Methods and systems for assuring compliance

Abstract

Systems and methods for collecting information, verifying authenticity of such information, processing, maintaining, and managing such information are described. The system can be a standalone unit or can comprise a combination of various units configured to function together.

1 .- 32 . (canceled) 
     
     
         33 . A method of measuring compliance to a protocol procedure, the protocol procedure including using a product related to the care of a subject, the method comprising:
 providing the product to the subject, a clinical practitioner, or a professional involved in the protocol procedure;   providing an electronic device loaded with a software application and/or accessing a remote application, and by the electronic device:   i) recording one or more features of the product when the subject, clinical practitioner, or professional uses the product according to the protocol procedure;   ii) processing the recorded one or more features of the product to produce recorded product data;   iii) determining whether the recorded product data are within a range of product data expected for subjects, clinical practitioners, or professionals using said product, wherein, when the recorded product data are within the range of the expected product data, the electronic device determines compliance with the protocol procedure.   
     
     
         34 . The method according to  claim 33 , wherein said one or more features are physical characteristics of the product. 
     
     
         35 . The method according to  claim 33 , wherein the one or more features of the product are associated with a container containing the product. 
     
     
         36 . The method according to  claim 33 , wherein said one or more features are selected from the group consisting of: barcode or RFID chip associated with the product; size, shape, color, pattern, and/or markings of the product. 
     
     
         37 . The method according to  claim 36 , wherein said processing the recorded one or more features includes scanning the barcode and/or RFID chip. 
     
     
         38 . The method according to  claim 36 , wherein said processing the recorded one or more features includes applying size, shape, color, pattern, and/or markings recognition algorithms. 
     
     
         39 . The method according to  claim 33 , wherein the electronic device is configured to compare the recorded product data with a library of expected product data of a plurality of products. 
     
     
         40 . The method according to  claim 33 , further comprising providing a camera, wherein the camera is embedded in the electronic device or external to the electronic device and wherein said recording one or more features of the product is a video and/or image recording obtained from the camera. 
     
     
         41 . The method according to  claim 33 , further comprising, by the electronic device, tracking a number of products used by the subject, clinical practitioner, or professional according to the protocol procedure. 
     
     
         42 . The method according to  claim 33 , further comprising tracking number of products expected to be remaining after use of the product by the subject, clinical practitioner, or professional. 
     
     
         43 . The method according to  claim 33 , further comprising:
 providing an automated product counter, the product counter configured to count a number of products actually remaining; and   comparing the number of products actually remaining with a number of products expected to be remaining, wherein the number of products expected to be remaining is obtained from the software application on the electronic device.   
     
     
         44 . The method according to  claim 33 , wherein the protocol procedure is selected from the group consisting of: consuming a pill, consuming a powder, consuming a liquid, injecting a medication, drawing blood, measuring bodily functions, measuring body temperature, measuring blood pressure, measuring glucose, answering medical questions, performing a physical examination; dispensing an investigational product, consuming an investigational study product, filling out a diary, scale, questionnaire; preparing food, consuming food, preparing a beverage, consuming a beverage, applying a cream, applying a gel, measuring weight, measuring height, measuring body size, performing an EKG, performing a stress test, collecting urine, collecting saliva, collecting stool, collecting semen, and drawing blood; answering medical questions; performing a physical examination; dispensing and/or taking an investigational study product; eating a specific study-related food or beverage; measuring a bodily function such as temperature, blood pressure, and blood sugar; measuring an anthropomorphic measurement; collecting a specimen such as urine, saliva, stool, semen, or blood; determining, measuring, or diagnosing a patient condition or parameter; analytical laboratories, surgeries, pathological procedures, dermatological procedures, gastroenterological procedures, cardiological procedures, obstetric procedures, gynecological procedures, oncological procedures, orthopedic procedures, pediatric procedures, internal medicine procedures, sleep medicine procedures, rehabilitation procedures, radiological procedures, and/or urological procedures. 
     
