WO2018010751A1 - Cardiac monitoring system and related method - Google Patents

Abstract

A method of operating a cardiac monitoring system and a cardiac monitoring system comprising a monitoring engine is disclosed, wherein the monitoring engine is configured to receive cardiac data indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device; obtain a patient state based on the cardiac data; generate a question configuration based on the patient state; transmit the question configuration to a patient device; receive patient input data from the patient device; align the cardiac data and the patient input data; and transmit the aligned patient input data to a clinic device.

Description

CARDIAC MONITORING SYSTEM AND RELATED METHOD

The present disclosure relates to a cardiac monitoring system and related method. In particular, a cardiac monitoring system comprising a monitoring engine configured to communicate with a cardiac device, a patient device, and a clinic device is disclosed.

BACKGROUND

Recent developments within cardiac health care has revealed that patient feedback, i.e. a patient's input to the clinician, is a very time-consuming and administratively heavy burden to heart clinics. Further, the developments within tele-monitoring, while reducing the administrative burden, has revealed problems with patients feeling insecure and left alone without sufficient feedback from a clinician. Further, the tele- monitoring practices have a consequence of the patients being absent from the interpretation practices, which has been identified as problematic for the clinicians due to lack of efficient and effective communication between the patient and clinician. SUMMARY

Thus, there is a need for devices and methods enabling a more effective and efficient monitoring and follow-up on cardiac patients.

Accordingly, a cardiac monitoring system is provided, the cardiac monitoring system comprising a monitoring engine, wherein the monitoring engine is configured to receive cardiac data indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device; optionally obtain a patient state based on the cardiac data; generate a question configuration based on the patient state and/or the cardiac data; transmit the question configuration to a patient device; receive patient input data from the patient device; optionally align the cardiac data and the patient input data; and transmit the aligned patient input data and/or the patient input data to a clinic device.

Further, a method of operating a cardiac monitoring system comprising a monitoring engine, a cardiac device, a patient device and a clinic device is provided, wherein the method comprises receiving cardiac data from a cardiac device, wherein the cardiac data are indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device; optionally obtaining a patient state based on the cardiac data; generating a question configuration based on the patient state and/or the cardiac data; transmitting the question configuration to the patient device; receiving patient input data from the patient device; optionally aligning the cardiac data and the patient input data; and transmitting the aligned the patient input data and/or the patient input data to the clinic device.

Further, a cardiac monitoring system is provided, the cardiac monitoring system comprising a monitoring engine, wherein the monitoring engine is configured to receive cardiac data and/or auxiliary patient data, the cardiac data indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device; optionally obtain a patient state based on the cardiac data and/or the auxiliary patient data; generate a question configuration based on the patient state and/or the auxiliary patient data and/or the cardiac data; transmit the question configuration to a patient device; receive patient input data from the patient device; optionally align the cardiac data and the patient input data; and transmit the aligned patient input data and/or the patient input data to a clinic device.

It is an important advantage that a patient/user has a reduced need for visiting a clinic or doctor's office and/or contacting a clinician, while still being able to provide effective patient feedback to the clinician. Further, the present disclosure enables early detection of deterioration of a patient's health or cardiac condition. It is an important advantage of the present disclosure that consistent clinical decision support (CDS) is provided to the clinician.

Further, the system and method allows patients and clinicians to have a two-way, asynchronous dialogue about a patient's health status and context in relation to remote and/or in-clinic monitoring of an implantable cardiac device, such as an Implantable Cardioverter Defibrillator (ICD), a Cardiac Resynchronization Therapy device (CRT-D), a Cardiac Resynchronization Therapy Pacemaker (CRT-P) and an Implantable Loop Recorder (ILR).

A problem with present remote monitoring systems is that communication between patients and clinicians is time-consuming. The general way of communicating is in real time - over the phone or through face to face consultations. The consequence is that patients and clinicians only initiate a dialogue when it is absolutely necessary (reactive care scheme) and patients feel left out because of the minimal information exchange between patient and clinician. The disclosed system and method provide improved clinical decision-making in remote monitoring and/or increased patient satisfaction through improved communication. The disclosed system advantageously guides and automates the collection of information from patients through the patient device and makes it easy for clinicians to inform and educate patients by giving individual feedback through the clinic device. Further, effective and consistent patient input data collection is provided for, by ensuring that the same question configuration can be presented to different users of the system.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features and advantages of the present invention will become readily apparent to those skilled in the art by the following detailed description of exemplary embodiments thereof with reference to the attached drawings, in which : Fig. 1 schematically illustrates an exemplary cardiac monitoring system, Fig. 2 schematically illustrates an exemplary signaling diagram, Fig. 3 is a flow diagram illustrating the method of the present invention, Fig. 4 schematically illustrates an exemplary question configuration, Fig. 5 schematically illustrates an exemplary question configuration, Fig. 6 schematically illustrates an exemplary monitoring engine, and Fig. 7 schematically illustrates an exemplary signaling diagram. DETAILED DESCRIPTION

The present disclosure relates to a cardiac monitoring system comprising a monitoring engine. The monitoring engine is configured to receive cardiac data indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device. The cardiac device may comprise an implantable unit, such as an Implantable Cardioverter Defibrillator (ICD), a Cardiac Resynchronization Therapy device (CRT-D), a Cardiac Resynchronization Therapy Pacemaker (CRT-P) or an Implantable Loop Recorder (ILR), and optionally a reader unit configured to receive cardiac data from the implantable unit. The reader unit may be configured to forward cardiac data to the monitoring engine, e.g. via a network and/or a centralized server device. The patient device may be used for reading cardiac data from the implantable unit. The cardiac data may comprise pulse data for the patient, the pulse data comprising the pulse of the patient, e.g . measured at a given pulse measurement frequency and/or at selected times, e.g. of a day. The pulse data may comprise a pulse time stamp for at least one pulse measurement.

The cardiac data may comprise cardiac action data indicative of one or more actions performed by the cardiac device and/or a patient. Exemplary actions performed by the cardiac device may include a Brady (pacing), Antitachycardia pacing (ATP), electrical cardioversion and/or defibrillation. Cardiac action data may comprise one or more action time stamps for respective one or more actions. Cardiac action data may comprise one or more operating values of the cardiac device, such as level (voltage and/or current) of action, e.g. Brady (pacing), Antitachycardia pacing (ATP), electrical cardioversion and/or defibrillation, and/or duration of the action. Exemplary actions performed by the cardiac device may include a patient activating one or more functions, such as one or more buttons, in a reader unit of the cardiac device.

Cardiac data may comprise cardiac fibrillation data indicative of cardiac fibrillation of the patient. The cardiac fibrillation data may comprise one or more fibrillation time stamps, each fibrillation time stamp being indicative of the time of cardiac fibrillation. The cardiac fibrillation data may comprise one or more fibrillation durations, each fibrillation duration being indicative of the duration of cardiac fibrillation.

In one or more exemplary cardiac monitoring systems, the cardiac data comprises time stamp data, such as at least one pulse time stamp, one or more action time stamps and/or one or more fibrillation time stamps, and the question configuration is optionally based on the time stamp data. For example, a question, such as a first question and/or a second question, and/or an instruction, such as a first instruction and/or a second instruction, of the question configuration may be based on a first action time stamp. For example, a question, such as a first question and/or a second question, and/or an instruction, such as a first instruction and/or a second instruction, of the question configuration may be based on a first fibrillation time stamp. For example, a question, such as a first question and/or a second question, and/or an instruction, such as a first instruction and/or a second instruction, of the question configuration may be based on a first action time stamp. Time stamp data-based question configurations allow the question configuration to be tailored to different ranges of time, e.g. whether an action has taken place during the day or during the night. The disclosed system advantageously avoids presenting too much information or too many questions to the patient, thus providing a time-efficient collection of information from patients as seen from the patient side.

