Method and system for video transmission

The method and system provide flexible, patient-specific video transmission for informed consent, addressing privacy and storage issues by using CGI animation and a unique identifier for tamper-proof documentation.

WO2025248016A1PCT designated stage Publication Date: 2025-12-04MEDUDOC AG
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Patent Information

Application Number
PCT/EP2025/064865
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-29
Filing Date
2025-05-28
Publication Date
2025-12-04

AI Technical Summary

Technical Problem

Existing methods for documenting informed consent in healthcare often require reproduction or recording of patient information, which poses privacy and storage challenges, and lack flexibility in providing patient-specific information.

Method used

A method and system for generating and transmitting personalized video content using CGI animation or recorded data, with optional subtitles and sound, ensuring data protection and versatility through a distributed video server system, and incorporating a unique treatment identifier for tamper-proof documentation.

Benefits of technology

Enhances data privacy and storage efficiency while providing flexible, patient-specific information, ensuring provability and integrity of informed consent documentation.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed are a method, system and computer program product The method comprises a data receiving step. The data receiving step comprises a first server receiving treatment data and / or patient data. The treatment data comprise an indication of at least one medical treatment. The method further comprises an information selecting step comprising generating a patient information data set and a document data generating step comprising generating a document data set based on the patient information data set. The document data set comprises patient consent document data. The first server performs the document data generating step. The method further comprises a video data providing step and a video transmission step comprising transmitting video data from a video server to a patient device. The method comprises generating a unique treatment identifier. The document data generating step comprises transmitting the patient consent document data from the first server to the HCP-device. The system is configured for performing the steps of the method. The system comprises a first server, an HCP-device and a patient device. The computer program product comprises instructions which, when the program is executed by the system, cause the system to carry out the steps of the method.
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Description

[0001] Method and system for video transmission

[0002] [1] The present invention relates to the field of video transmission. In particular, the present invention relates to the field of video transmission and documentation of user interaction.

[0003] [2] Today, acquiring informed consent for medical procedures typically involves the healthcare provider, in the following "the HCP", explains the details, risks, and potential alternatives of a proposed procedure to patients. Ideally, patients have a clear understanding of the treatment they will undergo, as well as of the risks and advantages of the treatment and can make informed decisions about their care.

[0004] [3] In most jurisdictions, the HCP is obligated to particularly inform the patient about risks associated with the treatment in an adequate manner. In case of complications and resulting medical malpractice suits, sufficient informed consent may be essential. However, in some jurisdictions, the scope of appropriate information enabling the patient to give her informed consent to a medical procedure is only defined in very abstract terms, e.g., in Germany by § 630d, 630e of the German Civil Code. In such proceedings, proof of the patient information may be essential.

[0005] [4] At the same time, as patient information is specific to the medical condition of the patient as well as the intended treatment, sensitive data are concerned. Thus, privacy and data protection may be of increased relevance.

[0006] [5] Some prior art solutions suggest the use of videos or 3D animations for informed consent.

[0007] [6] US 2014 / 0141397 Al discloses a computer-based apparatus for verified education of patient medical conditions and procedures provides 3D animations and 3D image stills, follow up quiz for patients, a built in informed consent form, usage tracking that gives a healthcare provider a consistent way to educated patients about anatomy, surgical and non-surgical procedures and medical conditions with the ability to track all usage records and a built in legal informed consent. Each view per patient is tracked and it is logged which healthcare provider was there, the 3D animations and / or 3D image stills viewed, a quiz was taken and scored, a digital informed consent form was signed and accompanied by screen grabs of the 3D animations and / or 3D image stills shared with the patient.

[0008] [7] US 2019 / 0019574 Al discloses an electronic consent-based medical record. The electronic consent-based medical record is created by: providing a processor(s) communicably coupled to an input / output interface, a memory and a data storage; receiving a medical procedure identifier for a patient; creating the electronic medical record and storing the electronic medical record in the data storage; storing a medical data and an education information for a medical procedure associated with the medical procedure identifier in the electronic medical record; storing a set of consent-based questions for the medical procedure in the electronic medical record; providing the educational information and the consent-based questions for the medical procedure to the patient via a remote device; receiving an electronic consent from the patient; storing the electronic consent in the electronic medical record; providing a report based on the electronic medical record to a medical provider; receiving an electronic authorization from the medical provider; and storing the electronic authorization in the electronic medical record.

[0009] [8] US 2010 / 0092937 Al discloses an interactive patient education system for use in operatory or office settings, provides interactive 3-D animations, graphics and other media, enabling real-time markup and customization to better illustrate and communicate not only generic information, but the individual patient's physiology, treatment options, and anticipated outcomes. Preferred embodiments are portable, computer-implemented, interactive multimedia educational tools. Import of patient-specific graphics, video and audio contributes to full-custom educational content to optimize patient understanding and to facilitate obtaining and recording a patient's informed consent.

[0010] [9] US6171112B1 discloses a method and apparatus for recorded information conveyance and comprehension that include a Virtual Interactive Teaching and Learning (VITAL) Center. The VITAL Center provides an interactive patient education and informed consent process that increases patient comprehension using presentations that offer a baseline education about medical and surgical procedures including the associated risks, benefits and alternatives. The patient's comprehension of the material is confirmed throughout the presentation using summary questions focused on key information. The patient is able to record their own questions or concerns about the procedure while watching the presentation. After the presentation is finished, A healthcare professional reviews the patient questions upon completion of the presentation, and any information the patient did not understand is further explained at this time. After all questions and concerns are addressed and the patient has a comfortable understanding of the procedure, the patient signs an informed consent electronically. Using digital video capture, the VITAL Center simultaneously records the information presented, the patient viewing the interactive presentation, the patient-physician interaction, and the informed consent process. The entire recorded education session and informed consent is stored permanently on optical disk media.

[0011]

[0010] US 2016 / 0110832 Al discloses a method for documenting informed consent, including obtaining a video recording of a patient indicative of informed consent, communicating the video recording across a network for data storage, and storing the video recording in a computer readable data storage medium. The video may include additional portions of a patient encounter. A software application for executing on a computing device may provide a user interface for obtaining video evidencing informed consent for the procedure, administering a quiz to the individual, presenting a document for signature to the individual, receiving a signature for the document from the individual.

[0012]

[0011] US 2016 / 0110504 Al discloses a method for documenting informed consent which includes obtaining a video recording of a patient indicative of informed consent, communicating the video recording across a network for data storage, and storing the video recording in a computer readable data storage medium. The video may include additional portions of a patient encounter. A software application for executing on a computing device may provide a user interface for displaying an educational video to the individual using the software application executing on the computing device, the educational video containing educational content about the procedure for which the informed consent is desired, obtaining video evidencing informed consent for the procedure, administering a quiz to the individual, presenting a document for signature to the individual, receiving a signature for the document from the individual.

[0013]

[0012] US 2017 / 0154159 Al discloses a multimedia system and method for use in at-home therapy. The multimedia system synchronizes data such as audio and video data with skeletal data of a patient. The system allows for a therapist to fully monitor, evaluate, advise and interact with a patient performing therapeutic physical activities at home.

[0014]

[0013] While the prior art approaches may be satisfactory in some regards, they have certain shortcomings and disadvantages.

[0015]

[0014] In particular, proof of the scope of patient information may either require reproduction of a video that was shown or require recording of the informed consent discussion. The latter may be disadvantageous for privacy reasons, as well as for reasons of efficient storage. Both require tamper-proof storage of the video and / or the recording.

[0016]

[0015] Further, the patient information may greatly vary among medical doctors. Also, prerecorded videos often cannot provide for flexible patient information specific to the procedure as well as the patient's condition.

[0017]

[0016] It is therefore an object of the invention to overcome or at least alleviate the shortcomings and disadvantages of the prior art. More particularly, it is an object of the present invention to provide an improved method, system and computer program product for patient information.

[0018]

[0017] It is an optional object of the present invention to provide a method, system and computer program product for patient information providing for increased versatility of the patient information.

[0018] It is another optional object of the present invention to provide a method, system and computer program product for patient information providing for improved provability of the scope of the patient information.

[0019]

[0019] It is another optional object of the present invention to provide a method, system and computer program product for patient information providing for improved data protection during and / or after patient information.

[0020]

[0020] In a first embodiment, a method is disclosed. The method comprises a data receiving step, an information selecting step and a document data generating step. The data receiving step comprises receiving treatment data and / or patient data. The information selecting step comprises generating a patient information data set. The patient information data set may relate to information to be provided to a patient. The document data generating step comprises generating a document data set based on the patient information data set.

[0021]

[0021] The term "patient" is intended to refer to a user in a medical context, such as a person for whom a medical procedure is foreseen, or a someone representing such person, e.g., a parent of a patient who is a minor or a custodian of a patient who is unable to give an informed consent. In more general terms, the term "patient" may relate to an information receiver.

[0022]

[0022] The method may comprise a video data providing step. The video data providing step may comprise video data. The video data providing step may also comprise generating video data.

[0023]

[0023] The method may comprise a video transmission step. The video transmission step may comprise transmitting video data from a video server to a patient device.

[0024]

[0024] The video data may comprise an image part. The image part of the video data may comprise image data relating to a plurality of images. The video data may for example be generated based on recorded video data and post-processing thereof. In another example, the video data may also be generated computer animation, that is, by CGI animation. The video data may, for example, also be generated by means of generative artificial intelligence based on respective input data.

[0025]

[0025] The video data may also comprise a sound part. The sound part of the video data may comprise sound data.

[0026]

[0026] For example, the sound data may be interleaved with an image portion of the video data, as in case of the .avi-format. On other words, the data may be stored in a single stream (comprising image data and sound data). In another example, the video data may also be non-interleaved video data. That is, the sound part may be stored in a stream separate from the image portion of the video data. In other words, the data may be stored in at least two streams. In still another example, the sound part and the video part may be stored in separate files.

[0027]

[0027] In other cases, the video data may not comprise sound data. This may for example in case of hearing impaired patients, as risk of an involuntary information bias between the patient and the HCP may be reduced.

[0028]

[0028] The video data may comprise subtitle data.

[0029]

[0029] The subtitle data may be a part of the image portion of the video data. In other words, the subtitle data may be integrated into the image data. However, alternatively, the subtitle data may be stored as separate from the image data and thus allow for improved adaptability, e.g., in case of translation.

[0030]

[0030] The video server may be a server configured for storing video data. The video server may further be configured for transmitting video data and comprise a data connection comprising a suitable capacity.

[0031]

[0031] The video server may also be a video server system, e.g., a distributed video server system comprising a plurality of servers located remote from each other. Thus, optionally advantageously, data transmission efforts to recipients at different locations may be reduced.

[0032]

[0032] The video transmission step may comprise outputting the video data, particularly by the patient device. In other words, the video transmission step may comprise playing a video corresponding to the video data, e.g., by the patient device.

[0033]

[0033] The method may further comprise an HCP login step. The HCP login step may comprise receiving login data from a user by means of an HCP-device.

[0034]

[0034] The term "user" is intended to refer to a user providing the information, such as a health care provider (in the following: "HCP"). For example, the health care provider may be a medical practitioner. In more general words, the user may be providing the information to the patient, who is thus enabled to give their informed consent.

[0035]

[0035] The HCP login step may comprise transmitting the login data to at least one of a first server and an authentication server.

[0036]

[0036] The HCP login step may comprise receiving an authentication result from the authentication server, particularly by at least one of the HCP-device and the first server.

[0037]

[0037] The HCP login step may comprise generating the authentication result by the first server.

