KR20000010996A - Method and apparatus for ascertaining medical conditions - Google Patents

Abstract

PURPOSE: A method and apparatus for collecting medical data from a test subject while preserving anonymity for the subject and anonymously providing medical data for humans including infectious status via unforgeable correlation characteristics are provided. CONSTITUTION: The method comprises the steps of 1) collecting a sample from a test subject; 2) taking biometric data from the subject, which permits a high order of probability of correlation of the subject with the sample and with the test results derived from the sample; 3) labeling the sample with the information including the biometric data and/or the unique correlating code; 4) analyzing the sample to provide a result for determining infectious status of the subject, presence of antigens or antibodies for human diseases, presence of drug levels of therapeutic drugs known to be used in treatment of infectious diseases or presence of drug levels of recreational drugs; 5) linking the result the biometric data and the unique correlating code together to form a single record; and 6) storing the single record in a database. A user's medical data is retrieved from the database by providing a biometric reading by the user; and receiving the user's medical data from the database when the biometric reading positively correlates with the user's medical data stored in the database.

Description

Method and apparatus for investigating medical conditions.

A wide variety of medical data collection, storage and labeling are frequently used for medical and non-medical purposes. Such examples include the device described in U.S. Patent No. 4,737,912, entitled Medical Image Filing Device, patented to Ichikawa, which is incorporated herein by reference, which relates to a medical image filing and display system.

Another example of this is described in US Pat. No. 5,193,541 entitled Health Test Methods and Systems Using Multiple Self-Diagnostic Stations and Magnetic Cards Patented by Hatsuwi, which is incorporated herein by reference. This patent relates to a system for storing medical data in magnetic media contained on a card, and the patient provides samples and the like to various test stations that also record self-diagnostic data on the card.

Another example is described in US Pat. No. 5,325,294 entitled Medical Privacy System, patented to Keene, which is incorporated herein by reference. Such patents describe devices and methods for retrieving medical data from a database and sharing these medical data with another party, but such devices and methods are intended to prevent access by unauthorized persons.

A feature common to these devices is a means for identifying a particular patient or customer and associated medical records.

Human disease states are very confidential information that can be misused by various groups or individuals. For example, many doctors use a doctor's office because a record generated during a test for human immunodeficiency virus (HIV) can be used by insurance companies to deny insurance to individuals who require such test results. You will be advised not to have the same HIV test.

If an individual wants to examine HIV status information, there may be an inference that the individual must have a reason for having a positive HIV status. Thus, the individual may be either (i) involved in high-risk behavior, (ii) continuously involved in high-risk behavior, (iii) (a) HIV-positive status, and (b) a fatal condition that is almost unchanged at this time. It is judged to have a high probability (compared to other population segments) indicating acquired immunodeficiency syndrome (AIDS). People will be denied employment if they think they are at risk of developing an HIV-positive condition or if they are infected with HIV and at risk of developing AIDS.

It is therefore desirable to be tested to fully protect the individual identification of test patients, especially in HIV testing. One such system is provided consistently through family planning. That is, (i) collecting blood samples from the test patient, and (ii) collecting any identification provided by the test patient, such as the pen name. And (iii) linking the identification mark, test sample, and a unique identifier or serial number in a computer database or other log, and (iv) ensuring that the test patient receives the test results after one or two week intervals. Inform. The time is the time for sending the test sample to a suitable laboratory or other test equipment and receiving the analysis results therefrom.

The test sample and code or serial number are then sent (v) to a remote location for testing and analysis. The result is then (vi) returned to the inspection site (or another designated location). The test patient (vii) returns to the test site or goes to the designated office (viii) to hear about the test result. If necessary, (ix) appropriate advice will be provided with subsequent services. In addition, (x) paper records may be provided with an indication of the test results.

Unfortunately, the test patient often provides a pen name, so there is no way for a third party to know that a particular record is the actual result of a test performed on a sample provided by the individual presenting such a record. In addition, paper records are easily fabricated or truncated to change the information contained therein because there is no standard or unfabricated format for such records. In short, such a system allows individual test patients a great deal of security in both anonymity and trust in test results, but such a system does not provide a reliable way to provide such test results to third parties. Moreover, although recent multiple-drug therapies can reduce the indications and symptoms of HIV to unmeasurably low levels, these therapies insert detectable drugs into the blood of test patients.

