Physiological sensing device having data access layer, and methods of operation of same

Abstract

An example system includes: a physiological sensor module and a mobile device including an application layer and a data access layer, where the mobile device is operably coupled to the physiological sensor; a processor connected to memory with computer-readable instruction stored thereon, where execution of the computer-readable instructions causes the processor to receive raw physiological data from the sensor; store the raw physiological data in a first memory of the data access layer; and in response to a data request from the application layer at the data access layer, providing a response to the application layer including a data structure. An example method includes: storing raw physiological data in a first memory of a data access layer, processing the raw physiological data, storing the processed physiological data in a second memory of the data access layer, and selectively providing access to the physiological data using a data access layer.

Description

Physiological Sensing Device having Data Access Layer, and Methods of Operation of SameRELATED APPLICATION

[0001] This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 518,869, filed August 10, 2023, entitled "Physiological Sensing Device having Data Model, and Methods of Operation of Same," which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Physiological sensors commonly include electrodes and optical sensors. For example, ECG sensors are commonly implemented as a set of electrodes to measure electrical signals, and PPG sensors commonly include a light source and optical sensor to illuminate the skin and measure light absorption. Thus, the raw signals measured by the physiological sensors (e.g., light absorption, an electrical signal(s)) may not be the signals that are of interest to a user (e.g., heart rate, ECG waveform, blood oxygen). Thus, the raw signals are processed to obtain physiological data (e.g., heart rate, ECG waveform, blood oxygen). The physiological data is then commonly stored and / or displayed to a user. The sensor, data processing, storage and / or display functions can be performed by multiple devices operating in communication with each other, for example a wearable physiological sensor may be in communication with one or more computing devices.SUMMARY

[0003] In some aspects, implementations of the present disclosure include a system including: a physiological sensor module; and a mobile device including an application layer anda data access layer, wherein the mobile device is operably coupled to the physiological sensor; a processor connected to memory with computer-readable instruction stored thereon, wherein execution of the computer-readable instruction by the processor causes the processor to: receive raw physiological data from the physiological sensor; store the raw physiological data in a first memory of the data access layer; and in response to receiving a data request from the application layer at the data access layer, provide, using the data access layer, a response to the application layer, wherein the response includes a data structure of the raw physiological data.

[0004] In some aspects, implementations of the present disclosure include a system, wherein the physiological sensor module includes a plurality of physiological sensors, and wherein the raw physiological data includes a plurality of raw physiological datasets.

[0005] In some aspects, implementations of the present disclosure include a system, wherein the data structure includes data a subset of the plurality of raw physiological datasets.

[0006] In some aspects, implementations of the present disclosure include a system wherein the memory further includes instructions that cause the processor to: process the raw physiological data to obtain processed physiological data; and store the processed physiological data in a second memory of the data access layer.

[0007] In some aspects, implementations of the present disclosure include a system, wherein the raw physiological data includes light absorbance data.

[0008] In some aspects, implementations of the present disclosure include a system, wherein the raw physiological data includes electrical potential data.

[0009] In some aspects, implementations of the present disclosure include a system, wherein the processed physiological data includes blood pressure.

[0010] In some aspects, implementations of the present disclosure include a system, wherein the processed physiological data includes a single-lead ECG signal.

[0011] In some aspects, implementations of the present disclosure include a system, further including a remote device in operable communication with the mobile device, wherein the remote device includes a remote device application layer configured provide a data request to the data access layer of the mobile device and receive a response from the data access layer.

[0012] In some aspects, implementations of the present disclosure include a system, wherein the physiological sensor module includes a filter configured to filter an output of a sensor of the sensor module, and wherein the raw physiological data includes filtered data output by the filter.

[0013] In some aspects, implementations of the present disclosure include a system, wherein the raw physiological data includes both filtered data output by the filter and data output by the sensor.

[0014] In some aspects, implementations of the present disclosure include a system, wherein the data request includes a data access function.

[0015] In some aspects, implementations of the present disclosure include a computer-implemented method including: storing raw physiological data in a first memory of a data access layer; processing the raw physiological data into processed physiological data; storing the processed physiological data in a second memory of the data access layer; and selectively providing access to a data structure including the raw physiological data and / or processed physiological data using the data access layer.

[0016] In some aspects, implementations of the present disclosure include a method, wherein selectively providing access to the data structure includes outputting a data structure including raw physiological data in response to receiving a data access function.

[0017] In some aspects, implementations of the present disclosure include a method, wherein the data structure including raw physiological data includes less than all the physiological data stored in the first memory of the data access layer.

[0018] In some aspects, implementations of the present disclosure include a method, wherein selectively providing access to the data structure includes outputting a data structure including processed physiological data in response to receiving a data access function.

[0019] In some aspects, implementations of the present disclosure include a method, wherein the data structure includes less than all the physiological data stored in the first memory of the data access layer.

[0020] In some aspects, implementations of the present disclosure include a method, wherein the data structure including processed physiological data includes less than all the processed physiological data stored in the second memory of the data access layer.

[0021] In some aspects, implementations of the present disclosure include a method, wherein selectively providing access to the data structure includes transmitting the data to a remote device.

[0022] In some aspects, implementations of the present disclosure include a method, wherein the data access layer is configured to only provide access to the first memory and second memory of the data access layer in response to a predetermined data access function.

[0023] It should be understood that the above-described subject matter may also be implemented as a computer-controlled apparatus, a computer process, a computing system, or an article of manufacture, such as a computer-readable storage medium.

[0024] Other systems, methods, features and / or advantages will be or may become apparent to one with skill in the art upon examination of the following drawings and detaileddescription. It is intended that all such additional systems, methods, features and / or advantages be included within this description and be protected by the accompanying claims.BRIEF DESCRIPTION OF THE FIGURES

[0025] FIG. 1A illustrates a block diagram of an example physiological sensing device, according to implementations of the present disclosure.

[0026] FIG. IB illustrates a block diagram of an example physiological sensing device, according to implementations of the present disclosure.

[0027] FIG. 1C illustrates a block diagram of an example physiological sensing device configured to supply different data to multiple applications, according to implementations of the present disclosure.

[0028] FIG. ID illustrates a block diagram of an example physiological sensing device configured to supply different data to multiple applications, according to implementations of the present disclosure.

[0029] FIG. IE illustrates an example physiological sensing device including example sensors, according to implementations of the present disclosure.

[0030] FIG. IF illustrates an example physiological sensing device including example sensors and data processing circuitry, according to implementations of the present disclosure.

[0031] FIG. 1G illustrates an example an example physiological sensing device including example sensors and data processing circuitry, according to implementations of the present disclosure.

[0032] FIG. 2A illustrates an example wearable / implantable sensing device including a data access layer extension, according to implementations of the present disclosure.

[0033] FIG. 2B illustrates an example wearable / implantable sensing device including a data access layer extension and data access layer, according to implementations of the present disclosure.

[0034] FIG. 3A illustrates an example wearable sensing device, communications, and server / storage / database, according to implementations of the present disclosure.

[0035] FIG. 3B illustrates an example wearable sensing device in operable communication with an edge computing system, according to implementations of the present disclosure.

[0036] FIG. 3C illustrates an example wearable sensing device in operable communication with an edge computing system, where the edge computing system is in operable communication with the sensing device, according to implementations of the present disclosure.

[0037] FIG. 3D illustrates an example an example wearable sensing device in operable communication with an edge computing system and a sensing device, according to implementations of the present disclosure.

[0038] FIG. 4A illustrates an example method of accessing data from a programming model.

[0039] FIG. 4B illustrates an example method of accessing data from a data access layer in the hardware and / or physical layer, according to implementations of the present disclosure.

[0040] FIG. 4C illustrates an example feature set of the example data access layer of FIG. 4B, according to implementations of the present disclosure.

[0041] FIG. 5A illustrates an example of a conventional data flow, according to implementations of the present disclosure.

[0042] FIG. 5B illustrates an example data flow in a system according to implementations of the present disclosure.

[0043] FIG. 6 illustrates an example system for performing physiological monitoring using a data access layer, according to implementations of the present disclosure.

[0044] FIG. 7 illustrates an example method of providing access to a data structure using a data access layer, according to implementations of the present disclosure.

[0045] FIG. 8 illustrates an example computing device.DETAILED DESCRIPTION

[0046] Implementations of the present disclosure include improvements to data access and control in systems including one or more computing devices. Example embodiments described herein include wearable systems with sensors that are configured to operate with one or more computing devices and / or applications to process and store patient physiological data.

[0047] Wearable systems and devices are used to monitor the health and performance of individuals. Common wearable devices include "smartwatches" (e.g., on a person's wrist), heart rate monitoring bands (e.g., placed around a person's chest), and fitness trackers (commonly on a patient's limb, including fingers). Likewise, implantable devices also commonly monitor the health and performance of individuals. For example, pacemakers and glucose monitors commonly perform monitoring functions.

[0048] Both implantable and wearable devices can collect large amounts of patient data, including important and / or sensitive physiological data. However, implantable and wearable devices often include limited computing capabilities. For example, wearable and implantable devices can be limited in size by the location that they are worn or implanted,and / or limited in processing power by the battery capacity that can be practically implemented in the device.

[0049] Accordingly, wearable and implantable devices are often configured to operate with external computing devices. For example, wearable and implantable devices can include networking features to connect to a mobile device (e.g., a cell phone or laptop), local computing devices (e.g., a personal computer or specialized diagnostic equipment), and / or remote computing devices (e.g., networked computing devices including remote servers or a "cloud" of remote servers.) The external computing devices may not include the same limitations of the wearable / implantable device, and therefore can include more processing power, storage, etc.

[0050] The use of external computing devices with wearable / implantable devices can create security and data control problems that are particularly important for devices that collect physiological data. In a conventional application, the interface between hardware devices integrated into a system and the software that runs on it can be implemented through a set of programming functions, often referred to as the programming model. In this conventional model, hardware devices (e.g., sensors) are configured to receive commands from higher level applications, and in response provide data from the hardware devices. Additionally, data from sensors is conventionally stored in memory with little control over the data. Outside the context of physiological monitoring devices, access to sensor data is commonly beneficial, for example a GPS or compass sensor of a mobile device can collect data that can be read by any number of applications. But it is desirable to restrict access to sensitive physiological data (e.g., heart rate, blood pressure, blood glucose, etc.) for security, medical, and / or privacy concerns. Thus, the conventional "programming model" approach to providing applications access to stored data in computing devices presents disadvantages when appliedto physiological monitoring systems like wearable devices / systems and implantable medical devices.

[0051] Implementations of the present disclosure address these and other problems. Implementations of the present disclosure include an alternative to the conventional programming model for access to stored data that is configured for use with physiological monitoring devices. An example implementation of the present disclosure includes a data access layer that can be implemented to control access to one or more memories and configured to store raw physiological data from physiological sensors. The data access layer can be further configured to process raw physiological data (e.g., to obtain a physiological measurement) and store the processed physiological data in memory of the data access layer. The raw physiological data and / or processed physiological data in memory of the data access layer can selectively be provided to applications to maintain privacy and security. For example, the data access layer can be configured to only provide processed data to certain application(s) (e.g., output an average blood pressure, or peak blood pressure to a health tracking application) while providing access to some or all of the raw data to other applications (e.g., for remote health monitoring, additional data processing, and / or research purposes). Thus, the data access layer of the present disclosure provides improved systems and methods for interfacing one or more applications on a mobile or remote computing devices with sensitive physiological data collected by wearable and / or implantable medical devices. The present disclosure can therefore improve privacy and / or security of physiological data.

