WO2024211334A1

WO2024211334A1 - Systems and methods for activating a medical testing device with near-field communication

Info

Publication number: WO2024211334A1
Application number: PCT/US2024/022726
Authority: WO
Inventors: Vivek Anand BALASUBRAMANYAM
Original assignee: Pfizer Inc.
Priority date: 2023-04-05
Filing date: 2024-04-03
Publication date: 2024-10-10
Also published as: TW202514642A

Abstract

The disclosure relates to a method for activating a medical testing device via near-field communication. The method can include verifying a digitally signed message received from a user device using a public key in a medical testing device. The medical testing device can be activated after the verification of the digitally signed message.

Description

SYSTEMS AND METHODS FOR ACTIVATING A MEDICAL TESTING DEVICE WITH NEAR-FIELD COMMUNICATION

FIELD

[0001] The application is directed to systems and methods for activating a medical testing device using an encrypted key via near-field communication (NFC).

BACKGROUND

[0002] Traditionally, a medical testing device such as an in vitro diagnostics (IVD) has tests done on samples that have been taken from human body. The medical testing device can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. The medical testing device can also be used to identify patients who are likely to benefit from some treatments or therapies. These medical tests can be used by a patient in a laboratory in a health care provider’s office or by a patient at home. However, activation of the tests and traceability at the point of use can be a concern when the patient uses the medical tests without being monitored by healthcare professionals. There is a need to improve the activation and traceability of the medical tests.

SUMMARY

[0003] Disclosed herein is a method for activating a medical testing device, the method comprising: receiving an digitally signed message from a user device; verifying, by one or more processors, the digitally signed message using a public key, the public key stored in a memory of the medical testing device; and activating, by the one or more processors, at least one test for at least one patient after verifying the digitally signed message using the public key.

[0004] In some embodiments, the method further comprises: collecting information for the at least one test of the at least one patient; and sending the information to a data storage, the information corresponding to a patient record in the data storage for the at least one patient.

[0005] In some embodiments, the digitally signed message is received from the user device using near-field communications (NFC). In some embodiments, the digitally signed message comprises an encryption value. In some embodiments, the encryption value is controlled by a user using the user device. In some embodiments, the user sends the digitally signed message to the medical testing device after the user receives a notification of one or more events. In some embodiments, the one or more events comprise at least a prescription order from a healthcare provider. In some embodiments, the one or more events comprise at least a test order from a court. In some embodiments, the one or more events comprise at least a clinical trial order. In some embodiments, the method further comprises: blocking the at least one patient from accessing the information. In some embodiments, the method further comprises: sending the information to a healthcare provider, the healthcare provider contacting the at least one patient for the information. In some embodiments, the method further comprises: receiving an instruction from a patient to send the information from the data storage to a healthcare provider for counseling.

[0006] In some embodiments, the medical testing device comprises a display, the display used to inform a patient of a status of the medical testing device. In some embodiments, the medical testing device comprises a NFC antenna connecting to one of the one or more processors of the medical testing device. In some embodiments, the NFC is established between the NFC antenna and a NFC terminal of the user device.

[0007] In some embodiments, the digitally signed message comprises a timestamp. In some embodiments, the medical testing device determines if the digitally signed message expires based on the timestamp. [0008] In some embodiments, the information comprises at least one of a test result, a device status, manufacturing information, an error code, and an identifier.

[0009] Additionally disclosed herein is a medical testing device, the device comprising: one or more data processing apparatus programmed to perform operations comprising: receiving an digitally signed message from a user device; verifying, by one or more processors, the digitally signed message using a public key, the public key stored in a memory of the medical testing device; and activating, by the one or more processors, at least one test for at least one patient after verifying the digitally signed message using the public key.

[0010] In some embodiments, the operations further comprise: collecting information for the at least one test of the at least one patient; and sending the information to a data storage, the information corresponding to a patient record in the data storage for the at least one patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the inventions. In the following description, various embodiments of the present disclosure are described with reference to the following drawings, in which:

[0012] FIG. 1 illustrates a diagram of a system environment for performing medical tests, according to various embodiments of the present disclosure;

[0013] FIG. 2 illustrates a system comprising a user device that can transmit information (e.g., a digitally signed message) to and from a medical testing device, according to various embodiments of the present disclosure; [0014] FIG. 3 illustrates a block diagram of a medical testing device for use with a user device via near-field communication (NFC), according to various embodiments of the present disclosure;

[0015] FIG. 4 illustrates a flowchart for activating the medical testing device after receiving a digitally signed message from a user device, according to various embodiments of the present disclosure; and

[0016] FIG. 5 illustrates a schematic diagram of a generic computer system, according to various embodiments of the present disclosure.

