US20180146266A1 - System and Method for Controlling Authentication of a Physiological Acquistion Device by a Patient Monitor - Google Patents
System and Method for Controlling Authentication of a Physiological Acquistion Device by a Patient Monitor Download PDFInfo
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- US20180146266A1 US20180146266A1 US15/359,165 US201615359165A US2018146266A1 US 20180146266 A1 US20180146266 A1 US 20180146266A1 US 201615359165 A US201615359165 A US 201615359165A US 2018146266 A1 US2018146266 A1 US 2018146266A1
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04Q—SELECTING
- H04Q9/00—Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
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- A—HUMAN NECESSITIES
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- H04L63/08—Network architectures or network communication protocols for network security for authentication of entities
- H04L63/0876—Network architectures or network communication protocols for network security for authentication of entities based on the identity of the terminal or configuration, e.g. MAC address, hardware or software configuration or device fingerprint
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- H—ELECTRICITY
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- H04L63/00—Network architectures or network communication protocols for network security
- H04L63/12—Applying verification of the received information
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- A—HUMAN NECESSITIES
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- H04Q—SELECTING
- H04Q2209/00—Arrangements in telecontrol or telemetry systems
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- H04Q2209/88—Providing power supply at the sub-station
Definitions
- the present disclosure generally relates to medical patient monitoring systems, and more particularly to methods and systems for authenticating approved physiological data acquisition devices for connection to a patient monitor.
- Patient monitors for monitoring physiological data often comprise a central patient monitor connectable to multiple auxiliary devices that acquire physiological data from the patient so that multiple different types of physiological data acquired by multiple different devices is collected and channeled through a central monitoring device.
- the central monitoring device often includes a display to display the patient physiological data, memory to store the patient physiological data, and/or a transmitter to transmit the patient physiological data to a central network for storage in a patient's electronic medical record.
- the patient monitor may be connectable with one or more of several different physiological data acquisition devices simultaneously, which could include a pulse oximeter (SPO2), a non-invasive blood pressure monitor (NIBP), an end-title CO2 (EtCO2) monitor, an electrocardiograph (ECG) device, an electroencephalograph (EEG) device, a temperature monitor, an invasive blood pressure monitor, a capnograph, or the like.
- SPO2 pulse oximeter
- NIBP non-invasive blood pressure monitor
- EtCO2 end-title CO2
- ECG electrocardiograph
- EEG electroencephalograph
- Patient monitors and physiological data acquisition devices come in regular contact with patients and must meet high standards of safety and reliability. Since patient monitors may be connected to various different physiological data acquisition devices, it is important to ensure that all physiological acquisition devices connected to the patient monitor are approved as meeting the appropriate quality and safety standards for device performance so that monitoring quality and patient safety are not compromised.
- a patient monitor in one embodiment, includes a data connector configured to connect to a corresponding data connector of an approved physiological data acquisition device to provide data transmission to and from the approved physiological data acquisition device, and a power connector configured to connect to a corresponding power connector of the approved physiological data acquisition device to provide power to the approved physiological data acquisition device.
- the patient monitor further includes a control module configured to detect connection of a corresponding power connector of an unidentified device at the power connection port and/or a corresponding data connector of the unidentified device to the data connector, and provide a limited power amount to the unidentified device through the power connector.
- the control module performs an authentication process to determine that the unidentified device is the approved physiological data acquisition device, and then provides a full power amount through the power connector to the approved physiological data acquisition device.
- One embodiment of a method for controlling authentication of an approved physiological data acquisition device by a patient monitor includes detecting connection of a corresponding power connector of an unidentified device to the power connector and providing a limited power amount to the unidentified device through the power connector. The method further includes performing an authentication process to determine that the unidentified device is the approved physiological data acquisition device, and then providing a full power amount through the power connector to the approved physiological data acquisition device.
- FIG. 1 depicts a patient monitor and physiological data acquisition devices according to one embodiment of the present disclosure.
- FIG. 2 depicts another patient monitor connected to a physiological data acquisition device according to one embodiment of the present disclosure.
- FIG. 3 depicts one embodiment of a method of controlling authentication of an approved physiological data acquisition device by a patient monitor.
- FIG. 4 depicts another embodiment of a method for controlling authentication of an approved physiological data acquisition device by a patient monitor.
- the present inventors have recognized that systems and methods are needed for reliably and safely operating patient monitoring devices, including patient monitors that are connectable with various physiological data acquisition devices. Unauthentic devices may not meet the rigorous safety or quality standards set for medical monitoring devices. The inventors have recognized that physiological data acquisition devices must be verified and validated for use in a clinical environment with a patient monitor, both to ensure patient safety and to ensure quality and reliability of the acquired physiological data. In situations where a patient monitor may be connected with any number of data acquisition devices, including unauthentic or unapproved devices, manufacturers of such patient monitors need a way to ensure that only approved devices—and thus devices that meet high quality and safety standards—are connected to the patient monitor.
- the patient monitor limits the amount of power available to any device connected thereto until that device has been verified as an approved physiological data acquisition device.
- the limited power amount may be a restricted amount that ensures patient safety until such time as the unidentified device is confirmed to be an approved physiological data acquisition device.
- the limited power amount may be an amount that is just sufficient to operate the identification aspects of the unidentified device and is not an amount sufficient to operate the physiological data acquisition aspects of the device, thus guaranteeing patient safety and that unreliable data is not acquired or transferred to the patient monitor.
- the patient monitor may further block any patient data from being displayed by the patient monitor, and may further prevent any physiological data from being stored on any memory of the patient monitor.
- the patient monitor may prevent transmission of any physiological data from unapproved devices via wired or wireless transmission means to any other devices or networks, such as to a host network of a medical facility.
- the authentication process may include any of various verification and validation steps.
- the authentication process may include receiving an identification code from a device and comparing the identification code to a list of acceptable identification codes prior to determining that an unidentified device is an approved physiological data acquisition device.
