GB2586161A - Method for obtaining Consent - Google Patents

Method for obtaining Consent Download PDF

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Publication number
GB2586161A
GB2586161A GB1911381.0A GB201911381A GB2586161A GB 2586161 A GB2586161 A GB 2586161A GB 201911381 A GB201911381 A GB 201911381A GB 2586161 A GB2586161 A GB 2586161A
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GB
United Kingdom
Prior art keywords
patient
consent
computer system
medical
validated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
GB1911381.0A
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GB201911381D0 (en
Inventor
O'Sullivan Jane
Fleming Eoin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Avow Ltd
Original Assignee
Avow Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Avow Ltd filed Critical Avow Ltd
Priority to GB1911381.0A priority Critical patent/GB2586161A/en
Publication of GB201911381D0 publication Critical patent/GB201911381D0/en
Publication of GB2586161A publication Critical patent/GB2586161A/en
Withdrawn legal-status Critical Current

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Public Health (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Biomedical Technology (AREA)
  • Medical Treatment And Welfare Office Work (AREA)

Abstract

Method comprising authenticating the identity of a patient, to create a validated patient account on a computer system; authenticating the identity of a health care professional, to allow access to the patient account; storing medical educational presentations on the computer system; allowing a validated patient to access a stored presentation for a medical procedure to be carried out by the health care professional; providing means to allow a validated patient to digitally confirm that the presentation has been viewed by the patient; making available a plurality of digital consent forms on the patient account only when the patient has confirmed that the presentation has been viewed; recording each instance of a digital signature of a consent form by the patient; and recording that informed consent has been obtained only when the patient has digitally signed at least two consent forms on separate occasions. Requiring multiple consents to be provided over a period of time between consultation and procedure allows the patient sufficient time for due consideration, consultation and understanding, so that obtaining informed consent is a dynamic process which provides a more secure consent. Also provided is a computer system.

