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Your Health
App may be
Illegal
AN OVERVIEW OF ETHICS IN HEALTHCARE
FOR AI & BLOCKCHAIN
PART OF THE IEEE: HEALTHCARE
BLOCKCHAIN & AI VIRTUAL SERIES
SEAN MANION, PHD - CHIEF SCIENTIFIC
OFFICER AT CONSENSYS HEALTH
Ethics
AUTONOMY – SELF
DETERMINATION
BENEFICENCE (DO GOOD)
NON-MALEFICENCE (DO NO HARM)
JUSTICE – EQUAL TREATMENT
2
3
Wikipedia's complete (as of 2016) list of cognitive biases, arranged and designed by John Manoogian III (jm3). Categories and descriptions originally by Buster Benson
Bias - the action of supporting or opposing
a particular person or thing in an unfair
way
•Cognitive bias can be good, bad or neutral
•Cognitive bias can be exacerbated and
exploited
•Individuals each have their own combination
of biases
•Laws and regulations are often meant to
offset individual biases
•Laws and regulations are drafted and
overseen by biased individuals
•Systematic and/or systemic bias can result
4
Ethical issues for AI & Blockchain
AI (NARROW – E.G. MACHINE LEARNING)
Consent
Data Privacy
Bias/Fairness
Transparency
Safety & Effectiveness
Economic – Job Loss and Wealth Creation
BLOCKCHAIN
Job Loss and Wealth Creation
Bias/Fairness
Facilitate crime?
Overhyping?
OTOH: Can it bring more transparency and
fairness to AI?
5
6
AI ETHICS – Facial Recognition
Surveillance group exposes disturbing Huawei patent for
AI-powered Uighur detection
Thomas Macaulay, TNW Neural, 13 Jan 2021
A range of Chinese tech firms have filed patents for
systems that identify ethnic groups.
A Huawei patent that mentions AI-powered
identification of Uighur people and other ethnic groups
has been discovered.
The patent was exposed by video surveillance research
group IPVM, the same organization that had previously
spotted references to an AI “Uighur alarm” on Huawei‘s
website, as well as evidence that Alibaba had offered
“Uighur-detection-as-a-service.”
Study finds gender and skin-type bias in commercial
artificial-intelligence systems
Larry Hardesty, MIT News Office, 11 Feb 2018
Examination of facial-analysis software shows error rate
of 0.8 percent for light-skinned men, 34.7 percent for
dark-skinned women.
Ref: “Gender Shades: Intersectional Accuracy
Disparities in Commercial Gender Classification”
Joy Buolamwini, Timnit Gebru ; Proceedings of
the 1st Conference on Fairness, Accountability
and Transparency, PMLR 81:77-91, 2018.
7
https://map.ai-global.org/
8
Artificial Intelligence is part of the
Digital Health Ecosystem.
Use of AI in healthcare & medicine is
booming – here's how the medical field
is benefiting from AI in 2021 and
beyond
Alicia Phaneuf Business Insider, Jan 29,
2021
•AI has the ability to analyze big data
sets – pulling together patient insights
and leading to predictive analysis.
•Insider Intelligence projects AI in
healthcare will grow at an annualized
48% between 2017 and 2023.
9
Tuskegee Experiment
10
Nuremberg Code
• The judgment by the war crimes tribunal at Nuremberg laid down 10
standards to which physicians must conform when carrying out experiments
on human subjects in a new code that is now accepted worldwide.
• This judgment established a new standard of ethical medical behavior for
the post World War II human rights era. Amongst other requirements, this
document enunciates the requirement of voluntary informed consent of the
human subject. The principle of voluntary informed consent protects the
right of the individual to control his own body.
• This code also recognizes that the risk must be weighed against the expected
benefit, and that unnecessary pain and suffering must be avoided.
• This code recognizes that doctors should avoid actions that injure human
patients.
• The principles established by this code for medical practice now have been
extended into general codes of medical ethics.
11
Belmont
Report
12
Human Subjects Research
Definition of Human Subjects Research
According to 45 CFR 46 , a human subject is "a living individual about whom an
investigator (whether professional or student) conducting research:
•Obtains information or biospecimens through intervention or interaction with
the individual, and uses, studies, or analyzes the information or biospecimens; or
•Obtains, uses, studies, analyzes, or generates identifiable private information or
identifiable biospecimens."
13
Identifiable Health Information
Full name or last name and initial(s)
Geographical identifiers smaller than a state, except the initial
three digits of a zip code, provided the combination of all zip
codes starting with those three digits. When the initial three
digits of a zip code contains 20,000 or fewer people it is
changed to 000
Dates directly related to an individual, other than year
Phone Numbers
Fax numbers
Email addresses
Social Security numbers
Medical record numbers
Health insurance beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers
Device identifiers and serial numbers;
Web Uniform Resource Locators (URLs)
IP addresses
Biometric identifiers, including finger, retinal and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
except the unique code assigned by the investigator to code
the data
14
Is Machine Learning
Generalizable
Research?
HHS has defined "research" as a systematic
investigation, including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge.
15
Institutional
Review Board
(IRB)
• Review Scientific, Medical, and
Ethical aspects of research
• Made of experts along with at
least one member whose interest
is non-scientific and another not
affiliated with the university/trial
site
• Some research is exempted, but
this generally requires an IRB rep
to determine, not the investigator
16
AI-Institutional Review Board (AIRB)?
