WO2020227739A1

WO2020227739A1 - Systems, devices, and methods for generating a physiological assessment

Info

Publication number: WO2020227739A1
Application number: PCT/US2020/070037
Authority: WO
Inventors: Gregory O'keeffe; Mark Seelig; Anthony Moffa; Brian Dutton; David Deforest KEYS
Original assignee: Human Resources Technologies, Llc
Priority date: 2019-05-08
Filing date: 2020-05-08
Publication date: 2020-11-12

Abstract

A plurality of physiological measurements of a patient may be received along with an indication that the patient has performed a physical activity. In some cases, a first physiological measurement may be taken following a performance of a physical activity by the patient but before a second physiological measurement. The plurality of physiological measurement may be analyzed to determine a physiological assessment of the patient. The physiological assessment may be, in some cases, clinically actionable data that a physician or medical treatment provider may use to, for example, that a patient may act upon, monitor the patient for the presence of disease, track disease progression, prescribe treatment for the patient, and/or adjust treatment for the patient.

Description

SYSTEMS, DEVICES, AND METHODS FOR

GENERATING A PHYSIOLOGICAL ASSESSMENT

RELATED APPLICATIONS

[0001] This application is a NON-PROVISIONAL of U.S. Provisional Patent Application Serial Number 62845296 filed on 08-MAY-2019 and entitled “SYSTEMS AND METHODS FOR GENERATING A COMBINED MEDICAL TEST RESULT” and U.S. Provisional Patent Application Serial Number 62845289 filed on 08-MAY-2019 and entitled“SYSTEMS AND METHODS FOR CREATING AND ACCESSING A USER ACCOUNT” both of which are incorporated, in their entireties, herein.

BACKGROUND

[0002] Known, wearable devices such as smart watches or fitness trackers are capable of taking rough measurements of a person’s heart rate or pulse, but these measurements are rarely accurate enough and/or put in context for clinical significance. Thus, they are unacceptable for use in a medical context where a patient may be monitored to, for example, track disease or symptom progression in order to determine when the patient may need clinical intervention. Use of more sophisticated equipment such as electrocardiogram machines and pulse oximeters while outside of a clinical setting may be impractical for patients who are, for example, recovering from a diagnosis or medical treatment or otherwise would like to participate in remote, or, telemedicine.

SUMMARY

[0003] Systems, devices, and methods for generating a physiological assessment are herein disclosed. In many instances, the physiological assessments may be determined using information gathered in something other than a clinical setting such as a patient’s home or care facility. In some embodiments, a plurality of physiological measurements of a patient may be received along with an indication that the patient has performed a physical activity. In some cases, a first physiological measurement may be taken following a first physiological measurement but before a second physiological measurement. The plurality of physiological measurement may be analyzed to determine a physiological assessment of the patient. The physiological assessment may be, in some cases, clinically actionable data that a physician or medical treatment provider may use to, for example, monitor the patient for the presence of disease, track disease progression, prescribe treatment for the patient, and/or adjust treatment for the patient.

[0004] In some embodiments, the method may be executed by a processor resident in, for example, a user’s and/or patient’s electronic device such as a smart phone or tablet computer. At times, the processor may be communicatively coupled to a server and may communicate with the server of a network (e.g., the Internet) in order to execute one or more of the methods disclosed herein. Exemplary users include a health monitoring service, a treatment provider, a caregiver for the patient, and/or the patient himself or herself.

[0005] In some embodiments, a first and second physiological measurement for a patient may be received by the processor. Often times, the first and physiological measurements are the same type of measurements performed using a single measurement device but, this may not always be the case. At times, the patient may be associated with a patient account stored on, for example, a server. The patient account may include information about the patient and his or her medical history and/or prescribed physical activities. The patient and/or user may enter patient account information to access the processor executing one or more of the methods disclosed herein. Additionally, or alternatively, the patient may be recognized by the processor by way of an identifier associated with a measurement device taking the physiological measurements. In some instances, the identifier of the measurement device is an optically-coded graphic present on the measurement device or packaging for the measurement device. In these instances, the user may optically scan the optically coded graphic using, for example, a camera on the user’s electronic device. The optically-coded graphic may be decoded to identify the measurement device, and, by extension, the patient associated with the measurement device.

[0006] In some embodiments, the measurement device is wirelessly communicatively coupled to the processor and the first physiological measurement, the second physiological measurement, and an identifier of the measurement device may be wirelessly communicated to the processor. [0007] The physiological measurement may be one or more of electrocardiogram (ECG) measurements, heart rate measurements, pulse measurements, oxygen saturation measurements, measurements of the patient’s respiratory rate, measurements of the patient’s peak expiratory flow, measurements of the patient’s forced expiratory volume in one second, measurements of the patient’s forced vital capacity, measurements of a duration of the patient’s exhalation, measurements of a duration of the patient’s inhalation, and/or measurements of the patient’s tidal volume.

[0008] In some embodiments, the plurality of physiological measurements may be compared with one another in order to, for example, verify that the different measurements align with, or otherwise make sense in light of, one another. This verification may include, for example, determining whether the plurality of measurements all have the same units of measure, are taken within a specified time period (e.g., 5 minutes, 1 hour, 1 day, etc.), are taken using the same, and/or a similar measurement device. Additionally, or alternatively, the first and second physiological measurements may be analyzed to verify that the conditions prescribed for the physical activity are met prior to determining the physiological assessment.

[0009] An indication that the patient has performed a physical activity after the first physiological measurement was taken and prior to when the second physiological measurement was taken may be received. The physical activity may be prescribed by a medical treatment provider in order to safely and temporarily exacerbate the medical condition of the patient. For example, a five minute walk may be the prescribed physical activity for a patient recovering from a respiratory disease.

[00010] The first and second physiological measurements may be analyzed to determine a physiological assessment of the patient may be determined based on the analysis. In some embodiments, it may be determined whether the physiological assessment indicates an alarm condition for the patient such as, for example, tachycardia, atrial fibrillation, hypoxia, and/or hypoxemia. The alarm may then be communicated to, for example, the user and/or an emergency medical service responsively to a determination that the physiological assessment indicates an alarm condition. [00011] The physiological assessment of the patient may then be provided to a user who may be, for example, the patient, a treatment provider, and/or a caregiver of the patient.

[00012] On some occasions, the analysis may be used to evaluate a state of a diagnosed medical condition of the patient based on the analysis and/or a progression (e.g., improving, stable, or declining) of the diagnosed medical condition. The state of the diagnosed medical condition may then be provided to the user.

[00013] In some embodiments, additional information that may be associated with the patient may be received, for example, prior to analyzing the first and second physiological measurements, wherein the analysis includes analyzing the additional information, the first physiological measurement, and the second physiological measurement. Exemplary additional information includes information regarding, for example, when a physiological measurement was taken, an identifier for a measurement device taking a physiological measurement, the patient’s general level of health, a time when the first or second physiological measurement was taken, the patient’s mental health, demographic information for the patient, a treatment the patient has undergone, when the patient underwent a treatment, local weather conditions for the patient, and the patient’s medical history.

[00014] On some occasions, more than two physiological measurements may be received. For example, third and fourth physiological measurements may be received, wherein the third physiological measurement is taken prior to the patient’s performance of the physical activity and the fourth physiological measurement is taken after to the patient’s performance of the physical activity. The third and fourth physiological measurements may then be analyzed and along with the first and second physiological measurements when determining the physiological assessment of the patient. On some occasions, the first and second physiological measurement may be a first type of physiological measurement and the third and fourth physiological measurements may be a second type of physiological measurement.

[00015] In some embodiments, an expected physiological measurement and/or assessment for the patient may be received. The expected physiological assessment and/or measurement may be, for example, a previously received and/or determined physiological assessment and/or measurement for the patient, a baseline physiological assessment and/or measurement for the patient, and/or a clinical average physiological assessment and/or measurement (e.g., a clinical average across a number of patients with a similar diagnosis or medical condition). The expected physiological assessment and/or measurement for the patient may then be compared with the received physiological measurement and/or determined physiological assessment of the patient to determine, for example, a relative indicator of the patient’s health and/or disease progression. Results of the comparison may be provided to the user.