[0038] The login data may comprise an indication of the user and a password. The indication of the user may for example be an e-mail address, a user name or a user ID.

[0038]

[0039] The login data may further comprise an IP-address of the HCP device. Thus, for example, a network with which the HCP device is connected may optionally advantageously be determined, allowing for at least one of determining health facility to which the user belongs and detecting fraudulent login requests.

[0039]

[0040] The HCP login step may comprise selecting the authentication server based on the login data. This may be performed, e.g., based on the e-mail address, the IP-address or e.g. a user database.

[0040]

[0041] The HCP login step may comprise only continuing the method once the authentication result is positive.

[0041]

[0042] The data receiving step may comprise the first server receiving the treatment data and / or the patient data.

[0042]

[0043] The treatment data may comprise an indication of at least one medical treatment. The indication may for example relate to a type of treatment, e.g., a specific surgical method, and / or a detail of the treatment, e.g., a type of anaesthesia used for a surgery or a type of implant to be used. The person skilled in the art will easily understand that, in the present disclosure, the term "treatment" may also relate to an examination where appropriate, e.g., in case of an invasive test such as a biopsy, an excision or an endoscopy.

[0043]

[0044] The treatment data may comprise an indication of procedural details of the at least one medical treatment.

[0044]

[0045] The treatment data may comprise an indication of a medical domain, such as a medical domain into which the treatment falls.

[0045]

[0046] The patient data may comprise an indication of a sex of the patient.

[0046]

[0047] The patient data may comprise medical data relating to the patient, such as a medical patient record.

[0047]

[0048] In some embodiments, optionally, the patient data do not comprise a name of the patient. Thus, privacy of the patient may be increased and a risk of loss of private data, e.g., in case of a security breach of the first server, may be avoided. This may be particularly relevant if the first server performs the method for a plurality of health care providers or health facilities.

[0048]

[0049] The method may comprise generating a unique treatment identifier.

[0050] The method may comprise associating the treatment data and the patient data, particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier. In other words, the received data may be associated with the unique treatment identifier. For example, the received data may be stored in a database with an ID, wherein the ID corresponds to the unique treatment identifier.

[0049]

[0051] The data receiving step may comprise generating the unique treatment identifier. However, the unique treatment identifier may also be generated after the data receiving step, as will be discussed with respect to the video data providing step.

[0050]

[0052] The data receiving step may comprise associating the treatment data and the patient data particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier. Thus, data integrity may optionally advantageously be improved, e.g., if the method is paused or interrupted.

[0051]

[0053] The data receiving step may comprise receiving the data from the HCP device and / or an HCP server system.

[0052]

[0054] The HCP server system may for example be a hospital information system (in the following: "HIS"). The HIS may for example store medical records of a plurality of patients. Receiving the data from the HIS and / or the HCP device may limit security risks associated with performing the method to the data provided by the HCP device and / or the HIS.

[0053]

[0055] Receiving the data from the HCP device and / or the HCP server system may comprise recording a voice input and processing the voice input by performing a speech recognition step.

[0054]

[0056] The term "speech recognition" is intended to refer to translation of spoken language into text, particularly by a data processing system. Examples of speech recognition steps are known to the person skilled in the art.

[0055]

[0057] In other words, the HCP-device may comprise a microphone or be connected to a microphone device, such as a dictation device. The HCP-device and / or the microphone device may be configured for the speech recognition step. That is, in still other words, the method may optionally comprise applying speech recognition to the voice of the user and utilizing Speech-to-Text Technology to translate freely spoken language into commands for data parameters selection without using an input device like a keyboard or stylus.

[0056]

[0058] Receiving the data from the HCP device and / or the HCP server system may comprise recording the voice input and determining a speaker based on the voice input by performing a voice recognition step.

[0059] The term "voice recognition" is intended to refer to identification of a speaker based on their voice, particularly by a data-processing system. Examples of suitable algorithms and voice recognition steps are known to the person skilled in the art.

[0057]

[0060] The login data may comprise at least one of the voice input and the determined speaker.

[0058]

[0061] In the information selecting step, generating the patient information data set may be based on a set of selected information elements. The information selecting step may comprise receiving the set of selected information elements. For example, the information selecting step may comprise receiving a user input corresponding to the set of selected information elements, particularly by means of the HCP-device.

[0059]

[0062] Each information element may correspond to an information to be output to the patient.

[0060]

[0063] The information selecting step may comprise receiving confirmation data relating to the set of selected information elements by means of the HCP-device. The confirmation data may comprise a modification instruction, such as an instruction to modify the set of selected information elements, e.g., by adding, removing or replacing information elements from the set.

[0061]

[0064] The information selecting step may comprise outputting a recommended set of information elements by the HCP-device.

[0062]

[0065] The information selecting step may comprise generating the recommended set of information elements by the first server based on the patient data and / or the treatment data and transmitting the recommended set of information elements from the first server to the HCP-device.

[0063]

[0066] Generating the recommended set of information elements by the first server may, e.g., comprise using a treatment database comprising indications of treatments and corresponding information elements or using a trained Al model.

[0064]

[0067] The information selecting step may comprise storing the patient information data set by the first server. Thus, the data are available for the subsequent method steps.

[0065]

[0068] Particularly, the information selecting step may comprise temporarily storing the patient information data set by the first server. Thus, as the data are removed from the first server after the method, privacy may be improved and risks in case of a security breach may be reduced.

[0066]

[0069] The information selecting step may comprise generating the unique treatment identifier. The set of selected information elements may be associated with the unique treatment identifier. This may optionally advantageously allow for discarding the patient data and / or the treatment data if the method is interrupted or stopped before the information set selected information elements is selected, i.e., if no information is to be provided to the user. Hence, storage of sensitive data may be reduced and privacy may be increased.

[0067]

[0070] The unique treatment identifier may comprise an alphanumeric string.

[0068]

[0071] The video data providing step may comprise generating an access data element, such as a link.

[0069]

[0072] The access data element may be unambiguously assigned to a set of selected information elements associated with the unique treatment identifier.

[0070]

[0073] The access data element may be unique. In other words, optionally, each access data element may be used only for one set of selected information elements in the method.

[0071]

[0074] The access data element may comprise an indication of the unique treatment identifier.

[0072]

[0075] The video data providing step may comprise providing video data corresponding to the set of selected information elements.

[0073]

[0076] Each of the information elements may correspond to a video section data element.

[0074]

[0077] The video section data elements may comprise video data, particularly video data relating to an information element. Thus, the set of selected information elements may correspond to a set of video section data elements.

[0075]

[0078] The video data providing step may comprise associating the access data element with the unique treatment identifier. For example, the link or a part of the link may comprise the unique treatment identifier. Alternatively or additionally, the access data element may be associated with the unique treatment identifier e.g. by a corresponding database entry or a lookup-table.

[0076]

[0079] The video data providing step may comprise associating the treatment data and the patient data, particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier.

[0077]

[0080] The associating may be performed after providing the video data and only temporarily storing the patient data until the video data are provided.

[0078]

[0081] Providing the video data corresponding to the set of selected information elements may comprise generating a playlist data element. The playlist data element may for example be a playlist file. The playlist data element may comprise a plurality of links. Each of the links may direct to a video section data element. The video data may comprise the playlist data element.

[0079]

[0082] Each of the links of the playlist data element may direct to a video section data element stored on the video server.

[0080]

[0083] In other words, in some embodiments, the video data may comprise a playlist file that directs to the video section data elements corresponding to the set of selected information elements.

[0081]

[0084] The method may comprise storing a timestamp of the generating of the playlist data element. Thus, unambiguous identification of the playlist data element may be optionally advantageously facilitated, e.g., in case that a plurality of playlist data elements is provided to the patient in case of a correction being performed by the user.

[0082]

[0085] The access data element may comprise a link to the playlist data element. The playlist data element may for example be a playlist file, such as a .m3u8-file. However, it may also be another type of playlist file, or, e.g., simply a text file comprising the plurality of links.

[0083]

[0086] The video data may comprise the video section data elements specified by the plurality of links. Transmitting the video data from the video server to the patient device may comprise transmitting the video section data elements from the video server to the patient device.

[0084]

[0087] Providing the video data by means of a corresponding playlist file may be optionally advantageous, as it may allow to flexibly generate a video based on a plurality of video sections with limited computing time and / or computing efforts. Further, optionally advantageously, efforts providing a video data for different sets of selected information sets may be reduced, as it is sufficient to provide a set of video section data elements for transmission, and it is not necessary to provide or render a new video file for each set of selected information elements.

[0085]

[0088] Providing the video data corresponding to the set of selected information elements may comprise generating a merged video data element based on a plurality of video section data elements.

[0086]

[0089] Each video section data element may correspond to a selected information element.

[0087]

[0090] The method may comprise storing a timestamp of the generating of the merged video data element. Thus, unambiguous identification of the merged video data element may be optionally advantageously facilitated, e.g., in case that a plurality of playlist data elements is provided to the patient in case of a correction being performed by the user.

[0088]

[0091] Providing the video data corresponding to the set of selected information elements may comprise transmitting the video data element to the video server and storing the video data element on the video server.

[0089]

[0092] The access data element comprises a link to the merged video data element. The video data element is stored on the video server.

[0090]

[0093] The video data comprise the merged video data element.

[0091]

[0094] Generating a merged video data element may optionally advantageously facilitate tamper-proof documentation of the provided video content, as the video data element provided to the video server does not need to be modified and / or is not further modified once it is available for transmission by the video server. Further, optionally advantageously, only the video data element may be available for access and no confidential data such as the video section data elements need to be stored at the video server.

[0092]

[0095] Each video section data element may be associated with a video section identifier. The video section identifier may be unique, that is, each video section identifier may only be associated with one video section data element. For example, the video section identifier may comprise a string, such as an alpha-numeric string, or a number.

[0093]

[0096] In some cases, the video section identifier may also be associated with a plurality of video section data elements that comprise an identical image part, but a different voice, such as a female or male voice. In other cases, the video section identifier may however be associated with exactly one video data element.

[0094]

[0097] Each video section data element is associated with a video section text element. The video section text element may for example be a transcript of an audio track of the video section data element.

[0095]

[0098] The method may comprise, upon a modification of a video section data element, generating a new video section identifier for the modified video section data element. Thus, optionally advantageously, a tamper-proof documentation of the provided video content may be facilitated, regardless of whether a playlist data element or a merged video data element is provided.

[0096]

[0099] The video data providing step may comprise providing subtitles with the video data. The subtitles may be integrated into video data. The subtitles may also be stored separately or in a separate part of the video data. However, in other cases, each video section data element comprises or does not comprise subtitle data and subtitles are not added in the method.

[0097]

[0100] The first server may perform the document data generating step.

[0098]

[0101] The document data set may comprise data representative of at least one or a plurality of document(s).

[0099]

[0102] The document data set may comprise patient consent document data. The patient consent document may for example comprise an indication of the unique treatment identifier. The patient consent document data may be representative of a patient consent document. The patient consent document may also be referred to as informed consent sheet.

[0100]

[0103] The informed consent sheet may be intended to document that the user provided to the patient all information necessary to make an informed decision, and that the patient gave their informed consent. It may thus be signed at an end of patient education and / or patient information.

[0101]

[0104] The document data set may comprise a patient information record. The patient information record may comprise patient information record data. The patient information record may comprise an indication of the unique treatment identifier.

[0102]

[0105] The patient information record may comprise a record of the information provided to the patient, particularly for the user. The patient information record may also be referred to as patient education record.