Should some medical AI be reviewed or
exempted by an IRB?
Should IRBs be utilized for expanded ethical
review for AI?
Should a parallel structure be developed?
◦ Future of Privacy Forum, “Designing an
Artificial Intelligence Research Review
Committee” (2019)
◦ AI Global, “Responsible AI Guidelines:
Independent Review” (2020)
17

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"Your Health App may be Illegal" IEEE 3 Feb 2021, Manion

  • 1. Your Health App may be Illegal AN OVERVIEW OF ETHICS IN HEALTHCARE FOR AI & BLOCKCHAIN PART OF THE IEEE: HEALTHCARE BLOCKCHAIN & AI VIRTUAL SERIES SEAN MANION, PHD - CHIEF SCIENTIFIC OFFICER AT CONSENSYS HEALTH
  • 2. Ethics AUTONOMY – SELF DETERMINATION BENEFICENCE (DO GOOD) NON-MALEFICENCE (DO NO HARM) JUSTICE – EQUAL TREATMENT 2
  • 3. 3 Wikipedia's complete (as of 2016) list of cognitive biases, arranged and designed by John Manoogian III (jm3). Categories and descriptions originally by Buster Benson
  • 4. Bias - the action of supporting or opposing a particular person or thing in an unfair way •Cognitive bias can be good, bad or neutral •Cognitive bias can be exacerbated and exploited •Individuals each have their own combination of biases •Laws and regulations are often meant to offset individual biases •Laws and regulations are drafted and overseen by biased individuals •Systematic and/or systemic bias can result 4
  • 5. Ethical issues for AI & Blockchain AI (NARROW – E.G. MACHINE LEARNING) Consent Data Privacy Bias/Fairness Transparency Safety & Effectiveness Economic – Job Loss and Wealth Creation BLOCKCHAIN Job Loss and Wealth Creation Bias/Fairness Facilitate crime? Overhyping? OTOH: Can it bring more transparency and fairness to AI? 5
  • 6. 6
  • 7. AI ETHICS – Facial Recognition Surveillance group exposes disturbing Huawei patent for AI-powered Uighur detection Thomas Macaulay, TNW Neural, 13 Jan 2021 A range of Chinese tech firms have filed patents for systems that identify ethnic groups. A Huawei patent that mentions AI-powered identification of Uighur people and other ethnic groups has been discovered. The patent was exposed by video surveillance research group IPVM, the same organization that had previously spotted references to an AI “Uighur alarm” on Huawei‘s website, as well as evidence that Alibaba had offered “Uighur-detection-as-a-service.” Study finds gender and skin-type bias in commercial artificial-intelligence systems Larry Hardesty, MIT News Office, 11 Feb 2018 Examination of facial-analysis software shows error rate of 0.8 percent for light-skinned men, 34.7 percent for dark-skinned women. Ref: “Gender Shades: Intersectional Accuracy Disparities in Commercial Gender Classification” Joy Buolamwini, Timnit Gebru ; Proceedings of the 1st Conference on Fairness, Accountability and Transparency, PMLR 81:77-91, 2018. 7
  • 9. Artificial Intelligence is part of the Digital Health Ecosystem. Use of AI in healthcare & medicine is booming – here's how the medical field is benefiting from AI in 2021 and beyond Alicia Phaneuf Business Insider, Jan 29, 2021 •AI has the ability to analyze big data sets – pulling together patient insights and leading to predictive analysis. •Insider Intelligence projects AI in healthcare will grow at an annualized 48% between 2017 and 2023. 9
  • 11. Nuremberg Code • The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects in a new code that is now accepted worldwide. • This judgment established a new standard of ethical medical behavior for the post World War II human rights era. Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body. • This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided. • This code recognizes that doctors should avoid actions that injure human patients. • The principles established by this code for medical practice now have been extended into general codes of medical ethics. 11
  • 13. Human Subjects Research Definition of Human Subjects Research According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: •Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or •Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." 13
  • 14. Identifiable Health Information Full name or last name and initial(s) Geographical identifiers smaller than a state, except the initial three digits of a zip code, provided the combination of all zip codes starting with those three digits. When the initial three digits of a zip code contains 20,000 or fewer people it is changed to 000 Dates directly related to an individual, other than year Phone Numbers Fax numbers Email addresses Social Security numbers Medical record numbers Health insurance beneficiary numbers Account numbers Certificate/license numbers Vehicle identifiers Device identifiers and serial numbers; Web Uniform Resource Locators (URLs) IP addresses Biometric identifiers, including finger, retinal and voice prints Full face photographic images and any comparable images Any other unique identifying number, characteristic, or code except the unique code assigned by the investigator to code the data 14
  • 15. Is Machine Learning Generalizable Research? HHS has defined "research" as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 15
  • 16. Institutional Review Board (IRB) • Review Scientific, Medical, and Ethical aspects of research • Made of experts along with at least one member whose interest is non-scientific and another not affiliated with the university/trial site • Some research is exempted, but this generally requires an IRB rep to determine, not the investigator 16
  • 17. AI-Institutional Review Board (AIRB)? Should some medical AI be reviewed or exempted by an IRB? Should IRBs be utilized for expanded ethical review for AI? Should a parallel structure be developed? ◦ Future of Privacy Forum, “Designing an Artificial Intelligence Research Review Committee” (2019) ◦ AI Global, “Responsible AI Guidelines: Independent Review” (2020) 17