topic 06 ethics, privacy and confidentiality · phia –the personal health information act...

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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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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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.


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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?


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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


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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


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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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


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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


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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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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


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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


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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


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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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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


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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


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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?

topic 06 ethics, privacy and confidentiality · phia –the personal health information act...

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