- the authentication process may include operation of a hash function, whereby each of the patient monitor and unidentified device have the same hashing algorithm that each device uses to create a hash result. The calculated results of both devices are compared by the patient monitor to authenticate the device.
- the patient monitor may communicate a hash key to the unidentified device.
- the patient monitor then processes the hash key with the hashing algorithm to create a monitor hash result.
- the device also processes the hash key with the same hashing algorithm to create a device hash result, which it communicates to the patient monitor.
- the patient monitor receives the device hash result from the unidentified device and compares the device hash result to the monitor hash result. If the hash results match, then the unidentified device is determined to be an approved physiological data acquisition device. At that point, a full power amount is supplied to the approved physiological data acquisition device, and patient monitoring commences.
- the patient monitor may continue to limit the available power to the unidentified device or may terminate power supplied to the unidentified device altogether. Alternatively or additionally, the patient monitor may continue to block physiological data from the unidentified device and/or prevent display or transmission of the physiological data. Alternatively or additionally, the patient monitor may generate an alert regarding the authentication failure, which may include generating an auditory alarm or providing a visual alert to a clinician operating the patient monitor.
- FIGS. 1 and 2 provide block diagrams of differing embodiments of a patient monitor 1 connectable to one or more approved physiological data acquisition devices 2 a, 2 b.
- the patient monitor 1 is generally configured to connect to any approved physiological data acquisition device 2 , which may include multiple different types of data acquisition devices, such as a pulse oximeter, an NIBP monitor, an EtCO2 monitor, an ECG, an EEG, a temperature monitor, or the like.
- the approved physiological data acquisition devices 2 a, 2 b include an NIBP monitor 2 a and an ECG 2 b.
- Each physiological data acquisition device 2 employs one or more sensors 8 connected to the patient 5 to gather the physiological data from the patient 5 .
- the NIBP monitor 2 a has a sensor 8 that is a blood pressure cuff.
- the ECG device 2 b gathers cardiac data through sensors 8 in the form of surface electrodes on the patient's chest and abdomen.
- the patient monitor 1 connects to the approved physiological data acquisition devices via a respective data connector 15 a, 15 b on the patient monitor 1 .
- Each data connector 15 a, 15 b is configured to connect to a corresponding data connector 14 a, 14 b on the approved physiological data acquisition device 2 a, 2 b.
- the patient monitor 1 also has on or more power connectors 18 a, 18 b configured to connect to a corresponding power connector 17 a, 17 b on the respective approved physiological data acquisition device 2 a, 2 b to transfer power from the patient monitor 1 to the respective approved physiological data acquisition devices 2 a, 2 b.
- the data connector 15 and power connector 18 may provide an electrical contact or any other connection that allows data communication and power transfer, respectively.
- the data and power connectors 15 and 18 and the corresponding data and power connectors 14 and 17 may be Universal Serial Bus (USB)-compliant connectors.
- the connectors 14 - 15 and 17 - 18 may be a custom medical USB connector designed for use in a clinical environment.
- one or more of the connections may be through means not requiring galvanic contact between the patient monitor 1 and the physiological data acquisition device 2 .
- the data connector 15 and corresponding data connector 14 may be optical devices configured to transfer data via optical data transfer means.
- the data connector 15 and corresponding data connector 14 may be wireless communication devices operating on any of various radio frequency communication protocols, such as Bluetooth, Bluetooth Low Energy, near field communication (NFC), ANT, or according to any of various wireless network protocols, such as on the wireless medical telemetry service (WMTS) spectrum or on a WiFi-compliant wireless local area network (WLAN).
- the power connector 18 may also provide connection with the corresponding power connector 17 by means other than through galvanic contact, such as via capacitive or inductive power transfer.
- the respective connectors may include control and other circuitry for facilitating the data and power transfer.
- the data connector 15 may include a universal asynchronous receiver/transmitter (UART), and thus may include an integrated circuit to translate data between parallel and serial forms.
- the data connector 15 and the corresponding data connector 14 may include I 2 C for serial peripheral interface (SPI) communication bus devices.
- SPI serial peripheral interface
- the data connector 15 and the power connector 18 may be provided in a single connection port 36 a, 36 b that receives a single corresponding connection element 38 a, 38 b containing both a corresponding data connector 14 a, 14 b and a corresponding power connector 17 a, 17 b.
- one or more cords 40 may be provided with the physiological data acquisition device 2 and may provide the corresponding data connector 14 and/or the corresponding power connector 17 , which may be connected and disconnected from the respective connectors at the patient monitor 1 .
- the data connector 15 and the power connector 18 may be provided in separate and distinct connector ports and connector elements that are independent of one another. As explained above, certain embodiments may require physical connection between the respective connectors of the patient monitor 1 and the approved physiological data acquisition device 2 ; other embodiments may only require that the devices be in proximity with one another.
- the physiological data acquisition device 2 may include any sensor 8 , which may include any lead, electrode, lead wire, or available physiological measurement device such as a blood pressure cuff, a pulse oximetry sensor, a temperature sensor, or other device available in the art for acquiring or detecting physiological information from a patient.
- any sensor 8 may include any lead, electrode, lead wire, or available physiological measurement device such as a blood pressure cuff, a pulse oximetry sensor, a temperature sensor, or other device available in the art for acquiring or detecting physiological information from a patient.
- the physiological signals recorded by the sensors 8 are digitized by an analog-to-digital converter (A/D converter) 9 in the approved physiological data acquisition device 2 .
- the A/D converter 9 may be any device or logic set capable of digitizing analog physiological signals.
- the A/D converter 9 may be an analog front end (AFE).
- the approved physiological data acquisition device 2 may include a processor 10 , such as a microprocessor or a microcontroller, that receives the digital physiological data from the A/D converter 9 and oversees transmission of the digitized physiological data to the patient monitor 1 via the corresponding data connector 14 .