DETAILED DESCRIPTION

[0017] Various non-limiting embodiments of the present disclosure will now be described to provide an overall understanding of the principles of the structure, function, and use of the apparatuses, systems, methods, and processes disclosed herein. One or more examples of these non-limiting embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. The features illustrated or described in connection with one non-limiting embodiment may be combined with the features of other non-limiting embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

[0018] Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” “some example embodiments,” “one example embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with any embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” “some example embodiments,” “one example embodiment,” or “in an embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments.

[0019] The term “approximately”, the phrase “approximately equal to”, and other similar phrases, as used in the specification and the claims (e.g., “X has a value of approximately Y” or “X is approximately equal to Y”), should be understood to mean that one value (X) is within a predetermined range of another value (Y). The predetermined range may be plus or minus 20%, 10%, 5%, 3%, 1%, 0.1%, or less than 0.1%, unless otherwise indicated.

[0020] Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed. Ordinal terms are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term), to distinguish the claim elements.

[0021] The examples provided herein are examples only and are provided to assist in the explanation of the apparatuses, devices, systems and methods described herein. None of the features or components shown in the drawings or discussed below should be taken as mandatory for any specific implementation of any of these apparatuses, devices, systems or methods unless specifically designated as mandatory. For ease of reading and clarity, certain components, modules, or methods may be described solely in connection with a specific figure. Any failure to specifically describe a combination or sub-combination of components should not be understood as an indication that any combination or sub-combination is not possible. Also, for any methods described, regardless of whether the method is described in conjunction with a flow diagram, it should be understood that unless otherwise specified or required by context, any explicit or implicit ordering of steps performed in the execution of a method does not imply that those steps must be performed in the order presented but instead may be performed in a different order or in parallel. Any dimension or example part called out in the figures are examples only, and the example embodiments described herein are not so limited.

[0022] Some of the figures can include a flow diagram. Although such figures can include a particular logic flow, it can be appreciated that the logic flow merely provides an exemplary implementation of the general functionality. Further, the logic flow does not necessarily have to be executed in the order presented unless otherwise indicated. In addition, the logic flow can be implemented by a hardware element, a software element executed by a computer, a firmware element embedded in hardware, or any combination thereof.

[0023] It is contemplated that apparatus, systems, methods, and processes of the present disclosure encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and/or modification of the apparatus, systems, methods, and processes described herein may be performed by those of ordinary skill in the relevant art.

[0024] It should be understood that the order of steps or order for performing certain actions is immaterial so long as the inventions remains operable. Moreover, two or more steps or actions may be conducted simultaneously.

[0025] With reference to the drawings, the inventions will now be described in more detail. The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). Reference throughout this document to “one embodiment”, “certain embodiments”, “an embodiment”, “an implementation”, “an example” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

[0026] FIG. l is a diagram of a system environment for performing medical tests according to one embodiment. The system environment includes a diagnostic server 150, a user device 110, a medical testing device 120, and one or more health care providers 130. The diagnostic server 150, user device 110, medical testing device 120, and health care providers 130 can be connected to each other via a network 140. In other embodiments, different and/or additional entities can be included in the system environment. The functions performed by the various entities of FIG. 1 may vary in different embodiments.

[0027] The user device 110 is an electronic device that enables the medical testing device 120 using at least a mobile device 110 (e.g., a smartphone, tablet, laptop computer, etc.). Since the user device 110 is portable, users can be the health care providers 130 and the users can physically use the user device 110 in the office. The medical testing device 120 is also portable, and user of the medical testing device 120 can be a patient. The patient can perform medical tests at the patient’s home or any other suitable location outside of health care facilities such as hospitals or central labs for the medical tests. The diagnostic server 150 is a computer server that can perform some or all functionality of the diagnostic system 102 in some embodiments. [0028] A user of the user device 110 interacts with the medical testing device 120 via a mobile application. The mobile application communicates information from the diagnostic system 102 in the medical testing device 120 via near-field communication (NFC) 108. For example, the mobile application in the user device 110 presents instructions for a medical test on a graphical user interface displayed on an electronic display on the user device 110. In some embodiments, the mobile application in the user device 100 can activate the medical tests on the medical testing device 120.