[00016] In some cases, the physiological measurements disclosed herein are received periodically or continuously over a period of time (e.g., while the patient is performing a physical activity).

[00017] In some embodiments, a user may be prompted to provide additional information about, for example, one or more symptoms of the patient that may be experienced, for example, during performance of the physical activity. The prompt may ask the user to, for example, enter qualitative feedback from the patient before, during, and/or after the patient has performed the physical activity.

[00018] In some embodiments, a first physiological measurement and a time the first physiological measurement was taken and a second physiological measurement and a time the second physiological measurement was taken. An indication that the user has performed a physical activity after the time the first physiological measurement was taken and prior to the time when the second physiological measurement was taken may also be received. The physical activity may have been prescribed by a medical treatment provider in order to, for example, exacerbate a medical condition of the patient. It may then be determined whether a duration of the physical activity complies with the prescribed instructions and, if so, the first and second physiological measurements may be analyzed to determine a physiological assessment incorporating a result of the analysis, which may be provided to a user.

BRIEF DESCRIPTION OF THE DRAWINGS

[00019] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which: [00020] FIG. 1A is a block diagram of an exemplary system, consistent with some embodiments of the present invention;

[00021] FIG. 1 B is a block diagram of exemplary components of a computer system, consistent with some embodiments of the present invention; and

[00022] FIG. 2 is a flowchart illustrating an exemplary process for generating a user account for a user of a measurement and/or monitoring device, consistent with some embodiments of the present invention;

[00023] FIG. 3 is an illustration of an exemplary label that includes an optically encoded image, consistent with some embodiments of the present invention; and

[00024] FIG. 4 is an illustration of exemplary packaging for a device that includes an optically encoded image, consistent with some embodiments of the present invention;

[00025] FIG. 5 is a flowchart illustrating an exemplary process for generating a combined test result and/or physiological assessment consistent with some embodiments of the present invention; and

[00026] FIG. 6 is a flowchart illustrating an exemplary process for physiological assessment of a patient consistent with some embodiments of the present invention.

[00027] Throughout the drawings, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.

WRITTEN DESCRIPTION

[00028] In some embodiments, a user (e.g., medical patient, an athlete, etc.) may be issued a kit or access card with a unique code affixed thereto as, for example, a label. The code may be a random, semi-random, and/or pseudorandom sequence of letters and digits which uniquely identifies the contents and status of a kit and verifies its authenticity. Codes can only be issued once and cannot be used again after activation. A user is instructed to scan the code which may be rendered as a QR or other 2-dimensional barcode contained within a graphic to simplify instruction (e.g.‘scan the sailboat’). The code is verified, and the user is prompted to enter their personal information (e.g., name, dob, email) to register a new account. If the code has been previously linked to an account, the user is prompted to confirm their identity. A unique user-selected passcode can also be used to provide additional authentication. When a kit or access card is returned its associated code will be decommissioned. A code can be set to expire after a given period of time (with or without prior activation).

[00029] Requests for patients, or users, to perform one or more tasks and/or take one or more physiological measurements may be combined sequentially or simultaneously in myriad ways to gain additional clinical insights into the health of the patient/user or to improve the accuracy of readings that, in some instances, may not be accomplished by requesting the patient/user perform individual tasks/take individual measurements alone. At times throughout the description, the terms patient and user may be used interchangeably. For example, a task of a deep breathing exercise may be paired with an oxygen saturation test measurement to improve the accuracy of the oxygen saturation reading and/or deductions made using the oxygen saturation reading. In addition to readings, a request/task may also include reading/viewing text or video instructions for tasks to be completed (e.g., exercising or deep breathing) which may be combined with other tasks (e.g., taking a physiological measurement) to enable multitude combined test results and/or physiological assessments that, in some instances, may approximate results of more complex, in-office, or on-site clinical/medical tests. For example, an ECG reading may be taken before, during, and/or after a task instructing the patient to take a 10-minute walk to observe the effect of moderate exercise on a patient’s cardiac health and generate a combined test result and/or physiological assessment that approximates a cardiac stress test. Often times, the physiological measurements are taken while the patient is at home using remote monitoring equipment and/or physiological testing/measuring devices that may automatically report a measurement to a processor that may be, for example, resident in a smart phone or computer operated by the user. In some embodiments, the combined test results and/or physiological assessments described herein may be a clinically actionable data set that a doctor or other treatment provider may use to make a decision regarding a diagnosis and/or the care or treatment of a patient. These decisions include, but are not limited to, changing medication, changing prescribed activities (e.g., exercise, breathing exercises, meditation), and changing a treatment plan.

[00030] In some embodiments, the invention employs a patient-facing component embodied in a software program, or application, which runs on an electronic device (e.g., smart phone or tablet computer) with a user interface (e.g., touch screen or keyboard). The electronic device may be a dedicated electronic device, a patient’s own electronic device and/or an electronic device provided/operated by a third-party (e.g., a party separate from). In many instances, the invention will employ a back-end component (sometimes referred to herein as a patient care computer system) operated by, for example, a healthcare monitoring service that may be in communication with a patient's physician(s) and/or hospital but may be separate from the patient's physician(s) and/or hospital. In many cases, the healthcare monitoring service may be a third-party (e.g., not a patient or her/her healthcare provider). In some instances, the healthcare monitoring service may employ a number of skilled individuals (e.g., nurses, physicians’ assistants, etc.) that may interact with patients via, for example, the software application.

[00031] Communication between the electronic device and the back-end component/patient care computer system may be facilitated by, for example, communication interfaces positioned within the respective electronic device and the back-end component each of which may be coupled to a communication network like the Internet via a Wi-Fi, wireless, or cellular network communication network. In some instances, the back-end component/ patient care computer system may be and/or incorporate a hospital’s or doctor’s electronic medical record (EMR) database, EMR management system, and/or scheduling or accounting systems.

[00032] In some embodiments, the present invention may be used to monitor the health and/or wellness of a patient in order to, for example, diagnose a medical condition, determine a severity of a medical condition, determine a rate of recovery from a medical condition. Additionally, or alternatively, a purpose of the invention disclosed herein is to monitor patient health and wellness following performance of, for example, a treatment or procedure (e.g., surgery, intubation, and/or use of a ventilator) that may be performed in a hospital. In many cases, the monitoring will continue for a defined period of time (e.g., 30, 45, or 90 days) but, in some instances the monitoring may be done periodically and/or perpetually throughout the lifespan of the patient following discharge from the hospital.

[00033] For the purposes of discussion, some of the exemplary embodiments disclosed herein refer to patient care for patients who have undergone cardiac surgery. However, those of skill in the art will understand that the invention disclosed herein may be easily adapted to monitor patient health and wellness following a variety of surgeries and/or treatments the patient may undergo. In some instances, the invention disclosed herein may be used to monitor an existing or potential acute (a viral illness or an infection) or chronic medical conditions (e.g., diabetes, drug addiction recovery, an autoimmune disease, heart disease, etc.) of a patient who, in some instances, may not undergo a surgical procedure. Additionally, or alternatively, the present invention may be configured to monitor one or more aspects of the health or wellness of a healthy person (e.g., an individual who has not undergone a surgery and/or is not undergoing treatment for one or more diagnosed medical conditions). Additionally, or alternatively, the present invention may be configured to provide pre-treatment, or pre-surgery, instructions to a patient who is expected to undergo a treatment or surgery and to gather measurement data therefrom prior to treatment/surgery in order to, for example, establish baseline measurement data.

