TELEMEDICINE

TELEMEDECINE

English Abstract

Automatic test tracking analysis and reporting are provided by an automated
process and computer system, which can provide a global communications
network, for the convenience of patients, health care providers and public
health agencies to lower health care costs. Advantageously, the speedy
accurate process and system can be used to detect many types of infectious
diseases, chronic diseases, genetic diseases, nutritional deficiency,
environmental and general health problems, fertility, mental disorders, drug
abuse, allergies, etc., as well as to automatically administer non-invasive
tests, such as vision tests, hearing tests, and cognitive function tests to
monitor the progress of Alzheimer's disease. Samples to be tested can be
conveniently collected by the patient or by others and placed in a test kit at
the patient's home or other location remote from a medical facility. The
sample can be tested in a laboratory or at the patient home or other remote
site. The test results and patient profile medical history can be inputted
into the system or network and compared with data bases of diseases,
disorders, treatments, care plans, nutritional supplements, and medicine. The
process and system can transmit an analysis and proposed treatment to the
patient's physician or health care provider for approval or change before the
test report and recommended medicine and treatment are sent to the patient.
The process and system are also useful for automatic test tracking and
reporting to public health organizations.

French Abstract

L'invention concerne un procédé automatisé et un système informatique destinés au suivi et à la transmission automatiques d'examens, qui peuvent constituer un réseau de communication global pour la commodité des patients, des fournisseurs de soins de santé et des services de santé publique et réduire le coût des soins de santé. Avantageusement, ce procédé et ce système rapides et précis peuvent être utilisés pour détecter de nombreux types de maladies infectieuses, maladies chroniques, maladies génétiques, carences nutritionnelles, problèmes de santé environnementaux et généraux, troubles de la reproduction, maladies mentales, toxicomanies, allergies, etc., ainsi que pour pratiquer automatiquement des examens non invasifs, tels qu'examens de la vue, de l'audition et des fonctions cognitives, afin de surveiller l'évolution de la maladie d'Alzheimer. Les échantillons à analyser peuvent être collectés d'une manière pratique par le patient ou par d'autres personnes, puis placés dans une trousse d'analyse au domicile du patient ou dans un autre lieu éloigné d'un établissement de soins. L'échantillon peut être analysé en laboratoire, au domicile du patient ou dans un autre lieu éloigné. Les résultats de l'examen et les antécédents médicaux du patient peuvent être entrés dans le système ou le réseau, puis comparés à des bases de données portant sur les maladies, les troubles, les traitements, les plans thérapeutiques, les suppléments nutritionnels et les médicaments. Le procédé et le système permettent de transmettre au médecin ou au fournisseur de soins de santé du patient le résultat d'un examen, ainsi qu'une proposition de traitement, en vue de son approbation ou de sa modification avant que le compte-rendu de l'examen, les médicaments et le traitement préconisés soient envoyés au patient. Ils sont également utiles pour le suivi et la transmission automatique d'examens aux organismes de santé publique.

Claims

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What is claimed is:

1. An automatic test reporting process, comprising the steps of:
inputting the results of at least one test into a central processing unit; and
automatically contacting a person selected by said central processing unit
with
said test results.
2. An automatic test reporting process in accordance with claim 1 wherein said
person or agency comprises at least one member selected from the group
consisting of: a
public health official, a health department employee, an official of the
Center for Disease
Control, an environmentalist, physician, a staff member of a hospital, trauma
center
personnel, a health care provider, a managed care provider, a medical doctor,
nurse, a
dentist, an insurance representative, a patient, a customer, a student, a
pharmacist, a
medical supply house, a nutritionist, a hygienist, psychiatrist, psychologist,
optometrist,
optomologist, and audiologist.
3. An automatic test reporting process in accordance with claim 1 wherein said
test
results are reported to said person selected by said central processing unit
based upon test
result information.
4. An automatic test reporting process in accordance with claim 1 wherein said
central processing unit is selected from the group consisting of a:
microprocessor,
computer, a computer system, computer network, computer chip, circuit board,
control
board, programmable controller, logic controller, mainframe, and data
processing center.
5. An automatic test reporting process in accordance with claim 1 wherein said
test
results are electrically inputted with at least one device selected from the
group consisting
of: a keyboard, optical scanner, a telephone, a modem, a cellular phone, an
internet
connection, world wide web connection, a computer, a touch screen display, and
a data
processing center.
6. An automatic test reporting process in accordance with claim 1 wherein said
contacting includes using at least one device selected from the group
consisting of: a
transmitter, a beeper, a receiver, a telephone, a modem, a cellular phone, a
cable, an
internet carrier, a world wide web link, a television, a closed circuit
monitor, a computer, a
display screen, a telephone answering machine, facsimile machine, and a
printer.



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7. An automatic test reporting process in accordance with claim 1 wherein said
automatic contacting includes verifying the identification of the person
before providing the
person with the test results.
8. An automatic test reporting process in accordance with claim 1 including:
administering a non-invasive test selected by said central processing unit
from
the group consisting of a hearing test, a vision test, reading test, and a
cognitive function
test;
electronically transmitting said test in proximity to the person being tested
to a
receiver selected from the group consisting of a television, monitor, display
screen,
computer screen, flat panel display, LED screen, active matrix display screen,
passive
matrix display screen, liquid crystal display, Internet, web site, telephone
and cellular
phone; and
automatically contacting the person or a health careprovider with a
recommendation selected from the group consisting of medical treatment,
prescription
drugs, over-the-counter drugs, medicine, and prescriptions for eyeglasses,
contact lenses,
or hearing aids.
9. An automatic test reporting process in accordance with claim 1 wherein:
a sample is collected by a member selected from the group consisting of a
patient, a customer, an assistant, a sample collector, and a public health
official; and
said sample is tested to obtain said test results.
10. An automatic test reporting process in accordance with claim 9 wherein
said
sample is tested by said member.
11. An automatic test reporting process in accordance with claim 9 wherein
said
sample is tested by a laboratory.
12. An automatic test reporting process in accordance with claim 9 wherein
said
sample is selected from the group consisting of: urine, saliva, breath, hair,
fingernails,
fingerprints, buccal cells, oral fluids, stool, skin, sweat, nasal fluids,
mucous, semen,
vaginal secretions, blood, ocular fluids, eye swabs, and ear wax.
13. An automatic test reporting process, comprising the steps of:
collecting a sample at a site remote from a central processing unit;
testing said sample with a test kit to obtain test results;



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inputting said test results into said central processing unit;
accessing at least one data base with said central processing unit, said data
base
comprising electronic and information selected from the group consisting of
chronic
diseases, infectious diseases, environmental diseases, general health
information, fertility,
nutrition, medical treatment, prescription drugs, over-the-counter drugs,
medicine, care
maps, treatment guidelines, medical texts, medical journals, product
information, DNA
data, sequence listings, and fingerprint information;
electronically comparing said test results with said data base via said
central
processing unit;
generating a recommended course of action with said central processing unit;
and
transmitting said recommended course of action.
14. An automatic test reporting process in accordance with claim 13 wherein
said site
is selected from the group consisting of a patient's home, place of business,
store, or other
location remote from a medical facility, hospital, trauma center and doctor's
office.
15. An automatic test reporting process in accordance with claim 13 wherein;
a patient's profile is inputted into said central processing units and
compared
with said data base; and
said patient's profile comprises data selected from the group consisting of a
patient's age, sex, height, weight, medical history, current medication,
physician, spouse,
sex partners, parents, and children.
16. An automatic test reporting process in accordance with claim 13 wherein
said
recommended course of action comprises at least one recommendation selected
from the
group consisting of medical treatment, medicine, dosage, product
identification,
prescription drugs, over-the-counter drugs, nutritional supplements, treatment
regimens,
exercise, diet, insurance, hospital, health care provider, physician, managed
care provider,
and compliance reminder.
17. An automatic test reporting process in accordance with claim 13 wherein
said
sample is collected by a patient in the absence of a medical doctor, medical
technician, and
nurse.
18. An automatic test reporting process in accordance with claim 17 wherein
said
sample is tested by said patient.



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19. An automatic test reporting process in accordance with claim 18 wherein
said patient contacts a counselor with said test results; and
said counselor inputs said test results into said central processing unit.
20. An automatic test reporting process in accordance with claim 17 wherein:
said sample is tested by a laboratory:
said recommendation is transmitted to medical personnel selected from the
group
consisting of a physician or health care provider;
said medical personnel approving or changing said recommendation to update
said recommendation; and
transmitting said updated recommendation to said patient.
21. An automatic test reporting process in accordance with claim 20 including
verifying the identification of the patient before said patient can access the
updated
information.
22. An automatic test reporting process in accordance with claim 20 wherein
said
updated information is printed and delivered to said patient and said medical
personnel by
mail, courier, facsimile or express delivery.
23. An automatic test reporting process in accordance with claim 13 wherein
said test
kit is obtained by purchasing said test kit from a facility selected from the
group consisting
of: a pharmacy; a store; a mail order supply house; or a company advertised on
television,
radio, newspaper, magazine, catalog, Internet or a web site.
24. An automatic test reporting process in accordance with claim 13 wherein:
said patient is selected by said central processing unit at a request of an
organization selected from the group consisting of: an insurance company, an
integrated
health care provider, a managed care provider, a health maintenance
organization, a medical
group, hospital, a public health agency, ministry of health, environmental
agency, and
Center for Disease Control; and
said test kit is delivered to said patient at the request and expense of said
organization.



