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Information Ethics and Clinical Decision Making
1. TMHG 529
Information Ethics and
Clinical Decision Making
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Faculty of Medicine Ramathibodi Hospital, Mahidol University
April 22, 2013
http://www.SlideShare.net/Nawanan
2. Outline
• Course Introduction
• Introduction to Ethics & Bioethics
• Ethical Issues in Health Informatics
• Information Ethics & Clinical Decision Making
• Case Studies
2
4. Course Introduction
• TMHG 529 Legal and Ethical Issues in Health
Informatics (1 credit)
• Topics
Information ethics and clinical decision making
Health information privacy and security
Legal aspects in health informatics
Medico-legal aspects in health informatics
Case Studies
• Grading
Class Attendance (30%) & Class Participation (70%)
4
6. Introduction to Ethics & Bioethics
• Ethics
a set of moral principles: a theory or system of moral values
the principles of conduct governing an individual or a group
the discipline dealing with what is good and bad and with
moral duty and obligation
• Moral
of or relating to principles of right and wrong in behavior
conforming to a standard of right behavior
• Norm
A principle of right action binding upon the members of a
group and serving to guide, control, or regulate proper and
acceptable behavior
Source: Merriam‐Webster Dictionary 6
11. Reality
Law
Professional Code of Conduct
? Option 1 Ethics
Option 2
11
12. Reconciling Conflicts
• Law
Is explicit but...
Often requires interpretation
Slow to create; outdated; sometimes not keep
up with technologies or social changes
Conflicting laws
• Professional Code of Conduct
Often explicit, but similar issues with law
Only focuses on narrow & traditional
professional practice
12
13. Reconciling Conflicts
• Ethics
Implicit
Requires interpretation, making arguments
and debates
Is often the basis when law is created
Helpful in cases where law & code of
conduct don’t cover or are conflicting
13
14. Branches of Ethics
• Descriptive ethics
What do people think is right?
• Normative ethics
How should people act? (prescriptive)
• Applied ethics
How do we take moral knowledge and put it into
practice?
• Meta-ethics
What does “right” even mean?
Source: http://en.wikipedia.org/wiki/Outline_of_ethics 14
15. Sample Areas in Applied Ethics
• Business ethics
• Bioethics
Study of typically controversial ethics brought about by
advances in biology and medicine
• Decision ethics
• Professional ethics
Computer ethics
Journalism ethics and standards
Research ethics
Legal ethics
Marketing ethics
Medical ethics
Nursing ethics
Source: http://en.wikipedia.org/wiki/Outline_of_ethics http://en.wikipedia.org/wiki/Bioethics 15
16. Some Terms in Ethics
• Ethical Issue
• Ethical Dilemma
A complex situation that often involves an apparent
mental conflict between moral imperatives, in which
to obey one would result in transgressing another.
• Ethical Principle
a standard of conduct defining the kind of behavior
an ethical person should and should not engage in.
(Josephson, 2010)
Provides a guide to making decisions & establish
criteria by which decisions will be judged by others.
(Josephson, 2010)
Source: http://en.wikipedia.org/wiki/Ethical_dilemma
http://josephsoninstitute.org/business/blog/2010/12/12‐ethical‐principles‐for‐business‐executives/ 16
17. Historic Cases in Bioethics
• Real cases of unethical or controversial
professional practice or research practice
• Raised important ethical issues
• Led to development of important ethical
principles in use today
17
19. Nazi Human Experimentation & Murder
• Doctors’ Trial at
Nuremberg, Germany
• Gave rise to the
Nuremberg Code, a set
of research ethics
principles for human
subject research
Source: http://en.wikipedia.org/wiki/Doctors%27_Trial http://en.wikipedia.org/wiki/Nuremberg_Code 19
20. Points from The Nuremberg Code (1)
• Voluntary consent of human subject is
absolutely essential
• Experiment should be to yield fruitful results
for the good of society, unprocurable by other
methods or means of study, and not random
and unnecessary in nature
• Should be based on animal study & knowledge
of natural history of disease
• Avoid all unnecessary physical & mental
suffering & injury
Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html 20
21. Points from The Nuremberg Code (2)
• Avoid study where it’s believed death or
disabling injury will occur
• Risk should not exceed importance of study
problem
• Proper preparations to protect subjects against
risks
• Study conducted by qualified scientists
• Subjects can decide to terminate participation
• Researcher in charge must be prepared to
terminate study if continuing is believed to
likely to result in injury or death
Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html 21
22. Beecher’s Article
• Originally published in 1966
• Described 22 examples of research studies with
controversial ethics conducted by reputable researchers
and published in major journals.