[0103]

[0106] The document data set may comprise patient information document data. The patient information document may comprise an indication of the unique treatment identifier.

[0104]

[0107] The patient information document data may be representative of the patient information document. The patient information document may also be referred to as patient information sheet. The patient information document may server to provide the patient with information relating to the treatment or access to said information, e.g., with the access data element.

[0105]

[0108] The patient consent document data may comprise an indication of the access data element, such as an indication of the link.

[0106]

[0109] The indication of the link may for example be in text form and / or as machine- readable code, e.g., QR-code. The indication of the link may also comprise a hyperlink (in an electronic document).

[0110] The link and / or the indication of the link may comprise unique treatment identifier. Thus, optionally advantageously, consistency is improved, hence providing for improved data integrity and / or tamper-proofness.

[0107]

[0111] The patient consent document data may comprise an indication of the timestamp of the generating of the playlist and / or the merged video data element.

[0108]

[0112] In other words, if the playlist is generated in the video data providing step, the patient consent document data may comprise an indication of the timestamp of the generating of the playlist. If the merged video data element is generated in the video data providing step, the patient consent document data may comprise an indication of the timestamp of the generating of the merged video data element. Hence, modifications to the video data by generation of new, different video data can optionally be inhibited.

[0109]

[0113] Thus, optionally advantageously, tamper-proofness and / or data integrity may be improved.

[0110]

[0114] The patient information record may comprise an indication of the access data element, such as an indication of the link, as discussed above.

[0111]

[0115] The patient information record may comprise the video section text elements associated with the video section data element to which the information elements correspond.

[0112]

[0116] The patient information record may comprise indications of the video section identifiers associated with the video section data element to which the information elements correspond.

[0113]

[0117] The patient information record comprising the indications of the video section identifiers may optionally advantageously provide for a storage-efficient, reliable representation of the content of the video data. This may be particularly relevant in cases where long term-storage is desired, as in patient information and / or education.

[0114]

[0118] Further, storing the video section text elements and the video section identifiers may provide for an improved data integrity and / or tamper-proofness of the patient information record.

[0115]

[0119] The patient information record may comprise an indication of a timestamp of the generating of the patient information record, optionally advantageously further improving data integrity and / or tamper-proofness.

[0116]

[0120] The patient information document data comprise an indication of the access data element, such as an indication of the link, as discussed above.

[0121] The document data set, particularly the patient information record and / or the patient information document data, may comprise an indication of an identity of the health care provider. Such indication may for example comprise a name of the health care provider and / or an indication of a health facility with which the health care provider is associated.

[0117]

[0122] The method may comprise determining the indication of the identity of the health care provider based on the login data. Hence, optionally advantageously, data integrity may further be improved.

[0118]

[0123] The document data generating step may comprise transmitting the patient consent document data and the patient information document data from the first server to the HCP- device.

[0119]

[0124] The document data generating step may further comprise transmitting the patient information record from the first server to the HCP-device.

[0120]

[0125] The method may comprise providing the patient with the access data element, such as an indication of the link, as discussed above. Hence, the patient may be enabled with a means to easily access the video data.

[0121]

[0126] The method may comprise providing the patient with the patient consent document data and the patient information document data.

[0122]

[0127] Providing the patient with the access data element, particularly further with the patient consent data document data and the patient information document data, may comprise sending these data to the patient device.

[0123]

[0128] Sending these data to the patient device may comprise generating, particularly by the first server, a link to retrieve these data, and further sending the link to the patient device. The sending may for example be performed by at least one of e-mail, SMS and an internet protocol-based messaging service.

[0124]

[0129] Sending these data, particularly the access data element, by at least one of e-mail and the internet protocol-based messaging service may be optionally advantageous compared to sending these data by SMS, as it may be possible to determine whether the sending was successful, while SMS services normally do not provide for means to verify whether a message was successfully transmitted.

[0125]

[0130] Providing the patient with the access data element, particularly with the patient consent document data and the patient information document data, may comprises sending these data to a printing server, particularly by at least one of the HCP-device and the first server.

[0131] Providing the patient with the access data element, particularly with the patient consent document data and the patient information document data, may comprise sending these data by the HCP-device. Thus, optionally advantageously, contact data of the patient do not need to be transmitted to the first server and privacy of the patient may be increased.

[0126]

[0132] The video transmission step may comprise receiving a request based on the access data element from the patient device and transmitting the video data from the video server to the patient device in response to the request.

[0127]

[0133] The transmission step may further comprise transmitting the playlist data element to the patient device. This may optionally be performed via another server, such as the video server, in order to not provide an IP-address of the patient device to the first server and optionally advantageously increase privacy of the patient.

[0128]

[0134] The transmission step may further comprise transmitting the playlist data element from the first server to the patient device.

[0129]

[0135] In the video transmission step, the video server may provide the video data for streaming to the patient device. For example, the video server may perform segment delivery of segments of the video data. The segments of the video data may for example be streaming sections, as known to the person skilled in the art, which do not need to be identical to the video section data elements.

[0130]

[0136] The video transmission step may comprise generating at least one timestamp associated with a transmission of the video data to the patient device. For example, a time of a begin and / or an end of the transmission, such as a first transmission, may be recorded.

[0131]

[0137] Thus, a proof of the transmission of the video data to the patient device may optionally advantageously be provided.

[0132]

[0138] The at least one timestamp may be associated with a transmission of the playlist data element to the patient device.

[0133]

[0139] The patient consent document data may comprise an indication of the timestamp of the transmission of the video data to the patient device.

[0134]

[0140] The patient information record may comprise an indication of the timestamp of the transmission of the video data to the patient device.

[0135]

[0141] The method may comprise an annotation step. The annotation step may comprise receiving annotation data and modifying the document data set based thereon.

[0142] The annotation data may, e.g., relate to a confirmation that or when a consultation has taken place and / or a content of the consultation, such further questions of the patient and / or remarks of the user.

[0136]

[0143] Modifying the document data set based on the annotation data may e.g. comprise adding the annotation data to the document data set and / or adding the annotation data to at least one of the patient information document data, the patient information record and the patient consent document data based on the annotation data. For example, the annotation data may be added as an additional layer in the document data or appended to the document data or a data element thereof.

[0137]

[0144] Adding the annotation data may optionally advantageously provide for improved data integrity, as the original data are not modified, and hence improve tamper-proofness, as the annotations may not serve for tampering with the original documents.

[0138]

[0145] Alternatively, the document data set or a data element thereof may be modified based on the annotation data.

[0139]

[0146] The annotation step may comprise receiving the annotation data from the HCP- device.

[0140]

[0147] Receiving the annotation data may comprise recording a voice input and processing the voice input by performing the speech recognition step.

[0141]

[0148] Receiving the annotation data from the HCP device and / or the HCP server system may comprise recording the voice input and determining the speaker based on the voice input by performing the voice recognition step.

[0142]

[0149] In other words, analogously to the data receiving step, the user may utilize a microphone equipped dictation device that recognizes the voice of the user and may utilizes speech-to-text technology to annotate the patient consent document data without using an input device like a keyboard or stylus.

[0143]

[0150] The login data may comprise at least one of the voice input and the determined speaker.

[0144]

[0151] Modifying the document data set based on the annotation data may comprise modifying the patient consent document data based on the annotation data.

[0145]

[0152] The method may comprise a signature step.

[0146]

[0153] The signature step may comprise receiving signature data from a signature server. The signature data relate to at least a part of the document data set.

[0154] The signature data may serve for document a consent of the patient and / or for documenting a confirmation of the user that the patient has been informed appropriately.

[0147]

[0155] The signature data may relate to the patient consent document data.

[0148]

[0156] The signature step may comprise sending at least the part of the document data set, particularly the patient consent document data, to the signature server.

[0149]

[0157] At least one of the first server and the HCP-device send the part of the document data set, such as the patient consent document data, to the signature server.

[0150]

[0158] The signature step may comprise the signature server establishing a secure signing environment.

[0151]

[0159] The signature step, particularly establishing the secure signing environment, may comprise establishing an encrypted connection between the signature server and the HCP device.

[0152]

[0160] Establishing the secure signing environment comprises establishing an encrypted connection between the signature server and the patient device.

[0153]

[0161] Thus, secure data transmission and improved privacy with respect to the data relating to the patient may optionally advantageously provided. Further, the content of the data transmission, e.g., the added signature data, may be protected from the first server, even if the data are forwarded by the first server.

[0154]

[0162] The signature step may comprise outputting the part of the document data set, particularly outputting the patient consent document data, and receiving a corresponding approval from the patient device. The approval from the patient device may for example be based on an input received from the patient.

[0155]

[0163] The signature step may comprise outputting the part of the document data set, particularly outputting the patient consent document data, and receiving a corresponding approval from the HCP device. The approval from the HCP device may for example be based on an input received from the user.

[0156]

[0164] Receiving the approval may comprise sensing a signing movement of the patient, particularly sensing biometric properties of a signing movement of the patient. Additionally or alternatively, receiving the approval may comprise sensing a signing movement of the user, particularly sensing biometric properties of a signing movement of the user. Hence, a tamper-proof documentation of the informed consent of the patient may optionally advantageously be provided.

[0165] The signature step may comprise sensing the biometric properties of the signing movement by at least one of the patient device and the HCP-device.

[0157]

[0166] The biometric properties may comprise a plurality of points of the signing movement, a velocity of the signing movement, a pressure of the signing movement and / or an acceleration of the signing movement.

[0158]

[0167] Receiving the approval may comprise receiving data authenticated by a cryptographic signature of the patient device and / or the HCP device. Hence, tamperproofness of the documentation of the informed consent of the patient may optionally advantageously be further improved.

[0159]

[0168] The part of the document data set may comprise the patient information document data. In other words, approval of the patient and / or the user may also be documented with respect to the patient information document data.

[0160]

[0169] The signature step further may comprise sending an indication of an identity of the patient, such as the name and / or date of birth of the patient, to the signature server.

[0161]

[0170] The indication of the identity of the patient may be transmitted from at least one of the HCP device, the patient device and the hospital information system.

[0162]

[0171] In other words, the method may comprise the first server generating the patient consent document data, particularly the document data set, and generating a link to retrieve the patient consent document data, particularly the document data set.

[0163]

[0172] Afterwards, an annotation layer may be added, which may contain annotations, as discussed above. The annotated version, i.e., the modified document data set additionally comprising the annotation data, may then be sent to the signature server. Further, the encrypted connection to the HCP device and / or the patient device may be established and displayed, e.g., by adding a frame in a website, such as a patient portal.

[0164]

[0173] The signature process may then be performed via the encrypted connection, allowing for separation of identity or other private data of the patient from the first server.

[0165]

[0174] The indication of the identity of the patient may be transmitted from the at least one of HCP device, the patient device and the hospital information system to the signature server by means of the encrypted connection.

[0166]

[0175] If the indication of the identity of the patient is transmitted from the hospital information system to the signature server, then the method may further comprise establishing an encrypted connection from the hospital information system to the signature server.

[0176] The method may comprise an archiving step. The archiving step may comprises sending the document data set to an archive server, such as the hospital information system, and storing the document data by the archive server. Thus, optionally advantageously, the data may be stored separate from the first server, which first server receives great amounts of requests with the method of the present disclosure and which first server may thus be more exposed to security risks. Hence, data protection and / or (long term) privacy of the patient may be improved.

[0167]

[0177] The method may comprise using the hospital information system as an archive server. However, also another data processing system may serve as archive server.

