TMHG 529Information Ethics and Clinical Decision Making

Nawanan Theera-Ampornpunt, M.D., Ph.D.Faculty of Medicine Ramathibodi Hospital, Mahidol University

December 15, 2014http://www.SlideShare.net/Nawanan

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Outline• Course Introduction• Introduction to Ethics & Bioethics• Ethical Issues in Health Informatics• Information Ethics & Clinical Decision Making• Case Studies

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Course Introduction

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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

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Introduction to Ethics & Bioethics

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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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? Option 1

Option 2

Society’s Standard

Standard of Acceptable Behaviors in Society

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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

Option 2

Professional Code of Conduct

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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 Often requires interpretation Slow to create; outdated; sometimes not keep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_dilemmahttp://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/PMC2566401/pdf/11368058.pdf

Source: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354‐60.

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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.

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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.

Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Tea Room Trade Study

• Ethical Issues Informed consentDeceptionUse of a vulnerable population

Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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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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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/

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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/

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Stanford Prison Experiment

• Ethical IssuesRisks 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/

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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

Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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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.

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Tuskegee Study (1932‐1972)

• Ethical issuesLack of informed consentDeceptionWithholding informationWithholding available treatment, putting

subjects & families at riskExploitation 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.

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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.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Belmont Principles

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

Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Belmont Principles

• Respect for Persons (or Autonomy) Treat individuals as autonomous human

beings. People must be allowed to choose for themselvesWe 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.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Belmont Principles

• BeneficenceMinimize harms and maximize benefits

within constraints of sound research designAvoid research without a favorable risk-

benefit ratio

Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Belmont Principles

• JusticeTreat people fairly and design studies so

that burdens and benefits are shared equitably Select subjects equitablyAvoid exploitation of vulnerable

populations or “populations of convenience”

Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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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...”

Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmlBankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.

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Ethical Issues in Health Informatics

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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?”

Why Important in Informatics?

Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition).

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ELSI

• ELSI - Ethical, Legal, and Social Issues• These three aspects are often interrelated• ELSI in InformaticsAMIA ELSI-WGhttp://www.amia.org/programs/working-groups/ethical-legal-social-issues

Professional Code of ConductAMIA: http://www.amia.org/about-amia/ethics/code-ethicsIMIA: 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

Inference

DECISION

PATIENT

Perception

Attention

WorkingMemory

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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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

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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.

Clinical Decision Support Systems (CDSSs)

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Issues

• Alert sensitivity & alert fatigue

Clinical Decision Support Systems (CDSSs)

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Workarounds

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Workarounds (Zoomed In)

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• “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.

Unintended Consequences of Health IT

55Ash et al. (2004)

Unintended Consequences of Health IT

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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)

Unintended Consequences of Health IT

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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)

Unintended Consequences of Health IT

58Campbell et al. (2006)

Unintended Consequences of Health IT

59Campbell et al. (2006)

Unintended Consequences of Health IT

60Koppel et al. (2005)

Unintended Consequences of Health IT

61Koppel et al. (2005)

Unintended Consequences of Health IT

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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

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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).

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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.

Appropriate Use of Health IT

Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition).

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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

Appropriate Use of Health IT

Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition).

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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).

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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

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“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

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“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)?

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“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

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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 bioethicsRespect for persons (autonomy)Beneficence JusticeNon-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