Information Ethics and Clinical Decision Making

TMHG 529
Information Ethics and
Clinical Decision Making
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Faculty of Medicine Ramathibodi Hospital, Mahidol University
December 15, 2014
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

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

5
Introduction to
Ethics & Bioethics

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

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Standard of Acceptable Behaviors in Society
Society’s Standard
? Option 1
Option 2

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Law as Standard of Acceptable Behaviors
? Option 1
Option 2
Law

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Professional Code of Conduct as Standard
of Acceptable Behaviors
? Option 1
Professional Code of Conduct
Option 2

10
Ethics as Standard of Acceptable Behaviors
? Option 1
Option 2
Ethics

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Reality
? Option 1
Option 2
Law
Professional Code of Conduct
Ethics

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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 Slow to create; outdated; sometimes not keep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

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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

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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

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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

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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/

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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

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Nazi Human Experimentation & Murder
Source: http://isurvived.org/TOC‐I.html#I‐6_MedExp

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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

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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

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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

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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.

Common Ethical Problems in Research
• Lack of informed consent
• Coercion or undue pressure on volunteers (or on a parent
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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.

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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.

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Tea Room Trade Study
• Ethical Issues
 Informed consent
 Deception
 Use of a vulnerable population

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Milgram Study
• Group Exercise #1
Source: http://en.wikipedia.org/wiki/Milgram_experiment

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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/

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• 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

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• 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

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• Ethical Issues
 Risks in terms of
psychological harms
present that should be
anticipated and
permitted to continue
for some time

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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

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• 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

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• 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)

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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.

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Belmont Principles
• Respect for Persons (or Autonomy)
• Beneficence
• Justice

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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)

37
Belmont Principles
• Beneficence
 Minimize harms and maximize benefits
within constraints of sound research
design
Avoid research without a favorable risk-benefit
ratio

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”

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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...”

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Ethical Issues in Health
Informatics

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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).

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

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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

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Some ELSI References
• 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.
Anderson JG & Goodman KW (2002)
Shortliffe 3rd Edition (2006)
Chapter 10 by Goodman KW &
Miller RA

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Information Ethics &
Clinical Decision Making

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A Model of Clinical Decision Making
External Memory
Knowledge Data
Long Term Memory
Knowledge Data
PATIENT
Perception
Attention
Working
Memory
Inference
DECISION
CLINICIAN
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

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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

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• 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

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Example of “Alerts & Reminders”

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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.

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Issues
• Alert sensitivity & alert fatigue

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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.

Ash et al. (2004) 55

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• 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)

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• 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)

Campbell et al. (2006) 58

Campbell et al. (2006) 59

Koppel et al. (2005) 60

Koppel et al. (2005) 61

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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.

63
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

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Fundamental Theorem of Informatics
(Friedman, 2009)

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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.

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 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

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Ethics for Developers
 Follow standard of care & scientific progress
(evidence-based)
 System evaluation is ethically imperative

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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

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

70
• 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)?

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• 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

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

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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

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