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25. An automatic test reporting process in accordance with claim 13 wherein:
said sample is collected by an employee of an organization selected from the
group consisting of a public health agency, ministry of health, environmental
agency, and
Center for Disease Control;
said test kit is obtained and paid for by said organization;
said test results are automatically tracked by said central processing unit
for said
group; and
said test results and recommendations are transmitted to said organization.
26. An automatic test reporting process in accordance with claim 13 wherein
said
recommended course of action is transmitted by a carrier selected from the
group consisting
of: a phone, modem, cellular phone, facsimile, cable, internet, world wide
web, global
interconnected communications network, a satellite system, a computer,
computer network,
mail, express delivery, courier, keyboard, computer screen, flat panel
display, monitor,
and television.
27. An automatic test reporting process in accordance with claim 13 wherein
said
inputting comprises electrically inputting with at least one device selected
from the group
consisting of: a keyboard, telephone, modem, cellular phone, internet
connection, world
wide web connection, computer, and touch screen display.
28. An automatic test reporting process in accordance with claim 13 wherein
said
sample is selected from the group consisting of: urine, saliva, breath, hair,
fingernails,
buccal cells, oral fluids, stool, skin, sweat, nasal fluids, mucous, semen,
vaginal
secretions, blood, ocular fluids, eye swabs, and ear wax.
29. An automatic test reporting process in accordance with claim 13 wherein
said
central processing unit is selected from the group consisting of a:
microprocessor,
computer, a computer system, computer network, semiconductor chip, circuit
board,
control board, programmable controller, logic controller, mainframe,
interconnected global
communication network, satellite system, internet, world wide web, and data
processing
center.
30. An automatic test reporting process in accordance with claim 13 wherein
said test
kit includes an indicator selected from the group consisting of: a bar code,
time marker,
date marker, clock, magnetic time stamp, magnetic date stamp, temperature
indicator,



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thermometer, blood pressure gauge, blood pressure monitor, fingerprint pad,
label,
identification number, name, lettering, code, graphics and indicia.
31. An automatic test reporting process, comprising the steps of:
obtaining a test kit comprising a remote sample collection and testing kit
with an
indicator selected from the group consisting of a bar code, time marker, date
marker, clock,
magnetic time stamp, magnetic date stamp, temperature indicator, thermometer,
blood
pressure gauge, blood pressure monitor, fingerprint pad, label, identification
number,
name, lettering, code, graphics and indicia;
said test kit being obtained by or for a patient;
said test kit being brought to a remote location site selected from the group
consisting of a patient's home, place of business, store, or other location
remote from a
medical facility, hospital, trauma center, and doctor's office;
said patient opening said test kit at said remote location site;
said patient collecting a sample at said remote location site in the absence
of a
medical doctor, medical technician and nurse;
said patient placing said sample in said test kit at said remote location
site;
said sample being selected from the group consisting of urine, saliva, breath,
hair, fingernails, fingerprints, buccal cells, oral fluids, stool, skin,
sweat, nasal fluids,
mucous, semen, vaginal secretions, blood, ocular fluids, eye swabs, and ear
wax;
testing said sample for a medical characteristic comprising an analyte,
disease
state, disease, medical condition, or medical environmental hazard, said
medical
characteristic being selected from the group consisting of diabetes, glycated
hemoglobin,
microalbumin, heart disease, coumadin therapy, digoxin monitoring, therapeutic
drug
monitoring, mental health, depression, cancer, carcinoembryonic antigen,
prostate specific
antigen, prostrate cancer, breast cancer, osteoporosis, estrogen therapy
monitoring,
epilepsy, anticonvulsant drug monitoring, kidney failure, BUN, creatinine,
albumin,
microalbumin, antibiotic therapy monitoring, acute c-reactive protein, strep
A, strep B,
influenza, urinary tract infection, sexually transmitted disease, chlamydia,
gonorrhea,
syphilis, infectious diseases, human immunodeficiency virus, HIV viral load,
acquired
immune deficiency syndrome (AIDS), herpes simplex virus, hepatitis, cognitive
function,
Alzheimer disease progression, fertility monitoring, LH, FSH, progesterone,
E3, hCG,
estrogen, testosterone, nutritional status, nutritional assessment,
environmental hazard
screening, environmental contaminants, heavy metal, mercury, lead, asbestos,
encephalitis,
E. coli, diabetes, glucose, glycated proteins, ketones, steroids, cancer
markers, drug
abuse, toxicology, vitamins, vitamin deficiency, dehydration, specific
gravity, smoking,
continine, carbon dioxide, asthma, lung cancer, lung capacity, tuberculosis,
pnemonia,


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halitosis, blood alcohol, gastrointestinal disease, H. Pylori, Ebola virus,
colon cancer,
colon cysts, occult blood, inflammatory bowl disease, fiber level, allergies,
cystic fibrosis,
bacteria, RSV, viruses, bacteria, infectious organisms, dental assessment,
tooth decay,
saliva acidity, yeast infections, yeast levels, genetic testing, forensics,
toe fungus, athletes
foot, pink eye, dandruff, lice, schelorsis, blood pressure, varicella zoster
virus,
cytomegalovirus, Epstein barr, papilloma virus, cellutitus, staphylococci,
streptococci,
mycobacteria, adenovirus, encephalitis, meningitis, arbovirus, arenavirus,
anaerobic
bacilli, picornavirus, coronavirus, synsytialvirus, pregnancy, and cholesterol
level;
obtaining results from said testing of said sample comprising test results
selected
from the group consisting of test data, information, answers, chemical
reaction, chemical
analysis, color change, and visual appearance;
electronically inputting said test results and a medical profile of said
patient into a
central processing unit with at least one device selected from the group
consisting of a
keyboard, optical scanner, telephone, modem, cellular phone, internet
connection, world
wide web connection, cable, phone line, computer, and touch screen display;
said medical profile comprising patient data selected from the group
consisting of
a patient's age, sex, height, weight, medical history, current medication,
physician,
spouse, sex partners, parents, and children;
said central processing unit being selected from the group consisting of a
microprocessor or computer, computer system, computer network, semiconductor
chip,
circuit board, control board, programmable controller, logic controller,
mainframe,
interconnected global communications network, satellite system, Internet
network, world
wide web network, and data processing center;
accessing at least one data base with said central processing unit, said data
base
comprising electronic information selected from the group consisting of
chronic diseases,
infectious diseases, environmental diseases, general health information,
fertility, nutrition,
medical treatment, prescription drugs, over-the-counter drugs medicine, care
maps,
treatment guidelines, medical tests, product information, DNA data, sequence
listings, and
fingerprint information;
electronically analyzing said test results;
said central processing unit electronically comparing said analysis of said
test
results with said medical profile and data base;
generating a diagnosis and recommendation with said central processing unit,
said recommendation being selected from the group consisting of medical
treatment,
medicine, dosage, prescription drugs, over-the-counter drugs, nutritional
supplements,
treatment regimens, exercise, diva, and compliance reminder:


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transmitting said diagnosis and recommendation to medical personnel selected
from the group consisting of a physician or health care provider;
said medical personnel approving or changing said diagnosis and
recommendation and inputting their approval or changes into said central
processing unit to
provide feedback for said patient;
signaling the patient to access the approved or changed diagnosis and
recommendation, said signaling being selected from the group consisting of
telephone,
transmitting electronic mail, and notification;
verifying that a person seeking to access the approved or changed diagnosis
and
recommendation is said patient; and thereafter
transmitting to said patient and permitting said patient to access and
retrieve said
approved or changed diagnosis and recommendation resulting from said sample
collection
and testing.
32. An automatic test reporting process in accordance with claim 31 wherein
said
sample is tested by a laboratory.
33. An automatic test reporting process in accordance with claim 31 wherein
said
sample is tested by said patient.
34. An automatic test reporting process in accordance with claim 31 wherein
said
patient informs a counselor of said test results by telephone or electronic
mail.
35. An automatic test reporting process in accordance with claim 31 wherein
said test
kit is obtained by purchasing said test kit from a facility selected from the
group consisting
of: a pharmacy; a store; a mail order supply house; or a company advertised on
television,
radio, newspaper, magazine, catalog, internet or a web site.
36. An automatic test reporting process in accordance with claim 31 wherein:
said patient is selected by said central processing unit at a request of an
organization selected from the group consisting of: an insurance company, an
integrated
health care provider, a managed care provider, health maintenance
organization, a medical
group, a public health agency, ministry of health, and Center for Disease
Control; and
said test kit is delivered to said patient at the request and expense of said
organization.



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37. An automatic test reporting process in accordance with claim 31 wherein
said
sample is collected with an instrument selected from the group consisting of
a: swab,
cotton, gauge, lance, tissue, nail clippers, scissors, cup, bottle, container,
test tube,
capillary tube, petri dish, condom, bag, glove, tape, blotter, paper,
paperboard, cardboard,
dermatological patches, eye dropper, pipettes, collector device, sample
retriever, and
medical instrument.
38. An automatic test reporting process in accordance with claim 31 wherein
said
sample is tested with diagnostics equipment selected from the group consisting
of an:
immunodiagnostics analyzer, immunoassay system, hematology analyzer, blood
screen
instrument, blood analyzer, chemistry instrument, chromatograph, urine
analyzer, semen
analyzer, hair analyzer, tissue and pore analyzer, drug monitor, microbiology
analyzer,
diagnostics instrument, and diagnostic device.
39. An automatic test reporting process in accordance with claim 31 wherein
said
diagnosis and recommendation are transmitted by telephone or electronic mail.
40. An automatic test reporting process in accordance with claim 39 wherein:
said approved or changed diagnosis and recommendation are printed; and
said printed diagnosis and recommendation are sent for confirmation to said
patient and medical personnel by facsimile, mail, express delivery, or
courier.
41. An automatic test reporting system, comprising:
a kit having an instrument for collecting a sample at a remote location
selected
from the group consisting of a patient's home, place of business, store or
other location
remote from a medical facility, hospital trauma center and doctor's office;
diagnostic equipment for testing the sample to obtain test results;
a central processing unit;
a patient's electronic profile comprising electronic data selected from the
group
consisting of a patient's age, sex, height, weight, medical history, current
medication,
physician, spouse, sex partners, parents, and children;
a data base comprising electronic information selected from the group
consisting
of chronic diseases, infectious diseases, environmental diseases, general
health
information, fertility, nutrition, medical treatment, prescription drugs, over-
the-counter
drugs, medicine, care maps, treatment guidelines, medical tests, medical
journals, product
information, DNA data, sequence listings, and fingerprint information;



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at least one inputting device for electronically inputting the patient's
electronic
profile and test results into said central process unit;
send control processing unit accessing said data base and comparing said test
results, patient's electronic profile and test results, and said central
processing unit
generating a recommended course of action comprising at least one
recommendation
selected from the group consisting of medical treatment, medicine, dosage,
product
identification, prescription drugs, over-the-counter drugs, nutritional
supplement treatment
regimens, exercise, diet, insurance, hospital, health care provider,
physician, managed care
provider, and compliance reminder; and
at least one carrier for transmitting said recommended course of action.
42. An automatic test reporting system in accordance with claim 41 wherein
said
central processing unit is selected from the group consisting of a:
microprocessor,
computer, computer system, computer network, semiconductor chip, circuit
board, control
board, programmable controller, logic controller, mainframe, global
communications
network, satellite system, Internet, world wide web, and data processing
center.
43. An automatic test reporting system in accordance with claim 41 wherein
said kit
comprises a test kit with an indicator selected from the group consisting of
a: bar code, time
marker, date marker, clock, magnetic time stamp, magnetic date stamp,
temperature
indicator, thermometer, blood pressure gauge, blood pressure monitor,
fingerprint pad,
label, identification number, name, lettering, code, and indicia.
44. An automatic test reporting system in accordance with claim 41 wherein
said
inputting device is selected from the group consisting of a: keyboard,
telephone, modem,
cellular phone, internet connection, world wide web connection, and touch
screen display.
45. An automatic test reporting system in accordance with claim 41 wherein
said
carrier is selected from the group consisting of a: phone, modem, cellular
phone, facsimile,
cable, internet, world wide web, global communications network, satellite
system,
computer network, keyboard, computer screen, flat panel display, monitor,
television, and
facsimile machine.
46. An automatic test reporting system in accordance with claim 41 including a
printer for printing said recommended course of action.


