WO1997043453A1 - Methode permettant de constater certains etats pathologiques et appareil correspondant - Google Patents

Methode permettant de constater certains etats pathologiques et appareil correspondant Download PDF

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Publication number
WO1997043453A1
WO1997043453A1 PCT/US1997/008015 US9708015W WO9743453A1 WO 1997043453 A1 WO1997043453 A1 WO 1997043453A1 US 9708015 W US9708015 W US 9708015W WO 9743453 A1 WO9743453 A1 WO 9743453A1
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WO
WIPO (PCT)
Prior art keywords
sample
subject
biometric
data
biometric data
Prior art date
Application number
PCT/US1997/008015
Other languages
English (en)
Inventor
James E. Beecham
Original Assignee
Beecham James E
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/686,211 external-priority patent/US5897989A/en
Application filed by Beecham James E filed Critical Beecham James E
Priority to JP09541021A priority Critical patent/JP2000510975A/ja
Priority to EP97924678A priority patent/EP0904413A4/fr
Priority to AU30042/97A priority patent/AU3004297A/en
Priority to CA002254962A priority patent/CA2254962A1/fr
Publication of WO1997043453A1 publication Critical patent/WO1997043453A1/fr
Priority to EA199800989A priority patent/EA199800989A1/ru

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Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60—Protecting data
    • G06F21/62—Protecting access to data via a platform, e.g. using keys or access control rules
    • G06F21/6218—Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
    • G06F21/6245—Protecting personal data, e.g. for financial or medical purposes
    • G06F21/6254—Protecting personal data, e.g. for financial or medical purposes by anonymising data, e.g. decorrelating personal data from the owner's identification
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/117—Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/117—Identification of persons
    • A61B5/1171—Identification of persons based on the shapes or appearances of their bodies or parts thereof

Definitions

  • This invention relates to a method, apparatus and system for anonymously providing medical data for humans including infectious status.
  • the present invention relates to anonymously providing infectious status data for humans via unforgeable correlation characteristics.
  • 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.
  • HIV immunodeficiency virus
  • 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.
  • 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.
  • 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.
  • this system affords an individual test subject great confidence in both the anonymity and the trustworthiness 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.
  • 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.
  • a method of ascertaining the medical condition of a subject 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.
  • 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 (l) 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 invention
  • 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.
  • FIG. 7 is a flowchart describing steps involved in secure data retrieval m accordance with the teachings of the instant invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
  • FIGs. 1 and 2 illustrating a data collection station, generally designated by the reference character 11, for taking (1) 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 (l) 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.
  • biometric scanners 18 could conceivably be employed to realize the desired function for biometric scanner 18.
  • human fingerprints provide unique indicia of identity
  • 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 Fishbme et al . , which patents are hereby incorporated herein by reference.
  • 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.
  • 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.
  • 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 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) .
  • 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.
  • 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.
  • 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 Hand", 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.
  • collection device 12 is a blood sample collection station.
  • Other types of bodily fluids such asmen, saliva etc. could be employed, however, at the present time, blood samples are preferred for testing uniformity and accuracy.
  • 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 m 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.
  • electronic link 20 is an encrypted digital link and may be effected via telephone line, for example.
  • 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.
  • 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.
  • 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
  • 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 Parenthood, i.e., providing the tested individual with great confidence m the accuracy of the test results but not providing a third party with any assurance that the test result corresponds to the presenting individual.
  • 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.
  • test subject can only activate access to the test results by first reviewing the test result with a trained counselor; m-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.
  • 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 49 for collecting (I) biological sample 14 from a test subject and (ii) 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.
  • sample collection 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.
  • a fmgerstick 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.
  • 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
  • the serial number, biometric data, test date and sample are linked (block 58) by (i) printing an correlating label on sample 14 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 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 96) biometric correlation device 18 (FIG. 4) .
  • Results are transmitted (block 98) to computer/database 39 (FIG. 3) via link 20.
  • ID serial number and biometric correlation
  • data retrieval station 43 FIG. 4
  • results and date of the test are transmitted back via link 20 and are received (block 100) by data retrieval station 43 (FIG. 4) .
  • 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.
  • process 90 loops back to entry of a second serial number (block 94) via 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.
  • ID biometric correlation
  • test results and date of sample collection are transmitted back via link 20 and are received (block 100) by data retrieval station 43 (FIG. 4) .
  • data retrieval station 43 FIG. 4
  • 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.
  • display is blanked (erased) and process 90 ends.
  • 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.