- the processor 10 may further execute instructions, such as computer readable software code, which may process the digital physiological data, and the processed data may be transmitted alone or in addition to the raw digitized physiological data from the A/D converter 9 .
- the physiological data acquisition device 2 may not include any processor.
- the digitized physiological data is sent from the A/D converter 9 to the corresponding data connector 14 for receipt by the patient monitor 1 .
- the patient monitor 1 may be configured to receive digitized raw data, digitized filtered data, processed data, or any other form of physiological data from the physiological data acquisition device 2 .
- the physiological data acquisition device 2 is powered by the patient monitor 1 , and such power is received via the connection between the corresponding power connector 17 and the power connector 18 of the patient monitor 1 .
- the power may be supplied via a galvanic connection between the corresponding power connector 17 and the power connector 18 , or through inductive or capacitive coupling, as is described above.
- the processor 10 and the A/D converter 9 receive power via the power management module 12 .
- the power management module 12 distributes the power to the various powered elements of the physiological data acquisition device 2 .
- the power management module 22 may include voltage and current regulation circuitry and associated controllers.
- the power management module 12 may include a battery that stores energy received from the patient monitor 1 .
- the physiological data acquisition device 2 contains only simple components, such as for a simple temperature sensor, the power management capabilities may not be necessary and may be excluded from the physiological data acquisition device 2 .
- the power supplied to the physiological data acquisition device 2 is controlled by the power management module 22 in the patient monitor 1 .
- the power management module 22 may include voltage and current regulation circuitry and associated controllers.
- the power management module 22 is controlled by and responsive to the control module 26 of the patient monitor 1 , which instructs the power management module 22 to limit the power amount provided to an unidentified device until such time as that unidentified device is verified to be an approved physiological data acquisition device 2 .
- the control module 26 and the power management module 22 cooperate to regulate the power distribution within the patient monitor and the power supplied to the one or more physiological data acquisition devices 2 .
- the managed power may be from a battery 20 or from a power supply 21 , such as an AC power supply in the medical facility building.
- the power management module 22 may provide a limited power amount at an available current of 50 milliamps to an unidentified device. Such a limited current ensures safety of the unidentified device, as it eliminates concern about an improper or unsafe data acquisition device discharging current and injuring a patient 5 .
- the limited power amount should be a restricted amount that ensures patient safety until such time as the unidentified device is confirmed to be an approved physiological data acquisition device 2 that can be safely operated for patient monitoring in conjunction with the patient monitor 1 .
- the limited power amount may be an amount that is just sufficient to operate the identification aspects of the unidentified device and is not an amount sufficient to operate the physiological data acquisition aspects of the device.
- a full power amount can be supplied such that the approved physiological data acquisition device 2 can perform all of its functions, including any one or more of gathering, processing, storing, and displaying physiological data, and transmitting physiological data to the patient monitor 1 .
- the full power amount may be an available current of 700 milliamps.
- the processor 10 of the physiological data acquisition device 2 may provide a device identification code to the patient monitor through the wireless or wired connection between the corresponding data connector 14 and the data connector 15 .
- the physiological data acquisition device 2 may have an identification chip or element 13 that provides an identification pin to the patient monitor 1 .
- the identification element 13 may be a passive or active radio frequency identification (RFID) chip, which may be energized or powered by the patient monitor 1 upon connection thereto.
- the identification element 13 could be an application specific integrated circuit (ASIC) or other electronic or logic circuit that performs the device end of the authentication process.
- RFID radio frequency identification
- the hashing portion of the authentication process may be performed by the identification element 13 , which may receive a hash key from the patient monitor 1 and process the hash key with the hashing algorithm to generate the device hash result.
- the hashing algorithm function may be performed by a processor 10 , such as a general purpose processor for the data acquisition device 2 .
- the processor 10 or the identification element 13 acts as and/or includes memory upon which the hashing algorithm, or hash function, is stored.
- the hashing algorithm accessed and used to calculate the device hash result.
- the hashing algorithm may be an iterated cryptographic hash function, or message digest functions, such as MD5 and SHA-1.
- the message authentication using the hash functions may be performed by any mechanism, such as hashed message authentication code (HMAC) described in RFC2104 of the Network Working Group of the Internet Engineering Task Force (IETF).
- HMAC hashed message authentication code
- steps may be performed by the control module 26 within the patient monitor 1 as part of the authentication process.
- the hashing algorithm may be stored in memory 26 b and accessible by a processor 26 a comprising part of the control module 26 .
- the control module 26 generates the hash key, which may be any value or string of values that it shares over the data connector 15 with the respective unidentified device or approved physiological data acquisition device 2 .
- the hash key may be communicated to the processor 10 and/or identification element 13 of the physiological data acquisition device 2 (or unidentified device) as described above.
- the hash key may be a preset value or string of values, or a randomly generated value or string of values.
- the control module 26 then processes the hash key with the hashing algorithm to create the monitor hash result. It receives the device hash result from the unidentified device, and compares the device hash result to the monitor hash result to determine whether they match—e.g., whether the hash results are identical or at least a predetermined portion of the results are identical.
- the control module 26 of the patient monitor 1 receives the digital physiological data transmitted from each of the one or more approved physiological data acquisition devices 2 a, 2 b connected thereto.
- the control module 26 may be configured to process the digital physiological data prior to transmitting the data to a host network 30 or displaying the physiological data on a display 24 incorporated in or associated with the patient monitor 1 .
- the control module 26 may not process the digital physiological data, and may simply relay that data to the host network 30 , such as via a wireless connection or transmission means.
- the host network 30 may be a computer network of a hospital, which may be comprised of locally-housed servers or may be a hosted or cloud-computing network.
- the host network 30 may include a patient electronic medical records (EMR) database 32 , and thus the patient monitor 1 transmits the physiological data to the host network 30 for storage in the patient's record within the EMR database 32 .
- the control module 26 may control a receiver transmitter 28 , such as a transceiver, which communicates with a corresponding receiver transmitter 34 within the host network via a communication link 29 in order to transmit the physiological data.
