EP3542365A1 - Verfahren und system zum einholen der informierten zustimmung eines patienten - Google Patents
Verfahren und system zum einholen der informierten zustimmung eines patientenInfo
- Publication number
- EP3542365A1 EP3542365A1 EP17804243.8A EP17804243A EP3542365A1 EP 3542365 A1 EP3542365 A1 EP 3542365A1 EP 17804243 A EP17804243 A EP 17804243A EP 3542365 A1 EP3542365 A1 EP 3542365A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- patient
- computer equipment
- server
- information
- session
- 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.)
- Ceased
Links
- 238000000034 method Methods 0.000 title claims description 31
- 230000005540 biological transmission Effects 0.000 claims abstract description 8
- 238000012545 processing Methods 0.000 claims abstract description 5
- 239000000463 material Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 230000004913 activation Effects 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 2
- 230000036541 health Effects 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 230000006399 behavior Effects 0.000 description 3
- 230000002452 interceptive effect Effects 0.000 description 3
- 230000008520 organization Effects 0.000 description 3
- 238000013515 script Methods 0.000 description 3
- 238000012549 training Methods 0.000 description 3
- 230000009471 action Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000004422 calculation algorithm Methods 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 1
- 238000009432 framing Methods 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000012502 risk assessment Methods 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000011477 surgical intervention Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Classifications
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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
- G16H70/00—ICT specially adapted for the handling or processing of medical references
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/10—Office automation; Time management
-
- 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
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
-
- 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
-
- 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
- G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
Definitions
- the present invention relates to the field of methods and information systems for automating the organization of the information procedure of a patient prior to the engagement of a medical act, and the management of the establishment of the proof informed consent of the patient. It relates in particular to the creation in paper or electronic form of a specific therapeutic action, such as the ideal theoretical information consultation of a patient in care procedure. The implementation of this therapy is considered a care element.
- the practitioner responsible for the care is required to ensure: first, the issuance of a information that is fair, clear and adapted to the patient's degree of understanding and whose contents, formatting and administration must be compatible with the expected caring principle. in a second step, the collection of the patient's consent, which must be not only informed by the information previously delivered, but also free of any pressure or constraint.
- the information delivered to the patient is not limited to standard information on the risks inherent in the act.
- the practitioner must make a personalized assessment of the benefits and risks of the proposed act taking into account the specificities of the patient (state of health, age, profession, habits and life projects, family environment ).
- the presentation is provided on a computer, to a patient who interacts with the informed consent presentation to ask and answer questions, indicating their ability to make a decision and to verify the understanding of the content of the presentation.
- the patient's consent may be recorded in an audio or video recording in order to more accurately capture the patient's consent and verify that the patient has consented to the intended medical procedure.
- US2013073310 discloses an interface for collaboration between patients, healthcare professionals and others. Patients, Healthcare professionals and third parties can share information about medical procedures, products, and services using computer-based and web-based human-machine interfaces that implement a highly interactive and personalized mobile health interface. This prior art document describes a solution that allows medical professionals to obtain informed consent from patients and to improve patient compliance with medical instructions and enable health professionals to monitor compliance.
- said hardware supports constitute a scheduler comprising a plurality of detachable leaflets.
- said program means for controlling the operation of the system comprise means for encrypting the information associated with an identifier and recording in the memory, at the end of a session of the information stamped under a form only encrypted.
- the invention also relates to a method for obtaining the informed consent of a patient comprising steps of establishing a computer session between a computer equipment of the patient equipped with a navigation software and a server, and steps of transmitting to said patient's computer equipment digital multimedia files and recording at least one information relating to the opening of a session between the patient's computer equipment and the server, as well as information transmitted by said patient's computer equipment; by means of a digital form characterized in that it comprises an initial step of communication by the practitioner and the patient of a material medium comprising a unique identifier, corresponding to an identifier previously stored in the server memory, the practitioner and the patient each retaining a copy of said material medium signed by each of s parts and in that said program means for controlling the operation of the system comprise means for recording in a memory space associated
- said program means for controlling the operation of the system comprise means for encrypting the information associated with an identifier and recording in the memory, at the end of a session of the time stamped information in an encrypted form only.
- the method comprises steps of transmission of a digital form activated after the transmission of digital multimedia files corresponding to the act requiring informed consent, said digital form comprising means for inputting information provided by the patient and stored in the memory in relation to said unique patient identifier.
- FIG. 1 shows a schematic view of a functional architecture of the invention.
- the practitioner has a prescribing prescription (1) of information relating to a nursing procedure.
- This prescription is an innovation in that it allows prescribing a care whose active ingredient is an information content and not a molecule or a therapeutic action physically exercised.
- This scheduler (1) is constituted in the example described of a set of sheets autocopiants (2) presenting textual areas (3) for context information of the patient information process and organization of the collection of informed consent.
- the two sheets (2) matched each has a unique identifier (4) and a pass mode (5).
