Note: Descriptions are shown in the official language in which they were submitted.
CA 022~4962 1998-11-09
W097/43453 PCT~S97/08015
METHODANDAPPARATUSFORASCERTA~nNGM~D~CALCOND~ONS
BACKGROUND OF THE INVENTION
,.
Field of the Invention
This invention relates to a method, apparatus and
system for anonymously providing medical data for humans
including infectious status.
More particularly, the present invention relates to
anonymously providing infectious status data for humans
via unforgeable correlation characteristics.
In a further and more specific aspect, the instant
invention concerns a method and apparatus for voluntarily
and anonymously providing infectious status data for
humans and allowing the subject to share that information
with a chosen associate or associates.
Prior Art
Medical data collection, storage and display systems
of great variety in construction and purpose are often
employed for medical and non-medical purposes. Examples
include the systems described in U.S. Patent No.
4,737,912 entitled "Medical Image Filing Apparatus",
issued to Ichikawa, hereby incorporated herein by
reference, directed to a medical image filing and display
system and the like.
Another example is described in U.S. Patent No.
5,193,541 entitled "Health Examination Method And System
Using Plural Self-Test Stations And A Magnetic Card",
issued to Hatsuwi, hereby incorporated herein by
reference. This patent is directed to a system for
storing medical data on magnetic media contained on a
CA 022~4962 1998-ll-09
W 097/43453 PCT~US97/08015
card, wherein the patient provides samples and the like
to a variety of testing stations that also record the
self-test data on the card.
A further example is taught in U.S. Patent No.
5,325,294 entitled "Medical Privacy System", issued to
Keene, hereby incorporated herein by reference. This
patent describes a system and method for retrieving
medical data from a database and sharing these medical
data voluntarily with another party while protecting
against unauthorized access by unauthorized parties.
A feature common to such systems is a means for
identifying a particular patient or client and the
associated, relevant medical records.
Human disease status is highly confidential
information subject to misuse by any of a variety of
agencies or individuals. For example, many doctors will
advise patients not to seek human immunodeficiency virus
(HIV) testing via the doctor because the records
generated in the process of testing for HIV may be used
by insurance companies to deny insurance coverage to the
individual requesting the test results.
The reasoning seems to be that if the individual
sought to ascertain HIV status information, the
individual must have reason to suspect a positive HIV
status. The individual therefore is adjudged likely (i)
to have engaged in high-risk behavior, (ii) to continue
to engage in high-risk behavior and (iii) to have an
enhanced probability (compared to other population
segments) of developing (a) HIV-positive status and (b)
later, acquired immune deficiency syndrome (AIDS),
presently an almost invariably fatal condition. People
may well be denied employment if it is suspected that
they are at risk of developing an HIV-positive status or
of contracting AIDS subsequent to infection by HIV.
CA 022~4962 1998-11-09
W097/43453 PCT~S97/08015
Accordingly, it is desirable, particularly with
respect to HIV testing, to be tested in a way that
completely protects the individual identity of the test
subject. One such system is provided in some states
through Planned Parenthood, which (i) collects a blood
sample from the test subject and (ii) collects whatever
identifying indicia the test subject cares to provide,
such as a pseudonym. The agency typically then (iii)
links the identifying indicia, the test sample and a
unique identifying code or serial number in a computer
database or other log and (iv) informs the test subject
that test results are to be expected to be available
following a set interval of one to two weeks, which
interval is for shipping the test sample to a suitable
laboratory or other testing facility and receiving the
results of the analysis therefrom.
The test sample and code or serial number are then
(v) sent to a remote site for testing and analysis.
Results are then (vi) sent back to the test site (or any
other designated place). The test subject (vii) returns
to the test site or goes to a designated office and
(viii) is advised of the test results. If warranted,
(ix) appropriate counseling is provided along with
follow-up services. Additionally, (x) a paper record is
often provided with an indication of the test results.