- the receiver transmitter 28 and 34 may communicate by any wireless or wired transmission protocols, several examples of which are listed above.
- the display 24 may be any digital display device capable of displaying information about the condition of the patient monitor 1 and/or a connected approved physiological data acquisition device 2 , and/or displaying physiological data or a value calculated therefrom.
- the control module 26 may control the display 24 to display summaries of the physiological data and/or the physiological data signals themselves to the clinician.
- the display may be associated with and connected to the patient monitor 1 , such as a standard computer monitor, or may be incorporated into a housing with the other elements of the patient monitor 1 .
- the display 24 may be a touchscreen providing a mechanism for a clinician to exercise user input control.
- the systems and methods described herein may be implemented with one or more computer programs executed by one or more processors 26 a, which may all operate as part of a single control module 26 .
- the computer programs include processor-executable instructions that are stored on a non-transitory, tangible computer readable medium, such as may comprise the memory 26 b.
- the computer programs may also include stored data, which may also be stored in memory 26 b.
- Non-limiting examples of the non-transitory tangible computer readable medium are nonvolatile memory, magnetic storage, and optical storage.
- module may refer to, be part of, or include an application-specific integrated circuit (ASIC), an electronic circuit, a combinational logic circuit, a field programmable gate array (FPGA), a processor (shared, dedicated, or group) that executes code, or other suitable components that provide the described functionality, or a combination of some or all of the above, such as in a system-on-chip.
- ASIC application-specific integrated circuit
- FPGA field programmable gate array
- module may include memory (shared, dedicated, or group) that stores code executed by the processor.
- code as used herein, may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects.
- shared means that some or all code from multiple modules may be executed using a single (shared) processor. In addition, some or all code to be executed by multiple different processors may be stored by a single (shared) memory.
- group means that some or all code comprising part of a single module may be executed using a group of processors. Likewise, some or all code comprising a single module may be stored using a group of memories.
- FIGS. 3 and 4 depict embodiments of a method 50 for controlling authentication of an approved physiological data acquisition device 2 by a patient monitor 1 .
- Connection of a device is detected at step 52 , which is an unidentified device until such time as the device has been authenticated and determined to be an approved physiological data acquisition device 2 .
- a limited power amount is supplied to the unidentified device at step 54 , which is supplied by the patient monitor 1 via the connection between the power connector 18 and the corresponding power connector 17 .
- the authentication process is performed at step 60 to authenticate the unidentified device. If the unidentified device is determined to be an approved physiological data acquisition device 2 at step 70 , then the full power amount is provided at step 72 so that the approved physiological data acquisition device 2 can perform its data acquisition function.
- the approved physiological data acquisition device 2 then acquires and digitizes physiological data, which is received by the patient monitor 1 at step 74 .
- the patient monitor displays the physiological data on the display 24 at step 76 , and transmits the physiological data to the host network 30 at step 78 .
- the limited power amount is not sufficient for the unidentified device to perform its data acquisition function, which effectively prevents the unidentified device from acquiring the physiological data from the patient in the first place and thus prevents transfer of the physiological data to the patient monitor 1 in the first place.
- the patient monitor 1 may take active steps to prevent transfer of data by preventing receipt of data, such as the physiological data, from the unidentified device.
- the limited power amount may continue to be provided to the unidentified device so that further authentication attempts can be made by re-performing the authentication process or performing different authentication steps.
- an unidentified device that fails the authentication process once or a predetermined number of times may be cut off completely, including ceasing to supply the limited power amount.
- FIG. 4 depicts one embodiment of an authentication process. After the limited power amount is supplied at step 54 , active steps may be taken at step 55 to prevent transfer and/or display of the physiological data.
- the authentication process then commences by receiving an identification code 62 from the unidentified device. The identification code is compared to a list of acceptable identification codes at step 63 . If the received device identification code is on the list, then the patient monitor 1 may provide a hash key to the unidentified device, which is communicated through data connector 15 to the corresponding data connector 14 . The patient monitor 1 then processes the hash key with the hashing algorithm to generate the monitor hash result at step 65 . The device hash result is received at step 66 and compared to the monitor hash result at step 67 . If the hash results match then the unidentified device is determined to be an approved physiological data acquisition device at step 69 .
- an alert is generated at step 68 to advise the clinician that the authentication process failed and that the unidentified device is not an approved physiological data acquisition device.
- the alert may be a visual alert provided on the display 24 of the patient monitor 1 , and/or may include an auditory alert, such as an alarm.
- the monitor may continue to provide the limited power amount and prevent data transfer, and then re-perform one or more of the authentication steps. Thereby, the patient monitor prevents operation of an unapproved and unidentified device, thereby maintaining control over the safety and quality standards of the physiological data acquisition devices connected to the patient 5 .
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Abstract
Description
- The present disclosure generally relates to medical patient monitoring systems, and more particularly to methods and systems for authenticating approved physiological data acquisition devices for connection to a patient monitor.
- Patient monitors for monitoring physiological data often comprise a central patient monitor connectable to multiple auxiliary devices that acquire physiological data from the patient so that multiple different types of physiological data acquired by multiple different devices is collected and channeled through a central monitoring device. The central monitoring device often includes a display to display the patient physiological data, memory to store the patient physiological data, and/or a transmitter to transmit the patient physiological data to a central network for storage in a patient's electronic medical record. The patient monitor may be connectable with one or more of several different physiological data acquisition devices simultaneously, which could include a pulse oximeter (SPO2), a non-invasive blood pressure monitor (NIBP), an end-title CO2 (EtCO2) monitor, an electrocardiograph (ECG) device, an electroencephalograph (EEG) device, a temperature monitor, an invasive blood pressure monitor, a capnograph, or the like.
- Patient monitors and physiological data acquisition devices come in regular contact with patients and must meet high standards of safety and reliability. Since patient monitors may be connected to various different physiological data acquisition devices, it is important to ensure that all physiological acquisition devices connected to the patient monitor are approved as meeting the appropriate quality and safety standards for device performance so that monitoring quality and patient safety are not compromised.
