Systems, methods, and computer program products for identifying diagnostic enabling data
The system addresses the challenge of unreliable physiological data acquisition by analyzing and providing real-time feedback, ensuring high-quality data transmission for accurate medical diagnoses.
Patent Information
- Application Number
- JP2023158818
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-05-11
- Filing Date
- 2023-09-22
- Publication Date
- 2026-01-16
- Estimated Expiration
- 2037-05-10
AI Technical Summary
Existing medical diagnostic devices lack the ability to provide real-time feedback on the quality of physiological data acquisition, leading to unreliable heart rate measurements and ineffective use of diagnostic data, particularly in noisy environments or due to patient movement.
A system and method that utilizes a processor to analyze physiological data in real-time, determine the presence of diagnostic-enabling data, and provide feedback to users on data quality, allowing for improved data acquisition and transmission to remote diagnostic entities.
Enables reliable acquisition and transmission of diagnostic-enabling data, enhancing the accuracy of medical diagnoses by providing real-time quality feedback and instructions for improving data collection.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to systems, methods, and computer program products for providing feedback related to medical tests. [Background technology]
[0002] 3M, located in Maplewood, Minnesota, USA, sells a line of digital stethoscopes, such as the Models 3100 and 3200, under the trademark "Littmann." The 3100 and 3200 display a special symbol (two dashes (--)) on the display if the heart rate measurement fails. The user manuals for these models list several possible causes for a failed heart rate determination, including a constant to irregular heart rate or excessive ambient noise, patient movement, or lung sounds during auscultation. However, among other things, the Littmann cardiac recordings are not relevant to the heart rate determination, and the quality of the recording data is not at all determinative.
[0003] Nonin Medical, Inc. sells a finger pulse oximeter under the name "GO2" that provides an indication of oxygen saturation based on measurements made on a patient's finger. Part of the GO2's user interface is called the "Pulse Quality Indicator," which displays the strength of the pulse rate signal detected by the device. The "Pulse Quality Indicator" provides a visual indicator (the number of bars in the display) of the strength of the pulse signal strength.
[0004] Patent document 1, filed February 16, 2012, entitled "System and Method for Performing an Automatic and Self-Guided Medical Examina" discloses a method for performing one or more medical examinations of a patient using a diagnostic device, the method including, for at least one of the medical examinations, the steps of: a. providing reference data indicating a desired spatial location of the device relative to the patient's body for performing the medical examination, and operating the device to acquire navigation-enabling data; b. determining a spatial location of the device relative to the desired spatial location using the acquired navigation-enabling data and the reference data; c. calculating a movement correction required from the determined spatial location to the desired spatial location in order to acquire medical data of the patient according to the at least one medical examination; d. providing operating instructions to a user to navigate the device to the desired spatial location according to the calculated path; and e. acquiring the medical data upon arrival at the desired spatial location. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] U.S. Patent No. 8,953,837 [Non-patent literature]
[0006] [Non-Patent Document 1] SOHN, "A statistical model-based voice activity detection," IEEE Signal Processing Letters, Vol. 6, January 1, 1999. Summary of the Invention [Means for solving the problem]
[0007] According to a first aspect of the presently disclosed subject matter, there is provided a system including a processor configured to acquire physiological data acquired during a medical examination of a patient's body conducted by a user who is not a medical practitioner using a sensor, analyze the acquired physiological data to determine the presence of diagnostic enabling data that will enable a diagnostic entity to subsequently diagnose a medical condition of the patient, and, if present, provide at least the diagnostic enabling data to the diagnostic entity, thereby enabling the diagnostic entity to diagnose the medical condition of the patient.
[0008] In some cases, the diagnostic entity is a medical practitioner.
[0009] In some cases, the system further includes a network interface, and providing includes transmitting at least the diagnostic-enabling data through the network interface to a separate device operated by the medical practitioner.
[0010] In some cases, the network interface is wireless.
[0011] In some cases, the system and sensors are contained within a handheld device that is operated by a user.
[0012] In some cases, the sensor is contained within a handheld device that is activated by the user, and the system is external to the handheld device.
[0013] In some cases, the acquiring and analyzing occur in real time during a medical examination, and the processor is further configured to provide an indication of the presence of the diagnostic enabling data to the user if the analysis indicates that the diagnostic enabling data is present in the physiological data.
[0014] In some cases, the indication is one or more of: (a) a visual indication provided through a user interface of a device activated by the user; (b) an audio indication provided through a speaker of a device activated by the user; or (c) a vibration indication provided through a vibration element within a device activated by the user.
[0015] In some cases, the device is a handheld device that includes a sensor.
[0016] In some cases, the medical test is a non-instantaneous physiological measurement taken over a continuous period of time, and the processor is further configured to determine, at multiple time points during the non-instantaneous physiological measurement, a multi-valued quality score indicative of the suitability of the currently acquired physiological data for diagnosis by the diagnostic entity, and to provide real-time multi-valued quality feedback information to the user that is based on the corresponding determined multi-valued quality score.
[0017] In some cases, the multi-value quality feedback information is provided through a user interface of a user-activated device.
[0018] In some cases, the processor is further configured to provide instructions to a user for improving physiological data acquisition when the multi-valued quality score is below a predetermined threshold.
[0019] In some cases, the command is to spatially reposition the sensor relative to the patient's body.
[0020] In some cases, the physiological data is raw data acquired by a sensor.
[0021] In some cases, the sensor is an audio sensor and the physiological data is an audio recording.
[0022] In some cases, the sensor is a camera and the physiological data is an image or video recording.
[0023] In some cases, the processor is further configured to instruct the user to reacquire physiological data using the sensor if an absence of diagnostic-enabling data is determined.
[0024] In some cases, the processor is configured to selectively provide a success indication for the physiological measurement in response to determining that a cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0025] In some cases, the processor is configured to stop the physiological measurements in response to determining that a cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0026] In some cases, the physiological data includes (a) first data resulting from a physiological process and (b) second data resulting from an additional source.
[0027] In some cases, the additional source includes an ambient signal, and analyzing includes identifying the ambient signal and alerting the user if the ambient signal exceeds a threshold.
[0028] In some cases, the processor is further configured to determine a cause of the ambient signal and provide an indication of the determined cause to a user.
[0029] In some cases, analyzing includes identifying first data resulting from a physiological process.
[0030] In some cases, analyzing further includes determining the presence of diagnostic-enabling data within the first data.
[0031] In some cases, the providing includes providing at least a portion of the acquired physiological data including the diagnosis-enabling data and the additional data, and the processor is further configured to provide information indicative of a location of the diagnosis-enabling data within the acquired physiological data.
[0032] In some cases, the processor is further configured to instruct the user to reacquire physiological data using the sensor if an absence of diagnostic-enabling data is determined.
[0033] In some cases, the acquiring and analyzing occurs in real time during a medical examination, and the processor is further configured to provide instructions to a user to spatially reposition the sensor relative to the patient's body according to the medical examination or according to a subsequent medical examination defined by the patient's predetermined examination plan.
[0034] In some cases, the processor is further configured to identify an ambient signal before acquiring the physiological data, and to alert the user if the ambient signal exceeds a threshold.
[0035] In some cases, the diagnostic entity is located remotely from the user and from the patient.
[0036] According to a second aspect of the presently disclosed subject matter, there is provided a method including the steps of acquiring, by a processor, physiological data acquired during a medical examination of a patient's body conducted by a user who is not a medical practitioner using a sensor; analyzing, by the processor, the acquired physiological data to determine the presence of diagnosis-enabling data that will enable a diagnostic entity to subsequently diagnose a medical condition in the patient; and, if present, providing, by the processor, at least the diagnosis-enabling data to the diagnostic entity, thereby enabling the diagnostic entity to diagnose the medical condition in the patient.
[0037] In some cases, the diagnostic entity is a medical practitioner.
[0038] In some cases, the providing step includes transmitting at least the diagnostic-enabling data over a network interface to a separate device operated by a medical practitioner.
[0039] In some cases, the network interface is wireless.
[0040] In some cases, the processor and sensor are contained within a handheld device that is operated by a user.
[0041] In some cases, the sensor is contained within a handheld device that is activated by a user, and the processor is external to the handheld device.
[0042] In some cases, the acquiring and analyzing steps occur in real time during a medical examination, and the method further includes providing an indication of the presence of the diagnostic enabling data to a user if the analyzing step indicates that diagnostic enabling data is present in the physiological data.
[0043] In some cases, the indication is one or more of: (a) a visual indication provided through a user interface of a device activated by the user; (b) an audio indication provided through a speaker of a device activated by the user; or (c) a vibration indication provided through a vibration element within a device activated by the user.
[0044] In some cases, the device is a handheld device that includes a sensor.
[0045] In some cases, the medical test is a non-instantaneous physiological measurement taken over a continuous period of time, and the method further includes determining, by the processor, at multiple points during the non-instantaneous physiological measurement, a multi-valued quality score indicative of the suitability of the currently acquired physiological data for diagnosis by the diagnostic entity, and providing real-time multi-valued quality feedback information to the user that is based on the corresponding determined multi-valued quality score.
[0046] In some cases, the multi-value quality feedback information is provided through a user interface of a user-activated device.
[0047] In some cases, the method further includes providing instructions to a user for improving physiological data acquisition when the multi-valued quality score is below a predetermined threshold.
[0048] In some cases, the command is to spatially reposition the sensor relative to the patient's body.
[0049] In some cases, the physiological data is raw data acquired by a sensor.
[0050] In some cases, the sensor is an audio sensor and the physiological data is an audio recording.
[0051] In some cases, the sensor is a camera and the physiological data is an image or video recording.
[0052] In some cases, the method further includes instructing the user to reacquire physiological data using the sensor if an absence of diagnostic-enabling data is determined.
[0053] In some cases, the method further includes selectively providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0054] In some cases, the method further includes stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0055] In some cases, the physiological data includes (a) first data resulting from a physiological process and (b) second data resulting from an additional source.
[0056] In some cases, the additional source includes an ambient signal, and analyzing includes identifying the ambient signal and alerting a user if the ambient signal exceeds a threshold.
[0057] In some cases, the processor is further configured to determine a cause of the ambient signal and provide an indication of the determined cause to a user.
[0058] In some cases, the analyzing step includes identifying first data resulting from a physiological process.
[0059] In some cases, the analyzing step further includes determining the presence of diagnostic-enabling data within the first data.
[0060] In some cases, the providing step includes providing at least a portion of the acquired physiological data including the diagnosis-enabling data and the additional data, and the method further includes providing information indicative of a location of the diagnosis-enabling data within the acquired physiological data.
[0061] In some cases, the method further includes instructing the user to reacquire physiological data using the sensor if an absence of diagnostic-enabling data is determined.
[0062] In some cases, the acquiring and analyzing steps occur in real time during a medical examination, and the method further includes providing instructions to a user to spatially reposition the sensor relative to the patient's body according to the medical examination or according to a subsequent medical examination defined by the patient's predetermined examination plan.
[0063] In some cases, the method further includes identifying an ambient signal before acquiring the physiological data and alerting a user if the ambient signal exceeds a threshold.
[0064] In some cases, the diagnostic entity is located remotely from the user and from the patient.
[0065] According to a third aspect of the presently disclosed subject matter, there is provided a non-transitory computer-readable storage medium having computer-readable program code embodied thereon that is executable by at least one processor to perform a method including acquiring, by a processor, physiological data acquired during a medical examination of a patient's body performed by a user who is not a medical practitioner using a sensor; analyzing, by the processor, the acquired physiological data to determine the presence of diagnostic enabling data that enables a diagnostic entity to subsequently diagnose a medical condition of the patient; and, if present, providing, by the processor, at least the diagnostic enabling data to the diagnostic entity, thereby enabling the diagnostic entity to diagnose the medical condition of the patient.
[0066] According to a fourth aspect of the presently disclosed subject matter, there is provided a system for physiological measurement of a physiological process in a patient's body, the system including: at least one physiological sensor operable to collect physiological data from the patient's body at multiple times during the physiological measurement, the physiological data resulting from (a) the physiological process and (b) an additional source; and a processor operable to perform, at multiple different times during the physiological measurement, the steps of identifying each portion of the physiological data resulting from the physiological process; determining a multi-valued quality score for the physiological data based on the physiological data and on the results of the identification, the multi-valued quality score indicating the suitability of the physiological data for analysis of the physiological process; and providing, via a tangible user interface, multi-valued quality feedback information based on the multi-valued quality score.
[0067] In some cases, the processor is further operable to generate analysis source data for analysis based on the physiological data collected by the physiological sensor and on at least one of the multi-value quality scores.
[0068] In some cases, the quality score is different from any value contained in the analyzed source data.
[0069] In some cases, the processor is operable to identify portions of the physiological data resulting from physiological processes based on identifying effects of a plurality of different physiological processes on the physiological data.
[0070] In some cases, the user interface is operable to present instructions to the user for performing the physiological measurement, the processor determining the instructions based on at least one of the multi-valued quality scores.
[0071] In some cases, the processor determines at least one of the multi-valued quality scores further based on parameters of an analytical procedure selected from a predetermined finite number of analytical procedures for analyzing the physiological data.
[0072] In some cases, the system is a portable handheld physiological monitoring device.
[0073] In some cases, the physiological sensor utilizes acquisition parameters for at least one of the measurements that are based on at least one of the quality scores.
[0074] In some cases, the acquisition parameters are further determined in response to quality criteria selected for the patient by a medical professional.
[0075] In some cases, the acquisition parameters are further determined in response to a patient's medical condition.
[0076] In some cases, the acquisition parameters are further determined in response to a quality score determined for at least one previous physiological measurement taken on a previous date.
[0077] In some cases, the multi-valued quality score indicates the degree to which the patient complies with instructions regarding physical activity.
[0078] In some cases, the processor determines the multi-valued quality score based on a selection of a scoring scheme from a plurality of predetermined scoring schemes, each scoring scheme being associated with an analytical procedure for a physiological process.
[0079] In some cases, the processor is configured to compress different portions of the physiological data relative to the analyzed source data based on different multi-value quality scores determined for the different portions.
[0080] In some cases, the system further includes at least one non-physiological sensor, and the processor is configured to determine a multi-value quality score for the at least one physiological data further based on data collected by the at least one non-physiological sensor.
[0081] In some cases, the processor is configured to selectively provide a success indication for the physiological measurement in response to determining that a cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0082] In some cases, the processor is configured to stop the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0083] In some cases, the additional source includes an ambient signal, and analyzing includes identifying the ambient signal and alerting the user if the ambient signal exceeds a threshold.
[0084] In some cases, the processor is further configured to determine a cause of the ambient signal and provide an indication of the determined cause to a user.
[0085] According to a fifth aspect of the presently disclosed subject matter, there is provided a computer-implemented method for providing feedback indicating suitability of data collected during physiological measurement for analysis of a physiological process of a patient's body, the method including the steps of: acquiring physiological data collected from the patient's body resulting from (a) the physiological process and (b) an additional source; identifying portions of the physiological data resulting from the physiological process; determining a multi-valued quality score for the physiological data based on the physiological data and results of the identification, indicating suitability of the physiological data for analysis of the physiological process; and providing multi-valued quality feedback information via a tangible user interface, the multi-valued quality feedback information being based on the quality scores, at multiple different times during the physiological measurement.
[0086] In some cases, the method further includes generating analysis source data for analysis of the physiological process based on at least one of the multi-valued quality scores and based on physiological data acquired at one of a plurality of different times.
[0087] In some cases, the quality score is different from any value contained in the analyzed source data.
[0088] In some cases, the identifying step is based on identifying the effects of a plurality of different physiological processes on the physiological data.
[0089] In some cases, the plurality of different times includes at least a first time and a second time later than the first time, and the step of acquiring physiological data at the second time is affected by a change in physiological measurement by a user resulting from the provision by the tangible user interface of multi-value quality feedback information resulting from multi-values determined for the physiological data acquired at the first time.
[0090] In some cases, the physiological data is collected by a physiological measurement device, and the relevance of the physiological data changes as a result of changes in the operation of the physiological measurement device by a user who perceives quality feedback information provided by a tangible user interface.
[0091] In some cases, the method further includes presenting instructions to the user via the tangible user interface for performing the physiological measurement.
[0092] In some cases, determining the multi-valued quality score is further based on parameters of an analytical procedure selected from a predetermined finite number of analytical procedures for analyzing the physiological data.
[0093] In some cases, the obtaining, identifying, and determining steps are performed by a portable handheld physiological monitoring device, and the obtaining step includes measuring a physiological measurement value with at least one physiological sensor of the portable handheld physiological monitoring device.
[0094] In some cases, the method further includes selecting a relevant portion of the physiological data collected during the physiological measurement based on the quality score, and generating a physiological measurement value preview based on the relevant portion for presentation via a tangible user interface.
[0095] In some cases, the method further includes modifying acquisition parameters of a physiological sensor that collects at least a portion of the measurement data based on at least one of the quality scores.
[0096] In some cases, modifying the acquisition parameters is further performed in response to quality criteria selected for the patient by a medical professional.
[0097] In some cases, modifying the acquisition parameters is further performed in response to a patient condition.
[0098] In some cases, modifying the acquisition parameters is further performed in response to a quality score determined for at least one previous physiological measurement taken on a previous date.
[0099] In some cases, the multi-valued quality score indicates the degree to which the patient complies with instructions regarding physical activity.
[0100] In some cases, determining the multi-valued quality score is based on selecting a scoring scheme from a plurality of predefined scoring schemes, each scoring scheme being associated with an analytical procedure for a physiological process.
[0101] In some cases, generating the analysis source data includes compressing different portions of the physiological data based on different multi-value quality scores determined for the different portions.
[0102] In some cases, determining the multi-valued quality score for the at least one physiological data is further based on data collected by a non-physiological sensor of the physiological measurement system that collected the physiological data.
[0103] In some cases, the method further includes providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0104] In some cases, the method further includes stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0105] In some cases, the additional source includes an ambient signal, and the method further includes identifying the ambient signal and alerting a user if the ambient signal exceeds a threshold.
[0106] In some cases, the method further includes determining a cause of the ambient signal and providing an indication of the determined cause to a user.
[0107] According to a sixth aspect of the presently disclosed subject matter, there is provided a non-transitory computer-readable medium for providing feedback indicative of suitability of data collected during physiological measurement for analysis of a physiological process of a patient's body, the non-transitory computer-readable medium storing instructions that, when executed on a processor, perform the following steps at multiple different times during the physiological measurement: acquiring physiological data collected from a patient's body and resulting from (a) a physiological process and (b) an additional source; identifying each portion of the physiological data resulting from the physiological process; determining a multi-valued quality score for the physiological data indicative of suitability of the physiological data for analysis of the physiological process based on the physiological data and on the results of the identification; and providing multi-valued quality feedback information through a tangible user interface, the multi-valued quality feedback information being based on the quality scores.