[0168]

[0178] The archiving step may comprise sending the signature data to the archive server and storing the signature data by the archive server.

[0169]

[0179] The document data set may comprise the signature data. As discussed with respect to the annotation data, the signature data may be appended to data relating to a document. Alternatively, the document data relating to a document may be modified based on the signature data.

[0170]

[0180] The archiving step may comprise the hospital information system receiving the unique treatment identifier and storing the unique treatment identifier together with the indication of the identity of the patient, such as the name and / or date of birth of the patient.

[0171]

[0181] In other words, by the technical implementation of the signature step and the archiving step, data comprising the indication of the identity of the patient, such as the patient's name, may optionally advantageously not need to be shared with the first server. Thus, privacy of the patient may be preserved independent of the first server. This may be particularly relevant when the first server is operated by another entity, such as a service provider.

[0172]

[0182] The method may further comprise a data clearing step.

[0173]

[0183] The data clearing step may comprise removing the patient data and the treatment data from the first server, particularly after a predetermined amount of time.

[0174]

[0184] The data clearing step may comprise removing the document data set from the first server, particularly after the predetermined amount of time.

[0175]

[0185] The data clearing step may comprise inhibiting access to the video data based on the access data element after the predetermined amount of time.

[0176]

[0186] By the data clearing step, an impact of a security breach of the first server may optionally advantageously be further reduced and hence, privacy of the patient's data that are necessary on the first server for performing the method may further be increased.

[0187] The predetermined amount of time may comprise at most 12 months, preferably at most 6 months, and still more preferably at most 3 months.

[0177]

[0188] The method may comprise a patient login step. For example, the patient login step may be a login step to a patient portal to which the patient device may be connected.

[0178]

[0189] The method may be a computer-implemented method.

[0179]

[0190] The method may be a method for patient information.

[0180]

[0191] Also disclosed are a system and a computer program product. Advantages and details discussed in the context of the method may respectively apply also in the context of the system as well as the computer program product.

[0181]

[0192] In a second embodiment, the system is disclosed. The system is configured for performing the steps of the method. The system comprises the first server, the HCP-device and the patient device.

[0182]

[0193] The system may comprise the video server. The system may particularly be configured for performing the video transmission step.

[0183]

[0194] The system may comprise the authentication server. The system may be configured for performing the HCP login step.

[0184]

[0195] The system may comprise the signature server. The system may be configured for performing the signature step.

[0185]

[0196] The system may comprise the archive server, particularly the hospital information system. The system may be configured for performing the archiving step.

[0186]

[0197] In a third embodiment, a computer program product comprising instructions which, when the program is executed by the system, cause the system to carry out the steps of the method, is disclosed.

[0187]

[0198] Thus, generally, the present invention provides a method and system for generating and delivering personalized medical information to patients, and for documenting informed consent in a verifiable and privacy-conscious manner. The method includes receiving treatment data and / or patient data, selecting relevant information elements to form a patient-specific information data set, and generating a document data set that reflects the information presented and may include consent records.

[0188]

[0199] In some embodiments, the system may incorporate an artificial intelligence model that is trained on historical treatment records, patient demographics, and prior consent data. This model may be used to recommend personalized information elements to include in the patient information data set. Each recommended element may be accompanied by a confidence score indicating the model's certainty, and the system may allow healthcare providers to review, approve, or modify the Al-generated selections before finalization.

[0189]

[0200] The patient data may optionally include psychographic or behavioral information, such as anxiety levels, cognitive load capacity, decision-making styles, and health literacy. This data may be used to adjust the tone, depth, or complexity of the content presented to the patient. For example, the system may present simplified explanations to risk-averse or anxious patients, and more detailed or technical content to patients with higher information-seeking tendencies.

[0190]

[0201] In some cases, the system may present information using an interactive, branched narrative structure that allows the patient to navigate treatment options through scenariobased decision points. These interactive simulations may be rendered on a patient device and may log the path taken by the patient for audit purposes. Each decision path may be uniquely identified and stored as part of the document data set to reflect the patient's interaction history and exposure to specific information.

[0191]

[0202] In certain embodiments, the system may be equipped with affective computing capabilities to monitor patient comprehension and emotional state in real time. Affective computing techniques may include facial expression recognition, eye tracking, speech analysis, or interaction timing metrics. If the system detects confusion or distress, it may pause the content and offer clarification, simplification, or refer the patient to a healthcare provider for further explanation.

[0192]

[0203] The system may also support multilingual and culturally adapted delivery. A multilingual content repository may be used to select appropriate language and culturally relevant content for each patient. Subtitles may be provided in the patient's preferred language, and regional analogies or metaphors may be dynamically included to enhance relatability and understanding. Language preferences may be specified manually or inferred from patient device settings or historical usage.

[0193]

[0204] In some embodiments, the system may be used in the context of clinical trials and support a dynamic consent model. The consent documents may be automatically updated if trial protocols change, with version control metadata included to track revisions. Patients may be notified via secure messaging, and re-consent may be requested through the patient device, enabling continuous compliance with evolving regulatory and ethical requirements.

[0194]

[0205] The system may further include provisions for proxy-based consent, where a legally authorized representative, such as a parent or guardian, provides consent on behalf of the patient. The proxy's identity may be verified using biometric voice recognition or other authentication methods. A co-signed consent document may be generated that includes an indication of proxy authority and associated contact information.

[0195]

[0206] Optionally, the system may include comprehension checkpoints or quizzes embedded within the educational content. The patient's responses may be used to calculate a comprehension score. This score may be stored in the patient information record and may be used to recommend additional resources or to determine whether the patient is eligible to proceed with consent. A minimum comprehension score may be required before a consent action is considered valid.

[0196]

[0207] In some embodiments, the system may support tamper-proof documentation through the use of blockchain technology. A cryptographic hash of the final consent or information record may be generated and stored on a distributed ledger. The hash may be associated with metadata such as the timestamp of document creation and the healthcare provider's identifier. This allows any authorized party to later verify the authenticity of the documentation without accessing the underlying patient data, thereby enhancing privacy and legal defensibility.

[0197]

[0208] Each of the features above may be used independently or in combination, depending on the use case, legal requirements, patient population, or institutional preferences. The present invention may thus enable highly adaptable, secure, and compliant informed consent workflows across a wide variety of healthcare and research environments.

[0198]

[0209] The following embodiments also form part of the invention.

[0199] Method embodiments

[0200]

[0210] Below, embodiments of a method will be discussed. The method embodiments are abbreviated by the letter "M" followed by a number. Whenever reference is herein made to the "method embodiments", these embodiments are meant.

[0201] Ml. A method comprising

[0202] - a data receiving step comprising receiving treatment data and / or patient data, an information selecting step comprising generating a patient information data set, and

[0203] - a document data generating step comprising generating a document data set based on the patient information data set.

[0204] M2. The method according to the preceding embodiment, wherein the method comprises a video data providing step. M3. The method according to any of the preceding embodiments, wherein the method comprises a video transmission step comprising transmitting video data from a video server to a patient device.

[0205] M4. The method according to any of the preceding embodiments with the features of M3, wherein the video transmission step comprising outputting the video data, particularly by the patient device.

[0206] M5. The method according to any of the preceding embodiments, wherein the method further comprises an HCP login step, wherein the HCP login step comprises receiving login data from a user by means of an HCP-device.

[0207] M6. The method according to the preceding embodiment, wherein the HCP login step comprises transmitting the login data to at least one of a first server and an authentication server.

[0208] M7. The method according to any of the preceding embodiments with the features of M5, wherein the HCP login step comprises receiving an authentication result from the authentication server, particularly by at least one of the HCP-device and the first server.

[0209] M8. The method according to any of the preceding embodiments with the features of M5, wherein the HCP login step comprises generating the authentication result by the first server.

[0210] M9. The method according to any of the preceding embodiments with the features of M5, wherein the login data comprise an indication of the user and a password.

[0211] MIO. The method according to the preceding embodiment, wherein the login data further comprise an IP-address of the HCP device.

[0212] Mil. The method according to any of the preceding embodiments with the features of M5, wherein the HCP login step comprises selecting the authentication server based on the login data.

[0213] M12. The method according to any of the preceding embodiments with the features of at least one of M7 and M8, wherein the HCP login step comprises only continuing the method once the authentication result is positive.

[0214] M13. The method according to any of the preceding embodiments, wherein the data receiving step comprises the first server receiving the treatment data and / or the patient data.

[0215] M14. The method according to any of the preceding embodiments, wherein the treatment data comprise an indication of at least one medical treatment. M15. The method according to the preceding embodiment, wherein the treatment data further comprise an indication of procedural details of the at least one medical treatment.

[0216] M16. The method according to any of the preceding embodiments, wherein the treatment data comprise an indication of a medical domain.

[0217] M17. The method according to any of the preceding embodiments, wherein the patient data comprise an indication of a sex of the patient.

[0218] M18. The method according to any of the preceding embodiments, wherein the patient data comprise medical data relating to the patient.

[0219] M19. The method according to any of the preceding embodiments, wherein the patient data do not comprise a name of the patient.

[0220] M20. The method according to any of the preceding embodiments, wherein the method comprises generating a unique treatment identifier.

[0221] M21. The method according to the preceding embodiment, wherein the method comprises associating the treatment data and the patient data, particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier.

[0222] M22. The method according to any of the preceding embodiments with the features of M20, wherein the data receiving step comprises generating the unique treatment identifier.

[0223] M23. The method according to any of the preceding embodiments with the features of M21, wherein the data receiving step comprises associating the treatment data and the patient data, particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier.

[0224] M24. The method according to any of the preceding embodiments, wherein the data receiving step comprises receiving the data from the HCP device and / or an HCP server system.

[0225] M25. The method according to the preceding embodiment, wherein receiving the data from the HCP device and / or the HCP server system comprises recording a voice input and processing the voice input by performing a speech recognition step.

[0226] M26. The method according to any of the two preceding embodiments, wherein receiving the data from the HCP device and / or the HCP server system comprises recording the voice input and determining a speaker based on the voice input by performing a voice recognition step.

[0227] M27. The method according to any of the preceding embodiments with the features of M5 and M26, wherein the login data comprise at least one of the voice input and the determined speaker. M28. The method according to any of the preceding embodiments, wherein in the information selecting step, generating the patient information data set is based on a set of selected information elements, and wherein the information selecting step comprises receiving the set of selected information elements, particularly by means of the HCP- device.

[0228] M29. The method according to the preceding embodiment, wherein the information selecting step comprises receiving confirmation data relating to the set of selected information elements by means of the HCP-device.

[0229] M30. The method according to any of the preceding embodiments, wherein the information selecting step comprises outputting a recommended set of information elements by the HCP-device.

[0230] M31. The method according to the preceding embodiment, wherein the information selecting step comprises generating the recommended set of information elements by the first server based on the patient data and / or the treatment data and transmitting the recommended set of information elements from the first server to the HCP-device.

[0231] M32. The method according to any of the preceding embodiments, wherein the information selecting step comprises storing the patient information data set by the first server, particularly temporarily storing the patient information data set by the first server.

[0232] M33. The method according to any of the preceding embodiments with the features of M20, wherein the information selecting step comprises generating the unique treatment identifier, and wherein the set of selected information elements is associated with the unique treatment identifier.

[0233] M34. The method according to any of the preceding embodiments with the features of M20, wherein the unique treatment identifier comprises an alphanumeric string.

[0234] M35. The method according to any of the preceding embodiments with the features of M2, wherein the video data providing step comprises generating an access data element, such as a link.