Description

Method for obtaining consent This invention relates to a method for obtaining consent, and in particular to a method and apparatus for obtaining and recording informed medical 5 consent.
The process of informed consent is central to all clinical practice.
Obtaining an effective informed medical consent is in the interests of both patients and doctors. Often, claims for medical negligence are linked to the issue of informed consent. Thus, the claim may not be that the medical professional was negligent in carrying out the treatment, but rather was negligent in advising the patient about the risks. The increase of numbers of medical negligence claims is a concern internationally. For example, in Eire, the number of High Court actions taken for medical negligence rose from 566 in 2007 to 1,001 in 2016, which represents a 77% increase.
The Health Service Executive recommendations for obtaining informed medical consent state that sufficient information should be provided about the nature, purpose, benefits and risks of a proposed intervention/ service; and that consent should be clearly and accurately documented in the service user's records. It is also stated that consent is a process not a once-off event In the UK, GMC guidelines state that doctors must ensure patients are aware of all material risks, and provide documentary evidence of a structured discussion between a competent healthcare professional and the individual patient, for the specific procedure being considered.
It is possible to obtain informed medical consent using digital methods, but in any such digital method, it is even more important to ensure that not only is the patient is fully informed, but also that the patient's -2 -sensitive clinical information is securely protected. Furthermore, consent should not be considered as a single event.
The present invention provides an improved digital method which satisfies those objectives by authenticating the identity of the patient and doctor, providing information digitally and recording medical consent by means of a dynamic process from the initial consultation until the medical procedure is carried out.
There are a number of known methods of providing information to a patient for the purpose of obtaining informed medical consent.
For example, WO 00/17837 discloses a system for obtaining informed patient consent, comprising a portable device coupled to a network, wherein the portable device includes a processor configured to provide an interactive presentation on a medical procedure.
US 2012031670 discloses a method for obtaining informed consent from a patient, comprising displaying an informed consent presentation to the patient using a computer with a processor, memory and display; and requesting the patient to provide oral consent after the informed consent presentation has finished.
US 2014141397 discloses a computer-based apparatus for verified education of patient medical conditions and procedures by providing 3D animations and 3D image stills, a follow up quiz for patients, and a built-in informed consent form.
In all three of those patent applications, a test of the patient's understanding of the presented information is performed. However, tests can often be unpopular with a patient; a patient may find them burdensome or feel insulted. Comprehension assessments may, in fact, -3 -deter patients from using such a system. There is a need for an efficient and reliable system for obtaining medical consent that does not involve the hurdle of a comprehension test.
The present invention provides a method for obtaining and recording an informed patient medical consent, which method comprises: authenticating the identity of a patient, to create a validated patient account on a computer system; authenticating the identity of a health care professional, to allow access to 10 the patient account storing medical educational presentations on the computer system; allowing a validated patient to access a stored medical educational presentation for the medical procedure to be carried out by the health care professional; providing means to allow a validated patient to digitally confirm that the educational presentation has been viewed by the patient; making available a plurality of digital consent forms on the patient account, only when the patient has confirmed that the presentation has been viewed; recording each instance of a digital signature of a consent form by the patient; and recording that informed consent has been obtained only when the patient has digitally signed at least two consent forms on separate occasions.
It is a key feature of the present invention that the process of obtaining informed consent is a dynamic process from the initial consultation until the medical procedure is carried out; and that the consent is not considered as a single event. This is achieved by allowing the patient sufficient time for due consideration, consultation and understanding, simply by requiring multiple consents to be provided by the patient over a period of time between the consultation with a health care professional and the day when the medical procedure is carried out. That process -4 -allows consent to be reassessed periodically to ensure that it is still present; and hence provide a more secure consent.
The time interval between the separate occasions of signing consents 5 depends on the time available before the medical procedure is carried out. For a short-term procedure, or when emergency surgery is required, for example if the patient has appendicitis, there may be less than a day between the initial consultation and the procedure being carried out. In this case, the separate occasions of the consent may be less than an hour apart, for example about 30 minutes apart. For longer term procedures, the time interval between the separate occasions of signing consents may be 6-12 hours, or at least one day, of from 2-5 days, suitable 2-3 days.
Suitably, two or three consents are given by the patient. Typically, the first consent is given by the patient immediately following the viewing of the educational presentation. Preferably, a final consent is given by the patient immediately prior to the medical procedure.
Often, patients have further questions after an initial consultation with a healthcare professional, such as a doctor. In the method of this invention, during the period between initial consultation and the carrying out of the medical procedure, the patent can ask further questions, before a final consent is confirmed. In a preferred aspect of this invention, the contact details of the health care professional are provided on the computer system, in order to further facilitate the dynamic consent process.
The first step the present method comprises the creation of a validated patient account on a computer system by authentication of the identity of a patient. The computer system contains a data store and may be on a cloud-based server operated by the owner of the system. A patient provides evidence of identification, which is checked by the operator of the computer system and stored in the data store on the computer -5 -system. Such evidence may include, for example, photographic identification, such as a passport or driving licence, proof of address, such as a valid official letter addressed to the residence of the patient.
The identity of the health care professional, such as a doctor, is also authenticated. In the case of a health care professional who is a sole practitioner, the authentication process will involve provision of a medical licence certificate as well as evidence of identification, such as photographic identification as described above for a patient. In addition, the operator of the computer system will search relevant official medical registers. However, if the health care professional is a member of an institution, such as a medical practice, a National Health Service Trust, a private hospital, or a clinic, then the authentication process will involve validation by that institution. In all cases, the authentication information is checked by the operator of the computer system and stored in the data store on the computer system. Preferably, a notification is transmitted to the patient, to confirm that the person is the patient's health care professional.