[0108] In some cases, the non-transitory computer-readable medium further stores instructions that, when executed on the processor, perform a step of generating analysis source data for analysis of a physiological process based on at least one of the multi-valued quality scores and on physiological data acquired at one of a plurality of different times.
[0109] In some cases, the quality score is different from any value contained in the analyzed source data.
[0110] In some cases, the identifying step is based on identifying the effects of a plurality of different physiological processes on the physiological data.
[0111] In some cases, the plurality of different times includes at least a first time and a second time that is later than the first time, and the step of acquiring physiological data at the second time is affected by a change in physiological measurement by a user as a result of the provision by the tangible user interface of multi-value quality feedback information resulting from multi-values determined for the physiological data acquired at the first time.
[0112] In some cases, the physiological data is collected by a physiological measurement device, and the relevance of the physiological data changes as a result of changes in the operation of the physiological measurement device by a user who perceives quality feedback information provided by a tangible user interface.
[0113] In some cases, the non-transitory computer-readable medium further stores instructions that, when executed on the processor, perform the step of presenting instructions for performing physiological measurements to a user via a tangible user interface.
[0114] In some cases, determining the multi-valued quality score is further based on parameters of an analytical procedure selected from a predetermined finite number of analytical procedures for analyzing the physiological data.
[0115] In some cases, the obtaining, identifying, and determining steps are performed by a portable handheld physiological monitoring device, and the obtaining step includes measuring a physiological measurement value with at least one physiological sensor of the portable handheld physiological monitoring device.
[0116] In some cases, the non-transitory computer-readable medium further stores instructions that, when executed on the processor, perform the steps of selecting a relevant portion of the physiological data collected during the physiological measurement based on the quality score, and generating a physiological measurement value preview based on the relevant portion for presentation via a tangible user interface.
[0117] In some cases, the non-transitory computer-readable medium further stores instructions that, when executed on the processor, perform a step of modifying acquisition parameters of a physiological sensor that collects at least a portion of the measurement data based on at least one of the quality scores.
[0118] In some cases, modifying the acquisition parameters is further performed in response to quality criteria selected for the patient by a medical professional.
[0119] In some cases, modifying the acquisition parameters is further performed in response to a patient condition.
[0120] In some cases, modifying the acquisition parameters is further performed in response to a quality score determined for at least one previous physiological measurement taken on a previous date.
[0121] In some cases, the multi-valued quality score indicates the degree to which the patient complies with instructions regarding physical activity.
[0122] In some cases, determining the multi-valued quality score is based on selecting a scoring scheme from a plurality of predefined scoring schemes, each scoring scheme being associated with an analytical procedure for a physiological process.
[0123] In some cases, generating the analysis source data includes compressing different portions of the physiological data based on different multi-value quality scores determined for the different portions.
[0124] In some cases, determining the multi-valued quality score for the at least one physiological data is further based on data collected by a non-physiological sensor of the physiological measurement system that collected the physiological data.
[0125] In some cases, the additional source includes an ambient signal and further stores instructions that, when executed on the processor, perform the steps of identifying the ambient signal and alerting a user if the ambient signal exceeds a threshold.
[0126] In some cases, the non-transitory computer-readable medium further stores instructions that, when executed on the processor, perform the steps of determining a cause of the ambient signal and providing an indication of the determined cause to a user.
[0127] According to a seventh aspect of the presently disclosed subject matter, there is provided a system for physiological measurement of a physiological process in a patient's body, the system including at least one physiological sensor operable to collect physiological data resulting from at least the physiological process from the patient's body at a plurality of different times during the physiological measurement; and a processor operable to (a) determine a multi-valued quality score for the physiological data collected at the plurality of different times, and (b) selectively provide a success indication for the physiological measurement in response to determining that a cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0128] According to an eighth aspect of the presently disclosed subject matter, there is provided a computer-implemented method for providing feedback indicative of suitability of data collected during a physiological measurement for analysis of a physiological process of a patient's body, the method including, executing on a processor: obtaining physiological data collected from the patient's body at a plurality of different times during the physiological measurement and resulting from at least the physiological process; determining a multi-valued quality score for the physiological data collected at the plurality of different times; and selectively providing a success indication for the physiological measurement in response to determining that a cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfies a predetermined criterion exceeds a predetermined amount.
[0129] According to a ninth aspect of the presently disclosed subject matter, there is provided a non-transitory computer-readable medium for providing feedback indicative of suitability of data collected during a physiological measurement for analysis of a physiological process of a patient's body, the non-transitory computer-readable medium storing instructions that, when executed on a processor, perform the following steps at a plurality of different times during the physiological measurement: acquiring physiological data collected from the patient's body at a plurality of different times during the physiological measurement and resulting from at least a physiological process; determining a multi-valued quality score for the physiological data collected at the plurality of different times; and selectively providing a success indication for the physiological measurement in response to determining that a cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfies a predetermined criterion exceeds a predetermined amount.
[0130] According to a tenth aspect of the presently disclosed subject matter, there is provided a system including a processor and a display, wherein the processor is configured to acquire physiological data acquired during a non-instantaneous physiological measurement of a patient, the physiological data including one or more first portions identified as diagnosis-enabling data and at least one second portion not identified as diagnosis-enabling data, and to display on the display a user interface that enables a medical practitioner to navigate through the acquired physiological data, the user interface including at least one indication of a location of at least one corresponding first portion of the first portions, and that enables a user to identify the location.
[0131] In some cases, the physiological data is an audio or video recording, and the display includes a first marking on a video or audio progress bar displayed on the user interface at the start location of at least one corresponding first portion and associated with the physiological data.
[0132] In some cases, the display includes a second marking on the video or audio progress bar of the end location of at least one corresponding first portion.
[0133] In some cases, the display includes a graph representing multiple multi-valued quality scores, each calculated for a corresponding time point during the non-instantaneous physiological measurement and each indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0134] In some cases, the video or audio recording will be at least 10 seconds in length.
[0135] In some cases, physiological measurements are taken by a user who is not a medical practitioner using sensors contained within a handheld diagnostic device.
[0136] In some cases, the physiological data is acquired during physiological measurements taken at a first geographic location and transmitted to a second geographic location of the medical practitioner that is remote from the first geographic location.
[0137] In some cases, the processor is further configured to receive a representation of an area of interest within the physiological data from the medical practitioner and to transmit the physiological data and the representation of the area of interest to a remote workstation operated by a second medical practitioner, thereby enabling the remote workstation to present the physiological data and the representation of the area of interest to the second medical practitioner for analysis.
[0138] In some cases, the processor is further configured to display a navigation user interface (UI) element on the display, and upon activation of the navigation UI element, the system automatically navigates to a next or previous one of the first locations, thereby enabling skipping over the second portion.
[0139] In some cases, the processor is further configured to receive an indication of the region of interest within the physiological data from the medical practitioner and store the indication in an electronic health record (EHR) associated with the patient.
[0140] According to an eleventh aspect of the presently disclosed subject matter, there is provided a method including: acquiring, by a processor, physiological data acquired during non-instantaneous physiological measurements of a patient, the physiological data including one or more first portions identified as diagnosis-enabling data and at least one second portion not identified as diagnosis-enabling data; and displaying, by the processor, on a display, a user interface that enables a medical practitioner to navigate through the acquired physiological data, the user interface including at least one indication of a location of at least one corresponding first portion of the first portions, and that enables a user to identify the location.
[0141] In some cases, the physiological data is an audio or video recording, and the display includes a first marking on a video or audio progress bar displayed on the user interface at the start location of at least one corresponding first portion and associated with the physiological data.
[0142] In some cases, the display includes a second marking on the video or audio progress bar of the end location of at least one corresponding first portion.
[0143] In some cases, the display includes a graph representing multiple multi-valued quality scores, each calculated for a corresponding time point during the non-instantaneous physiological measurement and each indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0144] In some cases, the video or audio recording will be at least 10 seconds in length.
[0145] In some cases, physiological measurements are taken by a user who is not a medical practitioner using sensors contained within a handheld diagnostic device.
[0146] In some cases, the physiological data is acquired during physiological measurements taken at a first geographic location and transmitted to a second geographic location of the medical practitioner that is remote from the first geographic location.
[0147] In some cases, the method further includes receiving, by the processor, a representation of an area of interest within the physiological data from the medical practitioner, and transmitting, by the processor, the physiological data and the representation of the area of interest to a remote workstation operated by a second medical practitioner, thereby enabling the remote workstation to present the physiological data and the representation of the area of interest to the second medical practitioner for analysis.
[0148] In some cases, the method further includes displaying a navigation user interface (UI) element on the display, wherein upon activation of the navigation UI element, the processor automatically navigates to a next or previous one of the first locations, thereby enabling skipping over the second portion.
[0149] In some cases, the method further includes receiving, by the processor, an indication of the region of interest within the physiological data from the medical practitioner, and storing, by the processor, the indication in an electronic health record (EHR) associated with the patient.
[0150] According to a twelfth aspect of the presently disclosed subject matter, there is provided a non-transitory computer-readable storage medium having computer-readable program code embodied thereon, the computer-readable program code being executable by at least one processor to perform a method including acquiring physiological data acquired during non-instantaneous physiological measurements of a patient, the first portion including one or more first portions identified as diagnosis-enabling data and at least one second portion not identified as diagnosis-enabling data; and displaying on a display a user interface that enables a medical practitioner to navigate through the acquired physiological data, the user interface including at least one indication of a location of at least one corresponding first portion of the first portions, and that enables a user to identify the location.
[0151] According to a thirteenth aspect of the presently disclosed subject matter, there is provided a system including a processor and a display, wherein the processor is configured to obtain, for each patient of a plurality of patients, one or more files associated with the patient, each file being obtained during a corresponding non-instantaneous physiological measurement toward analysis of a physiological process of the body of the corresponding patient, and each file having a quality score indicative of suitability of the physiological data contained in the file for diagnosis by a medical practitioner, and to display on the display (a) a list of the patients and (b) at least one indication of the patient medical test quality score for at least one of the patients.
[0152] In some cases, the patient medical test quality score is the maximum quality score of the files associated with the corresponding patient, and the list is ordered by at least the maximum quality score.
[0153] In some cases, the processor is further configured to, upon selection of a given one of the patients, display on the display a second list of files associated with the given patient and, for each of the files, its quality score.
[0154] In some cases, the quality score for each of the files is the maximum score from a plurality of multi-valued quality scores calculated for a corresponding time point during the corresponding non-instantaneous physiological measurement, each of the multi-valued quality scores indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0155] In some cases, the physiological data includes one or more first portions identified as diagnosis-enabling data and at least one second portion not identified as diagnosis-enabling data, and the processor is further configured to, upon selection of a given one of the files displayed on the display, display a user interface that enables a medical practitioner to navigate through the physiological data, the user interface including at least one indication of the location of at least one corresponding first portion identified as diagnosis-enabling data within the acquired physiological data and allowing the user to identify this location.
[0156] In some cases, the physiological data is an audio or video recording, and the display includes a first marking on a video or audio progress bar displayed on the user interface at the start location of at least one corresponding first portion and associated with the physiological data.
[0157] In some cases, the display includes a second marking on the video or audio progress bar of the end location of at least one corresponding first portion.
[0158] In some cases, the display includes a graph representing multiple multi-valued quality scores, each calculated for a corresponding time point during the non-instantaneous physiological measurement and each indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0159] In some cases, the video or audio recording will be at least 10 seconds in length.
[0160] In some cases, physiological measurements are taken by a user who is not a medical practitioner using sensors contained within a handheld diagnostic device.
[0161] In some cases, the physiological data is acquired during physiological measurements taken at a first geographic location and transmitted to a second geographic location of the medical practitioner that is remote from the first geographic location.
[0162] In some cases, the processor is further configured to receive a representation of an area of interest within the physiological data from the medical practitioner and to transmit the physiological data and the representation of the area of interest to a remote workstation operated by a second medical practitioner, thereby enabling the remote workstation to present the physiological data and the representation of the area of interest to the second medical practitioner for analysis.
[0163] In some cases, the list is ordered in descending order of maximum quality score.
[0164] According to a fourteenth aspect of the presently disclosed subject matter, there is provided a method including: obtaining, by a processor for each patient of a plurality of patients, one or more files associated with the patient, each file being obtained during a corresponding non-instantaneous physiological measurement for analysis of a physiological process of the body of the corresponding patient, and each file having a quality score indicative of the suitability of the physiological data contained in the file for diagnosis by a medical practitioner; and displaying, by the processor, on a display: (a) a list of the patients; and (b) at least one indication of the patient medical test quality score for at least one of the patients.
[0165] In some cases, the patient medical test quality score is the maximum quality score of the files associated with the corresponding patient, and the list is ordered by at least the maximum quality score.
[0166] In some cases, the method further includes, upon selection of a given one of the patients, displaying on the display a second list of files associated with the given patient and, for each of the files, its quality score.
[0167] In some cases, the quality score for each of the files is the maximum score from a plurality of multi-valued quality scores calculated for a corresponding time point during the corresponding non-instantaneous physiological measurement, each of the multi-valued quality scores indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0168] In some cases, the physiological data includes one or more first portions identified as diagnosis-enabling data and at least one second portion not identified as diagnosis-enabling data, and the method further includes, upon selection of a given one of the files displayed on the display, displaying by the processor a user interface that enables a medical practitioner to navigate through the physiological data, the user interface including at least one indication of the location of at least one corresponding first portion identified as diagnosis-enabling data within the acquired physiological data and allowing the user to identify this location.
[0169] In some cases, the physiological data is an audio or video recording, and the display includes a first marking on a video or audio progress bar displayed on the user interface at the start location of at least one corresponding first portion and associated with the physiological data.
[0170] In some cases, the display includes a second marking on the video or audio progress bar of the end location of at least one corresponding first portion.
[0171] In some cases, the display includes a graph representing multiple multi-valued quality scores, each calculated for a corresponding time point during the non-instantaneous physiological measurement and each indicating the suitability of the physiological data at the corresponding time point for diagnosis by a medical practitioner.
[0172] In some cases, the video or audio recording will be at least 10 seconds in length.
[0173] In some cases, physiological measurements are taken by a user who is not a medical practitioner using sensors contained within a handheld diagnostic device.
[0174] In some cases, the physiological data is acquired during physiological measurements taken at a first geographic location and transmitted to a second geographic location of the medical practitioner that is remote from the first geographic location.
[0175] In some cases, the method further includes receiving, by the processor, a representation of an area of interest within the physiological data from the medical practitioner, and transmitting, by the processor, the physiological data and the representation of the area of interest to a remote workstation operated by a second medical practitioner, thereby enabling the remote workstation to present the physiological data and the representation of the area of interest to the second medical practitioner for analysis.
[0176] In some cases, the list is ordered in descending order of maximum quality score.
[0177] According to a fifteenth aspect of the presently disclosed subject matter, there is provided a non-transitory computer-readable storage medium having computer-readable program code embodied thereon, the computer-readable program code being executable by at least one processor to perform a method including: obtaining, for each patient of a plurality of patients, one or more files associated with the patient, each file being obtained during a corresponding non-instantaneous physiological measurement for analysis of a physiological process of the body of the corresponding patient, and each file having a quality score indicative of suitability of the physiological data contained in the file for diagnosis by a medical practitioner; and displaying on a display (a) a list of the patients and (b) at least one indication of patient medical test quality scores for at least one of the patients.
[0178] In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]
[0179] [Figure 1] 1 is a functional block diagram illustrating an example system in accordance with the presently disclosed subject matter. [Figure 2] 1 is a functional block diagram illustrating an example system in accordance with the presently disclosed subject matter. [Figure 3A]1 is a flow chart illustrating an example method for providing feedback indicating the suitability of data collected during physiological measurements for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. [Figure 3B] 3B is a flow chart illustrating an example of the method of FIG. 3A adapted to prepare analysis source data for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. [Figure 3C] 1 is a flow chart illustrating an example method for providing feedback indicating the suitability of data collected during physiological measurements for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. [Figure 4] 1 is a flow chart illustrating an example method for providing feedback indicating the suitability of data collected during physiological measurements for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. [Figure 5] 7A-7C illustrate optional ways of implementing the method stages of FIGS. 3, 4, and 6 in accordance with the presently disclosed subject matter. [Figure 6] 1 is a flow chart illustrating an example method for providing feedback indicating the suitability of data collected during physiological measurements for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. [Figure 7] 7A-7C illustrate optional stages of the methods of FIGS. 3, 4, and 6 according to examples of the presently disclosed subject matter. [Figure 8] 1 is a flow chart illustrating an example method for providing feedback indicating the suitability of data collected during pulmonary auscultation for a patient's pulmonary analysis in accordance with the presently disclosed subject matter. [Figure 9] 1 is a flow diagram illustrating an example of a method for a user of a system in accordance with the presently disclosed subject matter. [Figure 10] 1 is a flow chart illustrating an example method for providing feedback indicating the presence / absence of diagnostic-enabling data within physiological data collected from a patient's body in accordance with the presently disclosed subject matter. [Figure 11]FIG. 1 is a diagram of a user interface shown on a display of a medical practitioner system in accordance with the presently disclosed subject matter and enabling navigation to points of interest (POI) within physiological data acquired during non-instantaneous physiological measurements. [Figure 12] 1 is a functional block diagram illustrating an exemplary medical practitioner system in accordance with the presently disclosed subject matter. [Figure 13] 1 is a flow chart illustrating an example of an operational sequence implemented to enable navigation to points / areas of interest (POIs) within physiological data acquired during non-instantaneous physiological measurements according to the presently disclosed subject matter. [Figure 14] 10 is a flow chart illustrating an example sequence of operations that may be performed to provide a second medical practitioner with physiological data and an indication of a region of interest for consideration in accordance with the presently disclosed subject matter. [Figure 15] FIG. 10 is a diagram of another user interface shown on a display of a medical practitioner system in accordance with the presently disclosed subject matter and allowing a medical practitioner to manage virtual visits for multiple patients. [Figure 16] 1 is a flow chart illustrating an example of a sequence of operations performed to enable a medical practitioner to manage multiple patient virtual visits in accordance with the presently disclosed subject matter.