Also, situations in which people want to meet and talk to each other do not allow people to access data during normal business hours. The social environment that forms a mutual desire for sexual activity tends to be focused on a time other than normal working hours, such as evenings in nightclubs. If there is a way to reliably and anonymously exchange information such as HIV-negative status indications and dates that provide such results, it may need to be useful in the above environments to be effective in preventing the spread of such horrible diseases. will be.

It is therefore advisable to provide reliable data on health and infection status anonymously so that the person verifying the data is confident that such data corresponds to the person they are considering performing the above activities. Can have However, this alone is not necessary enough because it is desirable to have access to such data at any time, and that the identity card may not belong to the person holding the identity card. Thus, it is desirable and useful to be able to continue to correlate the parameters unique to such individuals while continuing to ensure the anonymity of the test patient, the test results, and the fact that the test patient has such test performed.

To solve these various problems, some form of interrelationship is required that is unique to individuals who are not based on photographs or the like and who do not use fabricated identification devices (identity cards). This type of interrelationship is very reliable and must be able to work quickly in real time (eg in minutes) to provide a "go-to go" identification.

While the various prior art devices described above serve as devices for collecting, storing and retrieving human medical data, certain inherent deficiencies are suitable systems for the purpose of reducing the risk of individual identity exposure of a person using such a device.

The present invention relates to a method, apparatus and system for anonymously providing medical data of a person, including an infection state.

In particular, the present invention relates to anonymously providing infection status data for a person through a non-manufactureable correlation feature.

According to another aspect of the present invention, the present invention relates to a method and apparatus for allowing a patient to share such information with a selected colleague or colleagues and to volunteer and anonymously provide infection status data for a person.

1 is a schematic illustration of a collection station for (i) obtaining a biological sample from a test patient and (ii) collecting correlation data related to the test patient in accordance with the teachings of the present invention.

FIG. 2 is a schematic illustration of a collection station for (i) obtaining a biological sample from a test patient and (ii) simultaneously collecting correlation data associated with the test patient in accordance with the teachings of the present invention.

3 is a schematic illustration of a computer data entry station and biological sample analysis experiment of the present invention.

4 is a schematic illustration of an embodiment of a data recovery station of the present invention.

5 is a flow chart illustrating the steps involved in (i) collecting a biological sample from a patient and (ii) collecting correlation data associated with a test patient in accordance with the teachings of the present invention.

6 is a flow chart illustrating the steps involved in biological sample analysis experiments and computer data entry in accordance with the teachings of the present invention.

7 is a flow chart illustrating the steps involved in recovering supplemental material in accordance with the teachings of the present invention.

According to a preferred embodiment there is provided a method for examining the medical condition of a patient in order to achieve the desired objects of the invention. The method includes collecting a sample from the patient and obtaining biometric data from the patient. The sample is analyzed to elicit results as long as it represents the patient's medical condition. The results are linked to biometric data to form a single record. Such records are stored in the database. A system is also provided for performing the above steps.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

Similar chapters in the drawings represent the corresponding elements in the entire drawing. 1 and 2 show the data designated in Chapter 2 for obtaining a biological sample from a volunteer patient and providing a biometric scanner or correlator 18 in accordance with the teachings of the present invention and collecting correlated biometric data associated with the test patient. Describe the collection station. The device of FIG. 2 provides a single device 12 'to allow (i) obtaining a biological sample from a test patient and (ii) simultaneously collecting correlation data associated with the test patient in accordance with the teachings of the present invention. Such a device is preferred for a sample collection station 11 that is operated without humans and is desirable to maintain the dignity of biometric data and sample collection processing as described in more detail below.

Many different kinds of biometric scanners 18 can be used to realize the desired functionality for the biometric scanner 18. For example, a person's fingerprint provides a unique indication of person identification and automatic scanning of the planar geometry of the hand may be used to identify a specific person.