[0052] FIGS. 5A and 5B illustrate a comparison of example block diagram of data flow 500 in a conventional system (FIG. 5A) vs. a data flow 550 in an example implementation of the present disclosure (FIG. 5B). As shown in FIG. 5A, a hardware abstraction layer 504 is configured to provide access to device 502 (e.g., physiological sensor data). The programming layer 506 inthe conventional data flow 500 provides free access to the hardware abstraction layer 504 using conventional programming interfaces. Thus, an application 510 in in the conventional data flow may be able to access any data provided by the device 502 to the hardware abstraction layer 504.

[0053] In contrast, as shown in FIG. 5B, the example implementation of the present disclosure does not provide access to the hardware abstraction layer 504 through a programming model. Instead, a data access layer 512 is defined according to implementations of the present disclosure. The data access layer 512 includes memory to store the raw data from the device 502 and / or processed data based on the raw data from the device 502. The data access layer can define data access functions that can restrict the access of some or all applications to the data stored in the memory of the data access layer 512. Accordingly, any subset of the raw data or processed data stored in the data access layer 512 can be provided (or not provided) to any applications (shown as application 510a, 510b, 510c). In the example of FIG. 5B, the applications 510a, 510b, 510c are each permitted to access different subsets of the data of the data access layer, which can therefore improve security and / or privacy by preventing unauthorized access to physiological data from the device 502.

[0054] With reference to FIG. 6, an example system is shown according to implementations of the present disclosure. The system includes a physiological sensor module 610, a microcontroller 620, and a mobile device 630. The physiological sensor module 610 can include any number and / or combination of physiological sensors 612. Non-limiting examples of physiological sensors 612 that can be used in the physiological sensor module 610 are described with reference to the sensor circuitry 130 of FIG. IE, for example. The physiological sensor module 610 can further include wired and / or wireless communication links (e.g., the network connections 816 described with reference to FIG. 8).

[0055] It should be understood that the physiological data collected by the physiological sensor module 610 can be in any form. For example, the physiological data can be "raw" physiological data including light absorption, electrical potential, etc. As used herein, "raw" physiological data refers to the outputs of a sensor that senses any part of a person's physiology. By "raw" the present disclosure means that the physiological data can be unfiltered and lack the processing that is generally required to convert raw physiological data into useful physiological measurements. For example, light absorbance can be used to determine blood oxygen or other parameters, but a light absorbance measurement must be converted into a blood oxygen or other measurement to be meaningful. As another non-limiting example, an electrical potential measurement indicating a voltage measurement on the skin surface must be combined with many electrical potential measurements over a time period and analyzed to determine a heart rate during that time period.

[0056] The physiological sensor module 610 can be operably coupled (e.g., by any kind of wireless or wired network connections described herein) to a microcontroller 620, for example to provide the raw physiological data from the sensor(s) 612 to the microcontroller 620. The microcontroller 620 can include any / all of the components of the computing device 800 described with reference to FIG. 8. As a non-limiting example, the microcontroller 620 and / or physiological sensor module 610 can be part of the same wearable device (e.g., a wristband or ring). As another non-limiting example, the microcontroller 620 can be part of a wearable device (e.g., a wristband or ring) or an implantable device (e.g., a pacemaker) while the physiological sensor module 610 is located on (or in) a different part of the patient and configured to wirelessly communicate with the microcontroller 620.

[0057] As shown in FIG. 6, the microcontroller 620 can include a filter 622 for performing processing of the raw physiological data. Additionally, the microcontroller 620 can include memory 624 for storing raw and / or filtered physiological data.

[0058] Still with reference to FIG. 6, the microcontroller 620 can be operably coupled to the mobile device 630. The mobile device 630 can optionally include any / all of the components of the computing device 800 shown in FIG. 8, and the microcontroller 620 and mobile device 630 can optionally be in communication by the network device(s) described with reference to FIG. 8. The raw physiological data (optionally including filtered and / or unfiltered physiological data from the sensor(s) 612) can be transmitted by the microcontroller 620 to the mobile device 630.

[0059] At the mobile device 630, the received raw physiological data can be received by the data access layer 632. The data access layer 632 includes one or more memories. As shown in FIG. 6, a first memory 634 can store the raw physiological data, and a second memory 636 can store processed physiological data. Optionally, the data access layer 632 can include a processor (e.g., the computing device 800 of FIG. 8) and be configured to process raw physiological data stored in the first memory 634 into processed physiological data and store the processed physiological data in the second memory 636. As non-limiting examples, the processed physiological data can include blood pressure estimates, an ECG signal (e.g., a singlelead ECG signal), blood glucose estimates, blood oxygen estimates, heart rate estimates, etc., which can be derived from raw physiological data.

[0060] As used herein, it should be understood that the raw physiological data and / or processed physiological data can include one or more data sets. For example, the raw and / or processed physiological data can include multiple data sets corresponding to differentphysiological sensors 612. Alternatively or additionally, the multiple data sets can correspond to different time periods of data from the same sensors.

[0061] Still with reference to FIG. 6, the system can further include an application layer 638. The application layer 638 can be configured to run any number of applications 510a, 510b, 510c. As non-limiting examples, the applications 510a, 510b, 510c can be configured to process, store, and / or display data (e.g., physiological data). Applications 510a, 510b, 510c can send, using the application layer 638, data requests to the data access layer 632. The data requests can include data access functions (e.g., operations to verify that the application requesting the data has the appropriate permissions to access the data). In response to the data request, the data access layer 632 can provide a data structure to the application layer 638 and thereby to one or more of the applications 510a, 510b, 510c.

[0062] The data structure described herein can include any or all of the data stored in the first memory 634 and / or second memory 636. The data access layer 632 can be configured to limit access to based on a request provided by the applications 510a, 510b, 510c of the application layer 638. Optionally, the request can be configured as a data access function that the data access layer 632 selectively responds to. As used herein, the "data access function" can optionally be a predetermined data access function, for example a including a predetermined code or other authentication system to determine that the request for the data structure is a valid request (e.g., a request by an application or computing device that is preapproved). As another example, the predetermined access function can include license information (e.g., a password or cryptographic code that indicates that the application is licensed to access the data structure that is requested).

[0063] For example, a first application 510a can include a first data access function that only permits access to processed physiological data and does not permit access to rawphysiological data. Accordingly, the data access layer 632 can transmit to the first application 510a a data structure including only processed physiological data. As another non-limiting example, the second application 510b can include a second data access function that provides access to only the most recent item of processed physiological data (e.g., the most recent estimate of blood oxygen). Accordingly, the data access layer 632 can transmit to the second application 510b a data structure including only the most recent piece of processed physiological data. As yet another example, the third application 510c can include a third data access function that permits data to only the raw physiological data in the first memory 634 of the data access layer 632. Accordingly, the data access layer 632 can transmit to the third application 510c a data structure including only the raw physiological data. It should be understood that the three applications and data access functions described herein are intended only as non-limiting examples, and that any number or type of applications and data access functions are contemplated by the present disclosure. For example, a data access function can permit an application to only raw and / or processed physiological data from a subset of the sensors, and / or to specific time periods of raw and / or processed physiological data.

[0064] It should be understood that in some implementations of the present disclosure, both the application layer 638 and the data access layer 632 can be implemented by the same mobile computing device 630. Alternatively or additionally, the application layer 638 and data access layer 632 can be implemented using separate devices. For example, the application layer can be implemented using a second mobile device or personal computer (or any other computing device as described with reference to FIG. 8) that is operably coupled to the mobile device 630 by a network.

[0065] Optionally, the system further includes a remote device 640. The remote device can include any / all of the components described with reference to the computing device800 of FIG. 8. As described with reference to FIGS. 1A-3D, the remote device 640 can optionally be implemented using cloud computing, remote servers / storage / databases, remote computing devices, etc. As shown in FIG. 6, the remote device 640 can be configured to receive raw and / or filtered physiological data from the data access layer 632 of the mobile device 630. The data access layer 632 can be configured to selectively provide access to data stored in the data access layer to the remote device 640 using data requests as described with respect to the operation of the application layer 638. It should be understood that the data access layer can provide different data to applications in the application layer and remote device, or to any number of applications and remote devices.

[0066] Additionally, as shown in FIG. 6, the remote device 640 can be configured to perform storage and / or processing of the raw and / or processed physiological data. For example, the remote device 640 can be configured to apply additional (e.g., more complicated or sophisticated) processing to any of the data stored in the memory of the data access layer. For example, the remote device can be configured to perform a correction or calibration on any of the physiological data to obtain corrected physiological data 642. The corrected physiological data 642 can then be optionally transmitted to the data access layer 632 and / or application layer 638.

[0067] With reference to FIG. 7, an example computer-implemented method of using a data access layer is shown, that can be implemented for example, using the system of FIG. 6. As described with reference to FIGS. 1A-3D, the computer implemented method shown in FIG.7 can optionally be implemented using multiple computing devices and memories to control access to physiological data and improve privacy and security in systems including networked physiological sensors.

[0068] As shown in FIG. 7 , at step 710 the method can include storing raw physiological data in a first memory of a data access layer.

[0069] At step 720 the method can include processing the raw physiological data into processed physiological data.

[0070] At step 730 the method can further include storing the processed physiological data in a second memory of the data access layer.

[0071] At step 740 the method can further include selectively providing access to a data structure comprising the raw physiological data and / or processed physiological data using the data access layer. For example, the method can include only providing access to the first memory and / or second memory of the data access layer in response to a data access function. For example, the data access function can include a code (e.g., predetermined data access function including a predetermined password or code), or other authentication system to determine that the request for the data structure is a valid request (e.g., that the request is from a pre-approved application and / or device). As another example, the predetermined access function can include license information (e.g., a password or cryptographic code that indicates that the application is licensed to access the data structure that is requested at step 740).

[0072] Optionally, as described with reference to FIG. 6, selectively providing access to the data structure can include outputting a data structure comprising raw physiological data in response to receiving a data access function.

[0073] As also described in greater detail with respect to FIG. 6, the data structure provided at step 740 can optionally include less than all the processed physiological data and / or raw physiological data than is stored in the memory (e.g., the first and second memories described with reference to FIG. 6). Moreover, it should be understood that providing the datastructure at step 740 can be performed within one or more memories of a device, or, alternatively or additionally, by transmitting the data structure to a remote device.

[0074] Figs. 1A-4C include additional non-limiting examples of systems and methods that can be used to implement the present disclosure (e.g., the systems described with reference to in FIG. 6 and method shown in FIG. 7. In some implementations, the present disclosure includes devices and systems of, and methods implemented by, a wearable and / or an implantable physiological sensing device 102 having sensors to acquire, capture, measure, sense, detect, analyze and / or assess physiological data or information (blood pressure, glucose level or fluid state of an animal (e.g., a human to which the wearable and / or implantable device is affixed)) wherein one or more data access layers 110, executed from / in the hardware / physical layer 114 of the device, may acquire, organize, manage and / or warehouse the physiological data / data sets and / or control or manage access to such physiological data / data sets by, for example, application(s), which, for example, use, assess and / or analyze such physiological data or information. These appl ication(s) execute from / in the application layer(s) 104 of the device whereas the code corresponding to the one or more data access layers 110 execute from / in the hardware / physical layer 114 of the device.