[0180] It will be appreciated that for ease of illustration and clarity, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Furthermore, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or similar elements. DETAILED DESCRIPTION OF THE INVENTION
[0181] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
[0182] In the drawings and descriptions set forth, identical reference numbers indicate components common to different embodiments or configurations.
[0183] Unless expressly stated otherwise, as will be apparent from the following discussion, references throughout this specification utilizing terms such as "processing," "determining," or "generating" should be understood to include computational actions and / or processes that manipulate and / or transform data that is expressed as physical quantities, such as electronic quantities, and / or that represent physical objects, into other data. The terms "computer," "processor," and "controller" should be interpreted broadly to encompass any type of electronic device having data processing capabilities, including, by way of non-limiting example, a personal computer, a server, a computer system, a communication device, a processor (such as, for example, a digital signal processor (DSP), a microcontroller, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC)), any other electronic computing device, and / or any combination thereof.
[0184] Operations according to the teachings herein can be performed by a specially configured computer for the desired purpose, or by a general-purpose computer specially configured for the desired purpose by means of a computer program stored on a computer-readable storage medium.
[0185] As used herein, the phrases "for example," "such as," "for example," and variations thereof refer to non-limiting embodiments of the presently disclosed subject matter. Reference herein to "in one instance," "in some instances," "in other instances," or variations thereof means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the presently disclosed subject matter. Thus, appearances of "in one instance," "in some instances," "in other instances," or variations thereof are not necessarily referring to the same embodiment.
[0186] It will be appreciated that certain features of the presently disclosed subject matter, which are, for clarity reasons, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the presently disclosed subject matter, which are, for clarity reasons, described in the context of a single embodiment, can also be provided separately or in any suitable subcombination.
[0187] In embodiments of the presently disclosed subject matter, one or more of the stages illustrated in the figures may be performed in a different order and / or one or more groups of stages may be performed simultaneously, and vice versa. The figures show schematic diagrams of system architectures according to embodiments of the presently disclosed subject matter. Each module in the figures may be comprised of any combination of software, hardware, and / or firmware that performs the functions defined and described herein. The modules in the figures may be centralized in one location or distributed across more than one location.
[0188] Any reference in this specification to a method shall apply mutatis mutandis to a system capable of carrying out the method, and shall apply mutatis mutandis to a non-transitory computer-readable medium storing instructions that, when executed by a computer, result in the performance of the method.
[0189] Any reference herein to a system shall apply mutatis mutandis to methods that may be performed by the system, and shall apply mutatis mutandis to a non-transitory computer-readable medium storing instructions that may be executed by the system.
[0190] Any reference herein to a non-transitory computer readable medium shall apply mutatis mutandis to a system capable of executing instructions stored on the non-transitory computer readable medium, and shall apply mutatis mutandis to a method that may be executed by a computer reading instructions stored on the non-transitory computer readable medium.
[0191] FIG. 1 is a functional block diagram illustrating an example of a system 200 in accordance with the presently disclosed subject matter.
[0192] System 200 may be, but is not necessarily, a portable unit, a mobile unit, a handheld unit, etc. System 200 may be a user-activated mobile device designed to be operated by a user without medical training (also referred to herein as a “non-medical practitioner”). Optionally, system 200 may be a smart phone or another computer, optionally including one or more different types of sensors. Optionally, system 200 may be a dedicated portable handheld device including one or more sensors and a processor, such as the handheld medical device manufactured by Tytocare LTD., Netanya, Israel. Optionally, system 200 may be a handheld physiological monitor device, or any device capable of acquiring physiological data during a patient medical examination, or any device capable of acquiring physiological data (by this device or, optionally, another device other than system 200), for example, acquired through a wired / wireless communication channel.
[0193] The term "physiological measurement", which is well accepted in the art, should be construed to include, but is not limited to, the process of monitoring any time-varying physiological process over a period of time (heart, respiration, lungs, blood oxygen saturation, body temperature, tympanic membrane image, body location observation (observation means non-instantaneous image of body location), tonsil observation). Within the scope of the present disclosure, the term "physiological measurement" does not mean an instantaneous measurement, but rather a measurement that continues over a long period of time (e.g., longer than one second, and even minutes and even longer). The physiological measurement can be related to one or more medical tests of the patient (e.g., a medical test of the patient's lungs / heart / throat / skin or any other medical test of the patient).
[0194] Although so referred to, it should be noted that the term “physiological data” is intended to include, without limitation, data obtained non-instantaneously or instantaneously during a medical examination of a patient. Some examples of physiological data include images or videos of a patient or their associated body locations, blood samples of the patient's blood, or any other parameters representative of a patient's physiological characteristics. Physiological data may be collected or obtained by system 200 (e.g., using at least one physiological sensor 210) and may also be referred to as “physiological readings.” A patient may be any person (or animal) whose physiological parameters are measured, whether for medical use or for any other use (e.g., estimating the effectiveness of physical training). It should be noted that physiological data may be raw readings obtained using at least one physiological sensor 210.
[0195] The system 200 includes a processor 220 that can process and / or analyze physiological data. The physiological data can be acquired from the patient's body by at least one physiological sensor 210. The at least one physiological sensor 210 can optionally be included within the system 200. In other cases, the at least one physiological sensor 210 can be external to the system 200, and the system 200 can acquire the physiological data acquired by the at least one physiological sensor 210 through a wired / wireless communication channel.
[0196] In some cases, processor 220 may be configured to acquire and analyze physiological data (acquired by at least one physiological sensor 210 during a medical examination of a patient's body) to determine the presence of diagnosis-enabling data within the data. Diagnosis-enabling data is considered data that allows a diagnostic entity, such as a medical practitioner (e.g., a doctor, a technician), or a computer processing system configured to diagnose a medical condition based on the physiological data, to perform a diagnosis of the patient's medical condition. Note that in order for a diagnostic entity to be able to make a diagnosis based on the diagnosis-enabling data, the diagnosis-enabling data is required to be of a certain minimum quality that enables such a diagnosis. If the analysis indicates the presence of diagnosis-enabling data within the acquired physiological data, processor 220 may be further configured to provide at least this diagnosis-enabling data to the diagnostic entity, thereby enabling the diagnostic entity to diagnose the patient's medical condition.
[0197] It should be noted that the user operating system 200 is not necessarily a medical practitioner, or may be a medical practitioner (e.g., a nurse) who is not authorized or able to diagnose the physiological data, and in at least some cases, the user is not a medical practitioner authorized or able to diagnose the physiological data. The user operating system 200 may be the patient from whom the physiological data is acquired, or another non-medical practitioner such as a relative of the patient, or a medical practitioner (e.g., a nurse) who is not authorized or able to diagnose the physiological data. Such a user (a non-medical practitioner or a medical practitioner who is not authorized or able to diagnose the physiological data) often does not have the ability to determine whether the physiological data acquired from the patient's body includes diagnosis-enabling data. In many cases, the physiological data is acquired without any assistance, and more particularly, without real-time assistance, from a medical practitioner authorized or able to diagnose it. Thus, system 200 must provide feedback to users that enables such users to operate system 200 in a manner that will result in diagnosis-enabling data being sent to a medical practitioner (located remotely from the patient) for analysis (optionally some time after physiological data acquisition is complete). Otherwise, the patient's medical test (during which the physiological data is collected) must be repeated to obtain new or additional physiological data from the patient's body. This repetition necessarily requires the patient's, and optionally, the user's, time to operate system 200 if the patient does not operate the sensors themselves. In addition to the need to repeat the medical test, if the physiological data does not include diagnosis-enabling data, the diagnostic entity will attempt to diagnose the patient's condition based on data that does not include the diagnosis-enabling data, thus wasting the diagnostic entity's resources by failing or providing a poor or erroneous diagnosis.
[0198] In some cases, processor 220 may be further configured to provide an indication of the presence / absence of diagnosis-enabling data in the acquired physiological data, whether and when the analysis indicates that the physiological data includes diagnosis-enabling data, to a user (e.g., a patient or another non-medical practitioner, e.g., a relative of the patient) operating system 200, for example, using user interface 230. In some cases, the indication may be a V mark if diagnosis-enabling data is present in the acquired physiological data and an X mark if diagnosis-enabling data is absent.
[0199] In some cases, the physiological data is acquired and analyzed in real-time (e.g., immediately or substantially immediately after acquisition by at least one physiological sensor 210). In some cases, an indication of the presence of diagnosis-enabling data in the acquired physiological data is also provided in real-time (e.g., immediately or substantially immediately after determining that diagnostic-enabling data is present in the acquired physiological data), thereby allowing a user operating system 200 to determine when to stop performing physiological testing on the patient. Note that in some cases, the indication of the presence of diagnosis-enabling data in the acquired physiological data may be provided at a certain point (e.g., up to several seconds or minutes) after processor 220 determines that diagnostic-enabling data is present in the acquired physiological data.
[0200] In some cases, processor 220 may be further configured to utilize the physiological data to generate multi-valued quality feedback information, which is provided to a user via user interface 230, optionally in real time (e.g., immediately or substantially immediately after generating the multi-valued quality feedback information). Optionally, processor 220 may be configured to process the physiological data to generate analysis source data for analysis of physiological processes in the patient's body. Note that the analysis source data includes at least diagnosis-enabling data.
[0201] If so configured, processor 220 can optionally generate analysis source data from the physiological data according to one or more of the multi-valued quality scores that processor 220 assigns to physiological data collected by sensor 210 at different times. These quality scores indicate the suitability of the physiological data for analysis of a particular physiological process and are based on identifying portions of the physiological data that result from the physiological process (as some of the physiological data result from other sources, such as noise, ambient conditions, or other physiological processes that are also sampled by the physiological sensor).
[0202] "Suitability of physiological data for analysis of a particular physiological process" should be interpreted to include, without limitation, the extent to which the physiological data, or processed versions thereof, can be used with known systems or processes for (i.e., are advantageous to) analyzing a particular physiological process. The intended analysis can be performed by a computer or another machine, and / or by one or more humans (e.g., medical practitioners such as doctors, technicians, nurses, etc.).
[0203] Analysis of a physiological process may include, for example, any one or more of determining the state or nature of the physiological process, predicting a pathology related to the physiological process, diagnosing the physiological process or related physiological processes, classifying the physiological process, and the like. Some examples of physiological data that are more or less useful in analyzing different physiological processes are provided below.
[0204] A physiological process may involve one or more organs (e.g., breathing, heart rate, blinking, etc.). Other examples of physiological processes that can be analyzed using physiological data collected by system 200 include body temperature of one or more organs, electrocardiogram (ECG) measurements, sound signals (e.g., of the heart or lungs), ultrasound signals (e.g., of the heart, intestines), body tissue electrical resistance, and body tissue stiffness, etc.
[0205] Physiological processes can be measured using a sound-capturing physiological sensor (e.g., a microphone). For example, system 200 can be used for cardiac auscultation. The physiological sensor, a microphone in this example, can sample not only cardiac sounds but also other sounds, such as sounds arriving from the lungs (resulting from the physiological process of breathing). In such cases, a simple test (e.g., measuring the volume level of the microphone signal) is insufficient to determine the suitability of the collected sound signal for cardiac analysis because it cannot discern the source of the sound.
[0206] Physiological processes can be measured using an image / video capturing physiological sensor (e.g., a camera). For example, the physiological sensor 210 can be a camera intended to monitor a patient's respiration through chest movement. The camera can also collect chest movement that has various sources, such as the patient's body movement, muscle movement, and similar movements. The suitability of the video collected by the camera for analyzing a patient's respiration does not necessarily depend solely on the magnitude of the chest movement reflected by the video, as this movement may be unrelated to respiration.
[0207] Thus, processor 220 can be configured to identify portions of the physiological data resulting from physiological processes (e.g., heart rate and respiration in the above example) and determine a quality score for the collected data that indicates the suitability of the physiological data for analysis of the physiological processes. Processor 220 can be configured to determine the quality score based on the physiological data and the results of the identification. Thus, the quality score assigned to the collected data is not simply based entirely on the collected signal, but also on differentiation between portions of the collected physiological data identified as resulting from physiological processes and other portions of the physiological data. As discussed below, system 200 can use the collected physiological data and quality scores in various ways.
[0208] For example, the quality score can be provided as feedback to a user of system 200 during the performance of a medical test, optionally in real time (or near real time, e.g., with at most a one-second or few-second delay), so that the user can adapt and thus improve physiological data collection. Optionally, system 200 can provide instructions on how to modify the measurement process to improve the quality of physiological data collection for a particular physiological process. Optionally, processor 220 can use the quality score to determine that sufficient data has been collected (i.e., that the acquired physiological data includes diagnosis-enabling data). Based on the result of such a determination, system 200 can indicate to the user the end of the measurement or part of the measurement process. For example, the system can instruct the user to move itself to another location on their body and continue measuring.
[0209] The feedback and / or instructions provided by system 200 may optionally include information regarding possible causes of interference or degradation of the collected physiological data. The feedback and / or instructions provided by system 200 may optionally include information regarding actions that a user of the system can take to resolve such possible causes of interference or degradation of the collected physiological data.
[0210] In another example, the processor 220 can process the collected physiological data using the quality scores to generate analyzed source data that is more suitable for analyzing a physiological process. For example, the analyzed source data can omit portions of the collected physiological data that are less suitable for analyzing a particular physiological process (e.g., heart rate, respiration). As another example, the analyzed source data can be processed to reduce the relative effect of other contributions to the collected physiological data. Note that the analyzed source data can be data that enables a diagnosis of a physiological process (diagnosis-enabling data).
[0211] Although not necessarily so, the processor 220 may be configured to automatically analyze physiological processes based on the analyzed source data. The results of such analysis may be displayed to a user, stored in memory of the system 200, and / or transmitted to a remote system (e.g., a server, doctor's station, etc.).
[0212] Although not necessarily so, system 200 can be designed to be operated by a non-medical practitioner or non-professional operator (or semi-professional operator), such as the patient themselves, a relative of the patient, or another operator not specifically trained to provide each of the one or more physiological measurements provided by the system.
[0213] Although not necessarily so, system 200 may be a stand-alone unit including a rigid casing 260 with processor 220, power assembly 250, and other components contained therein. A stand-alone unit (if so implemented) may include elements such as cables, electrodes, connectors, etc. that reside (partially or entirely) outside the casing.
[0214] The rigid casing 260 can contain one or more physiological sensors 210, although one or more of the physiological sensors 210 can also be external to the casing 260. Note that the system 200 can utilize one or more external physiological sensors 210 that are not physically connected to the processor 220. Such physiological sensors 210 can even be part of another system. For example, the microphone of a smart phone with which the system 200 has established a communication channel can function as a physiological sensor 210. However, optionally, all of the one or more sensors 210 utilized by the system 200 are part of a single unit.
[0215] The system 200 can include one or more physiological sensors 210, each operable to collect physiological data from a patient. The physiological data can be collected directly from the patient's body, or it can be processed during the collection process. For example, an audio signal can be passed through a low-pass filter, a band-pass filter, or a high-pass filter. In another example, a photographic or video signal can be corrected for lighting or contrast levels.
[0216] It should be noted that if the system 200 includes more than one physiological sensor 210, the physiological sensors 210 can all be of the same type (e.g., microphones) or of two or more types (e.g., a microphone, a temperature sensor, and a camera). Different physiological sensors 210 can work in concert with each other to collect data related to a single physiological process (e.g., collecting both video and temperature measurements of the ear canal or measuring sound signals with two microphones).
[0217] It should be noted that physiological data can be collected by the physiological sensor 210 from different locations on the patient's body depending on the type of physiological sensor (e.g., camera, microphone, EEG, thermometer, etc.), the purpose of the physiological examination (e.g., diagnosing a medical condition, cardiac auscultation, pulmonary auscultation, monitoring nevus progression over time, etc.), etc. The examined body location can be a surface location on the patient's body (i.e., the skin, or one or more other features of the body such as the eye, fingernail, etc.) or internal (e.g., the heart, lungs, bladder, etc.).
[0218] Physiological sensors 210 may optionally be placed entirely outside the patient's body when acquiring physiological data. In other situations or implementations, some or all of physiological sensors 210 may optionally penetrate the patient's body (e.g., needles penetrating the skin and / or blood vessels, sensors penetrating body orifices such as the ear or mouth, etc.).
[0219] In some cases, but not necessarily, at least one physiological sensor 210 of system 200 is used at different times during a single physiological measurement to collect physiological data from the patient's body. The physiological data can be collected by one or more sensors. The collection by multiple sensors (if implemented) can be performed in coordination (e.g., multiple EEG electrodes can provide information about the electrocardiogram) or by uncoordinated sensors (e.g., measuring both temperature inside the ear canal and video data).
[0220] The physiological data collected may result from physiological processes (e.g., heartbeat, lung inhalation and exhalation), but may also result from additional sources. For example, the additional sources may be other physiological processes (e.g., blood flow in blood vessels, digestion, breathing, heartbeat), and ambient signals (e.g., ambient sound, light, temperature, etc.). Ambient sound may be sound emanating from one or more of people talking, blowing wind, the noise of cars coming and going, air conditioning noise, dogs barking, noise resulting from the operation of system 200 (e.g., the friction of system 200 on the patient's body or clothing), or any other noise not emanating from a physiological process.
[0221] Because the physiological data collected by system 200 is intended to be used to analyze physiological processes (e.g., for diagnosing a patient's medical condition), in most cases the data resulting from the physiological processes will be more important than the data resulting from additional sources. The relative proportions of data resulting from physiological processes and data resulting from other sources within the collected physiological data can vary, and in some situations the effect of the additional sources on the collected data signal may be greater than that of the physiological processes. This situation is addressed by system 200, and particularly by processor 220, as described below.
[0222] When analyzing a physiological process, physiological data collected by one or more physiological sensors 210 during physiological data collection is communicated to processor 220 (i.e., a portion of the physiological data is communicated to and processed by processor 220 before the end of the physiological data is collected). In such cases, processor 220 can be configured to perform the following steps at multiple different times during the physiological measurement (i.e., in real time or near real time in parallel with collection): Identifying portions of physiological data resulting from a physiological process. b. Determining, based on the physiological data and the results of the identification, a multi-valued quality score for the physiological data that indicates the suitability of the physiological data for analysis of the physiological process. c. Subsequently providing, via a tangible user interface, multi-valued quality feedback information that is based on the multi-valued quality score.
[0223] After completion of the measurement (or optionally before completion of the measurement), processor 220 may optionally generate analysis source data based on at least one of the multi-valued quality score and the physiological data acquired at at least one of a plurality of different times. The following paragraphs provide further details regarding any one of the operations (discussed in the immediately preceding paragraph and this paragraph) that processor 220 is operable to and may be configured to perform.