[0235] M36. The method according to the preceding embodiment and with the features of M33, wherein the access data element can be unambiguously assigned to a set of selected information elements associated with the unique treatment identifier.

[0236] M37. The method according to any of the two preceding embodiments, wherein the access data element is unique.

[0237] M38. The method according to any of the preceding embodiments with the features of M35 and M20, wherein the access data element comprises an indication of the unique treatment identifier. M39. The method according to any of the preceding embodiments with the features of M2 and M28, wherein the video data providing step comprises providing video data corresponding to the set of selected information elements.

[0238] M40. The method according to any of the preceding embodiments with the features of M28, wherein each of the information elements corresponds to a video section data element.

[0239] M41. The method according to any of the preceding embodiments with the features of M20, wherein the video data providing step comprises generating the unique treatment identifier.

[0240] M42. The method according to any of the preceding embodiments with the features of M20, wherein the video data providing step comprises associating the access data element with the unique treatment identifier.

[0241] M43. The method according to any of the preceding embodiments with the features of M21, wherein the video data providing step comprises associating the treatment data and the patient data, particularly the data relating to the at least one treatment of the patient, with the unique treatment identifier.

[0242] M44. The method according to any of the preceding embodiments with the features of M39, wherein providing the video data corresponding to the set of selected information elements comprises generating a playlist data element comprising a plurality of links, each link directing to a video section data element, and wherein the video data comprise the playlist data element.

[0243] M45. The method according to the preceding embodiment and with the features of M3, wherein each of the links of the playlist data element directs to a video section data element stored on the video server.

[0244] M46. The method according to any of the preceding embodiments, wherein the method comprises storing a timestamp of the generating of the playlist data element.

[0245] M47. The method according to any of the preceding embodiments with the features of M44 and M35, wherein the access data element comprises a link to the playlist data element.

[0246] M48. The method according to any of the preceding embodiments with the features of M44 and M3, wherein the video data comprise the video section data elements specified by the plurality of links, and wherein transmitting the video data from the video server to the patient device comprises transmitting the video section data elements from the video server to the patient device. M49. The method according to any of the preceding embodiments with the features of M39 but embodiments M44 to M48, wherein providing the video data corresponding to the set of selected information elements comprises generating a merged video data element based on a plurality of video section data elements.

[0247] M50. The method according to the preceding embodiment, wherein each video section data element corresponds to a selected information element.

[0248] M51. The method according to any of the preceding embodiments with the features of M49, wherein the method comprises storing a timestamp of the generating of the merged video data element.

[0249] M52. The method according to any of the preceding embodiments with the features of M49, wherein providing the video data corresponding to the set of selected information elements comprises transmitting the video data element to the video server and storing the video data element on the video server.

[0250] M53. The method according to the preceding embodiment and with the features of M35, wherein the access data element comprises a link to the merged video data element, and wherein the video data element is stored on the video server.

[0251] M54. The method according to any of the preceding embodiments with the features of M49 and M3, wherein the video data comprise the merged video data element.

[0252] M55. The method according to any of the preceding embodiments with the features of M40, wherein each video section data element is associated with a video section identifier.

[0253] M56. The method according to any of the preceding embodiments with the features of M40, wherein each video section data element is associated with a video section text element.

[0254] M57. The method according to any of the preceding embodiments with the features of M55, wherein the method comprises upon a modification of a video section data element, generating a new video section identifier for the modified video section data element.

[0255] M58. The method according to any of the preceding embodiments, wherein the first server performs the document data generating step.

[0256] M59. The method according to any of the preceding embodiments, wherein the document data set comprises data representative of at least one or a plurality of document(s).

[0257] M60. The method according to any of the preceding embodiments, particularly with the features of M20, wherein the document data set comprises patient consent document data, particularly wherein the patient consent document comprises an indication of the unique treatment identifier. M61. The method according to any of the preceding embodiments, particularly with the features of M20, wherein the document data set comprises a patient information record, particularly wherein the patient information record comprises an indication of the unique treatment identifier.

[0258] M62. The method according to any of the preceding embodiments, particularly with the features of M20, wherein the document data set comprises patient information document data, particularly wherein the patient information document comprises an indication of the unique treatment identifier.

[0259] M63. The method according to any of the preceding embodiments with the features of M60 and M35, wherein the patient consent document data comprise an indication of the access data element, such as an indication of the link.

[0260] M64. The method according to any of the preceding embodiments with the features of M60 and at least one of M46 or M51, wherein the patient consent document data comprise an indication of the timestamp of the generating of the playlist and / or the merged video data element.

[0261] M65. The method according to any of the preceding embodiments with the features of M61 and M35, wherein the patient information record comprises an indication of the access data element, such as an indication of the link.

[0262] M66. The method according to any of the preceding embodiments with the features of M40, M61 and M56, wherein the patient information record comprises the video section text elements associated with the video section data element to which the information elements correspond.

[0263] M67. The method according to any of the preceding embodiments with the features of M40, M61 and M55, wherein the patient information record comprises indications of the video section identifiers associated with the video section data element to which the information elements correspond.

[0264] M68. The method according to any of the preceding embodiments with the features of M61, wherein the patient information record comprises an indication of a timestamp of the generating of the patient information record.

[0265] M69. The method according to any of the preceding embodiments with the features of M62 and M35, wherein the patient information document data comprise an indication of the access data element, such as an indication of the link.

[0266] M70. The method according to any of the preceding embodiments with the features of M5 and M58, particularly with the features at least one of M61 and M62, wherein the document data set, particularly the patient information record and / or the patient information document data, comprise an indication of an identity of the health care provider, such as a name of the health care provider and / or an indication of a health facility.

[0267] M71. The method according to the preceding embodiment, wherein the method comprises determining the indication of the identity of the health care provider based on the login data.

[0268] M72. The method according to any of the preceding embodiments with the features of M58, M60 and M62, wherein the document data generating step comprises transmitting the patient consent document data and the patient information document data from the first server to the HCP-device.

[0269] M73. The method according to the preceding embodiment and with the features of M61, wherein the document data generating step further comprises transmitting the patient information record from the first server to the HCP-device.

[0270] M74. The method according to any of the preceding embodiments with the features of M35, wherein the method comprises providing the patient with the access data element, such as an indication of the link.

[0271] M75. The method according to the preceding embodiment and with the features of M58, M60 and M62, wherein the method comprises providing the patient with the patient consent document data and the patient information document data.

[0272] M76. The method according to any of the two preceding embodiments, wherein providing the patient with the access data element, particularly with the patient consent data document data and the patient information document data, comprises sending these data to the patient device.

[0273] M77. The method according to the preceding embodiment, wherein sending these data to the patient device comprises

[0274] - generating, particularly by the first server, a link to retrieve these data, and sending the link to the patient device, e.g. by at least one of e-mail, SMS and an internet protocol-based messaging service.

[0275] M78. The method according to any of the preceding embodiments with the features of M74 and M75, wherein providing the patient with the access data element, particularly with the patient consent document data and the patient information document data, comprises sending these data to a printing server, particularly by at least one of the HCP- device and first server.

[0276] M79. The method according to any of the preceding embodiments with the features of M74 and M75, wherein providing the patient with the access data element, particularly with the patient consent document data and the patient information document data, comprises sending these data by the HCP-device.

[0277] M80. The method according to any of the preceding embodiments with the features of M3 and M35, wherein the video transmission step comprises receiving a request based on the access data element from the patient device and transmitting the video data from the video server to the patient device in response to the request.

[0278] M81. The method according to the preceding embodiment and with the features of M44, wherein the transmission step further comprises transmitting the playlist data element to the patient device.

[0279] M82. The method according to the preceding embodiment, wherein the transmission step further comprises transmitting the playlist data element from the first server to the patient device.

[0280] M83. The method according to any of the preceding embodiments with the features of M3, wherein in the video transmission step, the video server provides the video data for streaming to the patient device, particularly wherein the video server performs segment delivery of segments of the video data.

[0281] M84. The method according to any of the preceding embodiments with the features of M3, wherein the video transmission step comprises generating at least one timestamp associated with a transmission of the video data to the patient device.

[0282] M85. The method according to the preceding embodiment and with the features of M44, wherein the at least one timestamp is associated with a transmission of the playlist data element to the patient device.

[0283] M86. The method according to any of the two preceding embodiments and with the features of M60, wherein the patient consent document data comprise an indication of the timestamp of the transmission of the video data to the patient device.

[0284] M87. The method according to any of the two preceding embodiments and with the features of M61, wherein the patient information record comprises an indication of the timestamp of the transmission of the video data to the patient device.

[0285] M88. The method according to any of the preceding embodiments with the features of M58, wherein the method comprises an annotation step, wherein the annotation step comprises receiving annotation data and modifying the document data set based thereon.

[0286] M89. The method according to the preceding embodiment, wherein the annotation step comprises receiving the annotation data from the HCP-device. M90. The method according to any of the preceding embodiments with the features of M88, wherein receiving the annotation data comprises recording a voice input and processing the voice input by performing the speech recognition step.

[0287] M91. The method according to any of the two preceding embodiments, wherein receiving the annotation data from the HCP device and / or the HCP server system comprises recording the voice input and determining the speaker based on the voice input by performing the voice recognition step.

[0288] M92. The method according to the preceding embodiment, wherein the login data comprise at least one of the voice input and the determined speaker.

[0289] M93. The method according to any of the preceding embodiments with the features of M60 and M88, wherein modifying the document data set based on the annotation data comprises modifying the patient consent document data based on the annotation data.

[0290] M94. The method according to any of the preceding embodiments, wherein the method comprises a signature step.

[0291] M95. The method according to the preceding embodiment, wherein the signature step comprises receiving signature data from a signature server, wherein the signature data relate to at least a part of the document data set.

[0292] M96. The method according to the preceding embodiment and with the features of M60, wherein the signature data relate to the patient consent document data.

[0293] M97. The method according to any of the two preceding embodiments, wherein the signature step comprises sending at least the part of the document data set, particularly the patient consent document data, to the signature server.

[0294] M98. The method according to the preceding embodiment, wherein at least one of the first server and the HCP-device send the part of the document data set to the signature server.

[0295] M99. The method according to any of the preceding embodiments with the features of M95, wherein the signature step comprises the signature server establishing a secure signing environment.

[0296] M100. The method according to any of the preceding embodiments with the features of M95, particularly according to the preceding embodiment, wherein the signature step, particularly establishing the secure signing environment, comprises establishing an encrypted connection between the signature server and the HCP device.

[0297] M101. The method according to any of the preceding embodiments with the features of M95, particularly according to any of the two preceding embodiments, wherein establishing the secure signing environment comprises establishing an encrypted connection between the signature server and the patient device.

[0298] M102. The method according to any of the preceding embodiments with the features of M95, wherein the signature step comprises outputting the part of the document data set, particularly outputting the patient consent document data, and receiving a corresponding approval from the patient device.

[0299] M103. The method according to any of the preceding embodiments with the features of M95, particularly according to the preceding embodiment, wherein the signature step comprises outputting the part of the document data set, particularly outputting the patient consent document data, and receiving a corresponding approval from the HCP device.

[0300] M104. The method according to any of the preceding two embodiments, wherein receiving the approval comprises sensing a signing movement of the patient and / or the user, particularly sensing biometric properties of a signing movement of the patient and / or the user.

[0301] M105. The method according to any of the preceding embodiments with the features of M104, wherein the signature step comprises sensing the biometric properties of the signing movement by at least one of the patient device and the HCP-device.