- This Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.
- In one embodiment, a patient monitor includes a data connector configured to connect to a corresponding data connector of an approved physiological data acquisition device to provide data transmission to and from the approved physiological data acquisition device, and a power connector configured to connect to a corresponding power connector of the approved physiological data acquisition device to provide power to the approved physiological data acquisition device. The patient monitor further includes a control module configured to detect connection of a corresponding power connector of an unidentified device at the power connection port and/or a corresponding data connector of the unidentified device to the data connector, and provide a limited power amount to the unidentified device through the power connector. The control module performs an authentication process to determine that the unidentified device is the approved physiological data acquisition device, and then provides a full power amount through the power connector to the approved physiological data acquisition device.
- One embodiment of a method for controlling authentication of an approved physiological data acquisition device by a patient monitor includes detecting connection of a corresponding power connector of an unidentified device to the power connector and providing a limited power amount to the unidentified device through the power connector. The method further includes performing an authentication process to determine that the unidentified device is the approved physiological data acquisition device, and then providing a full power amount through the power connector to the approved physiological data acquisition device.
- Various other features, objects, and advantages of the invention will be made apparent from the following description taken together with the drawings.
- The present disclosure is described with reference to the following Figures.
-
FIG. 1 depicts a patient monitor and physiological data acquisition devices according to one embodiment of the present disclosure. -
FIG. 2 depicts another patient monitor connected to a physiological data acquisition device according to one embodiment of the present disclosure. -
FIG. 3 depicts one embodiment of a method of controlling authentication of an approved physiological data acquisition device by a patient monitor. -
FIG. 4 depicts another embodiment of a method for controlling authentication of an approved physiological data acquisition device by a patient monitor. - The present inventors have recognized that systems and methods are needed for reliably and safely operating patient monitoring devices, including patient monitors that are connectable with various physiological data acquisition devices. Unauthentic devices may not meet the rigorous safety or quality standards set for medical monitoring devices. The inventors have recognized that physiological data acquisition devices must be verified and validated for use in a clinical environment with a patient monitor, both to ensure patient safety and to ensure quality and reliability of the acquired physiological data. In situations where a patient monitor may be connected with any number of data acquisition devices, including unauthentic or unapproved devices, manufacturers of such patient monitors need a way to ensure that only approved devices—and thus devices that meet high quality and safety standards—are connected to the patient monitor.
- Based on their recognition of the aforementioned problems and needs, the inventors developed the disclosed system wherein the patient monitor limits the amount of power available to any device connected thereto until that device has been verified as an approved physiological data acquisition device. For example, the limited power amount may be a restricted amount that ensures patient safety until such time as the unidentified device is confirmed to be an approved physiological data acquisition device. Further, the limited power amount may be an amount that is just sufficient to operate the identification aspects of the unidentified device and is not an amount sufficient to operate the physiological data acquisition aspects of the device, thus guaranteeing patient safety and that unreliable data is not acquired or transferred to the patient monitor. The patient monitor may further block any patient data from being displayed by the patient monitor, and may further prevent any physiological data from being stored on any memory of the patient monitor. Likewise, the patient monitor may prevent transmission of any physiological data from unapproved devices via wired or wireless transmission means to any other devices or networks, such as to a host network of a medical facility.
- The authentication process may include any of various verification and validation steps. For example, the authentication process may include receiving an identification code from a device and comparing the identification code to a list of acceptable identification codes prior to determining that an unidentified device is an approved physiological data acquisition device. Alternatively or additionally, the authentication process may include operation of a hash function, whereby each of the patient monitor and unidentified device have the same hashing algorithm that each device uses to create a hash result. The calculated results of both devices are compared by the patient monitor to authenticate the device.
- For example, upon connection of an unidentified device, the patient monitor may communicate a hash key to the unidentified device. The patient monitor then processes the hash key with the hashing algorithm to create a monitor hash result. Presumably, if the unidentified device is an approved physiological data acquisition device, the device also processes the hash key with the same hashing algorithm to create a device hash result, which it communicates to the patient monitor. The patient monitor receives the device hash result from the unidentified device and compares the device hash result to the monitor hash result. If the hash results match, then the unidentified device is determined to be an approved physiological data acquisition device. At that point, a full power amount is supplied to the approved physiological data acquisition device, and patient monitoring commences.
- If the unidentified device does not present a device hash result that matches the monitor hash result, then the operation of the device is not approved. In that case the patient monitor may continue to limit the available power to the unidentified device or may terminate power supplied to the unidentified device altogether. Alternatively or additionally, the patient monitor may continue to block physiological data from the unidentified device and/or prevent display or transmission of the physiological data. Alternatively or additionally, the patient monitor may generate an alert regarding the authentication failure, which may include generating an auditory alarm or providing a visual alert to a clinician operating the patient monitor.
- Aspects of the disclosure are described herein in terms of functional and/or logical block components and various processing steps. It should be appreciated that such block components may be realized by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, an embodiment may employ various integrated circuit components, e.g., memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which may carry out a variety of functions under the control of one or more processors or other control devices. In addition, those skilled in the art will appreciate that the present invention may be practiced in conjunction with any number of medical devices, including any number of different physiological data acquisition devices, and that the system described herein is merely one example application. The connecting lines shown in the various figures contained herein are intended to represent example functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical embodiment.
