Presented at FHIR North 2021 Informed Consent (also known as Consent for Medical Treatment) is required prior to most medical procedures. It allows the patient to actively participate in decisions about what his or her own care. Informed Consent is therefore an integral part of Patient-Centered Care. FHIR defines a Consent resource that is meant to cover four different uses cases: Privacy Consent, Medical Treatment Consent, Research Consent and Advance Care Directives. Currently, only the Privacy Consent use case has been elaborated. In this session we will explore the usage of the FHIR Consent Resource for the purpose of Informed Consent. This process will be captured using the BPM+ set of standards and combined with the usage of the FHIR Consent resource. Attendees will learn about: The FHIR Consent Resource. The Informed Consent/Medical Treatment Consent process. Representation of the process using BPM+ Standards. A demonstration of an automated Informed Consent for Total Hip Arthroplasty (THA) surgery.

1. Obtaining Informed Consent
using BPM+ Automation and
the FHIR Consent Resource
John Svirbely, MD
Chief Medical Informatics Officer
(CMIO),
jsvirbely@Trisotech.com
Denis Gagne
Chief Executive Officer (CEO),
dgagne@Trisotech.com

2. Trisotech.com
Abstract
 Informed Consent (also known as Consent for Medical Treatment) is required prior to most medical
procedures. It allows the patient to actively participate in decisions about what his or her own care. Informed
Consent is therefore an integral part of Patient-Centered Care.
 FHIR defines a Consent resource that is meant to cover four different uses cases: Privacy Consent, Medical
Treatment Consent, Research Consent and Advance Care Directives. Currently, only the Privacy Consent use
case has been elaborated.
 In this session we will explore the usage of the FHIR Consent Resource for the purpose of Informed Consent.
This process will be captured using the BPM+ set of standards and combined with the usage of the FHIR
Consent resource.
Attendees will learn about:
 The FHIR Consent Resource.
 The Informed Consent/Medical Treatment Consent process.
 Representation of the process using BPM+ Standards.
 A demonstration of an automated Informed Consent for Total Hip Arthroplasty (THA) surgery.
BPM+ AUTOMATION COMBINED TO FHIR CONSENT RESOURCE

3. Trisotech.com
Informed Consent
Getting on the same page

4. Trisotech.com
Introduction
 With Patient-Centered Care, patients have the right to control the decisions relating to the rendering of their
medical care.
 Patients may express their decisions through:
o Informed Consent, which are direct instructions by a competent patient.
o Advance Directives, which gives consent for future care in case the patient becomes incompetent or
unable to communicate.
 Informed Consent, also known as Consent for Medical Treatment:
o is required prior to most medical procedures.
o allows the patient to actively participate in care decisions.
INFORMED CONSENT

5. Trisotech.com
Patient Centered Care
INFORMED CONSENT
https://www.omg.org/spec/SBVR

6. Trisotech.com
Consent for Medical Treatment
 Valid Consent for Medical Treatment must be in place
o Consent is most often in writing but can be implied or oral.
o Consent must be given by a Competent Patient (or Authorized Representative)
o Sufficient information must be provided to ensure Informed Consent
 The more significant the treatment, the greater the need for consent to be documented.
 Rule: If the patient lacks capacity to consent, then
o Check for Advance Directives, or
o Obtain consent from authorized legal representative, or
o Provide care to preserve life in an emergent situation.
INFORMED CONSENT

7. Trisotech.com
Documented Informed Consent
Informed Consent
=Communication
 Provider communicates information relevant to
treatment
 Patient understands the material facts, e.g., benefits,
risks, and likely consequence of the proposed treatment
and alternatives
 Patient makes informed decision to consent or refuse
treatment
INFORMED CONSENT
Consent Form
=Documentation
 Supplements verbal or other information given by the
provider
 Documents that:
o the communication process took place, e.g., that
provider communicated relevant information to
the patient,
o the patient understood the information, and
o the patient made a voluntary, informed decision

8. Trisotech.com
Potential Failures at various Check Points
Check Points Potential Failures
Physician performing procedure actively engaged
in consent process
Over-delegation, disengaged
Physician develops rapport with patient and
establishes trust
Alienation or distrust
Procedure done for patient's best interest Conflict of interest, cheaper or better alternative
Key team members involved in case listed and
roles
Clinician getting consent is not the one
performing the case
Decision made by a competent person Patient incompetent; including transient
incompetence due to drugs or illness
Consent witnessed and documented in the
patient’s medical record
Consent not properly witnessed or not adequately
documented.
INFORMED CONSENT

9. Trisotech.com
Potential Failures at various Check Points
Check Points Potential Failures
Complete description of procedure Omission of key elements or misleading
information
Patient is informed of pros and cons of the
procedure, with educational materials provided to
aid understanding
Failure to comprehend due to language, culture
or education; impaired vision or hearing
Discussion of material risks and hazards
Alternative interventions described
Consequences of doing nothing explained
Process slow and measured, preferably over
multiple sessions to allow reflection
Signing just before procedure; hurried
Patient has the opportunity to ask as many
questions as needed to reach a decision
No opportunity given for questions
Patient is able to demonstrate an understanding
of information provided
Patient questions and clinician answers recorded No record of what was discussed
INFORMED CONSENT

