Method and system for informed consent

• US 10,366,463 B2
• Filed: 02/16/2015
• Issued: 07/30/2019
• Est. Priority Date: 10/20/2014
• Status: Active Grant

• Current Assignee: Rational Surgical Solutions, LLC
• Original Assignee: Rational Surgical Solutions, LLC
• Inventors: Fialkov, Jonathan
• Primary Examiner(s): Porter, Rachel L.
• Application Number:
  US14/622,978
• Publication Number:
  US 20160110832A1
• Time in Patent Office: 1,625 Days
• Field of Search: 705 2, 705 3
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G06Q 50/22 Social work or social welfare, e.g. community support activities or counselling services
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

A method for documenting informed consent includes obtaining a video recording of a patient indicative of informed consent, communicating the video recording across a network for data storage, and storing the video recording in a computer readable data storage medium. The video may include additional portions of a patient encounter. A software application for executing on a computing device may provide a user interface for obtaining video evidencing informed consent for the procedure, administering a quiz to the individual, presenting a document for signature to the individual, receiving a signature for the document from the individual.

Claims

1. A method for obtaining and documenting informed consent in a patient/healthcare provider setting, the method comprising:

providing a set of components comprising;

a gateway device for gaining access to the internee;

a server network in communication with the internet;

a data storage device in communication with the server network;

a healthcare information system in communication with the gateway for retrieving and storing healthcare information about plural patients;

a mobile computing device for use by a healthcare provider and/or a patient or authorized representative of the patient;

a video camera;

providing a software application to the mobile computing device for executing on the mobile computing device;

receiving a selection of a patient identification into the software application executing on the mobile computing device from a list of patients of the healthcare provider with the healthcare information system or by entry of new patient data by the healthcare provider;

receiving a selection of a medical procedure for which informed consent of the selected patient is desired into the software application executing on the mobile computing device, the medical procedure selected from a set of a plurality of procedures and one more procedure types from the healthcare information system;

receiving through the software application information about the selected procedure for presentation to the selected patient to educate the patient prior to requesting consent from the selected patient, the information comprising content from a library of videos stored in the server network and available from the healthcare provider or others via the mobile application;

making available a quiz for the selected patient using the software application executing on the mobile computing device, the quiz including a plurality of questions about the medical procedure for assessing informed consent;

documenting administration of the quiz to the selected patient using the software application executing on the mobile computing device;

presenting a document for signature to the selected patient using the software application executing on the mobile computing device, the documenting indicative of informed consent for the medical procedure;

receiving a signature on the document from the selected patient or authorized representative of the patient using the software application executing on the mobile computing device;

capturing video with the video camera evidencing informed consent for the medical procedure using the software application executing on the mobile computing device, wherein the video includes video of the selected patient or the authorized representative of the patient acknowledging that they are providing informed consent, and including a timer to record the time the patient takes in making the informed consent and an electronic time/date stamp of the informed consent associated with the video; and

sending to the server network from the mobile computing device the video and the document with the signature, and storing the video in a non-transitory computer readable data storage medium associated with the server network to thereby provide for documenting the informed consent of the selected patient for the medical procedure, further comprising making the video of the informed consent previously given available to the selected patient or an authorized representative of the patient through a portal associated with the server network, the video being sent by streaming or uploading from the mobile computing device after which the video is automatically deleted from the mobile device;

further comprising combining data from the health care information system with the video recording for the selected patient for review by the patient or authorized representative of the patient and the healthcare provider, and documentation of the selected patient'"'"'s healthcare records.

2. The method of claim 1 wherein the capturing video is performing using a camera integrated into the computing device.

3. The method of claim 1 further comprising receiving a selection of an option to bypass the quiz and documenting a reason for bypassing the quiz by sending the reason to the server.

4. The method of claim 1 further comprising making the video available to a service provider of the individual through a portal associated with the server.

5. The method of claim 1 wherein the video includes video of the individual and a service provider interacting with the individual.

6. The method of claim 1 further comprising receiving through the software application the plurality of questions about the procedure.