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WO2000028460A2 - Dispositif de controle de l'etat de sante et de diagnostic et systeme d'evaluation de l'etat de sante et d'actualisation de dossiers medicaux construit en reseau - Google Patents

Dispositif de controle de l'etat de sante et de diagnostic et systeme d'evaluation de l'etat de sante et d'actualisation de dossiers medicaux construit en reseau Download PDF

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Publication number
WO2000028460A2
WO2000028460A2 PCT/US1999/026521 US9926521W WO0028460A2 WO 2000028460 A2 WO2000028460 A2 WO 2000028460A2 US 9926521 W US9926521 W US 9926521W WO 0028460 A2 WO0028460 A2 WO 0028460A2
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WO
WIPO (PCT)
Prior art keywords
test strip
test
health
identification number
meter
Prior art date
Application number
PCT/US1999/026521
Other languages
English (en)
Other versions
WO2000028460A3 (fr
Inventor
Christopher T. Maus
Jackson B. Connolly
Craig A. Coad
Noah M. Coad
James L. Moody
Kenn A. Nesbitt
Kenneth D. Clegg
Original Assignee
Lifestream Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lifestream Technologies, Inc. filed Critical Lifestream Technologies, Inc.
Priority to CA002350145A priority Critical patent/CA2350145C/fr
Priority to EP99963882A priority patent/EP1133747A2/fr
Priority to IL14305999A priority patent/IL143059A0/xx
Priority to AU20231/00A priority patent/AU2023100A/en
Publication of WO2000028460A2 publication Critical patent/WO2000028460A2/fr
Publication of WO2000028460A3 publication Critical patent/WO2000028460A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/150854—Communication to or from blood sampling device long distance, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/150862—Communication to or from blood sampling device intermediate range, e.g. within room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • G—PHYSICS
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0475—Special features of memory means, e.g. removable memory cards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling devices
    • A61B5/150328—Sterilisation of piercing elements, piercing devices or sampling devices by aseptic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4261—Evaluating exocrine secretion production
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD

Definitions

  • the present invention meets the needs described above in a health monitoring and diagnostic device referred to as a LIFESTREAM cholesterol meter.
  • This meter is configured as a self-contained testing and diagnostic unit in a clam-shell type case.
  • One side of the case includes a biological sample gathering device, such as spring-loaded finger stick, and a compartment for carrying one or more packages of disposable items, typically 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 user input device such as a key pad, and a display device such as a liquid crystal display.
  • the meter reads a test strip carrying a biological sample, such as a droplet of blood, and within minutes displays test results, such as total cholesterol levels, on the meter's display.
  • the meter may use a well-known methodology, such as the Framingham Medical Study, to produce diagnostic results including the user's cardiac age (as compared to chronological age), recommended weight loss, 5-year risk of heart attack, 10-year risk of heart attack, an assessment of stroke risk, and other results that will be easily and immediately understood by the patient. Like the test results themselves, these more meaningful diagnostic results are displayed on the meter within minutes.
  • a well-known methodology such as the Framingham Medical Study
  • the meter also includes a number of advantageous security features. For example, the meter cannot be activated until a user enters a proper activation code. This typically requires that the user call the manufacturer, which provides an opportunity to verify the meter's authenticity, set up a data file for the meter in the health report server, and tell the user how to update the meter software, if necessary. If a software update is indicated, the user may be instructed to activate the meter, initialize a smartcard, load the smartcard into a computer station, and establish a network connection with the health report server. The server can then download the new software (e.g., new version of an existing software module or a new software module) to the smartcard, which, in turn, can be placed back in the meter.
  • the new software e.g., new version of an existing software module or a new software module
  • FIG. 1A is a front view of a hand-held health monitoring and diagnostic device in an open position.
  • FIG. 18 is a logic flow diagram illustrating a process for applying for access to a secure medical records maintenance system.
