Computer accessible methods for establishing certifiable informed consent for a procedure
First Claim
1. A computer accessed and implemented method of establishing certifiable informed consent to an event, said method comprising the steps of:
- a. estimating legal standards for establishing informed consent of a participant to said event;
then b. defining computer measurable participant behavior which can be approximately coincided with said estimated legal standards;
then c. accessing a computer system having said computer measurable participant behavior available to it;
d. computer training with a first set of instructions said participant on desired aspects of said event through a computer controlled automatic utilization of preprogrammed information stored in a computer; and
e. computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior said computer measurable participant behavior automatically varying said interaction; and
f. automatically computer analyzing said participant behavior;
then g. determining whether said training should be adjusted depending on said analyzing said participant behavior;
h. identifying which portions of said training should be adjusted;
i. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted;
j. additionally computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior; and
k. additionally computer analyzing said participant behavior;
then l. additionally determining whether said training should be adjusted depending on said analyzing said participant behavior; and
m. computer providing an automatic indication of certifiability that said participant likely meets said legal standards for establishing informed consent to said event.
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Accused Products
Abstract
A method for establishing certifiable patient informed consent for a medical procedure, where, in one embodiment, the patient interacts with a video training system until mastery of all required information is successfully achieved. Training techniques which permit elicitation of measurable behaviors from a patient as a guide to discerning the level of knowledge of the patient are utilized. Certification is only granted when the measurable behavior approximately coincide with the legal and medical standards for establishing informed consent. The system is capable of adapting to various medical procedures, as well as various patient attitudes and knowledge bases, while still maintaining a level of consistency throughout. In one embodiment, a minimum probability of understanding may be preset, and the training procedure will continue until the actual statistical probability of understanding is at least equal to the preset minimum. An interactive nature of the system is present in the present system for facilitating the training process and continuously monitoring the patient'"'"'s knowledge.
144 Citations
20 Claims
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1. A computer accessed and implemented method of establishing certifiable informed consent to an event, said method comprising the steps of:
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a. estimating legal standards for establishing informed consent of a participant to said event;
thenb. defining computer measurable participant behavior which can be approximately coincided with said estimated legal standards;
thenc. accessing a computer system having said computer measurable participant behavior available to it;
d. computer training with a first set of instructions said participant on desired aspects of said event through a computer controlled automatic utilization of preprogrammed information stored in a computer; and
e. computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior said computer measurable participant behavior automatically varying said interaction; and
f. automatically computer analyzing said participant behavior;
theng. determining whether said training should be adjusted depending on said analyzing said participant behavior;
h. identifying which portions of said training should be adjusted;
i. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted;
j. additionally computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior; and
k. additionally computer analyzing said participant behavior;
thenl. additionally determining whether said training should be adjusted depending on said analyzing said participant behavior; and
m. computer providing an automatic indication of certifiability that said participant likely meets said legal standards for establishing informed consent to said event. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
a. translating said legal standards to computer measurable behavior;
thenb. evaluating the validity of the correlation between said standards and said behavior.
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3. A computer implemented method of establishing certifiable informed consent as described in claim 2 wherein said step of defining further comprises the step of continuously refining said step of measuring to achieve better approximation between said standards and said computer measurable behavior.
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4. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of computer providing an automatic indication of computer certification comprises the step of achieving defined computer measurable participant behavior which approximately coincide with said legal standards.
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5. A computer implemented method of establishing certifiable informed consent as described in claim 4 wherein said step of computer providing an automatic indication of computer certification further comprises the step of statistically establishing a probability of satisfaction.
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6. A computer implemented method of establishing certifiable informed consent as described in claim 5 wherein said step of statistically establishing comprises the steps of:
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a. repetitively testing said participant through use of said computer to elicit responses;
thenb. evaluating said responses through use of said computer.
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7. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of computer providing an automatic indication of computer certification comprises proving mastery of aspects of said event by communicating with said computer.
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8. A computer implemented method of establishing certifiable informed consent as described in claim 7 wherein said step of proving further comprises the steps of:
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i) storing said computer measurable participant behavior; and
ii) providing evidence proving said mastery using said computer.