[0224] As described above, processor 220 identifies portions of the physiological data that result from physiological processes. This identification can be performed by different types of algorithms and / or electrical circuits (including digital signal processing and / or analog signal processing). It should be noted that identifying portions of the physiological data that result from physiological processes includes identifying the physiological process (e.g., heart rate), but can also (in addition or instead) include identifying other portions of the physiological data (e.g., other physiological processes such as respiration, ambient signals (e.g., ambient noise)). The identification of other portions of the physiological data (not resulting from physiological processes) can be used to reject such portions and / or to aid in identifying portions of the physiological data that result from physiological processes. It should be noted that the identification of other portions of the physiological data (not resulting from physiological processes) can also or alternatively be used to identify interference (e.g., sources of other portions of the physiological data) and to provide instructions to a user to reduce or eliminate such interference, as described in further detail herein.
[0225] It should be noted that the term "portion" with respect to portions of physiological data can refer to different types of portions in different implementations of the presently disclosed subject matter. For example, different portions of physiological data can be distinguished from one another using any combination of time, frequency, time patterns, and / or frequency patterns, etc.
[0226] The processor 220 may be operable to determine a multi-valued quality score indicative of the suitability of the physiological data for analysis of the physiological process based on the physiological data at different times during the physiological measurement and the results of the identification.
[0227] The term "multiple-valued score" (e.g., "multiple-valued quality score") means that the numerical value of the score has more than two options (i.e., the value is not fixed or binary). A multi-valued score represents more than two states (e.g., 1 or 0, fair or poor). Note that a multi-valued quality score can be discrete or continuous and can have any defined set of values, but this is not necessarily the case. For example, a multi-valued quality score determined by processor 220 can be an integer between 1 and 5, an integer between 1 and 10, a decimal number between 0 and 100, some descriptive words / phrases (e.g., "good," "fair," "low," and "poor"), etc.
[0228] "Result of identification" (based on which processor 220 determines the multi-valued quality score) refers to information generated by processor 220 during identification of each portion of physiological data that results from a physiological process. The "result of identification" indicates which portions of physiological data result from a physiological process (and sometimes also which portions of physiological data do not result from a physiological process).
[0229] Importantly, the multi-valued quality score determined by processor 220 is indicative of the suitability of the physiological data for analysis of a particular physiological process (e.g., for diagnosing a particular medical condition in a patient). A general quality score of a signal can be used to represent the general quality of the signal (e.g., volume level, overall brightness of the picture, signal-to-noise ratio). However, such a general quality score does not provide sufficient information to assess the suitability of the physiological data for analysis of a particular physiological process (e.g., for diagnosing any of the patients for a particular medical condition).
[0230] For example, an image collected by a camera may be highly detailed and well-lit and focused, but if it does not capture a clear image of the tonsils, it cannot be used to assess the condition of the tonsils (e.g., identify throat diseases). In such cases, the multi-valued quality score determined by processor 220 may further depend on, for example, the relative portion of the tonsils shown in the image (based on image processing of the image), the focus on the tonsils (based on respective image processing), and the correctness of the color of the tonsil area.
[0231] A multi-valued quality score for an image or video can take into account, for example, the extent to which an object related to a physiological process (e.g., a tonsil, a nevus, or an eardrum) is within the field of view (FOV) (e.g., how much of the tonsil / nevus / eardrum / etc. is visible in the image / video) and the degree to which the object is in focus. Additional factors can include, for example, whether the image / video of the object is sufficiently stable, well lit, at the correct distance, visible for a sufficient duration, etc.
[0232] In another example, sound samples collected by a digital stethoscope may capture a loud, low-noise signal that may be a good signal of another physiological process or even an ambient sound (e.g., other people talking in the room, or even the patient themselves, such as the friction of the system 200 on the patient's body or clothing). Such a signal may not be beneficial for, for example, respiratory and pulmonary condition analysis. In such cases, the multi-valued quality score determined by the processor 220 may further rely on, for example, identifying rhythmic (or non-rhythmic) breathing patterns and removing significant heartbeat sounds from the physiological data signal. A multi-valued quality score for an audio signal may include, for example, identifying that the relevant portion of the signal (i.e., that capturing the physiological process) is of sufficient duration and has a sufficient amplitude ratio relative to other portions of the signal (e.g., noise or other sources).
[0233] Processor 220 can be configured in different ways to determine a multi-valued quality score based on the physiological data and the results of the identification. In particular, processor 220 can be configured to determine a multi-valued quality score based on portions of the physiological data that the processor identifies as resulting from a physiological process (one or more of these portions), and optionally also based on other portions of the physiological data (e.g., portions of the physiological data that processor 220 identifies as resulting from other processes, from ambient signals, or generally from other sources).
[0234] Some examples of ways in which the processor 220 can use the results of the identification and the physiological data itself towards determining a multi-valued quality score are as follows. a. A multi-valued quality score may be determined based on the magnitude (eg, amplitude) of the portion of the physiological data determined to result from a physiological process. b. A multi-valued quality score may be determined based on a ratio between portions of the physiological data determined to result from a physiological process and other portions of the physiological data. c. A multi-valued quality score may be determined based on a ratio between the magnitude of a portion of the physiological data determined to result from a physiological process and the magnitude of another portion of the physiological data. d. A multi-valued quality score can be determined based on the cumulative amount of portions of the physiological data determined to result from a physiological process (e.g., a sufficient number of times that the data resulting from the physiological process is of sufficient quality). e. Where the physiological data is an image or video stream, the multi-valued quality score may be determined based on the visibility of certain organs in the physiological data, or the relative portion of such organs in the physiological data (e.g., the more visible such organs are in the physiological data, the higher the grade), or the presence of one or more particular markers (natural and / or artificial) in the physiological data, etc. f.Other.
[0235] It should be noted that processor 220 may be operable to determine more than one type of multi-valued quality score for either analysis of different physiological processes or analysis by different entities. For example, one type of quality score may be used when the analysis is intended to be performed by a human physician, while another type of quality score may be used when the signal (physiological data or portions thereof) is intended to be analyzed by a dedicated computer processing system. It should be noted that different types of quality scores may be used (and thus selected during or beforehand) over the time period in which the physiological data is measured, for example, to enable collection of data favorable to analysis by a particular analytical or diagnostic entity and / or analysis or diagnosis of a preselected physiological process. A number of degrees of quality levels or quality scales may be used by processor 220 and other components of system 200.
[0236] The processor 220 may further be configured to provide (at different times during the physiological measurement) multi-valued quality feedback information that is based on the quality scores. Because the multi-valued quality feedback information is based on the multi-valued quality scores, the multi-valued quality feedback information is also indicative of the suitability of the physiological data for analysis of the physiological process.
[0237] The multi-valued quality feedback information may be identical to or based on a multi-valued quality score determined by processor 220. For example, processor 220 may determine a decimal value between 0.01 and 100.00 as the multi-valued quality score at a time, while the multi-valued quality feedback information may be provided by a seven-LED (light-emitting diode) scale, with the number of lit LEDs indicating the quality level of the acquired physiological data for which the multi-valued quality score was determined (i.e., the suitability of the collected data for analysis of a physiological process).
[0238] The processor 220 provides the multi-valued quality feedback information using a tangible user interface 230 (also referred to as UI 230) of the system 200. Different types of user interface 230 can be used to provide the multi-valued quality feedback information. In some cases, the user interface 230 can be part of a handheld medical device operated by a user (e.g., a display, a speaker, one or more vibration elements, a group of LEDs, etc.). Additionally or alternatively, the user interface 230 can be external to the handheld medical device operated by a user, such as an external display, an output means of a smart phone (e.g., a display, a speaker, a vibration element of the smart phone), or another computer (in which case the information can be provided on a user interface of the computer), and so forth (in such cases the multi-valued quality feedback information can be provided to such an external user interface through a wired / wireless connection). It should be noted that, optionally, the UI 230 can be used to provide additional information to the user of the system 200, whether originating from the processor 220 or not. For example, UI 230 may optionally provide additional instructions, such as instructions on how to modify a measurement to improve measurement quality, instructions to indicate the end of a measurement (or part of a measurement, e.g., moving to another location on the body and continuing the measurement), etc. Such additional information may optionally be provided by UI 230 during the test, rather than just after the test is completed. However, it is not necessary for any information (whether multi-valued quality feedback information or any other information provided by UI 230) to be provided all the time (or at any particular time) throughout the test.
[0239] Optionally, processor 220 can be configured to generate analysis source data based on at least one of the multi-valued quality scores and physiological data acquired at at least one of a plurality of different times. For example, processor 220 can select to include information from only some of the measurement time points (e.g., when the quality score indicates high quality) in the analysis source data, but not from other times. For example, processor 220 can process the collected data to remove (or reduce) data coming from other physiological processes, ambient signals, or any other source other than the physiological process intended for analysis. Other methods for generating analysis source data based on one or more of the quality scores and the physiological data can be used to generate analysis source data more suitable for analyzing a particular physiological process. Note that other processing of the same physiological data will be performed by processor 220 to generate analysis source data for analysis of another physiological process. Note that the analysis source data can be different from the physiological data (e.g., the analysis source data optionally includes less / other / additional data than the physiological data, etc.).
[0240] While reference has been made to analyzing physiological processes, it should be noted that system 200 may be configured to operate based on images of a patient or their body location, instantaneously acquired physiological data such as a patient's blood sample, or any other instantaneously acquired physiological data. In such cases, processor 220 may be configured to analyze the instantaneously acquired physical data to determine the presence of diagnosis-enabling data, as described further herein. Diagnosis-enabling data is data that allows a diagnostic entity (e.g., a medical practitioner, a computerized diagnostic system, etc.) to subsequently diagnose a medical condition of the patient from which the instantaneous acquired physical data originated. Processor 220 may be configured to provide feedback to a user of system 200, for example, in the form of an indication of the presence / absence of diagnosis-enabling data in the instantaneously acquired physiological data.
[0241] 2 is a functional block diagram illustrating an example of a system 200 in accordance with the presently disclosed subject matter. It should be noted that in addition to one or more physiological measurement sensors 210, system 200 may include additional components such as a communication module 240 (enabling wired and / or wireless communication with external devices), a power source 250, and a casing 260.
[0242] FIG. 2 illustrates a few examples of physiological sensors 210: a camera 211 (labeled CAM 211), two microphones 212 (labeled MIC 212), and a thermometer 213 (labeled TMP 213). Optionally, camera 211 can be operated to capture visible light and generate an image based on the captured light. Camera 211 may, but is not necessarily, sensitive to other portions of the electromagnetic spectrum close to the visible spectrum (e.g., infrared radiation, such as near-IR radiation). Nevertheless, it should be noted that other types of sensors 210 and other combinations of these sensors 210 can be implemented, e.g., as discussed in more detail above. For example, physiological sensors 210 can include, e.g., a blood pressure sensor for measuring the patient's blood pressure, one or more accelerometers for measuring movement of system 200, a pressure sensor for determining the amount of pressure system 200 exerts on the patient's body, etc.
[0243] 3A is a flow diagram illustrating an example of a method 500 in accordance with the presently disclosed subject matter. Method 500 is a method for providing feedback indicating the suitability of data collected during physiological measurements for analyzing physiological processes in a patient's body. As with the examples shown in the previous figures, method 500 may be performed by system 200. Any variation, combination, or optional implementation discussed with respect to system 200 may also be implemented with respect to method 500, mutatis mutandis. Any variation, combination, or optional implementation discussed with respect to method 500 may also be implemented with respect to system 200, mutatis mutandis. As described in detail below, method 500 may be used to provide analytical source data for analyzing physiological processes in a patient's body.
[0244] It should be noted that the patient and / or any other person or person directing the measurement may not necessarily be informed as to the target of the measurement or which specific parameters are intended to be measured for further analysis / diagnosis.
[0245] Stage 510 of method 500 is performed during the physiological measurement and includes executing stages 520, 530, 540, and 550 of method 500 on a processor at multiple different times during the physiological measurement. For the examples shown with respect to the previous figures, stage 510 (or one or more sub-stages of stage 510, including any combination of stages 520, 530, 540, and optionally 550) may be performed by processor 220.
[0246] Stage 520 includes acquiring physiological data collected from the patient's body that comes from (a) physiological processes and (b) additional sources. As discussed with respect to system 200, the physiological data collected in stage 520 can be collected by one or more sensors.
[0247] Note that, optionally, stage 520 can include obtaining physiological data collected by a physiological sensor not directly connected to the unit performing stage 520. For example, stage 520 (and optionally stage 510 as a whole) can optionally be performed by a processor in a smart phone, another general-purpose computer, or a dedicated computer (e.g., laptop computers, servers, medical application computers, etc.), whereas the collection of physiological data is performed by a portable (optionally handheld) unit operated by the patient or someone in the patient's vicinity (e.g., within a distance range that allows such individual to manually activate the portable unit to obtain the physiological data).
[0248] Nevertheless, the collection of physiological data may optionally be performed by one or more physiological sensors connected, for example, through mechanical, wired, and wireless connections, to the processor performing stage 520. Optionally, method 500 may include stage 505 of collecting physiological data from the patient's body. Stage 505, if performed, may also be performed at different times during the physiological measurements. With respect to the examples shown with respect to the previous figures, stage 505 may be performed by one or more sensors 210 and / or one or more external sensors.
[0249] Stage 530 involves identifying portions of the physiological data resulting from the physiological processes. Additional information regarding how the identification can be effected is discussed above with respect to processor 220.
[0250] Stage 530 can be performed using different types of algorithms and / or electrical circuits (including digital signal processing and / or analog signal processing). It should be noted that identifying portions of the physiological data resulting from a physiological process can include identifying the physiological process (e.g., heart rate), but can also (in addition to or instead of) identifying other portions of the physiological data (e.g., other physiological processes such as respiration, ambient signals, etc.). Identifying other portions of the physiological data (not resulting from the physiological process) can be used to exclude such portions and / or to aid in identifying portions of the physiological data resulting from the physiological process.
[0251] It should be noted that stage 530 may be based on identifying the effects of multiple different physiological processes on the physiological data. For example, stage 530 may include identifying both heartbeat and breathing sounds within sound samples of the physiological data.
[0252] As described herein, in some cases, the physiological data acquired at stage 520 may come from physiological processes and additional sources. In some cases, the additional sources may include ambient signals. In such cases, the physiological data may be analyzed to determine whether the ambient signals exceed a threshold, and if so, a warning may be provided to the user. In some cases, the processor 220 may also provide the user with an indication of the source of the ambient sound (e.g., whether the ambient sound is people talking, a noisy air conditioner, the system 200 rubbing against the patient's body or clothing, etc.). The source of the ambient sound can be determined using, for example, filters, Mel-Frequency Cepstrum (MFC), Short-Time Fourier Transform (STFT), or other known statistical methods, such as comparing variances in both the frequency and time domains, generating Gaussian mixture models for speech and non-speech, or other methods and / or techniques known in the art (e.g., [Non-Patent Document 1] or "VOICEBOX" (a speech processing toolbox for MATLAB) and / or other standard machine learning models (such as support vector machines (SVM) or other techniques). In some cases, processor 220 can be configured to identify ambient signals greater than a threshold and warn the user before acquiring physiological data at stage 520.
[0253] 5 illustrates an optional manner of implementing stage 530 according to an example of the presently disclosed subject matter. Stage 530 may include any combination of one or more of stages 531 through 538.
[0254] Stage 531 involves determining that the physiological data contains a signal with a frequency pattern that matches the frequency behavior of the physiological process. Stage 531 can be performed based on predetermined parameters that characterize the frequency behavior of the physiological process. The frequency can be a temporal frequency (e.g., cycles per second), a spatial frequency (e.g., cycles per millimeter), or a combination of both. For example, a repetitive pattern occurring in the collected physiological data due to the physiological process can be searched for, e.g., detecting typical repetitive heart beats (as S1 and S2) to detect that the collected physiological data contains diagnostic-enabling data. Detecting this phenomenon can be done, for example, by training a classifier to detect S1 and S2 (based on positive and negative examples). Given an input signal, a sliding window can be used to obtain samples from this signal that can be classified using a classifier. Finally, the K highest-scoring samples classified by the classifier are cross-correlated with the overall signal (if these samples are above a certain threshold). Peaks in the cross-correlation indicate the quality of the cardiac signal.
[0255] Stage 532 includes determining that the physiological data includes a signal having an amplitude pattern that matches the amplitude behavior of a physiological process. Stage 532 can be performed based on predetermined parameters that characterize the amplitude behavior of the physiological process. The amplitude pattern can be time-dependent or independent, frequency-dependent or independent, etc.
[0256] Stage 533 includes determining that the physiological data includes a signal that matches a visual characteristic of the physiological process. Stage 533 can be performed based on predetermined parameters that characterize the visual characteristic of the physiological process. The visual characteristic may relate to, for example, visual similarity, characteristic lighting patterns, characteristic color patterns, characteristic contrast between portions, etc. It should be noted that the visual characteristic may relate to portions of the visible spectrum or other electromagnetic spectrum. It should be noted that the visual characteristic may relate to the behavior of the patient's physiological body elements under active lighting provided by an artificial system or under standard light.
[0257] Stage 534 includes determining that the physiological data includes a signal that matches a characteristic response of a physiological process to induced energy (e.g., ultrasound, mechanical pressure, electrical current, etc.) Stage 534 can be performed based on predetermined parameters that characterize such characteristic response of the physiological process.
[0258] Stage 535 includes determining that the physiological data includes a signal having a frequency pattern that matches the frequency behavior of a known interferer. The term "known interferer" refers to another physiological process, a known ambient sound (e.g., a characteristic noise such as a sensor, the surrounding environment, the patient's voice, or the friction of system 200 on the patient's body or clothing), or another known signal source (e.g., compensating for lighting other than that emitted by the measurement system). Stage 535 can be performed based on predetermined parameters that characterize the frequency behavior of the known interferer. The frequency can be a temporal frequency (e.g., cycles per second), a spatial frequency (e.g., cycles per millimeter), or a combination of both.
[0259] Stage 536 includes determining that the physiological data includes a signal having an amplitude pattern that matches the amplitude behavior of a known interferer. Stage 536 can be performed based on predetermined parameters that characterize the amplitude behavior of the known interferer. The amplitude pattern can be time-dependent or independent, frequency-dependent or independent, etc.
