. The mobile device used in the present invention may be embodied as for example a smartphone, a tablet, a pager, or any other kind of electronics mobile device on which the consent application can be installed and used by the user in order to generate his / her consent / consent data and in order to transmit the so generated consent, via the mobile device, to the computing device. In the context of the present invention said computing device shall be understood as a device that is capable of receiving the consent. Preferably, this computing device can be used by a researcher for communicating with and / or exchanging data with the mobile device of the patient, as will be detailed hereinafter.

[0015] The consent generated by the patient / user with the consent application and sent or transmitted to the computing device of the researcher shall be understood as consent data, in particular as consent data with which the patient agrees to all the consent criteria of said at least one individual research study regarding the use of his / her data in said study. Thus, presented method may also be seen as computer implemented method of configuring a data transfer application on a patient’s mobile device. And in general, the consent application may be seen as data transfer application on a patient’s mobile device. The consent generated by the patient / user with the consent application may be generated such that it has a particular data format, particularly a data format as required by and / or defined in the consent criteria of said at least one individual research study.

[0016] The consent criteria / consent items of an individual research study may define for example that in the study patient’s health data of type A will be analysed for a correlation with patient’s health data of type B in the context of a particular disease X, and / or that in the study particular parts of the patient’s health data A and B will be published with the study results, and / or that a particular party / research institution will get data access to the patient’s health data of type A and B. As is clear to the skilled reader, many other data criteria can be defined in this way, as will be explained in more detail hereinafter in the context of particular embodiments.

[0017] Therefore, upon processing said code by the consent application, the consent application is pre-configured in the way that the consent generated with the application comprises data that can be sent via the mobile device to the computing device and with which consent / consent data the user agrees that his / her health data are used in the specified way as set out and defined by the consent criteria.

[0018] As is clear to the skilled reader, the code, which is provided in the presented method to the consent application and which is specific for one or more individual research studies, allows for the digital pre-configuration of the consent application with respect to the desired settings of the consent application, such that the consent / consent data generated with the consent application will match the consent criteria required by this individual research study. In this way, a study compliant data generation can be ensured, as will be explained in detail hereinafter. In a non-limiting example, the code is a QR code which can be scanned by the camera of the mobile device causing for example a download of a configuration data / configuration file from the internet or a server or a data storage to the mobile device and causing to process said downloaded configuration data by the consent application thereby configuring settings of the consent application such that any subsequently generated consent / consent data matches the consent criteria of said individual study. This match of consent criteria is ensured by the use of said configuration data accessed upon and due to processing the provided code. This pre-configuration of the consent application achieved via reading the study specific code thereby triggering the pre-configuration has many technical advantages in collecting consent data from the patient and overcomes technical drawbacks of the prior art, as will be detailed hereinafter.

[0019] In particular, due to the provision of a consent application in combination with the study specific code causing the pre-configuration of the consent application, less or ideally no user input is needed from the patient’s side with respect to setting the parameters of the consent he / she wants to give. The digital pre-configuration of the application allows the patient via a user input in the consent app and / or on a user interface of the mobile device to simply agree to the criteria and requirements of the research study and generate a corresponding consent signal or consent message which will be sent by the consent app and the mobile device to the computing device. This solution is also less error prone as compared to the prior approaches, because due to the preconfiguration of the consent application, input errors of the patient / user are avoided. The configuration data / file for pre-configuring the consent app is installed on the mobile device in the consent application according to the instructions and / or settings carried out when the provided code is processed. The code, e.g., a QR code directing the mobile device with the consent application to a download from a website, causes upon being processed this pre-installation of the consent settings in the consent application. However, as is clear to the skilled reader, this pre-configuration of the consent application can also be achieved without downloading and storing such a configuration data / file. Indeed, according to another embodiment of the present invention, this pre-configuration is carried out purely online, i.e., the configuration of the consent settings in the consent application are carried out according to instructions received by the mobile device via e.g., the internet after having processed the code to be directed to a particular website. Of course, other embodiments of carrying out this pre-configuration of the consent application are covered by the present invention.

[0020] Positively, no data transmission and / or communication between the hospital and patient is needed, since with the consent application a direct communication channel between the computing device of the researcher and the mobile device of the patient is provided. Thus, a direct data transmission and / or communication channel is achieved between the computing device of the researcher and the device, on which the health data of the patient can be generated, i.e., the patient’s mobile device. This technical solution facilitates a timeliness and very fast transmission of the consent data from the patient’s mobile device to the computing device of the researcher. As no other third party is involved in generating and collecting this consent / consent data, the reliability of the consent / consent data is increased and errors due to third party involvement are reduced. Further, less communication and data transmission are needed. Moreover, no handwritten signature of the hitherto paper-based consent collection is needed. Further, due to the application-based solution provided by the present invent, i.e., the software or program-based solution, amendments, supplements and / or exchanges of the consent requirements or consent criteria triggered by the computing device of the researcher can be easily implemented by the patient on the mobile device, if agreed to. For example, via a push functionality, the consent application on the mobile device may receive data I a message from the computing device that an adaptation of the consent application is required, because e.g., the research study has to be changed due to new possible ways of analyzing the patient’s health data. In this way, for example, an automatic update of the preconfiguration of the consent application can be carried out. Amendments, supplements and / or exchanges of the consent requirements or consent criteria are easily implementable on the patient’s side. Even further, due to the fact that the patient has the mobile device and hence the consent application generally with him / her, he / she is always capable of changing or updating his / her consents that were generated earlier, if he / she wishes to do so. In a non-limiting example, the present invention allows for sending a changed consent from the consent application to the computing device via a communication channel requesting to delete all health data of the patient on the computing device, and / or on other data storage devices used for the study, in the context of the research study. With the present invention, this can be done within a short amount of time and without any necessary processing in hospital information systems, for example. These advantages of the present invention will be explained in more detail hereinafter in the context of particular embodiments.

[0021] The present invention thus relates to the concept that the configuration of the consent application, i.e. , the consent program / software, can be configured specifically for an individual research study based on processing a provided code, like e.g., a QR code, that is provided to the mobile device and / or to the consent app. The computing device mentioned before is the device, like e.g., a computer, a tablet, or a mobile phone etc., of the researcher used to communicate with the mobile device. As is clear to the skilled reader such communication and / or data exchange between the patient’s mobile device with the consent application and the computing device used by the researcher can be an end-to-end communication, but could also happen in a cloud system.

