Kevin Robertson, MBA
Topic 06Ethics, Privacy and Confidentiality
ACS-2816 Health Information Systems
Winter 2020
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
Reading: Biomedical Informatics, Chapter 10 (p329-353)
Two Questions
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Why is ethics important to Health Informatics?
What are some of the ethical issues in Health Informatics?
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
Ethical Issues in Health Informatics
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Fact: The good physician will never be a diagnostic robot!
Human values govern research and practice
Health Informatics encompasses issues of appropriate / inappropriate behavior
Health Informatics less familiar in ethical matters
Ethical Issues in Health Informatics: Areas
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Confidentiality & privacy of patient information
Appropriate selection & use of HI tools
Who are the users of HI tools
HI systems evaluation & selection
Ethical Issues in Health Informatics: Areas (… continue)
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Obligations of system developers, maintainers & vendors
Tracking of clinical outcomes for evidence
Regulatory and legal aspects
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
HI Apps: Appropriate Use, Users, and Contexts
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Leverage previous know-how to evaluate HI Apps in medical practice
To answer the clinical question ‘What should be done in this case?’ What is the problem? What am I competent to do? What will produce the most desirable results? What will maintain or improve patient care?
Apply same reasoning to HI applications!
Appropriate Use, Users, and Contexts –Standard View of Appropriate Use
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Health Informatics tools being developed and commercialized continuously
Standard view states that when tools are available, they should be viewed and used as supplementary and subservient to human clinical judgement
Appropriate Use, Users, and Contexts –Standard View of Appropriate Use
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How and when should computers be used in clinical practice?
Software should be evaluated to obtain evidence for actions that produce good outcomes
Caregivers have the obligation to be familiar with the evidence and acceptable levels of familiarity with the software they use
Appropriate Use, Users, and Contexts –Appropriate Users and Education
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Effective and efficient use of HIS needTraining
ExperienceEducation
Who should use the HIS applications? At what level?Clinicians, nurses, administrators,
students, paramedics, assistants, etc.
Appropriate Use, Users, and Contexts –Appropriate Users and Education
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Who is accountable for negligence and product liability?
E.g. Caregiver must be able to recognize outputs (e.g. good, err, meaning) from the diagnostic decision-support systems
What about products sold directly to patients?
Appropriate Use, Users, and Contexts –Appropriate Users and Education
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Ethical Principles for Appropriate Use Use HIS application only after proper
evidence of achieving stated goalsUsers should be caregivers who understand
the intended use. Technology augments / supplements caregiver’s wisdom
Before any HI tool is used, proper training must be provided and evidence of previous results reviewed
Appropriate Use, Users, and Contexts –Obligations and Standards for IT People
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Caregivers rely on work done by others removed from context of use
Evidence of outcomes must be in placeRandomized controlled trialsVerified by independent bodies
IT people obligations are similar to those of users, i.e. holding patient care as the leading value
Appropriate Use, Users, and Contexts –Obligations and Standards for IT People
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Quality standards should be in place and enforced, facilitating scientific progress
Users and society have responsibilities to ensure tools are used appropriately
HI best practices should include measures to test whether the tool performs as intended Design and implement software that cannot easily
be hacked
Appropriate Use, Users, and Contexts –Obligations and Standards for IT People
17 Criteria source: Shortliffe et al, ‘Biomedical Informatics’, 4th Edition, p335
Criteria for HIS evaluation (Anderson et al 1994)
Goal: What works best to improve health care delivery
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
Privacy, Confidentiality and Data Sharing -Foundations of Privacy & Confidentiality
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Health care challenge
Free access to information
Protection of patients’ privacy and confidentiality
Privacy vs confidentiality
Both are regarded as rights of all people
Vital for the caregiver-patient trust
Privacy, Confidentiality and Data Sharing -Foundations of Privacy & Confidentiality
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Public health needs both privacy and confidentiality protection
Risks of discrimination, bias and stigma including financial harm if both privacy and confidentiality is broken
Protection of privacy and confidentiality is not an option, but a duty irrespective how data is stored
What to do with high-risk patients?
