Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test.

Abstract: Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections. For unsuccessful data event instances, substitute data relating to data collections performed separately from the collection procedure are included in the data file records for the collection procedure if the substitute data is determined to meet conditions of the predetermined adherence criterion for the corresponding data event instance.

Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test.

Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test.

Abstract: Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections. For unsuccessful data event instances, substitute data relating to data collections performed separately from the collection procedure are included in the data file records for the collection procedure if the substitute data is determined to meet conditions of the predetermined adherence criterion for the corresponding data event instance.

Abstract: Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instances comprises a data collection pertaining to a biomarker to be performed according to one or more conditions of an adherence criterion. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections.

Abstract: Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

Abstract: A collection device for performing a structured collection procedure may include a processor that executes program instructions communicably coupled to at least one memory. The processor can initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met and segregate the at least one memory into a primary data store and a secondary data store. The processor can write structured patient data collected in accordance to the schedule of events to the secondary data store. The processor can transform a relevant portion of the structured patient data into an evaluated data object. The processor can generate a data abstraction based in part upon the evaluated data object. The processor can link the primary data store and the secondary data store with the data abstraction.

Abstract: Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instances comprises a data collection pertaining to a biomarker to be performed according to one or more conditions of an adherence criterion. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections.

Abstract: Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker samples, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via t

Abstract: A system and method described herein simplifies data entry by a subject of a structured blood glucose test as well as helps with dietary compliance by providing specific dietary suggestions to the user. The system includes a portable device configured to be possessed by the subject. The portable device has a location detection system configured to provide data indicative of the location of the subject. A food database provides to the portable device a list of food items that are limited based on foods available at the location, such as a restaurant. The portable device is configured to receive a selection from the list that is indicative of a food consumed by the subject. A blood glucose meter reads blood glucose readings from the subject. The food database is configured to store the blood glucose readings and information about the foods consumed by the subject. Compliance to a prescribed dietary regimen can be monitored by the user and/or a physician.

Abstract: Methods and systems for authorizing access to a medical device are disclosed. The methods and systems use authorization certificates to allow and prevent access to one or more operations of the medical device. The methods and systems also allow the tracking of changes made to the medical device by an authorized user.

Abstract: A method and system in which a short range wireless signal containing an activation code is received with a glucose meter. Upon receiving the signal, the glucose meter awakens from a low power state. A dormant function on the glucose meter that corresponds to the activation code is activated in response to receiving the short range wireless signal. In one example, the glucose meter includes an RFID tag configured to receive an RFID signal. A device reader coupled to a health care provider computer transmits the RFID signal. The dormant function on the glucose meter can include any number of functions, such as a structured glucose test and/or the ability to automatically generate reports.

Abstract: A technique and system utilizing a portable memory card in which data for an individual is stored and identified based on a personal identification number or key. With this system, a glucose meter and a health care provider are able to track testing data across multiple meters as well as between various individuals. Moreover, the system is configured to retrospectively collect structured testing data in which, while a structured test may have been intended but the specific questions or data input were not available at the time, the individual is allowed to update the data after the structured testing window. By having the data stored on a portable memory card, the individual is able to keep the data in their possession and also helps with patient confidentiality.

Abstract: A system and method described herein simplifies data entry by a subject of a structured blood glucose test as well as helps with dietary compliance by providing specific dietary suggestions to the user. The system includes a portable device configured to be possessed by the subject. The portable device has a location detection system configured to provide data indicative of the location of the subject. A food database provides to the portable device a list of food items that are limited based on foods available at the location, such as a restaurant. The portable device is configured to receive a selection from the list that is indicative of a food consumed by the subject. A blood glucose meter reads blood glucose readings from the subject. The food database is configured to store the blood glucose readings and information about the foods consumed by the subject. Compliance to a prescribed dietary regimen can be monitored by the user and/or a physician.

Abstract: Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker sample, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via th

Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated.

Abstract: In one embodiment, a method of performing a structured collection protocol by utilizing a collection device comprising a processor may include collecting at least one sample using the collection device. The at least one sample can be associated with biomarker data. A classification can be associated with the at least one sample via the processor. The classification can be based upon an intended use of the at least one sample. Compliance with an adherence criteria for the at least one sample can be determined via the processor. When the at least one sample is not compliant with the adherence criteria, an adherence event can be associated with the at least one sample, and the processor can perform at least one additional task that is based upon the classification associated with the at least one sample.

Abstract: A collection device for performing a structured collection procedure may include a processor that executes program instructions communicably coupled to at least one memory. The processor can initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met and segregate the at least one memory into a primary data store and a secondary data store. The processor can write structured patient data collected in accordance to the schedule of events to the secondary data store. The processor can transform a relevant portion of the structured patient data into an evaluated data object. The processor can generate a data abstraction based in part upon the evaluated data object. The processor can link the primary data store and the secondary data store with the data abstraction.