dr alex tang_ medical utopias
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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