A technique for automatically scanning fingerprints is disclosed in US Pat. No. 5,465,303 and "Fishbine et al." Entitled "A device and method for automatically classifying / identifying fingerprints," patented by Levison et al. Described in US Pat. No. 5,222,152 entitled "Portable Fingerprint Scanning Apparatus for Identification", all of which are incorporated herein by reference.

The above devices can be used easily and there is no need to remove clothing and the like, but one drawback of this type of system is that certain classes of people have their fingerprints on file. This class of people includes law enforcement officials, government-assisted owners, licensed areas where fingerprints are required, or those who have private property. Such people would not feel that fingerprint-based devices would provide some degree of anonymity as an access means to improve the use of such devices. Another possible way to correlate may include foot prints that do not have a record, but it may be necessary to remove shoes in order to use the system and may also cause annoying conditions such as the feet of an athlete. something to do.

Biometrics data used for other types of personal identification or correlation can identify specific individuals with high confidence in dental records, anatomical geometry, retinal patterns, speech recognition, genetic order, or personal identification accuracy. And other chemical and biological data.

The positive correlation of biometric data need not provide a unique identification of a particular individual when a second technique is used to associate a particular test patient with a particular test result. For example, when a unique serial number known to the test patient is combined with a biometric indication to provide a positive correlation between the test patient and the sample, the degree of confidence a third party can have that the test result is that of the individual Only biometric data can be very high as long as it provides a positive correlation with at least 95% confidence that the patient has been correctly identified ("positive correlation" means that the probability of identification is high and 95% or so). It means the above identification). This means that the biometric data need not be exhaustive and that a reduced dataset can be used for the purpose of reducing the amount of biological measurement data that must be collected, transmitted and correlated.

U.S. Patent Nos. 4,975,969 and Lambert, entitled "Methods and Apparatus for Identifying Individuals by Specific Physical Features and Complementary Systems Using Them" patented by Tal for feature recognition based on the front geometry US Pat. No. 5,012,522, entitled " Automatic Face Recognition Device, "

Retinal pattern-based identification techniques are described in US Pat. No. 5,369,415, entitled "Direct Retinal Scanning Indicators with Planar Imagers," patented by Richard et al. Described in U.S. Patent 5,359,669. An identification technique based on speech recognition is described in US Pat. No. 4,961,229 entitled "Voice Recognition Devices Using IC Cards to Store Unique Speech Patterns", patented by Takahashi. All of the above patents are used herein by reference.

Identification based on genetic factor sequences or other chemical and biological data that uniquely identifies a particular individual with high confidence in the accuracy of identification is described in US Pat. Nos. 5,270,167 and "Personal- US Pat. No. 4,880,750, entitled "Specific Antibody Identification Methods", all of which are incorporated herein by reference as patents to Francoeur.

A suitable algorithm for pattern recognition systems using a "reduced element feature subset" patented by Gaborski et al. To search a database of entries for conformance to the biometrics class technology described above. US Patent No. 5,479,523 entitled " Building Specific Gravity Matrix.

A preferred form of classification of biometrics for use with the present invention is automatic scanning of hand geometry. Hand geometry scanners are known to Falkner in US Pat. US Pat. No. 5,335,288 entitled " Apparatus and Method for Invention " US Patent No. 5,073,950 entitled "Finger Profile Identification Device" to Colbert et al., US Patent No. 5,073,949 to "Takeda et al.," US Patent No. 5,073,949, and Jacoby et al. No. 3,648,240, entitled " Personal Identification Device, "

The data collection station 11 also includes a sample collection device or station 12 for collecting the sample 14. In a preferred embodiment of the data collection station 11, the collection device 12 is a blood sample collection station. However, other types of liquids such as semen, saliva, etc. may be used and blood samples are preferred to check for uniformity and accuracy.

In addition, the sample collection station 12 may be used to perform further tests as needed (eg, antibodies associated with genital parasites, herpes, antigens or infectious diseases and those previously treated successfully but remaining in samples from test patients). Infectious diseases can be obtained by the use of a medicament or in particular a hypodermic needle used to treat other infectious or infectious conditions, sexually deliverable diseases of test subjects, including those that can be identified by antibodies or other indications. Use of "entertainment" medications associated with risk). The sample collection station 12 generates a sample 14 which is then labeled by the labeling device 24. The labeling device 24 includes an optional input port 26 whereby additional data can be entered for inclusion on the label of the sample 14 and (eg, via a keyboard by a medical staff) of biometrics. The correlation device 18 may include correlation data and an inspection date. The labeling device 24 may be a laser printer, bar code printer or other printing or labeling device as is well known in the art. The biometrics correlation data, serial number or other correlation indication, test date and other desirable data from the biometrics correlation device 18 are linked together and connected to the database 39 via the electronic link 20 (FIG. 3). It is supplied through the external link 20 to send.

