An overview of the ethical framework for a learning health care system and requirements for its implementation.

1. An Ethics Framework for the
Learning Health Care System
Ethics and Learning Health Care
Systems

2. Ethics Framework
1. Respect the rights and dignity of patients and
families
2. Respect the judgment of clinicians
3. Provide each patient optimal clinical care
4. Avoid imposing non-clinical risks and burdens
5. Address unjust health inequalities
6. Conduct continuous learning activities (clinicians
and health care institutions)
7. Contribute to the common purpose of improving the
quality and value of clinical care (patients and
families)

3. Obligation 1
How does a learning activity
impact patients’ rights, respectful
treatment, and dignity?
• Not every decision is of equal moral
relevance to patients
• Duties of respect go well beyond
autonomous decision making by
patients
Respect the rights
and dignity of the
patient and family.

4. Obligation 2
How does a learning activity
impact a clinician’s ability to use
his/her own judgment?
• Clinicians’ judgments advance
patients’ medical interests and
autonomy interests
• The importance of this obligation
is not equally stringent in all
circumstances
• Tension exists between honoring
this obligation and evidence that
clinicians’ judgments can be
biased or less than fully informed
Respect the
judgment of
clinicians.

5. Obligation 3 How will a learning activity
impact the net clinical benefit
to patients compared to
benefits from “ordinary care”
without a learning activity?
• General obligation to promote
the welfare interests of patients
toward the best clinical outcome
• Does “learning” make the care
any riskier for patients? Likely for
patients to be worse off? Or is it
the same?
Provide each
patient optimal
clinical care.

6. Obligation 4
What other non-clinical risks and
burdens do patients experience?
• How do these compare to those
likely from “ordinary care” outside of
a learning activity?
• Are there any additional burdens for
patients because the “learning
activity” is happening?
Avoid imposing
non-clinical risks or
burdens.

7. Obligation 5
Will a learning activity exacerbate
unjust inequalities? Decrease
them?
• What is the activity studying?
• Can the activity be structured to
advance the goal of reducing unjust
inequalities in healthcare?
Address unjust
health inequalities.

8. Obligation 6
Healthcare professionals,
institutions, payors have an
obligation to conduct and
contribute to learning activities
that advance the quality,
fairness, economic viability of
the healthcare system
• They are uniquely situated to
contribute such data
• Relevant to their responsibilities to
provide high quality care
Conduct continuous
learning activities
that improve the
quality of clinical
care.

9. Obligation 7
Patients have an obligation to
participate in learning activities
• Derived from moral norm of
common purpose-- a common
interest in having a high quality, just,
economically viable healthcare
system
• Derived from obligations of
reciprocity
• Does not mean patients must
participate in all learning activities!!!
• Activities that might adversely
impact rights and interests
(obligations 1-4) will require
consent/oversight
Contribute to the
common purpose of
improving the
quality and value of
clinical care and
health care systems.

10. IMPLEMENTATION
1. Ethics policies must be in place in a learning health care
system.
2. There must be evaluation (triage) of types of learning
activities.

11. Ethics Policies
Wide disclosure (at enrollment, in newsletters, etc.)
• That the health care system is committed to continuous
learning in order to improve care
• That confidentiality will be protected
• That a listing of all learning activities is available
• That key findings will be disseminated
• That key findings will be used to improve care (and then
disseminate examples)

12. Key Messages to Disclose
The health care system is committed to continuous
learning
• Learning is integrated into all care delivery
• Learning is an ethical imperative to ability to deliver high
quality care
The health care system is committed to protecting
patients’ rights and interests
• Confidentiality protections
• Quality of care is never knowingly compromised
• All activities are first evaluated with ethics framework
• Any activity that might meaningfully change care or how it is
delivered will always include explicit informed consent
requirements

13. Evaluation (Triage) of Learning
Activities
Category 1
• No additional risk/burden
• No change to clinical care
• Good protections [records
review]
• No consent required;
• No prospective oversight
required?
• Random audits to ensure
meeting criteria

14. Evaluation (Triage) of Learning
Activities
Category 2
• Low risk/burden
• no reason to think patients
object to research or prefer
one arm (approach) over
another
– e.g., comparison two similar
treatment approaches
• prospective oversight but
modified authorization/no
consent (?)

15. Evaluation (Triage) of Learning
Activities
Category 3
• Risk/burden
• Meaningful difference
among approaches
• Prospective oversight and
prospective patient consent