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47. An automatic test reporting system in accordance with claim 43 wherein:
said carrier includes a first carrier for transmitting said recommended course
of
action to medical personal to approve or change said recommendation, said
medical
personnel selected from the group consisting of a physician or a health care
provider;
said inputting device includes an updating device for inputting the approved
or
changed recommendation to said central processing unit;
said carrier includes a second carrier for transmitting the approved or change
recommendation to a patient after verification of the patient's identity; and
said first carrier being the same or different than said second carrier.
48. An automatic test reporting system in accordance with claim 41 wherein
said
sample is selected from the group consisting of: urine, saliva, breath, hair,
fingernails,
buccal, cells, oral fluids, stool, skin, sweat, nasal fluids, mucous, semen,
vaginal
secretions, blood, ocular fluids, eye swabs, and wax.
49. An automatic testing reporting system in accordance with claim 48 wherein
said
instrument for collecting said sample comprises a sample collector selected
from the group
consisting of a: swab, cotton, gauge, lance, tissue, nail clippers, scissors,
cup, bottle,
container, test tube, capillary tube, petri dish, condom, bag, glove, tape,
blotter, paper,
paperboard, cardboard, dermatological patches, eye dropper, pipettes,
collector device,
sample retriever, and medical instrument.
50. An automatic testing reporting system in accordance with claim 48 wherein
said
diagnostic equipment is selected from the group consisting of an:
immunodiagnostics
analyzer, immunoassay system, hematology analyzer, blood screen instrument,
blood
analyzer, chemistry instrument, chromatograph, urine analyzer, semen analyzer,
hair
analyzer, tissue and pore analyzer, drug monitor, microbiology analyzer,
diagnostics
instrument, and diagnostics device.
51. An automatic test reporting system comprising:
a central processing unit for electronically administering a non-invasive test
selected from the group consisting of a hearing test, vision test, reading
test, blood
pressure, pulse, EEG, EKG, respiration rate, respiratory function and a
cognitive function
test;
a receiver positioned in proximity to the person being tested at a location
remote
from said central processing unit, said receiver being selected from the group
consisting of
a television, monitor, display screen, computer screen, flat panel display,
LED screen,



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active matrix display screen, passive matrix display screen, liquid crystal
display, Internet,
web site, telephone, and cellular phone;
at least one transmitter operatively associated with said central processing
unit
and said receiver for
transmitting said non-invasive test from said central processing unit to
said receiver,
transmitting responses to said test from said receiver to said central
processing unit, and
transmitting a recommendation from said central processing unit to said
receiver;
at least one data base comprising electronic information selected from the
group
consisting of hearing, vision, color blindness, reading, cognitive function,
Alzheimer
disease, optical medical information, eye diseases, ear diseases, medical
treatment,
prescription drugs, over-the-counter drugs, medicine, care maps, treatment
guidelines,
medical tests, medical journals, optical lenses, eyeglasses, eyewear, and
hearing aids;
a modem connected to said central process unit for accessing said data base;
and
said central processing unit comparing said responses to said data base and
generating said recommendation, and said recommendation being selected from
the group
consisting of medical treatment, prescription drugs, over-the-counter drugs,
medicine, and
prescriptions for eyeglasses, contact lenses, or hearing aids.
52. An automatic test reporting system in accordance with claim 51 wherein
said
central processing unit is selected from the group consisting of a:
microprocessor,
computer, computer system, computer network, semiconductor chip, circuit
board, control
board, programmable controller, logic controller, mainframe, global
communications
network, satellite system, Internet, world wide web, and data processing
center.
53. An automatic test reporting system in accordance with claim 51 including a
printer operatively connected to said central processing unit for printing
said
recommendation.
54. An automatic test reporting system in accordance with claim 51 wherein
said
transmitter is selected from the group consisting of: a phone line, cable,
Internet, world
wide web, global communications network, satellite system, radio frequency
transmitter, a
cellular transmitter, computer link, and a facsimile machine.


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55. An automatic test reporting system in accordance with claim 51 wherein
said
recommendation comprises electronic mail (e-mail).
56. An automatic test reporting system, comprising:
a test kit comprising a remote sample collection and testing kit with an
indicator
selected from the group consisting of a bar code, time marker, date marker,
clock, magnetic
time stamp, magnetic date stamp, temperature indicator, thermometer, blood
pressure
gauge, blood pressure monitor, fingerprint pad, label, identification number,
name,
lettering, code, graphics and indicia;
said test kit being obtained by or for a patient, said test kit being brought
to a
remote location site selected from the group consisting of a patient's home,
place of
business, store, or other location remote from a medical facility, hospital,
trauma center,
and doctor's office; said patient opening said test kit and collecting a
sample for placement
in said test kit at said remote location site in the absence of a medical
doctor, medical
technician and nurse;
said sample being selected from the group consisting of urine, saliva, breath,
hair, fingernails, fingerprints, buccal cells, oral fluids, stool, skin,
sweat, nasal fluids,
mucous, semen, vaginal secretions, blood, ocular fluids, eye swabs, and ear
wax;
test equipment for testing said sample for a medical characteristic comprising
an
analyte, disease state, disease, medical condition, or medical environmental
hazard, said
medical characteristic being selected from the group consisting of diabetes,
glycated
hemoglobin, hormone replacement therapy, microalbumin, heart disease,
digitalis,
coumadin therapy, digoxin monitoring, therapeutic drug monitoring, mental
health,
depression, cancer, carcinoembryonic antigen, prostate specific antigen,
prostrate cancer,
breast cancer, osteoporosis, estrogen therapy monitoring, epilepsy,
anticonvulsant drug
monitoring, kidney failure, BUN, creatinine, albumin, microalbumin, antibiotic
therapy
monitoring, acute c-reactive protein, strep A, strep B, influenza, urinary
tract infection,
sexually transmitted disease, chlamydia, gonorrhea, syphilis, infectious
diseases, human
immunodeficiency virus, HIV viral load, acquired immune deficiency syndrome
(AIDS),
herpes simplex virus, hepatitis, cognitive function, Alzheimer disease
progression, fertility
monitoring, LH, FSH, progesterone, E3, hCG, estrogen, testosterone,
nutritional status,
nutritional assessment, environmental hazard screening, environmental
contaminants,
heavy metal, mercury, lead, asbestos, encephalitis, E. coli, diabetes,
glucose, glycated
proteins, ketones, steroids, cancer markers, drug abuse, toxicology, vitamins,
vitamin
deficiency, dehydration, specific gravity, smoking, continine, carbon dioxide,
asthma, lung
cancer, lung capacity, tuberculosis, pnemonia, blood alcohol, gastrointestinal
disease, H.
Pylori, Ebola virus, colon cancer, colon cysts, colon polyps, occult blood,
inflammatory



-34-



bowl disease, fiber level, allergies, cystic fibrosis, bacteria, RSV, viruses,
bacteria
infectious organisms, dental assessment, tooth decay, saliva acidity, yeast
infections, yeast
levels, genetic testing, forensics, toe fungus, athletes foot, pink eye, blood
pressure,
varicella zoster virus, cytomegalovirus, Epstein barr, papilloma virus,
cellutitus,
staphylococci, streptococci, mycobacteria, adenovirus; encephalitis,
meningitis, arbovirus,
arenavirus, anaerobic bacilli, picornavirus, coronavirus, synsytialvirus,
pregnancy, and
cholesterol level; said test equipment providing test results selected from
the group
consisting of test data, information, answers, chemical reaction, chemical
analysis, color
change, and visual appearance;
at least one device for electronically inputting said test results and a
medical
profile of said patient into a central processing unit, said device being
selected from the
group consisting of a keyboard, optical scanner, telephone, modem, cellular
phone, internet
connection, world wide web connection, cable, phone line, computer, and touch
screen
display;
said medical profile comprising patient data selected from the group
consisting of
a patient's age, sex, height, weight, medical history, current medication,
physician,
spouse, sex partners, parents, and children;
said central processing unit being selected from the group consisting of a
microprocessor, computer, computer system, computer network, semiconductor
chip,
circuit board, control board, programmable controller, logic controller,
mainframe, global
communications network, satellite system, Internet network, world wide web
network, and
data processing center;
a modem connected to said central processing unit for accessing at least one
data
base, said data base comprising electronic information selected from the group
consisting of
chronic diseases, infectious diseases, environmental diseases, general health
information,
fertility, nutrition, medical treatment, prescription drugs, over-the-counter
drugs medicine,
care maps, treatment guidelines, medical tests, product information, DNA data,
sequence
listings, and fingerprint information;
said central processing unit
electronically analyzing said test results;
electronically comparing said analysis of said test results with said medical
profile and data base;
generating a diagnosis and a recommendation selected from the group consisting
of medical treatment, medicine, dosage, prescription drugs, over-the-counter
drugs,
nutritional supplements, treatment regimens, exercise, diet, and compliance
reminder: and
transmitting said diagnosis and recommendation for approval or changes to
medical personnel selected from the group consisting of a physician or health
care provider;