     
         45 . The method according to  claim 33 , wherein using the product is selected from the group consisting of: consuming a pill, consuming a powder, consuming a liquid, injecting a medication, using a device to draw blood, using a device to measure a body function such as temperature, blood pressure, and blood sugar; using a device to answer medical questions, using a device to perform a physical examination; using a device to dispense an investigational product, consuming an investigational study product, filling out a diary, scale, questionnaire; using ingredients or a device to prepare food, consuming food, using ingredients or a device to prepare a beverage, consuming a beverage; applying a cream, applying a gel, using a device to measure an anthropomorphic measurement such as weight, height, or body size; using a device to perform an EKG or stress test, using a device to collect a specimen such as urine, saliva, stool, semen, or blood; eating a specific study-related food or beverage; using a device or a product to determine, measure, or diagnose a patient condition or parameter; using a device or a product to perform analytical laboratories, surgeries, pathological procedures, dermatological procedures, gastroenterological procedures, cardiological procedures, obstetrics procedures, gynecological procedures, oncological procedures, orthopedics procedures, pediatrics procedures, internal medicine procedures, sleep medicine procedures, rehabilitation procedures, radiological procedures, and/or urological procedures. 
     
     
         46 . A device for determining compliance to a protocol procedure, the protocol procedure including guidance steps intended to achieve, by using a product, a result related to care of a subject, the device comprising:
 an electronic device loaded with a software application and/or accessing a remote application;   a recording device configured to record one or more features of the product when the product is used by the subject, a clinical practitioner, or a professional involved in the protocol procedure;   a verifying device configured to process the recorded one or more features to produce product data and to determine whether said recorded product data are within a range of expected product data processed from products used by subjects, clinical practitioners, or professionals performing said protocol procedure, wherein, when the recorded product data are within the range of the expected product data, the electronic device determines compliance with the protocol procedure.   
     
     
         47 . The device according to  claim 46 , wherein the recording device comprises a camera embedded in the electronic device or external to the electronic device. 
     
     
         48 . The device according to  claim 46 , wherein the verifying device is a bar code scanner, an RFID scanner or near-field communication devices associated with the product and configured to operate with the verifying device for verifying the one or more features of the product. 
     
     
         49 . The device according to  claim 46 , wherein the verifying device is configured to identify physical characteristics of the product by way of one or more recognition algorithms. 
     
     
         50 . The device according to  claim 49 , wherein the one or more features are selected from the group consisting of: size, shape, color, pattern, and/or markings of the product. 
     
     
         51 . The device according to  claim 46 , wherein the electronic device includes a product counter, the product counter configured to count a number of products actually remaining; and wherein the electronic device is configured to compare the number of products actually remaining with a number of products expected to be remaining, wherein the number of products expected to be remaining is obtained from the software application on the electronic device. 
     
     
         52 . The device according to  claim 46 , wherein using a product is a consumption of the product. 
     
     
         53 . The device according to  claim 46 , wherein the protocol procedure is a dietary protocol procedure, and said using a product includes consumption of one or more food products and/or one or more beverage products by the subject, and wherein the verifying device is configured to determining whether recorded food and/or beverage product data are within a range of food and/or beverage product data expected for subjects consuming said one or more food products and/or the one or more beverage products, wherein, when the recorded food and/or beverage product data are within the range of the expected food and/or beverage product data, the electronic device determines compliance with the dietary protocol procedure. 
     
     
         54 . The device according to  claim 53 , wherein the verifying device is configured to calculate caloric value, macronutrient content and/or micronutrient content of the food or beverages that the subject is about to consume, and wherein the verifying device is configured to determine whether the caloric values, macronutrient content or micronutrient content are within a range of expected caloric values, macronutrient content or micronutrient content. 
     
     
         55 . The method according to  claim 53 , wherein said recording device is configured to record the rate at which the food or the beverage is being consumed, the amount of food or beverage being consumed, and/or the number of times food or beverage is being consumed per day. 
     