  • FIG. 19 is a logic flow diagram illustrating a process for logging into a secure medical records maintenance system.
  • FIG. 22 is an illustration of a "billing information" user interface in a secure medical records maintenance system.
  • the first compartment 14 also includes an openable enclosure 24 for storing one or more packages 26 of disposable items.
  • each package may contain a test strip 28, a needle 29 for the finger stick 20, and an alcohol swipe 30.
  • These disposable items are tailored for one-time use with the finger stick 20. If the meter 10 includes biological sample gathering devices other than the finger stick 20, other types of disposable items may be stored in the enclosure 24.
  • the enclosure 24 may have other configurations suitable for storing or holding disposable items, such as a drawer, a tilting channel, a clip, and so forth.
  • the comprehensive health report may also include additional patient-specific information, such as the diagnostic information and results compiled by the meter, and additional diagnostic and health assessment information compiled by the server.
  • the report may include a trend analysis showing how blood lipid, blood glucose, and weight levels have changed over multiple readings.
  • the report may also include generally-applicable educational information, such as coronary risk factors, dietary guidelines for reducing cholesterol levels, diabeties information, cancer information, and the like.
  • a patient may have to undergo a physical examination, pay thousands of dollars, and wait weeks to obtain a similar comprehensive health report.
  • the network-based comprehensive health analysis and reporting system working in concert with the LIFESTREAM cholesterol meter, allows the patient to obtain the report within minutes at a fraction of the cost.
  • the motherboard 152 includes a non-interruptible battery 162, such as a lithium battery.
  • the non-interruptible battery 162, which powers the on-board clock 164, is distinct from the power supply battery 62 (shown on FIG. IB).
  • the additional non-interruptible battery 162 allows the clock to continue functioning even when the power supply battery 62 runs down or is removed from the meter 10.
  • the motherboard 152 also includes a processor 166 and a memory 168 that control the functionality of the meter 10. Specifically, the memory 168 stores and the processor 166 implements a meter activation routine, test strip verification routine, diagnostic routines, and a read/write security routine. These program modules are described with reference to FIGS. 4-13.
  • the motherboard 152 also includes a data drive 170 that reads data from and writes data to the removable data storage device 54, such as a smartcard.
  • FIGS. 4-14 are logic flow diagrams illustrating examples of the functionality that may be implemented by the meter 10 and the system 100 for remotely generating health reports.
  • the following description of these logic flow diagrams will also refer to the elements shown on FIGS. 2 and 3. It should be understood that these examples illustrate the use of these components in producing total cholesterol tests and related health reports.
  • the specific diagnostic information gathered and the specific diagnostic results described are those associated with the well-known Framingham Medical Study, which is incorporated herein by reference.
  • this particular program module illustrates the operation of an illustrative embodiment of the invention, those skilled in the art will understand that the meter 10 and the system 100 could be programmed with additional and different program modules.
  • step 402 the meter 10 is programmed at the factory by setting the internal clock 164 to the correct date and storing an activation code algorithm within the meter.
  • routine 404 in which the activation site, typically the manufacturer, computes an activation code for the current day. That is, each day the activation site computes a new activation code that is valid only for that day.
  • the activation code is computed using the same algorithm that was stored in the meter 10 in step 402. This algorithm is described below with reference to FIG. 5.
  • routine 406 in which the activation site receives an activation communication for the purpose of activating a meter 10.
  • FIG. 5 is a logic flow diagram illustrating a routine 404 for computing an activation code for the meter 10 or the activation site, referred to collectively below as the "computing entity.”
  • Routine 404 begins following step 402 shown on FIG. 4.
  • the computing entity gets the day, month, and year (six digit decimal) from the internal clock 164.
  • Step 502 is followed by step 504, in which the computing entity combines the six digits defining the date into a hex value (six digit hex).
  • step 504 is followed by step 506, in which the computing entity applies a predetermined mathematical operation to this hex value to compute a new hex value (new six digit hex).