-35-



an inputting device for inputting approval or changes to said diagnosis and
recommendation from said medical personnel to said central processing unit to
provide
feedback for said patient;
a transmitter selected from the group consisting of telephone, facsimile
machine,
and electronic mail, for transmitting to said patient and permitting said
patient to access and
retrieve said approved or changed diagnosis and recommendation resulting from
said
sample collection and testing after said central processing unit has verified
that a person
seeking to access the approved or changed diagnosis and recommendation is said
patient.
57. An automatic test reporting system in accordance with claim 56 wherein
said test
kit is obtained by purchasing said test kit from a facility selected from the
group consisting
of: a pharmacy; a store; a mail order supply house; and a company advertised
on television,
radio, newspaper, magazine, catalog, Internet or a web site.
58. An automatic test reporting system in accordance with claim 56 wherein:
said patient comprises a person selected by said central processing unit at a
request of an organization selected from the group consisting of: an insurance
company, an
integrated health care provider, a managed care provider, health maintenance
organization, a
medical group, a public health agency, ministry of health, and Center for
Disease Control;
and
said test kit is delivered to said patient at the request and expense of said
organization.
59. An automatic test reporting system in accordance with claim 56 wherein
said test
equipment is selected from the group consisting of an: immunodiagnostics
analyzer,
immunoassay system, hematology analyzer, blood screen instrument, blood
analyzer,
chemistry instrument, chromatograph, urine analyzer, semen analyzer, hair
analyzer, tissue
and pore analyzer, drug monitor, microbiology analyzer, diagnostics
instrument, and
diagnostics device.
60. An automatic test reporting system in accordance with claim 56 including
an
instrument for collecting said samples, said instrument comprising a member
selected from
the group consisting of a: swab, cotton, gauge, lance, tissue, nail clippers,
scissors, cup,
bottle, container, test tube, capillary tube, petri dish, condom, bag, glove,
tape, blotter,
paper, paperboard, cardboard, dermatological patches, eye dropper, pipettes,
collector
device, sample retriever, and medical instrument.




-36-



61. An automatic test reporting system in accordance with claim 56 including a
printer connected to said central processing unit for printing said approved
or changed
diagnosis and recommendation for delivery and confirmation to aid patient and
medical
personnel, and said printer being selected from the group consisting of a
laser printer, an
ink jet printer, a dot matrix printer, and an impact printer.
62. An automatic test reporting system in accordance with claim 61 including a
facsimile machine operatively associated with said central processing unit for
transmitting
said printed approved or changed diagnosis and recommendation to said patient
and medical
personnel.

Description

CA 02294294 1999-12-14
WO 99/04043 PCT/US98/13681
-I-
TELEMEDICINE
BACKGROUND OF THE INVENTION
This invention pertains to test reporting and, more particularly, to an
automatic test
reporting process and system.
Medical tests and other types of tests traditionally require the patient or
other person
being tested to travel to a medical facility or other test site. This is
inconvenient and
cumbersome for many patients and test subjects, especially when they are
elderly, very
young, infirm, have difficulty in walking or traveling, live far away from the
medical
IO facility or test site, or when transportation is not readily available.
Furthermore, patients or
test subjects often have to wait at their doctor's office or other test site,
which is
inconvenient, time consuming and frustrating.
From a viewpoint of the medical facility or other testing facility, tests are
generally
administered by one or more persons with the assistance of facilitators and
others. The use
of many employees in the test process greatly increases the costs of tests,
because of
salaries, benefits, insurance, workmen's compensation, etc. Current test
procedures can be
costly arid burdensome to test subjects, as well as the testing facility.
For many types of medical tests, such as tests for human immunodeficiency
virus {HIV)
and genetic disease predispositions, patients usually prefer that their
identity be kept secret
or confidential, because of actual or perceived repercussions from their
families, relatives,
friends, neighbors, classmates, employer, fellow workers, associates,
government
officials, insurers, health care officials and the press. A call routing and
handling system
for conveying confidential medical test results information to anonymous
callers has also
been developed in which the caller can telephone the system and receive HIV
test result
information or status information from an automated system after providing
their personal
identification number (PII~.
Patients with chronic diseases, i.e., diabetes, asthma, hear disease, etc.,
find it difficult
to comply with treatment regimens, such as diet, testing and medication
schedules. Lack of
compliance leads to costly, preventable hospitalizations and complications.
Effective
methods to assist these patients in compliance are not generally available.
Presently,
patients have to regularly schedule appointments and periodically visit
clinics dedicated to
specific chronic disease states such as diabetes and coumadin clinics. These
clinics provide
patient education sessions with nurse educators, testing capability, and
general advice on
disease management. At a clinic, the patient will see a physician and/or a
nurse and
undergo an examination. Blood is drawn from the patient and tested in a
laboratory which,
often times, is at a site remote from where the blood was drawn. The
laboratory results are
reported to the physician who later telephones or meets with the patient to
discuss the test


CA 02294294 1999-12-14
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-2-
results and adjust the patient's medication, as necessary. The disadvantages
of this system
include: (1) inconvenience, time and cost for the patient and provider; (2)
patients find
these visits depressing and cumbersome, especially in cases where test results
are normal
and no change in regimen is therefore required; (3) patients often miss
scheduled
appointments, thereby losing any potential compliance assistance from the
system; (4)
there is usually no feedback and follow-up other than the clinic visits; (5)
patients rarely
receive help meeting regimen requirements on a day-to-day basis; (6) tests
performed in
clinics are not generally available on a home-use basis since many of these
tests require
some level of professional interpretation to adjust patient medication or
treatment regimens;
and (8) physicians and nurses often spend time with patients who are in good
health and/or
comply with their treatment regimens, and therefore do not need direct
professional
attention.
Physicians sometimes do not comply with patient "treatment guidelines" or
"care
maps", which describe detailed treatment regimens for a particular ailment,
because of, for
example, their busy schedules. Additionally, care maps simply may not exist
for a given
ailment. Lack of adherence to care maps or lack of care maps reduces the
effectiveness of
treatment and can cause costly preventable hospitalizations and complications.
Presently,
there is a lack of an effective method for helping physicians follow treatment
guidelines and
a lack of an effective method for generating care maps in cases where none
exist. The
disadvantages of current procedures include: (a) miscommunication or lack of
communication among physicians regarding care maps or treatment guidelines;
(b)
inadvertent failure to comply with care map pathway or treatment guidelines;
(c) lack of
time and misunderstanding of care maps and treatment guidelines; (d)
development of care
maps or treatment guidelines is expensive for integrated health systems and
manage care
organizations; and (e) lack of compliance with guidelines leading to reduced
health care
quality, increased patient costs, and adverse patient outcomes.
Many consumers employ the services of a health care provider for professional
diagnosis and treatment in an appropriate manner. On the other hand, some
consumers
ignore personal health issues to their detriment, or at the other end of the
spectrum, some
consumers seek the assistance of a health care professional too often. These
latter cases
have many disadvantages. For example, consumers may needlessly spend money on
an
unnecessary trip to see a health care provider; health care providers' time is
wasted seeing
patients who do not need to be treated; consumers are angered after seeing a
health care
professional who tells the consumer "nothing is wrong"; and consumers may
aggravate a
disease state by failing to appropriately visit a health care provider which
may result in
costly treatments and hospitalizations which could have been avoided.
...___.. . .._ _.__._ .. . ~.


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Outside the United States, health care is largely government financed. As
health care
costs are rising, governments are reducing and limiting levels of health care.
Many
governments are seeking ways to decrease the frequency of patient visits to
physicians and
hospitalizations. Governments are sending patients for regular visits to
health care
providers, but reduce allowable or reimbursed patient testing and other
diagnostic services.
To further reduce expenses, governments have undertaken the development of
care maps
and disease treatment guidelines to which health care providers must adhere.
Unfortunately,
patients are not always cognizant of the care maps to which health care
providers must
adhere. As a result, patients are unaware of changes in service andlor
reimbursement
allowances for those services which may lead to an increase costs to the
patient.
As the population is aging, the risk of developing age related problems, such
as
osteoporosis increases. Today, consumers have no effective way to judge their
level of
development of these problems and have little assistance in knowing
appropriate action to
be taken. The situation is currently handled in one of many ways: (1)
consumers visit a
health care provider for professional diagnosis and treatment; (2) consumers
attend
community health fairs or events where screening for conditions associated
with aging
occur; or (3) consumers visit pharmacies where screening for conditions
associated with
aging occur. The health care provider often conducts non-invasive tests, such
as vision
tests and hearing tests, as well as drawing blood to screen for conditions
associated with
aging such as, for example, diabetes, prostate cancer, and osteoporosis. The
patient is
given the test results directly or, more often, is sent home to await results.
Once the test
results are compiled, the provider recommends appropriate action. The
disadvantages of
the current procedure include: (a) cost and inconvenience for the patient;
(b) lack of good patient history and medical record keeping at health fairs
and pharmacies to
indicate the patient's baseline or normal conditions; (c) lack of
confidentiality for patients;
and (d) excessive cost to the health care provider to see healthy patients or
conduct health
screening on a mass market basis.
In the United States, managed care enrollment is increasing but consumers have
less
control over their health care decisions and are seeking to regain control.
Consumers desire
information about their health status and education about various maladies to
make
informed health care decisions. Many employers in the United States offer
employees a
variety of managed care and indemnity plans to cover employees' health care
needs, but
plans differ in coverage and costs to the employee. Employees must decide
which
programs are appropriate for themselves and their families based upon program
cost and
employee and family health status. Today employees often make decisions
empirically
based upon the plan availability, enrollment and participation costs, and
expected medical
expenses. The disadvantages of current methods include: (a) employees may be
"over

