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.

The invention claimed is: 
     
         1 . A test medium for use with a health monitoring device, comprising:
 a test strip for receiving and carrying a sample of biological fluid or tissue;   the test strip carrying the sample of biological fluid or tissue being readable by the health monitoring device to obtain test results based on the sample of biological tissue or fluid and calibration data specific to the test strip;   the test strip corresponding to a memory device readable by the health monitoring device, the memory device storing a code number and the calibration data;   the test strip having an associated test strip identification number that is mathematically derivable from the code number;   the test strip identification number being receivable by the health monitoring device through a user input device; and   the test strip identification number being usable to activate the health monitoring device for use with the test strip only if the received test strip identification number corresponds to a test strip identification number mathematically derived by the health monitoring device based on the code number read from the memory device.   
     
     
         2 . The test medium of  claim 1 , wherein:
 the memory device also stores an expiration date for the test strip;   the expiration date is readable by the health monitoring device; and   the expiration date is usable to activate the health monitoring device for use with the test strip only if the expiration date is prior to a current date read by the health monitoring device from an internal clock.   
     
     
         3 . The test medium of  claim 1 , wherein the memory device comprises a romkey insertable into a socket housed within the health monitoring device. 
     
     
         4 . The test medium of  claim 1 , wherein:
 a plurality of the test strips are packaged for distribution together with the romkey; and   the test strip identification number is printed on the test strips, printed on packaging for the test strips, or printed on a tag packaged with the test strip.   
     
     
         5 . A hand-held health monitoring device, comprising:
 an enclosure for housing a disposable test strip 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 strip reader operable for reading the test strip 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 strip;   a memory reading device functionally connected to the test strip 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 strip reader, the user input device, and the display device, the processor containing a program module operable for obtaining the test results from the test strip reader and causing the display device to display the test results; and   a data drive functionally connected to the processor and operable for writing the test results to a removable memory storage device.   
     
     
         6 . The health monitoring device of  claim 5 , 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.   
     
     
         7 . The hand-held health monitoring device of  claim 5 , further comprising:
 a clam-shell case openable to reveal first and second compartments;   the first compartment containing the enclosure for housing the disposable test strip and the holder for removably supporting the biological fluid or tissue gathering device; and   the second compartment containing the test strip reader, the memory reading device, the display device, the processor, and the data drive.   
     
     
         8 . The hand-held health monitoring device of  claim 5 , wherein:
 the biological fluid or tissue includes a droplet of human blood; and   the test results include total cholesterol levels.   
     
     
         9 . The hand-held health monitoring device of  claim 8 , wherein the test strip reader is operable for reading a second type of test strip 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 strip, further comprising:
 a second memory reading device functionally connected to the test strip reader and operable for reading calibration data from a second memory device corresponding to the second type of test strip.   
     
     
         10 . The hand-held health monitoring device of  claim 9 , wherein:
 the second biological fluid or tissue includes a droplet of human blood; and   the test results include blood glucose levels.   
     
     
         11 . A health monitoring device, comprising:
 a test strip reader operable for reading the test strip carrying a sample of biological fluid or tissue and obtaining health-related test results based on the sample of biological tissue or fluid and calibration data specific to the test strip;   a memory reading device functionally connected to the test strip reader and operable for reading the calibration data from a memory device;   a user input device operational for receiving user input commands;   a display device operable for displaying information; and   a processor functionally connected to the test strip reader, the user input device, and the display device, the processor containing a diagnostic program module operable for:
 obtaining the test results from the test strip 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. 
   
     
     
         12 . The health monitoring device of  claim 11 , 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 age, and a risk of stroke. 
   
     
     
         13 . The health monitoring device of  claim 12 , further comprising a data drive functionally connected to the processor and operable for writing the test results, the diagnostic information, and the diagnostic results to a removable memory storage device. 
     
     
         14 . The health monitoring device of  claim 13 , 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, the diagnostic information, and the diagnostic results to the removable memory storage device only if the stored personal identification number corresponds to the received personal identification number.   
     
     
         15 . The health monitoring device of  claim 14 , wherein the test strip reader is operable for reading a second type of test strip 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 strip, further comprising:
 a second memory reading device functionally connected to the test strip reader and operable for reading calibration data from a second memory device corresponding to the second type of test strip.   
     
     
         16 . The health monitoring device of  claim 15 , wherein:
 the second biological fluid or tissue includes a droplet of human blood; and   the test results include blood glucose levels.