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    Medical Utopias

    Ethical Reflections aboutEmerging Medical

    Technologies

    Dr Alex Tang MD PhD

    Consultant Paediatrician

    KPJ Johor Specialist Hospital

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    Living without pain, diseases or even dying

    No more fertility or reproductive problems Delaying or defying the aging process

    Personalized genomic medicine (P4 Medicine)

    personalised, predictive, preventive, participatory

    Optimize and enhance normal abilities

    Medical Utopias

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    EmergingTechnologies

    ConsumerExpectation

    Healthcareproviders

    Healthcareprofessionals

    Medical Utopias and

    Emerging Technologies

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    Respect for Autonomy

    Beneficence

    Non-maleficence

    Justice

    Biomedical Ethics Framework

    Beauchamp and Childress; Principles Biomedical Ethics, OUP, 5th edition 2001

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    1. Already in clinical applications (include phase 3

    trials)2. Research fields at preclinical stages

    3. Research fields at purely theological stages

    Ethical areas of concern

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    1. Already in clinical applications (include phase 3

    trials)tissue engineering, bioelectronics,

    health IT, genetic tests, drugs testing2. Research fields at preclinical stages -

    reproductive cloning, germ line genome

    modification, interventions in biological agingprocess

    3. Research fields at purely theological stages

    nanotechnology, virtual digital patient

    Ethical areas of concern

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    1. The emergence of the digital

    patient (to be or not be be)

    2. The direct to customer (DTG)

    genetic screening

    (to know or not to know)

    3. The development of new

    pharmaco-therapeutics

    (to treat or not to treat)

    Ethical Reflections on Emerging

    Medical Technologies

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    Medical Utopias

    Ethical Reflections aboutEmerging Medical

    Technologies

    1. The Emergence ofthe Digital Patient

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    Health IT and

    patient care

    Ethical Reflection on

    the Digital Patient

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    Use and Characteristics of Electronic Health Record

    Systems Among Office-based Physician Practices:

    United States, 20012013

    NCHS Data Brief Number 143, January 2014http://www.cdc.gov/nchs/data/databriefs/db143.htm

    Percentage of office-based physicians with EHR systems:United States, 20012013

    HITECH

    Medicare and

    Medicaid EHR

    Incentive Programs

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    Health IT

    AdministrativeFunctionality

    Health

    ManagementFunctionality

    Medical

    DeviceFunctionality

    Ethical Reflections: Digital Patient

    FDASIA Health IT Report April 2014

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    Is health IT the key to

    better healthcare?

    Ethical reflection

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    One quarter of the hospitalizations (937admissions) had at least 1 ADE

    9% resulted in serious harm, 22% in additional

    monitoring and interventions, 32% ininterventions alone, and 11% in monitoring alone

    Errors associated with ADEs: 61% ordering, 25%

    monitoring, 13% administration, 1% dispensing,and 0% transcription

    Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High Rates of Adverse Drug Events in a Highly Computerized Hospital. Arch Intern Med.

    2005;165(10):1111-1116. doi:10.1001/archinte.165.10.1111.

    Adverse Drug Events (ADEs) in a Highly

    Computerized Hospital (20 week period)

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    Technology

    People

    ProcessOrganisation

    ExternalEnvironment

    Health IT Sociotechnical System

    FDASIA Health IT Report April 2014

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    Poorly designed health IT new hazards in analready complex system of health care delivery

    Individual health IT components may meet theirstated performance requirements, yet thesystem as a whole may yield unsafe outcomes

    Problematic events involving complex systems

    often cannot be ascribed to a single causativefactor

    Poor human-computer interactions can

    contribute to serious injury and death

    Issues in health IT

    Sociotechnical System

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    e-iatrogenesis

    e-iatrogenic

    Issues in health IT

    Sociotechnical System

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    Is health IT the key to better healthcare?

    Data interoperabilitywill it ever be resolved?

    Ethical reflection

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    Health IT is a practical tool

    not a replacement for quality patient care

    Ethical reflection

    Norman Rockwell,Saturday Post Archives

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    Health IT and patient

    care

    Privacy, Confidentiality,Security

    Ethical Reflection on

    the Digital Patient

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    Ethical reflection

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    Most patients not aware of

    their right to privacy and

    confidentiality Cheaper and faster to

    develop non-privacy aware

    health IT software solutions Healthcare provider

    consolidation

    Hackers

    Privacy, confidentiality, security: how

    safe is the data?

    Employers

    Insurance companies

    Law

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    Is our healthcare providers

    keeping their data secure?

    Are we educating ourpatients on their privacy

    rights?

    Do we allow patient toaccess their own medical

    records?

    Data Protection Regulation

    Ethical reflection

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    Medical Utopias

    Ethical Reflections aboutEmerging Medical

    Technologies

    2. Direct to

    Customers (DTC)genetic screening

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    Direct To Consumer (DTC)

    Screening Tests

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    Scientific accuracy, clinical validity and utility of

    genetic tests

    Absence of and/or quality of pre- and post-test

    counselling

    Absence of individualized medical supervision

    Lack of adequate consent procedures

    Respect for privacy and confidentiality

    Direct To Consumer (DTC)

    Screening Tests

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    What is to be done

    about direct to

    consumer (DTC)genetic screening

    tests?

    Role of regulating

    direct to consumer

    medical tests?

    Ethical Reflections

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    Medical Utopias

    Ethical Reflections onEmerging Medical

    Technologies

    3. Development of new

    pharmacotherapeutics

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    Ethical Concerns on

    Pharmacotherapeutics

    Testing for

    carcinogenicity

    Pharmacogenomics

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    Test for carcinogenicity

    Short term in vitro

    mutagenicity test

    Lifespan in vivo tests in rodents

    (two species)

    12-24 months expensive

    Testing of new drugs

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    International Conference on Harmonisation of

    Technical Requirements for Registration of

    Pharmaceuticals for Human Use (ICH) approved

    using genetic engineered rats for one species

    short term lifespan studies in 1997

    The validation was done in the 2000s byInternational Life Sciences Institute (ILSI)

    Short term lifespan rodent studies

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    How accurate are these studies using genetically

    engineered rats?

    How safe are the new drugs?

    Ethical Reflections

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    Ethical Concerns on

    Pharmacotherapeutics

    Testing for

    carcinogenicity

    Pharmacogenomics

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    Design of clinical trails

    Cost as a barrier to access

    Professional standards of care

    Ethical Concerns on

    Pharmacogenomics

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    EmergingTechnologies

    ConsumerExpectation

    Healthcareproviders

    Healthcareprofessionals

    Medical Utopias and

    Emerging Technologies

    Beauchamp and Childress; Principles Biomedical Ethics, OUP, 5th edition 2001

    Respect for AutonomyBeneficence

    Non-Maleficence

    Justice

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    Ethical Reflections