[0022] As has become apparent from the foregoing explanation, the present invention covers the mobile application on the mobile device of the patient. Physicians would encourage patients to use this consent application so they can become part of a clinical study. The patient would download the app and go through the consent. The consent would need to cover the researcher’s use case, so by entering for example the physicians ID or scanning a QR-code the patient would set his consent parameters to include this study. So, physicians can process the digital data access concept upfront through some committee, or even without committee for some use cases, and link a few of their colleagues from other institutions to it. They would all encourage their patients to join and enter for example their information blocking rule access IDs to it. The patients would be able to sync to an upload portal with e.g., a QR code or similar to upload their images and other data. The app could also include the AppleHealth and / or GoogleFit data as well as PROMs, i.e. , Patient Reported Outcome Measures in a de-identified way. Hospitals in the US wouldn’t need to consent, and in fact would be barred by law to object.

[0023] The method presented herein can be carried out, for example, by the network of the present invention, which comprises the patient’s mobile device and the computing device.

[0024] Moreover, as is clear to the skilled reader, according to the present disclosure, the mobile device may be configured to display the consent application on an application user interface, the application user interface providing instructions guiding the patient through the process of generating a consent / consent data and / or generating or inputting his / her health data. Further, the application user interface may comprise at least a graphical user interface. Guiding the patient through the generation of a consent / consent data and / or generating or inputting his / her health data may comprise that the mobile device, particularly the user interface, outputs instructions, e.g., audio, visual and / or haptic cues, instructing the patient on how to input7generate data. The mobile device, in particular the application user interface, may also be configured to receive user input data, in particular, so as to allow for the patient to interact with the application. For example, a patient may input patient-specific health data and / or exercise-specific health data via the user interface and / or interact with the user interface so as to select e.g., an exercise and / or interact with the user interface so as to access and view feedback or success for one or more current or previous exercises and / or training progress. According to the present disclosure, the consent application may be configured to prompt the mobile device to store data indicative of the success of the generation of health data, e.g. the success of an exercise and / or to prompt the mobile device to access and optionally to visualize stored data indicative of the success of the exercise, in particular wherein the data indicative of the success may be used for tracking success over time and / or may be included in the input data. Thus, the consent application may be configured to talk to hardware, or configured to communicating with other devices or systems. According to the present disclosure, the input data may comprise user input data obtained via a user interface of the mobile device, in particular user input data reporting completion of health data generation, like e.g., completion of an exercise. As an example, user input data may be obtained via the user interface when a user interacts with a user interface element, for example a button that is part of the user interface. A user may confirm, via the user interface, that they completed the consent data generation / health data generation, like e.g., a current breathing exercise and / or one or more previous breathing exercises.

[0025] According to another embodiment, the code provided in step S2 is embodied as a QR- code, as a weblink, as researcher ID, or as a physician ID.

[0026] Different ways of embodying the code are presented. In one example, the code is a QR code which can be scanned by the camera of the mobile device causing the preconfiguration of the consent application. For example, a download may be triggered upon scanning the QR code such that configuration data / file is stored and processed on the mobile. In this way, the settings of the consent application are set according to the consent criteria defined for the research study such that any subsequently generated consent / consent data matches with the consent criteria of said research study. Alternatively, or in addition, a weblink, a researcher ID, or a physician ID may be used as said code in order to trigger the desired configuration of the consent application with respect to the software settings defining how a consent / consent data generated in the future will look like.

[0027] According to another embodiment, the method comprises the step of automatically preconfiguring the consent application, upon processing the code, with respect to data generation of health data of the patient with said patient’s mobile device.

[0028] In this embodiment, the aspect of data generation on the mobile device and data transmission from the mobile device to the computing device are introduced into the presented method. In this embodiment, the code used in the context of the present invention also defines what kind of data shall subsequently be generated when using the consent application after the data pre-configuration was carried out. In this way, a study compliant data generation can be ensured, as will become apparent from the present disclosure. According to another embodiment, the data pre-configuration of the consent application is carried out such that data generated with the consent application and / or with the patient’s mobile device complies with data criteria of said at least one individual research study.

[0029] This embodiment details that with such data pre-configuration of the consent application, the data, which is generated by the user using his mobile device and which shall be used in the research study, will comply with the data requirements, which the research study has with respect to the data to be used. Thus, a study compliant data generation with the mobile device by the patient can be ensured.

[0030] According to another embodiment, the data pre-configuration of the consent application at least defines what kind of data have to be generated by the user with the mobile device, and / or at which point in time and / or at which repetition the data have to be generated, and / or how the data have to be generated.

[0031] This embodiment defines when, how and what kind of data shall be generated when the patient, i.e., the user, follows the instructions of the consent application running on the mobile device. As will be detailed hereinafter, the consent application may guide and instruct the patient for the task of generating data that is required for the research study.

[0032] As non-limiting examples, the following ways of generating data by the patient on his mobile device to be used in the study and to be sent from the mobile device to the computing device are mentioned: providing patient provided outcome measures; filling out a form; carrying out exercise like e.g., walking a number of steps or reach a certain training level; playing a game on the mobile device for creating health data like e.g., breathing / relaxation exercise that monitors reaction time, cognitive ability, eyesight, memory, and / or speech markers; starting an interactive engagement using at least one of the mobile device, one or more gyro sensors of the mobile device, one or more wearables, one or more bluetooth-connects, one or more bluetooth spirometry devices; using home-based, mobile sensor devices for determining e.g., location and / or limb movement, and acquiring photographs and / or videos, e.g., of particular body parts. According to another embodiment, the method further comprises the step of generating health data by the mobile device according to the data pre-configuration of the consent application.

[0033] According to another embodiment, the data generated with the patient’s mobile device according to the data pre-configuration of the consent application are measurement data and / or data received by the consent application or by the mobile device via a user input.

[0034] The data generated by the mobile device or received by the mobile device are embodied as either measurement data and / or data received by the consent application or by the mobile device via a user input. Measurement data may e.g., heartbeat data or bloods gas measurement data measured with a smart watch and sent to the mobile device. Alternatively, or in addition, the data generated with the patient’s mobile device are generated by the user inputting the health data required by the consent application at this point in time.