• “...unethical or questionably ethical procedures are not
uncommon” (Beecher, 1966)
• Full text reprinted in Bull World Health Organ.
2001;79(4):367-72 & available at
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566
401/pdf/11368058.pdf
Source: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354‐60. 22
23. Common Ethical Problems in Research
• Lack of informed consent
• Coercion or undue pressure on volunteers (or on a parent
to volunteer his/her child)
• Use of a vulnerable population
• Exploitation of a vulnerable population
• Withholding information
• Withholding available treatment
• Withholding information about risks
• Putting subjects at risk
• Risks to subjects outweigh benefits
• Deception
• Violation of rights
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 23
24. Tea Room Trade Study
• Investigated homosexual
practices in public restrooms. The
researcher went undercover and
acted as a “look out” to directly
observe men engaging in sexual
acts.
• He then identified 100 subjects
by tracing their car license
numbers.
• A year later, he distributed a
“social health survey” throughout
the communities where the
subjects lived.
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 24
25. Tea Room Trade Study
• Ethical Issues
Informed consent
Deception
Use of a vulnerable population
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 25
26. Milgram Study
• Group Exercise #1
Source: http://en.wikipedia.org/wiki/Milgram_experiment 26
27. Stanford Prison Experiment
• In 1971 Philip
Zimbardo, a psychology
professor at Stanford
University conducted a
study of psychological
effects of becoming a
prisoner or prison
guard.
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 27
28. Stanford Prison Experiment
• 24 male students
randomly assigned to
roles of prisoners and
guards in a mock prison
in a basement at
Stanford which
continued for several
days
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 28
29. Stanford Prison Experiment
• Participants adapted to their
roles beyond researcher’s
expectations
• Guards enforced authoritarian
measures, became
psychologically abusive &
harassed prisoners
• Some prisoners joined the
guards in the abuse
• Study stopped after 6 days
(before 2-week intended
period) when ethical issues
were raised
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 29
30. Stanford Prison Experiment
• Ethical Issues
Risks in terms of
psychological harms
present that should be
anticipated and
permitted to continue
for some time
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/ 30
31. Tuskegee Study (1932‐1972)
• Designed to document natural
history of syphilis in African-
American men
• There was no known treatment
for syphilis at the time
• Hundreds of men with and
without syphilis were enrolled
but they were misinformed
about the need for some of the
procedures.
• Some procedures were told as
necessary and free treatment
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 31
32. Tuskegee Study (1932‐1972)
• After penicillin was found to be
safe & effective treatment for
syphilis in 1940s, they were not
given penicillin.
• The study continued to track
the men until 1972 when the
public became aware of study
• 28 deaths, 100 cases of
disabilities, and 19 cases of
congenital syphilis
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 32
33. Tuskegee Study (1932‐1972)
• Ethical issues
Lack of informed consent
Deception
Withholding information
Withholding available treatment, putting
subjects & families at risk
Exploitation of a vulnerable group of
subjects who would not benefit from
participation (black men)
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 33
34. The Belmont Report
• A report by the U.S. National Commission
for the Protection of Human Subjects of
Biomedical and Behavioral Research to
address ethical issues in the Tuskegee
Study
• Identifies 3 basic ethical principles for all
human subject research called “Belmont
Principles”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 34
35. Belmont Principles
• Respect for Persons (or Autonomy)
• Beneficence
• Justice
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 35
36. Belmont Principles
• Respect for Persons (or Autonomy)
Treat individuals as autonomous human
beings. People must be allowed to choose
for themselves
We must also provide extra protection to
those with limited autonomy
Autonomy includes mental capacity (ability
to understand and process information)
and voluntariness (freedom from control,
coercion, or influence of others)
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 36
37. Belmont Principles
• Beneficence
Minimize harms and maximize benefits
within constraints of sound research
design
Avoid research without a favorable risk-
benefit ratio
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 37
38. Belmont Principles
• Justice
Treat people fairly and design studies so
that burdens and benefits are shared
equitably
Select subjects equitably
Avoid exploitation of vulnerable
populations or “populations of
convenience”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 38
39. An Additional Ethical Principle
• Non-maleficence
• Primum non nocere
• “First, do no harm.”