[0075] A data access layer 110 is an organized data structure / warehouse of one or more sets of physiological data and includes one or more functions and features that (i) define, determine, organize and / or warehouse a type of physiological data / data sets (e.g., systolic related data, diastolic related data, guardrail related data, etc.), and / or (ii) control, manage and / or determine access to the physiological data / data sets (which may or may not be organized into one or more sets of organized data structures - each set including related physiological data). The physiological data associated with the data access layer 110 may be raw" physiological data (i.e., physiological related data which has not undergone processingbut is directly output from a sensor) and / or processed data (i.e., data, which is generated by and output from a sensor, which has undergone processing operation(s), e.g., filtering, limiting, error correction, etc. and / or more involved data processing such as derivation of related physiological data from the sensor data (e.g., heart rate data based on or determined from blood pressure related data detected by and output from a sensor).

[0076] The plurality of functions and features of a data access layer 110 may be fixed or programmable. In one embodiment, each function and feature of the plurality may be fixed (e.g., hardwired), one-time programmable (e.g., at manufacture or set-up / initialization, e.g., via a ROM and / or fuses), or more than one-time programmable (e.g., (i) at or via power-up, startup or performance / completion of the initialization sequence / process sequence, and / or (ii) in situ (i.e., during normal operation of the wearable physiological sensing device and / or an implantable physiological sensing device). Indeed, in one embodiment, the functions and features associated with a data access layer 110 may be individually configurable / programmable (e.g., either one-time or more than one-time) - for example, (i) at / during an update sequence, and / or (ii) in situ. Alternatively, certain functions and features associated with a data access layer 110 may be individually configurable / programmable (e.g., either one-time or more than one-time) -for example, (i) at / during an update sequence, and / or (ii) in situ, and other functions and features are configurable / programmable as a group or set. Notably, all combinations and permutations of configurability and non-configurability functions and features associated with a data access layer 110 are intended to fall within the scope of the present disclosure.

[0077] The one or more data access layers 110 execute from the hardware / physical layer 114 of the sensing device 102. In addition, one or more data access layers 110 preferably reside or are stored in the hardware / physical layer 114 (e.g., temporarily or permanently storedin memory of the hardware / physical layer 114 of the sensing device 102). In one embodiment, one or more functions and features of the data access layer 110 may control, manage and / or determine access to one or more subsets of data of a data access layer 110. In this way, access to the data of a data access layer 110 by one or more applications (e.g., application(s) that run in or execute from application layer 104 of the sensing device 102) may be managed or controlled (e.g., on a permissions or license / subscription basis). Here, the sensing device 102 (for example, via input from an operator, device manufacturer and / or system manager) may selectively control access of the data access layer 110, and data thereof, as well as additional security, performance and / or computational bandwidth to developers of applications of or residing in the application layer(s) 104 which, in turn, facilitates a sensing device 102 having greater security, higher performance and improved computational bandwidth.

[0078] For example, in conventional devices, data security, especially in healthcare, is managed by one or more of the applications of the application layer(s) 104 (applications that executed in the application layer(s)) 104. Executing the code of the data access layer 110, in the physical layer of the wearable or implantable physiological sensing device 102, to acquire or compile one or more data sets of the data access layer 110 provides additional security features via controlling, managing, limiting and / or restricting access to the sensor device and similarly controlling, managing, limiting and / or modulating the exposure or availability of data, via transmission of such data from the hardware layer to the application layer 104, that are acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the device to, for example, predetermined applications in the application layer 104. Here, in one embodiment, access to and control of the code of data access layer(s) 110, and the data of such data access layers(s) 110, facilitates implementing access levels, privilege control and / or authentication control for application(s) / user(s). Moreover, executing such code of one ormore data access layers 110 in the physical layer of the physiological sensing device 102 (in contrast to the application layer) may further enhance security for the same reason(s) as set forth above. In addition, locating the code of one or more data access layers 110 in the physical layer of the physiological sensing device 102 may provide even more security. Indeed, application developers may benefit from such an architecture by relying on faster feature development while also building upon or enhancing the security features of the device layer.

[0079] As noted above, the data access layer 110 includes both data organization, storage / warehousing as well as one or more functions and features that (i) define and determine a type of physiological data of one or more data sets and / or (ii) access to and control of the data of such data sets. The functions and features of the data access layers 110, and access thereto, may be defined, modified and / or changed by, for example, the operator, device manufacturer and / or system manager (e.g., over the air (OTA) and / or via point-to-point communication). Similarly, features of the data access layers(s) 110, and the access to the data of the data access layers(s) 110, may also be controlled or managed by the operator, device manufacturer and / or manager. Each of the functions, features, and data access / control, may be defined, modified, controlled and / or managed as a group (or one or more sub-groups) or individually / separately.

[0080] In addition, in the conventional computational models of wearable or implantable physiological sensing devices 102, the hardware / physical layer 114 of such devices are abstracted as programming models for software applications (e.g., the device software 108 shown in FIGS. 1A-3D). A programming model is an abstraction (usually a set of functions or a library of functions) provided by a hardware platform to enable or facilitate device access to software applications executing in the application layer 104. Additionally, it should be understood that the example embodiments can include firmware 112 (e.g., software includedin embedded systems). These abstractions are employed in, for example, controlling hardware features, parameters and to exchange data with the hardware device. A primary feature of the software application(s) is data organization / storing and manipulation. Indeed, conventional computational platforms "remove" control of the data from the hardware / physical layer 114 of the device which is responsible for data acquisition, capture, measurement, detection and / or sensing of one or more physiological characteristics of the animal (e.g., human). In conventional systems, that "raw" data may be provided (e.g., rapidly) to one or more applications which reside / execute in the application layer 104 of the device - however, typically after the hardware / sensing circuitry implements or performs certain post-acquisition processing operations such as filtering, extraction from packetized formats, error corrections of such data. In this way, applications residing / executing in the application layer 104 of conventional devices organize the data in local and remote data storage (e.g., memory residing in the wearable or implantable physiological sensing device 102) and computational functions are controlled, scheduled and / or driven by those applications which execute in the application layer 104.

[0081] Notably, in the context of the present disclosure, an "application" is a program which resides and executes / runs in the application layer 104, for example, Windows, Android and iOS. These programs are one or more layers above the hardware abstraction layer 106 and rely on elements such as device drivers or libraries or SDKs (or similar methods) to interact with or receive data from the hardware / physical layers (e.g., from the sensors of the hardware / physical layers). As such, the functions and features implemented by the data access layer 110 are not "applications" that execute / run in the application layer 104 of the sensing devices 102 of the present disclosure but are functions and features implemented / provided by the data access layer 110 which execute / run in the hardware / physical layer 114 of the sensingdevice 102 (and, e.g., are temporarily or permanently stored in memory of the hardware / physical layer). The data access layer 110 acquires, organizes, manages and / or warehouses physiological data / data sets and / or, in one embodiment, controls or manages access to such physiological data by, for example, applications that execute / run in the application layer 104 of the device. The applications that execute in the application layer 104 of the physiological sensing device 102 may, for example, assess and / or analyze such physiological data.

[0082] The functions provided by the data access layer 110 are not "applications" that execute / run in the application layer(s) 104 of the sensing devices 102 of the present disclosure but are functions performed or provided by the data access layer 110 which are stored in the hardware / physical layer 114 of the sensing device 102 (e.g., temporarily or permanently stored in memory of the hardware / physical layer) and, in one embodiment, available to and may be accessed by one or more applications of the application layer 104 of the device. FIGURES 4A and 4B illustrate an exemplary programming model wherein the application is executed from the application layer 104 (FIGURE 4A) and an exemplary functions or operations (set forth in pseudo code) implemented with a data access layer 110 that is executed from and / or stored in the hardware / physical layer 114 (e.g., temporarily or permanently stored in memory of the hardware / physical layer) of the sensor device (FIGURE 4B). Notably, FIGURE 4C illustrates exemplary functions or operations (set forth in pseudo code) implemented with a data access layer 110 associated with data acquired from sensor(s) employed to generate / detect data related to blood pressure sensors (e.g., pulse rate sensors based on photoplethysmogram (PPG) technology; such sensors are optically-based and can obtain plethysmograms that may be employed to detect / determine blood volume changes inthe microvascular bed of tissue via illuminating the skin, via LED(s), and measuring changes in light absorption, via photodetector(s)).

[0083] It should be noted that a wearable sensing device 302 is an electronic device or apparatus that is and / or can be attached to and / or worn by a human including, but not limited to, a device that is and / or can be temporarily attached to and / or worn by a human as accessories (e.g., watch, bracelet, pendant, patch, and / or eye glasses) or is and / or can be embedded in clothing, a mechanism or an attachment that is configured to be disposed on or worn by a human. In contrast, an implantable device is an electronic device or apparatus that is introduced, inserted, implanted and / or embedded into or onto a human's body (e.g., an implantable cardioverter defibrillator or an implantable glucose sensor in a human). Indeed, a wearable sensing device 302 may interact, interface (e.g., by an interface 304) and / or communicate with, receive data from, and / or provide data to an implantable physiological sensing device (e.g., implanted or embedded in a human) or remote circuitry (circuitry which is remote from the wearable sensing device 302), and / or sense, detect, analyze and / or assess physiological data of an animal based on such communication and / or such data from the implantable physiological sensing device or remote circuitry.

[0084] The present disclosure may be implemented in connection with embodiments illustrated in the attached drawings. These drawings show different aspects of the present disclosure and, where appropriate, reference numerals or names illustrating like structures, components, materials and / or elements in different figures are labeled similarly. It is understood that various combinations of the structures, components, and / or elements, other than those specifically shown, are contemplated and are within the scope of the present disclosure.

[0085] The present disclosure is neither limited to any single aspect nor embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the aspects of the present disclosure, and / or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and / or embodiments thereof. For the sake of brevity, certain permutations and combinations are not discussed and / or illustrated separately herein. Notably, an embodiment or implementation described herein as "exemplary" is not to be construed as preferred or advantageous, for example, over other embodiments or implementations; rather, it is intended to reflect or indicate the embodiment(s) is / are "example" embodiment(s).