Cardiac data may comprise fluid retention data indicative of fluid retention in the patient. The monitoring engine may be configured to receive auxiliary patient data, e.g. from the patient device and/or an auxiliary patient device. The auxiliary patient data may comprise activity data and/or physiological data of the patient. The activity data may comprise data indicative of the patients physical activity, such as one or more of step count data, distance data, location data, speed data, activity type data. Exemplary activity types are walk, run, bike, stair walk, sleep. The physiological data may comprise one or more of weight data, blood pressure data, blood oxygen saturation data, and glucose level data.

The auxiliary patient device may be a wearable, such as a smartwatch, a pedometer, a fitness tracker, a smart wristband, and/or a blood pressure meter

(sphygmomanometer).

The auxiliary patient device may be a glucose level meter device.

The monitoring engine may be configured to receive auxiliary patient data from a plurality of auxiliary patient devices.

The monitoring engine is optionally configured to obtain a patient state based on the cardiac data, e.g. based on one or more of cardiac action data, pulse data, and cardiac fibrillation data. The monitoring engine is optionally configured to obtain a patient state based on the auxiliary patient data, such as activity data and/or physiological data.

The patient state may be based on one or more time stamps of the cardiac data, e.g. action time stamp(s), pulse time stamp(s) and/or fibrillation time stamp(s). The patient state may be selected from a set of patient states, e.g. comprising at least three different states.

Examples of patient states may include "No patient input needed", "Ventricular Tachycardia (VT) occured", "Ventricular Fibrillation (VF) occured", "Atrial Fibrillation (AF) occurred", "AntiTachycardia Pacing (ATP) occurred", "Defibrillation shock occurred".

An exemplary first patient state may be indicative of "No patient input needed".

An exemplary second patient state may be indicative of "Ventricular Tachycardia (AT) occured". An exemplary third patient state may be indicative of "Ventricular Fibrillation (VF) occured".

An exemplary fourth patient state may be indicative of "Atrial Fibrillation (AF) occurred".

An exemplary fifth patient state may be indicative of "AntiTachycardia Pacing (ATP) occurred".

An exemplary sixth patient state may be indicative of "Defibrillation shock occurred".

The monitoring engine is configured to generate a question configuration, e.g. based on the patient state and/or the cardiac data. A question configuration enables a patient device to present questions/instructions to a patient and receive patient input on the questions/instructions from the patient. Generation of the question

configuration may be based on cardiac action data and/or cardiac fibrillation data. In one or more exemplary cardiac monitoring systems, generation of the question configuration may be based on pulse data. Generation of the question configuration may be based on time stamp data, e.g. comprising one or more time stamps of the cardiac data, such as action time stamp(s), pulse time stamp(s) and/or fibrillation time stamp(s).

To generate a question configuration may comprise to generate a first question configuration if time stamp data are indicative of a first time range and/or to generate a second question configuration if time stamp data are indicative of a second time range. To generate a question configuration may comprise to generate a first question configuration if the patient state is a first patient state and/or to generate a second question configuration if the patient state is a second patient state, e.g. different from the first patient state. The first question configuration may be different from the second question configuration. The monitoring engine is configured to transmit the question configuration to a patient device. The patient device may be a smartphone, e.g. with a patient app stored thereon.

A question configuration defines question(s) and/or instruction(s) to be presented to a patient via a patient device. In one or more exemplary monitoring systems, the question configuration comprises a set of question identifiers and/or a set of questions. In one or more exemplary monitoring systems, the question configuration comprises a set of instruction identifiers and/or a set of instructions. An instruction may be or be indicative of a text, audio, image and/or a video that is to be presented to the patient. An instruction may comprise information to the patient. The question configuration may comprise a hierarchy. A hierarchy comprises a first layer, a second layer and optionally a third layer, each layer comprising one or more elements. One or more rules may define the relation between a layer (or element(s) thereof) and a subjacent layer (or element(s) thereof) . An element may be or comprise a question or a question identifier. An element may be or comprise an instruction or an instruction identifier. The question configuration, such as a layer of the hierarchy, may comprise one or more questions or question identifiers. The question configuration, such as a layer of the hierarchy, may comprise one or more instructions and/or instruction identifiers.

In one or more exemplary cardiac monitoring systems, the question configuration comprises a hierarchy comprising a first layer including a first question and a first answer option configuration indicative of a first set of answer options associated with the first question. The first set of answer options may comprise at least three answer options. The question configuration may comprise a second layer including at least two second questions associated with the first question. The question configuration, such as the first layer of a hierarchy, may comprise a first set Qi of questions. The first set Qi of questions comprises one or more first questions or first question identifiers also denoted q., where i is an index from 1 to N i, where N i is the number of questions in the first set of questions. Accordingly, the first set of questions may comprise a first primary question qi and/or a first secondary question In the present context, first questions are indexed with a single index. For a hierarchy with more than one first question, e.g. qi and q2, the questions/instructions branched from the first question qi, e.g. qi,i, qi,2, qi,2,i, etc., are denoted first branch and the questions/instructions branched from the first question q2, e.g. q₂,i, q2,2, q2,2,i, etc., are denoted second branch. The first branch is presented to the patient and the second branch may be presented to the patient after the first branch has been answered to.

To generate a question configuration, such as the first question configuration and/or the second question configuration, may comprise selecting/generating a question from a first set of questions as the first question. The first question of the first question configuration may differ from the first question of the second question configuration.

To generate a question configuration, such as the first question configuration and/or the second question configuration, may comprise selecting/generating a first answer option configuration, e.g. indicative of a first set of answer options associated with the first question. The first answer option configuration of the first question configuration may differ from the first answer option configuration of the second question

configuration, e.g. in number of answers and/or answer content.

To generate a question configuration, such as the first question configuration and/or the second question configuration, may comprise selecting/generating question(s) from a second set of questions as the second question(s). The second question(s) of the first question configuration may differ from the second question(s) of the second question configuration, e.g. in number and/or content.

To generate a question configuration, such as the first question configuration and/or the second question configuration, may comprise selecting/generating a second answer option configuration, e.g. indicative of a second set of answer options associated with the second question. The second answer option configuration of the first question configuration may differ from the second answer option configuration of the second question configuration, e.g. in number of answers and/or answer content. To generate a question configuration may comprise to generate a first question configuration if the patient state is indicative of a first patient state and/or to generate a second question configuration if the patient state is indicative of a second patient state. The first patient state may differ from the second patient state. The question configuration, such as the first layer of a hierarchy, may comprise a first set Ii of instructions. The first set Ii of instructions comprises one or more first instructions or first instruction identifiers also denoted ii, where i is an index from 1 to N2, where N2 is the number of instructions/instruction identifiers in the first set of instructions.

A first question also denoted Questionl and selected from the first set of questions Qi = {q i, q2, q i} is presented to the user in the patient device. The user/patient inputs a first answer also denoted Answerl to the first question Questionl, e.g. by selecting the first answer from a first set of answer options associated with the first question Question l. Accordingly, the question configuration may comprise first answer option configuration(s), e.g. including first set(s) of answer options and/or first answer option configuration identifier(s) indicative of first set(s) of answer options associated with respective first question (s) of Qi . A first set of answer options to a first question may comprise two or at least three different answer options for a first question of the first set of questions. Accordingly, the first answer option configuration/the first set AOi of answer options to first question q, may comprise first answer options aoy, where j is an index of the j'th answer option for first question q,. The number of answer options for at least one first question may be at least three. For example, the first primary set AOi of answer options associated with first primary question q i may comprise at least three answer options including a first answer option, a second answer option and a third answer option.