[0260] Stage 537 includes determining that the physiological data includes a signal that matches the visual characteristics of the known interference. Stage 537 can be performed based on predetermined parameters that characterize the visual characteristics of the known interference. The visual characteristics may relate to, for example, visual similarity, characteristic lighting patterns, characteristic color patterns, characteristic contrast between portions, etc. It should be noted that the visual characteristics may relate to portions of the visible spectrum or other electromagnetic spectrum. It should be noted that the visual characteristics may relate to visual behavior under active illumination provided by an artificial system or under standard light.
[0261] Stage 538 includes determining that the physiological data includes a signal that matches a characteristic response of a known interferent to induced energy (e.g., ultrasound, mechanical pressure, electrical current, etc.) Stage 538 can be performed based on predetermined parameters that characterize such characteristic response of the known interferent.
[0262] It should be noted that in some cases, different machine learning models (such as support vector machines (SVM) or other techniques) can be used to determine the presence of diagnostic-enabling data within the physiological data (e.g., the presence of a particular morphology (e.g., tonsils, eardrum, body location) within an image) or the presence of a particular audio segment (e.g., S1, S2 within the heart).
[0263] It should be noted that these stages are merely examples, and many other ways of implementing stage 530 are equally possible.
[0264] 3A, stage 540 includes determining a multi-valued quality score for the physiological data based on the physiological data and the results of the identification, the multi-valued quality score indicating the suitability of the physiological data for analysis of the physiological process. Additional information regarding how the multi-valued quality score may be determined is discussed above with respect to processor 220.
[0265] The "result of the identification" (based on which the multi-valued quality score is determined in stage 540) refers to the information generated in stage 530 that indicates which portions of the physiological data result from physiological processes (and sometimes which portions of the physiological data do not result from physiological processes).
[0266] Optionally, the quality score determined for the physiological data at stage 540 (i.e., the multi-valued quality score) can be different from any corresponding value contained in the analyzed source data (i.e., different from the amplitude, volume, etc. of the portion of the physiological data for which the quality score is determined). Optionally, the quality score determined for the physiological data at stage 540 (i.e., the multi-valued quality score) can be different from any value contained in the analyzed source data.
[0267] It should be noted that different types of quality scores may be determined, e.g., scalars, vectors, etc. Optionally, more than one multi-valued quality score may be determined for the physiological data collected at any one or more times. The multiple multi-valued quality scores, if so determined, may be stored as a vector, multiple variables, or any other suitable manner. Optionally, the determining at stage 540 includes determining two or more multi-valued quality scores (in which case each of the scores is multi-valued, i.e., not just good / bad or other binary representation). The determining of multiple quality scores, if performed, may be, but is not necessarily, performed for all of the physiological data collected through the physiological measurements.
[0268] Determining the multi-valued quality score at stage 540 may be based on the physiological data and the results of the identification in different ways. In particular, the multi-valued quality score determined at stage 540 may be based on portions of the physiological data resulting from the physiological processes identified at stage 530 (one or more of these portions), and optionally further on other portions of the physiological data (e.g. portions identified at stage 530 as resulting from other processes, ambient signals, or generally from other sources).
[0269] Some examples of ways in which the results of the identification and the physiological data itself can be used at stage 540 are as follows: a. A multi-valued quality score can be determined based on the magnitude (eg, amplitude) of the portion of the physiological data determined to result from a physiological process. b. A multi-valued quality score may be determined based on a ratio between portions of the physiological data determined to result from a physiological process and other portions of the physiological data. c. A multi-valued quality score may be determined based on a ratio between the magnitude of a portion of the physiological data determined to result from a physiological process and the magnitude of another portion of the physiological data. d. A multi-valued quality score can be determined based on the cumulative amount of portions of the physiological data determined to result from a physiological process (e.g., a sufficient number of times that the data resulting from the physiological process is of sufficient quality). e. Where the physiological data is an image or video stream, the multi-valued quality score may be determined based on the visibility of certain organs in the physiological data, or the relative portion of such organs in the physiological data (e.g., the more visible such organs are in the physiological data, the higher the grade), or the presence of one or more particular markers (natural and / or artificial) in the physiological data, etc. f.Other.
[0270] Determining the multi-valued quality score may optionally be based on selecting a scoring scheme from a plurality of predefined scoring schemes, each associated with an analytical process for a physiological process. For example, a certain sample (physiological data, e.g., video of the ear canal) may be sufficient for a preliminary analysis (e.g., determining the color of the ear canal or a ruptured eardrum), but may not be sufficient for a detailed analysis (e.g., analyzing the condition of an ear fungus). The same sample may be assigned different quality scores based on the scoring scheme. For example, different scoring schemes may be used when the collected physiological data is used by a person (e.g., a physician) or a computer processing system (e.g., for analysis / diagnosis). The selection of the scoring scheme may occur during or before the physiological test.
[0271] It should be noted that the multi-valued quality score can indicate the degree to which the patient complies with instructions regarding physical activity. For example, during lung auscultation, the patient may be instructed to breathe in a different manner (such as inhale, exhale, pause, deep breath) or to hold the sensor in a stable position on the patient's skin during measurement to attempt to increase the multi-valued quality score at a later time when the multi-valued quality score is determined (e.g., a second time after the patient begins to act on the instructions, after a first time when the multi-valued quality score is determined, indicating the possibility of improving the reading by implementing the instructions provided to the user). A multi-valued quality score can be determined as an assessment of the degree to which the patient complied with instructions regarding physiological data.
[0272] The multi-valued quality score can be determined based in part on physiological (or other) data collected by one or more other sensors relative to physiological data collected by one or more other sensors. For example, a blood pressure measurement can be assigned a multi-valued quality score that is also based on an assessment of the patient's compliance with breathing pattern instructions, which can be determined by auscultation.
[0273] It should be noted that, optionally, determining the multi-valued quality score at stage 540 may be further based on data collected by non-physiological sensors of the physiological measurement system that collected the physiological data. The non-physiological sensors may optionally collect data about the environment (e.g., a microphone that samples ambient sound, a light sensor that measures the light level of the ambient environment, a thermometer that measures the ambient temperature, and an ambient humidity level sensor, etc.). The non-physiological sensors may optionally collect data about the state of the measurement system that includes the physiological sensors that collect the physiological data. For example, such non-physiological sensors may be inertial measurement units (IMUs) that measure the movement of the sensor in one or more dimensions (whether translation and / or rotation of the system). For example, such non-physiological sensors may measure the temperature of the measurement system (or one or more specific parts thereof), the state of a subsystem, etc.
[0274] It should be noted that the step of determining the multi-valued quality score at stage 540 can be performed based only on the physiological data and the result of the classification without using any additional data.It should be noted that the step of determining the multi-valued quality score at stage 540 can be performed based on the physiological data and the result of the classification without using any additional measurement data (but sometimes using some other form of data such as clock data).
[0275] Optionally, stage 540 can include determining a multi-valued quality score based on criteria determined by a remote expert (e.g., doctor, technician). Optionally, the criteria can be determined by the expert (e.g., doctor, technician) during the physiological measurement, sometimes based on data previously collected earlier in the physiological measurement. For example, the expert can indicate points of interest (POIs), such as specific locations within the body and specific acoustic measurement data ranges.
[0276] Stage 550 includes providing multi-valued quality feedback information based on the quality scores (the multi-valued quality scores discussed above) via a tangible user interface. With respect to the examples shown with respect to the previous figures, stage 550 may be performed by processor 220, UI 2230, or a combination of both. Note that the tangible user interface of stage 550 may, but is not necessarily, part of the same system as the processor executing stage 550. For example, a portable handheld physiological monitor unit may collect and process physiological data and then send feedback information to be provided by another system (e.g., the UI of the patient's smart phone, the UI of another computer in the room, a wireless speaker, etc.).
[0277] The quality feedback information provided at stage 550 may be identical to one or more of the quality scores determined at stage 540, or other information based on such one or more quality scores. Optionally, the quality feedback information provided at stage 550 may be different from any corresponding values contained in the analyzed source data (i.e., different from the amplitude, volume, etc. of the portion of the physiological data for which the quality score is determined). Optionally, the quality feedback information provided at stage 550 may be different from any values contained in the analyzed source data.
[0278] Optionally, the physiological data is collected by a physiological measurement device (e.g., system 200), and the suitability of the physiological data changes as a result of a user's modification of the physiological measurement device's operation based on the quality feedback information provided by the tangible user interface. The quality of the physiological measurement may be affected by modifications to the process initiated by a user (e.g., the patient or someone around the patient) who receives and acts on the feedback. The user's modification of the physiological measurement device's operation may include moving or readjusting the position / orientation of a measurement unit (e.g., a sensor or a unit containing a sensor used to acquire the physiological data), applying more pressure to the patient's body with one or more sensors, changing one or more measurement parameters, readjusting the patient's body position, breathing differently, replacing a module of the measurement unit (e.g., an otoscope), or any of the methods described herein. It should be noted that, in addition to the multi-valued quality feedback information, additional information may be provided to the user to improve the measurement process based on the data already collected and the suitability of these data for the analysis of a particular physiological process.
[0279] It should be noted that method 500 may include providing additional information to the patient and / or the person / system controlling the test (if the controlling individual is not the same person as the patient) using the UI.
[0280] 4 (which is a flow diagram illustrating an example of a method 500 in accordance with the presently disclosed subject matter), it is noted that stage 510 can further include presenting instructions to a user via a tangible user interface for performing physiological measurements 560. For example, stage 560 can include providing instructions via the tangible UI for modifying the physiological testing protocol determined as part of method 500 based on one or more of the multi-valued quality scores.
[0281] The feedback and / or instructions provided during the execution of method 500 may optionally include information regarding possible causes of interference or degradation of the collected physiological data. The feedback and / or instructions provided during the execution of method 500 may optionally include information regarding actions that a user of the system can take to resolve such possible causes of interference or degradation of the collected physiological data.
[0282] Stage 560 may be preceded by stage 558 in which the individual processes one or more of the multi-valued quality scores to determine instructions for modifying the processing of the physiological test. For the example shown with respect to the previous figure, stage 558 may be performed by processor 220.
[0283] For example (see stages 558 and / or 560), the instructions may relate to the positioning of physiological sensors to collect physiological data, operating parameters of the measurement device (e.g., system 200) and / or physiological sensors, actions the patient should take (e.g., stop breathing, cough, stand up and turn, etc.), and the environment (e.g., reduce ambient signals / ambient light), etc. The UI may be used as part of method 500 to indicate the end of a measurement or a stage or portion of a measurement (e.g., such as the end of a medical test or a particular portion of a medical test if the medical test has several parts).
[0284] Note that stages 558 and / or 560 can be performed one or more times during the entire physiological measurement. For example, the command can be generated only when the multi-valued quality score is less than a predetermined threshold or remains below a predetermined threshold for a predetermined amount of time.
[0285] Referring generally to stage 510, it should be noted that each of the substages of stage 510 is performed at a different time during the physiological measurement, but not necessarily the same number of times. For example, stage 520 may be performed virtually continuously (e.g., collecting 400 samples per second), stage 530 may be performed at a slower rate (e.g., 25 samples per second), stage 540 may be performed at yet another rate (e.g., once every half second), and so on. Each substage of stage 510 (e.g., stages 530, 560) may be based on one or more iterations of the immediately preceding substage. It should be noted that different substages of stage 510 can be, but are not necessarily, performed simultaneously. For example, at a particular time, new physiological data may be collected while simultaneously determining a quality score for the previously collected physiological data.
[0286] As described with respect to system 200 and method 500, some actions are performed at multiple times across the physiological measurement. Optionally, the multiple times may include at least a first time (e.g., a first time point or a first time period) and a second time (e.g., a second time point other than the first time point or a second time period other than the first time period). The second time is later than the first time, although in the case of the first and second time periods, the first and second time periods may optionally partially overlap. Optionally, acquiring the physiological data at the second time (e.g., at stage 520) is affected by a change in the physiological measurement by the user as a result of providing, via a tangible user interface, multi-valued quality feedback information resulting from multiple values determined for the physiological data acquired at the first time. Altering the physiological measurement may include one or more of the following: moving or readjusting the position / orientation of the measurement unit (e.g., a sensor or a unit including a sensor used to acquire physiological data), applying more pressure to the patient's body with one or more sensors, changing one or more measurement parameters, readjusting the patient's body position, breathing differently, avoiding friction of the system 200 on the patient's body or clothing, replacing a module of the measurement unit (e.g., an otoscope), or any of the methods described herein.
[0287] FIG. 3B is a flow chart illustrating an example of a method 500 adapted to prepare analysis source data for analysis of physiological processes in a patient's body in accordance with the presently disclosed subject matter. Method 500 may further include stage 590, which includes generating analysis source data (including at least diagnosis-enabling data) based on at least one of the multi-valued quality scores and based on physiological data acquired at at least one of a plurality of different times. With respect to the example illustrated with respect to the previous figure, stage 590 may be performed by processor 220. Note that stage 590 may be performed by a processor of a separate system. Stage 590 may be performed after stage 510 is fully performed or partially concurrently with stage 510. That is, some of the analysis source data may be generated before the collection and / or processing of physiological data in stage 510 is completed, but this is not necessarily the case. Additional information regarding how the generation of analysis source data may be effected is discussed above with respect to processor 220.
[0288] Regarding stage 590, it should be noted that optionally generating the analysis source data can include compressing different portions of the physiological data based on different multi-valued quality scores determined for the different portions. In some cases, portions of the physiological data assigned low quality scores can be compressed using a higher compression level (and / or a lower compression storage ratio) relative to portions that received high quality scores. It should be noted that some portions can be omitted entirely from the analysis source data (e.g., if the multi-valued quality scores of these portions indicate irrelevance or unsuitability for analysis due to, for example, the signal being of low quality or not containing information of the relevant body location).
[0289] Stage 590 can include generating analysis source data including metadata indicating times during the physiological measurement when high quality measurements were taken. Examples of high quality include low noise, a high signal ratio of the physiological process to other signals within the measurement, etc. Such metadata can include a ranking of different time points, an indication of the duration during which the highest quality measurements were taken (e.g., between 5.51 and 9.54 seconds during the measurement), etc.
[0290] Note that generating metadata for the analyzed source data can use time-accumulated parameters. For example, a time during a physiological measurement can be marked as being of high quality if there are consecutive measurements that qualify for a certain condition (e.g., the eardrum is visible) over at least a predetermined duration (e.g., for at least three consecutive seconds). For example, a time during a physiological measurement can be marked as being of high quality if there are consecutive measurements that qualify for a certain condition (e.g., the heartbeat is audible) over at least a predetermined cumulative duration (e.g., for at least 10 seconds, but not necessarily consecutive).
[0291] Method 500 may further include an optional stage 5100 of transmitting the analytical source data (including at least the diagnostic enabling data) to an external system. The transmitting step may include transmitting the analytical source data to the system that will analyze it or to any other system (e.g., to a storage server for later use). The transmitting step of stage 5100 may include transmitting the information wirelessly, through a cable connection, or in any other manner.
[0292] Optionally, stage 5100 may include transmitting the analyzed source data, including the compressed physiological data, to an external system.
[0293] Optionally, method 500 may include analyzing a physiological process based on the analysis source data (e.g., diagnosing a patient condition based on physiological data related to the physiological process). For the example shown with respect to the previous figure, stage 5110 may be performed by processor 220.
[0294] As noted above, sometimes a device that collects physiological data can collect physiological data that is intended to be used toward the analysis of different physiological processes, or even toward different types of analysis of a single physiological process. Similarly, sometimes a device that collects physiological data (whether or not the same device) can use the collected data to analyze different physiological processes, or even apply different forms of analysis to a single physiological process.
[0295] In some cases, determining a multi-valued quality score for the collected physiological data may be based on a selection as to which analysis is intended to be performed. Optionally, determining the multi-valued quality score may be further based on parameters of an analysis procedure selected from a predetermined finite number of analysis procedures for analyzing the physiological data.
[0296] The selection of which analytical processes to target for data collection and / or parameter selection can be made by the individual operating the machine, made automatically (e.g., based on sensor data, e.g., camera data can be used to determine proximity to particular organs on which the selection can be based), or received from an external system (e.g., a server, physician's station, etc.).
[0297] Thus, the device can collect physiological data that may be beneficial for other measurement and / or analysis processes, but scoring (determination of a multi-valued quality score) can be determined based on the target of the particular measurement.
[0298] For example, the device used in method 500 (e.g., system 200) can be used at one time for cardiac auscultation (recording sounds emanating from a patient's heart, in which case cardiac activity is the physiological process being monitored) and at another time for pulmonary auscultation (recording sounds emanating from the patient's lungs, in which case pulmonary activity is the physiological process being monitored). The selection of what the physiological process is and / or for what type of analysis the collected physiological data will be used can be made by the user, automatically, or by a remote system. Note that this selection can change at different times.
[0299] Note that stage 590 differs from general-purpose noise reduction at least in that it is specific to the preparation of high-quality data for analysis of a particular physiological process. As illustrated above, a very clean signal may not contain enough information to be meaningful for analysis of a particular physiological process. In contrast, method 500 enables the generation of analysis source data while monitoring the suitability of the collected data for analysis of a particular process and making any adjustments necessary to ensure that the analysis source data based on the collected data is suitable for this specific purpose, i.e., contains diagnostic-enabling data.
[0300] Referring generally to method 500, it should be noted that, optionally, the acquiring (stage 520), identifying (stage 530), and determining (stage 540) steps are performed by a portable, handheld physiological monitor device. In such cases, the acquiring (stage 520) step may include measuring physiological measurements (stage 505, shown for convenience as a separate step) by at least one physiological sensor of the portable, handheld physiological monitor device. It should be noted that, while all of these stages may be performed by the physiological measurement device (whether portable or not) that collects the data, this is not necessarily the case; some or all of these stages may be performed on another system, such as a personal computer, a smart phone, a server, a remote computer (e.g., a physician's station), etc.
[0301] Note that, optionally, the acquiring (520), processing (530), determining (540), and providing (550) steps are repeated across multiple successful physiological measurements, during which the determining step includes different multi-valued quality scores (i.e., different quality assessments) for different successful physiological measurements. In the context of this discussion, a successful physiological measurement means a measurement that meets a predetermined condition that is sufficient for medical analysis / diagnosis (i.e., the measurement includes diagnosis-enabling data), is stored, and is displayed to a user (e.g., a physician). By assigning different scores to different successful measurements, the measurement operator has the potential to improve measurement quality and make it more efficient (e.g., shorter). Providing feedback on quality rather than just success / failure allows for patient / operator education.
[0302] FIG. 6 is a flow diagram illustrating an example method 500 in which determination of mass number quality scores in accordance with the presently disclosed subject matter is used to automatically modify acquisition parameters used in acquiring physiological data.