[0029] The user device 110 can communicate with the diagnostic server 150 and health care providers 130 via the network 140, which may comprise any combination of local area and wide area networks employing wired or wireless communication links. In one embodiment, the network 140 uses standard communications technologies and internet protocols. In some embodiments, all or some of the communication links of the network 140 may be encrypted, for example, to provide a technical safeguard for Health Insurance Portability and Accountability Act (HIPAA) compliance.

[0030] The health care provider server 130 is a computer server associated a health care provider such as a pharmacy, a central laboratory, a hospital, other types of healthcare facilities, or any other suitable provider of health care services. As an example use case, the diagnostic system 100 provides a medical test result of a patient to a pharmacy. Based on the results, the pharmacy determines an appropriate prescription for the patient.

[0031] FIG. 2 is a diagram of a medical testing device 120 for use with a user device 110 according to one embodiment. In the example shown in FIG. 2, the medical testing device 120 includes one or more signals to indicate “ready,” “done,” “positive,” or “negative.” In some embodiments, the medical testing device 120 includes an electronic display on a surface. The electronic display may be, for example, a liquid crystal display (LCD), organic light emitting diode (OLED) display, electronic paper display, or one or more individual light emitting diodes (LEDs), among other types of displays. The electronic display may provide one or more results for presentation on an electronic readout or analysis of one or more properties (e.g., optical, color, or geometric) of at least one reaction chamber within the medical testing device 120. In some embodiments, the electronic display may provide a result using human-readable symbols (e.g., alphanumeric characters or graphics) or machine-readable symbols (e.g., a barcode or QR code). In some embodiments, the electronic display may provide one or more test results in a human-readable format and also send the one or more results to the user device 110 via NFC communication 108. The results displayed on a display of user device 110 may therefore be redundant of the electronic display of medical testing device 120.

[0032] In an embodiment, a user device 110 transmits information (e.g., digitally signed message 104). Furthermore, the user device 110 may communicate with the medical testing device 120 via NFC communication 108. In some embodiments, the user device 110 can communicate with the medical testing device 120 directly without connecting to the network 140. The details of the user device 110 and the medical testing device 120 will be discussed in detail in FIG. 3.

[0033] NFC communication 108 may include multiple data. For example, NFC communication 108 may comprise one or more data packets. The one or more data packets may include information in a number of fields. A data version field may indicate the version of the data mapping stored in NFC communication circuitry. This allows for future updated in NFC data formats as well as enables backward compatibility. A status filed may indicate the current status or state of the medical testing device 120 (e.g., “off,” “ready for test,” “analyzing,” “done,” or “error”). A result field may indicate the result of the test or tests being performed by medical testing device 120. These may be text indications (e.g., “CO VID: Positive,” COID: Negative,” “CO VID: Invalid,” “CO VID: Negative; Flu A: Positive; Flu B: Invalid”). In some embodiments, if medical testing device 120 is performing more than one test, a separate result field for each test may be included in the NFC communication 108. An error code field may identify an error or class of errors that occurred within medical testing device 120. The error codes may be numerical (e.g., 00, 01, 02, 03) and require decoding by the mobile application to provide detailed information.

Alternatively, the error codes may include at least some text describing the error (e.g., “00 - No Error,” “01 - Human Control Failed,” “02 - Unit Disturbed,” “03 - Unable to Reach Temperature”). A serial number field may identify the medical testing device 120 by its serial number. This may be important for regulatory requirements for traceability in a given country. An expiration field may indicate the date on which the medical testing device 120 expires. A device type field may include a descriptor of the type of device, such as the type of test(s) it can perform (e.g, “COVID,” “Flu+COVID,” “Flu+RSV+COVID,” “COVID USA,” or “CO VID CE”). A time since result field may indicate an elapsed time since the result of the test was determined. A signature field may include digital signature information associated with the NFC communication 108.

[0034] FIG. 3 is a block diagram of a medical testing device 120 for use with a user device 110 via NFC communication according to one embodiment. The medical testing device 120 includes a diagnostic system 102 and an NFC antenna 310 connected to the diagnostic system 102. The diagnostic system 102 includes a processor 304, and a memory 306. The memory stores medical tests 318 and a public key 308. The user device 110 includes an NFC terminal 312, a processor 314, and a memory 316.