An answer option configuration, e.g. comprising a set of answer options and/or an answer option configuration identifier (AOC_ID) indicative of a set of answer options, may be associated with a question and/or an instruction. Accordingly, the question configuration may comprise one or more answer option configurations/answer option configuration identifiers associated with respective one or more questions and/or respective one or more instructions. For example, the question configuration may comprise an answer option configuration (AOC_ID) for each question and/or for each instruction, thus enabling the patient device to present a tailored answer option to the patient.

In one or more exemplary monitoring engines, the question configuration may comprise one or more answer option configurations, wherein at least one, such as a plurality, of the one or more answer option configurations are based on time stamp data, such as at least one pulse time stamp, one or more action time stamps and/or one or more fibrillation time stamps.

For example, a first answer option configuration associated to a first question of a first question configuration may be different, e.g. different number of answers and/or content, from a first answer option configuration associated to a first question of a second question configuration.

For example, a first answer option configuration associated to a first question may be based on time stamp data, such as at least one pulse time stamp, one or more action time stamps and/or one or more fibrillation time stamps. For example, a second answer option configuration associated to a second question of a first question configuration may be different, e.g. different number of answers and/or content, from a second answer option configuration associated to a second question of a second question configuration.

For example, a second answer option configuration associated to a second question may be based on time stamp data, such as at least one pulse time stamp, one or more action time stamps and/or one or more fibrillation time stamps.

For example, a third answer option configuration associated to a third question of a first question configuration may be different, e.g. different number of answers and/or content, from a third answer option configuration associated to a third question of a third question configuration.

For example, a third answer option configuration associated to a third question may be based on time stamp data, such as at least one pulse time stamp, one or more action time stamps and/or one or more fibrillation time stamps.

In one or more exemplary cardiac monitoring systems, the question configuration comprises a first primary answer option configuration (e.g. AOC_IDi) for a first primary question qi of the first set of questions and/or for a first instruction ii. In one or more exemplary cardiac monitoring systems, the question configuration comprises a first secondary answer option configuration (e.g. AOC_ID2) for a first secondary question q20f the first set of questions and/or for a first instruction . The first secondary answer option configuration may be different from the first primary answer option configuration. An answer option configuration defines a set of answer options to be presented to a patient in response to a question and/or an instruction. A set of answer options may comprise two or at least three answer options, such as a first answer option, a second answer option and optionally a third answer option. An answer option configuration with at least three answer options allows for a detailed patient input.

In the monitoring engine, to generate a question configuration may comprise to generate one or more answer option configurations/answer option configuration identifiers based on the cardiac data, such as time stamp data of the cardiac data, e.g. one or more time stamps of the cardiac data, such as action time stamp(s), pulse time stamp(s) and/or fibrillation time stamp(s). One or more answer option configurations, such as first answer option configuration(s) and/or second answer option configuration(s), may be based on action time stamp(s).

In one or more exemplary cardiac monitoring systems, an answer option

configuration, such as a first answer option configuration and/or a second answer option configuration may be based on a first action time stamp. In one or more exemplary monitoring engines, where the cardiac data comprises an action/action identifier with associated action time stamp, an answer option configuration may be based on the action time stamp. In one or more exemplary monitoring engines, where the cardiac data comprises a fibrillation time stamp, an answer option configuration may be based on the fibrillation time stamp.

For example, for an action time stamp of 08.23 an exemplary answer option configuration may comprise answer options "Before 06.00", "Around 07.00", and "Around 08.00" based on the action time stamp. Accordingly, the monitoring engine may be able to tailor or customize the answer options presented to a patient to a specific action and time of the action.

It is an important advantage of the present disclosure, that a high degree of contextual relevance is provided in the question configuration. Thereby, the time spent in responding to the questions is optimized or reduced.

An exemplary answer option configuration identifier is indicative of an answer option configuration including a first answer option, a second answer option, and optionally a third answer option. An answer option, such as a first answer option, a second answer option, and/or optionally a third answer option, may be indicative of an activity (physical/emotional activity) and/or level of activity, such as "Resting", "Physical activity", "Sleeping", "Stressed", or "Relaxed". An answer option, such as a first answer option, a second answer option, a third answer option, and/or a fourth answer option may be a text field allowing a patient to input at text answer and/or a comment.

An answer option, such as a first answer option, a second answer option, a third answer option, and/or a fourth answer option may be indicative of the patient not knowing the answer, e.g. "Do not know".

An answer option, such as a first answer option, a second answer option, a third answer option, or a fourth answer option may be a number.

An answer option, such as a first answer option, may be indicative of the patient confirming an instruction, e.g . "Confirm". An answer option, such as a second answer option, may be indicative of the patient rejecting or not accepting an instruction, e.g. "Reject".

An answer option, such as a first answer option, a second answer option, a third answer option, or a fourth answer option, may be "Record and send audio".

An answer option, such as a first answer option, a second answer option, a third answer option, or a fourth answer option, may be "Record and send video".

An answer option, such as a first answer option, a second answer option, a third answer option, or a fourth answer option, may be "Record and send image".

An answer option, such as a first answer option, a second answer option, a third answer option, or a fourth answer option, may be "Sign". A first answer option may be "Yes", "1", "low", or "confirm".

A second answer option may be "No", "2", "Medium", or "Reject".

A third answer option may be "Do not know", "3", or "High". In one or more exemplary answer option configurations, the number of answer options is in the range from three to six.

An exemplary first answer option configuration may comprise the answer options "Yes", "No" and "Do not know". An exemplary second answer option configuration may comprise or be indicative of the answer options "1", "2" and "3". An exemplary second answer option configuration may comprise or be indicative of answer options indicating different values and/or ranges of values, such as "15 to 30 minutes", "30 to 60 minutes", "60 to 120 minutes", "More than 60 minutes". In one or more exemplary answer option configurations, the number of answer options is larger than 5. For example, in one or more exemplary monitoring systems, a second answer option configuration comprises or is indicative of answer options "1", "2", "3", "4", "5", "6", "7", "8", "9", and "10" or a subset thereof.

An exemplary third answer option configuration may comprise or be indicative of the answer options "Low", "Medium" and "High".

An exemplary fourth answer option configuration may comprise or be indicative of the answer options "Confirm" and "Reject".

The question configuration, such as the second layer of a hierarchy, may comprise a second set Q2 of questions. The second set of questions comprises one or more second questions or question identifiers also denoted qi,k, where k is an index from 1 to Ki of the k'th second question associated with the first question q, of Qi. Ki may be one, two, three or more. K2 may be one, two, three or more. K3 may be one, two, three or more. Ki may be different from K2. In the present context, second questions are indexed with a double index. Thus, the number of second questions associated with a first question may be two, three, or more.

For example, Qi may comprise two questions qi and q2 and Q2 may comprise at least two questions qi,i and qi,2 associated with the first primary question qi and/or at least three questions q₂,i, q2,2, and q2,3 associated with the first secondary question q2. Accordingly, for a given first element of the first layer, such as a first question and/or a first instruction, the second layer may comprise at least two elements associated with the given first element. A second question also denoted Question2 and selected from the second set of questions Q2={qi,i, qi ,KI, q2,i, q2,K2 ■ _/ C|NI,KN I} may be presented to the patient in the patient device. The second question Question2 may be selected based on Questionl and/or Answerl . The second question Question2 may be selected based on a first rule as described in further detail below. The user/patient inputs a second answer also denoted Answer2 to the second question Question2, e.g. by selecting the second answer from a second set of answer options associated with the second question Question2. Accordingly, the question configuration may comprise second answer option configuration(s), e.g. including second set(s) of answer options and/or second answer option configuration identifier(s) indicative of second set(s) of answer options associated with respective second question(s) of Q2. A second set of answer options to a second question may comprise two or at least three different answer options for a second question of the second set of questions. Accordingly, the second set AOi,k Of answer options to the second question qi,k may comprise second answer options aOi,k,j, where j is an index of the j'th answer option for second question qi,k. The number of answer options for at least one second question may be at least three. For example, the second set ΑΟι,ι of answer options associated with second question qi,i may comprise at least three answer options including a first answer option, a second answer option and a third answer option and/or the second set AOi,2 of answer options associated with second question qi,2 may comprise at least three answer options including a first answer option, a second answer option and a third answer option.