     
         56 . A method of measuring compliance to a dietary protocol procedure including consumption of one or more food products and/or one or more beverage products by a subject, the method comprising:
 providing the one or more food products and/or the one or more beverage products to the subject;   providing an electronic device loaded with a software application and/or accessing a remote application, and by the electronic device:   i) recording the one or more food products and/or the one or more beverage products when the subject consumes the one or more food products and/or the one or more beverage products according to the dietary protocol procedure;   ii) processing the recorded one or more food products and/or the recorded one or more beverage products to produce recorded food and/or beverage product data;   iii) determining whether the recorded food and/or beverage product data are within a range of food and/or beverage product data expected for subjects consuming said one or more food products and/or said one or more beverage products, wherein, when the recorded food and/or beverage product data are within the range of the expected food and/or beverage product data, the electronic device determines compliance with the dietary protocol procedure.   
     
     
         57 . The method according to  claim 56 , further comprising providing a camera, wherein the camera is embedded in the electronic device or external to the electronic device and wherein the recording the one or more food products and/or the one or more beverage products is a video and/or image recording obtained from the camera. 
     
     
         58 . The method according to  claim 56 , wherein said processing the recorded one or more food products and/or the recorded one or more beverage products is selected from the group consisting of:
 scanning a barcode, RFID chip or near-field communication device associated with a container containing the one or more food products and/or the one or more beverage products;   recognizing size, shape, color, pattern, and/or markings of the recorded one or more food products and/or the recorded one or more beverage products.   
     
     
         59 . The method according to  claim 56 , wherein the one or more food products and/or the one or more beverage products includes food or beverages, one or more food or beverage packages, or one or more menu. 
     
     
         60 . The method according to  claim 56 , wherein said processing the recorded one or more food products and/or the recorded one or more beverage products includes calculating caloric value, macronutrient content and/or micronutrient content of the food or beverages that the subject is about to consume. 
     
     
         61 . The method according to  claim 56 , wherein the recorded food and/or beverage product data are caloric values, macronutrient content and micronutrient content of the food or beverages, and wherein the electronic device determines whether the caloric values, macronutrient content or micronutrient content are within a range of expected caloric values, macronutrient content or micronutrient content. 
     
     
         62 . The method according to  claim 56 , further including, by way of the electronic device or by way of further electronic devices, triggering the subject that additional or alternative foods or beverages to be consumed instead of the one or more food products and/or one or more beverage products. 
     
     
         63 . The method according to  claim 61 , wherein the macronutrient content includes fat, carbohydrate, and protein. 
     
     
         64 . The method according to  claim 61 , wherein the micronutrient content includes vitamins and/or minerals. 
     
     
         65 . The method according to  claim 61 , further including weighing the food and/or beverage before and after consumption, in order to calculate actual caloric, macronutrient, and micronutrient contents of the consumed one or more food products and/or one or more beverage products. 
     
     
         66 . The method according to  claim 56 , wherein said recording the one or more food products and/or the one or more beverage products is performed for an entire meal being consumed. 
     
     
         67 . The method according to  claim 56 , wherein said recording the one or more food products and/or the one or more beverage products includes recording the rate at which the food or the beverage is being consumed, the amount of food or beverage being consumed, and/or the number of times food or beverage is being consumed per day. 
     
     
         68 . A method of verifying dietary compliance comprising:
 providing an electronic device loaded with a software application and/or accessing a remote application, the software application adapted to identify physical characteristics of food products;   identifying the food products according to the physical characteristics of the food products, wherein the identifying is adapted to determine nutritional values of the food products; and   analyzing the nutritional values of the food products, thereby verifying compliance or non-compliance of the food products according to dietary guidelines predetermined for a subject.   
     
     
         69 . The method of  claim 68 , wherein an alert is triggered and an alternative food product is suggested if the food products are analyzed to be non-compliant according to the dietary guidelines for the subject. 
     
     
         70 . The method of  claim 69 , further comprising storing results obtained from the analyzing in the electronic device.