[0035] The medical testing device 120 can be an in vitro diagnostics device. The medical testing device 120 can store static information and dynamic information in the memory 306. The static information include serial number or manufacturing date. The dynamic information includes device status, test results, manufacturing information, or error codes. The NFC antenna 310 is connected to the processor 304 in the medical testing device 120. The processor 304 can read the memory 306, and format data to be compatible with NFC standards such as ISO 14443.

[0036] The user device 110 can be a mobile device. The NFC terminal 312 in the user device 110 can read the static and the dynamic information from the medical testing device 120 via the NFC communication 108. The NFC communication 108 provides a fast, secure, and reliable transfer between the user device 110 and the medical testing device 120. The medical test information can also be transferred to the mobile application in the user device 110.

[0037] The static information can be wirelessly programmed during manufacturing via the NFC communication 108. The static information can include a test kit identification (“Test Kit ID”) or testing device ID. The Test Kit ID can be programmed onto the medical testing device 120 and the programming of the Test Kit ID can be performed by the NFC communication 108. The Test Kit ID or testing device ID can be stored in the memory 306 of the medical testing device 120. The integration of the Test Kit ID or testing device ID into the medical testing device 120 can improve the traceability at the point of use. In some embodiments, the Test Kit ID or testing device ID may be on a box of the medical testing device 120, and the Test Kit ID may be scanned from the box when a patient receives the medical testing device 120. By using the Test Kit ID and/or the testing device ID, test results 220 of the medical testing device 120 can be transmitted to the network 140. The test results 220 can be sent to an electronic health record (EHR) system via the network 140. In some embodiments, the test results 220 can be sent to the EHR system via the user device 110 or some other network-connected device. The test results 220 can be added to the patient’s record in the EHR system without requiring any intermediary system or a third party to collect or process personal identification information. In some embodiments, the test results 220 may include user’s medical history such as prescriptions, health conditions, genetic data, visits to health care providers, past or current medical services or interventions received, or previously completed diagnostic tests along with relevant details such as the date that the tests were taken and the test results. In some embodiments, the test results 220 are transmitted to the network (e.g., cloud) via the user device 110.

[0038] The memory 306 in the medical testing device 120 has an area corresponding to patient IDs. The patient ID can be wirelessly programmed via the NFC communication 108 in the memory 306 at the distribution point of the medical testing device 120. The health care provider, such as a nurse or a pharmacist, can program a unique patient ID or a one-time code onto a medical testing device 120. When the patient scans their medical testing devices 120, the test results 220 can be sent to the EHR via the network 140. In some embodiments, information such as medical test status and manufacturing information can also be programmed onto the medical testing device 120.

[0039] In one embodiment, the medical testing device 120 has a writable area of memory which is connected to the use device 110 via the NFC communication 108. In another area of the memory 306, the public key 308 associated with the digitally signed message 104 is stored. The digitally signed message 104 can be provided by the user device 110 via the NFC communication 108. In some embodiments, the digitally signed message 104 includes a timestamp, and the medical testing device 120 can determine whether the digitally signed message 104 expires based on the timestamp.

[0040] In some embodiments, the user device 110 can check whether the medical testing device 120 is expired and prevent activation of the medical testing device 120 if it is expired. In some embodiments, the medical testing device 120 is in a de-activated state for its factory setting. The mobile application of the user device 110 can write the digitally signed message 104 to the memory 306 of the medical testing device 120 via the NFC terminal 312 in the user device 110. The medical testing device 120 can use the public key 308 to verify the digitally signed message 104 from the user device 110. After verifying the digitally signed message 104 in the medical testing device 120, the medical testing device 120 can activate the medical tests 318. Therefore, the medical tests 318 can be activated before or after the medical testing devices 120 are distributed to patients. For example, if a medical test 318 is a prescription-only test, the physician can prescribe the medical test 318 and activate the medical test 318 using the mobile application on the user device 110 via the NFC communication 108. The medical testing device 120 is then distributed to the patient after the activation. Alternatively, the medical testing device 120 is then distributed to the patient before the activation, which would enable remote control or timed control of when the patient can access and perform the test. In some embodiments, if the medical test 318 is a court-ordered test, the medical test 318 can also be activated by the court before or after the medical testing device 120 is distributed to the patient. The activation of the medical test 318 can be performed by the mobile application on the user device 110 via NFC communication 108. The activation via NFC communication 108 allows a better control of when the medical test is completed and reduces false reporting.

