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Clinical investigation data logging with contextual time shifting

  • US 8,273,019 B2
  • Filed: 07/22/2008
  • Issued: 09/25/2012
  • Est. Priority Date: 07/22/2008
  • Status: Active Grant
First Claim
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1. A health monitoring device comprising:

  • a clock, wherein the value of the clock comprises an operating date-time of the health monitoring device as the device executes a health monitoring schedule based on a study definition that defines a planned date-time for scheduled elements and events of interest in the study definition to occur and wherein the clock value determines an operational state of the health monitoring device;

    a data logger module including logic for;

    collecting a first set of health information from a subject or clinician during a first time range and a second set of health information from the subject or clinician during a second time range, at least one of the second set of health information and the second time range being determined in part by a content of the first set of health information, the first and second time ranges being part of the health monitoring schedule;

    recording the first and second sets of health information in a computer readable medium; and

    including a time stamp with the recorded health information in the computer readable medium;

    a user interface for receiving the sets of health information from the subject or the clinician;

    a time shifting module including logic to permit, in a time shifting mode, an adjustment of the clock from a first event of interest in the health monitoring schedule, corresponding to a first operational state of the device, to at or relative to a second event of interest in the health monitoring schedule, corresponding to a second operational state of the device, the device operating at the second event of interest in the health monitoring schedule in the same manner and collecting health information from the subject or clinician in the same manner as if the device had reached the second event of interest without intervention by the time shifting module and resulting in activation of the second operational state of the health monitoring device;

    wherein the time shifting module further includes logic to prevent adjustment of the date and/or time to alter operational state of the health monitoring device and move to the second event of interest when the device is not in the time shifting mode;

    wherein adjustment of the clock from the first point in the health monitoring schedule to the second event of interest in the health monitoring schedule changes an operational state of the device without modification to the study definition; and

    a display having a screen for displaying information corresponding to the operational state of the device.

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