[0086] FIGURES 1A and IB illustrate, in block diagram form, exemplary embodiments of physiological sensing device 102 (e.g., a wearable and / or an implantable physiological sensing device) to acquire, capture, measure, sense, detect, analyze and / or assess physiological data or information (blood pressure, glucose level or fluid state of an animal (e.g., a human)) wherein a data access layer 110, the code of which is executed from / in the hardware / physical layer 114 of the sensing device 102, organizes and / or warehouses data acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the device and may selectively control or manage access to the data access layer 110, and data / data sets thereof; here, the sensing device 102 (for example, via input from an operator, device manufacturer and / or system manager) may selectively control access to the data / data sets of the associated data access layer 110 by, for example, application(s) operating and / or executing in the application layer(s) 104 of the device which, for example, assess or analyze physiological data or information; notably, a data access layer 110 is an organized data structure / warehouse of one or more sets of physiological data and includes one or more functions and features that (i) define and determine a type of physiological data of one or more data sets (e.g., systolic relateddata, diastolic related data, guardrail related data, etc.), and / or (ii) control, manage and / or determine access to the data (which may or may not be organized into one or more sets of organized data structures - each set including related physiological data); (see, FIGURE 1A, Inset A); code to implement the data access layers 110 executes from the hardware / physical layer 114 of the device and, in addition thereto, may be stored in the hardware / physical layer 114 of the device, for example, during manufacture or test such that the data access layers(s) 110 are preloaded prior to use by the user and / or during set-up by the user; in this illustrative embodiment, communication circuitry (not illustrated) in the sensing devices 102 facilitates communication (e.g., via an Intranet and / or Internet), with one or more remote servers / computers, storage systems and / or databases to, for example, receive one or and / or transmit one or more data access layers 110; notably, such communication circuitry may, in addition thereto or in lieu thereof, communicate (i.e., receive and / or transmit) control information to implement functions / operation of the device (e.g., in connection with one or more applications that execute or operate from the application layer 104) and / or data to "personalize" or associate the sensing device 102 with a particular human; in one embodiment, one or more data access layers 110 may be stored in the hardware / physical layer 114 of the device during manufacture or test such that the data access layers(s) llOare preloaded prior to use by the user; in addition thereto, or in lieu thereof, the sensing device 102 may (i) receive new / updated data and / or data access layers 110 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA)) for use in the sensing device 102 during operation and / or (ii) transmit new / updated data and / or modified data access layers 110 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data orinformation of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation (see, e.g., FIGURE IB). As will be described in greater detail herein, the present disclosure contemplates that the applications described herein can be executed as cloud applications 310, for example as shown in FIG. 3B.

[0087] FIGURES 1C and ID illustrate, in block diagram form, exemplary embodiments of physiological sensing device (e.g., a wearable and / or an implantable physiological sensing device) to acquire, capture, measure, sense, detect, analyze and / or assess physiological data or information (blood pressure, glucose level or fluid state of an animal (e.g., a human)) wherein a data access layers 110, executed from the hardware / physical layer 114 of the device, organizes and / or warehouses data acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the device and may, in this embodiment, selectively control or manage access of the data / data sets associated with the data access layer 110 by application(s) operating and / or executing in the application layer(s) 104 of the sensing device 102 which, for example, assess or analyze physiological data or information; here, the sensing device 102 (for example, via input from an operator, device manufacturer and / or system manager) may selectively control access of the data / data sets of the associated data access layer 110, via functions and features of the data access layer 110; in the illustrative embodiment of FIGURE 1C, Application 1 122a may access physiological data / data set(s) ("DMx" 124a) of the data access layer 110, Application 2 122b may access physiological data / data set(s) ("DMy" 124b) of the data access layer 110, and Application x may access physiological data / data set(s) ("DMz" 124c) of the data access layer 110; in the illustrative embodiment of FIGURE ID, Application 1 122a may access physiological data / data set(s) ("DMx" 124a ) of the data access layer 110,Application 2 122b may access physiological data / data set(s) ("DMx" 124a) of the data accesslayer, and Application x may access physiological data / data set(s) ("DMy" 124b) of the data access layer 110; as mentioned above, code to acquire data of the data access layers 110 executes from the hardware / physical layer 114 of the device and, in addition thereto, may be stored in the hardware / physical layer 114 of the device, for example, during manufacture or test such that code associated with the data access layers(s) 110 are preloaded prior to use by the user and / or during set-up by the user; in this illustrative embodiment, communication circuitry (not illustrated) in the sensing devices 102 facilitates communication (e.g., via an Intranet and / or Internet), with one or more remote servers / computers, storage systems and / or databases to, for example, receive one or and / or transmit one or more data access layers 110; notably, such communication circuitry may, in addition thereto or in lieu thereof, communicate (i.e., receive and / or transmit) control information to implement functions / operation of the device (e.g., in connection with one or more applications that execute or operate from the application layer 104) and / or data to "personalize" or associate the sensing device 102 with a particular human; in one embodiment, one or more data access layers 110 may be stored in the hardware / physical layer 114 of the device during manufacture or test such that the data access layers(s) 110 are preloaded prior to use by the user; in addition thereto, or in lieu thereof, the sensing device 102 may (i) receive new / updated data and / or data access layers 110 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 306 (i.e., edge computing) - overthe air (OTA)) for use in the sensing device 102 during operation and / or (ii) transmit new / updated data and / or modified data access layers 110 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 306 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose levelor fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation;

[0088] FIGURES 1E-1G illustrate, in block diagram form, exemplary embodiments of physiological sensing device (e.g., a wearable and / or an implantable physiological sensing device) including sensor circuitry 130 (which includes one or more sensors) to acquire, capture, measure, sense and / or detect physiological data or information of an animal (e.g., a human) wherein the data access layer 110, executed from the hardware / physical layer 114 of the device, may receive and organize "raw" physiological data and / or processed data based on the "raw" physiological data that are acquired, captured, measured, detected, and / or sensed by one or more physiological sensor(s) of the device; notably, Inset A illustrates, in block diagram form, exemplary physiological sensor(s) to determine, sense, detect, assess and / or obtain data / information which is representative of physiological condition of the user, according to at least certain embodiments of the present disclosure; in one embodiment, one or more physiological sensor(s) may be incorporated in and / or coupled to the exemplary physiological sensing device (for example, using the wired or wireless communications 120 illustrated in FIGS. 1A-3D, which can include connections that are physically, electrically and / or optically coupled, including wired and / or wirelessly coupled), wherein the data access layer 110 may acquire, organize, manage and / or warehouse the physiological data (and / or data / data sets related thereto) and / or control or manage access to such physiological data (and / or related data / data sets), according to at least certain embodiments of the present disclosure.

[0089] FIGURES 2A and 2B illustrate, in block diagram form, exemplary embodiments of physiological sensing device (e.g., a wearable physiological sensing device and / or an implantable physiological sensing device) to acquire, capture, measure, sense, detect, analyze and / or assess physiological data or information (blood pressure, glucose level or fluid state ofan animal (e.g., a human)) wherein, in addition to the hardware / physical layer 114 of the device acquiring and / or providing one or more data access layers 110 to the applications in the application layer(s) 104 of the device which, for example, assess or analyze physiological data or information, the sensing device 102 receives one or more data access layer extensions 202, having data associated therewith that may be imported, merged and / or integrated with data associated with data access layers(s) 110 of the sensing device 102 thereby forming or providing a composite or combined new data access layer (e.g., a continuous blood pressure monitor may import or merge data from a source such as an electro cardiogram and offer novel features) notwithstanding the programming model(s) associated with such data access layer extension may be the same or different (e.g., a continuous blood pressure sensor / monitor having a data access layer (and associated programming model) and may import or merge data from a sensor such as an electrocardiogram sensor / monitor (having a data access layer 110 and an associated programming model which is different from the blood pressure sensor / monitor) and provide different features relative to either the blood pressure sensor / monitor or the electrocardiogram sensor / monitor; notably, in this illustrative embodiment, communication circuitry (not illustrated) in the sensing devices 102 facilitates communication (e.g., via an Intranet and / or Internet), with (i) one or more remote servers / computers, storage systems and / or databases and / or (ii) one or more other sensor devices (not illustrated) to, for example, communicate one or more data access layers 110 of the data access layer extension 202; in this embodiment, the physiological sensing device may "personalize" or associate data from multiple (two, three, four or more) physiological sensing devices (each having data access layers(s) 110 and associated programming model(s)) with, for example, a particular user of the sensing device 102; in one embodiment, data associated with one or more data access layer extensions 202 may be stored in the memory of the physiological sensing device wherein theoutput of the data access layer extension(s) 202 may be available to the hardware / physical layer 114 and / or the application layer 104 of the device during start-up and / or operation; indeed, in one embodiment, the sensing device 102 may also (i) receive new / updated data access layer extension(s) 202 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA)) for use in the sensing device 102 during operation and / or (ii) transmit new / modified data access layer extension(s) 202 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation;

[0090] FIGURES 3A-3D illustrate, in block diagram form, exemplary embodiments of communication to a physiological sensing device (labeled as a "wearable sensing device 302" - although the embodiment is applicable to an implantable physiological sensing device as well) that is capable of acquiring, capturing, measuring, sensing, detecting, analyzing and / or assessing physiological data or information (see, e.g., FIGURES 1A-1C, 2A and 2B) from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306) and, in another embodiment, directly or more directly from another sensing device 312 (e.g., FIGURES 3C and 3D) which transmits one or more data access layer extensions 202 that may be employed by the wearable sensing device 302 to (i) generate, provide or present a composite or combined new data access layer 110 (see FIGURES 2A and 2B), and / or (ii) perform additional functions that are specific or particular to the user associated with the wearable sensing device302 using data access layers 110 generated by the sensor device and data access layerextension(s) 202 (e.g., a dehydration alert may be issued to a person diagnosed with orthostatic hypotension; and / or, an alert may be issued to a person having a history or arrhythmias when that person is exposed to high pollution environments), and / or (iii) generate and / or implement a data access layer 110 which is "personalized" to or associated with the user that is an aggregate of multiple sources from, for example, multiple sensor devices (whether or not one, some or all of such sensor devices are (i) wearable or implantable and / or (ii) particularly associated with or acquiring data unique to the user); notably, the communication may be two- way wherein the wearable / implantable physiological sensing device 302may transmit, output and / or provide data (e.g., in real-time), via the Internet or other communication network (e.g., over the air (OTA)), corresponding to the state / status and / or change in state / status of one or more, or all of the sensor data being monitored / acquired as well as the physiological characteristics of the user associated with the sensor device and / or the analysis / analyses thereof to one or more remote processing systems; as such, the physiological sensing device 302 may transmit updated data and / or data access layers 110 to Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308) for storage and / or additional processing; in addition thereto, or in lieu thereof, the physiological sensing device 302may (i) receive new / updated data, data access layers 110 and / or data access layer extensions 202 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 - over the air (OTA)) for use in the sensing device 312 during operation and (ii) transmit new / updated data, modified data access layers 110 and / or data access layer extensions 202 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose levelor fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 302 during operation;

[0091] FIGURES 4A and 4B illustrate an exemplary programming model wherein the application is executed from the application layer 104 (FIGURE 4A) and an exemplary function or an operation (set forth in pseudo code) implemented with a data access layer 110 that is executed from and / or stored in the hardware / physical layer 114 (e.g., temporarily or permanently stored in memory of the hardware / physical layer) of the sensor device (FIGURE 4B); a comparison of FIGURES 4A and 4B illustrates an exemplary difference between an exemplary application developed with a programming model versus an exemplary application developed with a data access layer 110 in pseudo code (e.g., which is stored and / or executed in the hardware / physical layer 114 of a physiological sensing device); and

[0092] FIGURE 4C illustrates exemplary functions / features that can be associated with a data access layer (e.g., the data access layers described with reference to FIGS. 1A-3D, 5B, 6, and 7) which generates data sets associated with the functions / features; the code associated with the data access layer 110 is executed from and / or stored in the hardware / physical layer 114 (e.g., temporarily or permanently stored in memory of the hardware / physical layer) of the sensor device.

[0093] Additional Example Embodiments

[0094] In one aspect, the present disclosure are directed to devices and systems of, and methods implemented by, a wearable physiological sensing device and / or an implantable physiological sensing device having sensors to acquire, capture, measure, sense, detect, analyze and / or assess physiological data or information (blood pressure, glucose level or fluid state of an animal (e.g., a human to which the wearable and / or implantable device is affixed)) wherein a data access layer 110 , executed from / in the hardware / physical layer 114 of the device, mayacquire, organize, manage and / or warehouse the physiological data (and / or data / data sets related thereto) and / or control or manage access to such physiological data (and / or related data / data sets) by, for example, application(s) that execute in / from the application layer(s) 104 of the device. Here, the application(s) may use, assess and / or analyze such physiological data or information. The code corresponding to the application(s) execute from the application layer(s) 104 of the device whereas the code corresponding to the data access layer 110 executes from / in the hardware / physical layer 114 of the device.