CA 02294294 1999-12-14
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covered" or "under covered" for their health care; (b) employers may spend
money offering
plans of little value to the majority of employees; (c) employees do not have
a convenient,
cost effective mechanism for verifying the health status of their families;
(d) employees
experience anxiety in the uncertainty of health care plan decisions; and (e)
because many
employees and physicians switch programs on an annual basis, there is no
central
depository for an employee's health care records, and employees must pick-up
records
from one physician and transfer the records to another physician, which is
inconvenient and
can cause loss of information.
Managed care organizations are trying to reduce overall costs per enrolled
head count.
This can be accomplished by better information management, decreasing use of
specialists,
minimizing visits to primary care providers and reducing unnecessary
hospitalizations.
Preferably, cost reductions are achieved without reducing the quality of
health care.
To reduce costs, health care organizations often place caps and/or controls on
fees for
health care services. Judgment on a patient's need for services is usually
made by an
administrative gatekeeper. The "gatekeeper" is typically a physician known as
a "primary
care physician". Procedurally, the physician sees the patient for laboratory
testing and
other diagnostic services to assess treatment needs, then submits paperwork to
an
administrator for approval to provide specific services. These procedures can
cause
problems including: (a) miscommunications or lack of communications regarding
this
gatekeeper function and requirements; (b) labor intensive and time consuming
administrative paperwork; and (c) expensive and time-consuming visits to the
gatekeeper.
Domestically, the budgets of U.S. Government Public Health organizations are
being
reduced. Public health organizations need to meet budgetary limitations, while
addressing
health concerns like HIV, sexually transmitted diseases (STD) and drug abuse.
The Center
for Disease Control (CDC) determines the charter of US Public Health. This
charter is
large and comprehensive, addressing a plethora of public health issues. The
charter
includes, but is not limited to: diagnosis, treatment, counseling, tracking
and reporting for
infectious diseases, sexually transmitted diseases, substance abuse; as well
as investigation,
tracking, and community notification of outbreaks of environmentally borne
diseases, such
as E. coli, hepatitis A, encephalitis; and detecting the presence of and
overseeing abatement
of environmental hazards, such as pollution, lead and asbestos.
Much of the data used by the CDC to track and investigate diseases and the
like comes
from public health agencies. Unfortunately, due to budgeting and priority
conflicts, data
gathering and management are handled manually in many public health
facilities. This is
inefficient, inadequate, time and labor intensive, and fraught with error and
data loss.
Inefficient data management often forces public health facilities and the CDC
to take a
blanket approach rather than a focused targeted approach to health screening,
environmental
.........._ ~.. ._.... r.. _.. .........._ _..__..........
.......,..._...~.....~..._.....,...........


CA 02294294 1999-12-14
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-5-
abatement and treatment. As a result, money is lost in broadly curing a
problem when a
more focused cure would suffice.
Some consumers with chronic diseases want a "mother hen" to help them comply
with
treatment regimens, such as diet, testing and medication schedules. These
consumers
S regularly schedule and visit clinics where samples are taken and sent to a
medical laboratory
for testing. Results from these tests are then reported back to the clinic.
Given the number
of trips the patient takes to the clinic as well as the system for obtaining
and reporting test
results, the present procedures at specialty clinics are inconvenient, time-
consuming and
expensive. In addition, patients often miss scheduled appointments and, often
times,
clinics do not remind patients of there appointments thereby losing any
potential compliance
assistance from the system. Moreover, patients receive little assistance from
the clinic in
meeting regimen requirements on a day-to-day basis.
Consumer diagnostics are not widely accepted because consumers have little or
no
knowledge about the meaning or consequences of a test result without input
from a health
care professional. Accordingly, even though a sample can be tested in the
privacy of ones
home, a trip to a health care provider is nevertheless necessary to interpret
or give meaning
to the result in spite of the fact that the test result may in fact be normal.
Hence, there is a need for a process and system for storing and dispensing
medical
information in a manner that saves consumers and health professionals time and
money by
dispensing with unnecessary meetings between these parties.
SUMMARY OF THE INVENTION
The present invention provides an automated test reporting system that
eliminates
unnecessary meetings between consumers and health professionals in an
economical and
convenient manner. In the novel process and system, the results from at least
one test or
testing kit, such as from a remote sample collection and/or testing kit, are
inputted into a
central processing unit (CPU)> which can track, analyze, compare, or otherwise
manipulate
the results. The results or information derived from, related to, or based on
the test results
are reported to a designated person or agency such as a patient, public health
official, health
department employee, official of the Center for Disease Control, physician
(medical
doctor), staff member of a hospital, trauma center personnel, health care
provider, a
managed care provider, nurse, dentist, insurance representative,
environmentalist,
customer, student, pharmacist, medical supply house, nutritionist, hygienist,
psychiatrist,
psychologist, optometrist, or audiologist. Hence, the CPU can select a person
or agency
based upon inputted test result information. Desirably, the identification of
the person is
verified by the system (CPU) before the person is provided with the test
results, or
information related to the results.


CA 02294294 1999-12-14
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-6-
The CPU can be a: microprocessor, computer, computer system, computer network,
a
semiconductor chip (computer chip), circuit board, control board, programmable
controller,
logic controller, mainframe, or data processing center. The test results can
be inputted into
the CPU by a: keyboard, telephone, modem, cellular phone, an Internet
connection, world
wide web link, computer, touch screen display, analyzer, or data processing
center.
Based upon manipulations performed by the CPU, the CPU selects and contacts an
appropriate person or agency through the use of, for example, transmitters,
receivers,
telephones, cellular phones, Internet sites, televisions, beepers, closed
circuit monitors,
computers, display screens, telephone answering machines, facsimile machines,
or
printers. Connections between the CPU and appropriate body or bodies can be
facilitated
with, for example, telephone lines, computer networks, Internet connections,
satellite
communication systems, and global communications networks.
In the inventive process and system, a sample can be collected by a patient,
customer,
public health official, assistant or other collector. The sample can be:
urine, saliva, breath,
hair, fingernails, buccal cells, oral fluids, stool, skin, sweat, nasal
fluids, mucous, semen,
vaginal secretions, blood, ocular fluids, eye swabs, or ear wax. In one
embodiment, the
sample is tested by a laboratory which may be remote from the sampling site.
In another
embodiment, the sample is tested by the patient, customer, nurse, public
health official,
which may be at the sampling site.
Non-invasive tests, such as a hearing test, a vision test, a reading test, or
a cognitive
function test to monitor progression of Alzheimer's disease, can be
administered by the
system (CPU). This can be accomplished by electronically transmitting the test
to a
receiver in proximity to the person being tested, such as a: television,
monitor, computer
screen, Internet address, telephone, cellular phone, beeper, flat panel
display, light emitting
diode (LED) screen, active matrix display screen, passive matrix display
screen, or liquid
crystal display.
The process and system can be used to detect, monitor and screen many types of
infectious diseases, chronic diseases, genetic diseases, nutritional
deficiencies,
environmental and general health problems, fertility, mental disorders, drug
abuse,
allergies. The process and system provides for better monitoring of a chronic
disease
patient's status, allowing early intervention to avoid future complications.
Furthermore, the
novel process and system can lead to better patient compliance for chronic
disease treatment
regimens by regularly contacting persons to remind them to follow a particular
treatment or
sampling regimen. Better patient compliance can reduce aggravation of the
disease,
complications and hospitalizations.
The inventive process and system can also save physicians time by sending
physicians
recommended care plans thereby automating portions of the care map, reds- ing
the
..~~_.~ v_._ .. .......~ _._..._...


CA 02294294 1999-12-14
WO 99/04043 PC1'/US98/13681
physicians' need to remember details of the care map and helping the
physicians better
comply with care maps and treatment guidelines resulting in improved patient
outcomes.
Additionally, the system can be employed to update and modify or create care
maps. The
process and system can also analyze medical and demographic information on the
patient
vis a vis statistically significant outcome information on other patients of
similar
demographic and disease backgrounds to assist health care providers and public
health
services diagnose or treat diseases. This allows the physician to make better
decisions on
patient management, ultimately improving quality of care and reducing
treatment costs.
Desirably, the novel process and system enable patients to manage their
disease or take tests
IO at home. The improved process and system are also helpful to individuals in
selecting a
health care provider.
A more detailed explanation of the invention is provided in the following
detailed
description and appended claims taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a process flow diagram of an automatic test reporting process in
accordance
with principles of the present invention; and
Figure 2 is a block flow diagram of an automated test reporting process and
system for
non-invasive tests in accordance with puinciples of tile present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
An automatic test reporting process and system for telemedicine provides rapid
accurate
automatic, comprehensive test tracking, analysis and reporting for the
convenience of the
consumer and health care organizations. Desirably, the economical process and
system
lowers health care costs and we automated, safe and reliable.
In the process and system, a test kit 10 (Figure 1) can be obtained by or for
a patient or
customer and brought to a site such as the patient's home, place of business,
store, or other
location remote from a site that performs tests or interprets test results
such as a medical
facility, hospital, trauma center, or doctor's office.
The term "test kit" is intended to encompass means for remote sampling as well
as
means for remote testing. Means for remote sampling are well known in the art
and may
include, for example, piercing instruments (such as lancets); and/or
collection receptacles
(such as cups, pouches, bags, bibulous or absorbent materials and the like).
Further
examples of sample collection instruments or collection receptacles include,
for example,
swabs, cotton gauze, nail clippers, scissors, cups, bottles, test tubes,
capillary tubes, petri
dishes, condoms, bags, gloves, tape, paperboard, cardboard, dermatological
patches, eye
droppers, pipettes, and the like. Remote testing kits are also well known and
may include