[00034] In some instances, implementation of the invention may serve to provide early indications of the presence of an illness or disease, a decline in a patient’s medical condition, an exacerbation of a diagnosed medical condition and/or the development of a complication directly or indirectly related to treatment or procedure the patient has undergone or is in the process of undergoing. These early indications may facilitate earlier intervention to correct the decline or otherwise cure the complication which may, in turn, improve patient health and recovery times and reduce instances of patient readmission to the hospital following a procedure. Additionally, or alternatively, the present invention may facilitate improvements to the patient recovery experience by, for example, monitoring the patient’s psychological and/or emotional needs as well as and/or in conjunction with their medical condition. It is anticipated that proper implementation of invention will lead to healthier patients with better treatment outcomes who require less medical intervention following a treatment or procedure than is typically the case. For at least these reasons, implementation of the invention may reduce expenses related to medical care for patients, healthcare providers, governmental agencies (e.g., Centers for Medicare and Medicaid Services (CMS)), and/or health insurance companies.

[00035] Components of the present invention may include a security protocol configured to run on a patient electronic device (e.g., a smart phone or tablet computer) that protects a patient’s privacy and/or personally identifiable information in accordance with, for example, HIPAA. In some instances, the software application may feature modular elements that can be easily adapted for any medical condition, procedure, treatment, and/or clinical application. In some instances, there are multiple embodiments of the software application: one for the patient by which the patient may enter measurements of physiological data and/or answer questions regarding his or her recovery and receive feedback related thereto; one for a caregiver of the patient (e.g., spouse, relative, friend, in-home healthcare professional, etc.) to keep track of the patient’s progress and needs so that he or she may provide support to the patient and/or intervene as necessary; and one for a healthcare provider for the patient who may, or may not, have access to the backend system/patient care computer system and/or the patient’s account. The system may also include one or more hardware devices that wirelessly transmit measurements, or readings, regarding vital signs and other physiological data (e.g., blood glucose level, weight, etc.) for the patient to the software application/patient electronic device via a wireless communication protocol such as Bluetooth.

[00036] The present invention may further include a secure web portal that defines a World Wide Web (web)-based interface to the back-end system/patient care computer system 115 for viewing patient readings and other information. In some embodiments, the back-end system/patient care computer system may provide a secure API that interfaces with the software application as well as other systems and databases to, for example, store patient data in an encrypted database which may be accessed by the web portal or other systems including, but not limited to, a hospital’s or doctor’s EMR system. In some embodiments, the back-end system/patient care computer system may also be configured to provide alerts and notifications to various other systems (e.g., computers, smartphones, etc.) via the web portal, backend system/patient care computer system, and/or electronic communication protocols (Short Message Service (SMS), secure email, etc.). Users of the web portal may include a clinical staff of medical professionals who are treating a patient who have two main responsibilities:

1. Follow a patient care protocol for each patient, which may be, for example, a scripted protocol of scheduled check-ins with/monitoring of recovering patients to ensure patients (1 ) have proper training with the software application, patient electronic device, and/or one or more measurement devices, (2) have filled their prescriptions (3) understand both how to take and why they are taking each prescribed medication, and/or (4) schedule and attend their follow-up appointment(s). Additionally or alternatively, the clinical staff may also serve as a patient advocate to help resolve day-to-day challenges that patients may encounter during recovery without, in some instances, requiring direct intervention of the patient’s doctor, and/or may review discharge, recovery, and/or lifestyle instructions that may have been provided to the patient by a patient care protocol, the hospital, and/or his or her physician(s).

2. Non-clinical monitoring of incoming readings, patient feedback, and call requests to help identify physiological, behavioral, and emotional (e.g., anxiety or depression) indicators that a diagnosis or other intervention may be necessary, and coordination of patient care with the hospital and or the patient’s physicians if such indicators are observed.

[00037] Thus, the clinical staff may be deployed to assist with a patient’s need for empathy and understanding during the recovery process. The clinical staff may also be deployed to help doctors and hospitals identify which patients are in the greatest need of attention prior to a crisis that may require readmission and/or administration of add-on or follow-up treatment(s).

[00038] In many cases, the present invention is deployed without impacting the existing patient discharge and patient care follow-up procedures for a hospital or treatment provider and/or clinician. In one embodiment this is accomplished via integration of the software system and/or patient care protocols with a hospital’s EMR and/or scheduling system, which may provide notifications and alerts regarding changes in a patient’s condition or status regarding discharge along with, for example, post-discharge instructions and follow-up procedures prescribed treatments/medications, patient lab results, patient caregiver instructions, and so on.

[00039] FIG. 1 A provides a block diagram of an exemplary system 100 that may be configured to monitor the health and wellness of one or more patients prior to and/or following treatment for a diagnosis and/or undergoing a medical (e.g., surgical) procedure. System 100 may include a treatment provider computer system 105, a patient electronic medical record (EMR) A database, a hospital computer system 110, a patient electronic medical record (EMR) B database, a patient care computer system 115, a patient data store 120, a patient care protocol data store 125, a communication network 130, a patient electronic device 135, a caregiver electronic device 140, a plurality of measurement devices A-N 145A-145N, a third-party communication system 150, a third-party server 155, and a treatment provider electronic device 160. In some instances, communication between two or more components of system 100 may be subject to one or more security protocols (e.g., encrypted) so as to protect patient-specific information and/or medically relevant information in accordance with, for example, HIPAA rules. Access to one or more components of system 100 may be limited by security protocols (e.g., passwords or identity verification protocols) designed to limit access to system 100 components to individuals who should access the component(s) and/or information stored thereon.

[00040] Treatment provider computer system 105 may be any computer system(s) associated with a treatment provider. Exemplary users of and/or treatment providers using treatment provider computer system 105 include physicians, surgeons, nurses, and administrative staff for a treatment provider as may be associated with, for example, a doctor’s office or medical facility. Treatment provider computer system 105 may be communicatively coupled to a patient EMR A 106 that stores information and a medical history for a plurality of patients who, for example, currently are receiving, or have in the past received, medical care from the treatment provider operating the treatment provider computer system 105.

[00041] Hospital computer system 110 may be any computer system resident within a hospital or treatment facility and may be communicatively coupled to patient EMR B database that stores information and a medical history for a plurality of patients who, for example, currently are receiving, or have in the past received, medical care from the a hospital operating the hospital computer system 110.

[00042] In most instances, treatment provider computer system 105 and hospital computer system 110 will be protected by a security protocol for protecting patient information, which in some instances may be a HIPPA- compliant firewall and/or a set of HIPPA-compliant security protocols. In some embodiments, the HIPAA-compliant firewall may be a secure virtual private network (VPN) tunnel and/or secure web-based API interfacing with a third- party integration service and/or source of patient data (not shown) provided by, for example, a health insurance company, an accountable care organization (ACO), as may be provided and/or facilitated by third-party communication system 150.

[00043] Patient data store 120 may store information regarding patients including, but not limited to, contact information for the patient, medical history of the patient, current prescriptions, and any surgeries or medical procedures scheduled for the patient. Patient care protocol data store 125 may store data regarding one or more patient care protocols recommended and/or required by a hospital and/or treatment provider. In some embodiments, patient data store 120 may store an electronic medical record (EMR) for a plurality of patients.

[00044] In some embodiments, patient care computer system 115 may be a secure server to which only authorized individuals may have access privileges. Exemplary authorized individuals include, but are not limited to, physicians, nurses, researchers, clinicians, lab technicians, pharmacists, hospital administrators, virtual homecare nurses, administrators of system 100 and/or a component thereof, and caregivers for patients. Patient care computer system 115 may be configured as a back-end system that communicates with treatment provider computer system 105, hospital computer system 110, patient device 135, caregiver device 140, treatment provider electronic device 160 through a secure internal communication network (e.g., a VPN tunnel). Often times, patient care computer system 115 will communicate directly with patient data store 120, and/or patient care protocol data store 125 to generate patient care protocols for one or more patients according to, for example, one or more processes described herein.