• Included in the Hippocratic Oath
“...Whatever houses I may visit, I will
come for the benefit of the sick...”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 39
41. Why Important in Informatics?
Research ethics
Leads to patient outcomes, including deaths
Provider-patient relationship threatened by IT?
“Rationing” of health care through CDSS
Information risks
Informatics practitioners as “professionals” with
specific skills, training, & competencies?
Most common question “Who owns the data?”
Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 41
42. ELSI
• ELSI - Ethical, Legal, and Social Issues
• These three aspects are often interrelated
• ELSI in Informatics
AMIA ELSI-WG
http://www.amia.org/programs/working-groups/ethical-legal-social-issues
Professional Code of Conduct
AMIA: http://www.amia.org/about-amia/ethics/code-ethics
IMIA: http://www.imia-medinfo.org/new2/pubdocs/Ethics_Eng.pdf
42
43. IMIA General Ethical Principles in Informatics
• Information Privacy & Disposition
• Openness
• Security
• Access
• Legitimate Infringement
• Least Intrusive Alternative
• Accountability
Source: http://www.imia‐medinfo.org/new2/pubdocs/Ethics_Eng.pdf 43
44. Some ELSI References
Shortliffe 3rd Edition (2006)
Chapter 10 by Goodman KW & Anderson JG & Goodman KW (2002)
Miller RA
• Anderson JG. The role of ethics in information technology decisions: a case-
based approach to biomedical informatics education. Int J Med Inform. 2004
Mar 18;73(2):145-50.
44
46. A Model of Clinical Decision Making
PATIENT
Perception
CLINICIAN
Attention
Long Term Memory External Memory
Working
Memory
Knowledge Data Knowledge Data
Inference
DECISION
Source: Elson RB, Faughnan JG, Connelly DP. An industrial process view of information delivery to support
clinical decision making: implications for system design and process measures. J Am Med Inform Assoc. 1997 Jul‐
Aug;4(4):266‐78. http://jamia.bmj.com/content/4/4/266.full.pdf+html 46
47. Clinical Decision Support Systems (CDSSs)
• The real place where most of the values of
health IT can be achieved
• A variety of forms and nature of CDSSs
Expert systems
• Based on artificial intelligence, machine learning,
rules, or statistics
• Examples: differential diagnoses, treatment options
47
48. Clinical Decision Support Systems (CDSSs)
• A variety of forms and nature of CDSSs
Alerts & reminders
• Based on specified logical conditions
• Examples: drug-allergy checks, drug-drug interaction
checks, drug-lab interaction checks, drug-formulary
checks, reminders for preventive services or certain
actions (e.g. smoking cessation), clinical practice
guideline integration
Evidence-based knowledge sources e.g. drug database,
literature
Simple UI designed to help clinical decision making
48
50. Clinical Decision Support Systems (CDSSs)
Issues
• CDSS as a supplement or replacement of clinicians?
The demise of the “Greek Oracle” model (Miller & Masarie,
1990)
The “Greek Oracle” Model
The “Fundamental Theorem”
Friedman CP. A ʺfundamental theoremʺ of biomedical informatics. J Am Med
Inform Assoc. 2009 Apr;16(2):169‐170.
50
54. Unintended Consequences of Health IT
• “Unanticipated and unwanted effect of health IT implementation”
(ucguide.org)
• Must-read resources
www.ucguide.org
Ash JS, Berg M, Coiera E. Some unintended consequences of
information technology in health care: the nature of patient care
information system-related errors. J Am Med Inform Assoc. 2004 Mar-
Apr;11(2):104-12.
Campbell, EM, Sittig DF, Ash JS, et al. Types of Unintended
Consequences Related to Computerized Provider Order Entry. J Am
Med Inform Assoc. 2006 Sep-Oct; 13(5): 547-556.
Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom
BL. Role of computerized physician order entry systems in
facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203.