Unfortunately, because the test subject often
provides a pseudonym, a third party has no way of
knowing that a particular record is actually the product
of a test conducted on samples provided by the individual
presenting such a record. Moreover, the paper record is
easily forged or mutilated to alter the information
contained thereon, in part because there is no standard
or unforgeable format for such records. In short, this
system affords an individual test subject great
confidence in both the anonymity and the trustworthiness
CA 022~4962 1998-11-09
W O 97/434S3 PCTAJS97108015
of the test result, but this system does not provide the
test subject with any verifiable way of providing the
test results to a third party. Additionally, recent
multiple-drug therapies can reduce presence of HIV and
indicia of HIV to immeasurably low levels but these
therapies introduce detectable levels of drugs into the
bloodstream of the test subject.
Further, the situations in which people might meet
and desire to know or communicate to each other the
status of one another do not lend themselves to accessing
of data during the course of normal business hours.
Social settings in which persons might meet and form a
mutual desire for sexual activity tend to be focused on
hours other than normal business hours, for example, in
the evening at a nightclub. If there were a method for
reliably and anonymously exchanging information such as
indicia of HIV-negative status and the date on which the
sample providing this result was collected, it would need
to be useful in such settings or in conjunction therewith
in order to be effective in controlling the spread of
this deadly disease.
Accordingly, it is desirable to provide reliable
data on health and/or infectious status in an anonymous
fashion whereby the person viewing the data has some
assurance that the data correspond to the individual with
whom they are considering carrying out such activities.
However, this alone is not necessarily sufficient because
it is desirable to be able to have access to the data on
a twenty-four-hour-a-day basis, and also because
identification cards and the like may not correspond to
the bearer thereof. Therefore, it is appropriate and
useful to base the correlation process on parameters
unique to the individual whilst continuing to ensure
anonymity of the test subject, the test results and the
fact that the test sub~ect had the testing performed.
CA 022~4962 1998-11-09
WO 97/43453 PCTrUS97/08015
In order to combat these varied problems, some form
of correlation that is unique to the individual, that is
not based on a photograph or the like of the individual
and that does not employ a transferable or forgeable
identity device (such as an identity card) is required.
The form of correlation needs to be highly reliable and
also must operate rapidly in real time to provide "go-no
go" identification in a short period of time (e.g., a
minute or less).
While the various mentioned prior art devices
function as apparatus for collecting, storing and
retrieving human medical data, certain inherent
deficiencies preclude adequate, satisfactory performance
of the purpose of reducing risk of exposure of the
individual identities of persons using the system.
SUMMARY OF THE INVENTION
Briefly, to achieve the desired objects of the
instant invention in accordance with a preferred
embodiment thereof, provided is a method of ascertaining
the medical condition of a subject. The method includes
collecting a sample from said subject and taking
biometric data from said subject. The sample is analyzed
to derive a result indicative of a medical condition of
the subject. The result is linked to the biometric data
to form a single record. This record is stored in a
database.
Also provided is a system for carrying out the steps
provided.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and further and more specific objects
and advantages of the instant invention will become
CA 022~4962 1998-11-09
WO g7/434S3 PCT/US97/08015
readily apparent to those skilled in the art from the
following detailed description of preferred embodiments
thereof taken in conjunction with the drawings in which:
FIG. 1 is a schematic illustration of a collecting
station for taking (i) a biological sample from a test
subject and (ii) collecting correlating data pertinent to
the test subject in accordance with the teachings of the
instant invention;
FIG. 2 is a schematic illustration of a collecting
station for contemporaneously taking (i) a biological
sample from a test subject and (ii) collecting
correlating data pertinent to the test subject in
accordance with the teachings of the instant invention;
FIG. 3 is a schematic illustration of a biological
sample analysis laboratory and computer data entry
station of the instant invention;
FIG. 4 is a schematic illustration of an embodiment
of the data retrieval station of the instant invention;
FIG. 5 is a flowchart describing steps involved in
collecting (i) a biological sample from a test subject
and (ii) collecting correlating data pertinent to the
test subject in accordance with the teachings of the
instant inventlon;
FIG. 6 is a flowchart describing steps involved in
biological sample analysis laboratory and computer data
entry in accordance with the teachings of the instant
invention; and
FIG. 7 is a flowchart describing steps involved in
secure data retrieval in accordance with the teachings of
the instant invention.
