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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 15, 2021
Introduction to Health Informatics and Health IT in Clinical Settings (Part 1...Nawanan Theera-Ampornpunt
Presented at the 10th Healthcare CIO Certificate Program, Ramathibodi School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on February 17, 2020
Presented at the 9th Healthcare CIO Certificate Program, School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on March 4, 2019
Introduction to Health Informatics and Health IT in Clinical Settings (Part 2...Nawanan Theera-Ampornpunt
Presented at the 10th Healthcare CIO Certificate Program, Ramathibodi School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on February 17, 2020
Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 15, 2021
Introduction to Health Informatics and Health IT in Clinical Settings (Part 1...Nawanan Theera-Ampornpunt
Presented at the 10th Healthcare CIO Certificate Program, Ramathibodi School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on February 17, 2020
Presented at the 9th Healthcare CIO Certificate Program, School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on March 4, 2019
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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on October 12, 2020
Presented at the 8th Healthcare CIO Certificate Program, Ramathibodi Hospital Administration School, Faculty of Medicine Ramathibodi Hospital, Mahidol University on March 12, 2018
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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on October 7, 2020
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Introduction to Health Informatics and Health Information Technology (Part 2)...Nawanan Theera-Ampornpunt
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Consumer Health Informatics, Mobile Health, and Social Media for Health: Part...Nawanan Theera-Ampornpunt
Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 10, 2021
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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on October 4, 2021
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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on October 12, 2020
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Presented at the 11th Healthcare CIO Certificate Program, School of Hospital Management, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on February 10, 2021
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Public Health Informatics, Consumer Health Informatics, mHealth & Personal He...Nawanan Theera-Ampornpunt
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Introduction to Health Informatics and Health Information Technology (Part 2)...Nawanan Theera-Ampornpunt
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Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 10, 2021
Introduction to Health Informatics and Health IT (Part 1) (February 10, 2021)Nawanan Theera-Ampornpunt
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Unit 8. Ethical Considerations in Reseaerch.pptxshakirRahman10
Ethical Consideration in Research:
Objectives:
1. Define the terms related to ethics in research
2. Discuss historical events of ethical mischiefs and evolution of ethics as protecting human rights
3. Discuss the ethical principles, declaration of Helsinki and research code of ethics
4. Describe different types of informed consent, i.e. verbal, written, individual and institutional consent.
5. Produce a meaningful informed consent form.
6. Identify role and importance of ethical considerations in research.
Ethical Considerations in Research:
Ethical considerations in research are a set of principles that guide the research designs and practices.
Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.
The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways.
What you decide to research and how you conduct that research involve key ethical considerations.
Ethical considerations work to:
Protect the rights of research participants
Enhance research validity
Maintain scientific or academic integrity.
History of Research Ethics:
Nuremberg Code
Dec. 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result.
As a direct result of the trial, the Nuremberg Code was established in 1948, stating that “The voluntary consent of the human subject is absolutely essential,” making it clear that subjects should give consent and that the benefits of research must outweigh the risks.
Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.
Thalidomide
In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA.
The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.
Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.
U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety.
For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.
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At the end of this lecture , all participants will be able to know …
What is Ethics
Brief History of ethics
Ethical Principles
Types Of Ethics
Research Ethical Codes and Policies
Importance Of Ethical Norms in Research
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- Distinguishing between MPM and Talc Pleurodesis.
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- The role of FDG PET in NET.
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Letter to MREC - application to conduct studyAzreen Aj
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CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
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Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
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Ethics in Biomedical Informatics (February 19, 2020)
1. Ethics in Biomedical
Informatics
For Faculty of Medicine Siriraj Hospital
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Faculty of Medicine Ramathibodi Hospital, Mahidol University
February 19, 2020
http://www.SlideShare.net/Nawanan
2. 2
Outline
• Introduction to Ethics & Bioethics
• Ethical Issues in Health Informatics
• Information Ethics & Clinical Decision Making
• Case Studies
4. 4
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
5. 5
? Option 1
Option 2
Society’s Standard
Standard of Acceptable Behaviors in Society
10. 10
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
11. 11
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
12. 12
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
13. 13
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
14. 14
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/
15. 15
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. 17
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
18. 18
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
19. 19
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
20. 20
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.
21. 21
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.
22. 22
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.
23. 23
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. 25
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/
26. 26
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/
27. 27
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/
28. 28
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/
29. 29
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.
30. 30
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.
31. 31
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.
32. 32
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.
33. 33
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.
34. 34
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.
35. 35
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.
36. 36
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.
37. 37
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. 39
▪ Research ethics
▪ Leads to patient outcomes, including deaths
▪ Provider-patient relationship threatened by IT?
▪ “Rationing” of health care through CDS systems
▪ Information risks
▪ Informatics practitioners as “professionals” with
specific skills, training, & competencies?
▪ Most common question “Who owns the data?”
Why Important in Informatics?
Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
40. 40
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
41. 41
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
42. 42
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
47. 47
A Model of Clinical Decision Making
External Memory
Knowledge Data
Long Term Memory
Knowledge Data
Inference
DECISION
PATIENT
Perception
Attention
Working
Memory
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
48. 48
Clinical Decision Support Systems (CDS)
• The real place where most of the values of
health IT can be achieved
• A variety of forms and nature of CDS
▪ Expert systems
• Based on artificial intelligence, machine learning,
rules, or statistics
• Examples: differential diagnoses, treatment options
49. 49
Clinical Decision Support Systems (CDS)
• A variety of forms and nature of CDS
▪ 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
50. 50
Issues
• CDS 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 "fundamental theorem" of biomedical informatics. J Am Med
Inform Assoc. 2009 Apr;16(2):169-170.
Clinical Decision Support Systems (CDSs)
53. 53
• “Unanticipated and unwanted effect of health IT
implementation”
• Must-read resources
▪ 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.
Unintended Consequences of Health IT
54. 54Ash et al. (2004)
Unintended Consequences of Health IT
55. 55
• 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)
Unintended Consequences of Health IT
56. 56
• 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)
Unintended Consequences of Health IT
61. 61
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).
Appropriate Use of Health IT
62. 62
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
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
64. 64
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.
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
65. 65
▪ 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
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
66. 66
▪ Follow standard of care & scientific progress
(evidence-based)
▪ System evaluation is ethically imperative
Ethics for Developers
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
67. 67
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. 68
“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. 69
“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. 70
“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. 71
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. 72
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