[0035] According to another embodiment, the method further comprises the step of transmitting health data of the patient generated with the mobile device via a communication channel to the computing device.

[0036] The mobile device may send the data to the computing device via a telecommunication network like 3G, 4G, 5G, LTE, or via WIFI, or via LAN, or via Bluetooth or the like.

[0037] According to another embodiment, the method comprises requesting study specific configuration data by the patient’s mobile device from the computing device upon processing said code, and receiving said study specific configuration data by the mobile device from the computing device.

[0038] In this embodiment, it is emphasized that the configuration data, which is study specific, is requested from the computing device upon processing said code, and is also received by the mobile device. The computing device thus sends this study specific configuration data to the mobile device. According to another embodiment, the study specific configuration data when processed by the consent application cause the consent application to define steps of interaction of the patient with the consent application for user input into the consent application to contribute to the research study.

[0039] In this embodiment the configuration data define the steps of interaction of the patient with the consent application to follow the protocol of data generation such that the patient’s input is according to the requirements of the study. Only in this way, it is ensured that the data generated by the interaction of the patient with the consent application, i.e., the interaction via a user interface of the mobile device, can successfully be used in the research study and hence contribute to the research study. In this way, a study compliant data generation can be ensured.

[0040] According to another embodiment, the steps defined by the consent application upon processing the study specific configuration data are selected from the group comprising: providing patient provided outcome measures, filling out a form by the user on the mobile device, carrying out exercise like e.g., walking a number of steps or reach a certain training level, playing a game on the mobile device for creating health data like e.g., breathing / relaxation exercise that monitors reaction time, cognitive ability, eyesight, memory, and / or speech markers, starting an interactive engagement using at least one of the mobile device, one or more gyro sensors of the mobile device, one or more wearables, one or more bluetooth-connects, one or more bluetooth spirometry devices, using home-based, mobile sensor devices for determining e.g., location and / or limb movement, and acquiring photographs and / or videos, e.g., of particular body parts.

[0041] This embodiment gives examples of how the patient can generate compliant data that can successfully contribute to the study. As is clear to the skilled reader, the health data generated on behalf of the consent application may make use of other applications and / or functionalities of the mobile device, like for example the camera and the respective app, GPS sensors, acceleration sensors, and the microphone, just to mention some non-limiting examples.

[0042] According to another embodiment, the study specific configuration data define a setup of the mobile device to be carried out by the patient in order to prepare the mobile device for use of the consent application.

[0043] This general set up of the consent application may take place before the user / patient may start using the app for taking part or enrolling in a particular research study. It prepares the consent app in its digital settings such that e.g., the needed access to other applications on the mobile device by the consent application is provided. Another such general setting for the consent application achieved therewith is setting for example allowance for push notifications for the consent application. This will elucidated even further with the next embodiment.

[0044] According to another embodiment, the setup of the mobile device defined in the study specific configuration data comprises at least one of: providing access to third party apps, including specific Healthkit access, setting allowance for push notifications for the consent application, setting conditions for establishing a connection to one or more healthcare systems, preferably using information blocking rule access IDs, executing of dynamic consent, and information input of patient biographies.

[0045] According to another embodiment, the method comprises the step generating the study specific configuration data based on a provided description of the research study, wherein the generation of the study specific configuration data is preferably carried out automatically, i.e., computer-implemented.

[0046] The description of the research study is provided, i.e., it is used as an input for the method presented herein. For example, a researcher may define his / her study and compose the description. In an improved version thereof, structured input is used, for example ..dynamic template" to structure the input provided by e.g. the researcher. Possibly an ethics board reviews this description. Moreover, the researcher may also generate a related consent form, i.e. , a data set of consent items that a patient would have to agree to. This may happen in a cloud system. As indicated before, this description of the study is used as an input for the computer implemented method of the present invention and the study specific configuration data is generated, preferably in an automated way, based on this description. With this automatic generation of the study specific configuration data, the pre-definition of necessary steps to be done later on by each patient / user to make the consent application work properly is achieved. This generic generation of the specific configuration data / file can then be carried out locally on the particular / individual patient’s mobile device.

[0047] According to another embodiment, the provided research study comprises a consent form, and wherein the consent form is a data set of consent items that a patient has to agree to in order to take part in the research study and so defines the consent criteria.

[0048] According to another embodiment, wherein a consent / consent data generated by the pre-configured consent application complies with the consent criteria defined in the consent form.

[0049] According to another embodiment, the method comprises the steps generating a consent with the pre-configured consent application, and storing the consent generated with the pre-configured consent application, preferably in form of a versioned document.

[0050] According to another embodiment the method comprises sending a digital patient invitation from the computing device to the patient’s mobile device via a link, a QR code, an SMS, and / or an ID Number.

[0051] According to another embodiment the method comprises the steps downloading the consent application onto the patient’s mobile device and starting enrolment into the study by the patient by using the consent application.

[0052] According to another embodiment, the method comprises regularly checking if a consent of patient generated with the consent application aligns with provided access in the consent application, and optionally remind the patient. Such reminding of the patient may preferably be carried out via one or more promptings, visual and / or acoustic signals, issued by the mobile device and caused by the consent application.

[0053] According to another embodiment, the method comprises the step of sending data from the patient’s mobile device via the consent application to the computing device, which data enable access to information in a hospital storage system by his / her patient access.

[0054] Part of contributing to the study may be that the use shares some of his / her already existing health data that are stored in a hospital storage system. With the present embodiment, the consent application allows sending access information to get access to said health data of the patient via the mobile phone to the computing device.

[0055] According to another embodiment, the method comprises the step carrying out a consent update by the consent application, wherein the consent update comprises at least one of: sending a changed consent from the consent application to the computing device via a communication channel after the consent application received an input from the patient changing his / her consent settings in the consent application, for example withdrawing the consent, receiving, by the mobile device, a request from the computing device for updating the consent criteria of said at least one individual research study and accordingly change the pre-configuration of the consent application, and sending a changed consent from the consent application to the computing device via a communication channel requesting to delete all health data of the patient in the context of the research study.