[0303] Thus, method 500 may further include stage 570 of modifying one or more acquisition parameters of a physiological sensor that collects at least a portion of the measurement data based on at least one of the quality scores. For the examples shown with respect to the previous figures, stage 570 may be performed or at least controlled by processor 220. For the examples shown with respect to the previous figures, the acquisition parameters may be parameters of sensor 210 (and in some cases of processor 220 or other components of system 200).
[0304] Some non-limiting examples of acquisition parameters that can be modified at stage 570 include: a. Temporal parameters (e.g., acquisition frequency, sampling rate, duration, timing, etc.); b. Electrical parameters (such as resistance, applied current, voltage), c. physical parameters (such as sampling temperature); d. Camera parameters (such as lighting threshold, white balance, contrast, focus, etc.); e. Microphone parameters (e.g., frequency-based filtering such as high-pass, low-pass, band-pass, band-stop, sampling volume, sampling sensitivity), f. Positioning parameters (movement relative to the body if possible); g. Sensor selection (e.g., if two or more similar sensors are used); h. Pre-processing parameters (such as noise reduction sensitivity parameters); i.Other.
[0305] Note that stage 570 can be performed one or more times during the entire physiological measurement. For example, modification of acquisition parameters may be required only when the multi-valued quality score is less than a predetermined threshold or continuously or cumulatively falls below a predetermined threshold for a predetermined amount of time. Optionally, stages 560 and 570 can be performed synergistically. For example, modification of acquisition parameters may be most effectively utilized when the user moves the sensor, while other changes by the user (commanded or uncommanded) may require modification of acquisition parameters.
[0306] In addition to the single multi-valued quality score (or scores), the acquisition parameters may be modified based on additional factors, such as patient parameters, sensor parameters, environmental parameters, etc., at stage 570. Other parameters may be used towards determining new acquisition parameters (e.g., new sampling frequency) and / or determining quality score thresholds (or other criteria) for when modification of acquisition parameters is required.
[0307] Optionally, modifying the acquisition parameters is also performed in response to a medical condition of the patient. The medical condition (or more generally, the patient's physiological condition) can be a long-term condition (such as weight, diabetes, normal blood pressure) or a more transient condition (e.g., illnesses such as sore throat, fever). For example, the optimal sound quality for auscultation may depend on the fat concentration in the patient.
[0308] Optionally, the step of modifying the acquisition parameters is further performed based on a reference quality score, which is a quality score determined for at least one previous physiological measurement of the patient taken on a previous date (i.e., a different day). For example, if the same physiological test for a particular patient on a previous date achieved a quality score of 7 out of 10, the acquisition parameters can be modified to produce a measurement of at least similar quality. For another patient whose best quality previously achieved was 5 out of 10 (e.g., due to weight, body fat, or anxiety), it may be futile to attempt to achieve a higher measurement quality level. The use of a previous quality score as a reference allows the system to continue improving its own measurement quality by using adaptive criteria.
[0309] Different acquisition parameters (and / or different criteria for the need for modification) can be used for different patients. Optionally, modifying the acquisition parameters is further performed in response to quality criteria selected for the patient by a medical professional. For example, different quality images can be acquired by devices or even doctors for different patients. For example, the optimal sound quality for auscultation and / or listening tests may depend on the fat concentration in the patient. For example, patients with known heart disease may, in certain aspects, require higher quality measurements compared to patients without a history of heart disease.
[0310] Note that similar criteria and requirements as those discussed above with respect to stage 570 may be used for issuing instructions at stage 560 .
[0311] FIG. 7 illustrates optional stage 580 of method 500 according to an example of the presently disclosed subject matter. Stage 580 includes selecting a pertinent portion of physiological data collected during physiological measurement based on a quality score and generating a physiological measurement preview based on the pertinent portion for presentation via a tangible user interface (e.g., of a device operated by a medical practitioner). The physiological measurement preview may be part of the analysis source data (in which case stage 580 may be part of stage 590), but this is not necessarily the case (in which case stage 580 is performed after some or all instances of stage 540). In some cases, the physiological measurement preview may at least partially overlap a given portion of the physiological data identified as diagnosis-enabling data. The physiological measurement preview may include, for example, one or several images, a short video clip, a thumbnail (static or dynamic), a short sound sample, and the like. Note that pertinent portion means some, but not all (A is a pertinent portion of B if A is part of B but B is not part of A). Method 500 may, but need not, further include presenting a physiological measurement preview. Note that stage 580 may be performed on a system separate from that performing other stages of method 500, e.g., a remote server.
[0312] 3C is a flow diagram illustrating an example of a method 500 according to the presently disclosed subject matter. In the example of FIG. 3C, some multi-valued quality scores are used in a cumulative manner with each other. Stages 520, 530, 540, and 550 may be performed multiple times, followed by optional stages 5120 and 5130, respectively.
[0313] Optional stage 5120 includes providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount. For the examples shown with respect to the previous figures, stage 5120 can be performed by processor 220 and / or UI 230.
[0314] With reference to processor 220, it is noted that, optionally, processor 220 may be configured to selectively provide a success indication for the physiological measurement in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0315] A success indication can be provided to a user using a user interface (e.g., according to any of the UI examples presented above), to a processor, and / or to any other system. The success indication can indicate that the physiological measurement was successful (i.e., diagnostic-enabling data was obtained). Optionally, other indications of failure of the physiological measurement can be used.
[0316] For example, a success indication may be provided if the multi-valued quality scores determined for different consecutive times satisfy (e.g., exceed a threshold) a predetermined criterion for a certain consecutive time (e.g., the quality score exceeds a score of 6 out of 10 for at least 5 consecutive seconds). For example, a success indication may be provided if the multi-valued quality scores determined for different times satisfy (e.g., exceed a threshold) a predetermined criterion for a predetermined cumulative duration (e.g., the quality score exceeds a score of 6 out of 10 for at least 15 seconds, which may not necessarily be consecutive). For example, a success indication may be provided if the multi-valued quality scores determined for different times satisfy (e.g., exceed a threshold) a predetermined criterion for a predetermined number of consecutive, optionally non-overlapping, durations (e.g., the quality score exceeds a score of 6 out of 10 at least three times for at least 5 consecutive seconds).
[0317] Optional stage 5130 includes stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount. With respect to the examples shown with respect to the previous figures, stage 5120 may be performed by processor 220 and / or UI 230. With respect to the examples shown with respect to the previous figures, stage 5130 may be performed by processor 220 (note with respect to processor 220 that, optionally, processor 220 may be configured to stop the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount).
[0318] For example, physiological measurements may be stopped when the multi-valued quality scores determined for different consecutive times satisfy a predetermined criterion (e.g., exceed a threshold) for a certain consecutive time, when the multi-valued quality scores determined for different times satisfy a predetermined criterion (e.g., exceed a threshold) for a predetermined cumulative duration, or when the multi-valued quality scores determined for different times satisfy a predetermined criterion (e.g., exceed a threshold) for a predetermined number of consecutive, optionally non-overlapping, durations.
[0319] It should be noted that similar uses of multi-valued quality scores determined for physiological measurements can be advantageous without necessarily identifying the portion of the collected physiological data that originates from the physiological process being analyzed.
[0320] For example, another method, namely, a computer-implemented method for providing feedback indicating the suitability of data collected during a physiological measurement for analysis of a physiological process of a patient's body, comprising the steps of: (a) acquiring physiological data collected from the patient's body at a plurality of different times during the physiological measurement and resulting from at least a physiological process; (b) determining a multi-valued quality score for the physiological data collected at the plurality of different times; and (c) selectively providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0321] Stage (c) may be replaced (or combined) with a stage of selectively stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0322] This method may include, mutatis mutandis, any of the variations discussed with respect to method 500, but does not require the step of identifying each portion of physiological data resulting from a physiological process.
[0323] Similarly, equivalent systems can be disclosed that do not require such identification of each portion of the physiological data resulting from the physiological process. Such a system for physiological measurement of a physiological process in a patient's body is hereby disclosed, comprising at least one physiological sensor operable to collect physiological data resulting from at least the physiological process from the patient's body at a plurality of different times during the physiological measurement, and a processor operable to (a) determine a multi-valued quality score for the physiological data collected at the plurality of different times, and (b) selectively provide a success indication for the physiological measurement in response to determining that the cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfied predetermined criteria exceeds a predetermined amount.
[0324] Alternatively (or additionally), the processor may be operable to (a) determine a multi-valued quality score for the physiological data collected at a plurality of different times, and (b) selectively stop the physiological measurements in response to determining that the cumulative amount of time from the plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
[0325] The system may include any of the variations described with respect to system 200 mutatis mutandis, but it is not necessarily possible to identify each portion of the physiological data resulting from a physiological process.
[0326] Similarly, a non-transitory computer-readable medium for providing feedback indicative of the suitability of data collected during a physiological measurement for analysis of physiological processes of a patient's body is described herein having stored thereon instructions that, when executed on a processor, perform the following steps at multiple different times during the physiological measurement: (a) acquiring physiological data collected from the patient's body at multiple different times during the physiological measurement and resulting from at least a physiological process; and (b) determining a multi-valued quality score for the physiological data collected at the multiple different times, and selectively providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from the multiple different times over which the determined multi-valued quality score satisfied predetermined criteria exceeds a predetermined amount.
[0327] Stage (c) may be replaced (or combined) with a stage of selectively stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied the predetermined criteria exceeds a predetermined amount.
[0328] This non-transitory computer-readable medium may include, mutatis mutandis, any of the variations described with respect to any of the non-transitory computer-readable media described below, but does not require the step of identifying each portion of physiological data resulting from a physiological process.
[0329] 8 is a flow chart illustrating an example of a method 800 in accordance with the presently disclosed subject matter. Method 800 is a variation of method 500 for providing feedback indicating the suitability of data collected during pulmonary auscultation (i.e., recording of sounds from the lungs) for a pulmonary analysis (i.e., relating to the lungs) of a patient. The pulmonary analysis may be aimed at diagnosing / assessing, for example, the patient's pulmonary condition, respiratory function, breathing patterns, etc. With respect to the example shown with respect to the previous figure, method 800 may be performed by system 200. If optional stage 890 is performed, method 800 may be used to provide auscultation source data for a pulmonary analysis (i.e., for diagnosing a medical condition relating to the patient's lungs) of the patient.
[0330] Method 800 is an implementation of method 500, and the details discussed above with respect to stage 510 may be applied mutatis mutandis to stage 810, the details discussed above with respect to stage 520 may be applied mutatis mutandis to stage 820, and so on.
[0331] In method 800, the physiological data are sound samples recorded from the patient's chest or back. For example, the sound samples can be collected by a portable handheld device that includes a microphone and a processor, such as the handheld medical device produced by Tytocare LTD., Netanya, Israel.
[0332] Optional stage 805 involves collecting sound samples from lung locations.
[0333] Stage 820 involves obtaining sound samples from lung locations resulting from respiration processing, but optionally also from other sources such as heartbeat, ambient sounds, sampling noise, etc.
[0334] Stage 830 involves identifying the portion of the sound sample that results from breathing. The manner in which this can be used to distinguish between sounds that result from breathing and sounds that result from other sources is described above.
[0335] Stage 840 includes determining a multi-valued quality score for one or more of the sound samples that indicates the suitability of the sound sample for pulmonary analysis based on one or more of the sound samples and the results of the identification.
[0336] Stage 850 includes providing, via a tangible user interface, multi-valued quality feedback information based on at least one of the multi-valued quality scores.
[0337] Optional stage 890 includes generating auscultation source data for pulmonary analysis based on one or more of the sound samples and at least one of the multi-valued quality scores, the auscultation source data including at least diagnostic enabling data that allows diagnosing a pulmonary condition in a patient.
[0338] Optional stage 860 includes presenting instructions to the user via the UI for performing the auscultation sampling process.
[0339] Optional stage 858 includes the individual processing one or more of the multi-valued quality scores to determine instructions for modifying the auscultation sampling process.
[0340] Optional stage 870 includes modifying one or more acquisition parameters of the microphone collecting the sound samples based on at least one of the multi-valued quality scores.
[0341] It should be noted that the method 800 described above can also be implemented for other auscultation types (eg, for heart sounds, bowel sounds, etc.).
[0342] 9 is a flow chart illustrating an example of a method 900 in accordance with the presently disclosed subject matter. Method 900 is a method that may optionally be performed by a user operating a physiological sensor / measuring device used for the physiological measurements of method 500 and / or a user operating system 200. Any details discussed above with respect to method 500 and / or system 200 may be applied to method 900 mutatis mutandis. Method 900 may be performed by the patient or another person (optionally a non-medical practitioner) around the patient whose body is being examined.
[0343] Stage 910 includes initiating a physiological measurement of a physiological process using a physiological measurement unit. The physiological measurement unit can be a handheld device or a larger device. Selection of the physiological measurement, the physiological process to be tested, etc. can be performed by the patient, an operator, the measurement unit, another computer, or a person at a remote location (e.g., a physician at a remote center). Stage 910 can, but does not necessarily, include setting parameters for the measurement.
[0344] At different times during the physiological measurement (labeled 920 ), the user performs stage 930 followed by stage 940 and / or stage 950 , followed by stage 960 .
[0345] Stage 930 includes receiving, through a tangible user interface, multi-valued quality feedback information based on portions of the physiological data resulting from the physiological process collected by the physiological measurement unit, with little or no consideration given to portions of the physiological data resulting from sources other than the physiological process.
[0346] The multi-valued quality feedback information can be presented in one or more of different ways, for example, as explained above, as a digital numeric display, as an LED display, in spoken language, by non-speech sounds, using vibration or other tactile information, and other similar ways.
[0347] Stage 940 involves modifying the manner in which the physiological measurement unit operates based on the multi-valued quality feedback information. The user can modify the measurement in different ways, such as by moving or readjusting the position / orientation of the measurement unit, changing the measurement parameters of the measurement unit, readjusting the user's own body position, breathing differently, replacing a module of the measurement unit (e.g., an otoscope), or any other way as described above.
[0348] Stage 950 includes receiving instructions to perform physiological measurements through a tangible user interface. The instructions are based on portions of physiological data resulting from physiological processes collected by the physiological measurement unit, optionally with little or no consideration of portions of the physiological data resulting from sources other than the physiological processes. The instructions can be presented to the user in one or more different ways, for example, as a digital numeric display, as an LED display, in spoken language, by non-spoken sounds, using vibration or other tactile information, and other similar ways, as discussed above.
[0349] Stage 960 involves modifying the manner in which the physiological measurement unit operates based on the instructions. The user can modify the measurements in different ways, as discussed above with respect to stage 940.
[0350] Optional stage 970 involves receiving feedback information regarding the quality of the physiological measurements and sometimes also the quality of the manner in which the measurements were performed by the user.
[0351] By performing method 900, the user can improve the quality of the physiological measurements to make them more suitable for analyzing physiological processes, and also better learn how to operate the measurement unit, thereby improving the user's skills for subsequent physiological measurements (if any).
[0352] Similarly, by receiving feedback (during and / or after the measurement is completed) regarding the quality of the measurement results and their suitability for analysis of physiological processes, the user can generate high-quality measurements suitable for analysis without the intervention of a trained professional.
[0353] This significantly reduces the chance that when the analysis source data (based on physiological measurements) is ultimately analyzed (which can take a long time, e.g., hours or even days and weeks), the data will not be of sufficient quality for analysis (i.e., the analysis source data will not contain diagnostic-enabling data).
[0354] 1 and 2, it should be noted that system 200 may, mutatis mutandis, implement any of the variations discussed above with respect to methods 500 and 800. The following description of system 200 is not limited to performing method 500, although this will hopefully become clearer after a detailed discussion of method 500.
[0355] System 200 is a system for providing analytical source data for analysis of a physiological process in a patient's body. System 200 includes at least one physiological sensor 210 operable to collect physiological data from the patient's body at multiple times during a physiological measurement, the physiological data resulting from (a) the physiological process and (b) additional sources.
[0356] The processor 220 is operable to perform the following steps at multiple different times during the physiological measurement: (a) identifying each portion of the physiological data resulting from the physiological process; (b) determining a multi-valued quality score (i.e., more than two options) for the physiological data based on the physiological data and the results of the identification, indicating the suitability of the physiological data for analysis of the physiological process; and (c) providing multi-valued quality feedback information based on the quality score via a tangible user interface.
[0357] The processor 220 is further operable to generate analysis source data based on the physiological data collected by the physiological sensor and at least one of the multi-value quality scores.
[0358] Although not necessarily so, the quality score determined by processor 220 can be different from any value contained in the analyzed source data.
[0359] Optionally, processor 220 may be operable to identify portions of the physiological data resulting from physiological processes based on identifying the effects of a plurality of different physiological processes on the physiological data.
[0360] The system 2000 may include a UI 230 operable to present instructions to a user for performing physiological measurements. In such cases, the processor 220 may optionally determine (and sometimes modify) these instructions based on at least one of the multi-valued quality scores.
[0361] Optionally, processor 220 is configured to determine at least one of the multi-valued quality scores further based on parameters of an analysis procedure selected from a predetermined finite number of analysis procedures for analyzing the physiological data.
[0362] For example, system 200 can be used for cardiac auscultation at one time and for pulmonary auscultation at another time. Processor 220 in such a case can be configured to determine at least one of the multi-valued quality scores based on the type of auscultation. The selection of what the physiological process is and / or for what type of analysis the collected physiological data will be used can be made by the user, automatically, or by a remote system. Note that this selection can be switched at different times.
[0363] Optionally, processor 220 is further operable to select a suitable portion of the physiological data collected during the physiological measurement based on the quality score, and to generate a physiological measurement preview based on the suitable portion for presentation via the tangible user interface.
[0364] It should be noted that processor 220 may determine different multi-value quality scores for multiple different successful physiological measurement results (examples of the meaning of the term "successful" are discussed above with respect to method 500).
[0365] Optionally, a physiological sensor 210 from among the at least one physiological sensor 210 can utilize acquisition parameters that are based on at least one of the quality scores for at least one of the measurements, the at least one quality score being a multi-valued quality score previously determined for physiological data collected by the physiological sensor 210 during the same physiological measurement.
[0366] Optionally, the above-mentioned acquisition parameters are further determined in response to quality criteria selected for the patient by a medical professional.
[0367] Optionally, the acquisition parameters are further determined in response to a medical condition of the patient.
[0368] Optionally, the above mentioned acquisition parameters are further determined in response to a quality score determined for at least one previous physiological measurement taken at a previous time / date.