Abstract

L'invention a trait à une méthode ainsi qu'à l'appareil correspondant permettant de collecter des données médicales relatives à un sujet de test tout en préservant l'anonymat de celui-ci. Cette méthode consiste à prélever un échantillon sur un sujet de test et à relever ses données biométriques. Ces dernières permettront, avec un degré élevé de fiabilité, de mettre en corrélation le sujet de test, l'échantillon qui est le sien et les résultats fournis par l'étude de cet échantillon. Cette méthode comporte, de préférence, une autre étape consistant à attribuer au sujet de test un code unique de corrélation, ce qui permettra également une corrélation unique du sujet de test avec l'échantillon et les résultats fournis par l'étude de cet échantillon. Mieux encore, cette méthode peut également comporter une autre étape qui consiste à marquer l'échantillon à l'aide d'information contenant les données biométriques.
PCT/US1997/008015 1996-05-13 1997-05-09 Methode permettant de constater certains etats pathologiques et appareil correspondant WO1997043453A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP09541021A JP2000510975A (ja) 1996-05-13 1997-05-09 ヒトの医学的状態を確かめる方法と装置
EP97924678A EP0904413A4 (fr) 1996-05-13 1997-05-09 Methode permettant de constater certains etats pathologiques et appareil correspondant
AU30042/97A AU3004297A (en) 1996-05-13 1997-05-09 Method and apparatus for ascertaining medical conditions
CA002254962A CA2254962A1 (fr) 1996-05-13 1997-05-09 Methode permettant de constater certains etats pathologiques et appareil correspondant
EA199800989A EA199800989A1 (ru) 1996-05-13 1998-12-07 Способ и система для установления медицинского состояния

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US1718196P 1996-05-13 1996-05-13
US1918896P 1996-06-06 1996-06-06
US08/686,211 1996-07-23
US08/686,211 US5897989A (en) 1996-07-23 1996-07-23 Method, apparatus and system for verification of infectious status of humans
US60/017,181 1996-07-23
US60/019,188 1996-07-23

Publications (1)

Publication Number Publication Date
WO1997043453A1 true WO1997043453A1 (fr) 1997-11-20

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PCT/US1997/008015 WO1997043453A1 (fr) 1996-05-13 1997-05-09 Methode permettant de constater certains etats pathologiques et appareil correspondant

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EP (1) EP0904413A4 (fr)
JP (1) JP2000510975A (fr)
AU (1) AU3004297A (fr)
CA (1) CA2254962A1 (fr)
EA (1) EA199800989A1 (fr)
WO (1) WO1997043453A1 (fr)

Cited By (5)

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WO1999007282A1 (fr) 1997-08-06 1999-02-18 Beecham James E Systeme servant a verifier des donnees medicales humaines
WO2001070023A1 (fr) * 2000-02-25 2001-09-27 Jan Jaap Nietfeld Procede d'enregistrement, de memorisation et d'utilisation anonyme de materiau anatomique et/ou d'information derivee de ce materiau
DE10206396A1 (de) * 2002-02-15 2003-02-06 Siemens Ag Verfahren zur Zuordnung medizinischer Daten zu einem Patienten
US7320685B2 (en) 2000-10-20 2008-01-22 Carl Zeiss Meditec Ag Method and device for identifying an eye that is to be treated in operations
US20210366607A1 (en) * 2020-05-19 2021-11-25 Bipin KOLLURI Health screening kiosk

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CA2504260A1 (fr) * 2002-11-06 2004-05-27 Baxter International Inc. Procede et dispositif destines a la mise en oeuvre d'un systeme de gestion de l'inactivation d'un agent pathogene
WO2006061771A2 (fr) * 2004-12-09 2006-06-15 Koninklijke Philips Electronics, N.V. Identification des patients pour diagnostics dans les centres de traitement
AU2013266193B2 (en) * 2012-05-23 2018-08-02 Iphenotype Llc Phenotypic integrated social search database and method

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Publication number Priority date Publication date Assignee Title
WO1999007282A1 (fr) 1997-08-06 1999-02-18 Beecham James E Systeme servant a verifier des donnees medicales humaines
WO2001070023A1 (fr) * 2000-02-25 2001-09-27 Jan Jaap Nietfeld Procede d'enregistrement, de memorisation et d'utilisation anonyme de materiau anatomique et/ou d'information derivee de ce materiau
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US20210366607A1 (en) * 2020-05-19 2021-11-25 Bipin KOLLURI Health screening kiosk

Also Published As

Publication number Publication date
EA199800989A1 (ru) 1999-06-24
EP0904413A4 (fr) 1999-09-29
CA2254962A1 (fr) 1997-11-20
EP0904413A1 (fr) 1999-03-31
JP2000510975A (ja) 2000-08-22
AU3004297A (en) 1997-12-05

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