In one or more exemplary cardiac monitoring systems, the question configuration comprises answer option configuration(s) for second question(s) of the second set of questions. In one or more exemplary cardiac monitoring systems, the question configuration comprises a second answer option configuration (e.g. AOC_IDi,i) for a second question qi,i associated with first question qi.

The question configuration, such as the second layer of a hierarchy, may comprise a second set I2 of instructions. The second set I2 of instructions comprises one or more second instructions or second instruction identifiers also denoted ij where j is an index from 1 to N3, where N3 is the number of instructions/instruction identifiers in the second set of instructions.

The hierarchy may comprise one or more rules including a first set of rules Rl comprising one or more first rules. A rule defines a relation between respective elements (question/instructions) of two layers of the hierarchy, e.g. based on one or more or the foregoing questions and/or answers to one or more of the foregoing questions. For example, a first rule may define a second question from the second set of questions to be presented to the user based on the first question and/or answer options to the first question. A first rule may define a second instruction from the second set of instructions to be presented to the user based on the first question and/or answer options to the first question. A first rule may define a second question from the second set of questions to be presented to the user based on a first instruction and/or answer options to the first instruction. A first rule may define a second instruction from the second set of instructions to be presented to the user based on a first instruction and/or answer options to the first instruction. A second rule may define a third question from a third set of questions to be presented to the user based on a second question and/or answer options to the second question. A second rule may define a third question from a third set of questions to be presented to the user based on a first question and/or answer options to the first question. A rule may be based on historic patient data

For example, the hierarchy may comprise a first set of rules Rl comprising first rules n defining the relationship between respective first questions q., where i is an index from 1 to Ni, and second questions q,,k, where k is an index from 1 to Ki of the k'th second question associated with the first question q, of Qi. First rules are indexed with a single index.

An exemplary first rule ri may be given by n: if Answerl= "Yes" or "No" then Question2=qi,i if Answerl= "Do not know" then Question2=qi,2 An exemplary first rule Γ2 may be given by

Γ2: if Answerl<6 then Question2=q2,i if Answerl=6 or Answerl=7 or Answerl=8 then Question2=q2,2 if Answerl>8 then Question2=q2,3

For example, the hierarchy may comprise a second set of rules R2 comprising second rules n,k where k is an index from 1 to Ki of the k'th second question associated with the first question q, of Qi, and i is an index from 1 to Ni, the second rule n,k defining the relationship between a second question qi,k and third questions qi,k,m, where m is an index from 1 to Mi,k of the m'th third question associated with the k'th second question associated with the first question q, of Qi . Second rules are indexed with a double index and third rules are indexed with a triple index.

The question configuration may comprise one or more time stamps of the cardiac data. For example, the question configuration may comprise an action time stamp of an action and/or an action identifier. A question configuration comprising an action time stamp and an action identifier enables the monitoring device to define a question based on the action time stamp and the action identifier. For example, if an action of defibrillation shock of the heart occurred at 15.00 last Friday, the question

configuration may comprise the following question presented on the patient device: "A defibrillation shock occurred Friday at 15.00. Did you notice the defibrillation shock?" A question configuration based on time stamp(s) enables more precise and detailed feedback from the patient since the questions presented to the patient can be tailored to a specific action of the cardiac device and/or specific cardiac measurements, such as pulse and/or fibrillation, or variations thereof.

The monitoring device is configured to receive patient input data from the patient device. Patient input data comprises answer data indicative of answers being input by the patient in response to questions and/or instructions presented to the patient based on the question configuration. The answer data may comprise text data, audio data, image data, and/or video data.

The monitoring device may be configured to align the cardiac data and the patient input data, e.g. by linking the patient input data to the cardiac data in a database. In one or more exemplary embodiments, the monitoring device may be configured to align the cardiac data and the patient input data by adding one or more time stamps to the patient input data.

The monitoring device may be configured to transmit the cardiac data and/or the patient input data to a clinic device. The monitoring engine may be configured to receive clinical input data from the clinic device and align the clinical input data and the patient input data. The monitoring engine may be configured to transmit clinical input data to the patient device.

The monitoring engine may be configured to obtain historic patient data. The question configuration may be based on the historic patient data. The historic patient data may comprise a defibrillation number indicative of the number of defibrillation shocks given to the patient, e.g. within a period of time. The historic patient data may comprise medication history of the patient and/or data derived from an electronic medical record (EMR) of the patient. The historic patient data may comprise data derived from an electronic medical record (EMR) of one or more relatives of the patient. The medication history may comprise or be indicative of patient medication including e.g. which medicine the patient has taken, medicine dose and times of medication, prescription list, dosage regimen, etc. Accordingly, the cardiac monitoring system according to the present disclosure may facilitate improved medication management. The question configuration may be based on medication history of the patient.

Medication history may comprise medication data generated by a patient and/or derived from an electronic medical record (EMR). Medication follow-up is thereby improved and made more efficient.

The historic patient data may comprise patient-generated data and/or clinician- generated data. The historic patient data may comprise previous question configurations and/or answers to previous question configurations. The monitoring engine may be configured to include a question in a question configuration if the patient in an earlier answer to the same question in an earlier question configuration has provided an answer triggering a repetition of the question, e.g. if an answer indicates a value below or above a threshold value. For example, the patient may have been asked to indicate his/her level of concern in an earlier question configuration and answered "High", e.g. from answer options "Low", "Medium" and "High", or "9" from answer options 1-10. The monitoring engine may be configured to generate the question configuration based on the earlier answer, e.g. include or repeat the question from the earlier question configuration in the question configuration if the earlier answer is not "Low" or if the value indicated in the earlier answer is larger than "5".

The monitoring engine may be configured to receive preliminary clinical input data from the clinic device, and wherein the question configuration is based on the preliminary clinical input data. The preliminary clinical input data may be indicative of triage. The preliminary clinical input data are indicative of a clinicians input prior to generation of the question configuration.

The monitoring engine may be configured to transmit a first notification to the patient device if the patient input data are not received within a patient input period.

Advantageously, a notification increases the chance of the patient responding and/or reduces the time from cardiac device action until the patient responds, in turn increasing the feedback quality. Further, the administrative resources used are reduced, e.g . the time spent for ensuring patient feedback. The patient input period may be based on patient availability data. A patient may update patient availability data, e.g . via the patient device. Thus, irrelevant and/or annoying notifications to the patient may be avoided, in turn improving user experience.

The monitoring engine may be configured to receive patient input data comprising symptom data, and wherein the monitoring engine is configured to transmit a second notification based on the symptom data to the patient device. The monitoring engine may be configured to transmit symptom data to the clinic device. The monitoring engine may be configured to include the symptom data in historic patient data.

The monitoring engine may be configured to generate a question configuration based on the symptom data.

In the cardiac monitoring system, to generate a question configuration may comprise generating a decision tree. To generate a question configuration may comprise to generate a first set of questions/question identifiers and include the first set of questions/question identifiers in the question configuration. To generate a question configuration may comprise to generate a second set of questions/question identifiers and include the second set of questions/question identifiers in the question configuration. To generate a question configuration may comprise to generate a first set of first rules, the first set of first rules defining a relation between first questions and second questions, and include the first set of first rules in the question

configuration. To generate a question configuration may comprise to generate a third set of questions/question identifiers and include the third set of questions/question identifiers in the question configuration. To generate a question configuration may comprise to generate a second set of second rules, the second set of second rules defining a relation between second questions and third questions, and include the second set of second rules in the question configuration. To generate a question configuration may comprise to generate answer option configurations for respective questions of the question configuration.