[0369] Optionally, the multi-valued quality score indicates the degree to which the patient complies with instructions regarding physical activity.
[0370] Optionally, processor 220 may be configured to determine a multi-valued quality score based on a selection of a scoring scheme from a plurality of predefined scoring schemes, each associated with an analytical procedure for a physiological process.
[0371] Optionally, the processor 220 may be configured to compress different portions of the physiological data into the analyzed source data based on different multi-value quality scores determined for the different portions. Optionally, the communication module 240 may be operable to transmit the analyzed source data including the compressed physiological data to an external system.
[0372] In some cases, portions of the physiological data assigned low quality scores can be compressed using a higher compression level (and / or a lower compression storage ratio) relative to portions that received high quality scores. Note that some portions can be omitted entirely from the analysis source data (e.g., if the multi-valued quality scores of these portions indicate irrelevance or unsuitability for analysis due to, for example, the signal being of low quality or not containing relevant body location information).
[0373] Optionally, processor 220 can be configured to determine the multi-valued quality score based on criteria determined by a remote expert. Optionally, the criteria can be determined by an expert (e.g., a doctor, a technician) during the physiological measurement, sometimes based on data previously collected at an earlier point in the physiological measurement. For example, the expert can indicate points of interest (POIs), such as specific locations on the body and specific acoustic measurement data ranges.
[0374] It should be noted that system 200 may optionally include one or more non-physiological sensors (e.g., an IMU, a microphone, or other examples discussed above with respect to non-physiological sensors in method 500). In such cases, processor 220 may be configured to determine a multi-valued quality score for the at least one physiological data further based on data collected by the at least one non-physiological sensor.
[0375] It should be noted that the step of determining the multi-valued quality score by the processor 220 may be based solely on the physiological data and the result of the identification without using any additional data.It should be noted that the step of determining the multi-valued quality score by the processor 220 may be performed based on the physiological data and the result of the identification without using any additional measurement data (but sometimes using some other form of data such as clock data).
[0376] Any reference herein to methods 500 or 800 shall apply mutatis mutandis to a system capable of performing the respective method, and shall also apply mutatis mutandis to a non-transitory computer-readable medium storing instructions that, when executed by a computer, result in the performance of the method.
[0377] For example, a non-transitory computer-readable medium for providing feedback indicating the suitability of data collected during physiological measurements is disclosed. The non-transitory computer-readable medium, when executed on a processor, comprises: At multiple different times during the physiological measurement i. acquiring physiological data collected from the patient's body that comes from (a) physiological processes and (b) additional sources; ii. identifying, at a plurality of different times during the physiological measurement, portions of physiological data resulting from (a) the physiological process; iii. determining a multi-valued quality score for the physiological data based on the physiological data and the results of the identification, the quality score indicating the suitability of the physiological data for analysis of the physiological process; iv. providing multi-valued quality feedback information based on the quality scores via a tangible user interface; performing Stores instructions to implement the above.
[0378] Optionally, the non-transitory computer-readable medium may further store instructions that, when executed on the processor, perform the step of generating analysis source data based on at least one of the multi-value quality scores and further based on physiological data acquired at a plurality of different times.
[0379] Optionally, the quality score can be different from any value contained in the analyzed source data.
[0380] Optionally, the identifying step may be based on identifying the effects of a plurality of different physiological processes on the physiological data.
[0381] Optionally, the plurality of different times may include at least a first time and a second time that is later than the first time, and the step of acquiring physiological data at the second time is affected by a change in physiological measurement by the user as a result of the provision by the tangible user interface of multi-value quality feedback information resulting from multi-values determined for the physiological data acquired at the first time.
[0382] Optionally, the physiological data may be collected by a physiological measurement device, and the suitability of the physiological data may change as a result of changes in operation of the physiological measurement device by a user perceiving quality feedback information provided by a tangible user interface.
[0383] Optionally, the non-transitory computer-readable medium may further store instructions that, when executed on the processor, perform the step of presenting instructions for performing physiological measurements to a user via a tangible user interface.
[0384] Optionally, the step of determining the multi-valued quality score may be further based on one or more parameters of an analytical procedure selected from a predetermined finite number of analytical procedures for analyzing the physiological data.
[0385] Optionally, the obtaining, identifying, and determining steps may be performed by a portable handheld physiological monitoring device, and the obtaining step includes measuring a physiological measurement value by at least one physiological sensor of the portable handheld physiological monitoring device.
[0386] Optionally, the non-transitory computer readable medium further comprises, when executed on a processor: a. selecting a relevant portion of physiological data collected during a physiological measurement based on a quality score; b. generating a physiological measurement preview based on the fitness portion for presentation via a tangible user interface; The method may store instructions for implementing the following:
[0387] Optionally, the non-transitory computer-readable medium may further store instructions that, when executed on the processor, perform a step of modifying acquisition parameters of a physiological sensor that collects at least a portion of the measurement data based on at least one of the quality scores.
[0388] Optionally, the step of modifying the acquisition parameters may further be performed in response to quality criteria selected for the patient by a medical professional.
[0389] Optionally, modifying the acquisition parameters may also be performed in response to a patient's medical condition.
[0390] Optionally, modifying the acquisition parameters may further be performed in response to a quality score determined for at least one previous physiological measurement taken on a previous date.
[0391] Optionally, the multi-valued quality score may indicate the degree to which the patient complies with instructions regarding physical activity.
[0392] Optionally, determining the multi-valued quality score may be based on selecting a scoring scheme from a plurality of predefined scoring schemes each associated with an analytical procedure for a physiological process.
[0393] Optionally, generating the analysis source data may include compressing different portions of the physiological data based on different multi-value quality scores determined for the different portions.
[0394] Optionally, determining the multi-valued quality score for the at least one physiological data may be further based on data collected by a non-physiological sensor of the physiological measurement system that collected the physiological data.
[0395] 10 , a flow diagram illustrates an example of a method 600 in accordance with the presently disclosed subject matter. Method 600 is a method for providing feedback indicating the presence / absence of diagnostic-enabling data within physiological data collected from a patient's body. As with the examples illustrated with respect to the previous figures, method 600 may be performed by system 200. Any variation, combination, or optional implementation discussed with respect to system 200 may also be performed with respect to method 600, mutatis mutandis. Any variation, combination, or optional implementation discussed with respect to method 600 may also be performed with respect to system 200, mutatis mutandis. Method 600 may be performed by processor 220 in addition to or instead of method 500. In some cases, method 600 may be performed as part of method 600.
[0396] Method 600 is performed during a physiological measurement and includes executing on a processor at one or more different times during the physiological measurement stages 610 and 620, and optionally one or both of stages 630 and 640. Note that any one or more (and optionally all) of stages 610, 620, 630, and 640 may be performed by processor 220.
[0397] Stage 610 involves acquiring physiological data collected from a patient's body during a medical test of the patient. The physiological data can be data acquired by instantaneous measurements or data acquired over a period of time rather than instantaneously. In some cases, the physiological data can be (a) physiological processes and (b) data resulting from additional sources. As discussed with respect to system 200, the physiological data collected in stage 610 can be collected by one or more sensors. The medical test can be performed by a user using one or more sensors. The user performing the medical test is not necessarily a medical practitioner with formal medical training, and in some cases the user is not a medical practitioner.
[0398] Stage 620 involves analyzing the acquired physiological data to determine the presence of diagnosis-enabling data. Diagnosis-enabling data is data that allows a diagnostic entity (such as a medical practitioner, a computerized diagnostic system) to diagnose a patient's medical condition. Note that in order for a diagnostic entity to be able to make a diagnosis based on the diagnosis-enabling data, the diagnosis-enabling data needs to be of a certain minimum quality that enables such a diagnosis.
[0399] Note that in some cases, the diagnostic entity will perform a diagnosis based on the diagnosis-enabling data some time after execution of method 600. Therefore, it is desirable to verify that the acquired physiological data includes the diagnosis-enabling data so that the diagnostic entity has access to the diagnosis-enabling data once it has performed the diagnosis. Otherwise, the patient's medical test (during which the physiological data is collected) will have to be repeated to obtain new or additional physiological data from the patient's body. This repetition necessarily requires the patient's, and optionally the user's, availability to operate the sensor if the patient does not operate the sensor themselves. In addition to the need to repeat the medical test, if the physiological data does not include the diagnosis-enabling data, the diagnostic entity will attempt to diagnose the patient's condition based on data that does not include the diagnosis-enabling data, thus wasting the diagnostic entity's resources by failing or providing a poor or erroneous diagnosis.
[0400] It should be noted that the determination of whether the physiological data includes diagnosis-enabling data can be performed using any one or more of the sub-stages of stage 530, i.e., one or more of stages 531 through 538 detailed above. In some cases, additional / alternative methods can be used to determine the presence of diagnosis-enabling data in the acquired physiological data. In more particular cases, the determination can be made based on a multi-valued quality score determined based on the results of performing one or more sub-stages of stage 530 detailed above with respect to stage 540. In such cases, the calculated score can be required to be greater than a certain threshold, which can optionally be based on the particular medical tests performed on the patient and / or the particular patient characteristics detailed above, etc. In some cases, an analysis to determine the presence of diagnosis-enabling data is performed on the portion of the physiological data identified as originating from a physiological process.
[0401] In the particular example where the physiological data is audio data, determining whether the physiological data includes diagnostic-enabling data can be performed as follows: The physiological data can be transformed into the frequency domain. It is then weighted by frequency, for example using equal loudness curves. Furthermore, the energy of the weighted signal can be calculated and transformed to a logarithmic scale, and then rescaled to fit the number of options for the multi-valued quality score.
[0402] Stage 630 includes, if the analysis indicates that diagnosis-enabling data is present in the acquired physiological data, providing at least the diagnosis-enabling data to a diagnostic entity (e.g., by processor 220), thereby enabling the diagnostic entity to diagnose the patient's medical condition. Providing the diagnosis-enabling data to the diagnostic entity may include transmitting the diagnosis-enabling data through a network interface (whether wired or wireless) to a separate device other than system 200 operated by a medical practitioner (e.g., a computing workstation, smart phone, tablet, etc.).
[0403] In some cases, the data provided at stage 630 includes diagnosis-enabling data and additional data. In some cases, an indication of the location of the diagnosis-enabling data within the data provided at stage 630 may be provided. For example, all of the physiological data acquired at stage 610, including the diagnosis-enabling data and additional data that does not enable a diagnosis (e.g., data having only low quality), may be provided at stage 630 so that a diagnostic entity can locate the diagnosis-enabling data within the provided data (e.g., to avoid having to solicit data for the diagnosis-enabling data), and an indication of the location(s) of the diagnosis-enabling data within the acquired physiological data may be provided.
[0404] Stage 640 includes providing (e.g., by processor 220) an indication of the presence / absence of diagnosis-enabling data in the acquired physiological data to a user operating system 200 (e.g., the patient or another non-medical practitioner, e.g., a relative of the patient) if the analysis of stage 620 indicates that the physiological data includes diagnosis-enabling data. In some cases, the indication may be a V mark if the diagnosis-enabling data (or a sufficient amount thereof) is present in the acquired physiological data, and an X mark if the diagnosis-enabling data is absent.
[0405] As shown herein, in some cases, user interface 230 can be part of a user-activated handheld medical device (e.g., a display, a speaker, one or more vibration elements, a set of LEDs, etc.). Additionally or alternatively, user interface 230 can be external to the user-activated handheld medical device, such as an external display, an output means of a smart phone (e.g., a display, a speaker, a vibration element of the smart phone), or another computer (in which case information can be provided on a user interface of the corresponding computer), and the like (in such cases, an indication of the presence / absence of diagnostic-enabling data in the acquired physiological data can be provided to such an external user interface through a wired / wireless connection).
[0406] It should be noted that UI 230 can optionally be used to provide additional information to a user of system 200, whether or not originating from processor 220. For example, UI 230 can optionally additionally provide instructions on how to modify a measurement to improve the quality of the measurement, to indicate the end of a measurement (or part of a measurement, e.g., moving to another location on the body and continuing the measurement), and other similar things. Such additional information can be provided by UI 230 optionally during the examination, rather than just after the examination is completed. However, neither information (whether multi-valued quality feedback information or any other information provided by UI 230) needs to be provided constantly throughout the examination (or at any particular time).
[0407] In some cases, the physiological data is acquired and analyzed in real-time (e.g., immediately or substantially immediately after acquisition by at least one physiological sensor 210 (e.g., by way of non-limiting example, within no more than 5 seconds)). In some cases, an indication of the presence of diagnosis-enabling data in the acquired physiological data is also provided in real-time (e.g., immediately or substantially immediately after determining that diagnosis-enabling data is present in the acquired physiological data (e.g., by way of non-limiting example, within no more than 5 seconds)), thereby allowing a user operating system 200 to determine when to stop performing physiological testing on the patient. Note that in some cases, the indication of the presence of diagnosis-enabling data in the acquired physiological data can be provided at a certain point in time (e.g., up to several seconds or minutes) after processor 220 determines that diagnosis-enabling data is present in the acquired physiological data.
[0408] When physiological data is acquired and analyzed in real time (e.g., immediately or substantially immediately after being acquired by at least one physiological sensor 210), the processor 220 can be configured to provide instructions to the user to spatially reposition the sensor(s) relative to the patient's body in accordance with a medical test after determining that the acquired physiological data includes diagnostic-enabling data, or in accordance with a subsequent medical test defined by the patient's predetermined test plan (e.g., defining a certain sequence of one or more medical tests).
[0409] Please note FIG. 11 of a user interface presented on the display of a medical practitioner system in accordance with the presently disclosed subject matter to enable navigation to points of interest (POI) within physiological data acquired during non-instantaneous physiological measurements.
[0410] As shown herein (e.g., with respect to stage 590), in some cases, physiological data provided to a medical practitioner (e.g., a doctor, technician, or any other entity authorized to view physiological data acquired, e.g., for diagnostic purposes) that is remote (e.g., physiological measurements may be taken at a first geographic location and the measurements may be transmitted to a second geographic location of the medical practitioner, which may be remote from the first geographic location, e.g., a different town / city / state / country / etc.) may be accompanied by metadata indicating particular portions of the physiological data that are identified as diagnosis-enabling data (e.g., suitable for analysis for purposes of providing a diagnosis, e.g., being of higher quality than other portions of the physiological data that are not identified as diagnosis-enabling data). Such metadata may be used to provide the medical practitioner with the ability to navigate to portions of the physiological data identified as diagnosis-enabling data. In this regard, it should be noted that the need to navigate the physiological data arises when the physiological data is acquired during non-instantaneous physiological measurements, i.e., the physiological measurements are acquired over a non-instantaneous period of time rather than at a particular instantaneous point in time. In some cases, the period may be greater than 10 seconds, greater than 1 minute, or the like.
[0411] Note that in some cases, the physiological data (contained in one or more files, such as video and / or audio files) may include data acquired over an extended period of time, in which case only a small amount of the data is diagnosis-enabling data. Using metadata to indicate the specific portions of the physiological data identified as diagnosis-enabling data can save the medical practitioner time analyzing the data by allowing the medical practitioner to only concern themselves with the portions of the physiological data identified as diagnosis-enabling data. In some cases, the portion of the physiological data identified as diagnosis-enabling data may be less than 50% or very little of the physiological data. Therefore, saving the medical practitioner time is certainly possible.
[0412] In the illustrated example, an exemplary medical practitioner system display 110 is shown. Display 110 can be a computer display or any other display, such as the display of a smart phone, tablet computer, or any other device operated by a medical practitioner.
[0413] The physiological data may be an audio stream or a video stream. In such a case, a video / audio player 120 may be displayed on the display 110 along with a progress bar 130 associated with the physiological data video / audio stream. The progress bar 130 allows navigation through the video / audio stream to a particular point in time in the video / audio stream. Metadata indicating specific portions of the physiological data identified as diagnosis-enabling data may be used to provide a respective display across the progress bar 130.
[0414] In the illustrated example, three portions of the physiological data are identified as diagnosis-enabling data. Such portions may be marked by assigning a certain color to the section of the progress bar 130 associated with the portion of the physiological data identified as diagnosis-enabling data. Additionally or alternatively, flags (e.g., POI1, POI2, and POI3 as shown) may be provided on the display 110 pointing to the respective progress bar portions of the progress bar 130 associated with the physiological data identified as diagnosis-enabling data. In such a case, the flags may point to the start location of each portion within the progress bar 130 and, optionally, the end location of each portion.
[0415] In addition to or instead of marking particular portions of the progress bar, a graph (e.g., graph 132 shown in the figure) indicating the relative quality of the physiological data over time can be displayed on the display 110. In such cases, the metadata associated with the physiological data can include multiple quality scores (optionally multi-valued quality scores) calculated at multiple different times during the physiological measurement (during which the physiological data was obtained). Each quality score can indicate the suitability of the physiological data at the corresponding time for diagnosis by a medical practitioner. Graph 132 can be generated based on the multiple quality scores and can be presented to the medical practitioner to enable the medical practitioner to navigate to portions of the physiological data that contain diagnosis-enabling data (or at least have high quality relative to other portions of the physiological data).
[0416] In some cases, in addition to the progress bar 130, a different navigation user interface (UI) element 135 may be displayed on the display. Such a navigation UI element 135 may allow a user of the system to quickly navigate between portions of the physiological data identified as diagnosis-enabling data (e.g., POI1, POI2, and POI3 as shown in the figure). In some cases, the navigation UI element 135 may be a button that allows jumping from any current location in the physiological data to the next or previous POI (which is a portion of the physiological data identified as diagnosis-enabling data).
[0417] In some cases, a medical practitioner system (not shown) may enable a medical practitioner to communicate with another medical practitioner (e.g., an expert in a certain type of disease) to obtain information from the other medical practitioner. To this end, a user interface provided to the medical practitioner on the display 110 may enable the medical practitioner to provide a display of one or more specific regions of interest (which are certain portions of the physiological data) that the medical practitioner has identified, and the medical practitioner system may be configured to send the physiological data to a second medical practitioner system of a second medical practitioner along with metadata indicating the regions of interest identified by the medical practitioner. The second medical practitioner system may then enable the second medical practitioner to mark the specific regions of interest marked by the medical practitioner on the display of the second medical practitioner system (e.g., on a progress bar shown therein) to enable the second medical practitioner to navigate to the marked regions of interest in the physiological data (in a manner similar to the medical practitioner's navigation to portions of the physiological data that include diagnosis-enabling data).
