Methods and apparatus for authenticating informed consent

• US 6,149,440 A
• Filed: 09/18/1998
• Issued: 11/21/2000
• Est. Priority Date: 09/18/1998
• Status: Expired due to Fees

• Current Assignee: Vital Link Financial Services LLC
• Original Assignee: Wyngate, Inc.
• Inventors: Clark, Robert L., Morgan, Glen A.
• Primary Examiner(s): Harrison, Jessica J.
• Assistant Examiner(s): ADAMS, CHANDA L
• Application Number:
  US09/156,460
• Time in Patent Office: 795 Days
• Field of Search: 434/322, 434/362, 434/350, 434/323, 434/354, 434/321, 434/310, 434/315, 705/2, 705/3
• US Class Current: 434/322
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention relates generally to methods and apparatus for presenting selected information to one or more individuals, and authenticating both the individual'"'"'s receipt and the individual'"'"'s comprehension of the information presented. In a preferred embodiment of the present invention, the methods and apparatus relating to the authenticating operation include methods and apparatus for visually and, optionally, otherwise recording the individual'"'"'s responses to the information presented simultaneously with the presentation thereof. Preferably the authenticating operation further includes methods and apparatus for archiving, retrieving and observing in a correlated fashion both the information presented and the recorded individual'"'"'s responses thereto. The present invention is particularly well-suited to providing an individual with information apprising the individual of risks associated with a particular activity and authenticating the individual'"'"'s receipt and comprehension of the information presented and informed consent to assume such risks when participating in such activity.

Claims

1. A method for authenticating a recipient'"'"'s receipt and comprehension of information comprising the steps of:

a) providing a device for conveying information to a recipient;

b) selecting information to be provided to the recipient by the information conveying means;

c) recording at least one uniquely personal marker of said recipient to establish recipient'"'"'s exposure to said information;

d) conveying said information to said recipient;

e) providing said recipient with at least one inquiry selected to determine said recipient'"'"'s comprehension of the information conveyed;

f) directing said recipient to provide an answer to said inquiry;

g) recording each of said information conveyed, said inquiry and said recipient'"'"'s answer to said inquiry while simultaneously visually recording said recipient as said recipient reviews said conveyed information, said inquiry and provides said answer; and

h) correlatedly archiving on a storage medium said conveyed information, said inquiry, said answer and said visual recording of said recipient such that said conveyed information, said inquiry, said answer and said visual recording of said recipient are retrievable to simultaneously observe at least one element selected from the group consisting of said conveyed information, said inquiry, said answer and the corresponding visual record of said recipient reviewing said conveyed information, said inquiry or providing said answer.

2. An apparatus for authenticating a recipient'"'"'s receipt and comprehension of information comprising:

a) a device for conveying information to a recipient;

b) a means for selecting information to be provided to the recipient by the information conveying means;

c) a means for recording at least one uniquely personal marker of said recipient to establish recipient'"'"'s exposure to said information;

d) a means for conveying said information to said recipient;

e) a means for providing said recipient with at least one inquiry selected to determine said recipient'"'"'s comprehension of the information conveyed;

f) a means for directing said recipient to provide an answer to said inquiry;

g) a means for recording each of said information conveyed, said inquiry and said recipient'"'"'s answer to said inquiry;

h) a means for simultaneously visually recording said recipient as said recipient reviews said conveyed information, said inquiry and provides said answer; and

i) a means for correlatedly archiving on a storage medium said conveyed information, said inquiry, said answer and said visual recording of said recipient such that said conveyed information, said inquiry, said answer and said visual recording of said recipient are retrievable to simultaneously observe at least one element selected from the group consisting of said conveyed information, said inquiry, said answer and the corresponding visual record of said recipient reviewing said conveyed information, said inquiry or providing said answer.

3. A system for conveying information and providing confirmation of its receipt by at least one recipient comprising:

an information relaying device for providing preselected information to the recipient; and

an image retention system coupled to the information relaying device, wherein the image retention system contemporaneously records images of the recipient viewing the preselected information as the preselected information is displayed to the recipient.

4. The system as recited in claim 3, wherein the information relaying device includes audio and video display equipment.

5. The system as recited in claim 3, wherein information relaying device includes an interactive presentation system that provides the preselected information to the recipient and requests at least one response from the recipient for providing an indicator corresponding to a relative level of comprehension for the preselected information by the recipient.