  • FIG. 6 is a logic flow diagram illustrating a routine 600 for verifying a test strip for the meter 10.
  • the meter 10 is programmed at the factory with a test strip validation algorithm.
  • Step 602 is followed by step 604, in which a romkey with a corresponding lot of test strips is programmed with a test type ID.
  • This test type ID together with a lot number for the test strips placed on the romkey by the test strip manufacturer, forms a four-digit code number that is resident on the romkey when it leaves the factory.
  • step 618 the "YES” branch is followed from step 618 to step 622, in which the meter 10 activates for use with the instant test strip and romkey.
  • Step 622 is followed by the "END” step.
  • step 618 the "NO" branch is followed from step 618 to step 620, in which the meter 10 determines whether a timeout condition or an allowed number of tries has been reached. If a timeout condition or an allowed number of tries has not been reached, the "NO” branch loops from step 620 to step 610, and the meter 10 displays an error and prompts the user to reenter the test strip ID and/or insert the correct romkey. If a timeout condition or an allowed number of tries has been reached, the "YES” branch is followed from step 620 to the "END” step, and the meter 10 is not activated for the instant test strip and romkey.
  • the mathematical operation applied in step 706 may be any of a variety of algorithms designed to quasi-randomize the result.
  • the digits may be grouped into subsets that, in turn, are used in one or more linear mathematical operations, such as addition, subtraction, multiplication, division, raising to a power, raising to a fraction, and the like.
  • a polynomial formula may be applied to the digits or subsets of the digits.
  • the digit shuffling operation applied in steps 708 and 710 is also applied to quasi-randomize the result. Many other types of quasi-randomizing methodologies will be apparent to those skilled in the art.
  • FIG. 8 is a logic flow diagram illustrating a routine 800 for entering diagnostic program modules into the meter 10.
  • the meter 10 is programmed at the factory with one or more initial diagnostic algorithms.
  • a computer maintained at the programming site typically the manufacturer, is programmed with a cross reference table indicating the serial number for the meter and the version number of each diagnostic program module installed in the meter 10.
  • step 812 in which the programming server loads new diagnostic program modules, new versions of diagnostic program modules, or updates for existing program modules on the smartcard.
  • step 814 the smartcard is placed back in the meter 10.
  • step 816 in which the new diagnostic program modules, new versions of diagnostic program modules, or updates for existing program modules stored on the smartcard are uploaded to the meter 10.
  • step 816 is followed by the "END" step. Diagnostic Analysis
  • Step 906 is followed by routine 908, in which the meter 10 prompts the user for additional diagnostic information.
  • Routine 908 is described below with reference to FIG. 10.
  • Routine 908 is followed by routine 910, in which the meter 10 computes immediate diagnostic results.
  • Routine 910 is described below with reference to FIG. 11.
  • Routine 910 is followed by step 912, in which the meter 10 displays the diagnostic results on the display device 34.
  • Step 912 is followed by step 914, in which the meter 10 stores the test results, the diagnostic information, and the diagnostic results (and also stores the meter's serial number) on the smartcard.
  • the user reads the smartcard with a computer station.
  • Step 1104 is followed by step 1106, in which the meter 10 calculates and displays a medical risk index associated with heart disease or heart attack, such as "very high,” “high,” “moderate,” “low,” or “very low.”
  • Step 1106 is foUowed by step 1108, in which the meter 10 calculates and displays a recommended weight loss, if appropriate.
  • Step 1108 is followed by step 1110, in which the meter 10 calculates and displays a 5-year cardiac risk (e.g., risk of cardiac arrest in five years is 10%).
  • step 1110 is followed by step 1112, in which the meter 10 calculates and displays a 10-year cardiac risk (e.g., risk of cardiac arrest in ten years is 20%).
  • FIG. 12 is a logic flow diagram illustrating routine 922 for remotely producing health reports.
  • Routine 922 begins following step 920 shown on FIG. 9.