In a preferred embodiment of the present invention, the electronic link 20 is an encrypted digital link and may be implemented, for example, over a telephone line. In one preferred embodiment of the present invention, the computer 13 supplies a serial number to the printer 19 via a link 15 which is provided by the test patient with a slip 21 having a serial number for later use. Output

The system of FIG. 2 in which the biometric scanner 18 is integrally coupled with the sample collection device 12 to provide a combined scanner / sample collection device 12 'is a preferred device for the practice of the present invention. Collecting the sample 14 concurrently with signs or indications of biometrics provides confidence that the labeling biometrics and the sample 14 correspond to the same person without requiring the presence of a human monitor to comply with the request. For example, a small sample of blood may be taken from a fingertip (eg a stop) during scanning of biometric data from the test patient's hand or at least once inserting the test patient's hand into the combined scanner / sample collection device 12 '. Become.

Such a device avoids situations that may arise if the test subject has biometric data and is allowed to volunteer to use previously collected samples. In this case there is no guarantee that the sample is actually taken from the test patient, not the test patient's friend, child or pet. Devices for the collection of small blood samples are well known in the medical industry for which such procedures have been used for decades to test for, for example, phenylketone urine in newborns.

The labeled sample 14 is sent via the link 16 to the sample analysis station 35 of FIG. 3. Delivery via link 16 may be sent by a conventional carrier to a remote location (eg, a central laboratory) or another room within the same laboratory. This can be done through the Confidence HIV Testing Service (TM), which is provided through Direct Access Diagnatics, a subsidiary of Johnson & Johnson Incorporated. The Direct Access Diagnosis obtained FDA approval for testing procedures similar to those used by the Blood Sample Collection Kit, which can be sold without a doctor, and by family planning. In other words, the test patient is given a high degree of confidence in the accuracy of the test results, but there is no guarantee to the third party that the test results are consistent with the test individual.

Such confirmation may be provided to third parties by placing the test sample under the supervision of a medical staff in connection with the collection of correlated biometrics data. The test patient can also realize the advantage of not having to disclose the address or telephone number to a supplier such as Direct Access Diagnosis. This information can also be revealed by others. Another advantage arises even if only the test patient is allowed access to the test results by first reviewing the test results with the trained counselor. With appropriate identification and attention, face-to-face counseling can be used in test patients when there is a positive test result for HIV or other unfortunate events in a treatable or untreated condition. Other methods for providing the link 16 and appropriate inspection apparatus may likewise be used.

3 is a schematic illustration of a biological sample analysis experiment and computer data entry / storage station 35 of the present invention. Sample 14 arrives via link 16 and is identified by label reader 17 to determine a serial number or other correlation indication associated with the biometric data and to be associated with the analysis results of sample 14. . Sample 14 is supplied to sample analyzer 37 via link 16 and analysis of the contents of sample 14 is performed and sent to computer / database 39 via link 38. The analysis results of sample 14 are coupled to biometrics correlation data and coupled to serial numbers by computer and database 39.

4 shows a schematic description of the implementation of the data recovery station 43 of the present invention. The data recovery station 43 is coupled to the database 39 of the computer data entry station 35 (FIG. 3) via a link 20. The data retrieval station 43 also includes a display device 45 and preferably includes a data entry device 47. The data entry device 47 comprises a keyboard in a preferred embodiment of the present invention. The data entry device 47 and the display device 45 are connected to the computer data entry station 35 (FIG. 3) and the database 39 via a link 20.