CA 02294294 1999-12-14
WO 99/04043 PCT/US98/13681
_g_
means for sampling (as referred to above) and an assay designed to detect an
analyte of
interest. Such assays are well known and may include for example immunological
or
chemical based assays. Self performing assays (SPAs) are exemplary of an assay
that may
be included in a test kit. Generally, SPAs contain all reagents necessary for
performing a
chemical or immunological assay. These reagents are often times applied to a
platform such
as a bibulous strip or contained in a receptacle such as a tube. While all of
the reagents are
supplied with the SPA itself, the test sample is provided by the person being
tested.
Typically, the person being tested places the test sample on the platform or
in the receptacle
and waits for a short incubation time for a result. It should be understood
that SPAs are
merely exemplary of assays that may be contained in a test kit and that other
assays are
available and choices of which assay to employ are a matter of choice largely
based upon
nature of the sample and test required. Hence, the test kit will typically
comprise (1) one
or more collection or sampling instruments 12 (Figure 1) to assist in
collecting a sample,
and/or (2) an assay or receptacle for holding the sample, and, optionally, (3)
a return
envelope or the like into which a sample can be placed and sent to a testing
facility
(laboratory). Additionally, the test kit or element thereof can be provided
with an indicator
11 (Figure 1) such as a: bar code, time marker, date marker, clock, magnetic
time and date
stamp, temperature indicator or thermometer, blood pressure gauge or monitor,
fingerprint
pad or marker, label, identification number, name, lettering, code, graphics
or other indicia
of the person using the kit, the time it was used, the location where it was
bought or used,
the purpose of the kit, or like indicia.
At the remote location site, the patient can open the test kit, collect a
sample with the
sample collection instrument 12 (Figure 1) and place the sample in the
collection device of
the test kit, preferably without a medical doctor, medical technician or
nurse. The sample
can be, for example, urine, saliva, breath, hair, fingernails, buccal cells,
oral fluids, stool,
skin, sweat, nasal fluids, mucous, semen, vaginal secretions, blood, ocular
fluids, eye
swabs, or ear wax.
The collected sample can be sent by delivery service 13 (Figure 1), such as by
express
delivery, courier service or mail, to a designated site equipped with
appropriate
instruments, assays, and/or personnel to test the sample and/or interpret the
results of the
sample or assay. In cases where the contents of a used test kit require
further testing as in
the case where, for example, a urine or blood sample is taken and sent to a
remote site, the
sample can be tested for an analyze, medical characteristic, condition,
disease state, medical
environmental hazard, or disease, such as: digoxin, glycated hemoglobin,
albumin,
microalbumin, heart disease, coumadin therapy, digitalis, therapeutic drug
monitoring,
mental health, depression, cancer, carcinemhyonic antigen (CEA), prostate
specific antigen
(PSA), prostrate cancer, hormone replacement therapy (HRT), breast cancer,
osteoporosis,
r r. _ ......___ ?.


CA 02294294 1999-12-14
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estrogen therapy monitoring, estrogen levels, epilepsy, anticonvulsant drug,
kidney
problems or failure, diabetes, BUN, creatinine, antibiotic therapy monitoring,
acute C-
reactive protein (CRP), strep. A, strep. B, influenza, urinary tract infection
(UTI), sexually
transmitted diseases (STD), chlamydia, gonorrhea, syphilis, infectious
diseases, human
immunodeficiency virus (HIV), HIV viral load, acquired immune deficiency
syndrome
(AIDS), herpes simplex virus, hepatitis, cognitive function, Alzheimer disease
progression,
fertility monitoring, LH, FSH, progesterone, estrogen, testosterone, E3, hCG,
nutritional
status, nutritional assessment, environmental hazard screening, environmental
contaminants
and pollutants, heavy metal, mercury, lead, asbestos, encephalitis, E. coli,
glucose,
glycated proteins, ketones, steroids, cancer markers, drugs of abuse,
toxicology, vitamins,
vitamin deficiency, specific gravity, smoking problems, lung cancer, cotinine,
carbon
dioxide, asthma, Lung capacity, tuberculosis, pnemonia, blood alcohol,
gastrointestinal
diseases, H. pylori, Ebola virus, colon cancer, colon cysts, colon polyps,
occult blood,
inflammatory bowl disease, fiber level, allergies, cystic fibrosis, bacteria,
infectious
organisms, dental assessments, tooth decay, saliva acidity, yeast infections,
yeast levels,
genetic testing, forensics, toe fungus, athlete's foot, pink eye, blood
pressure, cholesterol
level, varicella zoster virus (herpes zoster), cytomegalovirus, Epstein barn,
papilloma virus,
cellutitus, staphylococci, streptococci, mycobacteria, adenoviruses,
encephalitis,
meningitis, arbovirus, arenavirus, anaerobic bacilli, picornavirus,
coronavirus,
synsytialvirus, and the like.
The test equipment or diagnostic equipment 14 (Figure 1 ) employed to test a
sample at,
for example, a laboratory are well known and a matter of choice depending upon
the sample
and test desired. Such instruments include but are not limited to
immunodiagnostic
analyzers, immunoassay systems, hematology analyzers, blood screening
instruments,
blood analyzers, chemistry instruments, chromatography instruments, urine
analyzers,
semen analyzers, hair analyzers, tissue and pore analyzers drug monitors,
microbiology
analyzers, and SPAs. Diagnostic equipment available from Abbott Laboratories
in Abbott
Park, Illinois USA is well suited for such analysis and examples of such
instrumentation
includes the AxSYMO brand high-volume immunoassay testing system, the IMx~
brand
immunoassay testing system, the TDx~ brand and TDxFLx~ brand therapeutic drug
monitoring systems, LCxO systems for analyze detection based upon nucleic acid
probe
technology, the Cell-Dyn~ 3000 brand and Cell-Dyn~ 3500 brand automated
hematology
analyzers, Spectmm brand clinical chemistry instruments, CCXT"'' brand
clinical chemistry
instrument, Vision0 brand desk-top clinical chemistry analyzer, and TestPack~
brand and
TcstPack PlusO brand self-performing tests for pregnancy, strop throat and
chlamydia.
The test results obtained from testing of the sample may be, for example, test
data,
information answers, chemical reactions, chemical analysis, color change, or
visual

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appearance. Test results and/or any interpretation thereof and desirably
medical profile 1~
(Figure 1) of the patient are electronically inputted or scanned and fed into
a central
processing unit (CPU) with an electronic inputting device 16 (Figure 1) such
as a:
keyboard, optical scanner, telephone, modem, cellular phone, Internet link,
world wide
web connection, cable, phone line, computer, or touch screen display. The CPU
18
(Figure 1) can be for example, a microprocessor, computer, computer system,
computer
network, data processing center and the like. The medical profile can comprise
electronic
patient data and files about, for example, the patient's age, sex, height,
weight, current
and/or past medical history, physician, spouse, sex partners, parents, and
children.
The CPU can access at least one data base 19 (Figure 1), using, for example, a
modem
20, and can compare the analysis of or actual test results with the medical
profile and a data
bases) in order to generate an electronic diagnosis and recommendation
(recommended
course of action), such as: medical treatment, medicine, dosage, prescription
drugs, over-
the-counter drugs, nutritional supplements, treatment regimens, exercise,
diet, and
IS compliance reminders. The data bases) can comprise comprehensive electronic
(computerized) information about: chronic diseases, infectious diseases,
environmental
diseases, general health information, fertility, nutrition, medical treatment,
prescription
drugs, over-the-counter drugs, medicine, care maps, treatment guidelines,
medical texts,
product information, insurance guidelines, DNA data, sequence listings,
fingerprint
information, statistical probability tables, patient information and the like.
The CPU's electronic diagnosis and recommendation can be transmitted by a
transmitter
21 (Figure 1) to medical personnel 22 (Figure 1), such as a physician or
health care
provider who can personally or through the assistance of others input their
approval or
changes via an electronic inputting updating device 24 (Figure 1) into the CPU
at step 26
(Figure 1) to provide feedback to the patient. The CPU can then contact the
patient, health
care professional or other qualified person, to notify the person that an
approved or
changed diagnosis and recommendation has been entered into the CPU. The CPU
can
contact the appropriate person using transmitters 28-30 (Figure 1) such as a
modem 28 to
send, for example, e-mail, a recorded telephone message or a facsimile. In
order to assure
the confidentiality and security of the user, the CPU will verify that the
person seeking to
access the approved or changed diagnosis and recommendation is in fact an
appropriate
person, before transmitting to the approved or changed diagnosis and
recommendation
resulting from the sample collection and testing. Desirably, confirmation of
the approved
or changed diagnosis and recommendation are printed on a printer 32 (Figure l)
connected
to the CPU and sent by facsimile, mail, express delivery, or courier to the
patient 34
(Figure 1) and physician or health care provider at step 36 (Figure 1).
L.....t. ........ _. .... _. .. ........ ....... _..._..._. ....,.,..".~,._~.
..,_......... ....


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In some circumstances and for some types of tests, it may be desirable that
the patient
self test 38 (Figure 1) the sample at the patient's home or other remote
location site in
accordance with instructions in the test kit, instead of sending the sample to
the laboratory
to be tested. For self tests, the patient or others can input and feed the
test results into the
CPU, for interpretation and analysis, although it is preferred that the
patient first contact a
designated counselor or advisor 40 (Figure 1), or the patient's physician or
health care
provider, with a transmitting device 41, such as with a telephone, Internet or
e-mail
(electronic mail) etc. to discuss the test and test procedure. The counselor
or others can
input and feed the test results into the CPU with an inputting device 42
(Figure 1), similar
to those described above.
The patient can obtain and acquire the test kit by purchasing the test kit
from a retailer 44
(Figure 1 ) such as a: pharmacy, store, mail order supply house, or from an
approved
company advertised on television, radio, newspaper, magazine, catalog,
Internet or a web
site. The test kit can also be delivered to a patient identified, designated
and selected by the
CPU at the request and expense of an organization 46 (Figure 1) such as: an
insurance
company, an integrated health care provider, a managed care provider, a health
maintenance
organization {HMO), a medical group, a public health agency, a Ministry of
Health, the
Center for Disease Control, an environmental agency, or a hospital. The
patient or an
employee of the organization can collect the sample, test the sample, input
and feed the test
results into the CPU, or can have the sample sent to and tested by a
laboratory. The test
results can be automatically tracked by the CPU for the organization and the
electronic
computerized diagnosis and recommendation (recommended course of action) can
be
transmitted to the organization by a transmitter 47 (Figure 1) by telephone
via a modem, by
electronic mail (e-mail), by facsimile, express delivery, or mail. The CPU can
also transmit
recommended drug prescriptions via a transmitter 48 to a designated pharmacy
50 (Figure
1 ).
The CPU and automatic test reporting process can further assist patients in
selecting a
health care provider such as a: managed care organization, medical group,
hospital,
physician, etc. In this regard, the CPU can electronically compare the
financial criteria and
location of the patient with: a list of available health care providers for
the patient, the health
status and medical recommendations for the patient and the patient's family,
and health care
programs available from the employers of the patient's family, before
identifying and
recommending a health care provider.
The automatic test reporting process and system can also be useful for
electronically
administering non-invasive tests 60 (Figure 2) to a patient, customer or
student, such as:
hearing tests, blood pressure, pulse, electroencephalograph (EEG),
electrocardiograph
(EKG), respiration rate and function, vision tests, reading tests, and
cognitive function