- the patient can then, according to his availability and at his own pace, connect to the server (10) using any computer equipment (13) via navigation software opening a secure session type https .
- Access to the server (10) is realized in the example described anonymously, by the use of the identifier and the password on the slip (11) given to the patient.
- the system may implement an IP address anonymization server (14) to prevent the recording of any personal data.
- the anonymization server (14) may be an entity that provides access to the network to the user and assigns an identifier to communicate on said network.
- the anonymization server (14) is for example a mobile network operator, a virtual mobile network operator or an Internet access provider (ISP) in which the user is subscribed.
- the anonymization server (14) can also be a server of a specialized and recognized private organization.
- a set of digital media files stored in a multimedia memory are, for example, graphic or video presentations concerning the anatomical context, the didactic presentation of a surgical intervention, the postoperative risks, etc.
- the multimedia files recorded in the database (15) are, for example, in an XML format, incorporating a script (or program) that executes each time a web page, containing this script, is read on the equipment (13) of the patient, i.e., is downloaded.
- a copy of each file is stored in the memory (20), in a non-modifiable form, in relation to an electronic signature.
- the scripts generated by the server (10) and inserted into the XML document can count the accesses to the site via the search tool in which it is referenced.
- this tool records data relating to the patient and his consultation.
- the information recorded in relation to the unique identifier of the patient in the encrypted memory (20) comprises in whole or in part:
- the server conditionally offers an acknowledgment form allowing the patient to confirm informed consent.
- This form is transmitted only if the patient's journey is in accordance with a minimal path, necessary for a complete information of the patient. This path is calculated based on the information stored in the memory (20) in relation to the unique identifier of the patient.
Landscapes
- Engineering & Computer Science (AREA)
- Business, Economics & Management (AREA)
- Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Public Health (AREA)
- Primary Health Care (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- General Business, Economics & Management (AREA)
- Entrepreneurship & Innovation (AREA)
- Human Resources & Organizations (AREA)
- Strategic Management (AREA)
- Biomedical Technology (AREA)
- Economics (AREA)
- Theoretical Computer Science (AREA)
- Marketing (AREA)
- General Physics & Mathematics (AREA)
- Quality & Reliability (AREA)
- Operations Research (AREA)
- Physics & Mathematics (AREA)
- Tourism & Hospitality (AREA)
- Data Mining & Analysis (AREA)
- Pathology (AREA)
- Medical Treatment And Welfare Office Work (AREA)
- Storage Device Security (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1661295A FR3059140B1 (fr) | 2016-11-21 | 2016-11-21 | Procede et systeme pour le recueil du consentement eclaire d'un patient |
PCT/FR2017/053081 WO2018091806A1 (fr) | 2016-11-21 | 2017-11-13 | Procédé et système pour le recueil du consentement éclairé d'un patient |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3542365A1 true EP3542365A1 (de) | 2019-09-25 |
Family
ID=58401681
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17804243.8A Ceased EP3542365A1 (de) | 2016-11-21 | 2017-11-13 | Verfahren und system zum einholen der informierten zustimmung eines patienten |
Country Status (4)
Country | Link |
---|---|
US (1) | US20200075174A1 (de) |
EP (1) | EP3542365A1 (de) |
FR (1) | FR3059140B1 (de) |
WO (1) | WO2018091806A1 (de) |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5799282A (en) | 1992-05-19 | 1998-08-25 | Medical Training And Services, International | Methods for establishing certifiable informed consent for a medical procedure |
FR2837316B1 (fr) * | 2002-03-12 | 2006-02-03 | Geckomedia Sa | Procede d'information et de communication medicales |
US8190446B2 (en) * | 2002-04-10 | 2012-05-29 | Emmi Solutions, Llc | Enhanced system and method for enhancing and supplementing the informed consent process of a patient undergoing a medical procedure |
KR20050075339A (ko) * | 2002-09-26 | 2005-07-20 | 비반티 피티와이 엘티디 | 전문적인 절차정보로의 액세스를 제어하기 위한 새로운시스템 |
WO2006047832A1 (en) | 2004-11-05 | 2006-05-11 | Medical Consent Systems Pty Ltd | Interactive consent system |
US20120310670A1 (en) | 2011-06-01 | 2012-12-06 | nPruv, Inc. | Systems and methods for automated informed consent |
US20130073310A1 (en) | 2012-06-15 | 2013-03-21 | Richard Awdeh | Mobile health interface |
-
2016
- 2016-11-21 FR FR1661295A patent/FR3059140B1/fr active Active
-
2017
- 2017-11-13 EP EP17804243.8A patent/EP3542365A1/de not_active Ceased
- 2017-11-13 WO PCT/FR2017/053081 patent/WO2018091806A1/fr unknown
- 2017-11-13 US US16/462,705 patent/US20200075174A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US20200075174A1 (en) | 2020-03-05 |
WO2018091806A1 (fr) | 2018-05-24 |
FR3059140A1 (fr) | 2018-05-25 |
FR3059140B1 (fr) | 2021-11-26 |
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