[00045] Patient care computer system 115 may be configured to communicate a patient care protocol to the patient electronic device 135 via communication network 130 and receive one or more physiological measurements, readings, and/or responses from patient electronic device 135. Communication network 130 may be any network configured to facilitate communication between the components of system 100, such as the Internet or a mobile communication network. Additionally, communication network 130 may be used to interface with other web-based systems employed to collect and transmit measurements or other information through secure APIs. In some instances, these web-based systems may be realized as a software application running on the patient electronic device 135 and/or a measurement device A- N 145A-145N

[00046] Patient electronic device 135 may be any device enabled to communicate with patient care computer system 115 and measurement devices A-N 145A-145N. Exemplary patient electronic devices 135 include smart phones, smart watches, wearable monitors, and tablet computers. In some instances, patient electronic device 135 may include one or more measurement devices including, but not limited to, a camera and a heart rate monitor. In some embodiments, patient electronic device 135 may be a device that was owned and/or operated by the patient prior to receipt of a patient care protocol from patient care computer system 115. This provides the advantage of a patient electronic device 135 that the patient is already familiar with using and does not require the patient to purchase a separate device to communicate with, for example, a measurement device A-N 145A-145N. Additionally, or alternatively, patient electronic device 135 may be a dedicated, or proprietary, device configured to integrate with patient care computer system 115 and/or one or more of measurement devices A-N 145A-145N using communication network 130 and may serve to provide a turn-key integrated device for operating within system 100. [00047] Measurement devices A-N 145A-145N may be configured to take one or more physiological measurements of a patient’s health and/or progress while recovering from a surgery or other treatment or illness. Exemplary physiological measurements include, but not limited to vital signs (i.e., body temperature, heart rate, pulse, respiratory rate, heart rhythm, respiratory rate, blood oxygen saturation, body mass index, blood pressure, etc.) pain severity indications, body weight, urine tests, tidal volume, lung capacity, and blood glucose level. Exemplary measurement devices A-N 145A-145N include a smart phone, tablet computer, scale, thermometer, blood pressure monitor, pulse oximeter, incentive spirometer, mobile ECG machine, blood glucose monitor, heart rate monitor, measuring tape, pulmonary function test, and camera. In some instances, a particular measurement device A-N 145A-145N may be enabled to take two or more types of measurements. For example, a heart rate monitor may also be able to monitor blood pressure. A camera measurement device A-N 145A-145N may be used to, for example, capture an image of an incision or symptom of a patient (e.g., a rash or poor skin tone). In many cases, measurement devices A-N 145A-145N are configured to wirelessly communicate with patient electronic device 135 via one or more wireless communication protocols (e.g., Bluetooth) but this need not be the case. For instance, one or more of measurement devices A-N 145A-145N may be communicatively coupled to patient electronic device 135 via a wired or other interface. Such a measurement may be of particular importance for patients diagnosed with heart-failure-related medical issues as water retention/ankle swelling is an indication of heart failure.

[00048] In one embodiment, one or more of measurement devices A-N 145A-145N may be a telehealth tool (e.g., a computer or video conferencing system) that enables communication between the patient and a caregiver and/or between the patient and a healthcare provider. Additionally, or alternatively, one or more of measurement devices A-N 145A-145N may be a virtual reality system or audio/video presentation device.

[00049] In some circumstances, the patient may use two or more measurement devices A-N 145A-145N simultaneously or concurrently. For example, a patient may use an incentive spirometer measurement device 145A to perform breathing exercises while wearing a pulse oximeter measurement device 145B. In some cases, these two measurements may be analyzed together to, for example, determine lung capacity and oxygen processing by the lungs.

[00050] In some embodiments, a patient may have a user account and/or use a service for measuring physiological and/or medical data that is operated by a third-party (i.e., not the patient, physician, and/or operator of system 100 (with the exception of third-party server 155, or a component thereof (e.g., patient care computer system 115))) via a third-party server 155. Third-party server 155 may act in conjunction with for example, a software application running on the patient electronic device 135 that is dedicated to the third-party (also referred to herein as a “third-party software application”). In some embodiments, the patient-facing component embodied in the software program running on the patient electronic device 135 may communicate (e.g., share information) with the third-party software application so that physiological data and/or measurement data received and/or recorded by the third-party software application may be, for example, associated with the user account and/or communicated to the patient care computer system 115.

[00051] Optionally, in some embodiments, system 100 may include treatment provider electronic device 160 communicatively coupled to the patient care computer system via third-party communication system 150 and/or communication network 130. Exemplary treatment provider electronic device 160 include, but are not limited to, smart phones, pagers, tablet computers, and laptop computers. The treatment provider electronic device 160 may receive notifications regarding, for example, patient status for a treatment provider and/or clinician (e.g., doctor, nurse, administrator, etc.) from patient care computer system 115 in the form of, for example, SMS messages, phone calls, emails, and pages.

[00052] FIG. 1 B depicts components of a computer system 1000 in which computer readable instructions instantiating the methods of the present invention may be stored and executed. As is apparent from the discussion herein, aspects of the present invention involve the use of various computer systems and computer readable storage media having computer-readable instructions stored thereon. FIG. 1 B provides an example of a system 1000 that may be representative of any of the computing systems (e.g., patient care computer system 115, third-party communication system 150, treatment provider computer system 105, hospital computer system 110, patient electronic device 135, caregiver electronic device 140, and/or one or more measurement devices A-N 145A-145N) discussed herein. Examples of system 1000 may include a smartphone, a desktop computer, a laptop computer, a mainframe computer, an embedded system, etc. Note, not all of the various computer systems discussed herein have all of the features of system 1000. For example, certain ones of the computer systems discussed above may not include a display inasmuch as the display function may be provided by a client computer communicatively coupled to the computer system or a display function may be unnecessary. Such details are not critical to the present invention.

[00053] System 1000 includes a bus 1002 or other communication mechanism for communicating information, and a processor 1004 coupled with the bus 1002 for processing information. Computer system 1000 also includes a main memory 1006, such as a random-access memory (RAM) or other dynamic storage device, coupled to the bus 1002 for storing information and instructions to be executed by processor 1004. Main memory 1006 may also be used for storing temporary variables, or other intermediate information, during execution of instructions to be executed by processor 1004. Computer system 1000 further includes a read only memory (ROM) 1008 or other static storage device coupled to the bus 1002 for storing static information and instructions for the processor 1004. A storage device 1010, for example, a hard disk, flash memory-based storage medium, or other storage medium from which processor 1004 can read, is provided and coupled to the bus 1002 for storing information and instructions (e.g., operating systems, applications programs and the like).

[00054] Computer system 1000 may be coupled via the bus 1002 to a display 1012, such as a flat panel or touch screen display, for displaying information to a computer user/operator. An input device 1014, such as a keyboard including alphanumeric and other keys, may be coupled to the bus 1002 for communicating information and command selections to the processor 1004. Another type of user input device is cursor control device 1016, such as a mouse, a track pad, or similar input device for communicating direction information and command selections to processor 1004 and for controlling cursor movement on the display 1012. Other user interface devices, such as microphones, speakers, etc. are not shown in detail but may be involved with the receipt of user input and/or presentation of output.

[00055] Processor may implement the processes referred to herein 1004 executing appropriate sequences of computer-readable instructions contained in main memory 1006. Such instructions may be read into main memory 1006 from another computer-readable medium, such as storage device 1010, and execution of the sequences of instructions contained in the main memory 1006 causes the processor 1004 to perform the associated actions. In alternative embodiments, hard-wired circuitry or firmware-controlled processing units may be used in place of, or in combination with, processor 1004 and its associated computer software instructions to implement the invention. The computer- readable instructions may be rendered in any computer language.

[00056] In general, all of the above process descriptions are meant to encompass any series of logical steps performed in a sequence to accomplish a given purpose, which is the hallmark of any computer-executable application. Unless specifically stated otherwise, it should be appreciated that throughout the description of the present invention, use of terms such as“processing”, “computing”, “calculating”, “determining”, “displaying”, “receiving”, “transmitting” or the like, refer to the action and processes of an appropriately programmed computer system, such as computer system 1000 or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within its registers and memories into other data similarly represented as physical quantities within its memories or registers or other such information storage, transmission or display devices.