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FIGS. 1 and 2 provide block diagrams of differing embodiments of apatient monitor 1 connectable to one or more approved physiological 2 a, 2 b. Thedata acquisition devices patient monitor 1 is generally configured to connect to any approved physiologicaldata acquisition device 2, which may include multiple different types of data acquisition devices, such as a pulse oximeter, an NIBP monitor, an EtCO2 monitor, an ECG, an EEG, a temperature monitor, or the like. In the depicted embodiment, the approved physiological 2 a, 2 b include an NIBPdata acquisition devices monitor 2 a and anECG 2 b. Each physiologicaldata acquisition device 2 employs one ormore sensors 8 connected to thepatient 5 to gather the physiological data from thepatient 5. In the depicted embodiment, the NIBPmonitor 2 a has asensor 8 that is a blood pressure cuff. TheECG device 2 b gathers cardiac data throughsensors 8 in the form of surface electrodes on the patient's chest and abdomen. These and other types of physiological data acquisition devices are well known and standard in the field of medical patient monitoring. - The
patient monitor 1 connects to the approved physiological data acquisition devices via a 15 a, 15 b on therespective data connector patient monitor 1. Each 15 a, 15 b is configured to connect to adata connector 14 a, 14 b on the approved physiologicalcorresponding data connector 2 a, 2 b. Thereby, data can be transferred in both directions between thedata acquisition device patient monitor 1 and the respective approved physiological 2 a, 2 b. Thedata acquisition device patient monitor 1 also has on or 18 a, 18 b configured to connect to amore power connectors 17 a, 17 b on the respective approved physiologicalcorresponding power connector 2 a, 2 b to transfer power from thedata acquisition device patient monitor 1 to the respective approved physiological 2 a, 2 b.data acquisition devices - The
data connector 15 andpower connector 18 may provide an electrical contact or any other connection that allows data communication and power transfer, respectively. For example, the data and 15 and 18 and the corresponding data andpower connectors 14 and 17 may be Universal Serial Bus (USB)-compliant connectors. Alternatively, the connectors 14-15 and 17-18 may be a custom medical USB connector designed for use in a clinical environment.power connectors - In alternative embodiments, one or more of the connections may be through means not requiring galvanic contact between the
patient monitor 1 and the physiologicaldata acquisition device 2. For example, thedata connector 15 andcorresponding data connector 14 may be optical devices configured to transfer data via optical data transfer means. Alternatively, thedata connector 15 andcorresponding data connector 14 may be wireless communication devices operating on any of various radio frequency communication protocols, such as Bluetooth, Bluetooth Low Energy, near field communication (NFC), ANT, or according to any of various wireless network protocols, such as on the wireless medical telemetry service (WMTS) spectrum or on a WiFi-compliant wireless local area network (WLAN). Thepower connector 18 may also provide connection with thecorresponding power connector 17 by means other than through galvanic contact, such as via capacitive or inductive power transfer. - The respective connectors may include control and other circuitry for facilitating the data and power transfer. For example, the
data connector 15 may include a universal asynchronous receiver/transmitter (UART), and thus may include an integrated circuit to translate data between parallel and serial forms. Alternatively, thedata connector 15 and the correspondingdata connector 14 may include I2C for serial peripheral interface (SPI) communication bus devices. - As depicted in
FIG. 1 , thedata connector 15 and thepower connector 18 may be provided in a 36 a, 36 b that receives a singlesingle connection port 38 a, 38 b containing both acorresponding connection element 14 a, 14 b and acorresponding data connector 17 a, 17 b. In certain embodiments, one orcorresponding power connector more cords 40 may be provided with the physiologicaldata acquisition device 2 and may provide thecorresponding data connector 14 and/or thecorresponding power connector 17, which may be connected and disconnected from the respective connectors at thepatient monitor 1. - Alternatively, as depicted in
FIG. 2 ., thedata connector 15 and thepower connector 18 may be provided in separate and distinct connector ports and connector elements that are independent of one another. As explained above, certain embodiments may require physical connection between the respective connectors of thepatient monitor 1 and the approved physiologicaldata acquisition device 2; other embodiments may only require that the devices be in proximity with one another. - The physiological
data acquisition device 2 may include anysensor 8, which may include any lead, electrode, lead wire, or available physiological measurement device such as a blood pressure cuff, a pulse oximetry sensor, a temperature sensor, or other device available in the art for acquiring or detecting physiological information from a patient. - The physiological signals recorded by the
sensors 8 are digitized by an analog-to-digital converter (A/D converter) 9 in the approved physiologicaldata acquisition device 2. The A/D converter 9 may be any device or logic set capable of digitizing analog physiological signals. For example, the A/D converter 9 may be an analog front end (AFE). The approved physiologicaldata acquisition device 2 may include aprocessor 10, such as a microprocessor or a microcontroller, that receives the digital physiological data from the A/D converter 9 and oversees transmission of the digitized physiological data to the patient monitor 1 via the correspondingdata connector 14. Theprocessor 10 may further execute instructions, such as computer readable software code, which may process the digital physiological data, and the processed data may be transmitted alone or in addition to the raw digitized physiological data from the A/D converter 9. In an alternative embodiment, the physiologicaldata acquisition device 2 may not include any processor. In such an embodiment, the digitized physiological data is sent from the A/D converter 9 to the correspondingdata connector 14 for receipt by thepatient monitor 1. Accordingly, the patient monitor 1 may be configured to receive digitized raw data, digitized filtered data, processed data, or any other form of physiological data from the physiologicaldata acquisition device 2. - The physiological
data acquisition device 2 is powered by thepatient monitor 1, and such power is received via the connection between thecorresponding power connector 17 and thepower connector 18 of thepatient monitor 1. The power may be supplied via a galvanic connection between thecorresponding power connector 17 and thepower connector 18, or through inductive or capacitive coupling, as is described above. Theprocessor 10 and the A/D converter 9 receive power via thepower management module 12. Thepower management module 12 distributes the power to the various powered elements of the physiologicaldata acquisition device 2. For example, thepower management module 22 may include voltage and current regulation circuitry and associated controllers. Thepower management module 12 may include a battery that stores energy received from thepatient monitor 1. In other embodiments, where the physiologicaldata acquisition device 2 contains only simple components, such as for a simple temperature sensor, the power management capabilities may not be necessary and may be excluded from the physiologicaldata acquisition device 2. - The power supplied to the physiological