[0095] A data access layer 110 can include an organized data structure / warehouse of one or more sets of physiological data and includes one or more functions and features that (i) warehouse, organize, define and determine a type of physiological data of one or more data sets (e.g., systolic related data, diastolic related data, guardrail related data, etc.), and / or (ii) control, manage and / or determine access to the data (which may or may not be organized into one or more sets of organized data structures - each set including related physiological data). (See, e.g., FIGURE 1A, Inset A). The devices and systems of, and methods implemented by, a wearable or implantable physiological sensing device include one or more data access layers 110 having one or more functions and features that, in one embodiment, facilitate or enable communication and interaction with, for example, application(s) operating in the application layer 104 of the device. These functions and features are similar to "controls" of the programming model typically provided to application(s) of the application layers 104. That is, in addition to, or in lieu of the application layer 104 being provided a set of access functions (APIs / drivers or other means) as typically found in conventional systems, the data access layer, in one embodiment, include one or more access functions and features that define, determine, facilitate and / or enable communication and interaction between data / data sets associatedwith the data access layer 110 and, for example, a ppi ication (s) operating or executing in the application layer 104 of the device. (See, e.g., FIGURE 1A).

[0096] Notably, the physiological data associated with the data access layer 110 can be "raw" physiological data (e.g., physiological related data which has not undergone processing but is directly output from a sensor). In addition thereto, or in lieu thereof, the physiological data associated with the data access layer 110 may be processed data (i.e., data, generated by and output from a physiological sensor, which has undergone one or more processing operations, e.g., filtering, limiting, error correction, and / or more involved data processing such as derivation of related physiological data from the sensor data (e.g., heart rate data based on or determined from blood pressure related physiological data detected by and output from the sensor (e.g., a PPG sensor))).

[0097] The plurality of functions and features of a data access layer 110 can be fixed or programmable. In one embodiment, each function and feature of the plurality may be fixed (e.g., hardwired), one-time programmable (e.g., at manufacture or set-up / initialization, e.g., via a ROM and / or fuses), or more than one-time programmable (e.g., (i) at or via power-up, startup or performance / completion of the initialization sequence / process sequence, and / or (ii) in situ (i.e., during normal operation of the physiological sensing device). Indeed, in some implementations, the functions and features associated with a data access layer 110 may be individually configurable / programmable (e.g., either one-time or more than one-time) -for example, (i) at / during an update sequence, and / or (ii) in situ. Alternatively or additionally, certain functions and features associated with a data access layer 110 can be individually configurable / programmable (e.g., either one-time or more than one-time) - for example, (i) at / during an update sequence, and / or (ii) in situ, and other functions and features are configurable / programmable as a group or set.

[0098] For example, in an example embodiment, the functions and features of the data access layer 110 (e.g., access to the data / data sets associated therewith), can be defined, modified and / or changed by, for example, the operator, device manufacturer and / or system manager (e.g., over the air (OTA) and / or via point-to-point communication). Similarly, features of the data access layers, and the access to the data of the data access layers(s) 110, may also be controlled or managed by the operator, device manufacturer and / or manager. Each of the functions, features, and data access / control, may be defined, modified, controlled and / or managed as a group (or one or more sub-groups) or individua I ly / sepa rate ly. Notably, all combinations and permutations of configurability and non-configurability functions and features associated with a data access layer 110 are intended to fall within the scope of the present disclosure.

[0099] The one or more data access layers 110 execute from the hardware / physical layer 114 of the sensing device. (See, e.g., FIGURES 1A and IB). That is, the code of the data access layer 110 (which define the function(s) and feature(s) of the data access layer 110 and / or control, manage and / or determine access to the data / data sets associated with the data access layer 110) executes in the hardware / physical layer 114 of the wearable or implantable physiological sensing device and the data / data sets associated with the data access layer 110 are stored, managed and / or maintained in the hardware / physical layer. In addition, in one embodiment, the code of the data access layer 110 is preferably stored in the hardware / physical layer 114 of the sensing device (e.g., temporarily or permanently stored in memory of the hardware / physical layer).

[0100] Notably, executing the code of the data access layer 110 , in the physical layer of the physiological sensing device, to acquire, manage and / or store data / data sets of physiological related information associated with the data access layer 110 may provideadditional security features via controlling, managing, limiting and / or restricting access to the physiological data / data sets (which are obtained from the sensors of the device) and similarly controlling, managing, limiting and / or modulating the exposure or availability of data, via transmission of such data from the hardware layer to the application layer 104, that are acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the device to, for example, predetermined applications in the application layer 104. In addition, locating or storing the code of data access layer(s) 110 in the physical layer of the wearable or implantable physiological sensing device may provide even more security.

[0101] The data access layer 110 may be preloaded prior to normal operation (e.g., at manufacture, at or via power-up or start-up, and / or during an initialization sequence) and / or may be installed or enable in situ (i.e., during normal operation of the wearable sensing device 302 and / or an implantable physiological sensing device). For example, with reference to FIGURE IB, in one embodiment, the physiological sensing device may receive new / updated data and / or data access layers 110 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA) and / or point-to-point communications) for use in the sensing device 102 during operation. Here, data / datasets and / or code of a data access layer 110 may be received and / or downloaded, by the sensing device 102, from an external server, storage and / or database, and stored in, for example, the device memory 116. In addition, the code of the data access layer 110, as described above, may execute in / from the hardware / physical layer 114 and may be associated with new data / data sets to be generated by the sensing device 102 and / or data / data sets received / downloaded from, for example, the Internet or remote processing system for use in the sensing device 102 during operation.

[0102] With continued reference to FIGURE IB, in addition to receiving a data / data sets associated with a data access layer 110 from external circuitry, the wearable or implantable physiological sensing device may transmit and / or upload data / data sets, which have been generated, organized, warehoused by data access layer 110 operating in the sensing device 102, from the sensing device 102 to remote circuitry. In this embodiment, the such data / data sets may be further organized and / or processed by the remote circuitry. For example, the physiological sensing device may transmit new / updated data and / or modified data access layers 110 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation.

[0103] The data access layer 110, in addition to acquiring, organizing, managing and / or warehousing the physiological data (or data / data sets related thereto), or in lieu thereof, may control or manage access to such data by, for example, application(s) operating or executing in the wearable or implantable physiological sensing device. For example, the data access layer 110 may include functions and features that selectively (for example, via input from an operator, device manufacturer and / or system manager) control access to the data / data sets associated with the data access layer 110. In one embodiment, the data access layer 110 includes access level and privilege functionality that controls or limits access of the application(s), operating or executing in the physiological sensing device, to one or more (or all) data sets organized, managed and / or warehoused by the data access layer 110.

[0104] For example, with reference to FIGURE 1C, the data access layer 110 operating in a wearable or implantable physiological sensing device may be programmed / configured to control or manage access and / or use by Applications 1, 2 and x to selected data / data sets associated with the data access layer 110. That is, the functions and features of the data access layer 110 may restrict / limit access of Application 1 122a, which is executing or operating on / in the sensing device 102, to only the physiological data / data set DMx 124a of associated with the data access layer 110. Similarly, the access and / or use by Application 2 122b may be restricted / limited to the physiological data / data set DMy 124b of the data access layer 110. Here, the physiological data / data set DMx 124a may be different from the physiological data / data set DMy 124b. Similarly, Application x may be permitted to access and / or use the physiological data / data set DMz 124c associated with the data access layer 110. Here again, the physiological data / data set DMz 124c may be different from the physiological data / data sets DMx 124a and DMy 124b.

[0105] With that in mind, assume for explanation purposes, the data access layer 110 operating in a wearable or implantable physiological sensing device may include functions and features that acquire, organize, manage and / or warehouse the physiological data / data sets (and / or data / data sets related thereto) of:Function / Feature 1: Mean Systolic (start_time, end_time) Function / Feature 2: Mean Diastolic (start_time, end_time) Function / Feature 3: Systolic_range (start_time, end_time) Function / Feature 4: Diastolic_range (start_time, end_time) Function / Feature 5: Systolic_fluctuation_on_wakeup (date); Function / Feature 6: Diastolic_fluctuation_on_wakeup (date); Function / Feature 7: Upper_guardrail_events (date) Function / Feature 8: Lower_guardrail_events (date)

[0106] With reference to FIGURES 1C and 4C, in operation, one or more of the functions and features of the data access layer 110 may manage, control or determine access by one or more (or all) applications (for example, operating in the sensing device 102) to data / data set(s) associated with the data access layer 110. For example, the data access layer 110 may limit / restrict Application 1 122a to access and / or use of only data / data sets of features 1-4 (i.e., DMx 124a in the illustrative embodiment), whereas Application 2 122b may access and / or use only data / data sets of features 3-6 (i.e., DMy 124b in the illustrative embodiment), and Application x may access and / or use data / data sets associated with all of the features of the data access layer 110 (i.e., features 1-8 - DMz 124c in the illustrative embodiment).

[0107] The functions and features of the data access layer 110 that manage, control or determine access by one or more (or all) applications / users to data / data set(s) associated with the data access layer 110 may be based on any criteria / criterion now known or later developed. For example, the criteria / criterion may be based on subscription, authentication, privilege, operator, device manufacturer and / or system manager. Moreover, the application operating in the application layer 104 may have access to the same or different data / data set(s) associated with the data access layer 110 With reference to FIGURE ID, the data access layer 110 may limit / restrict Application 1 122a and Application 2 122b to access and / or use of only data / data sets of features 1-4 (i.e., DMx 124a in the illustrative embodiment), whereas Application x may access and / or use only data / data sets of features 3-6 (i.e., DMy 124b in the illustrative embodiment).

[0108] Notably, the sensing device 102 may receive new / updated data access layers from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA)) that modify access by one or more (or all) applications operating in the application layer 104 of the sensingdevice 102. Here, the manage and control of the access functions and features of the data access layer 110 may be modified, for example, in situ, whereby the data / data sets available or accessible to one or more applications operating on the sensing device 102 may change. For example, the subscription, authentication and / or privilege of a given application may change thereby allowing access to certain data / data sets or denying access to certain data / data sets.

[0109] Remote access to and / or use of data / data sets of a data access layer 110 operating in a given sensing device 102 may be controlled similarly. That is, access and / or use by remote circuitry (e.g., remote processing system such as one or more servers 118 in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) may be based on subscription, authentication, privilege, operator, device manufacturer and / or system manager - and may be modified in the same manner as described above with respect to applications operating on the sensing device 102. For the sake brevity, such discussion will not be repeated.

[0110] As noted above, the wearable / implantable physiological sensing device includes sensor circuitry 130, having one or more sensors, to acquire, capture, measure, sense and / or detect physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human)) wherein such data is representative of a physiological condition (e.g., current or historical) of the user to which the device is affixed. The physiological sensor(s) determine, sense, detect, assess and / or obtain data / information which is representative of physiological condition of the user, according to at least certain embodiments of the present disclosure. In one embodiment, one or more physiological sensor(s) may be incorporated in and / or coupled to the exemplary wearable / implantable physiological sensing device (e.g., physically, electrically and / or optically coupled, including wired and / or wirelessly coupled), wherein the data access layer 110 may acquire, organize, manage and / or warehouse the physiological data (and / or data / data sets related thereto)and / or control or manage access to such physiological data (and / or related data / data sets), according to at least certain embodiments of the present disclosure.