[00057] Computer system 1000 also includes a communication interface 1018 coupled to the bus 1002. Communication interface 1018 may provide a two-way data communication channel with a computer network, which provides connectivity to, and among, the various computer systems discussed above. For example, communication interface 1018 may be a local area network (LAN) card that provides a data communication connection to a compatible LAN, which itself is communicatively coupled to the Internet through one or more Internet service provider networks. The precise details of such communication paths are not critical to the present invention. What is important is that computer system 1000 can send and receive messages and data through the communication interface 1018 and in that way communicate with hosts accessible via the Internet. In some embodiments, communication interface 1018 may be a transceiver adapted for wireless communication using a nearfield communication protocol/standard such as Bluetooth or near-field communication (NFC). It is noted that the components of system 1000 may be located in a single device or located in a plurality of physically and/or geographically distributed devices.

[00058] FIG. 2 provides a flowchart for a process 200 for generating a user account for a user of a measurement and/or monitoring device like measurement devices 145A-145N. Process 200 may be executed by, for example, a system like system 100, a component therein, or any combination of components included therein. In some embodiments, process 200 may be executed by way of a software application downloaded to and/or running on a patient’s personal electronic device, such as patient electronic device 135.

[00059] Prior to execution of process 200, a measurement device, a monitoring device and/or a kit including same may be associated with a code (e.g., bar, QR, alpha/numeric) and/or identifier at, for example, a distribution and/or manufacturing location. The code/identifier may be embedded in an optically coded graphic and/or proximate to a graphic provided by/ affixed to a measurement device and/or a kit and/or packaging for same as, for example, a label and/or stamp. FIG. 3 is an illustration of an exemplary label that includes an optically encoded image wherein a graphic image of a sailboat includes an optically coded graphic in the form of a QR code. Other graphic images and/or manners of encoding an image may also be used. For example, a portion of the image may include a barcode (not shown) and/or other optically encoded information. The optically encoded information may be configured so that it is machine-readable and capable of being captured by an imaging device (e.g., camera) that may be included in a patient electronic device like patient electronic device 135. A purpose of positioning and optically coded graphic proximate to and/or embedded within an image or other graphic is to facilitate ease-of-use by the user so that the user may point his or her electronic/ imaging device in the direction of the graphic which may be more easily understood by the user then an instruction to capture an image of an optically encoded graphic.

[00060] FIG. 4 is an illustration of exemplary packaging for a kit of one or more monitoring devices that includes an optically encoded graphic positioned approximate to and/or embedded within. The optically encoded graphic is embodied as a label like the label shown in FIG. 3, that is being imaged by the user via his or her personal electronic device.

[00061] Initially, an indication that user would like to set up a user account pertaining to, for example, remote monitoring of the user’s health and/or vital signs and/or use a monitoring device and/or kit of monitoring devices may be received (step 205) via, for example, the user interacting with a software application running on his or her personal electronic device. An instruction to the user to scan, or otherwise image, an optical encoded graphic that may be part of, for example, a picture or other graphic included in the label such as the label provided by FIG. 3 may be provided (step 210). The instruction may be, in the case of the label shown in FIG. 3,“take a picture of the sailboat.” Such an instruction is easy to understand by the user because he or she may be able to easily see/find the sailboat image/label since it is more familiar to the user than the optical encoded graphic approximate to and/or embedded within the image/label.

[00062] The scan and/or image of the optically encoded graphic may be received (step 215) and a request for personal (e.g., name, age, gender, etc.) and/or identifying information (e.g., patient identification number, user name, etc.) for the user may be communicated to the user via, for example, a device of the personal electronic device (step 220). In some embodiments, the code may be directly entered by the user when, for example, the user’s personal electronic device does not include a camera and/or when the optically encoded graphic is corrupted or otherwise unreadable. Then, the requested information may be received (step 225) and communicated to a server, or other computer system, like patient care computer system 115, along with the scan of the optically encoded graphic and/or a translation of the optically included graphic (step 230). The code included within the optically encoded graphic may be verified and then used to set up an account for the user. Then, the user may be enabled to use the user account, measurement device, kit of measurement devices, and/or communicate information to be associated with their user account (step 240).

[00063] Optionally, in step 245, input from a monitoring/measurement device may be received and associated with the user’s account (step 250).

[00064] FIG. 5 provides a flowchart for a process 500 for generating a combined test result and/or physiological assessment. Process 500 may be executed by, for example, a system like system 100, a component therein, or any combination of components included therein. In some embodiments, process 500 may be executed by way of a software application downloaded to and/or running on a patient’s personal electronic device, such as patient electronic device 135.

[00065] Optionally, in step 505, user account and/or patient identifying information may be received. The user account/patient identifying information verified/validated to, for example, enable a patient to sign into his or her user account, access a software program running on the patient’s electronic device, and/or communicate with a server or external Computer system, such as, patient care computer system 115. In some embodiments, the user account and/or patient identifying information may be received and/or verified via execution of process 200, or a portion thereof. In some embodiments, the user account of step 505 may be similar to the user account of process 200 and may be established and/or set up by executing process 200, or a portion thereof.

[00066] In step 510, a first test result and/or measurement may be received and in step 515, an optional subsequent test result, physiological measurement, and/or information from the patient may be received. Exemplary first and/or subsequent test results and/or measurements are oxygen saturation readings, heart rate, blood pressure, blood glucose, international normalized ratio (INR), brain natriuretic peptide (BNP), temperature, body weight, pulmonary function tests, lung capacity, electrocardiogram (ECG) measurements, pulmonary stress tests (e.g., stair climbing, shuttle walk, 6 minute walk test, etc.), allergy tests, administration of medication, and/or qualitative feedback associated with the measurements. The first and/or subsequent test result(s) and/or measurement(s) may be received from, for example, a measurement device like measurement device A-N 145A-145N and/or entry of the first and/or subsequent test result and/or measurement by the user into the patient electronic device. Exemplary information received from the patient includes, but is not limited to, answers to subjective questions (e.g., Do you feel dizzy or lightheaded? Are you short of breath? Can you comfortably do more physical activity?) and feedback regarding his or her performance of the physical activity.

[00067] In some embodiments, the tests, physiological measurements, and/or information from the user may be received in steps 510 and/or 515 may be received while a patient is performing an activity as opposed or in addition to before and after the patient performs the activity. In some cases, the test results and/or physiological measurements may be received continuously and may be facilitated by a wearable physiological measurement device.

[00068] Optionally, in step 520, additional information may be received. The additional information received may include, but is not limited to, information regarding the patient’s general level of health, information regarding the patient’s mental health, information regarding activities performed by the patient before, during, and/or after the first and/or subsequent test result and/or measurement is received.

[00069] Optionally, a determination of whether or not further information from the patient may be desired and/or preferred in order to, for example, execute step 5 660 may be made (step 525). Further information may include answers to questions regarding, for example, the patient’s general health and/or symptoms of a medical condition (e.g., shortness of breath, aches and pains, lethargy, mood, etc.) that, in some cases, cannot be easily measured using measurement devices like measurement device 145. When further information is desired, it may be requested (step 530) in the form of, for example, a request to take additional physiological measurements, a question, a set of questions, a request to take a picture of a portion of the patient’s body, and/or a hyperlink that directs the patient’s electronic device (e.g., electronic device 135) to, for example, a website or other online resource where the patient may receive and/or provide further information. For example, if the patient has an incision, then in step 525 further information in the form of, for example, the patient’s body temperature, a photograph of the incision, and/or a patient’s assessment of soreness surrounding the incision may be requested in step 530 and received in step 515. Continuing the example above, if, for example, the analysis of the first and second physiological measurements indicate that the patient’s incision may be infected then, further information may be requested in step 530 and information received in step 515 may be used to determine whether the incision is, or may be, infected. In another example, a patient with a potential respiratory condition may be monitored at home using first, second, third, and/or fourth physiological measurements to determine if/when he or she develops the respiratory condition and/or if/when he or she may need medical attention (e.g., be admitted to a hospital for care).