CA 022~4962 l998-ll-09
W O 97/43453 PCTrUS97tO8015
DETAILED DFSCRIPTION OF THE PREFERRED EMBODIMENT
Turning now to the drawings, in which like reference
characters indicate corresponding elements throughout the
several views, attention is first directed to FIGs. 1 and
2, illustrating a data collection station, generally
designated by the reference character 11, for taking (i)
a biological sample from a voluntary test subject and
(ii) collecting correlating biometric data pertinent to
the test subject, and provided with biometric scanner or
correlation device 18 in accordance with the teachings of
the instant invention. The arrangement of FIG. 2
provides a single apparatus 12' for contemporaneously
(and preferably simultaneously) taking (i) a biological
sample from a test subject and (ii) collecting
correlating data pertinent to the test subject in
accordance with the teachings of the instant invention.
This arrangement is preferred for sample collection
stations 11 operating without a human caretaker and for
maintaining the integrity of the biometric data and
sample collection process as is described in more detail
below.
It will be appreciated that many different types of
biometric scanners 18 could conceivably be employed to
realize the desired function for biometric scanner 18.
For example, human fingerprints provide unique indicia of
identity, while automatic scanning of hand geometry may
also be employed for attempting to identify specific
individuals.
Techniques for automatically scanning fingerprints
are described in U.S. Patent No. 5,465,303, "Automated
Fingerprint Classification/Identification System And
Method", Levison et al. and U.S. Patent No. 5,222,152,
entitled "Portable Fingerprint Scanning Apparatus For
Identification Verification", issued to Fishbine et al.,
CA 022~4962 l998-ll-09
W O 97143453 PCT~US97/08015
which patents are hereby incorporated herein by
reference.
While such systems are readily used and do not
require removal of clothing etc. in most climates, one
disadvantage of these types of systems is that certain
classes of persons may already have their fingerprints on
file. These classes of persons include but are not
limited to law enforcement officials, persons holding
governmental security clearances, persons holding certain
types of permits or personal property for which
fingerprints are required and other people. These
persons may not feel that a system based on
fingerprinting as a means of access provides a degree of
anonymity sufficient to promote use of the system. Other
possible methods of correlation might include toeprints,
which are not usually on file, but this would require a
person to remove their footgear in order to use the
system and also might lend itself to the spread of
annoying conditions such as athlete's foot.
Other types of biometric data successfully used for
positive identification or correlation of an individual
include dental records, anatomical geometries, retinal
patterns, speech recognition or, for that matter, gene
sequences or other chemical biodata that uniquely
identify a particular individual with a high degree of
confidence in the accuracy of the identification.
It will be appreciated that positive correlation of
biometric data need not necessarily provide unique
identification of a particular individual when a second
technique for associating a specific test subject with a
specific test result is employed. For example, when a
unique serial number known to the test subject is coupled
with biometric indicia for providing positive correlation
of the test subject and sample, the degree of confidence
a third party might have that the test results correspond
CA 022~4962 1998-11-09
W097/434S3 PCT~S97/08015
to the individual could be quite high (even approaching
certainty) if the biometric data alone would only
provide, for example, a positive correlation carrying at
least 95~ confidence that the subject was correctly
identified (as used herein, the term "positive
correlation" means "a high order of probability of
identification", i.e., a 95~ certainty or better of
identification). This means that the biometric data need
not be exhaustive and that reduced datasets may be
employed for the purpose of reducing the amount of
biometric data that must be collected, transmitted and
correlated.
Feature recognition based on face geometry is
described in U.S. Patent No. 4,975,969 entitled "Method
And Apparatus For Uniquely Identifying Individuals By
Particular Physical Characteristics And Security System
Utilizing Same", issued to Tal, and in U.S. Patent No.
