Health monitoring and diagnostic device and network-based health assessment and medical records maintenance system

Abstract

A health monitoring and diagnostic device (LIFESTREAM cholesterol meter) configured as a self-contained testing and diagnostic unit in a clam-shell type case. One side of the case includes a spring-loaded finger stick and a compartment for carrying one or more packages of disposable items including a test strip, a needle for the finger stick, and an alcohol swipe. The other half of the case includes a test strip reader, a key pad, and a liquid crystal display. The meter reads a test strip carrying a droplet of blood and receives additional diagnostic information from the patient, such as age, gender, weight, and family history of heart disease. Within minutes, the meter displays test results, including total cholesterol levels. The meter also displays additional diagnostic results, such as the patient's “cardiac age,” recommended weight loss, and a cardiac risk assessment. The meter also works in connection with a network-based comprehensive health analysis and reporting system. The meter writes patient data to a smartcard. This patient data typically includes patient identification information, the test results, the diagnostic information, and the diagnostic results. A computer station reads the smartcard and establishes a network connection with a health report server over the Internet. The computer then downloads the patient data to the health report server, which prepares a comprehensive health report. Within minutes, this report is transmitted back to the computer station, where it is printed out and delivered to the patient.

1 - 49 . (canceled) 
     
     
         50 . A system for producing health reports, comprising:
 a health monitoring device including:
 a reader operable for reading a test media carrying a sample of biological fluid or tissue and obtaining test results based on the sample of biological tissue or fluid and calibration data specific to the test medium, wherein the reader is operable for reading a second type of test media carrying a second sample of biological fluid or tissue and obtaining health-related test results based on the second sample of biological tissue or fluid and calibration data specific to the second type of test media, further comprising: a second memory reading device functionally connected to the reader and operable for reading calibration data from a second memory device corresponding to the second type of test media, 
 a memory reading device functionally connected to the reader and operable for reading the calibration data from a memory device, and 
 a data drive functionally connected to the reader and operable for writing the test results to a memory storage device; and 
   a health report server operable for:
 receiving the test results and additional diagnostic information, 
 compiling a health report based on the test results and the additional diagnostic information, and 
 outputting the health report. 
   
     
     
         51 . The system for remotely producing health reports of  claim 50  wherein:
 the biological fluid or tissue includes a droplet of human blood;   the test results include blood lipid levels; and   the additional diagnostic information includes one or more of the following data items corresponding to a person providing the droplet of human blood: gender, ethnicity, family history of heart disease, personal history of heart disease, personal history of diabetes, personal history of smoking, height, weight, age, blood pressure, and fitness level.   
     
     
         52 . The system for remotely producing health reports of  claim 50  wherein:
 the test results include blood glucose levels; and   the health report further includes a trend analysis including test results compiled for a number of samples of the biological fluid or tissue.   
     
     
         53 . The system of  claim 50  wherein the health monitoring device further includes a secure data system for maintaining the security of the test results. 
     
     
         54 . The system of  claim 53  wherein the secure data system includes a first server containing patient identification information and no medical data and a second server containing medical data and no patient identification information. 
     
     
         55 . The system of  claim 54  wherein access to only the second server or only the first server will not reveal medical information specific to a patient. 
     
     
         56 . The system of  claim 54  wherein access is granted to the first server for creating mailing lists. 
     
     
         57 . The system of  claim 54  wherein access is granted to the first server for the purpose of conducting medical analysis. 
     
     
         58 . The system of  claim 53  wherein the secure data system includes a smart card and a pin specific to a patient, wherein secure information on the smart card may only be accessed by the pin. 
     
     
         59 . A system for producing health reports, comprising:
 a health monitoring device including:
 a reader operable for reading a test media carrying a sample of biological fluid or tissue and obtaining test results based on the sample of biological tissue or fluid and calibration data specific to the test medium, wherein the reader is operable for reading a second type of test media carrying a second sample of biological fluid or tissue and obtaining health-related test results based on the second sample of biological tissue or fluid and calibration data specific to the second type of test media, further comprising: a second memory reading device functionally connected to the reader and operable for reading calibration data from a second memory device corresponding to the second type of test media, and 
 a memory reading device functionally connected to the reader and operable for reading the calibration data from a memory device; and 
   a health report server operable for:
 receiving the test results and additional diagnostic information, 
 compiling a health report based on the test results and the additional diagnostic information, and 
 outputting the health report. 
   