[00070] Then, a combined test result and/or physiological assessment may be generated (step 540) using, for example, a combination of:

• the first and subsequent test results and/or measurements;

• the first test result and/or measurement and the additional information; or

• the first test result and/or measurement, the subsequent test result and/or measurement, and the additional information.

Provision of the combined test result and/or physiological assessment to a user (e.g., the patient, a caregiver, and/or doctor) may then be facilitated (step 545).

[00071] Examples of how process 500 may be executed include receiving an oxygen saturation test result and additional information indicating that the patient has conducted a deep breathing exercise. This information may be combined to, for example, generate an enriched, or more accurate oxygen saturation reading, determine the patient’s capacity, and/or diagnose a patient’s lung health (e.g., determine whether fluid in the lungs and/or a pleural effusion is present).

[00072] In another example, process 500 may be executed by first receiving a first ECG measurement for the patient, receiving additional information that the patient has exercised (e.g., walk or run) for a predetermined period of time (e.g., 5, 10, 20 minutes), and then receiving a second ECG measurement for the patient. The first and second ECG measurements combined with the additional information regarding how the patient has exercised may be combined in step 540 to generate an approximation of a cardiopulmonary exercise test. Additionally, or alternatively, first and second ECG measurements combined with the additional information regarding how the patient has exercised may be combined in step 540 to determine whether the patient has complied with a treatment provider and/or clinician’s instructions when he or she prescribed the physical activity. For example, if a patient is prescribed a 5-minute walk and they walk 3 miles, that would indicate that the walked well beyond the prescribed 5 minutes and that an intervention may be necessary to keep the patient from over-exercising and potentially injuring himself or herself.

[00073] FIG. 6 provides a flowchart for a process 600 for generating a combined test result and/or physiological assessment. Process 600 may be executed by, for example, a system like system 100, a component therein, or any combination of components included therein. In some embodiments, process 600 may be executed by way of a software application downloaded to and/or running on a patient’s personal electronic device, such as patient electronic device 135.

[00074] Optionally, in step 605, user account and/or patient identifying information may be received. The user account/patient identifying information verified/validated to, for example, enable a patient to sign into his or her user account, access a software program running on the patient’s electronic device, and/or communicate with a server or external Computer system, such as, patient care computer system 115. In some embodiments, the user account and/or patient identifying information may be received and/or verified via execution of process 200, or a portion thereof. In some embodiments, the user account of step 505 may be similar to the user account of process 200 and may be established and/or set up by executing process 200, or a portion thereof.

[00075] In some embodiments, the patient account and/or identifying information may include and/or may be associated with information regarding one or more diagnosed medical conditions of the patient and/or a treatment the patient has had or is expected to have. Exemplary treatments include, but are not limited to, surgery such as open heart surgery, joint replacement surgery, or surgery to remove a tumor; treatment for respiratory disease, and/or an oncological treatment. ^'

[00076] Optionally, in step 605, conditions for a physical activity that the patient is supposed to perform may be received. In some cases, the conditions for the physical activity are prescribed by a medical treatment provider. Exemplary physical activities include, but are not limited to, exercising (e.g., walking or climbing stairs), performing breathing exercises, and meditating.

[00077] In some embodiments, the physical activity may temporarily exacerbate the diagnosed medical condition of the patient. For example, if the patient is diagnosed with cardiac disease, the physical activity may be exercise like walking or jogging, which may act to temporarily exacerbate the patient’s medical condition. In another example, if the patient is diagnosed with respiratory disease, the physical activity may be breathing exercises, which may assist with, or aid, the patient’s medical condition and/or a physical exercise like walking or jogging, which may act to temporarily exacerbate the patient’s medical condition.

[00078] In step 610, one or more (e.g., 2, 4, 6, 10, 20, 25) physiological measurements for a patient may be received. Exemplary physiological measurements include, but are not limited to, electrocardiogram (ECG) measurements, heart rate measurements, pulse measurements, blood or tissue oxygen saturation measurements, measurements of the patient’s respiratory rate, blood pressure, the patients inhale-to-exhale ratio, the patient’s peak expiratory flow, patient’s forced expiratory volume in one second, the patient’s forced vital capacity, patient’s tidal volume, a duration of the patient’s exhalation (e.g., how long the patient can exhale for), and/or a duration of the patient’s inhalation.

[00079] In some embodiments, the first and second physiological measurement are a first type of physiological measurement and the third and fourth physiological measurement are a second type of physiological measurement. For example, a first type of physiological measurement may be a heart rate measurement and a second type of physiological measurement may be blood or tissue oxygen saturation measurements. In another example, a first type of physiological measurement may be blood pressure measurement and a second type of physiological measurement may be a respiratory rate.

[00080] In some cases, the first physiological measurement and the second physiological measurement may be the same type of measurements and may be taken by the same measurement device. Exemplary measurement devices that may be used to take the first and/or second physiological measurement include, but are not limited to, measurement devices 145 described herein and/or ECG machines, pulse oximeters, heart monitors, pulse monitors, respiratory monitors, spirometers, pedometers, and thermometers. In some embodiments, the measurement device(s) used to make the physiological measurements may be wirelessly communicatively coupled (via, e.g., a near-field communication protocol) to the processor executing process 600.

[00081] In step 620, an indication that the patient has performed a physical activity after the first physiological measurement was taken but prior to when the second physiological measurement was taken may be received. Often times, the physical activity pertains to a diagnosed medical condition of the patient, such as cardiac disease and/or respiratory disease, and may be prescribed by a medical treatment provider and/or health care worker to have one or more parameters such as type of activity, duration of the activity, and/or how strenuous the activity should be.

[00082] In step 620, it may be determined whether the physiological measurements and/or physical activity may be verified as being, for example, accurately measured, accurately communicated, and/or whether the physical activity was performed in a manner that aligns, or is otherwise consistent, with how it may have been prescribed. In some embodiments, execution of step 620 may include verifying that the second physiological measurement is consistent with the first physiological measurement and/or that the fourth physiological measurement is consistent with the third physiological measurement. This may be done by, for example, comparing a unit of measurement for the first and second physiological measurement/third and fourth physiological measurement, comparing a time the first and second/third and fourth physiological measurements were received to determine, for example, whether they are spaced apart in time in a manner that is consistent with how the physical activity was supposed to be performed. In some embodiments, an indication of the verification may be provided to the user.

[00083] Additionally, or alternatively, the first, second, third, and/or fourth physiological measurement may be analyzed in step 620 to verify that the conditions prescribed for the physical activity are met. For example, if the patient is prescribed a slow-paced 5 minute walk as his or her physical activity, a time period between when the first and second physiological measurements are taken and/or a time between when the third and fourth physiological measurements are taken may be determined to see if the interval between when the first and second physiological measurements are taken and/or a time between when the third and fourth physiological measurements are taken is approximately 5 minutes. Additionally, or alternatively, if the first and second physiological measurements or the third and fourth physiological measurements are pedometer measurements of how many steps the patient may have taken, then step 620 may be executed to determine if the number of measured steps is within the range expected for a slow-paced 5 minute walk. If the number of steps taken is above the expected range, an error message in the form of, for example,“slow down” or“don’t push yourself may be provided to the user who may be the patient and/or a caregiver of the patient. In some embodiments, when the first, second, third, and/or fourth physiological measurement are not verified, process 600 may end following step 625.

[00084] In some embodiments, execution of step 620 may include associating an indication, result, and/or confidence level associated with the verification with the information received via process 600 so that this indication may be provided to a user as part of, for example, execution of step 670 as will be discussed in greater detail below.

[00085] Optionally, in step 630, additional information about the patient may be received. Execution of step 630 may, in some cases, be similar to execution of step 520. The additional information may include, for example, information regarding the physical activity performed (e.g., duration, number of steps taken, type of activity, etc.), the weather (e.g., temperature and/or humidity), air quality, an environmental factor, and/or location (e.g., inside or outside) in which the physical activity was performed. Additionally, or alternatively, the additional information may be information regarding at least one of the patient’s general level of health, a time when the first or second physiological measurement was taken, a schedule for when the physical activity is to be done, a timetable for when the physical has been historically done by the patient, the patient’s mental health, demographic information for the patient, a treatment the patient has undergone, when the patient underwent a treatment, air quality for the patient, an environmental factor for the patient, local weather conditions for the patient, and the patient’s medical history. Additionally, or alternatively, the additional information may include one or more benchmarks or expected physiological measurement values or determinations made using a physiological measurement value.