The cardiac monitoring system may comprise a patient device. The patient device may be configured to receive the question configuration from the monitoring engine;

generate a first representation with one or more questions based on the question configuration; obtain patient input in response to the one or more questions; generate patient input data based on the patient input; and transmit patient input data to the monitoring engine.

The cardiac monitoring system may comprise a clinic device. The clinic device may be configured to obtain the cardiac data; receive the aligned patient input data from the monitoring engine; determine a patient state based on the cardiac data and the patient input data; generate a first representation if the patient state fulfills a first criterion; obtain clinician input in response to the first representation; generate clinical input data based on the clinician input; and transmit clinical input data to the monitoring engine.

The clinic device may be configured to receive cardiac data; determine a patient state based on the cardiac data; generate a second representation if the patient state fulfills a second criterion; obtain preliminary clinician input in response to the second representation; generate preliminary clinical input data based on the preliminary clinician input in response to the second representation; and transmit preliminary clinical input data to the monitoring engine.

Fig. 1 schematically illustrates a cardiac monitoring system according to the present invention. The cardiac monitoring system 2 comprises a monitoring engine 4, wherein the monitoring engine 4 is configured to receive cardiac data 5 indicative of cardiac activity of a patient. The cardiac data 5 are sent from a cardiac device 6 comprising an implantable unit and optionally a reader unit configured to receive cardiac data from the implantable unit. The monitoring engine 4 is configured to obtain a patient state based on the cardiac data 5 and generate a question configuration based on the patient state and to transmit the question configuration 7 to a patient device 8, such as a mobile device with a patient app stored thereon. The patient answers a

questionnaire based on the question configuration, and the patient device 8 generates patient input data based on the answers and transmits the patient input data 9 to the monitoring engine 4 that is configured to receive the patient input data from the patient device. The monitoring engine 4 is configured to align the cardiac data 5 and the patient input data 9, and to transmit the cardiac data and the patient input data 10 to a clinic device 12. Further, the monitoring engine 4 is optionally configured to receive clinical input data 14 from the clinic device 12 and align the clinical input data and the patient input data. Fig. 2 is a signalling diagram of a cardiac monitoring system and associated devices. Cardiac device 6 transmits cardiac data 5 to the monitoring engine 4, e.g. via the Internet and/or other suitable network. The monitoring engine receives the cardiac data, and generates and transmits a question configuration 7 based on a patient state/cardiac data to patient device 8. The patient device 8 receives input from a user/patient based on the question configuration and transmit patient input data 9 to the monitoring engine 4. The monitoring engine 4 aligns the cardiac data and the patient input data and transmits the aligned data 10 to clinic device, where a clinician provides input in order to generate clinical input data 14 that are transmitted to the monitoring engine 4. The monitoring engine 4 optionally transmits 16 the clinical input data or at least parts thereof to the patient device.

Fig. 3 is a flow diagram of an exemplary method according to the invention. The method 100 of operating a cardiac monitoring system comprising a monitoring engine, a cardiac device, a patient device and a clinic device comprises receiving 102 cardiac data from a cardiac device, wherein the cardiac data are indicative of cardiac activity of a patient. Optionally, the method 100 comprises receiving 102A auxiliary patient data from the patient device and/or from an auxiliary patient device ; determining 104 a patient state based on the cardiac data and/or the ; generating 106 a question configuration based on the patient state; transmitting 108 the question configuration to a patient device; receiving 110 patient input data from the patient device; aligning 112 the cardiac data and the patient input data; and transmitting 114 the cardiac data and the patient input data to the clinic device.

Fig. 4 illustrates a part of an exemplary question configuration 200. The question configuration comprises or can be illustrated by a decision tree with associated questions/instructions, answer options and rules. The question configuration 200 comprises a hierarchy with seven layers including a first layer 202 including a first question q. and a second layer 204 including second questions qi,i, qi,2, qi,3

associated with the first question qi. A first answer option configuration or a first set of first answer options AOi is associated with the first question qi, e.g. by first answer option configuration identifier AOC_IDi. The first answer option configuration defines the answer options to be presented to a user for responding to the first question qi. Further, a first rule n is associated with the first question qi. The first rule n defines the relationship between the first question q. and associated second questions qi,i, qi,2, qi,3 dependent on the first answer selectable by a patient from the first set of first answer options AOi. The hierarchy comprises a third layer 206 including third question qi, i,i associated with the second question q_,i, and third questions qi,3,i, q 1,3,2

associated with the second question qi,3.

The hierarchy optionally comprises a fourth layer 208 including fourth questions qi, 1,1, 1-5 associated with the third question qi,i,i and fourth question qi,3,i,i associated with the third question qi,3,i. The hierarchy optionally comprises a fifth layer 210 including fifth questions qi, 1,1, 1-5,1 associated with the fourth questions qi, 1,1, 1-5 as indicated by the arrows. In the illustrated question configuration, the hierarchy comprises a sixth layer 212 and a seventh layer 214.

A second rule n,i is associated with the second question qi,i. The second rule n,i defines the relationship between the second question qi,i and associated third question qi,i,i dependent on the second answer selectable by a patient from the second set of second answer options ΑΟι,ι associated with the second question qi,i.

A second rule n,3 is associated with the second question qi,3. The second rule n,3 defines the relationship between the second question qi,3 and associated third questions qi,3,i, qi,3,2 dependent on the second answer selectable by a patient from the second set of second answer options AOi,3 associated with the second question

A third rule η,ι,ι is associated with the third question qi,i,i. The third rule η,ι,ι defines the relationship between the third question qi, 1,1 and associated fourth questions qi, 1,1, 1-5 dependent on the third answer selectable by a patient from the third set ΑΟι,ι,ι of third answer options associated with the third question qi,i,i.

Fourth rules n, 1,1, 1-5 are associated with respective fourth questions qi, 1,1, 1-5. The fourth rule n, 1,1,1 defines the relationship between the fourth question qi, 1,1,1 and associated fifth question qi, 1,1,1 dependent on the fourth answer selectable by a patient from the fourth set AOi, 1,1,1 of fourth answer options associated with the fourth question qi, 1,1,1.

In the example of Fig. 4, the cardiac data comprises cardiac action data, the cardiac action data comprising an action <Action > with action time stamp <Action_Time>, wherein <Action> is indicative of the patient activating the reader unit of the cardiac device, e.g . by pressing a button, and <Action_Time>= 11.48 on 24-06-2016.

The monitoring engine generates a question configuration based on the cardiac data (<Action> and <Action_Time>) by generating a first primary question qi based on the cardiac data, where qi= "Hello <PATIENT_NAME>. You have activated the reader unit on Friday 24-06-2016 at 11.48. What is the reason for the activation?". Accordingly, the first question is based on the action and/or the action time stamp of the cardiac data. Further, the monitoring engine generates an answer option configuration AOi associated with the first question qi and a first rule n. In the present example, AOi comprises three answer options, namely "I experience symptoms", "I experienced defibrillation" and "Technical or other reasons".

The first rule ri is given by: ri : if Answerl= "I experience symptoms" then Question2=qi,i if Answerl= "I experienced defibrillation" then Question2=qi,2 if Answerl= "Technical or other reasons" then Question2=qi,3

The second layer of the hierarchy/question configuration comprises second questions given by: qi,i = "When did you experience the symptoms?" with answer option configuration ΑΟι,ι = "From 10.00 to 11.48 on 24-06-2016", "Earlier than 10.00 on 24-06-2016", "The day before", "More than one day earlier". Accordingly, ΑΟι,ι is based on the action time stamp <Action_Time>. qi,2 = "How did you experience the defibrillation?" with answer option configuration AOi,2 = "Record and send audio". qi,3 = "What was the technical reason?" with answer option configuration AOi,3 = "Activated by error", "Test", "Activated in agreement with Clinic", "I have noted an alarm", "Other".