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tests, such as for monitoring the progress of Alzheimer's disease. The tests
can be
administered in the patient's home or other remote location site without the
physical
presence of a physician, optometrist, optomologist, audiologist, nurse or
medical
technician. For these tests, the test kit can take the form of an electronic
auditory (hearing)
test which can be transmitted by an auditory transmitter 62 (Figure 2) or
carrier, such as by
telephone, modem, cable, Internet, world wide web, television, radio, etc.
andlor a visual
test which can be transmitted by a visual transmitter 64, such as by cable,
satellite or other
signaling system to a receiver 66 (Figure 2) such as: a monitor, computer
display screen,
flat panel display, light emitting diode (LED) screen, active matrix display
screen, passive
matrix display screen, liquid crystal display, or television. The test answers
and results can
be inputted into the CPU 68 (Figure 2) by the person taking the test with the
same or a
similar transmitter or inputting device 70 (Figure 2), such as a: telephone,
modem,
computer keyboard, Internet, or test controller. The patient's medical profile
72 can also be
inputted into the CPU. The CPU analyzes the test results; accesses a data
bases) 74
(Figure 2) containing electronic information about hearing tests, vision
tests, reading tests,
cognitive function, Alzheimer's disease, eye care, eye diseases, optical
lenses, eyeglasses,
contact lenses, ear care, hearing aids, ear drums, ear diseases, etc.;
electronically compares
the test results with the patient's medical profile and data base; and
generates an electronic
diagnosis and recommendation (recommended course of action) for the patient.
Before
being sent to the patient, the electronic diagnosis and recommendation can be
transmitted by
transmitter 76 (Figure 2), similar to those previously described, to medical
personnel 78,
such as: the patient's physician; optamologist; optometrist, audiologist; eye,
ear and nose
doctor; or health care provider; who can input their approval or changes of
the electronic
diagnosis and recommendation with an electronic updating inputting device 80,
similar to
those previously descabed, into the CPU at stage 82 to provide feedback for
the patient 84.
The diagnosis and recommendation can include: medical treatment, prescriptions
for
eyeglasses, contact lenses or hearing aids, prescription drugs, over-the-
counter drugs, etc.
The CPU can then transmit the approved or changed diagnosis and
recommendation, via a
carrier or transmitter 86 (similar to those previausly described) to the
patient.
For invasive testing, the process and system include a remate sample
collection and
testing device with automated test results tracking, automated result
reporting to the
physician or health care provider, and automated call back from the physician
or health care
provider to the patient with the test results, as well as interpretation and
medication or
treatment regimen changes. The autamated system (CPU) can call the patient's
pharmacy
with prescription changes as recammended by physician or health care provider.
To further
assist patients with compliance to medication and treatment regimens in
everyday living, the
process and system can contact chronic disease patients an a regular schedule
in order to
_. t


CA 02294294 1999-12-14
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prompt patients to take medications, exercise, diet or follow any other area
of disease
treatment regimen. For example, at regular intervals, the CPU can contact a
patient wearing
a beeper to remind them to take their medication. Chronic diseases to which
this invention
apply include, but are not limited to: diabetes (i.e., glycated hemoglobin,
microalbumin),
heart disease (i.e. coumadin therapy, digoxin monitoring), therapeutic drug
monitoring,
transplant drug monitoring, mental health (i.e., anticonvulsant drug
monitoring), kidney
failure (BUN, creatinine, albumin, antibiotic therapy monitoring).
Chronic disease patients can acquire a remote sample collection and testing
device for an
analyte identified to monitor the status of their disease progression or their
compliance with
medication and treatment regimens. Such sample collection and testing kits can
be acquired
via: purchase in a retail outlet such as a pharmacy, issuance from an
insurance company,
issuance from a managed care provider, or issuance from any channel involved
in the
patient's health care. The remote sample collection and test kits preferably
contains all
materials required to obtain the necessary sample type, to send the sample to
a laboratory,
or to perform the necessary test on the sample directly at home. Each remote
sample
collection and testing kit can contain a bar-coded, unique, personal
identification number
(PIN) for the patient. After the patient acquires a remote sample collection
and testing kit,
the patient collects samples for non-invasive testing directly. Direct tests
or home testing
can be interpreted by the consumer or by a designated advisor. A decision to
see a health
care provider is made by the consumer based on test results. Patient results
are sent to the
system and tracked by a unique bar-coded ID. This procedure can be used to
update the
patient database and patient history regardless of the decision to see a
health care provider.
The process and system then transmits the patient test results with the
patient history and
recommends changes to the health care provider, if necessary. The physician or
health care
provider can approve or change recommendations. The process and system
automatically
calls the patient with the doctor's recommendation. The process and system can
automatically call the patient's pharmacy with medication or prescription
changes approved
by the health care provider. The process and system can further automatically
schedule
visits to the health care provider if necessary.
In the case of samples sent to a laboratory, the laboratory will test the
sample using
appropriate professional laboratory tests. The laboratory will track the
patient sample via
the patient's unique, bar-coded remote sample collection and/or test kit
identification (ID)
number. Patient test results will be repocrted automatically through computer
link, wireless
transmission, or other secured, available technology to the patient's
identified physician or
health care provider. Physicians or providers will receive the patient's
history, current test
results, and any recommended changes in the patient's medication or treatment
regimen.
The physician or health care provider will approve or change the
recommendations of the