[0056] Due to the application-based solution provided by the present invent, i.e. , the software or program-based solution, amendments, supplements and / or exchanges of the consent requirements or consent criteria triggered by the computing device of the researcher and also consent changes of the patient can be easily implemented by the patient on the mobile device, if agreed to. For example, via a push functionality, the consent application on the mobile device may receive data I a message from the computing device that an adaptation of the consent application is required, because e.g., the research study has to be changed due to new possible ways of analyzing the patient’s health data. In this way, for example, an automatic update of the preconfiguration of the consent application can be carried out. Amendments, supplements and / or exchanges of the consent requirements or consent criteria are easily implementable on the patient’s side. Even further, due to the fact that the patient has the mobile device and hence the consent application generally with him / her, he / she is always capable of changing or updating his / her consents that were generated earlier, if he / she wishes to do so.

[0057] According to second aspect of the present invention a program, preferably in form of a consent application, is presented which, when running on a patient’s mobile device or when loaded onto a patient’s mobile device, causes the patient’s mobile device to perform the following steps processing a provided code, which code is specific for at least one individual research study, and upon processing the provided code by the consent application, automatically pre-configuring the consent application such that a consent subsequently generated with said pre-configured consent application complies with consent criteria of said at least one individual research study, and sending the consent generated with the pre-configured consent application to a computing device for a usage of health data of said patient in said research study.

[0058] The computer program element may be part of a computer program, but it can also be an entire program by itself. For example, the computer program element may be used to update an already existing computer program to get to the present invention. In the second aspect, the invention is directed to a computer program which, when running on at least one processor (for example, a processor) of at least one computer (for example, a computer) or when loaded into at least one memory (for example, a memory) of at least one computer (for example, a computer), causes the at least one computer to perform the above-described method according to the first aspect. The invention may alternatively or additionally relate to a (physical, for example electrical, for example technically generated) signal wave, for example a digital signal wave, carrying information which represents the program, for example the aforementioned program, which for example comprises code means which are adapted to perform any or all of the steps of the method according to the first aspect. A computer program stored on a disc is a data file, and when the file is read out and transmitted it becomes a data stream for example in the form of a (physical, for example electrical, for example technically generated) signal. For example, the signal is constituted to be transmitted via a computer network, for example LAN, WLAN, WAN, for example the internet. The invention according to the second aspect therefore may alternatively or additionally relate to a data stream representative of the aforementioned program.

[0059] According to third aspect of the present invention a program storage medium is presented on which such a program is stored.

[0060] The computer readable medium may be seen as a storage medium, such as for example, a USB stick, a CD, a DVD, a data storage device, a hard disk, or any other medium on which a program element as described above can be stored. In the third aspect, the invention is directed to a non-transitory computer-readable program storage medium on which the program according to the second aspect is stored.

[0061] According to fourth aspect of the present invention, a network for configuring a consent application on a patient’s mobile device is presented. The network comprises the patient’s mobile device with the consent application and a computing device. The consent application is capable and configured for sending to the computing device a consent of said patient for a usage of health data of said patient in a research study; wherein the computing device is configured to provide a code to the consent application, which code is specific for at least one individual research study. The patient’s mobile device and / or the consent application is / are configured to process said provided code, and the patient’s mobile device and / or the consent application is / are configured to automatically pre-configure the consent application upon processing the provided code such that a consent subsequently generated with said pre-configured consent application complies with consent criteria of said at least one individual research study. In a particualr embodiment, the patient’s mobile device and the computing device can exchange data via a network connection for configuring the consent application. The mobile device and the computing device may send and receive the respective data via a telecommunication network like 3G, 4G, 5G, LTE, or via WIFI, or via LAN, or via Bluetooth or the like.

[0062] In a particular embodiment the network is configured to carry out the method steps of the method of the present invention disclosed herein.

[0063] DEFINITIONS

[0064] In this section, definitions for specific terminology used in this disclosure are offered which also form part of the present disclosure.

[0065] Computer implemented method

[0066] The method in accordance with the invention is for example a computer implemented method. For example, all the steps or merely some of the steps (i.e. less than the total number of steps) of the method in accordance with the invention can be executed by a computer (for example, at least one computer). An embodiment of the computer implemented method is a use of the computer for performing a data processing method. An embodiment of the computer implemented method is a method concerning the operation of the computer such that the computer is operated to perform one, more or all steps of the method.

[0067] The computer for example comprises at least one processor and for example at least one memory in order to (technically) process the data, for example electronically and / or optically. The processor being for example made of a substance or composition which is a semiconductor, for example at least partly n- and / or p-doped semiconductor, for example at least one of II-, III-, IV-, V-, Vl-sem iconductor material, for example (doped) silicon and / or gallium arsenide. The calculating or determining steps described are for example performed by a computer. Determining steps or calculating steps are for example steps of determining data within the framework of the technical method, for example within the framework of a program. A computer is for example any kind of data processing device, for example electronic data processing device. A computer can be a device which is generally thought of as such, for example desktop PCs, notebooks, netbooks, etc., but can also be any programmable apparatus, such as for example a mobile phone or an embedded processor. A computer can for example comprise a system (network) of "sub-computers", wherein each sub-computer represents a computer in its own right. The term "computer" includes a cloud computer, for example a cloud server. The term "cloud computer" includes a cloud computer system which for example comprises a system of at least one cloud computer and for example a plurality of operatively interconnected cloud computers such as a server farm. Such a cloud computer is preferably connected to a wide area network such as the world wide web (WWW) and located in a so-called cloud of computers which are all connected to the world wide web. Such an infrastructure is used for "cloud computing", which describes computation, software, data access and storage services which do not require the end user to know the physical location and / or configuration of the computer delivering a specific service. For example, the term "cloud" is used in this respect as a metaphor for the Internet (world wide web). For example, the cloud provides computing infrastructure as a service (laaS). The cloud computer can function as a virtual host for an operating system and / or data processing application which is used to execute the method of the invention. The cloud computer is for example an elastic compute cloud (EC2) as provided by Amazon Web Services™. A computer for example comprises interfaces in order to receive or output data and / or perform an analogue-to-digital conversion. The data are for example data which represent physical properties and / or which are generated from technical signals. The technical signals are for example generated by means of (technical) detection devices (such as for example devices for detecting marker devices) and / or (technical) analytical devices (such as for example devices for performing (medical) imaging methods), wherein the technical signals are for example electrical or optical signals. The technical signals for example represent the data received or outputted by the computer. The computer is preferably operatively coupled to a display device which allows information outputted by the computer to be displayed, for example to a user. One example of a display device is a virtual reality device or an augmented reality device (also referred to as virtual reality glasses or augmented reality glasses) which can be used as "goggles" for navigating. A specific example of such augmented reality glasses is Google Glass (a trademark of Google, Inc.). An augmented reality device or a virtual reality device can be used both to input information into the computer by user interaction and to display information outputted by the computer. Another example of a display device would be a standard computer monitor comprising for example a liquid crystal display operatively coupled to the computer for receiving display control data from the computer for generating signals used to display image information content on the display device. A specific embodiment of such a computer monitor is a digital lightbox. An example of such a digital lightbox is Buzz®, a product of Brainlab AG. The monitor may also be the monitor of a portable, for example handheld, device such as a smart phone or personal digital assistant or digital media player.

