Methods and systems for assuring compliance
First Claim
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1. A method of measuring compliance to a protocol procedure, the protocol procedure including guidance steps intended to achieve, by one or more activities, a result related to care of a subject, comprising:
- providing an electronic device loaded with a software application and/or accessing a remote application, and by the electronic device;
i) providing instruction to the subject, a clinical practitioner, or a professional involved in the protocol procedure to perform an activity according to the protocol procedure;
ii) validating identity of the subject, clinical practitioner, or the professional accessing the electronic device and performing the activity;
iii) recording said identity to keep evidence that the activity is being performed by the subject, clinical practitioner, or the professional;
iv) recording movement or action of the subject, clinical practitioner, or the professional when the subject, clinical practitioner, or the professional performs the activity according to the protocol procedure;
v) processing the recorded movement or action of the subject to produce recorded movement or action data;
vi) determining whether the recorded movement or action data of the subject, clinical practitioner, or the professional are within a range of expected movement or action data processed from movements or actions expected for subjects, clinical practitioners, or professionals performing said activity, wherein, when the recorded movement or action data are within the range of the expected movement or action data, the electronic device determines compliance with the protocol procedure.
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Abstract
Systems and methods for collecting information, verifying authenticity of such information, processing, maintaining, and managing such information are described. The system can be a standalone unit or can comprise a combination of various units configured to function together.
124 Citations
31 Claims
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1. A method of measuring compliance to a protocol procedure, the protocol procedure including guidance steps intended to achieve, by one or more activities, a result related to care of a subject, comprising:
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providing an electronic device loaded with a software application and/or accessing a remote application, and by the electronic device; i) providing instruction to the subject, a clinical practitioner, or a professional involved in the protocol procedure to perform an activity according to the protocol procedure; ii) validating identity of the subject, clinical practitioner, or the professional accessing the electronic device and performing the activity; iii) recording said identity to keep evidence that the activity is being performed by the subject, clinical practitioner, or the professional; iv) recording movement or action of the subject, clinical practitioner, or the professional when the subject, clinical practitioner, or the professional performs the activity according to the protocol procedure; v) processing the recorded movement or action of the subject to produce recorded movement or action data; vi) determining whether the recorded movement or action data of the subject, clinical practitioner, or the professional are within a range of expected movement or action data processed from movements or actions expected for subjects, clinical practitioners, or professionals performing said activity, wherein, when the recorded movement or action data are within the range of the expected movement or action data, the electronic device determines compliance with the protocol procedure. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A device for determining compliance to a protocol procedure, the protocol procedure including guidance steps intended to achieve, by one or more activities, a result related to care of a subject, the device comprising:
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an electronic device loaded with a software application and/or accessing a remote application; a validating device configured to identify identity of a subject, a clinical practitioner, or professional involved in the protocol procedure; a recording device configured to record movement or action carried out by the subject, clinical practitioner, or the professional when the subject, clinical practitioner, or the professional performs the protocol procedure; and a memory for use with the electronic device configured to record said identity and the movement or action when the subject, clinical practitioner, or professional performs the protocol procedure, wherein the electronic device is configured to process the recorded movement or action to produce movement or action data and to determine whether said recorded movement or action data are within a range of expected movement or action data processed from movements or actions expected for subjects, clinical practitioners, or professionals performing said activity, wherein, when the recorded movement or action data are within the range of the expected movement or action data, the electronic device determines compliance with the protocol procedure. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31)
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Specification