[0418] In some cases, a medical practitioner system (not shown) may allow the medical practitioner to store different metadata that they generate along with an indication that they generated such metadata. Such metadata may be stored, for example, in an electronic health record (EHR) associated with the patient from which the physiological data originated. A user interface provided to the medical practitioner on display 110 may allow the medical practitioner to provide an indication of one or more particular regions of interest (which are certain portions of the physiological data) that the medical practitioner has identified, and the medical practitioner system may be configured to store such indication as metadata associated with the physiological data displayed to the medical practitioner.
[0419] 12 shows a functional block diagram illustrating an exemplary medical practitioner system in accordance with the presently disclosed subject matter. The medical practitioner system 100 can include a processor 140 and a medical practitioner system display 110. The medical practitioner system 100 can be a workstation, a smart phone, a tablet computer, or any other device operated by a medical practitioner and has a display 110. The medical practitioner system 100 can be configured to control resources of an associated medical practitioner system 100 and enable operations related to the medical practitioner system 100.
[0420] Please note that flowchart 13 illustrates an example of an operational sequence that may be implemented to enable navigation to a region / area of interest (POI) within physiological data acquired during non-instantaneous physiological measurements according to the subject matter disclosed herein.
[0421] Block 710 is a method for displaying a user interface on display 110 that enables navigation to a region / area of interest (POI) within physiological data acquired during non-instantaneous physiological measurements. The method of block 710 can be performed by processor 140, which executes steps 720 and 730.
[0422] Step 720 includes acquiring physiological data acquired during the non-instantaneous physiological measurement that includes one or more first portions identified as diagnostic enabling data and at least one second portion not identified as diagnostic enabling data.
[0423] Step 730 includes displaying a user interface on the display 110 that enables a medical practitioner to navigate through the physiological data within the acquired physiological data and that includes at least one indication of a location of at least one corresponding first portion of the first portions and enables a user to identify the location.
[0424] An illustrative and detailed description of the user interface is provided with respect to FIG.
[0425] Turning to FIG. 14, a flow chart illustrating an example of an operational sequence performed to provide a second medical practitioner with physiological data and an indication of an area of interest for consideration in accordance with the presently disclosed subject matter is shown.
[0426] Block 410 is a method of providing physiological data and an indication of regions of interest for consideration within the physiological data to a second medical practitioner. The method of block 410 can be performed by processor 140 performing steps 420 and 430.
[0427] Step 420 includes receiving an indication of a region of interest within the physiological data from a medical practitioner.
[0428] Step 430 includes sending the physiological data and the representation of the region of interest to a remote workstation operated by a second medical practitioner, thereby enabling the remote workstation to present the physiological data and the representation of the region of interest to the second medical practitioner for analysis. In some cases, the POIs are displayed in a manner that enables their origin to be determined (e.g., POIs generated by system 200 are displayed in a first color, POIs generated by the first medical practitioner are displayed in a second color other than the first color, POIs generated by a third medical practitioner are displayed in a third color other than the first and second colors, and so on). In some cases, the POIs may be displayed in a manner that enables indication of POIs generated by one or more selected sources (e.g., system 200, one or more selected medical practitioners) such that some POIs related to the physiological data are displayed to the second medical practitioner, while some POIs related to the physiological data are not displayed.
[0429] Further discussion of the method of block 410 is provided with respect to FIG.
[0430] Turning to FIG. 15, there is shown an illustration of another user interface that may be presented on the display of a medical practitioner system in accordance with the presently disclosed subject matter, allowing the medical practitioner to manage multiple patient virtual visits.
[0431] The presently disclosed subject matter can provide one or more virtual patient visits to each of one or more medical practitioners. The virtual patient visit includes providing the medical practitioner with information associated with the patient, including physiological data acquired during physiological measurements. The physiological measurements can be performed using system 200. As shown herein, the diagnostic entity (e.g., the medical practitioner) can be located remotely from the patient (e.g., the physiological measurements can be performed at a first geographic location and the measurement results can be transmitted to a second geographic location of the medical practitioner, which can be remote from the first geographic location, e.g., a different town / city / state / country / etc.). When two or more medical practitioners are present, the medical practitioners (and their respective medical practitioner systems 100) can be located remotely from each other (e.g., in different towns / cities / states / countries / etc.).
[0432] In the illustrated example, an exemplary medical practitioner system display 110 is shown. Display 110 can be a computer display or any other display, such as the display of a smart phone, tablet computer, or any other device operated by a medical practitioner.
[0433] The medical practitioner system 100 can generate a user interface on the medical practitioner system display 110, which can include a patient list 150, which is a queue list of patient encounters. Each patient encounter is associated with a corresponding patient requesting medical diagnostic services, for example, based on physiological data obtained during physiological measurements taken from the corresponding patient's body using the system 200.
[0434] In some cases, patient list 150 may optionally be ordered in descending order of the quality score determined for each patient visit. The quality score for a patient visit may be the maximum quality score of one or more files containing physiological data acquired from the patient's body during physiological measurements taken (e.g., using system 200) for the patient visit.
[0435] Upon selection of a certain patient visit from the patient list 150, the user interface can provide the medical practitioner operating the medical practitioner system 100 with a file list 160 that includes one or more files, each containing physiological data acquired from the patient's body during physiological measurements taken (e.g., using the system 200) for the patient visit.
[0436] In some cases, file list 160 may optionally be ordered in descending order of the quality score determined for each file. As shown herein, the quality score (which may optionally be multi-valued) indicates the suitability of the physiological data (in the file) for analysis of a particular physiological process and may be calculated based at least on identifying the portion of the physiological data that results from the corresponding physiological process being measured. Because quality scores are calculated multiple times during a physiological measurement, the quality score for each file may be the maximum quality score calculated during the measurement during which the physiological data from which those quality scores were calculated were acquired.
[0437] Upon selection of a particular file from the file list by the medical practitioner, a video / audio player 120 can be displayed on the display 110 along with a progress bar 130 associated with the video / audio stream (which can be an audio stream or a video stream) of physiological data contained within the particular selected file. The user interface shown in FIG. 15 can enable the medical practitioner to perform any of the actions detailed herein with respect to FIG. 11 on the selected file. This includes enabling the medical practitioner to navigate the physiological data using user interface markings / graphs determined according to metadata about the physiological data contained within the selected file. Furthermore, this includes enabling the medical practitioner to obtain information from another medical practitioner (e.g., an expert in a certain type of disease) and communicate with the other medical practitioner to provide the other medical practitioner with an indication of one or more particular areas of interest for review.
[0438] Turning to FIG. 16, a flow chart illustrating an example of the operational sequence performed by the presently disclosed subject matter to enable a medical practitioner to manage multiple patient virtual visits is shown.
[0439] Block 161 is a method that allows a medical practitioner to manage virtual visits for multiple patients. The method of block 1610 can be performed by processor 140, which executes steps 1620, 1630, 1640, and 1650.
[0440] Step 1620 includes obtaining, for each patient of the plurality of patients, one or more files associated with the patient, each file having a quality score indicative of the suitability of the physiological data contained in the file for diagnosis by a medical practitioner, where each file was obtained during a corresponding non-instantaneous physiological measurement for analysis of physiological processes in the body of the corresponding patient.
[0441] Step 1630 includes displaying on the display 110 a patient list 150, which is a list of patients ordered by the maximum quality score of the files associated with at least the corresponding patients.
[0442] Step 1640 includes, upon selection of a given patient in patient list 150, displaying on display 110 a second list of files (file list 160) associated with the given patient, and further displaying for each of these files a corresponding file quality score.
[0443] Step 1650 includes, upon selection of a given file in the file list 160 displayed on the display 110, displaying a user interface that allows a medical practitioner to navigate through the physiological data within the acquired physiological data and that includes at least one indication of the location of at least one corresponding first portion that has been identified as diagnosis-enabling data and allows the user to identify this location.
[0444] A detailed description of the method of block 1610 is provided with respect to Figure 15. It is further noted that the method of block 1610 may also enable a medical practitioner to perform the method of block 410.
[0445] The subject matter disclosed in the present invention can be implemented by a computer program for running on a computer system that includes at least code portions for performing the steps of a method according to the present invention when running on a programmable apparatus such as a computer system, or for enabling a programmable apparatus to perform the functions of a device or system according to the present invention.
[0446] A computer program is a listing of instructions, such as a particular application program and / or operating system. A computer program may include, for example, one or more of the following: subroutines, functions, procedures, methods, implementations, executable applications, applets, servlets, source code, code, shared libraries / dynamic load libraries, and / or other sequences of instructions designed for execution on a computer system.
[0447] The computer program may be stored internally on a non-transitory computer-readable medium. All or a portion of the computer program may be provided on a computer-readable medium that is permanently, removably, or remotely coupled to an information processing system. The computer-readable medium may include, by way of example and not limitation, any number of magnetic storage media including disk and tape storage media, optical storage media such as compact disc media (e.g., CD-ROM, CD-R) and digital video disc storage media, non-volatile memory storage media including semiconductor-based memory units such as FLASH memory, EEPROM, EPROM, ROM, ferromagnetic digital memory, MRAM, registers, buffers or caches, main memory, RAM, etc.
[0448] A computer process typically includes an executing (running) program or portion of a program, current program values and state information, and resources used by an operating system to manage the execution of the process. An operating system (OS) is software that manages the sharing of a computer's resources and provides programmers with the interface used to access those resources. An operating system processes system data and user input and responds by allocating and managing tasks and internal system resources as services to the system's users and programs.
[0449] A computer system may include, for example, at least one processing unit, associated memory, and a number of input / output (I / O) devices. When executing a computer program, the computer system processes information in accordance with the computer program and generates resulting output information through the I / O devices.
[0450] While the presently disclosed subject matter has been described in the foregoing specification with reference to specific exemplary embodiments, it will be apparent that various modifications and changes can be made to these embodiments without departing from the broader spirit and scope of the presently disclosed subject matter as set forth in the appended claims.
[0451] The connections described herein may be any type of connection suitable for conveying signals to or from a respective node, unit, or device, e.g., through intermediate devices. Thus, unless otherwise indicated or described, a connection may be, for example, a direct connection or an indirect connection. These connections may be illustrated or described with reference to being a single connection, multiple connections, unidirectional connections, or bidirectional connections. However, different embodiments may vary the implementation of these connections. For example, separate unidirectional connections may be used rather than bidirectional connections, and vice versa. Similarly, multiple connections may be replaced with a single connection that conveys multiple signals serially or in a time-multiplexed manner. Similarly, a single connection that conveys multiple signals may be separated into various different connections that convey subsets of these signals. Thus, many options exist for conveying signals.
[0452] However, other modifications, variations, and alternatives are possible. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.
[0453] While certain features of the presently disclosed subject matter have been illustrated and described herein, many modifications, substitutions, variations, and equivalents will now occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and variations that fall within the true spirit of the presently disclosed subject matter.
[0454] It will be appreciated that the above embodiments have been given by way of example and that variations and modifications of various features and combinations of features thereof are possible.
[0455] While various embodiments have been shown and described, it will be appreciated that such disclosure is not intended to limit the presently disclosed subject matter, but rather to cover all modifications and alternative constructions that fall within the scope of the presently disclosed subject matter as defined in the appended claims. [Explanation of symbols]
[0456] 500 Methods according to the presently disclosed subject matter 520 stage for acquiring physiological data collected from the patient's body. 530 a stage for identifying portions of physiological data resulting from physiological processes; 540 a stage for determining a multi-valued quality score for the physiological data, which indicates the suitability of the physiological data for the analysis of the physiological process based on the physiological data and the classification results; 550. A stage for providing multi-valued quality feedback information, which is based on quality scores, via a tangible user interface.
Claims
1. a sensor configured to be used by a user who is not a medical practitioner to perform a medical examination of a patient's body; acquiring physiological data acquired during the medical examination of the patient's body by the sensor; analyzing the acquired physiological data to determine whether the acquired physiological data includes (a) a signal having a frequency pattern that matches the frequency behavior of a physiological process, or (b) a signal having an amplitude pattern that matches the amplitude behavior of the physiological process; determining whether diagnostic enabling data exists that allows a diagnostic entity to subsequently diagnose a medical condition in the patient when the acquired physiological data includes (a) the signal having a frequency pattern that matches the frequency behavior of the physiological process, or (b) the signal having an amplitude pattern that matches the amplitude behavior of the physiological process; and providing at least said diagnosis enabling data, if any, to said diagnostic entity, thereby enabling said diagnostic entity to diagnose said medical condition of said patient based on said diagnosis enabling data; a processor in communication with the sensor configured to: convert the physiological data to audio data; and determine whether the physiological data includes diagnosis-enabling data; and A system comprising:
2. said acquiring and said analyzing occurring in real time during said medical examination; the processor is further configured to, if the analysis indicates that the diagnostic enabling data is present in the physiological data, provide an indication of the presence of the diagnostic enabling data to the user.
2. The system of claim 1.
3. 3. The system of claim 2, wherein the indication is one or more of: (a) a visual indication provided through a user interface of a device operated by the user; (b) an audio indication provided through a speaker of the device operated by the user; and (c) a vibration indication provided through a vibration element within the device operated by the user.
4. the medical test is a non-instantaneous physiological measurement taken over a continuous period of time; The processor: determining, at multiple time points during the non-instantaneous physiological measurements, a multi-valued quality score indicative of the suitability of the currently acquired physiological data for diagnosis by the diagnostic entity; and providing real-time multi-valued quality feedback information to the user, the real-time multi-valued quality feedback information being based on the corresponding determined multi-valued quality scores; further configured as follows:
3. The system of claim 2.
5. 5. The system of claim 4, wherein the processor is further configured to provide instructions to the user for improving acquisition of the physiological data when the multi-valued quality score is below a predetermined threshold.
6. 5. The system of claim 4, wherein the processor is configured to selectively provide a success indication for the physiological measurement in response to determining that a cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied predetermined criteria exceeds a predetermined amount.
7. 5. The system of claim 4, wherein the processor is configured to stop the physiological measurements in response to determining that a cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
8. providing includes providing at least a portion of the acquired physiological data including the diagnostic-enabling data and additional data; the processor is further configured to provide information indicative of a location of the diagnostic enabling data within the acquired physiological data.
2. The system of claim 1.
9. said acquiring and said analyzing occurring in real time during said medical examination; the processor is further configured to provide instructions to the user to spatially reposition the sensor relative to the patient's body according to the medical examination or according to a subsequent medical examination defined by a predetermined examination plan for the patient.
2. The system of claim 1.
10. acquiring, by a processor, physiological data acquired during a medical examination of the patient's body performed with the sensor by a user who is not a medical practitioner; analyzing, by the processor, the acquired physiological data to determine whether the acquired physiological data includes (a) a signal having a frequency pattern that matches the frequency behavior of a physiological process, or (b) a signal having an amplitude pattern that matches the amplitude behavior of the physiological process; determining whether diagnostic enabling data exists that would allow a diagnostic entity to subsequently diagnose a medical condition in the patient when the acquired physiological data includes (a) the signal having a frequency pattern that matches the frequency behavior of the physiological process, or (b) the signal having an amplitude pattern that matches the amplitude behavior of the physiological process; providing, by said processor, at least said diagnosis enabling data, if present, to said diagnostic entity, thereby enabling said diagnostic entity to diagnose said medical condition of said patient based on said diagnosis enabling data; Including, The method, wherein the physiological data is audio data, and wherein the determining whether the physiological data includes diagnostic-enabling data includes transforming the audio data into the frequency domain and weighting the audio data by frequency.
11. the acquiring and analyzing steps are performed in real time during the medical examination; The method is if the analyzing step indicates that the diagnostic enabling data is present in the physiological data, providing an indication to the user of the presence of the diagnostic enabling data; Further comprising:
11. The method of claim 10.
12. 12. The method of claim 11, wherein the indication is one or more of: (a) a visual indication provided through a user interface of a device activated by the user; (b) an audio indication provided through a speaker of the device activated by the user; or (c) a vibration indication provided through a vibration element within the device activated by the user.
13. the medical test is a non-instantaneous physiological measurement taken over a continuous period of time; The method is determining, by the processor, at multiple time points during the non-instantaneous physiological measurement, a multi-valued quality score indicative of the suitability of the currently acquired physiological data for diagnosis by the diagnostic entity; providing real-time multi-valued quality feedback information to the user, the real-time multi-valued quality feedback information being based on the corresponding determined multi-valued quality scores; Further comprising:
12. The method of claim 11 .
14. 14. The method of claim 13, further comprising providing instructions to the user for improving acquisition of the physiological data when the multi-valued quality score is below a predetermined threshold.
15. 14. The method of claim 13, further comprising selectively providing a success indication for the physiological measurement in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
16. 14. The method of claim 13, further comprising: stopping the physiological measurements in response to determining that the cumulative amount of time from a plurality of different times over which the determined multi-valued quality score satisfied a predetermined criterion exceeds a predetermined amount.
17. the providing step includes providing at least a portion of the acquired physiological data including the diagnostic-enabling data and additional data; The method is providing information indicative of the location of the diagnostic enabling data within the acquired physiological data; Further comprising:
11. The method of claim 10.
18. the acquiring and analyzing steps are performed in real time during the medical examination; The method is providing instructions to the user to spatially reposition the sensor relative to the patient's body according to the medical examination or according to a subsequent medical examination defined by the patient's predetermined examination schedule; Further comprising:
11. The method of claim 10.
19. A non-transitory computer-readable storage medium having computer-readable program code embodied thereon that is executable by at least one processor, the non-transitory computer-readable storage medium comprising: acquiring, by said processor, physiological data acquired during a medical examination of the patient's body performed with a sensor by a user who is not a medical practitioner; analyzing, by the processor, the acquired physiological data to determine whether the acquired physiological data includes (a) a signal having a frequency pattern that matches the frequency behavior of a physiological process, or (b) a signal having an amplitude pattern that matches the amplitude behavior of the physiological process; determining whether diagnostic enabling data exists that would allow a diagnostic entity to subsequently diagnose a medical condition in the patient when the acquired physiological data includes (a) the signal having a frequency pattern that matches the frequency behavior of the physiological process, or (b) the signal having an amplitude pattern that matches the amplitude behavior of the physiological process; providing, by said processor, at least said diagnosis enabling data, if present, to a diagnostic entity, thereby enabling said diagnostic entity to diagnose said medical condition of said patient based on said diagnosis enabling data; Including, A non-transitory computer-readable storage medium having computer-readable program code embodied thereon executable to implement a method, wherein the physiological data is audio data, and the determining whether the physiological data includes diagnostic-enabling data includes transforming the audio data to the frequency domain and weighting the audio data by frequency.
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