[0302] M106. The method according to any of the two preceding embodiments, wherein the biometric properties comprise a plurality of points of the signing movement, a velocity of the signing movement, a pressure of the signing movement and / or an acceleration of the signing movement.

[0303] M107. The method according to any of the preceding embodiments with the features of M102, wherein receiving the approval comprises receiving data authenticated by a cryptographic signature of the patient device and / or the HCP device.

[0304] M108. The method according to any of the preceding embodiments with the features of M97 and M62, wherein the part of the document data set comprises the patient information document data.

[0305] M109. The method according to any of the preceding embodiments with the features of M97, wherein the signature step further comprises sending an indication of an identity of the patient, such as the name and / or date of birth of the patient, to the signature server.

[0306] MHO. The method according to the preceding embodiment, wherein the indication of the identity of the patient is transmitted from at least one of the HCP device, the patient device and the hospital information system.

[0307] Mill. The method according to the preceding embodiment, particularly with the features of at least one of M100 and M101, wherein the indication of the identity of the patient is transmitted from the at least one of the HCP device, the patient device and the hospital information system to the signature server by means of the encrypted connection.

[0308] M112. The method according to any of the preceding embodiments, wherein the method comprises an archiving step, wherein the archiving step comprises sending the document data set to an archive server, such as a hospital information system, and storing the document data by the archive server.

[0309] M113. The method according to the preceding embodiment, wherein the archiving step comprises further sending the signature data to the archive server, such as the hospital information system, and storing the signature data by the archive server.

[0310] Ml 14. The method according to any of the preceding embodiments with the features of M95, wherein the document data set comprises the signature data.

[0311] M115. The method according to any of the preceding embodiments with the features of M20, wherein the archiving step comprises the hospital information system receiving the unique treatment identifier and storing the unique treatment identifier together with the indication of the identity of the patient, such as the name and / or date of birth of the patient.

[0312] M116. The method according to any of the preceding embodiments, wherein the method comprises a data clearing step.

[0313] Ml 17. The method according to the preceding embodiment, wherein the data clearing step comprises removing the patient data and the treatment data from the first server, particularly after a predetermined amount of time.

[0314] Ml 18. The method according to any of the two preceding embodiments, wherein the data clearing step comprises removing the document data set from the first server, particularly after the predetermined amount of time.

[0315] Ml 19. The method according to any of the preceding embodiments with the features of M35, wherein the data clearing step comprises inhibiting access to the video data based on the access data element after the predetermined amount of time.

[0316] M120. The method according to any of the three preceding embodiments, wherein the predetermined amount of time comprises at most 12 months, preferably at most 6 months, and still more preferably at most 3 months.

[0317] M121. The method according to any of the preceding embodiments, wherein the method comprises a patient login step.

[0318] M122. The method according to any of the preceding embodiments, wherein the method is a computer-implemented method. M123. The method according to any of the preceding embodiments, wherein the method is a method for patient information.

[0319] M124. The method according to any of the preceding method embodiments, wherein the information selecting step further comprises using an artificial intelligence model trained on prior treatment outcomes to recommend personalized information elements for inclusion in the patient information data set.

[0320] M125. The method according to the preceding embodiment, wherein the artificial intelligence model is trained using a treatment database comprising outcome data, demographic data, and prior patient education records.

[0321] M126. The method according to any of the 2 preceding embodiments, wherein the artificial intelligence model generates a confidence score for each recommended information element, and the information selecting step includes only those elements above a predefined threshold.

[0322] M 127. The method according to any of the 3 preceding embodiments, wherein a healthcare provider is prompted to approve, reject, or revise the Al-generated information elements prior to finalizing the patient information data set.

[0323] M128. The method according to any of the preceding embodiments, wherein the data receiving step further comprises receiving psychographic or behavioral profile data of the patient, and the information selecting step adjusts the patient information data set based on a psychological risk tolerance model.

[0324] M129. The method according to the preceding embodiment, wherein the psychographic profile data includes anxiety levels, information-seeking behavior, or past medical experiences.

[0325] M130. The method according to any of the 2 preceding embodiments, wherein a different visual or narrative style is selected for video content based on the patient's psychographic profile.

[0326] M131. The method according to any of the 3 preceding embodiments, wherein the method comprises limiting exposure to complex risk elements unless a high information-seeking score is detected.

[0327] M132. The method according to any of the preceding method embodiments, wherein the document data generating step further comprises generating an interactive informed consent simulation comprising branched narratives rendered on a patient device.

[0328] M133. The method according to the preceding embodiment, wherein the branched narratives are based on patient choices in real time. M134. The method according to any of the 2 preceding embodiments, wherein each branch is logged and stored with a unique branch path identifier.

[0329] M135. The method according to any of the 3 preceding embodiments, wherein a summary of the patient's chosen branches is embedded into the document data set for auditability.

[0330] M136. The method according to any of the preceding method embodiments, further comprising a comprehension sensing step comprising monitoring patient interactions and measuring indicators of confusion or distress using affective computing techniques, and modifying the patient information data set based on the measured indicators.

[0331] M137. The method according to the preceding embodiment, wherein patient eye tracking, facial expression analysis, or voice sentiment is used to assess comprehension.

[0332] M 138. The method according to any of the 2 preceding embodiments, wherein the method comprises automatically pausing the video and prompting a simplified explanation if distress is detected.

[0333] M139. The method according to any of the 3 preceding embodiments, wherein a comprehension flag is included in the patient information record.

[0334] M140. The method according to any of the preceding method embodiments, wherein the information selecting step includes selecting from a multilingual content repository and generating the patient information data set in a language matching a language preference associated with the patient data.

[0335] M141. The method according to the preceding embodiment, wherein subtitle data is dynamically translated into the patient's preferred language and synchronized with the video content.

[0336] M142. The method according to any of the 2 preceding embodiments, wherein the method comprises including culturally adapted examples or analogies relevant to the patient's geographic region.

[0337] M143. The method according to any of the 3 preceding embodiments, wherein the language preference is inferred from prior interaction history or device settings.

[0338] M144. The method according to any of the preceding method embodiments, wherein the document data generating step further comprises generating a clinical trial-specific dynamic consent document, the contents of which are automatically updated based on changes in protocol, and transmitting an updated document data set to a patient device.

[0339] M145. The method according to the preceding embodiment, wherein version control metadata is included in the consent document to track protocol changes. M146. The method according to any of the 2 preceding embodiments, wherein patients are notified, via a secure messaging interface, of protocol updates and are prompted to reconsent.

[0340] M147. The method according to any of the 3 preceding embodiments, wherein multiple trial sites can access a synchronized document state via a central compliance server.

[0341] M148. The method according to any of the preceding method embodiments, wherein the data receiving step comprises receiving voice input from a caregiver or proxy, and wherein the document data generating step comprises generating a co-signed patient information record acknowledging proxy consent.

[0342] M149. The method according to the preceding embodiment, wherein the voice input is authenticated via a biometric voiceprint linked to the caregiver's user ID.

[0343] M150. The method according to any of the 2 preceding embodiments, wherein the cosigned document includes an explicit declaration of proxy legal authority.

[0344] M151. The method according to any of the 3 preceding embodiments, wherein the proxy's contact details are included in the patient information record for verification.

[0345] M152. The method according to any of the preceding method embodiments, wherein the document data set includes a patient comprehension score derived from patient responses to embedded comprehension checkpoints within video or document content.

[0346] M153. The method according to the preceding embodiment, wherein the comprehension score is based on multiple-choice or open-text responses given by the patient during a video session.

[0347] M154. The method according to any of the 2 preceding embodiments, wherein the score is used to suggest additional educational materials post-session.

[0348] M155. The method according to any of the 3 preceding embodiments, wherein a threshold comprehension score is required before consent can be digitally accepted.

[0349] M156. The method according to any of the preceding method embodiments, wherein the document data generating step comprises generating a blockchain-signed hash of the patient information data set and storing the hash on a distributed ledger for verification purposes.

[0350] M157. The method according to the preceding embodiment, wherein the hash is generated using a cryptographic algorithm and includes the unique treatment identifier.

[0351] M158. The method according to any of the 2 preceding embodiments, wherein an access timestamp and healthcare provider identity are recorded on the blockchain along with the hash. M159. The method according to any of the 3 preceding embodiments, wherein a verification module authenticates the document data set using the stored hash.

[0352] System embodiments

[0353]

[0211] Below, embodiments of a system will be discussed. The system embodiments are abbreviated by the letter "S" followed by a number. Whenever reference is herein made to the "system embodiments", these embodiments are meant.

[0354] 51. A system configured for performing the steps of the method according to any of the method embodiments, the system comprising a first server, an HCP-device and a patient device.

[0355] 52. The system according to the preceding embodiment, wherein the system further comprises a video server, and wherein the system is configured for performing the steps of the method with the features of M3 or any method embodiment dependent thereon.

[0356] 53. The system according to any of the preceding system embodiments, wherein the system further comprises an authentication server, and wherein the system is configured for performing the steps of the method with the features of M5 or any embodiment dependent thereon.

[0357] 54. The system according to any of the preceding system embodiments, wherein the system further comprises a signature server, and wherein the system is configured for performing the steps of the method with the features of M94 or any embodiment dependent thereon.

[0358] 55. The system according to any of the preceding system embodiments, wherein the system further comprises an archive server, particularly a hospital information system, and wherein the system is configured for performing the method with the features of Ml 12 or any embodiment dependent thereon.

[0359] Computer program product embodiments

[0360]

[0212] Below, embodiments of a computer program product will be discussed. These embodiments are abbreviated by the letter "C" followed by a number. Whenever reference is herein made to the "computer program product embodiments", these embodiments are meant.

[0361] Cl. A computer program product comprising instructions which, when the program is executed by a system according to any of the system embodiments, cause the system to carry out the steps of the method according to any of the method embodiments.

[0362]

[0213] Exemplary features of the invention are further detailed in the figures and the below description of the figures. Brief description of the figures

[0363] Fig. 1 shows a system configured for performing a method

[0364] Fig. 2a shows another embodiment of the system

[0365] Fig. 2b shows still another embodiment of the system

[0366] Fig. 3 shows an embodiment of a method

[0367] Fig. 4 shows another embodiment of the method

[0368] Detailed figure description

[0369]

[0214] For the sake of clarity, some features may only be shown in some figures, and others may be omitted. However, also the omitted features may be present, and the shown and discussed features do not need to be present in all embodiments.

[0370]

[0215] Fig. 3 shows an exemplary embodiment of a method. The method may for example be a method for providing data for informed consent of a patient.

[0371]

[0216] The exemplary method comprises a data receiving step, which comprises receiving treatment data 30 from a health care provider device 10 (in the following: HCP-device) by a first server 12. The treatment data relate to a medical treatment, such as a surgical intervention, for a patient. For example, a HCP user selects details about the treatment (e.g. surgery method, type of anaesthesia) and inputs these to the HCP device 10.

[0372]

[0217] The data receiving step further comprises receiving patient data relevant for the treatment, such as background data about the patient (demographic data, historic medical data or data about a health status of the patient).

[0373]

[0218] Alternatively, this data can be received by the first server 12 from another server, for example a health care provider server system 16 (in the following : HCP server system 16). For example, data from an electronic health record relating to the patient can be transmitted via an API to the first server 12.

[0374]

[0219] The exemplary method further optionally comprises generating a recommended set of information elements 34. The recommended set of information elements 34 comprises for example references to information that is relevant for the patient to give his / her informed consent, e.g., details relating to the treatment, risks associated with the treatment, or instructions to follow after the treatment.