     
     
         60 . The system of  claim 59 , further comprising:
 a data drive functionally connected to the reader and operable for writing the test results to a smart card.   
     
     
         61 . A health monitoring device, comprising:
 an enclosure for housing a test media for use with the health monitoring device;   a holder for removably supporting a device for gathering a sample of biological fluid or tissue;   a test media reader operable for reading the test media carrying the sample of biological fluid or tissue and obtaining test results based on the sample of biological tissue or fluid and calibration data specific to the test media;   a memory reading device functionally connected to the test media reader and operable for reading the calibration data from a memory device;   a user input device operable for receiving user input commands;   a display device operable for displaying information;   a processor functionally connected to the test media reader, the user input device, and the display device, the processor containing a program module operable for obtaining the test results from the test media reader and causing the display device to display the test results; and   a diagnostic program module operable for:
 obtaining the test results from the test media reader, 
 causing the display device to prompt the user to enter diagnostic information using the user input device, 
 performing a diagnostic analysis to produce diagnostic results including a health report based on the test results and the diagnostic information, and 
 causing the display device to display the diagnostic results. 
   
     
     
         62 . The system of  claim 61 , further comprising:
 a data drive functionally connected to the processor and operable for writing the test results to a removable memory storage device.   
     
     
         63 . The health monitoring device of  claim 62  wherein the processor is further operable for:
 determining whether a personal identification number has been previously stored on the removable memory storage device;   if the personal identification number has not been previously stored on the removable memory storage device prompting the user to enter a personal identification number, storing the received personal identification number on the removable memory storage device; and   if the personal identification number has been previously stored on the removable memory storage device, prompting the user to enter a personal identification number, comparing the stored personal identification number to the received personal identification number, and writing the test results to the removable memory storage device only if the stored personal identification number corresponds to the received personal identification number.   
     
     
         64 . The health monitoring device of  claim 61 , wherein the processor is further operable for:
 obtaining the test results from the test medium reader;   causing the display device to prompt the user to enter diagnostic information using the user input device;   performing a diagnostic analysis to produce diagnostic results based on the test results and the diagnostic information; and   causing the display device to display the diagnostic results.   
     
     
         65 . The health monitoring device of  claim 64  wherein:
 the biological fluid or tissue includes a droplet of human blood;   the test results include blood lipid levels;   the diagnostic information includes one or more of the following data items corresponding to a person providing the droplet of human blood:
 gender, ethnicity, family history of heart disease, personal history of heart disease, personal history of diabetes, personal history of smoking, height, weight, age, blood pressure, fitness level; and 
   the diagnostic results include one or more of the following data items corresponding to the person providing the droplet of human blood:
 a medical risk index, a recommended weight loss, a five-year risk of heart attack, a ten-year risk of heart attack, a cardiac age, an extended cardiac age, and a risk of stroke. 
   
     
     
         66 . A health monitoring device for use with a disposable test medium, comprising:
 a test medium reader operable for reading the test medium carrying a sample of biological fluid or tissue to obtain test results based on the sample of biological tissue or fluid and calibration data specific to the test medium;   a memory device readable by the health monitoring device and storing a code number and the calibration data specific to the test medium;   a user input device operable for entering a test medium identification number into the health monitoring device; and   a processor functionally connected to the test medium, the memory device, and the user input device, the processor operable for:
 reading the code number from the memory device, 
 comparing the received test medium identification number to the code number, and 
 activating the health monitoring device for use with the test medium only if the received test medium identification number corresponds to the code number; 
   obtaining the test results from the test media reader;   causing the display device to prompt the user to enter diagnostic information using the user input device;   performing a diagnostic analysis to produce diagnostic results including a health report based on the test results and the diagnostic information; and   causing the display device to display the diagnostic results.   
     
     
         67 . The system of  claim 66 , further comprising:
 a data drive functionally connected to the processor and operable for writing the test results to a removable memory storage device.