The second layer of the hierarchy/question configuration comprises second rules n,i, ri,2, ri,3 given by the following, where Answer2 is the answer from the patient to Question2 : if Answer2= "From 10.00 to 11.48 on 24-06-2016" then Question3 if Answer2= "Earlier than 10.00 on 24-06-2016" then Question3=qi,i,i if Answer2= "The day before" then Question3=qi,i,i if Answer2= "More than one day earlier" then Question3=qi,i,i ri,3: if Answer2= "Activated by error" or "Test" then <Terminate> if Answer2= "Activated in agreement with Clinician" then Question3=qi,3,i if Answer2= "I have noted an alarm" then <Terminate> if Answer2= "Other" then Question3=qi,3,2

The third layer of the hierarchy/question configuration comprises third questions given by: qi,i,i = "Which symptom has initiated your activation of the cardiac device" with answer option configuration ΑΟι,ι,ι = "Palpitations", "Fainting/unconsciousness", "Shortness of breath", "Nuisance from Cardiac Device", "Other". q i,3,i = "What is the agreement with the Clinician?" with answer option configuration AOi,3,i = "To restart the reader unit", "To read data according to a schedule",

"Elaborate". q i,3,2 = "Why did you activate the reader unit?" with answer option configuration AOi,3,2 = "Record and send audio"

The third layer of the hierarchy/question configuration comprises third rules η,ι,ι, n,3,i given by the following, where Answer3 is the answer from the patient: η,ι,ι : if Answer3= "Palpitations" then Question4=qi, ι,ι,ι if Answer3= "Fainting/unconsciousness" then Question4=qi,i,i,2 if Answer3= "Shortness of breath" then Question4=qi, 1,1,3 if Answer3= "Nuisance from Cardiac Device" then Question4=qi, 1,1,4 if Answer3= "Other " then Question4=qi,i,i,s n,3,i : if Answer3= "To restart the reader unit" or "To read data according to a schedule" then <Terminate> if Answer3= "Elaborate" then Question4=qi,3,i,i

The fourth layer of the hierarchy/question configuration comprises fourth questions given by: qi, 1,1,1 = "In which situations do palpitations occur?" with answer option configuration ΑΟι,ι,ι,ι = "Hard activity", "Moderate activity", "Light activity", "Resting", "Any time", "Specific situations". qi, i,i,2 = "What did you do and how did you experience the fainting/u nconsciousness?" with answer option configuration AOi, 1,1,2 = "Record and send audio". qi, 1,1,3 = "In which situations does shortness of breath occur?" with answer option configuration AOi,i,i,3 = "Hard activity", "Moderate activity", "Light activity", "Resting", "Other". qi, 1,1,4 = "Which nuisance do you experience?" with answer option configuration AOi, 1,1,4 = "Record and send audio". qi,i,i,5 = "Which other symptoms do you experience?" with answer option

configuration AOi,i,i,s = "Record and send audio". qi,3,i,i = "What is the agreement with Clinic?" with answer option configuration AOi,3,i,i = "Record and send audio".

The fourth layer of the hierarchy/question configuration comprises fourth rules n, 1,1,1, ri, 1,1,2, ri, 1,1,3, ri, 1,1,4, ri,i, i,s given by the following, where Answer4 is the answer from the patient: ri, 1,1,1 : if Answer4= "Hard activity" then Question5=qi,i,i,i,i if Answer4= "Moderate activity" then Question5= qi, 1,1, 1,1 if Answer4= "Light activity" then Question5= qi, 1,1, 1,1 if Answer4= "Resting" then Question5= qi, 1,1, 1,1 if Answer4= "Any time" then Question5=qi,i,i,i,i if Answer4= "Specific situations" then Question5=qi,i,i,i,i ri, 1,1,2 : if Answer4= "Record and send audio" then Question5=qi, 1,1,2,1 ri, 1,1,3: if Answer4= "Hard activity" then Question5 if Answer4= "Moderate activity" then Question5 if Answer4= "Light activity" then Question5 if Answer4= "Resting" then Question5= qi, 1,1,3,1 if Answer4= "Other" then Question5 ri, 1,1,4: if Answer4= "Record and send audio" then Question5

I^' , 1,5: if Answer4= "Record and send audio" then Question5

The fifth layer of the hierarchy/question configuration comprises fifth questions given by: qi, 1,1, 1,1 = "How often do you experience palpitations?" with answer option

configuration ΑΟι,ι,ι,ι,ι = "First time", "Daily", "Weekly", "Monthly", "Rarely". qi, 1,1,2,1 = "What is your level of nuisance from fainting/unconsciousness? with answer option configuration AOi,i,i,₂,i = " 1", "2", "3", "4", "5". qi, 1,1,3,1 = "How do you experience the shortness of breath?" with answer option configuration AOi, 1,1,3,1 = "Record and send audio". qi, 1,1,4,1 = "What is your level of nuisance from Cardiac device? with answer option configuration A0i,i,i,₄,i = "1", "2", "3", "4", "5". qi, 1,1, 5,1 = "What is your level of nuisance from other symptoms? with answer option configuration AOi,i,i,s,i = "1", "2", "3", "4", "5". The fifth layer of the hierarchy/question configuration comprises fifth rules ri, 1,1, 1,1, ri, 1,1,2,1, ri, 1,1, 3,1, ri, 1,1,4,1, ri, 1,1, 5,1 given by the following, where Answer5 is the answer from the patient:

ΓΙ,Ι,Ι,Ι, Ι : if Answer5= "First time" or "Daily" or "Weekly" or "Monthly" or "Rarely" then Question6 1-1,1,1,2,1 : if Answer5= "1" or "2" or "3" or "4" or "5" then Question6=qi,i,i,₂,i,i. ri,i,i,3,i : if Answer5= "1" or "2" or "3" or "4" or "5" then Question6=qi,i,i,₃,i,i. ri,i,i,4,i : i Answer5= "1" or "2" or "3" or "4" or "5" then Question6=qi,i,i,₄,i,i . ri,i,i,5,i : i Answer5= "1" or "2" or "3" or "4" or "5" then Question6=qi,i,i,₅,i,i .

The sixth layer of the hierarchy/question configuration comprises sixth questions given by: qi, i,i, 1,1,1 = "How long time does the palpitations last?" with answer option

configuration AOi, 1,1,1,1,1 = "Less than 1 minute", "1 to 2 minutes", "2 to 5 minutes", "5 to 10 minutes", "More than 10 minutes". qi, 1,1,2,1,1 = "How worried are you about the fainting/unconsciousness? with answer option configuration AOi,i,i,₂,i,i = " 1", "2", "3", "4", "5". qi, 1,1,3,1,1 = "What is your level of nuisance from shortness of breath? with answer option configuration AOi,i,i,₃,i,i = " 1", "2", "3", "4", "5". qi, 1,1,4,1,1 = "How worried are you about the nuisance from the cardiac device? with answer option configuration Α0ι,ι,ι,₄,ι,ι = "1", "2", "3", "4", "5". qi, 1,1, 5,1,1 = "How worried are you about the other symptoms? with answer option configuration AOi,i,i,₂,i = "1", "2", "3", "4", "5".

The sixth layer of the hierarchy/question configuration comprises sixth rule n, 1,1, 1,1,1, ri, 1,1,3,1,1 given by the following, where Answer6 is the answer from the patient: ri, 1,1, 1,1,1 : if Answer6= "Less than 1 minute" or "1 to 2 minutes" or "2 to 5 minutes" or "5 to 10 minutes" or "More than 10 minutes" then

Question7=qi,i,i,i,i,i,i . ri,i,i,3,i,i : if Answer6= "1" or "2" or "3" or "4" or "5" then Question7=qi,i,i,₃,i,i,i .