[0041] In some embodiments, the medical testing device 120 can have a built-in status display without a display for the test results 220. The status display can be used to inform the user of the status of the medical testing device 120. The status includes “off,” “analyzing,” and “done.” The users can tap the medical testing device 120 with their user devices 110, e.g., a mobile phone via the NFC communication 108, and the test results 220 or any error message can be transferred to the mobile application on the user devices 110. The mobile application on the user device 110 may display the test results 220 to a third party. In some embodiments, the mobile application on the user devices 110 may send the test results 220 to the network 140 such as a cloud server, and the health care providers 130 can access the test results 220 from the network 140 or the cloud server. The health care providers 130 can contact the patients and provide the test results 220 to the patients with appropriate counselling. The benefits of using the medical testing device 120 without a display for the test results 220 include enabling the patient to perform “psychologically difficult medical tests” at patient’s home but the patient has to wait for the health care provider to report and/or explain the test results 220 to the patient. With proper counselling from the health care provider while delivering the test results to the patient, the risk of patient distress, selfdestructive behavior or self-harm is significantly reduced compared to scenarios where the patient receives the test results 220 directly from the medical testing device 120. In some embodiments, the medical testing device 120 can be used for clinical trial use cases in which the patient must be blinded to the test results 220. Examples of psychologically difficult medical tests are known to those of ordinary skill in the art and include, without limitation, test for incurable diseases (e.g., cancer, HIV/AIDS, Alzheimer’s disease, herpes simplex, HSV-1, HSV-2, genital herpes, etc.), sexually transmitted diseases (e.g., HIV/AIDS, herpes simplex, HSV-1, HSV-2, Bacterial Vaginosis (BV), Chlamydia, Gonorrhea, Human Papillomavirus (HPV), Syphilis, etc.), and commonly stigmatized disease (e.g., HIV/AIDS, tuberculosis, ebola, leprosy, herpes simplex, etc.).

[0042] In some embodiments, the medical tests of the present disclosure can facilitate group testing in the same location (e.g., more than one patient in the same room). In some embodiments, each patient can tap one of the medical testing devices 120 via the NFC communication 108 individually with the mobile application on patient’s user device 110. The patient’s name can be written into the memory 306 of the medical testing device 120. After the patients finish the testing, an operator can scan all the medical testing devices 120 via the NFC communication 108 by the operator’s user device 110 to read the test results 220 and the associated name for each test result 220. This approach protects patient confidentiality while allowing larger scale tests to be conducted at the same site. The mobile application on the user devices 110 of the patients can ensure that each of the patients cannot write or read other patients’ name on their user devices 110.

[0043] In some embodiments, the medical testing device 120 can be used in a health center for anonymous sexual transmitted infections (STI). For example, a college health center can provide a college student a medical testing device 120 such as an at-home test kit with the ability of NFC communication 108. If the college student tests positive for chlamydia, he or she can tap the medical testing device 120 via the NFC communication 108 to a treatment vending machine for automatic dispensing of their treatment (e.g., associated antibiotics or other drugs for treating symptoms of their diagnosed disease, disorder, or condition). Such testing can be fully anonymous. The testing can be patient-identified by recording the Test Kit ID when the patient or the student receives the medical testing device 120, and matching the medical testing device 120 with the antibiotics dispenser when the medical testing device 120 is scanned by the antibiotic dispenser.

[0044] FIG. 4 illustrates a method 400 for activating the medical testing device 120, according to various embodiments of the present disclosure.

[0045] At step 402, a digitally signed message from a user device is received. At step 404, an attempt is made to verify the digitally signed message using a public key. The digitally signed message is received from the user device using near-field communications (NFC). The digitally signed message comprises an encryption value, and the encryption value is controlled by a user using the user device. At step 406, the medical testing device 120 determines whether the digitally signed message is verified. If not (“No” at step 406), then, at step 408, an error is returned and processing returns to step 404. If the digitally signed message is verified (“Yes” at step 406), then, at step 408, at least one test for at least one patient is activated. At step 410, information for the at least one patient is collected. The information includes at least one of a test result, a device status, manufacturing information, an error code, and an identifier. At step 412, the information is sent to a data storage. In some embodiments, an error code returned at step 408 is sent to data storage as well.