The documentation provided by a patient, healthcare professional, or institution is inspected, prior to inputting data therefrom into the data store. The inspection may be carried out by physical presentation of the documents. Preferably, however the inspection is carried out remotely, via a computer network. Information from the inspection step is recorded in the data store. The input of the data may be carried out manually, such as via a computer keyboard, or the documents may be scanned to capture the relevant information electronically. The step of inputting data into the data store also ensures that the inspection step is sufficiently thorough to be effective.
The data store may be, for example, a database, a distributed database, a distributed ledger, a dedicated ledger, or a flat file.
When the authentication process has been completed, the health care professional is allowed access to the patient account, which contains sensitive clinical information about the patient.
At that stage in the method of this invention, the users of the method are the validated patient and the validated health care professional.
The user, either the patient or the health care professional, may communicate to the computer system data store via a network linked to the user's own electronic device, such as a personal computer, a laptop computer, a tablet computer, a handheld portable electronic device, or a smartphone. A smartphone is generally recognized as a handheld electronic device having a processor, a memory and a graphical user interface (GUI). Suitably, the user's electronic device is provided with a digital application, such as a software application, which enables communication with the computer system of this invention. Typically, the digital application is present on a smartphone.
Part of the identification validation step preferably also includes the association of the computer system with biometric data generated through biometric input device on the user's electronic device, such as the smartphone, and held thereon. Biometric data include human physiological features, such as fingerprint, palm veins, face recognition, DNA, palm print, hand geometry, iris recognition and retinal scan.
Alternatively, the biometric input device may be adapted to receive audio characteristics of a user. For example, a microphone in conjunction with a speech digitizer may be used to receive and digitize speech. The biometric input device may be used to receive other physical characteristics such as facial and body appearance via, for example, a camera, or the genetic composition of the user by means of genetic material gathering procedures, such as blood lancets.
In particular, a user's fingerprint is suitably stored on the electronic device, and associated with the computer system database. That association is achieved via the digital application on the user's electronic device.
The biometric data provide both the patient and the health care professional with secure access to the validated patient account on the data store of the computer system. It also provides an authentication mechanism to confirm the patient's identity when confirming that an educational presentation has been viewed, or signing a consent. The authentication mechanism may be in the form of an authentication token, digital certificate, or more specifically, a digital signature.
Any process to obtain informed medical consent from a patient normally starts with a face to face consultation between the patient and the healthcare professional. In a preferred feature of this invention, the consultation is recorded by the health care professional, in audio and/or video format. The recording is stored on the computer system. Although the recording may not be accessible to the patient, it does represent a record of the consultation for future reference.
Medical educational presentations are stored on the computer system.
Each presentation contains information about the procedure and may include the associated risks, benefits and alternatives. The presentation may comprise text, audio, animations and video material. The presentation made available on the patient account is selected by the healthcare professional to be relevant to the medical procedure to be carried out.
The patient views the educational presentation on the computer system and confirms electronically that the presentation has been viewed. When -8 -that confirmation has been recorded, the computer system generates a plurality of consent forms on the patient account. Suitably, the computer system also records that the presentation has been viewed, and the number of times it has been viewed.
The patient is requested to digitally sign a consent form provided on the patient account. If the patient agrees to the consent form, the computer system records that one consent has been executed. The interaction between the patient and the health care professional continues.
Subsequently, the computer system generates further requests to the patient to digitally sign a further consent form. The number of further requests for consent may be pre-determined, or may be decided by the health care professional based on the procedure, or on the facts specific to the interactions with the patient. However, a total of at least two consent requests are generated by the computer, at least one day apart, in order to confirm that the consent is still valid. Preferably, the computer generates a final consent request on the day that the medical procedure is carried out.
When the agreed number of consent forms have been signed by the patient, the computer system records that informed medical consent has been obtained.
It is part of the present invention that all signed consent forms are stored on the computer system. This ensures that there is a permanent record of the number and dates of the executed consent forms over the duration of the time of interaction between the patient and health care professional, up to the time of the procedure being carried out.
In a further aspect of this invention, there is provided a computer system for obtaining and recording an informed patient medical consent, the computer system comprising: a server having a searchable data store, containing inter alia medical educational presentations; means for connecting a patient's electronic device with said data store via 5 a network; means for recording the authentication of a patient, to produce a validated patient account in the data store; means for recording the authentication of a health care professional, to allow access to a validated patient account; means for a validated patient to access a stored medical educational presentation for the medical procedure to be carried out by the health care professional; means for a validated patient to digitally confirm that the educational presentation has been viewed by the patient; means to generate a plurality of digital consent forms on the patient account, only when the patient has confirmed that the educational presentation has been viewed; means to record each instance of a digital signature of a consent form by the patient; and means to record that informed consent has been obtained when the patient has digitally signed at least two consent forms on separate occasions.
It can be seen that the present invention provides an efficient digital method of obtaining informed consent for a medical procedure, which not only stores sensitive clinical details in secure manner, but also ensures that the patient can reassess consent over a period of time so that the final informed consent is more reliable.