Privacy, Confidentiality and Data Sharing – Electronic Clinical & Research Data
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Health data readily and timely access to caregivers vs easy access to other people
ThreatsEconomic abusesDiscriminationRecord snoopingBlackmail Information alteration Information dissemination
Privacy, Confidentiality and Data Sharing – Electronic Clinical & Research Data
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How to ensure appropriate access?
Technological methodsUser authentication,
Audit trials, etc
Policy methods Security and confidentiality committees,
Education and training programs, etc
Privacy, Confidentiality and Data Sharing – Electronic Clinical & Research Data
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Use of patient data for research and quality assessment implications
Large benefits for public health
Establish safeguards to research ethically
Anonymize data records
Medical record committees / review boards
Bioinformatics challenges and benefits
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
Social Challenges and Ethical Obligations – Informatics and Managed Care
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Evidence-based medicine & managed care require heavy use of HI tools
E.g. prognostic scoring systems that compare new critical patients with 1000’s previous
Great value for internal research
Benefits for quality management
Social Challenges and Ethical Obligations – Informatics and Managed Care
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Should care be provided when there is objective evidence that such care will not be efficacious?
What to do when a decision-support system challenges a medical decision?
Why to reimburse providers for doing procedures that are not indicated? as per tool
Social Challenges and Ethical Obligations – Informatics and Managed Care
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Problematic to use HI tools to guide policy or practice Human cognition still superior to machine’s
intelligence Decision for treatment that improve quality of
life but not extend life and vice versa, pursue treatment goal
Bias on data aggregation for decision support intelligence
A policy should not disallow individual clinical judgement and expertise
Social Challenges and Ethical Obligations – Informatics and Managed Care
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Health informatics can contribute in many ways to health care reform
Illuminate ways to reduce costs
Optimize clinical outcomes
Improve care delivery
Fundamental to quality care and public health
Social Challenges and Ethical Obligations – Effects on Traditional Relationships
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New challenges to traditional duties and the relationships that duties govern
Professional – Patient relationships Do they have better communication? Do patients trust caregivers better?
Consumer health informatics – makes vast amount of information available to patients
Peer review Online consultations Support groups
Personal Health Records
Topic 6 Outline
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Ethical Issues in Health Informatics
Appropriate Use, Users and Context
Privacy, Confidentiality and Data Sharing
Social Challenges and Ethical Obligations
Legal and Regulatory
Legal and Regulatory Matters - Law versus Ethics
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Their issues often overlap
Ethics focuses on what is good and correct in accordance with principlesWhat?
Law focuses on practical regulation of morality and activities but generally derived from ethical principlesHow?
Legal and Regulatory Matters - Legal Issues in Health Informatics
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Liability under tort law
Potential use of HI tools as expert witnesses in the courtroom
Legislation governing privacy and confidentiality
Copyrights, patents and intellectual property issues
Legal and Regulatory Matters - Legal Issues in HI: Tort Law
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Tort law govern situations in which harm or injuries result from the manufacture and sale of goods and services
Products vs services
Practice of medicine is a service
HI tools as products or services
Legal and Regulatory Matters - Legal Issues in HI: Tort Law
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Malpractice prosecutions
E.g. Patients who are harmed by clinical practice based on imperfect HI tools
E.g. Patients who are harmed by clinical practice that do not use decision-support tools when it is shown that the tools are part of the current standard of care
Legal and Regulatory Matters - Legal Issues in HI: Tort Law
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Key Point
As long as the quality of care has met the standards, the caregiver should not be found liable in a malpractice case
Legal and Regulatory Matters - Legal Issues in HI: Privacy and Confidentiality
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HIPAA – The Health Insurance Portability and Accountability Act
PHIA – The Personal Health Information Act Individuals should control disclosure of their health
data, e.g. Patients be informed about their confidentiality and
privacy rights Operations be limited to ‘minimum necessary’
amount of information All employees in ‘covered entities’ be educated
about privacy
Legal and Regulatory Matters - Legal Issues in HI: Copyright, Patents & IP
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Copyright – protects IP from being copied verbatim
Patents – protect specific methods of implementing or instantiating ideas
Information made accessible to the public that does not contain copyright annotations is considered to be in the public domainE.g. Web material
Two Questions (Recap)
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Why is ethics important to Health Informatics?
What are some of the ethical issues in Health Informatics?