[0046] Embodiments of this disclosure can be performed on a computing device. An example of a type of user’s computer is shown in FIG. 5, which shows a schematic diagram of a generic computer system 500. A graphical user interface (GUI) may be implemented as a software application and the software application may be used on the user’s computer.

[0047] In some embodiments, the system 500 may be used for the operations described in association with any of the methods. The functions and the algorithms described above may be performed in the software application on the user’s computer.

[0048] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments.

[0049] It is to be understood that the above descriptions and illustrations are intended to be illustrative and not restrictive. It is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims. Other embodiments as well as many applications besides the examples provided will be apparent to those of skill in the art upon reading the above description. The scope of the present disclosure should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The omission in the following claims of any aspect of subject matter that is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventor did not consider such subject matter to be part of the disclosed inventive subject matter. [0050] Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

[0051] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0052] Having thus described several aspects of at least one embodiment of the present disclosure, it is to be appreciated that various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure and are intended to be within the spirit and scope of the present disclosure. Accordingly, the foregoing description and drawings are by way of example only.

[0053] Numerous modifications and variations are possible in light of the above teachings. Within the scope of the appended claims, embodiments of the present disclosure may be practiced otherwise than as specifically described herein. While the inventions have been particularly shown and described with reference to a preferred embodiment and various alternate embodiments, it will be understood by persons skilled in the relevant art that various changes in form and details can be made therein without departing from the spirit and scope of the inventions.

[0054] All references, issued patents and patent applications cited within the body of the instant specification are hereby incorporated by reference in their entirety, for all purposes.

Claims

CLAIMS What is claimed is:

1. A method for activating a medical testing device, the method comprising: receiving an digitally signed message from a user device; verifying, by one or more processors, the digitally signed message using a public key, the public key stored in a memory of the medical testing device; and activating, by the one or more processors, at least one test for at least one patient after verifying the digitally signed message using the public key.

2. The method of claim 1, further comprising: collecting information for the at least one test of the at least one patient; and sending the information to a data storage, the information corresponding to a patient record in the data storage for the at least one patient.

3. The method of claim 1, wherein the digitally signed message is received from the user device using near-field communications (NFC).

4. The method of claim 1, wherein the digitally signed message comprises an encryption value.

5. The method of claim 4, wherein the encryption value is controlled by a user using the user device.

6. The method of claim 5, wherein the user sends the digitally signed message to the medical testing device after the user receives a notification of one or more events.

7. The method of claim 6, wherein the one or more events include at least a prescription order from a healthcare provider.

8. The method of claim 7, wherein the one or more events include at least a test order from a court.

9. The method of claim 6, wherein the one or more events include at least a clinical trial order.

10. The method of claim 2, further comprising blocking the at least one patient from accessing the information.

11. The method of claim 2, further comprising sending the information to a healthcare provider, the healthcare provider contacting the at least one patient for the information.

12. The method of claim 2, further comprising receiving an instruction from a patient to send the information from the data storage to a healthcare provider for counseling.

13. The method of claim 1, wherein the medical testing device comprises a display, the display used to inform a patient of a status of the medical testing device.

14. The method of claim 3, wherein the medical testing device comprises a NFC antenna connecting to one of the one or more processors of the medical testing device.

15. The method of claim 14, wherein the NFC is established between the NFC antenna and a NFC terminal of the user device.

16. The method of claim 1, wherein the digitally signed message comprises a timestamp.

17. The method of claim 16, wherein the medical testing device determines if the digitally signed message expires based on the timestamp.

18. The method of claim 2, wherein the information comprises at least one of a test result, a device status, manufacturing information, an error code, and an identifier.

19. A medical testing device, the device comprising: one or more data processing apparatus programmed to perform operations comprising: receiving an digitally signed message from a user device; verifying, by one or more processors, the digitally signed message using a public key, the public key stored in a memory of the medical testing device; and activating, by the one or more processors, at least one test for at least one patient after verifying the digitally signed message using the public key.

20. The device of claim 19, wherein the operations further comprise: collecting information for the at least one test of the at least one patient; and sending the information to a data storage, the information corresponding to a patient record in the data storage for the at least one patient.