[0068] The invention also relates to a program which, when running on a computer, causes the computer to perform one or more or all of the method steps described herein and / or to a program storage medium on which the program is stored (in particular in a non- transitory form) and / or to a computer comprising said program storage medium and / or to a (physical, for example electrical, for example technically generated) signal wave, for example a digital signal wave, carrying information which represents the program, for example the aforementioned program, which for example comprises code means which are adapted to perform any or all of the method steps described herein.

[0069] Within the framework of the invention, computer program elements can be embodied by hardware and / or software (this includes firmware, resident software, micro-code, etc.). Within the framework of the invention, computer program elements can take the form of a computer program product which can be embodied by a computer-usable, for example computer-readable data storage medium comprising computer-usable, for example computer-readable program instructions, "code" or a "computer program" embodied in said data storage medium for use on or in connection with the instructionexecuting system. Such a system can be a computer; a computer can be a data processing device comprising means for executing the computer program elements and / or the program in accordance with the invention, for example a data processing device comprising a digital processor (central processing unit or CPU) which executes the computer program elements, and optionally a volatile memory (for example a random access memory or RAM) for storing data used for and / or produced by executing the computer program elements. Within the framework of the present invention, a computer-usable, for example computer-readable data storage medium can be any data storage medium which can include, store, communicate, propagate or transport the program for use on or in connection with the instruction-executing system, apparatus or device. The computer-usable, for example computer-readable data storage medium can for example be, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system, apparatus or device or a medium of propagation such as for example the Internet. The computer-usable or computer-readable data storage medium could even for example be paper or another suitable medium onto which the program is printed, since the program could be electronically captured, for example by optically scanning the paper or other suitable medium, and then compiled, interpreted or otherwise processed in a suitable manner. The data storage medium is preferably a non-volatile data storage medium. The computer program product and any software and / or hardware described here form the various means for performing the functions of the invention in the example embodiments. The computer and / or data processing device can for example include a guidance information device which includes means for outputting guidance information. The guidance information can be outputted, for example to a user, visually by a visual indicating means (for example, a monitor and / or a lamp) and / or acoustically by an acoustic indicating means (for example, a loudspeaker and / or a digital speech output device) and / or tactilely by a tactile indicating means (for example, a vibrating element or a vibration element incorporated into an instrument). For the purpose of this document, a computer is a technical computer which for example comprises technical, for example tangible components, for example mechanical and / or electronic components. Any device mentioned as such in this document is a technical and for example tangible device.

[0070] Acquiring data

[0071] The expression "acquiring data" for example encompasses (within the framework of a computer implemented method) the scenario in which the data are determined by the computer implemented method or program. Determining data for example encompasses measuring physical quantities and transforming the measured values into data, for example digital data, and / or computing (and e.g. outputting) the data by means of a computer and for example within the framework of the method in accordance with the invention. The meaning of "acquiring data" also for example encompasses the scenario in which the data are received or retrieved by (e.g. input to) the computer implemented method or program, for example from another program, a previous method step or a data storage medium, for example for further processing by the computer implemented method or program. Generation of the data to be acquired may but need not be part of the method in accordance with the invention. The expression "acquiring data" can therefore also for example mean waiting to receive data and / or receiving the data. The received data can for example be inputted via an interface. The expression "acquiring data" can also mean that the computer implemented method or program performs steps in order to (actively) receive or retrieve the data from a data source, for instance a data storage medium (such as for example a ROM, RAM, database, hard drive, etc.), or via the interface (for instance, from another computer or a network). The data acquired by the disclosed method or device, respectively, may be acquired from a database located in a data storage device which is operably to a computer for data transfer between the database and the computer, for example from the database to the computer. The computer acquires the data for use as an input for steps of determining data. The determined data can be output again to the same or another database to be stored for later use. The database or database used for implementing the disclosed method can be located on network data storage device or a network server (for example, a cloud data storage device or a cloud server) or a local data storage device (such as a mass storage device operably connected to at least one computer executing the disclosed method). The data can be made "ready for use" by performing an additional step before the acquiring step. In accordance with this additional step, the data are generated in order to be acquired. The data are for example detected or captured (for example by an analytical device). Alternatively or additionally, the data are inputted in accordance with the additional step, for instance via interfaces. The data generated can for example be inputted (for instance into the computer). In accordance with the additional step (which precedes the acquiring step), the data can also be provided by performing the additional step of storing the data in a data storage medium (such as for example a ROM, RAM, CD and / or hard drive), such that they are ready for use within the framework of the method or program in accordance with the invention. The step of "acquiring data" can therefore also involve commanding a device to obtain and / or provide the data to be acquired. In particular, the acquiring step does not involve an invasive step which would represent a substantial physical interference with the body, requiring professional medical expertise to be carried out and entailing a substantial health risk even when carried out with the required professional care and expertise. In particular, the step of acquiring data, for example determining data, does not involve a surgical step and in particular does not involve a step of treating a human or animal body using surgery or therapy. In order to distinguish the different data used by the present method, the data are denoted (i.e. referred to) as "XY data" and the like and are defined in terms of the information which they describe, which is then preferably referred to as "XY information" and the like.