Claims (10)

  1. CLAIMS1. A method for obtaining and recording an informed patient medical consent, which method comprises: authenticating the identity of a patient, to create a validated patient account on a computer system; authenticating the identity of a health care professional, to allow access to the patient account; storing medical educational presentations on the computer system; allowing a validated patient to access a stored medical educational presentation for the medical procedure to be carried out by the health care professional; providing means to allow a validated patient to digitally confirm that the educational presentation has been viewed by the patient; making available a plurality of digital consent forms on the patient account, only when the patient has confirmed that the presentation has been viewed; recording each instance of a digital signature of a consent form by the patient; and recording that informed consent has been obtained only when the patient has digitally signed at least two consent forms on separate occasions.
  2. 2. A method as claimed in claim 1, wherein two or three consents are given by the patient.
  3. 3. A method as claimed in either claim 1 or claim 2, wherein the final consent is given by the patient immediately prior to the medical procedure.
  4. 4. A method as claimed in any one of claims 1 to 3, wherein the contact details of the health care professional are provided on the computer system.
  5. 5. A method as claimed in any one of claims 1 to 4, wherein the patient communicates to the computer system via a network linked to the patient's electronic device.
  6. 6. A method as claimed in claim 5, wherein the electronic device is a smartphone.
  7. 7. A method as claimed in claim 5 or claim 6, wherein the identification validation step also includes the association of the computer system with biometric data generated through biometric input device on the user's electronic device.
  8. 8. A method as claimed in any one of claims 1 to 7, wherein the consultation between the patient and healthcare professional is recorded by the health care professional, and the recording is stored on the computer system.
  9. 9. A method as claimed in any one of claims 1 to 8, wherein the computer generates a final consent request on the day that the medical procedure is carried out.
  10. 10. A computer system for obtaining and recording an informed patient medical consent, the computer system comprising: a server having a searchable data store, containing inter alia medical educational presentations; means for connecting a patient's electronic device with said data store via a network; means for recording the authentication of a patient, to produce a validated patient account in the data store; means for recording the authentication of a health care professional, to allow access to a validated patient account; means for a validated patient to access a stored medical educational presentation for the medical procedure to be carried out by the health care professional; means for a validated patient to digitally confirm that the educational presentation has been viewed by the patient; means to generate a plurality of digital consent forms on the patient account, only when the patient has confirmed that the educational presentation has been viewed; means to record each instance of a digital signature of a consent form by the patient; and means to record that informed consent has been obtained when the patient has digitally signed at least two consent forms on separate occasions.
GB1911381.0A 2019-08-08 2019-08-08 Method for obtaining Consent Withdrawn GB2586161A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB1911381.0A GB2586161A (en) 2019-08-08 2019-08-08 Method for obtaining Consent

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Application Number Priority Date Filing Date Title
GB1911381.0A GB2586161A (en) 2019-08-08 2019-08-08 Method for obtaining Consent

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GB201911381D0 GB201911381D0 (en) 2019-09-25
GB2586161A true GB2586161A (en) 2021-02-10

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