[0111] With reference to FIGURES 1E-1G, wearable / implantable physiological sensing device including sensor circuitry 130 (which includes one or more physiological sensors) to acquire, capture, measure, sense and / or detect physiological data or information of an animal (e.g., a human). Inset A of FIGURE IE illustrates, in block diagram form, exemplary physiological sensor(s) to determine, sense, detect, assess and / or obtain data / information which is representative of physiological condition of the user. Notably, any physiological sensor, and data generated and output thereby, now known or later developed are intended to fall within the scope of the present disclosure wherein such physiological sensor may be incorporated in and / or coupled to the physiological sensing device (e.g., physically, electrically and / or optically coupled, including wired and / or wirelessly coupled), and the data access layer 110 operating in the device may acquire, organize, manage and / or warehouse the physiological data (and / or data / data sets related thereto) and / or control or manage access to such physiological data (and / or related data / data sets).

[0112] With continued reference to FIGURES 1E-1G, in one embodiment, the data access layer 110, executed from the hardware / physical layer 114 of the device, may receive and organize "raw" physiological data acquired, captured, measured, detected, and / or sensed by one or more physiological sensor(s) of the device. (See, e.g., FIGURE IE). In another embodiment, the data access layer 110, executed from the hardware / physical layer 114 of the device, may receive and organize processed physiological data which is based on the "raw" physiological data generated and / or output by the sensor circuitry 130 (e.g., one or more sensors). (See, e.g., FIGURE IF). Optionally, as also shown in FIG. IF, data processing circuitry132 can be included to process the outputs of the sensor circuitry 130. Indeed, in anotherembodiment, the data access layer 110, executed from the hardware / physical layer 114 of the physiological sensing device may be "raw" physiological data (i.e., physiological related data which has not undergone processing but is directly output from a sensor) and processed data (i.e., data, which is generated by and output from a sensor, which has undergone processing operation(s), e.g., filtering, limiting, error correction, etc. and / or more involved data processing such as correlating the physiological data from the sensor(s) to a physiological condition of the user and / or derivation of related physiological data from the sensor data (e.g., heart rate data based on or determined from blood pressure related data detected by and output from a sensor). (See, e.g., FIGURE 1G).

[0113] As mentioned above, the functions and features associated with a data access layer 110 may be individually configurable / programmable (one-time or more than onetime), or configurable / programmable as sub-groups (each sub-groups including one or more functions and features associated with a data access layer), or configurable / programmable as one set of functions and features associated with a data access layer 110. Such configurable / programmable function(s) and feature(s) of the data access layer 110 may be programmable, configurable and / or reconfigurable in situ (i.e., during normal operation of the wearable physiological sensing device and / or an implantable physiological sensing device) by, for example, the device operator, device manufacturer and / or system manager. In one embodiment, functions of the data access layer 110 may be defined, modified and / or changed (e.g., updated) by, for example, the operator, device manufacturer and / or manager (e.g., over the air (OTA) and / or via point-to-point communication). (See, e.g., FIGURE IB). Similarly, features of the data access layers 110, and the access thereto, may be controlled or managed by the operator, device manufacturer and / or manager. Each of the set of functions and features, and access thereto, may be modified, controlled and / or managed as a group (or oneor more sub-groups) or individual ly / separately. Indeed, in one embodiment, the data access layer(s) 110 may be replaced / augmented by distributed network storage elements or via a cloud computing device. Notably, the one or more of the data access layers 110 are stored or reside in local / resident memory (i.e., memory of the sensing device 102) and code thereof is executed from the hardware / physical layer. (See, e.g., FIGURES 1A and IB).

[0114] In one exemplary embodiment, the data access layer 110 stored in the wearable sensing device 302 and / or implantable sensing device may be supported by a set of functions and features via the manufacturer, operator and / or service provider which may include one, some or all of the following functions / features:1. Access levels and privilege control for applications and / or users.2. Authentication methods for applications and / or users.3. Channel the access to the device and data access layer 110 exclusively or through a select combination of programming model(s) and / or application model(s). Here, the device manufacturer, operator and / or service provider may control and / or modulate under what circumstance(s) access is provided, if at all, to each of the programming and data access layers or combination thereof. For example, the device manufacturer, operator and / or service provider may control and / or modulate when access is provided, if at all, to each of the programming and data access layers 110 or combination thereof. a. The device manufacturer, operator and / or service provider may provision or provide this access control from time-to-time, from user-to-user and / or on an application basis.4. Encryption and security techniques / features which may be different for memory / storage local to or resident in the sensing device as compared to the implementation at one or more remote and / or distributed storage elements.5. Consistency and persistence across storage elements for the data access layer 110. In one embodiment, the device manufacturer, operator and / or service provider may control consistency and persistence across storage elements for the data access layer 110. The device manufacturer, operator and / or service provider may define, control and / or choose, for instance, the circumstances of access of the data of a data access layer 110 from the remote memory / storage (e.g., a cloud "copy") until completion of a transaction. Indeed, the device manufacturer, operator and / or serviceprovider may implement a memory / data "flush" or clear operation of certain portions of local storage and maintain data of the data access layer 110 in remote memory / storage (e.g., the cloud) - thereby maintaining (e.g., storing and / or updating) a cloud version of the data access layer 110 only.6. Compression and compaction methods related to continuous data.7. Computational functions using, based on and / or related to data of the data access layer 110 that is acquired, in operation, by the physiological sensing device and / or implantable sensing device and computed via one or more processors and / or state machines of the sensing device. For example: a. Get mean systolic (3 mins) b. Get mean sleep diastolic (llpm-3am) c. Get_num_diastolic_over (98, <date range>) d. Notably, in conventional devices / systems, these functions would be written by one or more (or all) applications (operating from or executing in the application layer) that receive(s) data of the data access layer 110 from the associated device.

[0115] Notably, the output of the computational functions / operations (Item 7 above) may be stored in one or more new / other / different data access layers 110 that are stored in the sensing device 102. The data of such data access layer 110 extensions may be accessed or employed, in one or more ways, operations, functions and / or techniques described above (see Items 1-7 immediately above), by one or more programming model(s) and / or application model(s) executed in the programming layer(s). Indeed, the data of the data access layer 110 generated via the output of the computational functions / operations may be stored in the wearable sensing device 302 and / or implantable sensing device and may also be supported by a set of policy features via the manufacturer or service provider which may include one, some or all of the immediately above policy features. The set of policy features (including, e.g., Item 1 and / or Item 2) associated with a data access layer extension 202 may be the same as or different from the associated data access layer 110 (i.e., the data access layer of which the data access layer extension 202 relates to or is imported / merged with).

[0116] Moreover, executing code of the data access layer 110, in the physical layer of the wearable or implantable sensing device, to organize, warehouse, define and determine data / data sets provides security advantages via controlling, managing, limiting and / or restricting access to critical features of the sensor device and similarly controlling, managing, limiting and / or modulating the exposure or availability of data / data sets, via transmission of such data from the hardware layer to the application layer 104, that are acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the device to, for example, predetermined applications in the application layer 104. With the aforementioned functions and features in mind, in one embodiment, access to data access layer(s) 110 managed, stored, generated and / or accumulated via code, executed in the physical layer of the wearable or implantable sensing device, facilitates implementing access levels, privilege control and / or authentication control for application(s) / user(s). Moreover, as noted above, executing such code of the data access layer 110 in the physical layer of the wearable or implantable sensing device (in contrast to the application layer 104), may further enhance security. Indeed, application developers may benefit from such an architecture by relying on faster feature development while also building upon or enhancing the security features of the device layer. (See, Item 4 above).

[0117] With reference to FIGURES 1A-1D and 3A-3D, in one embodiment the functions and features of the data access layers 110, and access thereto, may be defined, modified and / or changed by remotely, for example, via an operator, device manufacturer and / or manager (e.g., over the air (OTA) and / or via point-to-point communication, e.g., via wired communications). Each of the set of functions, features, and access thereto, may be modified, controlled and / or managed as a group (or one or more sub-groups) or individually / separately. Similarly, the data / data sets of the data access layers 110, and theaccess thereto, may be controlled or managed remotely, for example, by the operator, device manufacturer and / or manager. For example, the physiological sensing device may receive new / updated data and / or data access layers 110 remotely, for example, from the Internet or other remote processing system (e.g., one or more servers 118 in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA)) for use in the sensing device 102 during operation. In addition, the physiological sensing device may transmit new / updated data and / or modified data access layers 110 to remote processing circuitry, for example, via the Internet (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation).

[0118] With reference to FIGURES 2A and 2B, the physiological sensing device, in addition to executing code of a data access layer 110 in the hardware / physical layer 114 of the device to generate, organize and / or warehouse data / data sets, may receive one or more data access layer extensions 202, having data / data sets associated therewith that may be imported, merged and / or integrated with data / data sets associated with other data access layer(s) 110 thereby providing or presenting a composite and / or combined new data access layer 110 (e.g., a continuous blood pressure monitor may import / merge data from a source such as an electro cardiogram and offer novel features). Notably, the programming model(s) associated with such data access layer extension 202 may be the same or different (e.g., a continuous blood pressure sensor / monitor having a data access layer 110 (and associated programming model).Moreover, the programming model(s) associated with the data access layer extension 202 may import / merge data associated with the data access layer extension 202 that originates from aphysiological sensor that is different from the physiological sensor associated with the data access layer 110 that is / was "resident" in the physiological sensing device (i.e., the "original" data access layer executing in the hardware / physical layer). For example, data originating from a first sensor / monitor (e.g., electrocardiogram), which are associated with the data access layer extension 202 (and associated programming model) input or imported into the physiological sensing device, may be different from data associated with a second sensor / monitor (e.g., blood pressure sensor / monitor), which is (i) resident in the physiological sensing device, (ii) associated with the resident / original data access layer 110 of the physiological sensing device, and (iii) associated with the resident / original programming model of the physiological sensing device. Here, the programming model associated with the first sensor / monitor (e.g., electrocardiogram) may be different from the programming model associated with the resident in the physiological sensing device (e.g., blood pressure sensor / monitor)

[0119] With continued reference to FIGURES 2A and 2B, in this illustrative embodiment, communication circuitry (not illustrated) in the physiological sensing device 102 facilitates communication (e.g., via an Intranet and / or Internet), with (i) one or more remote servers / computers, storage systems and / or databases and / or (ii) one or more other sensor devices (not illustrated) to, for example, transmit data / data sets of one or more data access layer extensions 202. In this embodiment, the sensing device may "personalize" or associate data from multiple physiological sensing devices (each having data access layer(s) 110 and associated programming model(s)) with, for example, a particular human / user of the physiological sensing device. In one embodiment, data associated with one or more data access layer extensions 202 may be stored in the memory of the physiological sensing device wherein the output of the data access layer extension(s) 202 may be available to the hardware / physical layer 114 and / or the application layer 104 of the device during start-upand / or operation. Indeed, in one embodiment, the physiological sensing device may also (i) receive new / updated data access layer extension(s) 202 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 (i.e., edge computing) - over the air (OTA)) for use in the sensing device 102 during operation and / or (ii) transmit new / modified data access layer extension(s) 202 to the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation.