  • the health report server 102 prompts for and receives a new drug therapy, such as a cholesterol-lowering prescription.
  • Step 1202 is followed by step 1204, in which the health report server 102 gets a prescription data sheet for the drug therapy.
  • This data sheet typically includes instructions for taking the prescription, such as dosage, times to take each dose, whether to take with food or liquid, whether to avoid driving, pregnancy-related instructions, foods to avoid, and so forth.
  • step 1314 in which the meter 10 determines whether a timeout condition or an allowed number of tries has been reached. If a timeout condition or an allowed number of tries has not been reached, the "NO" branch is foUowed to step 1318, in which the meter 10 displays an error and prompts the user to reenter the activation code. From step 1318, routine 1300 loops to step 1312. If a timeout condition or an allowed number of tries has been reached, the "YES" branch is followed from step 1316 to the "END” step, and the meter 10 is not activated for use with the instant smartcard.
  • the secure medical records maintenance system 1400 which is presently known as the "PRIVALINK” system, operates in connection with a software module 1402 installed on the accessing computer 108.
  • This software is presently known as the "PRIVALINK” user site software.
  • the server-side "PRIVALINK” system 1400 includes a first remote server 1404 that stores patient identification information, a second remote server 1406 that stores patient medical data, an encryption/decryption module 1408 that implements encryption and other security-related functions, and a booklet generation module 1410, which produces printed health report booklets 112 based on the information stored in the servers 1404, 1406.
  • the patient identification information and medical data are maintained in separate, secure servers 1404, 1406 to prevent correlation of a specific patient's medical data with the associated patient identification information.
  • each smartcard 54 may be automatically erased from the smartcard after the data is entered into the second remote server 1406.
  • the smartcard 54 is received within the meter 10, which stores the medical data on the smartcard.
  • the removable memory storage device is receivable within the interface 106 for communication with the computer 108, which is operable for transmitting the medical data to the second remote server 1406 over the Internet 110.
  • the "PRIVALINK" user site software 1402 implements a menu-driven user interface system 1414 for conducting communications between the practitioner computer 108 and the secure medical records maintenance system 1400.
  • This interface system includes a health care provider data entry screen 2100 shown in FIG. 21, a patient address data entry screen 2500 shown in FIG. 25, a patient test data entry screen 2600 shown in FIG. 26, a booklet selection screen 2700 shown in FIG. 27, and a booklet preview/printing screen 2800.
  • the menu-driven user interface system 1412 also includes other related user interface screens. The operation of the menu-driven user interface system 1412 is described below with reference to FIG. 17.
  • FIG. 16 a functional block diagram illustrating security aspects of the secure medical records maintenance system 1400.
  • the secure medical records maintenance system 1400 preferably includes a large number of smartcards 54a- n, which operate in concert with a large number of meters lOa-n. Although each smartcard 54a-n is preferably used to store medical data for an associated patient, each card could be used to store medical data for multiple patients.
  • Each smartcard 54 also stores a patient-specified personal identification number (PIN), and may store PINs for multiple patients if the smartcard is configured to store medical data for multiple patients. Each PIN is used to gain access to a secure storage area on the smartcard 54, which stores an associated patient identification number and medical records identification number, which are assigned by the secure medical records maintenance system 1400.
  • PIN personal identification number
  • FIG. 17 is a logic flow diagram illustrating an illustrative process 1700 for communicating with the secure medical records maintenance system 1400.
  • routine 1702 a medical practitioner conducts a client application procedure to obtain a secure client certificate, which is also known as a "CA" or certificate- authentication.
  • Routine 1702 is described in greater detail with reference to FIG. 18.
  • Routine 1702 is followed by a client login procedure 1704, which is described in greater detail with reference to FIG. 19.
  • These procedures ensure that access to the secure medical records maintenance system 1400 is limited to registered medical practitioners using the same computer and browser that the practitioner used to obtain a secure client certificate through the application procedure.