The seventh layer of the hierarchy/question configuration comprises seventh questions given by: qi, 1,1, 1,1, 1,1 = "How would you describe your palpitations?" with answer option configuration AOi, 1,1, 1,1, 1,1 = "Record and send audio". qi, 1,1,3,1, 1,1 = "How worried are you about the shortness of breath? with answer option configuration ΑΟι,ι,ι,₃,ι,ι,ι = "1", "2", "3", "4", "5".

Fig. 5 illustrates an exemplary question configuration 250 based on a patient state of "Atrial Fibrillation (AF) occurred" and cardiac data comprising cardiac fibrillation data including a fibrillation time stamp <Fibrillation_Time>, wherein

<Fibrillation_Time>=20.27 on 28-06-2016. The monitoring engine has generated the question configuration 250 based on the cardiac data (<Fibrillation_Time>) by generating a first layer 252 comprising a first primary question qi based on the cardiac data, where qi= "Hello <PATIENT_NAME>. Your ICD has registered Atrial Fibrillation (AF) on 28-06-2016 at 20.27. Have you had atrial fibrillation before? Accordingly, the first question qi is based on the patient state and/or the fibrillation time stamp of the cardiac data. Further, the monitoring engine generates an answer option configuration AOi associated with the first question qi and a first rule n. In the present example, AOi comprises three answer options, namely "Yes", "No", and "Do not know".

The first rule ri is given by: ri : if Answerl= "Yes" then Question2=qi,i if Answerl= "No" then Question2=qi,i if Answerl= "Do not know" then Question2=qi,2

The second layer 254 of the hierarchy/question configuration 250 comprises second questions given by: qi,i = "Did you experience atrial fibrillation around the time of 20.27 on 28-06-2016? with answer option configuration ΑΟι,ι = "Yes and still feel atrial fibrillation", "Yes, but atrial fibrillation stopped", "No". qi,2 = "Do you wish to obtain information on atrial fibrillation?" with answer option configuration AOi,2 = "Yes, please show a video", "Yes, please contact me by phone", "No".

The second layer of the hierarchy/question configuration comprises second rules n,i, ri,2 given by the following, where Answer2 is the answer from the patient to

Question2 : ri,i : if Answer2= "Yes and still feel atrial fibrillation" or "Yes, but atrial

fibrillation stopped"" then Question3=qi,i,i if Answer2= "No" then Question3=qi,i,2 ri,2 : if Answer2= "Yes, please show a video" then <Show video> if Answer2= "Yes, please contact me by phone" or "No" then

<Terminate>

The third layer 256 of the hierarchy/question configuration 250 comprises third questions given by: qi,i,i = "How did you experience the palpitations?" with answer option configuration ΑΟι,ι,ι = "Record and send audio". qi,i,2 = "Did you experience other symptoms?" with answer option configuration AOi,3,i = "No", "Yes, chest pain", "Yes, fatigue", "Yes, other".

The third layer of the hierarchy/question configuration 250 comprises third rules ri,i,i, ri,3,i given by the following, where Answer3 is the answer from the patient to

Question3 :

ΓΙ,Ι,Ι : if Answer3= "Record and send audio" then Question4=qi,i,i,i ri,i,2 : if Answer3= "No" then <Terminate> if Answer3= "Yes, chest pain" or "Yes, fatigue" then Question4=qi, 1,2,1 if Answer3= "Yes, other" then Question4=qi, 1,2,2

The fourth layer 258 of the hierarchy/question configuration 250 comprises fourth questions given by: qi, 1,1,1 = "What is your level of nuisance from atrial fibrillation? with answer option configuration ΑΟι,ι,ι,ι = "1", "2", "3", "4", "5" qi, i,2,i = "How do you experience the chest pain/fatigue?" with answer option configuration AOi, 1,2,1 = "Record and send audio". qi, 1,2,2 = "What other symptoms do you experience?" with answer option configuration AOi, 1,2,2 = "Record and send audio".

The fourth layer 258 of the hierarchy/question configuration 250 comprises fourth rules ri, 1,1,1, n, 1,2,1, ri, 1,2,2 given by the following, where Answer4 is the answer from the patient to Question4:

ΓΙ,Ι,Ι,Ι : if Answer4= "1" or "2" or "3" or "4" or "5" then Question5=qi,i,i,i,i . ri, 1,2,1 : if Answer4= "Record and send audio" then Question5=qi, 1,2,1,1. Γι, 1,2,2: if Answer4= "Record and send audio" then Question5

The fifth layer 260 of the hierarchy/question configuration 250 comprises fifth questions given by: qi, 1,1, 1,1 = "How worried are you about the palpitations?" with answer option configuration ΑΟι,ι,ι,ι,ι = "1", "2", "3", "4", "5". qi, i,2,i,i = "What is your level of nuisance from chest pains/fatigue?" with answer option configuration AOi,i,₂,i,i = " 1", "2", "3", "4", "5". qi, 1,2,2,1 = "What is your level of nuisance from the other symptoms?" with answer option configuration AOi,i,₂,2,i = " 1", "2", "3", "4", "5". The fifth layer 260 of the hierarchy/question configuration 250 comprises a fifth rule ri, 1,1, 1,1 given by the following, where Answer5 is the answer from the patient to Question5 : ri,i,i,i,i : if Answer5= "1" or "2" or "3" or "4" or "5" then Question6=qi,i,i,i,i,i.

The sixth layer 262 of the hierarchy/question configuration 250 comprises a sixth question given by: qi, 1,1, 1,1,1 = "Did you experience other symptoms?" with answer option configuration ΑΟι,ι,ι,ι,ι,ι = "No", "Yes, chest pain", "Yes, fatigue", "Yes, other".

The sixth layer 262 of the hierarchy/question configuration 250 comprises a sixth rule ri, 1,1, 1,1,1 given by the following, where Answer6 is the answer from the patient to Question6: ri, 1,1, 1,1,1 : if Answer6= "No" then <Terminate> if Answer6= "Yes, chest pain" or Yes, fatigue" then

Question7=qi,i,i,i,i,i,i. if Answer6= "Yes, other" then Question7

The seventh layer 264 of the hierarchy/question configuration 250 comprises seventh questions given by: qi, 1,1, 1,1, 1,1 = "How do you experience the chest pain/fatigue?" with answer option configuration AOi, 1,1, 1,1, 1,1 = "Record and send audio". qi, 1,1, 1,1, 1,2 = "What other symptoms do you experience?" with answer option configuration AOi, 1,1,1,1, 1,2 = "Record and send audio".

The seventh layer 264 of the hierarchy/question configuration 250 comprises seventh rules ri, 1,1, 1,1, 1,1, n, 1,1, 1,1, 1,2 given by the following, where Answer7 is the answer from the patient to Question7: ri, 1,1, 1,1, 1,1 : if Answer7= "Record and send audio" then Question8= qi, 1,1, 1,1, 1,1,1 ri, 1,1, 1,1, 1,2: if Answer7= "Record and send audio" then Question8= qi, 1,1, 1,1, 1,2,1.

The eighth layer 266 of the hierarchy/question configuration 250 comprises eighth questions given by: qi, 1,1, 1,1, 1,1,1 = "What is your level of nuisance from chest pains/fatigue?" with answer option configuration ΑΟι,ι,ι,ι,ι,ι,ι,ι = "1", "2", "3", "4", "5". qi, 1,1, 1,1, 1,2,1 = "What is your level of nuisance from the other symptoms?" with answer option configuration ΑΟι,ι,ι,ι,ι,ι,₂,ι = "1", "2", "3", "4", "5".