[0120] In another embodiment, the data of a particular user of the physiological sensing device (e.g., a wearable and / or an implantable sensing device), may be aggregated into a personalized data access layer 110 wherein additional functions that are specific to that individual / user may be generated and implemented. For example, based on analysis of past or previous events / episodes, a dehydration alert may be issued to a person diagnosed with orthostatic hypotension. In another example, a person with history of arrhythmias may be alerted when exposed to high pollution environments. In current practice, these alerts require the activation of devices such as smartphones / cloud services and / or user intervention (e.g., automatic cardio defibrillators ("ICDs")). The alerts are often generated via an application executed in the application layer 104 of smartphones / cloud services. Here, however, generating an extension of a data access layer 110 that merges with data associated with a data access layer 110 of a physiological sensing device as described herein (e.g., the code of the data access layer 110 executes in the hardware / physical layer of the device), provides functions that are associated with or unique to the user of the sensing device 102 - that is, personalizedfunctions and features of a data access layer 110 that is directly and / or autonomously associated with the user of the physiological sensing device. In this way, the alert may be generated directly and / or autonomously from the physiological sensing device - thereby saving time and effort for the user while enhancing clinical benefit. Indeed, in one embodiment, two, three, four or more devices generating and / or monitoring physiological data of a given individual may, via a plurality of data access layers 110 and / or data access layer extensions 202, and data associated therewith, may be imported or merged to form a data access layer, which generates data / data sets, that is personal or unique to a given individual or user of the device (e.g., importing / merging / aggregating physiological related data associated with an individual from multiple devices or sources).

[0121] As discussed above, the wearable or implantable physiological sensing device of the present disclosure may communicate with (transmit and / or receive) devices and circuitry that is / are external and / or remote to the sensing device. For example, with reference to FIGURES 3A-3D, a physiological sensing device, according to at least one embodiment, is capable of acquiring, capturing, measuring, sensing, detecting, analyzing and / or assessing physiological data or information (see, e.g., FIGURES 1A-1C, 2A and 2B) from the Internet or remote processing system (e.g., one or more servers on the edge of the "cloud" 308 and / or in the "cloud" 306). In another embodiment, the wearable or implantable physiological sensing device may directly or more directly from another physiological sensing device (e.g., FIGURES 3C and 3D) which transmits one or more data access layer 110 extensions that may be employed by the wearable sensing device 302 to (i) generate, provide or present a composite, unified or combined new data access layer 110 (see FIGURES 2A and 2B). In one embodiment, the wearable or implantable physiological sensing device may be configured to perform additional functions that are specific or particular to the user associated with the wearablesensing device 302 using data access layers 110 generated by the sensor device and data access layer extension(s) 202 (e.g., a dehydration alert may be issued to a person diagnosed with orthostatic hypotension; and / or, an alert may be issued to a person having a history or arrhythmias when that person is exposed to high pollution environments). Indeed, the wearable or implantable physiological sensing device in one embodiment may generate and / or implement a data access layer 110 which is "personalized" to or associated with the user that is, as described above, an aggregate of multiple sources from, for example, multiple sensor devices (whether or not one, some or all of such sensor devices are (i) wearable or implantable and / or (ii) particularly associated with or acquiring data unique to the user); notably, the communication may be two-way wherein the wearable / implantable physiological sensing device may transmit, output and / or provide data (e.g., in real-time), via the Internet or other communication network (e.g., over the air (OTA)), corresponding to the state / status and / or change in state / status of one or more, or all of the sensor data being monitored / acquired as well as the physiological characteristics of the user associated with the sensor device and / or the analysis / analyses thereof to one or more remote processing systems.

[0122] As such, with continued reference to FIGURES 3A-3D, in one embodiment, the physiological sensing device may transmit updated data and / or data access layers 110 to Internet or remote processing system (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308) for storage and / or additional processing. In addition thereto, or in lieu thereof, the physiological sensing device may (i) receive new / updated data, data access layers 110 and / or data access layer extensions 202 from the Internet or remote processing system (e.g., one or more servers in the "cloud" 306 - over the air (OTA)) for use in the sensing device 102 during operation and (ii) transmit new / updated data, modified data access layers 110 and / or data access layer extensions 202 to the Internet or remote processingsystem (e.g., one or more servers in the "cloud" 306 or on the "edge" of the "cloud" 308 - over the air (OTA)) for use in, for example, assessing the physiological data or information of the user (e.g., blood pressure, glucose level or fluid state of an animal (e.g., a human user)) acquired, captured, measured, detected, and / or sensed by one or more physiological sensors of the sensing device 102 during operation.

[0123] While certain embodiments, features, attributes and advantages of the present disclosure have been described and illustrated, it should be understood that many others, as well as different and / or similar embodiments, features, attributes and advantages of the present disclosure, are apparent from the description and illustrations. As such, the above embodiments of the disclosure are merely exemplary. They are not intended to be exhaustive or to limit the disclosure to the precise forms, techniques, materials and / or configurations disclosed. Many modifications and variations are possible in light of this disclosure. It is to be understood that other embodiments may be utilized and operational changes may be made without departing from the scope of the present disclosure. As such, the scope of the disclosure is not limited solely to the description above because the description of the above embodiments has been presented for the purposes of illustration and description.

[0124] For example, the present disclosure have been described and illustrated in the context a physiological sensing device, having a data access layer 110 which executes from / in the hardware / physical layer 114 of the device. Although the data access layer 110 has largely / extensively described in the context of (i) acquiring, organizing, managing and / or warehousing the data / data sets associated physiological sensors and / or (ii) controlling or managing access to such data / data sets, the functions and features of the data access layers 110 of the present disclosure are configurable to employ or access other hardware resources of the sensing device 102 including for example, communication circuitry, as well as resources inthe cloud 306. Indeed, the discussion above of the features, devices, systems, processes, and operations of a physiological sensing device, having a data access layer 110 that acquires, organizes, manages and / or warehouses the data / data sets associated physiological sensors, are entirely applicable to data access layers 110 that employ or access other hardware resources of the sensing device 102 including for example, communication circuitry, as well as hardware resources of an associated system and / or in the cloud 306, and, for the sake of brevity, that discussion will not be repeated here.

[0125] Moreover, although the code associated with the data access layer 110 has often been described in the context of executing in the hardware / physical layer 114 of the sensing device 102, the code of the data access layer 110 may execute / run on any available / accessible processor resource (e.g., CPU plus memory resource). Indeed, the sensing device 102 of the present disclosure may be configurable to be distributed across a plurality of storage elements, and local and / or remote and implement policies for synchronization across them. In this context, however, each device of the distribution includes a resident data access layer 110 that is suitable for that aspect of the distributed system. Notably, this notwithstanding, the data access layer 110 of the present disclosure is encapsulated and / or separate from the applications that execute in the application layer 104 of the physiological sensing device.

[0126] In addition, the functions and features associated with a data access layer 110 may be individually configurable / programmable (for example, one time or more than one time), or configurable / programmable as groups or sub-groups (each group including one or more functions and features associated with a data access layer 110), or configurable / programmable as one set of functions and features associated with a data access layer 110. Such configurable / programmable function(s) and feature(s) of the data access layer110, for example, access to particular data or particular data set(s), may be programmable, configurable and / or reconfigurable in situ (i.e., during normal operation of the wearable physiological sensing device and / or an implantable physiological sensing device) by, for example, the device operator, device manufacturer and / or system manager. In this way, access to particular data or one or more particular data sets by an application operating in the application layer 104 of the physiological sensing device may be controlled (enabled or disabled), in situ and wirelessly - that is, over the air (OTA). Indeed, in one embodiment, functions and features of the data access layer 110 (e.g., access to data / data sets) may be defined, modified and / or changed (e.g., updated) by, for example, the operator, device manufacturer and / or manager. The one or more of the data access layers 110 are stored or reside in local / resident memory (i.e., memory of the physiological sensing device) and the code thereof is executed in / from the hardware / physical layer 114 of that sensing device 102. Notably, however, in some embodiments embodiment, the data access layers(s) 110 can be replaced / augmented by distributed network storage elements or via a cloud computing device.

[0127] The techniques described herein may be implemented using control circuitry (e.g., one or more processors (suitably programmed)) to perform, execute and / or assess one or more of the functions or operations described herein to program the data storage elements and thereby configure the robust type memory cell according to the present disclosure. Here, the control circuitry (which may be disposed on the integrated circuit) is employed to program the robust type memory cell during initialization or at start-up, and / or in situ such that the output of the robust type memory cell is employed to establish or implement a mode of operation or function in, for example, the logic tile.

[0128] Notably, various circuits, circuitry and techniques disclosed herein may be described using computer aided design tools and expressed (or represented), as data and / orinstructions embodied in various computer-readable media, in terms of their behavioral, register transfer, logic component, transistor, layout geometries, and / or other characteristics. Formats of files and other objects in which such circuit, circuitry, layout and routing expressions may be implemented include, but are not limited to, formats supporting behavioral languages such as C, Verilog, and HLDL, formats supporting register level description languages like RTL, and formats supporting geometry description languages such as GDSII, GDSIII, GDSIV, CIF, MEBES and any other formats and / or languages now known or later developed. Computer- readable media in which such formatted data and / or instructions may be embodied include, but are not limited to, non-volatile storage media in various forms (e.g., optical, magnetic or semiconductor storage media) and carrier waves that may be used to transfer such formatted data and / or instructions through wireless, optical, or wired signaling media or any combination thereof. Examples of transfers of such formatted data and / or instructions by carrier waves include, but are not limited to, transfers (uploads, downloads, e-mail, etc.) over the Internet and / or other computer networks via one or more data transfer protocols (e.g., HTTP, FTP, SMTP, etc.).

[0129] Indeed, when received within a computer system via one or more computer-readable media, such data and / or instruction-based expressions of the above described circuits may be processed by a processing entity (e.g., one or more processors) within the computer system in conjunction with execution of one or more other computer programs including, without limitation, net-list generation programs, place and route programs and the like, to generate a representation or image of a physical manifestation of such circuits. Such representation or image may thereafter be used in device fabrication, for example, by enabling generation of one or more masks that are used to form various components of the circuits in a device fabrication process.

[0130] Moreover, the various circuits, circuitry and techniques disclosed herein may be represented via simulations using computer aided design and / or testing tools. The simulation of the circuits, circuitry, layout and routing, and / or techniques implemented thereby, may be implemented by a computer system wherein characteristics and operations of such circuits, circuitry, layout and techniques implemented thereby, are imitated, replicated and / or predicted via a computer system. The present disclosure is also directed to such simulations of the inventive circuits, circuitry and / or techniques implemented thereby, and, as such, are intended to fall within the scope of the present disclosure. The computer-readable media corresponding to such simulations and / or testing tools are also intended to fall within the scope of the present disclosure.

[0131] Notably, the term "circuitry", means, among other things, a circuit (whether integrated or otherwise), a group of such circuits, one or more processors, one or more state machines, one or more processors implementing software, one or more gate arrays, programmable gate arrays and / or field programmable gate arrays, or a combination of one or more circuits (whether integrated or otherwise), one or more state machines, one or more processors, one or more processors implementing software, one or more gate arrays, programmable gate arrays and / or field programmable gate arrays.