[0375]

[0220] The recommendation may for example be generated based on a database, priorcases, a rule-based engine or a trained machine learning model.

[0221] The method also comprises an information selecting step. The first server 12 receives a set of selected information elements 36. In the example of Fig. 3, the set of selected information elements 36 is input by means of the HCP-device 10. For example, the HCP user inputs the information elements to the HCP-device 10, for example by confirming or modifying the recommended set of information elements 34, and / or by choosing information elements 34 for example from a library of information elements.

[0376]

[0222] The information elements correspond to video section data elements (not shown). Each video section data element relates to a certain information, e.g., a certain risk, a detail of the treatment or an instruction for behaviour post-surgery. In the example of Fig. 3, each video section data element is associated with a video section identifier configured for unambiguously identifying the video section data element. Thus, based on the identifiers, a video comprising a plurality of video section data element can be identified in future without having access to the video or the video section data elements.

[0377]

[0223] The set of selected information elements 36 may also be referred to as a video list, e.g., a playlist. In other words, upon receiving a recommended playlist, the HCP can edit this playlist and add or remove information and then confirm his choices.

[0378]

[0224] The method of Fig. 3 also comprises a video data providing step. The video data providing step comprises providing video data corresponding to the set of selected information elements.

[0379]

[0225] The video data providing step may for example comprise generating a playlist data element. The playlist data element may comprise a plurality of links, each link directing to a video section data element. In this case, the video section data elements can be retrieved from a video server 14 and the links ultimately direct to the video server.

[0380]

[0226] The video data providing step may also comprise generating a merged video data element based on the plurality of video section data elements specified by the set of selected information elements. In this case, the merged video data element is stored by the video server 14 and can be retrieved from there.

[0381]

[0227] The video server 14 in the example of Fig. 3 is suitable for sending a large volume of data to computer devices. Thus, efficiency of the system may be increased compared to providing video data by the first server 12.

[0382]

[0228] The video data providing step further comprises an access data element 40. The access data element 40 in the example of Fig. 3 comprises a link which is unique for each set of selected information elements 36. If the video data providing step comprising generating the playlist data element, the link directs to the playlist data element. The playlist data element may be stored and retrieved from the video server 14, the first server 12 or another computer system.

[0383]

[0229] If the video data providing step comprises generating the merged video data element, the link directs to the merged video data element stored on the video server 14.

[0384]

[0230] In the example of Fig. 3, the access data element 40 is provided to the HCP-device 10. Further, the access data element 40 is provided to a patient device 18. The patient device is an end user computer device for use by the patient or a legal representative, such as a parent of a patient who is a minor or a custodian of a patient who is unable to give an informed consent.

[0385]

[0231] The exemplary method further comprises a video transmission step. By means of the access data element 40, the video data 44 are transmitted from the video server 14 to the patient device 18. For example, the video data may be streamed to the patient device 18 from the video server 14, thus allowing for faster outputting. Alternatively, the video data may also be downloaded and then be outputted on the patient device 18. In the example of Fig. 3, the video transmission step further comprises outputting the video data by the patient device 18.

[0386]

[0232] In the example of Fig. 3, the video server 14 inhibits modification of video data accessible by a link. Thus, the video data provided in response to the access data element 40 may optionally be more tamperproof and it may be easier to determine which video data where indeed available. In the field of informed consent, the question which data have been available may become relevant years after the treatment. It may thus be optionally advantageous to be able to determine which video data where indeed available or provided.

[0387]

[0233] Additionally, using the video server 14 may increase security, as the video server 14 may be accessed by the patient device 18 for retrieving the video, access to the first server 12 and the HCP-device 10 by the patient device 18 is not necessary. The HCP-device 10 can thus be located in a local network where it is not directly accessible to devices outside the local network.

[0388]

[0234] Further, optionally advantageously, privacy may be increased without decreasing efficiency, as the video data can be transmitted to the patient device 18 without interaction to the first server 12. Thus, combining the treatment data 30 and / or patient data received by the first server 12 with an identity of the patient device 18 can be inhibited or rendered more difficult if desired. An alternative, but less efficient implementation to achieve this effect would be transmitting the video data as a whole via the HCP-device 10 or another computer system.

[0235] The exemplary method of Fig. 3 further comprises a document data generating step. The document data generating step comprises generating a document data set 42. The document data set comprises at least one document. In the example of Fig. 3, the document data set comprises a patient consent document data 46 corresponding to a patient consent document. The patient consent document 46 may also be referred to as informed consent sheet.

[0389]

[0236] In the example of Fig. 3, the patient consent document or another document of the document data set comprises a representation of the access data element 42, e.g., a text string corresponding to the link or a QR-code corresponding to the link.

[0390]

[0237] The document data set 42 further comprises a patient information record (not shown in Fig. 3). The patient information record comprises an indication of the access data element 40 as well as the video section identifiers corresponding to the video section data elements to which the video data correspond. Optionally, the patient information record further comprises video section text elements corresponding to the video section data elements of the video data 44.

[0391]

[0238] Thus, an unambiguous indication of the video section data elements may optionally advantageously be stored in a reliable and storage-efficient manner: It may be not necessary to store each generated video data, but it may be sufficient to store relations between the video section identifiers and the video data sections or indications of their content.

[0392]

[0239] In an embodiment not shown in Fig. 3, the document data set 42 comprises patient information document data. The patient document data correspond to a document comprising the indication of the video data. The patient document data can for example be transmitted from the HCP-device 10 to the patient device 18 independent of the first server 12. Thus, privacy of the patient may optionally advantageously be increased, as an identity of the patient device may be obscured to the first server 12.

[0393]

[0240] Further, the method comprises a signature step. In the example of Fig. 3, the signature step comprises providing the patient consent document data 46 to a signature server. The signature server 24 provides the patient device 18 with access to a signing environment. The signing environment comprises a version of the patient consent document data 46a for signing by the patient, e.g., comprising a modifiable field for a signature.

[0394]

[0241] The signature may be provided physically, e.g., by performing a signing movement that is captured by the patient device 18 or another end user computer device. In this case, e.g., at least one biometric property of the signing movement is sensed and stored by the patient device 18 or the other end user computer device. The signature may also be provided cryptographically, e.g., by use of a corresponding certificate.

[0395]

[0242] In the example of Fig. 3, the signature server 24 also provides the HCP-device 10 with access to the signing environment, comprising a version of the patient consent document data 46a for signing by the HCP and captures the signature as set out above. It is to be noted that the signature of the HCP may be of a different type than the signature of the patient, e.g., in a case where the HCP uses a cryptographic certificate and the patient does not. Data relating to the signature of the patient 48a and the HCP 48b are transmitted to the signature server 24. These data relate, e.g., to the to the biometric property of the signing movement and / or the cryptographic signature.

[0396]

[0243] Corresponding services are available for example by Signaturit Solutions, S.L., Barcelona, Spain or DocuSign, Inc., San Francisco, CA (US).

[0397]

[0244] In the example of Fig. 3, for increased privacy, the document data to be signed are sent to the signature server 24 by the HCP-device 10. However, additionally or alternatively, a HCP server system, such as a Hospital information system 16 may transmit the data to the signature server 24.

[0398]

[0245] The signature step may comprise adding personal data, such as a name of the patient and / or the HCP, to the document data, e.g., to the patient consent document data 46. The data may e.g. be added based on input of the HCP-device 10. Thus, privacy may optionally advantageously be increased, as these data do not need to be shared with the first server 12.

[0399]

[0246] Fig. 4 shows another embodiment of the method. The embodiment of the method comprises several steps discussed with respect to Fig. 3. Further, the method comprises an archiving step. In the archiving step, the document data set 42 is sent to an archive server, such as the HCP server system 16. Further, the signature data 48 are sent to the HCP server system 16. In Fig. 4, the signature server 24 sends the signature data 48 to the HCP server system 16.

[0400]

[0247] However, the signature server 24 may also send the signature data to the HCP- device 10, which may then for example forward the signature data 48 to the archive server, or modify the document data set 42 based on the signature data 48. Modifying the document data set 42 may for example comprise appending the signature data 48 to the data set or document data thereof, or otherwise modifying data relating to a document of the document data set. For example, data indicative of the signature or its at least one biometric property may be added or inserted.

[0248] By using an archive server, such as the HCP server system 16, privacy may be further increased, as read access to the archive server may be limited and can thus be implemented in a more secure manner, reducing a risk of unauthorized access.

[0401]

[0249] Fig. 1 shows an embodiment of a system related to the method. The system comprises the HCP-device 10, the first server 12, the video server 14 and the patient device 18.

[0402]

[0250] As discussed above, the data receiving step comprises receiving treatment data 30 and / or patient data by the first server 12. In the example of Fig. 1, the treatment data 30 and / or the patient data (not shown) are received from the HCP-device 10.

[0403]

[0251] Further, data is transmitted from the HCP-device 10 to the patient device 18, particularly data from the document data set. However, while the data transfer is indicated from the HCP-device 10 to the patient device 18, in some cases, for easier use and / or for more efficient data transmission, the document data set or a part thereof may be transmitted directly from the first server 12 to the patient device 18. In order to preserve privacy of the patient, highly sensitive personal data such as the patient's name and / or date of birth may optionally not be indicated in said part of the document data.

[0404]

[0252] The data transmitted from the HCP-device 10 to the patient device 18 may comprise data indirectly transmitted from the first server 12 to the patient device 18, for example the access data element 40.

[0405]

[0253] Based on the access data element 40, the video data 44 are transmitted to the patient device 18.

[0406]

[0254] Fig. 2a shows another embodiment of the system, which also relates to the above discussed method. Further shown is a printing server 20, which receives from the HCP- device 10 data for printing, which data comprise a representation of the access data element 40 for the patient, e.g., corresponding document data of the document data set 42. The printing server 20 is configured for causing a printer to print the corresponding document comprising the representation of the access data element 40.

[0407]

[0255] Further, Fig. 2a additionally shows the HCP server system 16. The HCP server system 16 may be a concrete example of the archive server. In some embodiments, the HCP server system 16 may be located in a same network as the HCP-device 10. In other embodiments, the HCP server system 16 may comprise a server performing the archiving, e.g., long-time storing, of the corresponding data.

[0408]

[0256] Fig. 2b shows additionally shows an embodiment of the system, which relates to the signature step of the method. Further, the example shown in Fig. 2b comprises an HCP login step.

[0257] In the signature step, as discussed above, a part of the document data set 42, such as the patient consent document data 46, is transmitted to the signature server as discussed above.

[0409]

[0258] In the HCP login step, login data are received from the user by means of the HCP- device 10. The login data are then transmitted to the authentication server 22. The authentication server 22 may be selected based on a section of the login data, e.g., an e- mail address. Hence, for different HCP organisations or HCP facilities, e.g., different hospitals, different authentication servers 22 can be selected, e.g., based on the e-mail address of the user, i.e., the HCP. The authentication server 22 transmits an authentication result to the first server 12, based on which the first server 12 determines, e.g., whether the method is to be continued or to be paused until a positive authentication result is received.

