Sweat sensing device communication security and compliance

Abstract

The invention addresses confounding difficulties involving continuous sweat analyte measurement. Specifically, the present invention provides: at least one component capable of monitoring whether a sweat sensing device is in sufficient contact with a wearer's skin to allow proper device operation; at least one component capable of monitoring whether the device is operating on a wearer's skin; at least one means of determining whether the device wearer is a target individual within a probability range; at least one component capable of generating and communicating alert messages to the device user(s) related to: wearer safety, wearer physiological condition, compliance with a requirement to wear a device, device operation; compliance with a behavior requirement, or other purposes that may be derived from sweat sensor data; and the ability to utilize aggregated sweat sensor data that may be correlated with information external to the device to enhance the predictive capabilities of the device.

1 . A method of monitoring whether a sweat sensing device contacts a wearer's skin adequately to allow the device to operate, comprising:
 using the sweat sensing device to take at least one skin contact reading;   comparing the at least one reading to a threshold value indicating adequate contact with skin; and   generating an alert message communicating whether skin contact is adequate for operation.   
     
     
         2 . The method of  claim 1  in which the at least one skin contact reading is chosen from the following: a skin impedance sensor measurement; and a capacitive sensor measurement. 
     
     
         3 . (canceled) 
     
     
         4 . A method of determining whether a sweat sensing device is operating on a wearer's skin, comprising:
 taking at least one measurement of at least one sweat analyte; and   using the at least one measurement to determine if the device is operating on the skin.   
     
     
         5 . A method of determining whether a sweat sensing device wearer is a target individual, comprising:
 measuring at least one of the following metrics on the device wearer: sweat analyte data; body composition, skin type, positive correlation of device identification number, communication strength between sweat sensing device and a computer network, sweat sensing device location, reader device location, the wearer's electro-physical response, and concentration of a tracer molecule administered to the individual;   comparing the at least one metric with known information about the target individual to calculate an identification probability estimate; and   determining if the estimate adequately correlates the wearer with the target individual.   
     
     
         6 . The method of  claim 5  where the identification probability estimate is calculated using data from at least one of the following sensors: accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry. 
     
     
         7 . The method of  claim 5  where the identification probability estimate is a combined probability of at least two independent identification probability estimates. 
     
     
         8 . The method of  claim 5  where an identification metric is the application of the sweat sensing device onto the target individual under supervision of a device user. 
     
     
         9 . The method of  claim 5  where the identification probability estimate is calculated using aggregated sweat sensor data that is correlated with relevant data external to the sweat sensor device. 
     
     
         10 . A method of using data to improve the capabilities of a sweat sensing device, comprising:
 obtaining and recording sensor readings from the device;   gathering information from sources external to the device;   correlating the sensor readings with the external information; and   comparing the correlated readings to previously-aggregated sensor data.   
     
     
         11 . A method of determining whether a sweat sensing device should send a safety and health alert message, comprising:
 using the device to take at least one reading;   calculating a threshold value indicating a message should be sent, where the threshold value is calculated using data from at least one of the following sensors: ion-selective electrode sensor; sweat analyte sensor; skin impedance sensor; skin capacitance sensor; accelerometer; gait analysis sensor; heart rate monitor; galvanic skin response sensor; and pulse oximetry sensor;   comparing the at least one reading to the threshold value; and   generating an alert message if said at least one reading indicates an alert message should be sent.   
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 11  where the threshold value is calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device. 
     
     
         14 . A method of monitoring a clinical trial participant with a sweat sensing device, comprising:
 configuring the device to take at least one measurement of a sweat analyte relevant to the participant's safety;   configuring the device to take at least one measurement of a sweat analyte relevant to the participant's compliance with at least one drug regimen;   calculating a safety profile for the wearer;   calculating at least one drug regimen compliance profile;   comparing said at least one safety measurement to said safety profile;   comparing said at least one compliance measurement to the at least one compliance profile; and   generating an alert message if said at least one safety measurement or said at least one compliance measurement indicates a message should be sent.   
     
     
         15 . The method of  claim 14  where the participant is administered a tracer compound. 
     
     
         16 . The method claim of  14  where the profile values are calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device. 
     
     
         17 . A method of monitoring a wearer's exposure to at least one toxin with a sweat sensing device, comprising:
 configuring the device to take at least one measurement of a sweat analyte associated with at least one toxin;   calculating a toxin safety profile for the wearer;   comparing the at least one analyte measurement to the safety profile; and   generating an alert message if the at least one measurement indicates exposure to the at least one toxin.   
     
     
         18 . The method claim of  17  where the safety profile is calculated using the wearer's history of toxin exposure. 
     
     
         19 . The method claim of  17  where the profile values are calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device. 
     
     
         20 . A sweat sensing device capable of determining whether the device is in adequate contact with, and operating on, the skin of a wearer, comprising:
 a sweat sensor to provide at least one measurement of sweat;   computation, communication, and data storage means; and   a skin contact detector.   
     
     
         21 . The device of  claim 20  where the skin contact detector is one of the following: a plurality of electrical impedance sensing electrodes; and a plurality of capacitive sensor electrodes. 
     
     
         22 . (canceled) 
     
     
         23 . The device of  claim 20  where the at least one sensor measurement is reported to a computer network. 
     
     
         24 . The device of  claim 23  where the communication strength between the sweat sensing device and the network can be determined and reported. 
     
     
         25 . The device of  claim 23  where the location of the device can be determined using at least one of the following means: network access location; or global positioning satellite. 
     
     
         26 . The device of  claim 20  where the communication means is a separate device. 
     
     
         27 . The device of  claim 20  where the device is assigned an identification code. 
     
     
         28 . The device of  claim 20  where the device generates and reports an alert message communicating whether the device is in adequate contact with the wearer's skin. 
     
     
         29 . The device of  claim 20  where the device generates and reports an alert message communicating whether the device is operating on the wearer's skin. 
     
     
         30 . The device of  claim 20  where the device generates and reports an alert message communicating whether a device wearer is the target individual. 
     
     
         31 . The device of  claim 20  where the device generates and reports an alert message communicating whether the at least one sensor measurement indicates that the wearer has a health condition. 
     
     
         32 . The device of  claim 20  where the device uses aggregated sweat sensor data correlated with relevant data external to the sweat sensor device to enhance the device's ability to predict future health or performance conditions of the wearer. 
     
     
         33 . (canceled) 
     
     
         34 . The device of  claim 20  where the at least one sensor measurement is used with aggregated sweat sensor data that is correlated with relevant data external to the sweat sensor device to construct a data set correlated with the individual within a probability range. 
     
     
         35 . The device of  claim 34  where the external information is comprised of data from at least one of the following sensors: accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry. 
     
     
         36 . The device of  claim 34  where the data set is comprised of at least one of the following metrics: a first sweat analyte concentration; a ratio between the first analyte concentration and a second sweat analyte concentration; a ratio among a plurality of sweat analyte concentrations; a sweat analyte concentration trend; and a sweat analyte ratio trend. 
     
     
         37 . The device of  claim 34  where the data set is comprised of data from at least one of the following sensors: accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry. 
     
     
         38 . The device of  claim 34  where the data set is comprised of at least one of the following metrics: body composition; skin type; and electro-physical response to a given stimulus. 
     
     
         39 . The device of  claim 36  where the sweat analyte is at least one of the following: electrolyte; nucleotide; RNA; micro RNA; DNA; hormone; steroid; oligomer; and protein. 
     
     
         40 . The device of  claim 20  where the sweat measurement is of at least one of the following analytes: electrolyte; nucleotide; RNA; micro RNA; DNA; hormone; steroid; oligomer; and protein.