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9. A computer implemented method of establishing certifiable informed consent as described in claim 1 further comprising the steps of:
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a. analyzing said event procedure comprising the steps of;
(1) compiling fundamental information on said event, then (2) selecting information which may be stored within a computer and which is legally likely to be necessary for informed consent;
thenb. designing a computer stored system utilizing an instructional system development model for computer training said participant on said selected information.
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10. A computer implemented method of establishing certifiable informed consent as described in claim 9 further comprising automatically periodically performing computer controlled criterion referenced testing on said participant wherein said testing automatically varies said computer controlled presentation.
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11. A computer implemented method of establishing certifiable informed consent as described in claim 10 wherein said step of automatically performing periodic, computer controlled criterion referenced testing comprises the steps of:
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a. posing a set of applicable considerations to said participant through use of said computer, wherein said considerations relate to said selected information;
thenb. requiring said participant to respond to said considerations by communicating with said computer.
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12. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of determining whether said training should be adjusted comprises the steps of:
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a. predetermining an acceptable statistical probability for indicating a correlation between said participant response and said legal standards;
thenb. periodically computing an actual statistical probability of said correlation through use of said computer;
thenc. comparing said actual probability to said acceptable probability through use of said computer;
thend. adjusting said training until said actual probability is at least equal to said acceptable probability.
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13. A computer accessed and implemented method of establishing certifiable informed consent for a medical procedure, said method comprising the steps of:
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a. estimating legal and medical standards for establishing informed consent to said procedure;
thenb. defining computer measurable patient behavior which can be approximately coincided with said estimated legal and medical standards;
thenc. accessing a computer system having said computer measurable patient behavior available to it;
d. computer training with a first set of instructions said patient on desired aspects of said medical procedure through a computer controlled automatic utilization of preprogrammed information stored in a computer; and
e. computer interacting with said patient in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable patient behavior said computer measurable patient behavior automatically varying said interaction; and
f. automatically computer analyzing said patient behavior;
theng. determining whether said training should be adjusted depending on said analyzing said patient behavior;
h. identifying which portions of said training should be adjusted;
i. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted;
j. additionally computer interacting with said patient in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable patient behavior said computer measurable patient behavior automatically varying said interaction; and
k. additionally computer analyzing said patient behavior;
thenl. additionally determining whether said training should be adjusted depending on said analyzing said patient behavior; and
m. computer providing an automatic indication of certifiability that said patient likely meets said legal and medical standards for establishing informed consent to said procedure. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
a. translating said legal and medical standards to computer measurable behavior;
thenb. evaluating the validity of the correlation between said standards and said behavior.
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15. A computer implemented method of establishing certifiable informed consent as described in claim 13 wherein said step of computer providing an automatic indication of computer certification comprises the step of achieving defined computer measurable patient behavior which approximately coincide with said legal and medical standards.
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16. A computer implemented method of establishing certifiable informed consent as described in claim 15 wherein said step of computer providing an automatic indication of computer certification further comprises the step of statistically establishing a probability of satisfaction.
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17. A computer implemented method of establishing certifiable informed consent as described in claim 13 further comprising the steps of:
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a. analyzing said medical procedure comprising the steps of;
(1) compiling fundamental information on said medical procedure;
then(2) selecting information which may be stored within a computer and which is legally likely to be necessary for informed consent;
thenb. designing a computer stored system utilizing an instructional system development model for computer training said patient on said selected information.
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18. A computer implemented method of establishing certifiable informed consent as described in claim 17 further comprising automatically periodically performing computer controlled criterion referenced testing on said patient wherein said testing automatically varies said computer controlled presentation.
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19. A computer implemented method of establishing certifiable informed consent as described in claim 18 wherein said step of automatically performing periodic, computer controlled criterion referenced testing comprises the steps of:
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a. posing a set of applicable considerations to said patient through use of said computer, wherein said considerations relate to said selected information;
thenb. requiring said patient to respond to said considerations by communicating with said computer.
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20. A computer implemented method of establishing certifiable informed consent as described in claim 13 wherein said step of determining whether said training should be adjusted comprises the steps of:
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a. predetermining an acceptable statistical probability for indicating a correlation between said patient response and said legal and medical standards;
thenb. periodically computing an actual statistical probability of said correlation through use of said computer;
thenc. comparing said actual probability to said actable probability through use of said computer;
thend. adjusing said training until said actual probability is at least equal to said acceptable probability.
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Specification