[0410]

[0259] Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise one or more processing units configured to carry out computer instructions of a program (i.e. machine readable and executable instructions). The processing unit(s) may be singular or plural. For example, each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise at least one of CPU, GPU, DSP, APU, ASIC, ASIP or FPGA. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise memory components, such as, main memory (e.g. RAM), cache memory (e.g. SRAM) and / or secondary memory (e.g. HDD, SDD). Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise volatile and / or non-volatile memory such an SDRAM, DRAM, SRAM, Flash Memory, MRAM, F-RAM, or P-RAM. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise internal communication interfaces (e.g. busses) configured to facilitate electronic data exchange between components of the respective servers or server systems, such as, the communication between the memory components and the processing components. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise external communication interfaces configured to facilitate electronic data exchange between the respective server or server system and devices or networks external thereto, such as one of the other servers or server systems. For example, each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise network interface card(s) that may be configured to connect the data processing system to a network, such as, to the Internet. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be configured to transfer electronic data using a standardized communication protocol. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 processing system may be a centralized or distributed computing system.

[0411]

[0260] Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may comprise user interfaces, such as: output user interface, such as: o screens or monitors configured to display visual data (e.g. displaying graphical user interfaces of the questionnaire to the user), o speakers configured to communicate audio data (e.g. playing audio data to the user), input user interface, such as: o camera configured to capture visual data (e.g. capturing images and / or videos of the user), o microphone configured to capture audio data (e.g. recording audio from the user), o keyboard configured to allow the insertion of text and / or other keyboard commands (e.g. allowing the user to enter text data and / or other keyboard commands by having the user type on the keyboard) and / or o trackpad, mouse, touchscreen, joystick - configured to facilitate the navigation through different graphical user interfaces of the questionnaire.

[0412]

[0261] To put it simply, each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be a processing unit configured to carry out instructions of a program. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be a system-on-chip comprising processing units, memory components and busses. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be a server, a server system, a portion of a cloud computing system or a system emulating a server, such as a server system with an appropriate software for running a virtual machine. Each of the first server 12, the video server 14, the HCP server system 16, the printing server 20, the authentication server 22 and / or the signature server 24 may be a processing unit or a system-on-chip that may be interfaced with a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer and / or user interfaces (such as the upper-mentioned user interfaces).

[0413]

[0262] The HCP-device as well as the patient device may comprise one or more processing units configured to carry out computer instructions of a program (i.e. machine readable and executable instructions). The processing unit(s) may be singular or plural. For example, the data-processing system may comprise at least one of CPU, GPU, DSP, APU, ASIC, ASIP or FPGA. The HCP-device as well as the patient device may comprise memory components, such as, main memory (e.g. RAM), cache memory (e.g. SRAM) and / or secondary memory (e.g. HDD, SDD). The HCP-device as well as the patient device may comprise volatile and / or non-volatile memory such an SDRAM, DRAM, SRAM, Flash Memory, MRAM, F-RAM, or P-RAM. The HCP-device as well as the patient device may comprise internal communication interfaces (e.g. busses) configured to facilitate electronic data exchange between components of the HCP-device as well as the patient device, such as, the communication between the memory components and the processing components. The HCP-device as well as the patient device may comprise external communication interfaces configured to facilitate electronic data exchange between the HCP-device as well as the patient device and devices or networks external to the HCP-device as well as the patient device. For example, the HCP-device as well as the patient device may comprise network interface card(s) that may be configured to connect the HCP-device as well as the patient device to a network, such as, to the Internet. The HCP-device as well as the patient device may be configured to transfer electronic data using a standardized communication protocol. The HCP-device as well as the patient device may be a centralized or distributed computing system.

[0414]

[0263] The HCP-device as well as the patient device may comprise user interfaces, such as: output user interface, such as: o screens or monitors configured to display visual data (e.g. displaying graphical user interfaces of the questionnaire to the user), o speakers configured to communicate audio data (e.g. playing audio data to the user), input user interface, such as: o camera configured to capture visual data (e.g. capturing images and / or videos of the user), o microphone configured to capture audio data (e.g. recording audio from the user), o keyboard configured to allow the insertion of text and / or other keyboard commands (e.g. allowing the user to enter text data and / or other keyboard commands by having the user type on the keyboard) and / or o trackpad, mouse, touchscreen, joystick - configured to facilitate the navigation through different graphical user interfaces of the questionnaire.

[0415]

[0264] To put it simply, the HCP-device as well as the patient device may be a processing unit configured to carry out instructions of a program. The HCP-device as well as the patient device may be a system-on-chip comprising processing units, memory components and busses. The HCP-device as well as the patient device may be a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer. The HCP-device as well as the patient device may be a server, a server system, a portion of a cloud computing system or a system emulating a server, such as a server system with an appropriate software for running a virtual machine. The HCP-device as well as the patient device may be a processing unit or a system-on-chip that may be interfaced with a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer and / or user interfaces (such as the upper-mentioned user interfaces).

[0416]

[0265] While in the above, a preferred embodiment has been described with reference to the accompanying drawings, the skilled person will understand that this embodiment was provided for illustrative purpose only and should by no means be construed to limit the scope of the present invention, which is defined by the claims.

[0417]

[0266] Whenever a relative term, such as "about", "substantially" or "approximately" is used in this specification, such a term should also be construed to also include the exact term. That is, e.g., "substantially straight" should be construed to also include "(exactly) straight".

[0418]

[0267] Whenever steps were recited in the above or also in the appended claims, it should be noted that the order in which the steps are recited in this text may be accidental. That is, unless otherwise specified or unless clear to the skilled person, the order in which steps are recited may be accidental. That is, when the present document states, e.g., that a method comprises steps (A) and (B), this does not necessarily mean that step (A) precedes step (B), but it is also possible that step (A) is performed (at least partly) simultaneously with step (B) or that step (B) precedes step (A). Furthermore, when a step (X) is said to precede another step (Z), this does not imply that there is no step between steps (X) and (Z). That is, step (X) preceding step (Z) encompasses the situation that step (X) is performed directly before step (Z), but also the situation that (X) is performed before one or more steps (Yl), followed by step (Z). Corresponding considerations apply when terms like "after" or "before" are used.

[0419] Reference numerals

[0420] 10 HCP-device

[0421] 12 First server

[0422] 14 Video server

[0423] 16 HCP server system

[0424] 18 Patient device

[0425] 20 Printing server

[0426] 22 Authentication server

[0427] 24 Signature server

[0428] 30 Treatment data

[0429] 34 Recommended set of information elements

[0430] 36 Set of selected information elements

[0431] 40 Access data element

[0432] 42 Document data set

[0433] 44 Video data

[0434] 46, 46a, 46b Patient consent document data

[0435] 48a, 48b Signature data

Claims

Claims1. A method comprising- a data receiving step comprising a first server receiving treatment data and / or patient data, wherein the treatment data comprise an indication of at least one medical treatment, an information selecting step comprising generating a patient information data set,- a document data generating step comprising generating a document data set based on the patient information data set, wherein the document data set comprises patient consent document data, wherein the first server performs the document data generating step,- a video data providing step, and a video transmission step comprising transmitting video data from a video server to a patient device; wherein the method comprises generating a unique treatment identifier, wherein the document data generating step comprises transmitting the patient consent document data from the first server to the HCP-device, particularly wherein the patient consent document comprises an indication of the unique treatment identifier, and wherein the method particularly comprises a signature step.

2. The method according to the preceding claim, wherein the signature step comprises receiving signature data from a signature server, wherein the signature data relate at least the part of the document data set, particularly the patient consent document data.

3. The method according to the preceding claim, wherein the signature step comprises sending at least the part of the document data set, particularly the patient consent document data, to the signature server, wherein the signature step comprises the signature server establishing a secure signing environment, wherein establishing the secure signing environment comprises establishing an encrypted connection between the signature server and the HCP device and / or between the signature server and the patient device.

4. The method according to any of the preceding claims, wherein the method further comprises an HCP login step, wherein the HCP login step comprises receiving login data from a user by means of an HCP-device,- transmitting the login data to an authentication server, and receiving an authentication result from the authentication server, particularly by the first server.

5. The method according to the preceding claim, wherein the HCP login step comprises selecting the authentication server based on the login data.

6. The method according to any of the preceding claims, wherein in the information selecting step, generating the patient information data set is based on a set of selected information elements, and wherein the information selecting step comprises receiving the set of selected information elements, particularly by means of the HCP-device.

7. The method according to the preceding claim, wherein the video data providing step comprises generating an access data element, wherein the access data element comprises an indication of the unique treatment identifier, and wherein the video data providing step comprises providing video data corresponding to the set of selected information elements.

8. The method according to the preceding claim, wherein providing the video data corresponding to the set of selected information elements comprises generating a playlist data element comprising a plurality of links, each link directing to a video section data element, and wherein the video data comprise the playlist data element, wherein each of the links of the playlist data element directs to a video section data element stored on the video server, wherein each video section data element corresponds to a selected information element, or wherein providing the video data corresponding to the set of selected information elements comprises generating a merged video data element based on a plurality of video section data elements, wherein each video section data element corresponds to a selected information element.

9. The method according to any of the three preceding claims, wherein each of the information elements corresponds to a video section data element, wherein each video section data element is associated with a video section identifier, and wherein the method comprises upon a modification of a video section data element, generating a new video section identifier for the modified video section data element.

10. The method according to any of the three preceding claims and with the features of claim 7, wherein the patient consent document data comprise an indication of the access data element, such as an indication of the link.

11. The method according to any of the two preceding claims with the features of claim 9, wherein each video section data element is associated with a video section text element, wherein the document data set comprises a patient information record, wherein the patient information record comprises the video section text elements associated with the video section data element to which the information elements correspond and indications of the video section identifiers associated with the video sectiondata element to which the information elements correspond, particularly wherein the patient information record further comprises an indication of the unique treatment identifier,12. The method according to any of the preceding five claims with the features of claim 7, wherein the method comprises providing the patient with the access data element, wherein providing the patient with the access data element, particularly with the patient consent data document data and a patient information document data, comprises sending these data to the patient device, wherein sending these data to the patient device comprises- generating, particularly by the first server, a link to retrieve these data, and sending the link to the patient device, e.g. by at least one of e-mail, SMS and an internet protocol-based messaging service.

13. The method according to any of the preceding six claims with the features of claim 7, wherein the video transmission step comprises receiving a request based on the access data element from the patient device and transmitting the video data from the video server to the patient device in response to the request, and wherein in the video transmission step, the video server provides the video data for streaming to the patient device, particularly wherein the video server performs segment delivery of segments of the video data.

14. The method according to any of the preceding claims, wherein the video transmission step comprises generating at least one timestamp associated with a transmission of the video data to the patient device.

15. The method according to any of the preceding claims, wherein the method comprises an annotation step, wherein the annotation step comprises receiving annotation data from the HCP-device and modifying the document data set based thereon, wherein receiving the annotation data comprises recording a voice input and processing the voice input by performing the speech recognition step.

16. The method according to any of the preceding claims with the features of claim 2, wherein the signature step comprises outputting the part of the document data set, particularly outputting the patient consent document data, and receiving a corresponding approval from the patient device, wherein receiving the approval comprises sensing a signing movement of the patient, particularly sensing biometric properties of a signing movement of the patient.

17. The method according to any of the preceding claims with the features of claim 3, wherein the signature step further comprises sending an indication of an identity of the patient to the signature server, wherein the indication of the identity of the patient is transmitted from at least oneof the HCP device, the patient device and a hospital information system to the signature server by means of the encrypted connection.

18. The method according to any of the preceding claims, wherein the method comprises a data clearing step, wherein the data clearing step comprises removing the patient data and the treatment data from the first server, particularly after a predetermined amount of time.

19. A system configured for performing the steps of the method according to any of the preceding claims, the system comprising a first server, an HCP-device and a patient device.

20. A computer program product comprising instructions which, when the program is executed by a system according to claim 19, cause the system to carry out the steps of the method according to any of claims 1-18.

Citation Information

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