10. Trisotech.com
FHIR Consent Resource
R 4.0.1

11. Trisotech.com
Introduction
 FHIR R4 already defines a Consent Resource. We will be using this resource.
FHIR CONSENT RESOURCE
https://www.hl7.org/fhir/consent.html
[…]

12. Trisotech.com
Introduction
 The FHIR Consent Resource is meant to cover four different uses cases:
1. Privacy Consent
o Agreement to collect, access, use or disclose (share) information
2. Medical Treatment Consent
o Consent to undergo a specific treatment (or record of refusal to consent)
3. Research Consent
o Consent to participate in research protocol and information sharing required.
4. Advance Care Directives
o Consent to instructions for potentially needed medical treatment (e.g. DNR).
FHIR CONSENT RESOURCE
Currently, only the Privacy Consent use case has been elaborated

13. Trisotech.com
Modeling Best Practices
Computational
Independent Model
(CIM)
Platform Independent
Model
(PIM)
Platform Specific
Model
(PSM)
MODEL DRIVEN APPROACH
Narrative

14. Trisotech.com
Medical Treatment Consent Directive
FHIR CONSENT RESOURCE
https://www.omg.org/spec/SBVR

15. Trisotech.com
Consent Detailed Description
FHIR CONSENT RESOURCE

16. Trisotech.com
Controlled Vocabulary
FHIR CONSENT RESOURCE
https://www.omg.org/spec/SBVR

17. Trisotech.com
Term Disambiguation
FHIR CONSENT RESOURCE

18. Trisotech.com
BPM+ Automation
Workflows and Decisions on top of FHIR

19. Trisotech.com
BPM+ AUTOMATION
Established to foster the sharing and
promulgation of best-practices around
modeling and sharing:
• shareable pathways,
• clinical pathways,
• automatable clinical guidelines, and
• other healthcare knowledge
A robust and thriving community-of-
practice of healthcare institutions,
professional societies, and vendors
www.BPM-Plus.org
https://www.BPM-Plus.org

20. Trisotech.com
Setting some Basic Terminology
Workflow
Automation
Decision
Automation
Open Standards
DMN
(DECISION MODEL AND NOTATION)
Decision tables and logical expressions
BPMN
(BUSINESS PROCESS MODEL AND NOTATION)
Prescriptive sequence of activities
CMMN
(CASE MANAGEMENT MODEL AND NOTATION)
Declarative unstructured event-condition-action
Technology enabled
orchestration of activities, able
to react to business events.
Both may have humans in the loop or not.
(Referred to as Knowledge Workers.)
Technology enabled decisions,
returning answers given some
inputs.
BPM+ AUTOMATION
https://www.omg.org/spec/DMN
https://www.omg.org/spec/BPMN
https://www.omg.org/spec/CMMN

21. Trisotech.com
BPM+ Value Add
BPM+ AUTOMATION
Data
Intelligent
Healthcare
Automation
Computable Data
Aggregated Data
Data Automation
Information Automation
Orchestration of knowledge
Workflow and Decision Automation
Data in clinical context
• EMR 1
• EMR 2
• Devices
• Wearables
• Diagnostics
• Claims
• Common schema
• Identity resolution
• Medical resources
• Metadata
• Context
• Events awareness
• Tasks and activities
• Roles and responsibilities
• Decisioning
• Case management
• Event orchestration
• AI and ML

22. Trisotech.com
Medical Treatment Consent
An example

23. Trisotech.com
Global Context
MEDICAL TREATMENT CONSENT

24. Trisotech.com
FHIR Patient Resource
MEDICAL TREATMENT CONSENT

25. Trisotech.com
FHIR Patient Resource
MEDICAL TREATMENT CONSENT

26. Trisotech.com
FHIR Consent Resource
MEDICAL TREATMENT CONSENT

27. Trisotech.com
FHIR Consent Resource
MEDICAL TREATMENT CONSENT

28. Trisotech.com
Medical Treatment
Consent Demo

29. Trisotech.com
Future Directions
 The FHIR Consent resource allows us to store the informed
consent form and lists involved stakeholders.
 There is quite a bit of additional data that needs to be stored to
document the consent process. This information could be
voluminous and so is not appropriate to include in the patient’s
chart.
 Examples: a listing of all questions that were asked with
responses; a list of resources reviewed; details of the discussion
on benefits and possible complications.
OBTAINING INFORMED CONSENT USING BPM+ AUTOMATION AND THE FHIR CONSENT RESOURCE

30. Trisotech.com
Conclusions
 We explored the usage of the FHIR Consent Resource for the
Medical Treatment Consent use case
 We presented the value-added benefits of using the BPM+ Health
set of standards on top of FHIR and CDS Hooks standards
 We demoed the combined solution:
oA BPM+ Health Consent Automation consuming FHIR
Resources within a CDS Hooks Sandbox context
OBTAINING INFORMED CONSENT USING BPM+ AUTOMATION AND THE FHIR CONSENT RESOURCE

31. Trisotech.com
Any questions?
THANKS!
Dr. John Svirbely, MD
Chief Medical Informatics Officer (CMIO),
jsvirbely@Trisotech.com
Denis Gagne
Chief Executive Officer (CEO),
dgagne@Trisotech.com
FHIR North Prize Pack Code: trisotech