  • This encryption program module typically includes a "key” or nugget of information to be stored in the accessing browser.
  • the server-side encryption/decryption module 1408 can later check an accessing computer for the presence of the "key” to ensure that the accessing computer and browser is the same as the one going through the application procedure.
  • Step 1808 is followed by step 1810, in which the server-side encryption/decryption module 1408 validates the registration number (e.g., DEA number) entered by the applicant, typically by comparing the received registration number to the table of valid registration numbers 1411 received from the registration authority (e.g., table of valid DEA numbers). If the registration number is properly validated, step 1810 is followed by step 1812, in which the server-side encryption/decryption module 1408 transmits an e-mail message to the PRIVALINK software 1402 including a URL for accessing the secure servers 1404, 1406. Step 1812 is followed by step 1814, in which the PRIVALINK software 1402 transmits a client link to the designated URL. Upon receipt of the link, the server-side encryption/decryption module 1408 checks for the presence of the "key" to ensure that the accessing computer and browser is the same as the one that went through the application procedure.
  • the registration number e.g., DEA number
  • step 1810 is followed by step 1812, in
  • step 1820 is followed by step 1822, in which the PRIVALINK software 1402 links the applicant to a login screen.
  • step 1822 is followed by step 1824, in which the encryption decryption module 1408 saves the transaction documentation for the client's application procedure.
  • step 1824 is followed by the "CONTINUE" step, which returns to routine 1704 shown in FIG. 7.
  • Step 1904 is followed by step 1906, in which the PRIVALINK software 1402 receives the practitioner's personal identification number (PIN).
  • step 1906 is followed by step 1908, in which the encryption decryption module 1408 validates the practitioner's personal identification number (PIN) for use with the received professional registration number.
  • step 1908 is followed by step 1910, in which the encryption/decryption module 1408 determines whether the received PIN is a new PIN for use in connection with the received professional registration number. If the received PIN is a new PIN for use in connection with the received professional registration number, the "YES" branch is followed from step 1910 to step 1912, in which the PRIVALINK software 1402 prompts the user to complete the interface screens 2000-2007 (HGS. 20-27).
  • step 1912 and the "NO” branch from step 1910 are followed by step 1914, in which the client is linked to the interface screens 2000-2007 (HGS. 20-27).
  • step 1914 is followed by "CONTINUE” step, which returns to step 1706 shown on
  • FIG. 21 is an illustration of a typical "address" user interface 2100.
  • the interface 2100 includes a first field 2102 for entering a practitioner registration number, typically a DEA number, and a second field 2104 for entering a practitioner-assigned PIN.
  • the interface 2100 also includes a number of other fields for entering the practitioner's contact information, such as address, phone number, and so forth.
  • the interface 2100 also includes an "address” tab 2106, a "billing info” tab 2108, and a "cover letter” tab 2110 displayed adjacent to the user interface 2100. These tabs aUow the user to toggle among corresponding user interface screens. As noted above, the interface 2100 initiaUy appears in a "default" mode with the "address" tab 2106 selected.
  • step 1712 may be followed by step 1714, in which the PRIVALINK software 1402 displays a "cover letter" user interface 2300 in response to user selection of the "cover letter” tab 2110.
  • FIG. 23 is an iUustration of a typical "cover letter” user interface 2300. This interface allows the practitioner to author a cover letter that wiU be included with a health report booklet to be produced by the booklet generation module 1410 on the server- based system 1400, as described previously with reference to FIG. 9. This aUows the practitioner to customize the cover letter for each health report booklet produced by the system.
  • Step 1716 is followed by step 1718, in which the PRIVALINK software 1402 displays a "patient information" user interface 2500.
  • FIG. 25 is an illustration of a typical "patient information" user interface 2500. This interface includes a number of fields for entering patient identification information, such as address, phone number, and so forth. As described previously with reference to FIG. 16, this patient identification information is typically indexed by the patient identification number and stored in the first server 1404, whereas the patient's medical data is typically indexed by the patient's medical records identification number and stored in the second server 1406.