54
56. Unintended Consequences of Health IT
• Errors in the process of entering and retrieving
information
A human-computer interface that is not
suitable for a highly interruptive use context
Causing cognitive overload by
overemphasizing structured and “complete”
information entry or retrieval
• Structure
• Fragmentation
• Overcompleteness
Ash et al. (2004) 56
57. Unintended Consequences of Health IT
• Errors in the communication and coordination process
Misrepresenting collective, interactive work as a linear, clearcut, and
predictable workflow
• Inflexibility
• Urgency
• Workarounds
• Transfers of patients
Misrepresenting communication as information transfer
• Loss of communication
• Loss of feedback
• Decision support overload
• Catching errors
Ash et al. (2004) 57
62. Appropriate Use of Health IT
Standard view
With uncertainties around new technology, “scientific
evidence counsels caution and prudence.”
Evidence & reason determine appropriate level of
caution
If such systems improve care at acceptable cost in
time & money, there’s an obligation to use it
Follows evolving evidence and standards of care
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 62
63. Appropriate Use of Health IT
Standard view
For computer-assisted clinical diagnosis CDS, human
cognitive processes are more suited to complex task
of diagnosis than machine, and should not be
overridden or trumped by computers.
When adequate CDS tools are developed, they should
be viewed and used as supplementary and subservient
to human clinical judgment
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 63
65. Appropriate Use of Health IT
Standard view
Practitioners have obligation to use tools responsibly,
through adequate training & understanding the
system’s abilities & limitations
Practitioners must not ignore their clinical judgment
reflexively when using CDS.
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 65
66. Appropriate Use of Health IT
Health IT “should be used in clinical practice only
after appropriate evaluation of its efficacy and the
documentation that it performs its intended task at an
acceptable cost in time & money”
Qualified (licensed, trained & experienced) health
professionals as users
Systems should be used to augment/supplement,
rather than replace or supplant individuals’ decision
making
Adequate training
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 66
67. Ethics for Developers
Follow standard of care & scientific progress
(evidence-based)
System evaluation is ethically imperative
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition). 67
68. Why Clinical Judgment Is Still Necessary?
• Nothing is certain in medicine & health care
• Large variations exist in patient presentations,
clinical course, underlying genetic codes, patient
& provider behaviors, biological responses &
social contexts
• Human is good at pattern recognition, while
machine is good at logic & computations.
• Diagnosis is often achieved through recognizing
clinical patterns
• Not everything can be digitized or digitally
acquired
• Experience, context & human touch matters
68
69. “Learned Intermediary” Doctrine
• A defense doctrine used in the U.S. legal
system (and some other countries) which
states that “a manufacturer of a product has
fulfilled his duty of care when he provides all
of the necessary information to a ‘learned
intermediary’ who then interacts with the
consumer of a product.” (Wikipedia)
• Primarily used by pharmaceutical & medical
device manufacturers in defense of tort
lawsuits.
Source: http://en.wikipedia.org/wiki/Learned_intermediary 69
70. “Learned Intermediary” Doctrine
• Because health IT developers can’t expect a
CDS advice (e.g., alerts & reminders) to be
100% appropriate for each individual patient,
clinical judgment is still necessary.
• Health IT developers & manufacturers are
protected from liabilities for
poor/inappropriate advices or for bad
outcomes associated with them, as long as
there is a clinician using it that can intervene
• What about software bugs (e.g. wrong dose
calculations)?
70
71. “Learned Intermediary” Doctrine
• Applicability of this doctrine varies based
on legal jurisdictions, context of each
case, and legal arguments
• Recently, this doctrine has been noted by
some legal and informatics experts that it
doesn’t apply to health IT cases
• It remains unclear until there are rulings
from real legal cases
71
72. Summary
• Ethical principles are guides and standards
of practice that can help us navigate
through situations that arise.
• History was full of unethical conduct
• 4 important principles in bioethics
Respect for persons (autonomy)
Beneficence
Justice
Non-maleficence
72
73. Summary
• Ethical issues are present in informatics
practice (whether as developers, implementers,
executives, users, researchers, etc.)
• Codes of conduct & ethics codes by
professional organizations govern acceptable
& ethical behaviors by informaticians
• In use of health IT in clinical decision
making, there are standard & appropriate
guidelines that are based on ethical principles
73