6. The system as recited in claim 5, wherein the interactive presentation provides an educational information session for a medical procedure to obtain informed consent.

7. The system as recited in claim 5, wherein the interactive presentation system includes an input mechanism for receiving prompted input from the recipient during the course of displaying the preselected information.

8. The system as recited in claim 7, wherein the input mechanism is a touch screen monitor.

9. The system as recited in claim 3, wherein the information relaying device includes a narrative presentation.

10. The system as recited in claim 3, wherein the information relaying device includes a video and graphic presentation.

11. The system as recited in claim 3, wherein the image retention system includes a memory storage device for storing the information relayed to the recipient and the correlated images of the recipient observing the delivery of the relayed information.

12. The system as recited in claim 11, wherein the memory storage device is in communication with an optical disk storage medium.

13. The system as recited in claim 3, wherein the image retention system includes a video camera that synchronously records the images of the recipient during delivery of the relayed information to the recipient.

14. The system as recited in claim 13, wherein the images of the recipient and the display of the relayed information are time stamped.

15. The system as recited in claim 3, wherein the image retention system includes an input device for recording a personal marker unique to the recipient.

16. The system as recited in claim 3, wherein the input device is a signature capture device.

17. The system as recited in claim 3, wherein the image retention system includes measurement apparatus for detecting and contemporaneously recording selected parameters associated with the reactions of the recipient.

18. A system for retrieving archived information and displaying its receipt by at least one recipient comprising:

an information storage device for storing an archival record that includes preselected information provided to the recipient and correlated images of the recipient viewing the preselected information as the preselected information is provided to the recipient; and

a display monitor for simultaneously displaying the archival record of the preselected information and the correlated images of recipient receiving the preselected information.

19. The system as recited in claim 18, wherein information storage device further stores an interactive presentation record that includes the preselected information to the recipient and at least one response from the recipient that provides an indication as to the level of comprehension of the preselected information by the recipient.

20. The system as recited in claim 19, wherein the interactive presentation record is contemporaneously displayed on the display monitor with the archival record.

21. The system as recited in claim 18, wherein the information storage device is an archival repository.

22. The system as recited in claim 21, wherein a plurality of archival records are stored in the archival repository, and wherein an identifying label is provided for each archival record that uniquely corresponds to the record.

23. The system as recited in claim 18, wherein the record includes an audio and visual record of the preselected information and the correlated images of the recipient viewing the preselected information.

24. The system as recited in claim 23, wherein the audio and visual record is displayed in a split-screen format.

25. A computer-based information storage and retrieval system for providing confirmation of relayed information comprising:

a computer having a processor and a memory storage device, wherein the memory includes a program for generating an interactive presentation that displays preselected information to the recipient, and wherein the computer is adapted to receive at least one prompted input response from the recipient to demonstrate a level of comprehension of the preselected information by the recipient;

a visual recorder coupled to the computer, wherein the visual recorder contemporaneously records a visual record of the recipient observing the preselected information within the interactive presentation as the preselected information is provided to the recipient;

a memory storage device in communication with the visual recorder for storing the visual record, wherein the visual record includes the preselected information within the interactive presentation provided to the recipient and correlated images of the recipient viewing the preselected information as the preselected information is provided to the recipient; and

a display monitor for simultaneously displaying the visual record including the preselected information within the interactive presentation and the correlated images of recipient receiving the preselected information.

26. The computer-based information storage and retrieval system recited in claim 25, wherein the interactive presentation includes a graphical user interface that displays the preselected information.

27. The computer-based information storage and retrieval system recited in claim 26, wherein the graphical user interface includes prompts for receiving the prompted input response from the recipient while the preselected information is provided to the recipient.

28. The computer-based information storage and retrieval system recited in claim 26, wherein the display monitor is configured to simultaneously display the preselected information and the visual record of the recipient receiving the preselected information.

29. The computer-based information storage and retrieval system recited in claim 26, whrein the memory storage device is a hard-disk drive, and wherein the visual record is locally stored on the hard-disk drive.

30. The computer-based information storage and retrieval system recited in claim 26, further comprising a central record repository with optical disk drives in communication with the hard-disk drive for archived information storage.

31. The computer-based information storage and retrieval system recited in claim 25, further comprising a real-time monitor of the visual record and the interactive presentation as it is presented to the recipient.