[0072] BRIEF DESCRIPTION OF THE DRAWINGS

[0073] In the following, the invention is described with reference to the appended figures which give background explanations and represent specific embodiments of the invention. The scope of the invention is however not limited to the specific features disclosed in the context of the figures, wherein

[0074] Fig. 1 illustrates a flow diagram of a computer implemented method of configuring a consent application on a patient’s mobile device according to an aspect of the present invention; and

[0075] Fig. 2 illustrates a network for configuring a consent application on a patient’s mobile device according to an embodiment of the present invention.

[0076] The reference symbols used in the drawings, and their meanings, are listed in summary form in the list of reference symbols. In principle, identical parts are provided with the same reference symbols in the figures.

[0077] DESCRIPTION OF EMBODIMENTS

[0078] Figure 1 illustrates a computer implemented method of configuring a consent application on a patient’s mobile device. The presented method may also be seen as a computer implemented method of configuring a data transfer application on a patient’s mobile device. And in general, the consent application may be seen as data transfer application on a patient’s mobile device. The method comprises the step S1 of providing the patient’s mobile device with the consent application, wherein the consent application is configured for sending to a computing device handling the research study a consent or consent data of said patient for a usage of health data of said patient in said research study. In step S2, a code is provided to the consent application, which code is specific for at least one individual research study and is processable by the patient’s mobile device and / or the consent application. Moreover, in step S3 an automatic pre-configuration of the consent application is carried out upon processing the provided code by the consent application, such that the consent / consent data subsequently generated with said pre-configured consent application complies with the consent criteria defined in or by said at least one individual research study. For an exemplary network 200 comprising the patient’s mobile device 201 with the consent application and the researcher’s computing device 212 connected via the internet and / or a data connection 209, 210, 221 , which together may carry out the method shown in Figure 1 , it is kindly referred to Figure 2.

[0079] With the method shown in Figure 1 , a study compliant consent and data generation can be ensured. Further, due to the software-based, i.e. , the application-based solution provided by the method of Figure 1 , amendments, supplements and / or exchanges of the consent requirements or consent criteria triggered by the computing device 212 of the researcher and also consent changes triggered by the patient on his / her mobile device 201 can be easily implemented by the patient on the mobile device 201 . For example, via a push functionality, the consent application on the mobile device 201 may receive data I a message from the computing device 212 that an adaptation of the consent application is required, because e.g., the research study has to be changed due to new possible ways of analyzing the patient’s health data. In this way, for example, an automatic update of the pre-configuration of the consent application can be carried out. Amendments, supplements and / or exchanges of the consent requirements or consent criteria are easily implementable on the patient’s mobile device 201 . Even further, due to the fact that the patient has the mobile device 201 and hence the consent application generally with him / her, he / she is always capable of changing or updating his / her consents that were generated earlier, if he / she wishes to do so. In a non-limiting example, the present invention allows for sending a changed consent from the consent application 201 to the computing device 212 via the communication channel 210, 209 and 211 requesting to delete all health data of the patient on the computing device 212, and / or on other data storage devices used for the study. With the presented method of Figure 1 and the network described in the context of Figure 2, this can be done within a short amount of time and without any necessary data processing in hospital information systems.

[0080] Figure 2 schematically shows an exemplary network 200 with an exemplary patient’s mobile device 201 and a researcher’s computing device 212 which both together are configured for carrying out the method presented herein. The mobile device 201 shown in Figure 2 is a smartphone on which the consent application, schematically shown as program element 205 stored in a storage of the mobile device 201 and processed by the processor 204, shown only schematically, of the mobile device 201 , is running as a software application. The user can interact with and input data into the consent application 205 via the touch sensitive display 202 on which a graphical user interface (GUI) of the consent application is shown to the patient / user. However, is will be appreciated by the skilled reader, the mobile device may also be embodied as for example a tablet, a pager, or any other kind of electronics mobile device on which the consent application can be installed and used by the user in order to generate his / her consent data and in order to transmit the so generated consent via the mobile device 201 to the computing device 212 on the researcher’s side. The mobile device 201 of the embodiment of Figure 2 additionally comprises a camera 203 for generating photos and video and to which the consent application has access to. As has been explained in detail hereinbefore, with the method and network presented herein, the patient can generate data with the mobile device 201 , which data is compliant with the data requirements of the research study, and so can successfully contribute to the research study. Thus, the health data generated on behalf of the consent application 205 stored and running on the mobile device 201 makes beneficial use of other applications and functionalities of the mobile device 201 , like the camera 203, GPS sensors 206, acceleration sensors 208, and the microphone 207, and the respective apps. These are only exemplary, non-limiting examples. As was explained in detail hereinbefore, the setup of the mobile device 201 , which can be defined in a study specific configuration data set via the network 200 to the mobile device comprises at least one of providing access to third party apps, like the camera 203, GPS sensors 206, acceleration sensors 208, and the microphone 207, and the respective applications.

[0081] In other words, the network 200 is used for configuring the consent application 205 on a patient’s mobile device 201 . The consent application 205 is capable and configured for sending to the computing device and via the mobile device’s data transmission capability the generated consent / consent data of said patient for the usage of his / her health data in a research study. The computing device 212 of network 200 provides a code to the consent application 205 via the communication / data channel 211 , 209, 210. In this embodiment, the patient’s mobile device 201 and the computing device 212 can exchange data via this network connection for configuring the consent application 205. The mobile device 201 and the computing device 212 may send and receive the respective data via a telecommunication network like 3G, 4G, 5G, LTE, or via WIFI, or via LAN, or via Bluetooth or the like. The sent or provided code, e.g., a QR code, is specific for at least one individual research study. The patient’s mobile device 201 and / or the consent application 205 is / are configured to process said provided code, and the patient’s mobile device and / or the consent application is / are configured to automatically pre-configure the consent application upon processing the provided code. In this way it is ensured that any consent or consent data subsequently generated with said pre-configured consent application 205 complies with the consent criteria of said at least one individual research study. With the network 200 one can easily carrying out a consent update by the consent application 205. The presented method and network allow, for example, sending a changed consent from the consent application 205 to the computing device 212 via the communication channel 210, 209, 211 after the consent application 205 received an input from the patient changing his / her consent settings in the consent application 205 via the graphical user interface displayed to the user on display 202 of the mobile device, for example withdrawing the consent, and receiving, by the mobile device 201 , a request from the computing device 212 for updating the consent criteria of said at least one individual research study and accordingly change the pre-configuration of the consent application 205 in the settings of the stored consent application, and sending a changed consent from the consent application 205 to the computing device 212 via the communication channel 210, 209, 211 requesting to delete all health data of the patient stored in the computing device, and / or any other data storage storing health data of the patient, in the context of the research study.