5,012,522 entitled "Autonomous Face Recognition Machine",
issued to Lambert, which patents are hereby incorporated
herein by reference.
Identification techniques based on retinal patterns
are described, for example, in U.S. Patent No. 5,369,415
entitled "Direct Retinal Scan Display With Planar
Imager", issued to Richard et al., and in U.S. Patent No.
5,359,669 entitled "Remote Retinal Scan Identifier",
issued to Shanley et al., which patents are hereby
incorporated herein by reference. Identification based
on speech recognition is described, for example, in U.S.
Patent No. 4,961,229 entitled "Speech Recognition System
Utilizing IC Cards For Storing Unique Voice Patterns",
issued to Takahashi, which patent is hereby incorporated
herein by reference.
Identification based on gene sequences or other
chemical biodata that uniquely identify a particular
individual with a high degree of confidence in the
.. . . . . . .
CA 022~4962 1998-11-09
W097/43453 PCT~S97/08015
accuracy of the identification is described in U.S.
Patent No. 5,270,167 entitled "Methods Of Identification
Employing Antibody Profiles", and in U.S. Patent No.
4,880,750 entitled "Individual-Specific Antibody
Identification Methods", both issued to Francoeur, which
patents are hereby incorporated herein by reference.
An algorithm suitable for searching a database of
entries for a match for any of the above-noted biometric
classification techniques is described in U.S. Patent No.
5,479,523, entitled "Constructing Classification Weights
Matrices For Pattern Recognition Systems Using Reduced
Element ~eature Subsets", issued to Gaborski et al.
A preferred form of biometric classification for use
with the present invention is automated scanning of hand
geometry. Hand geometry scanners are described in, for
example, U.S. Patent No. 5,483,601, entitled "Apparatus
And Method For Biometric Identification Using Silhouette
And Displacement Images Of A Portion Of A Person's ~and",
U.S. Patent No. 5,335,288, entitled "Apparatus And Method
For Biometric Identification", both issued to Faulkner;
U.S. Patent No. 5,073,950, entitled "Finger Profile
Identification System", issued to Colbert et al.; U.S.
Patent No. 5,073,949, entitled "Personal Verification
Apparatus", issued to Takeda et al.; and U.S. Patent No.
3,648,240, entitled "Personnel Identification Apparatus",
issued to Jacoby et al.
Data collection station 11 also includes sample
collection device or station 12 for collecting sample 14.
In a preferred embodiment of data collection station 11,
collection device 12 is a blood sample collection
station. Other types of bodily fluids (semen, saliva
etc.) could be employed, however, at the present time,
blood samples are preferred for testing uniformity and
accuracy.
CA 022~4962 l998-ll-09
W O 97/434S3 PCTrUS97/08015
Additionally, it will be appreciated that sample
collection station 12 may be employed, if desired, for
conducting additional tests (e.g., for pubic lice,
herpes, and/or antigens or antibodies associated with
infectious diseases and any other infectious or
communicable conditions of the test subject, including
those previously successfully treated but identifiable by
remaining antibodies or other indicia in samples from the
test subject, drugs used to treat sexually transmissible
diseases and/or "recreational" drug use, especially that
associated with risk of acquiring communicable diseases,
for example, via sharing of hypodermic needles) as
desired or required. Sample collection station 12 yields
sample 14 and sample 14 is then labeled by labeling
device 24. Labeling device 24 includes optional input
port 26, whereby additional data may be entered (e.g.,
via a keyboard by medical personnel) for inclusion on the
label of sample 14 and/or included with biometric
correlation data and test date from biometric correlation
device 18. Labeling device 24 may be a laser printer,
bar code printer or other printing or labeling device as
is well known in the art. Biometric correlation data
from biometric correlation device 18, a serial number or
other correlating indicia, the date of the test and any
other desired data are then linked together and supplied
via external link 20 for shipment to database 39 (FIG. 3)
via electronic link 20.
In a preferred embodiment of the instant invention,
electronic link 20 is an encrypted digital link and may
be effected via telephone line, for example. In a
preferred embodiment of the instant invention, computer
13 supplies the serial number via link 15 to printer 19,
which prints out slip 21 bearing the serial number for
later use by the test subject.