CA 02294294 1999-12-14
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CPU. The process and system will then automatically call the patient back with
the
patient's result report and recommended medication or treatment regimen
changes. In order
to assure and guarantee that the patient receives the call back, the following
procedures can
be followed: 1 } the patient will punch in or speak an identification number
into the phone or
Internet or other computer link upon receiving the automatic call back. If the
correct patient
ID is given, the patient will access the test results and physician feedback.
If the patient ID
is incorrect, the process and system will hang up and call again later. Once
the patient call
back is cleared from the process and system, written confirmed delivery of the
results will
be sent via mail to the patient and the physician or health care provider. 2)
Upon receiving
the call back, the patient is prompted to call a telephone number, such as an
800#, punch in
an ID, to receive the test results. Written confirmed delivery of results will
be sent via mail
or express delivery to the patient and the doctor or health care provider. The
system can
also automatically call the patient's pharmacy with the necessary medication
and
prescription changes. Patient records can be maintained in the computer system
(CPU) for
the patient's life time or until the patient requests that the patient's
records be expunged. In
the case of direct testing of samples at home, test results may be coded. The
results can
also be masked, requiring the patient to contact a designated advisor for test
result
interpretation. When a patient contacts an advisor, via phone, Internet,
wireless system, or
other secured communication technology, the patient's test results can be
inputted into the
CPU by the advisor and can be tracked based upon the unique, bar-coded remote
sample
collection and test kit ID number. The advisor can interpret the patient's
results based upon
a pattern or number code appearing on the direct test device. Patients can be
advised of the
test results by phone from the advisor or told to wait for a physician or
health care provider
response. Patient results will be reported automatically through computer
link, wireless
transmission, or other secured, available technology to the patient's
identified physician or
health care provider. Physicians or providers will receive from the CPU the
patient's
history, current test result, and any recommended changes in the patient's
medication or
treatment regimen. The physician or health care provider will approve or
change the
computer's recommendations and have the approval or changes inputted into the
CPU. The
process and system will then automatically call the patient back with the
patient's test
results, as well as recommended medication or treatment regimen changes.
Guarantee that
the patient receives the call back will be generated in one of several ways
discussed
previously.
Assurance that a specific patient performed the sample collection procedure on
themselves can be provided via various time and identification verification
methods, such as
with a magnetic-tape date-stamp built into the collection device to record the
exact date and
time of testing, or a date and time clock built into the test that stops when
patient sample is
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CA 02294294 1999-12-14
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applied, a sample temperature verifying mechanism, or a patient fingerprint
applied with the
sample.
Upon entering or inputting test result information, the CPU can analyze,
compare,
calculate or otherwise manipulate the input and, based upon this manipulation,
select, for
example, a recommended course of action, suggest a health insurance option,
contact
various professional personnel or agencies, and/or contact the patient.
For example, depending upon whether or not a patient fits a particular
profile, the
process and system can contact a provider and direct the provider to send a
remote sample
collection or test kit to appropriate chronic disease patients on a schedule
which may be
determined by a managed care organization or other health care provider. While
chronic
disease patients may be on a schedule determined by a health care provider, it
is the system
provided herein that maintains this schedule by insuring that an appropriate
kit is provided
at the designated times. The system can perform this function through the use
of look up
tables to match a patient with an appropriate test kit. Additionally, time
schedules can be
maintained by the present system by referencing an internal clock, well known
to those
skilled in the art, to determine when to contact a provider.
The system also provides patient result tracking and result reporting to
various health
care providers, as well as the patient. For example, upon entry of a test
result and the type
of test that was performed, the CPU can consult commonly used look up tables
to
determine sites that need to be contacted based upon the inputted information.
In a simple
case, the CPU may consult a look up table to match a patient with her
physician who is then
contacted with the test result. According to another embodiment, the patient's
test results
can be reported to the physician and health care provider along with the
patient's medical
history and a listing of current medications after accessing and pulling such
information
from a data base containing this information. Additionally, the CPU can
deliver treatment
recommendations based upon a statistical analysis of the patients history and
previous
treatments, as they relate to outcomes from similarly situated patients of
like demographic
information. The CPU can make such recommendations through the use of look up
tables
containing a listing of various treatments and an outcomes database comprising
information
about other similarly situated patients who previously have been treated with
varying
degrees of success.
In cases where the CPU provides a treatment recommendation to a physician or
other
health care provider, the physician or health care provider may have the
opportunity to
access the CPU and approve or modify the CPU's recommendation. Upon receipt of
an
approval or modification signal, the CPU recognizes that such a signal has
been received
which then permits the CPU to take further actions. For example, in cases
where a
medication is prescribed, a pharmacy can be contacted with the appropriate
prescription.
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Additionally, the patient can be notified that a medication has been
prescribed and is
available at a particular pharmacy. The patients outcome of the approved or
modified
treatment recommendation can be added to the outcome database so that the
database
contains the most current information about various treatments for future
recommendations
to patients of like condition and demographic background.
The process and system can also provide a remote sample collection and testing
device
for analytes which monitor health status. The process and system includes
automated
consumer results tracking, consumer counseling, test interpretation and
referral, as well as
automated result reporting to physician as requested by the patients. This
process includes,
but is not limited to, tests such as: acute CRP, Strep A. Strep B, influenza
tests, UTI,
sexually transmitted diseases, e.g., chlamydia, gonorrhea, etc., infectious
diseases e.g,
hepatitis, etc.
Patients can acquire a remote sample collection and testing device for an
analyte
identified to monitor their health status. For direct testing of samples at
home, results may
appear directly on the testing platform, allowing the consumer to interpret
the test on their
own and offering the alternative to call a manufacturer's designated advisor
for result
interpretation and referral information. Alternately, results may be coded or
masked,
requiring the patient to contact a designated advisor for test result
interpretation.
When consumers contact an advisor, via phone, intemet, wireless system, or
other
secured communication technology, the consumer's test result can be tracked
with, for
example, a unique bar-coded remote sample collection and test kit iD number.
Advisors
can interpret the patient's results based upon a pattern or number code
appearing on the
direct test device. The patients can be advised of their test results by the
advisor and
recommended to visit a health care provider, if necessary. The patient can
also enter the test
results into the CPU. The CPU detemlines and analyzes the test results and
reports the test
results and its analysis automatically through computer link, wireless
transmission, or other
secured, available technology to the patient's identified physician or health
care provider.
Physicians or providers will receive the patient's history, current test
results, test result-
interpretation, and a recommended diagnosis and treatment plan generated by
the CPU.
The physician or health care provider can approve or change the computer's
recommendations. Upon confirmation, the process and system will then
automatically call
the patient back with the test results, physician's recommendations, and any
recommended
medication or treatment regimen changes, as described previously.
The process and system can identify patients for testing each month or on a
regular
basis. The system can initiate posting of collection and test kit to patients.
The process and
system can automatically send remote sample collection and testing device kits
for specific
analytes to appropriate patients on a schedule determined by the Ministry of
Health, health
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CA 02294294 1999-12-14
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agency or other health care provider according to group care maps or treatment
guidelines.
The patient's results and physician treatment decision will be added to the
outcomes
database to keep current the statistical analysis of patient treatment and
outcomes. Areas to
which this process apply include, but are not limited to: chronic diseases,
such as: diabetes
(i.e., glycated hemoglobin, microalbumin), heart disease (i.e. coumadin
therapy, digoxin
monitoring), therapeutic drug monitoring, transplant drug monitoring, mental
health {e.g.,
depression), cancer (e.g., prostate cancer, breast cancer), osteoporosis (i.e.
estrogen
therapy monitoring), epilepsy (i.e. anticonvulsant drug monitoring), general
health
monitoring (e.g., general chemistry panels and CBCs), fertility monitoring
(LH, FSH,
progesterone, estrogen, testosterone, etc), STD testing (chlamydia, gonorrhea,
etc),
infectious disease testing and monitoring (e.g., HN viral load, hepatitis,
etc) and
nutritional status monitoring. The system can down load patient data to the
database for
updating.
The automated process also can provide vision monitoring, hearing loss testing
and
cognitive function testing to track the progress of Alzheimer's disease. In
the case of non-
invasive tests, such as vision, hearing or cognitive function, the consumers
contact or are
contacted by a testing center via phone, interet, wireless system, or other
secured
communication technology. The consumer will be assigned a unique )D number.
Desired
tests will then be administered via telephone (hearing or cognitive function
test), interet
(vision or cognitive function test), wireless system (hearing, vision, or
cognitive function
test), or other secured communication technology appropriate for the necessary
test. The
CPU can compare the patient's responses to the tests with a database of test
answers to
calculate test results. Test results will be reported to the consumer or
others as described
above. The consumer can be advised about the test results by an advisor and
recommended
to visit a health care provider, if necessary. The computer system (CPU) can
schedule a
physician office visit, if necessary, based upon test results above or below a
designated
baseline value. Patient results can be reported through computer link,
wireless
transmission, or other secured, available technology to the patient's
identified physician
optometrist, optomologist, audiologist, or health care provider.
The process and system are also useful to monitor elderly patients. The
computer
system (CPU) can track a patient's results over time and flag results as the
results begin to
indicate a change in the patient's status as the patient ages. For example,
upon determining
that a patient is above a certain baseline level of an analyte being
monitored, the CPU alerts
a patient and/or the patient's physician, if the test results of the medical
condition being
monitored, reach a predetermined level. This will allow patients and
physicians to take
proactive measures to help prevent catastrophic health care needs in the
future. Test sample
collection, analysis and reporting are similar to the described above.
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CA 02294294 1999-12-14
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The process and system can also be helpful to an employee in selecting a
health care
plan. The process and system can include a remote sample collection and
testing device, in
conjunction with a patient access to a computer system that utilizes
relational databases to
recommend actions. The computer system can use databases to access historical
health
information on the employee and or the employee's family members, store test
results
indicating the employee's current health status, access statistically
significant health
information on demographically similar individuals, access a house-call on a
disk-type
program that makes medical recommendations based upon test results and patient
history,
and put all this information into an algorithm or software program that
contrasts health care
insurance and programs available in comparison to the employee's health
status, financial
status, and history. Once a test result has been obtained, the computer system
can analyze
the test results in relation to the patient's medical history, current
clinical vital signs,
statistically significant health data from individuals of like demographics,
and medical
decision software. The computer system (CPU) can use an algorithm or software
program
to compare and contrast salient parameters of the various health care programs
(i.e.,
deductibles, maximum lifetime coverage, prescription drug benefits, etc) and
make a
recommendation to the employee on which health care plan the employee should
select.
The process and system can also feature a remote sample collection and testing
device
and provide computerized data handling and automated community notification.
The
process and system can provide automated patient result tracking and automated
result
reporting to public health facilities and the Center for Disease Conuol (CDC).
The patient
results can be reported to the public health with statistical analysis of
disease prevalence in
that facility and in the state as a whole. Patients can contact the system for
test results,
interpretation, counseling and referral recommendations. The automated process
and
system can schedule referral visits for the patient, as desired, if the test
results exceed a
selected range. The automated system can call patient's exposed partners as
required by
law or requested by the patient. The patient's results can be added to the CDC
database to
keep current the statistical analysis of disease prevalence. Areas to which
the process and
system can apply include, but are not limited to: mental health (e.g.,
depression), cancer
(e.g., prostate cancer, breast cancer), osteoporosis (i.e. estrogen therapy
monitoring},
epilepsy (i.e. anticonvulsant drug monitoring) general health monitoring (i.e.
general
chemistry panels and CBCs), fertility monitoring (LH, FSH, progesterone,
estrogen,
testosterone, etc), sexually transmitted disease (STD) testing (e.g.,
chlamydia, gonorrhea,
syphilis, etc), infectious disease testing and monitoring (e.g., HIV,
hepatitis, etc),
nutritional status monitoring, environmental hazard screening (e.g.,
pollution, asbestos,
lead), environmental borne disease testing (e.g., encephalitis, E. coli), and
cardiovascular
health (e.g. blood pressure, pulse, EEG, EKG).
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CA 02294294 1999-12-14
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For infectious disease diagnosis, treatment, counseling, tracking and
reporting the
patient can acquire a remote collection and testing kit from public health.
The patient,
collects the sample and posts or otherwise sends the sample or tests directly.
The samples
are tested by a laboratory. Self tests can be interpreted by the patient or an
advisor
(consultant). The patient results can be sent to public health facility and to
the Center for
Disease Control (CDC). The patient results can be tracked by a unique bar-
coded ID. The
public health facility prevalence statistics can be calculated by the CPU to
provide overall
data. The patient contacts the system for results, counseling and referral, as
described
previously. The process and system can schedule referral appointment on
request.
Environmentally borne disease investigation and reporting are typically
initiated by a
report of the disease outbreak to the Public Health. Public health scientists
visit the
suspected site, collect samples with remote sample and testing kits and gather
names of
exposed individuals. The samples are tested in a laboratory or direct tested
on site. Test
results are entered into the CPU as previously described. The CPU tracks and
analyzes the
test results. The CPU can also compare the test results with databases
concerning the test,
environmental borne diseases, and treatments to determine if the patient has
an
environmental borne disease and, if so, determine an appropriate treatment.
The test
results can be collated and sent to public health facility and the CDC
automatically by the
CPU. The process and system can automatically notify exposed individuals and
send them
test kits. The exposed individual can collect and send the sample to the
indicated laboratory
as described previously. The samples are tested in the laboratory and the test
results can be
reported by the process and system to the public health facility, individual
and the CDC.
The process and system can also perform needed statistical analysis of data
and reports for
public health and CDC.
For environmental hazard screening and abatement, the automated process and
system
can provide analysis of population, flagging high risk areas. The public
health can
distribute remote sample and test kits to high risk targets. The targets
(persons at risk)
collect samples and send the sample to an indicated laboratory for testing.
The test results
are entered into the CPU as described previously. The CPU tracks and analyzes
the test
results. The CPU can also compare the test results with databases concerning
the test,
environmental hazards and treatment, to detern~ine if the patient has a
medical condition
attributable to the environmenta.i hazard and, if so, identify an appropriate
treatment. The
process and system can report the test results to public health and the CDC.
The process
and system can automatically notify positive individuals with public health
approval.
Positive patients are treated, to the extent possible. Suspect environments
should be
abated. The process and system can prompt the patient's health care provider
or health
agency to re-test the patients.
SUBSTITUTE SHEET (RULE 26)

CA 02294294 1999-12-14
WO 99/04043 _ 2p _ PCT/US98/I3681
To further assist patients with compliance to medication and treatment
regimens in
everyday living, the process and system can be programmed to automatically
call chronic
disease patients on a regular schedule to prompt patients to take medications,
exercise, diet
or follow any other area of disease treatment regimen.
Although embodiments of this invention have been shown and described, it is to
be
understood that various modifications and substitutions of process steps, test
procedures,
equipment, instruments, devices and test kits, can be made by those skilled in
the art
without departing from the novel spirit and scope of this invention.
SUBSTITUTE SHEET (RULE 26)
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