  • Step 1718 is followed by step 1720, in which the PRIVALINK software
  • FIG. 29 is an illustration of an additional health assessment chart 2900 generated by the secure medical records maintenance system 1400 for inclusion in a patient's health report booklet.
  • This chart includes a pictorial representation of cardiac risk factors, such as gender, smoker, personal history, and so forth.
  • the health assessment chart 2900 typically presents a pictorial assessment of the "coronary risk factors" shown in chart 2802.

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Abstract

L'invention concerne un dispositif de contrôle de l'état de santé et de diagnostic (compteur de cholestérol LIFESTREAM) configuré sous la forme d'une unité d'analyse et de diagnostic autonome dans un boîtier de type à deux coques. Une face du boîtier comprend un bâtonnet pour doigts à ressort ainsi qu'un compartiment contenant un ou plusieurs paquets d'articles jetables comprenant une bande d'analyse, une aiguille pour le bâtonnet de doigts ainsi qu'un tampon d'alcool. L'autre moitié du boîtier comprend un lecteur de bande d'analyse, un bloc de touches et un affichage à cristaux liquide. Le compteur lit une bande d'analyse portant une gouttelette de sang et il reçoit des informations diagnostiques supplémentaires du patient telles que l'âge, le sexe, le poids ainsi que l'historique familiale des maladies cardiaques. En quelques minutes, le compteur affiche les résultats d'analyse, y compris les niveaux de cholestérol total. Le compteur affiche également des résultats diagnostiques supplémentaires tels que l''âge cardiaque' du patient, la perte de poids recommandée, ainsi qu'une évaluation de risques d'accidents cardiaques. Le compteur travaille également en liaison avec un système d'analyse et d'établissement de rapport de l'état de santé exhaustif construit en réseau. Le compteur inscrit les données du patient sur une carte à mémoire. Les données de ce patient comprennent typiquement des informations d'identification du patient, les résultats des analyses, les informations de diagnostic et les résultats du diagnostic. Un poste informatique lit la carte à puce et établit une connexion en réseau avec un serveur de rapports d'état de santé sur l'Internet. L'ordinateur télécharge ensuite les données du patient vers le serveur de rapports d'état de santé, lequel prépare un rapport d'état de santé exhaustif. En quelques minutes, ce rapport est retransmis au poste informatique où il est imprimé et remis au patient.
PCT/US1999/026521 1998-11-09 1999-11-08 Dispositif de controle de l'etat de sante et de diagnostic et systeme d'evaluation de l'etat de sante et d'actualisation de dossiers medicaux construit en reseau WO2000028460A2 (fr)

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CA002350145A CA2350145C (fr) 1998-11-09 1999-11-08 Dispositif de controle de l'etat de sante et de diagnostic et systeme d'evaluation de l'etat de sante et d'actualisation de dossiers medicaux construit en reseau
EP99963882A EP1133747A2 (fr) 1998-11-09 1999-11-08 Dispositif de controle de l'etat de sante et de diagnostic et systeme d'evaluation de l'etat de sante et d'actualisation de dossiers medicaux construit en reseau
IL14305999A IL143059A0 (en) 1998-11-09 1999-11-08 Health monitoring and diagnostic device and network-based health assessment and medical records maintenance system
AU20231/00A AU2023100A (en) 1998-11-09 1999-11-08 Health monitoring and diagnostic device and network-based health assessment and medical records maintenance system

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US10770498P 1998-11-09 1998-11-09
US60/107,704 1998-11-09
US14470599P 1999-07-20 1999-07-20
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CA2350145A1 (fr) 2000-05-18
WO2000028460A3 (fr) 2001-07-12
CA2350145C (fr) 2005-02-08
EP1133747A2 (fr) 2001-09-19
IL143059A0 (en) 2002-04-21

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