data acquisition device 2 is controlled by thepower management module 22 in thepatient monitor 1. For example, thepower management module 22 may include voltage and current regulation circuitry and associated controllers. In the depicted embodiment, thepower management module 22 is controlled by and responsive to thecontrol module 26 of thepatient monitor 1, which instructs thepower management module 22 to limit the power amount provided to an unidentified device until such time as that unidentified device is verified to be an approved physiologicaldata acquisition device 2. Thus, thecontrol module 26 and thepower management module 22 cooperate to regulate the power distribution within the patient monitor and the power supplied to the one or more physiologicaldata acquisition devices 2. The managed power may be from abattery 20 or from apower supply 21, such as an AC power supply in the medical facility building. For example, thepower management module 22 may provide a limited power amount at an available current of 50 milliamps to an unidentified device. Such a limited current ensures safety of the unidentified device, as it eliminates concern about an improper or unsafe data acquisition device discharging current and injuring apatient 5. Generally, the limited power amount should be a restricted amount that ensures patient safety until such time as the unidentified device is confirmed to be an approved physiologicaldata acquisition device 2 that can be safely operated for patient monitoring in conjunction with thepatient monitor 1. Further, the limited power amount may be an amount that is just sufficient to operate the identification aspects of the unidentified device and is not an amount sufficient to operate the physiological data acquisition aspects of the device. - Once the authentication process has been successfully completed to determine that the unidentified device is the approved physiological
data acquisition device 2, a full power amount can be supplied such that the approved physiologicaldata acquisition device 2 can perform all of its functions, including any one or more of gathering, processing, storing, and displaying physiological data, and transmitting physiological data to thepatient monitor 1. To provide just one exemplary embodiment, the full power amount may be an available current of 700 milliamps. - In various embodiments of the authentication process, the
processor 10 of the physiologicaldata acquisition device 2 may provide a device identification code to the patient monitor through the wireless or wired connection between the correspondingdata connector 14 and thedata connector 15. In certain embodiments, the physiologicaldata acquisition device 2 may have an identification chip orelement 13 that provides an identification pin to thepatient monitor 1. In one example, theidentification element 13 may be a passive or active radio frequency identification (RFID) chip, which may be energized or powered by the patient monitor 1 upon connection thereto. In other embodiments, theidentification element 13 could be an application specific integrated circuit (ASIC) or other electronic or logic circuit that performs the device end of the authentication process. For example, in embodiments where the authentication process includes a hashing algorithm, the hashing portion of the authentication process may be performed by theidentification element 13, which may receive a hash key from thepatient monitor 1 and process the hash key with the hashing algorithm to generate the device hash result. Alternatively, the hashing algorithm function may be performed by aprocessor 10, such as a general purpose processor for thedata acquisition device 2. Either theprocessor 10 or theidentification element 13 acts as and/or includes memory upon which the hashing algorithm, or hash function, is stored. Upon receipt of a hash key from thepatient monitor 1, the hashing algorithm is accessed and used to calculate the device hash result. For example, the hashing algorithm may be an iterated cryptographic hash function, or message digest functions, such as MD5 and SHA-1. The message authentication using the hash functions may be performed by any mechanism, such as hashed message authentication code (HMAC) described in RFC2104 of the Network Working Group of the Internet Engineering Task Force (IETF). - Likewise, steps may be performed by the
control module 26 within the patient monitor 1 as part of the authentication process. For example, the hashing algorithm may be stored inmemory 26 b and accessible by aprocessor 26 a comprising part of thecontrol module 26. In one embodiment, thecontrol module 26 generates the hash key, which may be any value or string of values that it shares over thedata connector 15 with the respective unidentified device or approved physiologicaldata acquisition device 2. The hash key may be communicated to theprocessor 10 and/oridentification element 13 of the physiological data acquisition device 2 (or unidentified device) as described above. For example, the hash key may be a preset value or string of values, or a randomly generated value or string of values. Thecontrol module 26 then processes the hash key with the hashing algorithm to create the monitor hash result. It receives the device hash result from the unidentified device, and compares the device hash result to the monitor hash result to determine whether they match—e.g., whether the hash results are identical or at least a predetermined portion of the results are identical. - In the embodiment of
FIGS. 1 and 2 , thecontrol module 26 of the patient monitor 1 receives the digital physiological data transmitted from each of the one or more approved physiological 2 a, 2 b connected thereto. Thedata acquisition devices control module 26 may be configured to process the digital physiological data prior to transmitting the data to ahost network 30 or displaying the physiological data on adisplay 24 incorporated in or associated with thepatient monitor 1. In other embodiments, thecontrol module 26 may not process the digital physiological data, and may simply relay that data to thehost network 30, such as via a wireless connection or transmission means. For example, thehost network 30 may be a computer network of a hospital, which may be comprised of locally-housed servers or may be a hosted or cloud-computing network. Thehost network 30 may include a patient electronic medical records (EMR)database 32, and thus the patient monitor 1 transmits the physiological data to thehost network 30 for storage in the patient's record within theEMR database 32. For instance, thecontrol module 26 may control areceiver transmitter 28, such as a transceiver, which communicates with a correspondingreceiver transmitter 34 within the host network via acommunication link 29 in order to transmit the physiological data. The 28 and 34 may communicate by any wireless or wired transmission protocols, several examples of which are listed above.receiver transmitter - The
display 24 may be any digital display device capable of displaying information about the condition of thepatient monitor 1 and/or a connected approved physiologicaldata acquisition device 2, and/or displaying physiological data or a value calculated therefrom. For example, thecontrol module 26 may control thedisplay 24 to display summaries of the physiological data and/or the physiological data signals themselves to the clinician. The display may be associated with and connected to thepatient monitor 1, such as a standard computer monitor, or may be incorporated into a housing with the other elements of thepatient monitor 1. In certain embodiments, thedisplay 24 may be a touchscreen providing a mechanism for a clinician to exercise user input control. - The systems and methods described herein may be implemented with one or more computer programs executed by one or
more processors 26 a, which may all operate as part of asingle control module 26. The computer programs include processor-executable instructions that are stored on a non-transitory, tangible computer readable medium, such as may comprise thememory 26 b. The computer programs may also include stored data, which may also be stored inmemory 26 b. Non-limiting examples of the non-transitory tangible computer readable medium are nonvolatile memory, magnetic storage, and optical storage. - As used herein, the term module may refer to, be part of, or include an application-specific integrated circuit (ASIC), an electronic circuit, a combinational logic circuit, a field programmable gate array (FPGA), a processor (shared, dedicated, or group) that executes code, or other suitable components that provide the described functionality, or a combination of some or all of the above, such as in a system-on-chip. The term module may include memory (shared, dedicated, or group) that stores code executed by the processor. The term code, as used herein, may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. The term shared, as used above, means that some or all code from multiple modules may be executed using a single (shared) processor. In addition, some or all code to be executed by multiple different processors may be stored by a single (shared) memory. The term group, as used above, means that some or all code comprising part of a single module may be executed using a group of processors. Likewise, some or all code comprising a single module may be stored using a group of memories.