CA 022~4962 1998-11-09
W O 97/43453 PCTrUS97/08015
The system of FIG. 2, wherein biometric scanner 18
is integrally combined with sample collection device 12
to provide combined scanner/sample collection device 12',
is a preferred arrangement for the practice of the
instant invention. By collecting sample 14
contemporaneously (and preferably simultaneously) with
biometric indicia, assurance that sample 14 and the
labeling biometric indicia correspond to one and the same
person is provided without requiring the presence of a
human monitor in order to ensure compliance. For
example, a small blood sample is taken from the tip of
one finger (e.g., the middle finger) during the scanning
of biometric data from the test subject's hand or at
least during a single insertion of the test subject's
hand into combined scanner/sample collection device 12'.
This arrangement avoids a situation that could occur
if the test subject were allowed to simply volunteer a
previously-collected sample when having biometric data
collected. In the latter scenario, there is no assurance
that the sample actually came from the test subject,
rather than the test subject's friend, child or pet.
Apparatus for collection of small blood samples are well
known in the medical industry where such procedures have
been employed for decades for testing for, for example,
phenylketonuria in newborns.
Labeled sample 14 is transferred via link 16 to
sample analysis station 35 of FIG. 3. Transfer via link
16 may be by common carrier to a remote site (e.g., a
central testing facility) or to another room in the same
facility. This could be effected via the Confide HIV
Testing Service~ provided via Direct Access Diagnostics,
a subsidiary of Johnson and Johnson, Inc. Direct Access
Diagnostics has obtained FDA approval for an over-the-
counter blood sample collection kit and testing procedure
similar to the testing approach used by Planned
CA 022~4962 1998-11-09
W O 97/43453 PCTrUS97/08015
Parenthood, i.e., providing the tested individual with
great confidence in the accuracy of the test results but
not providing a third party with any assurance that the
test result corresponds to the presenting individual.
By taking the test sample either under supervision
of a neutral medical person or in conjunction with the
collection of correlating biometric data, this assurance
can be provided to third parties. An additional
advantage is realized in that the test subject needn't
reveal a personal address or telephone number to an
agency such as Direct Access Diagnostics, where this
information might be discoverable by others. A further
advantage accrues if the test subject can only activate
access to the test results by first reviewing the test
result with a trained counselor; in-person, face-to-face
counseling with appropriate compassion and concern is
then available to the test subject in the unfortunate
event of a positive test result for HIV or other curable
or incurable conditions. Other methods for providing
link 16 and suitable testing facilities are available as
well.
FIG. 3 is a schematic illustration of biological
sample analysis laboratory and computer data
entry/storage station 35 of the instant invention.
Incoming samples 14 arrive via link 16 and are identified
by label reader 17 to determine the serial number or
other correlating indicia associated with the biometric
data and to be associated with the results of analysis of
sample 14. Sample 14 is supplied to sample analyzer 37
via link 16 and an analysis of the contents of sample 14
is performed and communicated to computer/database 39 via
link 38. The results of the analysis of sample 14 are
coupled to the biometric correlation data and to the
serial number by computer and database 39.
CA 022~4962 l998-ll-o9
W O 97/43453 PCTrUS97/08015
14
FIG. 4 is a schematic illustration of an embodiment
of data retrieval station 43 of the instant invention.
Data retrieval station 43 includes biometric correlation
device 18 coupled to database 39 of computer data entry
station 35 ~FIG. 3) via link 20. Data retrieval station
43 also includes display 45 and desirably includes data
entry device 47. Data entry device 47 comprises a
keyboard in a preferred embodiment of the instant
invention. Data entry device 47 and display 45 are
coupled to computer data entry station 35 (FIG. 3) and
database 39 via link 20.