[0082] Moreover, with the network 200 the consent application 205 on the mobile device 201 can be automatically pre-configured with respect to data generation of health data of the patient with the patient’s mobile device 201 when receiving or processing said code provided to the mobile device via the network. This the data pre-configuration of the consent application 205 is carried out such that data generated with the patient’s mobile device 201 complies with data criteria of said at least one individual research study. In a particular embodiment, this data pre-configuration of the consent application 204 at least defines what kind of data have to be generated by the user with the mobile device 201 , and / or at which point in time the data have to be generated by the mobile device 201 , and / or how the data have to be generated by the mobile device 201 . The method and the network presented in Figures 1 and 2 also allow that upon processing said provided code by the consent application 204, a study specific configuration data may be requested by the patient’s mobile device from the computing device via communication channel 209, 210 and 211 . The mobile device 201 may so receive said study specific configuration data from the computing device 212. This study specific configuration data when processed by the consent application 204 cause the consent application 204 in the mobile device 201 to define steps of interaction of the patient with the consent application 204 for user input into the consent application to contribute to the research study, as was explained in detail hereinbefore in the context of particular embodiments.

[0083] As has become apparent from the foregoing explanation, the method of Figure 1 covers the mobile application on the mobile device of the patient and Figure 2 covers the network according to an aspect of the present invention. Thus, physicians could encourage patients to use this consent application so they can become part of a clinical study. The patient would download the app and go through the consent. The consent would need to cover the researcher’s use case, so by entering for example the physicians ID or scanning a QR-code the patient would set his consent parameters to include this study. So, physicians can process the digital data access concept upfront through some committee, or even without committee for some use cases, and link a few of their colleagues from other institutions to it. They would all encourage their patients to join and enter for example their information blocking rule access IDs to it. The patients would be able to sync to an upload portal with e.g., a QR code or similar to upload their images and other data. The app could also include the AppleHealth and / or GoogleFit data as well as PROMs, i.e. , Patient Reported Outcome Measures in a de-identified way.

[0084] Another non limiting example of the present invention will be detailed hereinafter:

[0085] 1 . Generation of a research study description in form of structured human input, possibly ethics board reviewed, and generation of a related consent form. The consent form may be a data set of consent items that a patient would have to agree to; it is highly study-specific. This step may be carried out in / via a cloud system.

[0086] 2. Generation of the patient-provided steps to the study protocol, generated preferably automatically. a. Setup: this part is about steps the patient needs to do in order to prepare the mobile device: i. Provide access to third party apps, including e.g., specific Healthkit access (Apple dialog) - Legal consent could be less coarse then technical consent patient reported outcome because this is out of our control. In app consent could be different / finer than external access to other apps. ii. Push notification allowance iii. Connection to healthcare systems I information blocking rule access IDs iv. Execution of dynamic consent, Freigabepass v. Information input of patient biographies b. Sequence of steps: these are steps the patient needs to do to contribute to the study: i. Provide input PROMs [fill out forms... ] ii. Exercise [e.g. walk number of steps, reach certain training level] iii. Play games (Level Ex) [e.g. breathing exercises, relaxation] that monitors your reaction time, cognitive ability, eyesight, memory, speech markers - interactive engagement using your mobile device, gyro sensors + wearables, bluetooth-connects, bluetooth spirometry, iv. Home-based, mobile sensor devices, location, limb movement v. Acquire photographs and videos, e.g. of self, of your eye c. Repeat b or subset of b at predefined intervals - transmit data to computing device of researcher, or to several computing devices of a team of researchers.

[0087] 3. Consent form includes consent to the collected data (incl. PROMs, including Healthkit data);

[0088] 4. Store consent form as versioned document;

[0089] 5. Digital Patient invitation by doctor to patient, e.g., via a link, QR code, SMS, or ID Number); preferred could be to use an SMS to get phone number use as identifier; this could be based on the study protocol;

[0090] 6. One or more clinical forms to fill by doctor (web browser interface, cloud based system) a. Only common identifier is the phone number, or without identifier b. Doctor measures additional information

[0091] 7. Patient downloads app and starts enrollment into the study

[0092] 8. Follow protocol as provided under 2

[0093] 9. Regularly check if consent of patient aligns with provided access in the app; remind user

[0094] 10. Linking separate researchers -> some exposed to phone number, some not; push additional consent request to patient; (primary researcher allows secondary researcher into the study; this might make change or update to the consent necessary; this update consent request is pushed to the patient’s mobile device for the patient to react (consent). Store new version of consent form (see 4) a. or patient agrees to any* person 11 . Feedback to user about used data; feedback to user about study results (both provided in the app)

[0095] 12. As a further option: Patient enables access to information in the hospital storage system by his / her patient access and data is used in the study like other patient- reported data, e.g. downloaded for a certain amount of time

[0096] 13. Consent update a. Patient can change (incl. withdraw consent) b. Updated based on researchers request, and / or c. Delete all data

[0097] In an exemplary study, researchers could compare patient cohorts that underwent knee replacement surgery, where one group received an implant during a robot- assisted surgery and others with a non-robot-assisted surgery. They were invited by the researchers to take part in an outcome-study and reported regularly e.g., on their walking or movements patterns, pain. The study is focussed on short-term recovery and the input has to happen in this time frame.

[0098] Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from the study of the drawings, the disclosure, and the appended claims. In the claims the word “comprising” does not exclude other elements or steps and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfil the functions of several items or steps recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. A computer program may be stored / distributed on a suitable medium such as an optical storage medium or a solid- state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems. Any reference signs in the claims should not be construed as limiting the scope of the claims.