-
FIGS. 3 and 4 depict embodiments of amethod 50 for controlling authentication of an approved physiologicaldata acquisition device 2 by apatient monitor 1. Connection of a device is detected atstep 52, which is an unidentified device until such time as the device has been authenticated and determined to be an approved physiologicaldata acquisition device 2. A limited power amount is supplied to the unidentified device atstep 54, which is supplied by the patient monitor 1 via the connection between thepower connector 18 and thecorresponding power connector 17. The authentication process is performed atstep 60 to authenticate the unidentified device. If the unidentified device is determined to be an approved physiologicaldata acquisition device 2 atstep 70, then the full power amount is provided atstep 72 so that the approved physiologicaldata acquisition device 2 can perform its data acquisition function. The approved physiologicaldata acquisition device 2 then acquires and digitizes physiological data, which is received by the patient monitor 1 atstep 74. The patient monitor displays the physiological data on thedisplay 24 atstep 76, and transmits the physiological data to thehost network 30 atstep 78. - Returning to step 70, if the unidentified device is not an approved physiological data acquisition device, then the limited power amount continues to be provided and no physiological data is displayed or transmitted to the host network. Presumably, the limited power amount is not sufficient for the unidentified device to perform its data acquisition function, which effectively prevents the unidentified device from acquiring the physiological data from the patient in the first place and thus prevents transfer of the physiological data to the patient monitor 1 in the first place. Alternatively or additionally, the patient monitor 1 may take active steps to prevent transfer of data by preventing receipt of data, such as the physiological data, from the unidentified device. In certain embodiments, the limited power amount may continue to be provided to the unidentified device so that further authentication attempts can be made by re-performing the authentication process or performing different authentication steps. In other embodiments, an unidentified device that fails the authentication process once or a predetermined number of times may be cut off completely, including ceasing to supply the limited power amount.
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FIG. 4 depicts one embodiment of an authentication process. After the limited power amount is supplied atstep 54, active steps may be taken atstep 55 to prevent transfer and/or display of the physiological data. The authentication process then commences by receiving anidentification code 62 from the unidentified device. The identification code is compared to a list of acceptable identification codes atstep 63. If the received device identification code is on the list, then the patient monitor 1 may provide a hash key to the unidentified device, which is communicated throughdata connector 15 to the correspondingdata connector 14. The patient monitor 1 then processes the hash key with the hashing algorithm to generate the monitor hash result atstep 65. The device hash result is received atstep 66 and compared to the monitor hash result atstep 67. If the hash results match then the unidentified device is determined to be an approved physiological data acquisition device atstep 69. - If it is determined at
step 63 that the received device identification code is not on the list of acceptable identification codes, or it is determined atstep 67 that the device hash result does not match the monitor hash result, then an alert is generated atstep 68 to advise the clinician that the authentication process failed and that the unidentified device is not an approved physiological data acquisition device. For example, the alert may be a visual alert provided on thedisplay 24 of thepatient monitor 1, and/or may include an auditory alert, such as an alarm. The monitor may continue to provide the limited power amount and prevent data transfer, and then re-perform one or more of the authentication steps. Thereby, the patient monitor prevents operation of an unapproved and unidentified device, thereby maintaining control over the safety and quality standards of the physiological data acquisition devices connected to thepatient 5. - This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to make and use the invention. Certain terms have been used for brevity, clarity and understanding. No unnecessary limitations are to be inferred therefrom beyond the requirement of the prior art because such terms are used for descriptive purposes only and are intended to be broadly construed. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have features or structural elements that do not differ from the literal language of the claims, or if they include equivalent features or structural elements with insubstantial differences from the literal languages of the claims.
Claims (20)
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140223037A1 (en) * | 2013-02-07 | 2014-08-07 | Apple Inc. | Method and system for detecting connection of a host device to an accessory device |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10410446B1 (en) * | 2016-07-25 | 2019-09-10 | United Services Automobile Association (Usaa) | Authentication based on through-body signals |
| US10755512B1 (en) | 2016-07-25 | 2020-08-25 | United Services Automobile Association (Usaa) | Authentication based on through-body signals |
| US11049348B1 (en) | 2016-07-25 | 2021-06-29 | United Services Automobile Association (Usaa) | Authentication based on through-body signals |
| US11798341B1 (en) | 2016-07-25 | 2023-10-24 | United Services Automobile Association (Usaa) | Authentication based on through-body signals |
Also Published As
| Publication number | Publication date |
|---|---|
| CN110113989B (en) | 2022-09-13 |
| CN110113989A (en) | 2019-08-09 |
| EP3544493A1 (en) | 2019-10-02 |
| US9986314B1 (en) | 2018-05-29 |
| WO2018098008A1 (en) | 2018-05-31 |
| EP3544493B1 (en) | 2021-08-18 |
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