[00086] In step 635, the first, second, third, and/or fourth physiological measurements may be analyzed in order to, for example, determine one or more physiological assessments and/or inferences of the patient (step 655). In some embodiments, execution of step 655 may include evaluating a state (e.g., stable, improving, or declining) of a diagnosed medical condition of the patient based on the analysis. The physiological assessment, physiological inference, and/or the state of the diagnosed medical condition of/for the patient may then be communicated and/or provided to a user via, for example, providing instructions to display the physiological assessment and/or physiological inference on a display device such as display device 1012 (step 670). Exemplary users include, but are not limited to, a third-party health monitoring service, the patient, a treatment provider of the patient, and a healthcare administrator associated with the patient. On some occasions, a result of the verification performed at step 620 may also be provided to the user at step 670. The verification result may be provided as, for example, a confidence indicator (e.g., low, medium, or high confidence) and/or a flag applied to physiological assessments and/or physiological inferences made using physiological measurements and/or physical activity information that is not verified with a certain degree of confidence. The flag may be shown on, for example, a graphic user interface that displays the physiological assessment and/or physiological inference.

[00087] Optionally, in step 660, a determination of whether the physiological measurement and/or physiological inference for the patient presents and/or triggers an alert condition may be made. If alert criteria are met, an alert may be communicated to the user and/or a medical service such as a treatment provider and/or an emergency responder organization (e.g., police or emergency medical technician) (step 665).

[00088] In some embodiments, alert condition criteria may be a set of criteria pre-loaded into the processor executing process 600 and/or a memory or database coupled thereto. Exemplary alarm criteria include, but are not limited to, an irregularity in the patient’s heartbeat, pulse, or ECG information, an indication of tachycardia, an indication of atrial fibrillation, an indication of hypoxia, an indication of hypoxemia, an indication of respiratory distress, and/or an indication of low blood oxygen saturation.

[00089] In some embodiments, execution of step 660 may include comparing the physiological assessment and/or physiological inference determined in step 655 with, for example, a previously determined physiological assessment and/or physiological inference for the patient, a benchmark physiological assessment and/or physiological inference for the patient’s medical condition, and/or a threshold value for a physiological assessment and/or physiological inference. A result of the comparison may be used to determine that an alert criteria has been met and, in some cases, a result of the comparison may be provided to the user so that, for example, the physiological assessment and/or physiological inference determined in step 655 may be viewed in context with the data it has been compared to. In one example, the physiological assessment and/or physiological inference determined in step 655 may be compared with a physiological assessment that indicates the patient is experiencing tachycardia, hypertension, atrial fibrillation, hypoxia, hypoxemia, respiratory distress, and/or a low blood oxygen saturation.

[00090] In one exemplary use case of process 600, a patient may be diagnosed with heart disease and may have recently undergone open heart surgery. This information may be received by the processor in step 605. In step 610, first and second physiological measurement may be received in the form of first and second electrocardiogram (ECG) measurements. In step 615, an indication that the patient performed a physical activity prescribed to temporarily exacerbate the heart condition (e.g., a five minute, slow paced walk) may be received. The first and second ECG measurements may then be analyzed (step 635) to determine a physiological assessment of the patient, which may be provided to the user (step 670). Physiological assessments in this example may include a detection of tachycardia, hypertension, and/or atrial fibrillation. If the physiological assessment meets one or more alert criteria and/or conditions (step 660), an alert may be communicated to, for example, the user, a treatment provider, a hospital, and/or emergency services.

[00091] Optionally, a determination of whether or not further information from the patient may be desired and/or preferred in order to, for example, execute step 660 may be made (step 640). Further information may include answers to questions regarding, for example, the patient’s general health and/or symptoms of a medical condition (e.g., shortness of breath, aches and pains, lethargy, mood, etc.) that, in some cases, cannot be easily measured using measurement devices like measurement device 145. Additionally, or alternatively, further information may be additional physiological measurements. When additional physiological measurements are desired, process 600 may proceed to step 610. In some embodiments, information and/or instructions may be provided to the user so that he or she knows to take the physiological measurements and/or perform additional physical activities in prior to, during, and/or after the taking of the additional physiological measurements.

[00092] When further information is desired, it may be requested (step 645) in the form of, for example, a request to take additional physiological measurements, a question, a set of questions, a request to take a picture of a portion of the patient’s body, and/or a hyperlink that directs the patient’s electronic device (e.g., electronic device 135) to, for example, a website or other online resource where the patient may receive and/or provide further information. For example, if the patient has an incision, then in step 640 further information in the form of, for example, the patient’s body temperature, a photograph of the incision, and/or a patient’s assessment of soreness surrounding the incision may be requested in step 645 and received in step 650. In some embodiments, the request of step 645 may be triggered by the analysis of step 635. Continuing the example above, if, for example, the analysis of the first and second physiological measurements indicate that the patient’s incision may be infected then, further information may be requested in step 645 and information received in step 650 may be used to determine whether the incision is, or may be, infected. In another example, a patient with a potential cardiovascular and/or respiratory condition may be monitored at home using first, second, third, and/or fourth physiological measurements to determine if/when he or she develops the cardiovascular and/or respiratory condition and/or if/when he or she may need a clinical intervention (e.g., a telehealth visit, prescription of a medication, and/or be admitted to a hospital for care). In this example, analysis of the first and second measurements in step 635 may indicate a blood oxygen saturation level that is slightly below an expected level, which may indicate that further information about the patient is desired in step 640. The patient may then be asked questions about, for example, whether they have difficulty breathing or walking upstairs in step 645 to determine if, for example, the patient is in respiratory distress and answers to those questions may be used to determine the physiological assessment in step 655.

[00093] In another exemplary use case of process 600, a patient may be diagnosed with respiratory disease. This information may be received by the processor in step 605. In step 610 a first and second physiological measurement may be received in the form of, for example, first and second blood oxygen saturation measurements and third and fourth physiological measurements may be peak expiratory flow. In step 615, an indication that the patient performed a physical activity prescribed to temporarily exacerbate the respiratory condition (e.g., a set of breathing exercises or a walk) may be received. The first and second blood oxygen saturation measurements and the third and fourth peak expiratory flow measurements may then be analyzed (step 635) to determine a physiological assessment of the patient, which may be provided to the user (step 670). Physiological assessments in this example may include a detection of hypoxia, hypoxemia, and/or respiratory distress. If the physiological assessment meets one or more alert criteria and/or conditions (step 660), an alert may be communicated to, for example, the user, a treatment provider, a hospital, and/or emergency services.

[00094] In a further exemplary use case of process 600, a patient may be diagnosed with cardiovascular disease. This information may be received by the processor in step 605. In step 610 a first and second physiological measurement may be received in the form of, for example, first and second ECG measurement. In step 615, an indication that the patient performed a physical activity prescribed to temporarily exacerbate the respiratory condition in the form of a 5 minute may be received. The first and second ECG measurements may then be analyzed (step 635) to determine a physiological assessment of the patient, which may be provided to the user (step 670). Physiological assessments in this example may indicate that the patient’s cardiovascular disease was not exacerbated by the 5 minute walk and additional information in the form of ECG measurements prior to and after more rigorous exercise may be desired to determine if, for example, the patient’s cardiovascular disease is improving. The patient may then be asked to perform a 5 minute jog or run, and ECG measurements may be taken prior to and after the 5 minute jog or run. A second physiological assessment of the patient may be made (step 665) and the physiological assessment may be provided to the user (step 670).