Claims

CLAIMS1 . A computer implemented method of configuring a consent application on a patient’s mobile device, the method comprising the steps providing the patient’s mobile device with the consent application (step S1 ), wherein the consent application is capable of sending to a computing device a consent of said patient for a usage of health data of said patient in a research study; the method further comprising the step providing a code to the consent application, which code is specific for at least one individual research study (step S2), wherein the code is processable by the patient’s mobile device and / or the consent application, the method further comprising the step upon processing the provided code by the consent application, automatically pre-configuring the consent application such that a consent subsequently generated with said pre-configured consent application complies with consent criteria of said at least one individual research study (step S3).

2. Method according to claim 1 , wherein the code provided in step S2 is embodied as a QR-code, as a weblink, as researcher ID, or as a physician ID.

3. Method according to claim 1 or 2, further comprising the step upon processing the code, automatically pre-configuring the consent application with respect to data generation of health data of the patient with said patient’s mobile device.

4. Method according to claim 3, wherein the data pre-configuration of the consent application with respect to the data generated is carried out such that data generated with the patient’s mobile device complies with data criteria of said at least one individual research study.

5. Method according to any of claims 3 or 4, wherein the data pre-configuration of the consent application at least defines what kind of data have to be generated by the user with the mobile device, and / or at which point in time the data have to be generated, and / or how the data have to be generated.

6. Method according to any of the claims 3 to 5, the method further comprising the step generating health data by the mobile device according to the data preconfiguration of the consent application.

7. Method according to claim 6, wherein the data generated with the patient’s mobile device according to the data pre-configuration of the consent application are measurement data and / or data received by the consent application or by the mobile device via a user input.

8. Method according to any of the preceding claims, the method further comprising the step transmitting health data of the patient generated with mobile device via a communication channel to the computing device.

9. Method according to any of the preceding claims, the method comprising the step upon processing said code, requesting study specific configuration data by the patient’s mobile device from the computing device, and receiving said study specific configuration data by the mobile device from the computing device.

10. Method according to claim 9, wherein the study specific configuration data when processed by the consent application cause the consent application to define steps of interaction of the patient with the consent application for user input into the consent application to contribute to the research study.11 . Method according to claim 10, wherein the steps defined by the consent application upon processing the study specific configuration data are selected from the group comprising:- provide patient provided outcome measures,- fill out a form,- carrying out exercise like e.g., walking a number of steps or reach a certain training level,- playing a game on the mobile device for creating health data like e.g., breathing / relaxation exercise that monitors reaction time, cognitive ability, eyesight, memory, and / or speech markers,- starting an interactive engagement using at least one of the mobile device, one or more gyro sensors of the mobile device, one or more wearables, one or more bluetooth-connects, one or more bluetooth spirometry devices,- using home-based, mobile sensor devices for determining e.g., location and / or limb movement, and- acquiring photographs and / or videos, e.g., of particular body parts.

12. Method according to any of the claims 9 to 11 , wherein the study specific configuration data define a setup of the mobile device to be carried out by the patient in order to prepare the mobile device for use of the consent application.

13. Method according to claim 12, wherein the setup of the mobile device defined in the study specific configuration data comprises at least one of:- providing access to third party apps, including specific Healthkit access,- setting allowance for push notifications for the consent application,- setting conditions for establishing a connection to one or more healthcare systems, preferably using information blocking rule access IDs,- executing of dynamic consent, and- information input of patient biographies.

14. Method according to any of the claims 9 to 13, the method comprising the stepsgenerating the study specific configuration data based on a provided description of the research study, wherein the generation of the study specific configuration data is preferably carried out automatically, i.e. , computer-implemented.

15. Method according to claim 14 wherein the provided research study comprises a consent form, and wherein the consent form is a data set of consent items that a patient has to agree to in order to take part in the research study and so defines the consent criteria.

16. Method according to claim 15, wherein a consent generated by the pre-configured consent application complies with the consent criteria.

17. Method according to any of the preceding claims, the method comprising the step generating a consent with the pre-configured consent application, and storing the consent generated with the pre-configured consent application, preferably in form of a versioned document.

18. Method according to any of the preceding claims, the method comprising the step sending a digital patient invitation by a researcher from the computing device to the patient’s mobile device via a link, a QR code, an SMS, and / or an ID Number.

19. Method according to any of the preceding claims, the method comprising the step downloading the consent application onto the patient’s mobile device and starting enrollment into the study by the patient by using the consent application.

20. Method according to any of the preceding claims, the method comprising the stepregularly checking if a consent of patient generated with the consent application aligns with provided access in the consent application, and optionally remind the patient.21 . Method according to any of the preceding claims, the method comprising the step sending data, which enable access to information in a hospital storage system by his / her patient access, from the patient’s mobile device via the consent application to the computing device.

22. Method according to any of the preceding claims, the method comprising the step carrying out a consent update by the consent application, and wherein the consent update comprises at least one of:- sending a changed consent from the consent application to the computing device via a communication channel after the consent application received an input from the patient changing his / her consent settings in the consent application, for example withdrawing the consent,- receiving, by the mobile device, a request from the computing device for updating the consent criteria of said at least one individual research study and accordingly change the pre-configuration of the consent application, and- sending a changed consent from the consent application to the computing device via a communication channel requesting to delete all health data of the patient in the context of the research study.

23. A program, preferably in form of a consent application, which, when running on a patient’s mobile device or when loaded onto a patient’s mobile device, causes the patient’s mobile device to perform the following steps processing a provided code, which code is specific for at least one individual research study, and upon processing the provided code by the consent application, automatically pre-configuring the consent application such that a consent subsequently generatedwith said pre-configured consent application complies with consent criteria of said at least one individual research study, and sending the consent generated with the pre-configured consent application to a computing device for a usage of health data of said patient in said research study.

24. A program storage medium on which a program according to claim 23 is stored.

25. A network for configuring a consent application on a patient’s mobile device, the network comprising the patient’s mobile device with the consent application, a computing device, wherein the consent application is capable of sending to the computing device a consent of said patient for a usage of health data of said patient in a research study; wherein the computing device is configured to provide a code to the consent application, which code is specific for at least one individual research study, wherein the patient’s mobile device and / or the consent application is configured to process said provided code, wherein the patient’s mobile device and / or the consent application is configured to automatically pre-configure the consent application upon processing the provided code such that a consent subsequently generated with said preconfigured consent application complies with consent criteria of said at least one individual research study.

26. Network according to claim 25, wherein the patient’s mobile device and the computing device can exchange data via a network connection for configuring the consent application.

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