5 is a flow chart illustrating the steps involved in the process 49 for (i) collecting biological samples 14 from test subjects and (ii) collecting correlation data related to test subjects in accordance with the teachings of the present invention. . Process 49 begins by taking the quantified biometric correlation reading (block 52) for further processing by computer / database 39 (FIG. 3) (block 50). Lower samples 14 are collected under the supervision of one or more witnesses for both the biometric correlation reading (block 52) to ensure the accuracy of sample collection and data collection and control (block 54).

Optionally, sample collection (block 54) can be automated by combining the retinal injection with a blood sample collection device or blood sample collection device such that sample 14 must come from an individual patient for which biometric correlation data will be collected. Can be. Similarly, a finger blood sample collected simultaneously with the fingerprint provides similar confidence by taking a sample 14 from the finger from which the fingerprint is taken and at the same time the fingerprint is taken. This method has the advantage of allowing the sample collection station to operate without the need for humans while protecting the accuracy of the system. That is, the third party can have great confidence that the medical information obtained from the sample 14 is from the person providing the corresponding biometric data.

The numerical correlation number or serial number is determined (block 56) which is the computer / database 39 of the computer 13 or the computer data entry station 35 (FIG. 3) in the station 11 (FIGS. 1 and 2). The latter case is the preferred device. The serial number, biometric data, test date and sample (i) print a correlation label on the sample 14 via the labeling device 24 (FIGS. 1, 2) (ii) the serial number, test date and The biometrics data is connected by sending to computer / database 39 via link 20 (FIG. 3) (block 58). The serial number can be used from the printer 19 to the test patient through the slip 21 (block 59) (FIGS. 1 and 2). Labeled sample 14 is then sent via link 16 to biological sample analysis laboratory and computer data entry station 35 (FIG. 3).

6 is a flow chart illustrating the 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 present invention. Process 69 begins when sample 14 is sent to label reader 17 via link 16 (FIG. 3), and the serial number, biological data and test date on the label of sample 14 are labeled reader 17 (Block 72) (FIG. 3). Sample 14 is analyzed to determine the infection status of the test subject, the presence of antigens or antibodies associated with past or current infectious diseases, and the presence of treatment or "entertainment" medications (block 74). The results of this analysis are linked to serial number, sample collection date and biometric correlation data (block 76) and stored in database 39 (block 78) (FIG. 3). The analysis process 69 then ends (block 80).

7 is a flowchart illustrating the steps involved in the supplemental data recovery process 90 in accordance with the teachings of the present invention. The data recovery process 90 begins with at least two parties ("A" and "B" herein) accessing the data recovery station 43 (FIG. 4) (block 92). "A" and "B" may be a couple who have recently met in a nightclub and have shown an interest in sexual activity with each other but who are interested in each other's infection status or medical treatment status. "A" enters the serial number SN through data entry device 47 (FIG. 4) (block 94) and also has access to biometrics correlation device 18 (FIG. 4) (block 96). . The result is sent via link 20 to computer / database 39 (FIG. 3) (block 98). Between the serial number sent from the data recovery station 43 (FIG. 4) and the correlation of biometrics (collectively referred to as "ID") stored in the biological sample analysis laboratory and the computer data entry station 35 (FIG. 3). When a match with the data is achieved, the test results and the test date are sent back via the link 20 and received by the data recovery station 43 (FIG. 4) (block 100). These results and the sample collection date are then displayed on the display device 45 (block 102) (FIG. 4), where "A" and "B" can examine them.

Allow the data recovery station 43 to determine whether a second set of data (corresponding to "B" in this case) is needed after a suitable interval or in response to a signal from the data entry device 47 (FIG. 4). do. When a second set of data is needed, the process 90 is followed by accessing the "B" biometrics correlation device 18 (FIG. 4) (block 96) followed by the data entry device 47 (FIG. 4). Return to the entry of the second serial number (block 94). The result corresponding to "B" is sent to the computer / database 39 (FIG. 3) via the link 20 (block 98). Between the serial number sent from the data recovery station 43 (FIG. 4) and the correlation of biometrics (referred to herein as "ID") to the biological sample analysis laboratory and the computer data entry station 35 (FIG. 3). When a match with the stored data is achieved, the test results and sample collection date are sent back via link 20 and received by data collection station 43 (FIG. 4) (block 100). These results and the sample collection date are then displayed on the display device 45 (FIG. 4) (block 102), where "A" and "B" can examine them. When no more data is needed, the display is cleared and the process 90 ends.