Claims

CLAIMS We claim:

1. A method comprising:

receiving, by a processor, a first physiological measurement for a patient;

receiving, by the processor, a second physiological measurement for the patient;

receiving, by the processor, an indication that the patient has performed a physical activity after the first physiological measurement was taken and prior to when the second physiological measurement was taken;

analyzing, by the processor, the first and second physiological measurements;

determining, by the processor, a physiological assessment of the patient based on the analysis; and

providing, by the processor, the physiological assessment of the patient to a user.

2. The method of claim 1 , further comprising:

evaluating, by the processor, a state of a diagnosed medical condition of the patient based on the analysis; and

providing, by the processor, the state of the diagnosed medical condition to the user.

3. The method of claim 1 or 2, wherein the physical activity temporarily exacerbates the medical condition of the patient.

4. The method of any of claims 1-3, wherein the first physiological measurement and the second physiological measurement are the same type of measurements.

5. The method of any of claims 1-4, wherein the first and second physiological measurement are the same type of measurements and are performed using a single measurement device.

6. The method of any of claims 1-5, wherein the patient is associated with a patient account, the patient account including information about the patient and his or her medical history.

7. The method of claim 6, wherein an identifier of the measurement device is associated with the patient account.

8. The method of claim 7, wherein the identifier of the measurement device is an optically-coded graphic present on the measurement device.

9. The method of claim 7, wherein the measurement device is wirelessly communicatively coupled to the processor and the first physiological measurement, the second physiological measurement, and the identifier of the measurement device are wirelessly communicated to the processor.

10. The method of any of claims 1 -9, wherein the first and second physiological measurement are electrocardiogram (ECG) measurements.

11. The method of any of claims 1 -9, wherein the first and second physiological measurement are at least one of heart rate and pulse measurements.

12. The method of any of claims 1 -9, wherein the first and second physiological measurement are oxygen saturation measurements.

13. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of the patient’s respiratory rate.

14. The method of any of claims 1-9, wherein the first and second physiological measurement are measurements of the patient’s peak expiratory flow.

15. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of the patient’s forced expiratory volume in one second.

16. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of the patient’s forced vital capacity.

17. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of a duration of the patient’s exhalation.

18. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of a duration of the patient’s inhalation.

19. The method of any of claims 1 -9, wherein the first and second physiological measurement are measurements of the patient’s tidal volume.

20. The method of any of claims 1-19, wherein a diagnosed medical condition of the patient is at least one of cardiac disease and respiratory disease.

21. The method of any of claims 1-19, wherein the physical activity is at least one of a walk, a jog, and a run.

22. The method of any of claims 1-19, wherein the physical activity is a set of breathing exercises.

23. The method of any of claims 1-19, the physical activity is prescribed by a medical treatment provider.

24. The method of any of claims 1-23, further comprising:

verifying, by the processor, that the second physiological measurement aligns with the first physiological measurement; and

providing, by the processor, an indication of the verification to the user.

25. The method of any of claims 1-23, wherein conditions for the physical activity are prescribed by a medical treatment provider, the method further comprising: analyzing, by the processor, that the first and second physiological measurement to verify that the conditions prescribed for the physical activity are met prior to determining the physiological assessment; and

providing, by the processor, an indication of the verification to the user.

26. The method of any of claims 1-25, further comprising;

determining, by the processor, whether the physiological assessment indicates an alarm condition; and

communicating, by the processor, an alarm to the user responsively to a determination that the physiological assessment indicates an alarm condition.

27. The method of claim 26, wherein the alarm condition is at least one of tachycardia and atrial fibrillation.

28. The method of claim 26, wherein the alarm condition is at least one of hypoxia and hypoxemia.

29. The method of any of claims 1-28, further comprising:

receiving, by the processor, additional information associated with the patient prior to analyzing the first and second physiological measurements, wherein the analysis includes analyzing the additional information, the first physiological measurement, and the second physiological measurement.

30. The method of claim 29, wherein the additional information is information regarding at least one of the patient’s general level of health, a time when the first or second physiological measurement was taken, the patient’s mental health, demographic information for the patient, a treatment the patient has undergone, when the patient underwent a treatment, local weather conditions for the patient, air quality, an environmental factor, the patient’s medical history, and the patient’s family medical history.

31. The method any of claims 1-30, further comprising: receiving, by the processor, a third physiological measurement, wherein the third physiological measurement is taken prior to the patient’s performance of the physical activity;

receiving, by the processor, a fourth physiological measurement, wherein the fourth physiological measurement is taken after to the patient’s performance of the physical activity;

analyzing, by the processor, the third and fourth physiological measurements, wherein the physiological assessment of the patient is based on the analysis of the first, second, third, and fourth physiological measurements.

32. The method of claim 31 , wherein the first and second physiological measurement are a first type of physiological measurement and the third and fourth physiological measurement are the second type of physiological measurement.

33. The method of claims 31 or 32, wherein the third and fourth physiological measurements are at least one of ECG measurements, heart rate measurements, pulse measurements, oxygen saturation measurements, patient’s respiratory rate measurements, inhale-to-exhale ratio measurements, measurements of the patient’s peak expiratory flow, measurements of the patient’s forced expiratory volume in one second, measurements of the patient’s forced vital capacity, measurements of the patient’s tidal volume, measurements of a duration of the patient’s exhalation, and are measurements of a duration of the patient’s inhalation.

34. The method any of claims 1-33, further comprising:

receiving, by the processor, an expected physiological assessment for the patient;

comparing, by the processor, the expected physiological assessment for the patient to the determined physiological assessment of the patient; and providing, by the processor, the comparison to the user.

35. The method of any of claims 1-34, wherein the user is a health monitoring service.

36. The method of any of claims 1-34, wherein the user is the patient.

37. The method of any of claims 1-36, wherein the first and second physiological measurements are included in a plurality of physiological measurements continuously taken over a period of time.

38. The method of claim 37, wherein the period of time extends through a portion of the patient’s performance of the physical activity.

39. The method of any of claims 1-38, further comprising:

providing, by the processor, the user with a prompt to enter information about one or more symptoms of the patient;

receiving, by the processor, the entered information from the user regarding, wherein the analysis is further based on the entered information.

40. The method of claim 39, wherein the prompt asks the user to enter qualitative feedback from the patient at least one of before, during, and after the patient has performed the physical activity.

41. The method of any of claims 1 -40, wherein the physical activity pertains to a diagnosed medical condition of the patient.

41. The method of any of claims 1 -40, wherein the physical activity pertains to an undiagnosed medical condition of the patient.

42. A method comprising:

receiving, by the processor, a first physiological measurement and a time the first physiological measurement was taken;

receiving, by the processor, a second physiological measurement and a time the second physiological measurement was taken; receiving, by the processor, an indication that the user has performed a physical activity after the time the first physiological measurement was taken and prior to the time when the second physiological measurement was taken, the physical activity being prescribed by a medical treatment provider;

determining, by the processor, whether a duration of the physical activity complies with the prescribed instructions;

analyzing, by the processor, the first and second physiological measurements responsively to a determination that the duration of the physical activity complied with the prescribed instructions;

determining, by the processor, a physiological assessment incorporating a result of the analysis; and

providing, by the processor, the physiological assessment to a user.

43. A method comprising:

receiving, by the processor, a first electrocardiogram (ECG) measurement for a patient;

receiving, by the processor, a second ECG measurement for the patient; receiving, by the processor, an indication that the patient has performed a physical activity after the first ECG was taken and prior to when the second ECG was taken;

analyzing, by the processor, the first and second ECG measurements; determining, by the processor, a physiological assessment of the patient based on the analysis; and

44. The method of claim 40, further comprising:

receiving, by the processor, information regarding the physical activity performed by the patient, wherein the determination of the physiological assessment is further based on the information regarding the physical activity performed by the patient.

45. A method comprising: receiving, by the processor, a first blood oxygen saturation measurement for a patient;

receiving, by the processor, a second blood oxygen saturation measurement for the patient;

receiving, by the processor, an indication that the patient has performed a physical activity after the first blood oxygen saturation was taken and prior to when the second blood oxygen saturation was taken;

analyzing, by the processor, the first and second blood oxygen saturation measurements;