Fig. 6 schematically illustrates an exemplary monitoring engine according to the invention. The monitoring engine 4 comprises a processing unit 270, a

memory/database 272 connected to the processing unit 270, and a data interface 274 connected to the processing unit 270 for receiving/transmitting data from other devices, e.g. via one or more networks such as the Internet, phone network, etc. The processing unit 270 is configured to receive cardiac data of a cardiac device and/or auxiliary patient data via the data interface 274. Further, the processing unit is optionally configured to obtain a patient state based on the cardiac data and/or the auxiliary patient data, e.g. by receiving the patient state from an external device, such as the cardiac device and/or a clinic device, or determine a patient state based on the cardiac data and/or auxiliary patient data. The processing unit is configured to generate a question configuration based on the patient state and/or the cardiac data. Different question configurations may be generated based on the same patient state but different cardiac data. The processing unit 270 is configured to transmit the question configuration to a patient device via the data interface 274 and optionally storing the question configuration in the memory 272, e.g. together with or linked to the cardiac data on which the question configuration was based. Further, the processing unit 270 is configured to receive patient input data from the patient device via the data interface 274 and align the cardiac data and the patient input data, e.g. by storing the patient input data in the memory with or linked to the question configuration. The processing unit 270 is also configured to transmit the aligned patient input data to a clinic device via the data interface 274.

Fig. 7 is a signalling diagram of an exemplary cardiac monitoring system and associated devices. Cardiac device 6 transmits cardiac data 5 to the monitoring engine 4, e.g. via the Internet and/or other suitable network. Patient device 8 optionally transmits auxiliary patient data 5A, such as activity data, to the monitoring engine 4, e.g. via the Internet and/or other suitable network. The patient device 8 may receive at least some auxiliary patient data 5A from an auxiliary patient device 8A, such as smartwatch or other wearable and forward the received auxiliary patient data from the auxiliary patient device 8A to the monitoring engine 4. In one or more exemplary cardiac monitoring systems, the auxiliary patient device 8A bypasses patient device 8 and transmits auxiliary patient data 5A to the monitoring engine 4, e.g. via the Internet and/or other suitable network. The access to auxiliary patient data allows for a more precise determination of a patient state.

The monitoring engine 4 receives the cardiac data 5 and the auxiliary patient data 5A, and generates and transmits a question configuration 7 based on a patient

state/cardiac data/auxiliary patient data to patient device 8. The patient device 8 receives input from a user/patient based on the question configuration and transmit patient input data 9 to the monitoring engine 4. The monitoring engine 4 aligns the cardiac data and the patient input data and transmits the aligned data 10 to clinic device 12, where a clinician provides input in order to generate clinical input data 14 that are transmitted to the monitoring engine 4. The monitoring engine 4 optionally transmits 16 the clinical input data or at least parts thereof to the patient device 8.

LIST OF REFERENCES

2 cardiac monitoring system

4 monitoring engine

5 cardiac data

5A auxiliary patient data

6 cardiac device

7 question configuration

8 patient device

8A Auxiliary patient device

9 patient input data

10 aligned cardiac data and patient input data

12 clinic device

14 clinical input data

100 Method of operating a cardiac monitoring system

102 receiving cardiac data

102A receiving auxiliary patient data

104 determining a patient state based on the cardiac data

106 generating a question configuration based on the patient state

108 transmitting the question configuration to a patient device 110 receiving patient input data from the patient device

112 aligning the cardiac data and the patient input data

114 transmitting the cardiac data and the patient input data 200, 250 question configuration

202, 252 first layer

204, 254 second layer

206, 256 third layer

208, 258 fourth layer

210, 260 fifth layer

212, 262 sixth layer

214, 264 seventh layer

266 eighth layer

270 processing unit

272 memory/database

274 data interface

Claims

1. A cardiac monitoring system comprising a monitoring engine, wherein the monitoring engine is configured to

- receive cardiac data comprising time stamp data, the cardiac data indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device;

- obtain a patient state based on the cardiac data;

- generate a question configuration based on the patient state and the time stamp data; - transmit the question configuration to a patient device;

- receive patient input data from the patient device;

- align the cardiac data and the patient input data; and

- transmit the aligned patient input data to a clinic device.

2. Cardiac monitoring system according to claim 1, wherein the monitoring engine is configured to receive clinical input data from the clinic device and align the clinical input data and the patient input data.

3. Cardiac monitoring system according to any of claims 1-2, wherein the monitoring engine is configured to transmit clinical input data to the patient device.

4. Cardiac monitoring system according to any of claims 1-3, wherein the monitoring engine is configured to obtain historic patient data, and wherein the question configuration is based on the historic patient data.

5. Cardiac monitoring system according to any of claims 1-5, wherein the monitoring engine is configured to receive preliminary clinical input data from the clinic device, and wherein the question configuration is based on the pre-clinical input data.

6. Cardiac monitoring system according to any of the preceding claims, wherein the monitoring engine is configured to transmit a first notification to the patient device if the patient input data are not received within a patient input period.

7. Cardiac monitoring system according to claim 6, wherein the patient input period is based on patient availability data.

8. Cardiac monitoring system according to any of the preceding claims, wherein the monitoring engine is configured to receive patient input data comprising symptom data, and wherein the monitoring engine is configured to transmit a second

notification based on the symptom data to the patient device.

9. Cardiac monitoring system according to claim 8, wherein the monitoring engine is configured to transmit symptom data to the clinic device.

10. Cardiac monitoring system according to any of claims 8-9, wherein the monitoring engine is configured to generate a question configuration based on the symptom data.

11. Cardiac monitoring system according to any of the preceding claims, wherein to generate a question configuration comprises generating a decision tree.

12. Cardiac monitoring device according to any of the preceding claims, wherein the question configuration comprises a hierarchy comprising a first layer including a first question and a first answer option configuration indicative of a first set of answer options associated with the first question, the first set of answer options comprising at least three answer options, and wherein the question configuration comprises a second layer including at least two second questions associated with the first question.

13. Cardiac monitoring system according to any of the preceding claims, wherein the cardiac monitoring system comprises a patient device configured to:

- receive the question configuration from the monitoring engine;

- generate a first representation with one or more questions based on the question configuration;

- obtain patient input in response to the one or more questions; - generate patient input data based on the patient input; and

- transmit patient input data to the monitoring engine.

14. Cardiac monitoring system according to any of the preceding claims, wherein the cardiac monitoring system comprises a clinic device configured to: - obtain the cardiac data;

- receive the aligned patient input data from the monitoring engine;

- determine a patient state based on the cardiac data and the patient input data;

- generate a first representation if the patient state fulfills a first criterion;

- obtain clinician input in response to the first representation;

- generate clinical input data based on the clinician input; and

- transmit clinical input data to the monitoring engine.

15. Cardiac monitoring system according to claim 14, wherein the clinic device is configured to:

- receive cardiac data;

- determine a patient state based on the cardiac data;

- generate a second representation if the patient state fulfills a second criterion;

- obtain preliminary clinician input in response to the second representation;

- generate preliminary clinical input data based on the preliminary clinician input in response to the second representation; and

- transmit preliminary clinical input data to the monitoring engine.

16. Method of operating a cardiac monitoring system comprising a monitoring engine, a cardiac device, a patient device and a clinic device, the method comprising :

- receiving cardiac data comprising time stamp data from a cardiac device, wherein the cardiac data are indicative of cardiac activity of a patient and/or indicative of cardiac device activity of a cardiac device;

- obtaining a patient state based on the cardiac data; - generating a question configuration based on the patient state and the time stamp data;

- transmitting the question configuration to the patient device;

- receiving patient input data from the patient device;

- aligning the cardiac data and the patient input data; and

- transmitting the aligned patient input data to the clinic device.