It will be appreciated that for the first time presenting the settings described above to know the status of the test results is not a benefit of A or B. In addition, it is advisable to provide counseling, particularly for those who are positive for HIV and for test results that are indeterminate or possibly false positive. Proper identification and counseling can be ensured if access to the system can only be activated by requiring the individuals to present themselves at the data collection station 43, where the individuals and counselors are identified as "A" and " It acts as B "and examines the test results of A or B together in a private setting.

The detailed description of the invention for the purposes of the above description has been made particularly with regard to the separate equipment of data storage and data collection. It will be appreciated that the present invention is equally useful for systems where data storage may also be performed at each data collection station, for example.

A system for anonymously examining an infectious disease or related antigen or antibody or other treatment or "entertainment" medication does not require the test subject to have any identity card with the system and provides a photo or home address to the system. Do not require to do The system provides (i) a high confidence in the accuracy of the test results to the user and an applicability of the test results to the user, and (ii) to a user whose attention to the test result and test sample collection date is noticeable to another user. 24 hours to provide high confidence in the accuracy of the patient's infection / contagion or presence of related antigens or antibodies or other treatments or "entertainment" medications, without compromise to the identity of the user or other person. Allow access to the data.

It will be appreciated that the need for serial numbers, or at least the need for test subjects to have some knowledge of serial numbers, can be eliminated by using only biometrics data as a means to access the system. However, the use of the serial number must be known to all parties using the data recovery station 43 (FIG. 4) and also requires compliance with the data recovery process. The use of "stress codes" (i.e. codes that prevent the opening of closed areas and implicitly notify the authority) in complementary systems is widespread and similar procedures are used to prevent abuse of the system or abuse of system users. It can also be incorporated within. It is therefore advisable to use serial numbers in data collection.

Various changes and modifications to the embodiment selected for the purpose of explanation will be readily apparent to those of ordinary skill in the art. For example, different types of disease may be tested to implement a combination of capabilities when needed for a particular application. It is understood that such modifications and variations are intended to be included within the scope of evaluation only by a fair interpretation of the following claims as long as they do not depart from the spirit of the present invention.

Claims (10)

Collecting a sample from the patient; Obtaining biometric data from the patient; Analyze the sample to determine results indicative of the medical condition of the patient; Linking the biometric data with the results to form a single record and And storing the single signal. The method of claim 1, further comprising labeling the sample with information comprising the biometrics data. 3. The method of claim 2, wherein said steps of collecting a sample and obtaining biometric data occur simultaneously. 2. The method of claim 1, further comprising forming a database of a plurality of said single records. The method of claim 4, further comprising providing biometrics readings by a user and Receiving the results from the database when the biometrics reading is correlated with biometrics data linked to the record stored in the database. Providing biometrics readings by the user and Receiving a medical record from the database when the biometric reading is correlated with a biometric reading associated with a medical record stored in the database. 7. The method of claim 6, wherein providing a database Collecting a sample from the patient; Obtaining a biometric reading from the patient; Analyzing the sample to obtain results indicative of the medical condition of the patient; Link the biometric readings with the results to form a medical record; And Storing the medical record in a database. 8. The method of claim 7, further comprising labeling the sample with information comprising the biometrics reading. 9. The method of claim 8, wherein the step of collecting the sample and obtaining the biometrics reading occurs simultaneously. A sample collection device for collecting biological samples from a patient, A biometrics data collection device for collecting biometrics data that allows a high probability of correlating the biological sample with a patient, An apparatus for labeling said biological sample with said biometrics data, A label reader for reading the collection date and biometric data of the biological test sample from the label on the biological test sample from the patient, An analyzer connected to the label reader and analyzing the biological test sample to provide test results including evidence of the presence or treatment of an antigen or antibody associated with the infectious disease or infectious disease of the volunteer test patient or the presence of an "entertainment" medication , And A computer coupled to the label reader and the analyzer and including a computer for linking the biometric data, date and test results from the label reader to provide a single record and to store the single record in a database. System for Investigating Medical Conditions.