[0132] Importantly, the present disclosure is neither limited to any single aspect nor embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the aspects of the present disclosure, and / or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and / or embodiments thereof.

[0133] Notably, reference herein to "one embodiment" or "an embodiment" (or the like) means that a particular feature, structure, or characteristic described in connectionwith the embodiment may be included, employed and / or incorporated in one, some or all of the embodiments of the present disclosure. The usages or appearances of the phrase "in one embodiment" or "in another embodiment" (or the like) in the specification are not referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of one or more other embodiments, nor limited to a single exclusive embodiment. The same applies to the term "implementation." The present disclosure is neither limited to any single aspect nor embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the aspects of the present disclosure, and / or embodiments thereof, may be employed alone or in combination with one or more of the other aspects of the present disclosure and / or embodiments thereof. For the sake of brevity, certain permutations and combinations are not discussed and / or illustrated separately herein.

[0134] Further, an embodiment or implementation described herein as "exemplary" is not to be construed as ideal, preferred or advantageous, for example, over other embodiments or implementations; rather, it is intended convey or indicate the embodiment or embodiments are example embodiment(s).

[0135] Although the present disclosure has been described in certain specific aspects, many additional modifications and variations would be apparent to those skilled in the art. It is therefore to be understood that the present disclosure may be practiced otherwise than specifically described without departing from the scope and spirit of the present disclosure. Thus, embodiments of the present disclosure should be considered in all respects as illustrative / exemplary and not restrictive.

[0136] It should be noted that a wearable sensing device 302 is an electronic device or apparatus that is and / or can be attached to and / or worn by a human including, butnot limited to, a device that is and / or can be temporarily attached to and / or worn by a human as accessories (e.g., watch, bracelet, pendant, patch, and / or eye glasses) or is and / or can be embedded in clothing, a mechanism or an attachment that is configured to be disposed on or worn by a human. In contrast, an implantable device is an electronic device or apparatus that is introduced, inserted, implanted and / or embedded into or onto a human's body (e.g., an implantable cardioverter defibrillator or an implantable glucose sensor in a human). Indeed, a wearable sensing device 302 may interact, interface (e.g., by an interface 304) and / or communicate with, receive data from, and / or provide data to an implantable sensing device (e.g., implanted or embedded in a human) or remote circuitry (circuitry which is remote from the wearable sensing device 302), and / or sense, detect, analyze and / or assess physiological data of an animal based on such communication and / or such data from the implantable sensing device or remote circuitry.

[0137] For example, in one aspect, the present disclosure includes a physiological sensing device, and processes and / or operations implemented thereby, including a data access layer 110 having functions and features:

[0138] 1. that is configurable to interact with program(s) and a programming model when applications (i.e., those programs which are in the application layers 104 of paradigms such as Windows, Android and iOS which are one or more layers above the hardware abstraction layer 106 and rely on elements such as device drivers or libraries or SDKs (or similar methods) to interact with or receive data from the hardware / physical layers) interact with hardware devices; and / or

[0139] 2. that is configurable to authenticate application(s) and user(s) for access to data / data sets associated with the data access layer 110; and / or

[0140] 3. that is capable of enhancing performance of applications and care pathways by accelerating or speeding-up data processing by the physiological sensing device; and / or

[0141] 4. that is configurable to be distributed across a plurality of storage elements, and local and / or remote and implement policies for synchronization across them; here, however, each device of the distribution includes a resident data access layer 110 that is suitable for that aspect of the distributed system; and / or

[0142] 5. that is configurable to support and implement complex functions- which may simplify application development / implementation; and / or

[0143] 6. that is configurable to interact with other data access layer(s) 110 and / or programming model(s) of other / remote devices; and / or that is configurable to personalize a data access layer 110 from a single or multi device sources (or even other sources such as data of, for example, laboratory reports) and implement / support functions and features that are "personal" to a given user of the physiological sensing device.

[0144] The terms "comprises," "comprising," "includes," "including," "have," and "having" or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, circuit, system, article, or apparatus that comprises a list of parts or elements does not include only those parts or elements but may include other parts or elements not expressly listed or inherent to such process, method, article, or apparatus. Further, use of the terms "connect", "connected", "connecting" or "connection" herein should be broadly interpreted to include direct or indirect (e.g., via one or more conductors and / or intermediate devices / elements (active or passive) and / or via inductive or capacitive coupling)) unless intended otherwise (e.g., use of the terms "directly connect" or "directly connected").

[0145] The terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the terms "first," "second," and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element / circuit / feature from another.

[0146] While certain embodiments, features, attributes and advantages of the disclosure have been described and illustrated, it should be understood that many others, as well as different and / or similar embodiments, features, attributes and advantages of the present disclosure, are apparent from the description and illustrations.

[0147] While certain embodiments, features, attributes and advantages of the disclosure have been described and illustrated, it should be understood that many others, as well as different and / or similar embodiments, features, attributes and advantages of the present disclosure, are apparent from the description and illustrations.

[0148] Referring to FIG. 8, an example computing device 800 upon which the methods described herein may be implemented is illustrated. It should be understood that the example computing device 800 is only one example of a suitable computing environment upon which the methods described herein may be implemented. Optionally, the computing device 800 can be a well-known computing system including, but not limited to, personal computers, servers, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, network personal computers (PCs), minicomputers, mainframe computers, embedded systems, and / or distributed computing environments including a plurality of any of the above systems or devices. Distributed computing environments enable remote computing devices, which are connected to a communication network or other data transmission medium, to perform various tasks. In the distributed computing environment, the program modules, applications, and other data may be stored on local and / or remote computer storage media.

[0149] In its most basic configuration, computing device 800 typically includes at least one processing unit 806 and system memory 804. Depending on the exact configuration and type of computing device, system memory 804 may be volatile (such as random access memory (RAM)), non-volatile (such as read-only memory (ROM), flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in FIG. 8 by dashed line 802. The processing unit 806 may be a standard programmable processor that performs arithmetic and logic operations necessary for operation of the computing device 800. The computing device 800 may also include a bus or other communication mechanism for communicating information among various components of the computing device 800.

[0150] Computing device 800 may have additional features / functionality. For example, computing device 800 may include additional storage such as removable storage 808 and non-removable storage 810 including, but not limited to, magnetic or optical disks or tapes. Computing device 800 may also contain network connection(s) 816 that allow the device to communicate with other devices. Computing device 800 may also have input device(s) 814 such as a keyboard, mouse, touch screen, etc. Output device(s) 812 such as a display, speakers, printer, etc. may also be included. The additional devices may be connected to the bus in order to facilitate communication of data among the components of the computing device 800. All these devices are well known in the art and need not be discussed at length here.

[0151] The processing unit 806 may be configured to execute program code encoded in tangible, computer-readable media. Tangible, computer-readable media refers to any media that is capable of providing data that causes the computing device 800 (i.e., a machine) to operate in a particular fashion. Various computer-readable media may be utilized to provide instructions to the processing unit 806 for execution. Example tangible, computer- readable media may include, but is not limited to, volatile media, non-volatile media,removable media and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. System memory 804, removable storage 808, and non-removable storage 810 are all examples of tangible, computer storage media. Example tangible, computer- readable recording media include, but are not limited to, an integrated circuit (e.g., field- programmable gate array or application-specific IC), a hard disk, an optical disk, a magnetooptical disk, a floppy disk, a magnetic tape, a holographic storage medium, a solid-state device, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices.

[0152] In an example implementation, the processing unit 806 may execute program code stored in the system memory 804. For example, the bus may carry data to the system memory 804, from which the processing unit 806 receives and executes instructions. The data received by the system memory 804 may optionally be stored on the removable storage 808 or the non-removable storage 810 before or after execution by the processing unit 806.

[0153] It should be understood that the various techniques described herein may be implemented in connection with hardware or software or, where appropriate, with a combination thereof. Thus, the methods and apparatuses of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computing device, the machine becomes an apparatus for practicing the presently disclosed subject matter. In the case of program code execution onprogrammable computers, the computing device generally includes a processor, a storage medium readable by the processor (including volatile and non-volatile memory and / or storage elements), at least one input device, and at least one output device. One or more programs may implement or utilize the processes described in connection with the presently disclosed subject matter, e.g., through the use of an application programming interface (API), reusable controls, or the like. Such programs may be implemented in a high level procedural or object- oriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language and it may be combined with hardware implementations.

Claims

CLAIMS1. A system comprising: a physiological sensor module; and a mobile device comprising an application layer and a data access layer, wherein the mobile device is operably coupled to the physiological sensor; a processor connected to memory with computer-readable instruction stored thereon, wherein execution of the computer-readable instruction by the processor causes the processor to: receive raw physiological data from the physiological sensor; store the raw physiological data in a first memory of the data access layer; and in response to receiving a data request from the application layer at the data access layer, provide, using the data access layer, a response to the application layer, wherein the response comprises a data structure of the raw physiological data.

2. The system of claim 1, wherein the physiological sensor module comprises a plurality of physiological sensors, and wherein the raw physiological data comprises a plurality of raw physiological datasets.

3. The system of claim 2, wherein the data structure comprises data a subset of the plurality of raw physiological datasets.

4. The system of claim 2 wherein the memory further comprises instructions that cause the processor to: process the raw physiological data to obtain processed physiological data; and store the processed physiological data in a second memory of the data access layer.

5. The system of any one of claims 1-4, wherein the raw physiological data comprises light absorbance data.

6. The system of any one of claims 1-5, wherein the raw physiological data comprises electrical potential data.

7. The system of claim 6, wherein the processed physiological data comprises blood pressure.

8. The system of claim 6, wherein the processed physiological data comprises a single-lead ECG signal.

9. The system of any one of claims 1-8, further comprising a remote device in operable communication with the mobile device, wherein the remote device comprises a remote device application layer configured provide a data request to the data access layer of the mobile device and receive a response from the data access layer.

10. The system of any one of claims 1-9, wherein the physiological sensor module comprises a filter configured to filter an output of a sensor of the sensor module, and wherein the raw physiological data comprises filtered data output by the filter.

11. The system of claim 10, wherein the raw physiological data comprises both filtered data output by the filter and data output by the sensor.

12. The system of any one of claims 1-11, wherein the data request comprises a data access function.

13. A computer-implemented method comprising: storing raw physiological data in a first memory of a data access layer; processing the raw physiological data into processed physiological data; storing the processed physiological data in a second memory of the data access layer; and selectively providing access to a data structure comprising the raw physiological data and / or processed physiological data using the data access layer.

14. The method of claim 13, wherein selectively providing access to the data structure comprises outputting a data structure comprising raw physiological data in response to receiving a data access function.

15. The method of claim 14, wherein the data structure comprising raw physiological data comprises less than all the physiological data stored in the first memory of the data access layer.

16. The method of claim 13 or claim 14, wherein selectively providing access to the data structure comprises outputting a data structure comprising processed physiological data in response to receiving a data access function.

17. The method of any one of claims 13-16, wherein the data structure comprises less than all the physiological data stored in the first memory of the data access layer.

18. The method of claim 17, wherein the data structure comprising processed physiological data comprises less than all the processed physiological data stored in the second memory of the data access layer.

19. The method of any one of claims 13-19, wherein selectively providing access to the data structure comprises transmitting the data to a remote device.

20. The method of any one of claims 13-19, wherein the data access layer is configured to only provide access to the first memory and second memory of the data access layer in response to a predetermined data access function.

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