FIG. 5 is a flowchart describing steps involved in
process 4g for collecting (i) biological sample 14 from a
test subject and tii) collecting correlating data
pertinent to the test subject in accordance with the
teachings of the instant invention. Process 49 begins
(block 50) by taking a biometric correlation reading
(block 52) which is digitized for further processing by
computer~database 39 (FIG. 3). Phlebotomy sample 14 is
collected (block 54), preferably under the supervision of
one or more witnesses to both sample collection and the
taking of the biometric correlation reading (block 52) in
order to ensure the integrity of the data collection and
collation process.
Alternatively, sample collection (block 54) may be
automated by, for example, combining a retinal scan with
an expectorate collection device or blood sample
collection device such that sample 14 could only have
come from the individual test subject from whom biometric
correlation data were collected. Similarly, a
fingerstick blood sample collected simultaneously with a
finger print by drawing sample 14 from the finger from
which the fingerprint is being taken and at the same time
as the fingerprint is taken provides similar assurances.
These methods have the advantage of allowing the sample
CA 022~4962 1998-11-09
W097/43453 PCT~S97tO8015
collection station to operate without requiring human
operators while still protecting the integrity of the
system, i.e., a third party could still reasonably have
great confidence that the medical information derived
from sample 14 corresponds to the individual providing
matching biometric data.
A numeric correlation number or serial number is
assigned (block 56) and this may be effected via either
computer 13 within station 11 (FIGs. 1, 2) or by
computer/database 39 of computer data entry station 35
(FIG. 3), with the latter being a preferred arrangement.
The serial number, biometric data, test date and sample
are linked (block 58) by (i) printing an correlating
label on sample lq via labeling device 24 (FIGs. 1, 2)
and (ii) transmission of the serial number, test date and
biometric data via link 20 to computer/database 39 (FIG.
3). The serial number is desirably but optionally made
available to the test subject (block 59) via slip 21 from
printer 19 (FIGs. 1, 2). Labeled sample 14 is then
transported (block 60) via link 16 (FIGs. 1, 2) to
biological sample analysis laboratory and computer data
entry station 35 (FIG. 3). The data collection process
then ends (block 62).
FIG. 6 is a flowchart describing steps involved in
biological sample analysis and computer data entry in
biological sample analysis laboratory and computer data
entry station 35 (FIG. 3) in accordance with the
teachings of the instant invention. Process 69 begins
(block 70) when incoming samples 14 are transported via
link 16 to label reader 17 (FIG. 3) and the serial number
and/or biodata and test date on the label of sample 14
are read (block 72) by label reader 17 (FIG. 3). Sample
14 is analyzed (block 74) to determine infectious status,
presence of antigens or antibodies associated with past
or present infectious disease of the test subject and/or
..............
CA 022~4962 l998-ll-09
W O 97t43453 PCT~US97/08015
16
presence of therapeutic or "recreational" drugs. The
results of the analysis are linked to the serial number,
sample collection date and biometric correlation data
(block 76) and are stored (block 78) in database 39 (FIG.
3). Analysis process 69 then ends (block 80).
FIG. 7 is a flowchart describing steps involved in
secure data retrieval process 90 in accordance with the
teachings of the instant invention. Data retrieval
process 90 begins ~block 92) with at least two parties
(herein designated "A" and "B") who approach data
retrieval station 43 (FIG. 4) . "A" and "B" could, for
example, be a couple who have recently met at a nightclub
and who may have expressed mutual interest in sexual
activity but who may also have concerns about the
infectious status and/or drug treatment status of each
other. "A" enters a serial number SN (block 94 ) via data
entry device 47 (FIG. 4) and also accesses (block g6)
biometric correlation device 18 (FIG. 4). Results are
transmitted (block 98) to computer/database 39 (FIG. 3)
via lin~ 20. When a match is achieved between the serial
number and biometric correlation (collectively referred
to as "ID") sent from data retrieval station 43 (FIG. 4)
with those data stored in biological sample analysis
laboratory and computer data entry station 35 ( FIG . 3),
the test results and date of the test are transmitted
back via link 20 and are received (block 100) by data
retrieval station 43 ( FIG . 4). These results and the
date of sample collection are then displayed (block 102)
on display 45 (FIG. 4), where "A" and/or "B" may view
them.
