Relationship of Law to Research and Clinical Care |
Liability shapes behaviors
Regulatory improvements are necessary
Physician apprehension about ordering genetic testing
Law encroaching on medicine
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Liability concerns
Need new/updated regulations
Genomic testing regulations
Defensive medicine
Law encroaching on medicine
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Liability shapes behaviors
Regulatory improvements are necessary
Physician apprehension about ordering genetic testing
Law encroaching on medicine
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Sources and Uses of Genomic Data Outside the Health Care Setting |
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Emerging Field |
Knowledge/understanding will increase over time
Defining the role of a genetic counselor
Bolstering the consent process
Balancing privacy and access to data vs. scientific advances
Professional society involvement is needed
Need for clear guidelines
Need for consistency between state, federal, and international law and guidelines
Enthusiastic endorsement of genomic testing
No genetic exceptionalism
Existence and usability of electronic health record
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Knowledge will increase over time
Integration of genetic counselor
Informed consent
Implications of privacy and access for research
Deidentification
Privacy concerns
Conflict among state, federal, and international regulations
Biospecimen use and storage
Government agency involvement and capacity
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Knowledge/understanding will increase over time
Defining the role of a genetic counselor
Bolstering the consent process
Balancing privacy and access to data vs. scientific advances
Professional society
Professional society involvement is needed
Need for clear guidelines
Need for consistency between state, federal, and international law and guidelines
Enthusiastic endorsement of genomic testing
No genetic exceptionalism
Existence and usability of electronic health record
Biospecimen use and storage
Government agency involvement and capacity
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Genomic Data |
Data sharing
Return of results and incidental findings
Responsibility/need to recontact
Quality of genetic analysis & quality assessment in laboratories
Reinterpretation of data
Ownership of genomic data
Transparency of genomic data and quality control
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Data sharing
Return of results and incidental findings
Responsibility/need to recontact
Quality of genetic analysis & quality assessment in laboratories
Reinterpretation of data
Ownership of genomic data
Transparency of genomic data and quality control
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Educational Needs |
Educating the public
Need for specialty (genetic/genomic) education for professionals
Uncertainty causes anxiety
Evolving practice and standard of care
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Educating the public
Need for specialty (genetic/genomic) education for professionals
Uncertainty causes anxiety
Evolving practice and standard of care
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