Data retrieval station 43, after a suitable interval
or in response to signals from data entry device 47 (FIG.
4), then determines if a second set of data
(corresponding to "B" in this example) are desired. When
a second set of data are desired, process 90 loops back
CA 022~4962 1998-11-09
W097/43453 PCT~S97/08015
to entry of a second serial number (block 94) vla data
entry device 47 (FIG. 4) followed by "B's" accessing
(block 96) biometric correlation device 18 (FIG. 4).
Results corresponding to "B" are transmitted (block 98)
to computer/database 39 (FIG. 3) via link 20. When a
match is achieved between the serial number and biometric
correlation (collectively referred to as "ID") sent from
data retrieval station 43 (FIG. 4) with those data stored
in biological sample analysis laboratory and computer
data entry station 35 (FIG. 3), the test results and date
of sample collection are transmitted back via link 20 and
are received (block lO0) by data retrieval station 43
(FIG. 4). These results and the date of the sample
collection are then displayed (block 102) on display 45
(FIG. 4), where "A" and/or "B" may view them. When
another set of data are not desired, the display is
blanked (erased) and process 90 ends.
It will be appreciated that it is not to A's or B's
advantage to present themselves in the above-described
setting in order to learn the status of the test results
for the first time. Additionally, it is desirable to
provide counseling for persons who test positive,
particularly for HIV, and for test results where there is
a possibility of an indeterminate test result or of a
false positive. Suitable compassion and counseling can
be guaranteed if access to the system is only activated
by mandatorily requiring the individual to present him-
or her-self at a data retrieval station 43 where the
individual and the counselor play the roles of "A" and
"B" and review A's or B's test results together in a
private setting.
The foregoing detailed description of the instant
invention for the purposes of explanation have been
particularly directed toward separate facilities for data
storage and data retrieval. It will be appreciated that
CA 022~4962 1998-11-09
W O 97/43453 PCTrUS97/08015
the invention is equally useful for systems where data
storage is also performed at each data retrieval station,
for example.
It will be appreciated that a system for anonymously
testing for infectious disease and/or associated antigens
or antibodies and/or other therapeutic or "recreational"
drugs has been described that does not require the test
subject to carry any identification card or to provide
any photograph or home address to the system has been
described. The system permits twenty-four hour access to
the data in a fashion that (i) provides high credibility
to the user as to the accuracy of the test result and the
applicability of the test result to the user and ~ii)
provides high credibility to another person that the test
results and test sample collection date correspond to the
observable user and accurately reflect the
infectious/communicable status of the test subject and/or
presence of associated antigens or antibodies and/or
other therapeutic or "recreational" drugs as of the date
of sample collection, without compromise of the identity
of the user or of the another.
It will be appreciated that need for a serial number
or at least need for the test subject to have any
knowledge of a serial number could be eliminated by
employing the biometric data alone as means for accessing
the system. However, use of a serial number does require
that the parties employing data retrieval station 43
(FIG. 4) both be conscious and also requires voluntary
compliance with the data retrieval process. Use of
"stress codes" (i.e., codes which inactivate the opening
of a closed area and also silently notify authorities) in
security systems is widespread and similar procedures may
be incorporated into the system of the instant invention
in order to obviate abuse of the system or of users of
CA 022~4962 1998-11-09
WOs7/43453 PCT~S97/08015
19
the system. Accordingly, use of a serial number in data
retrieval is desirable.
Various changes and modifications to the embodiment
herein chosen for purposes of illustration will readily
occur to those skilled in the art. For example, other
types of diseases may be tested for, to effectuate a
combination of capabilities as may be desired for a
specific application. To the extent that such
modifications and variations do not depart from the
spirit of the invention, they are intended to be included
within the scope thereof which is assessed only by a fair
interpretation of the following claims.
Having fully described the invention in such clear
and concise terms as to enable those skilled in the art
to understand and practice the same, the invention
claimed is:
.. .. . . . . . . . .. .
