Introduction to Biomedical Informatics Introduction to Biomedical Informatics

Topic: Ethics and Standards

Funded by NIH Grant XYZ Funded by NIH Grant XYZ

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Outline • Key issues in BMI ethics • Training and Standards • Discussion Recommended Reading • Recommended Reading

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Motivating Example:  Therac‐25 • Many problems with the machine functioning: the machine functioning: – institutional – engineering

• Result: many accidents and injuries to patients

see more at  http://computingcases org/case materials/therac/anal http://computingcases.org/case_materials/therac/anal ysis/SocioTechnical_Analysis.html

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Key Ethical Issues in BMI Key Ethical Issues in BMI • Health‐Informatics Applications: Appropriate Use, Users, and  Contexts o1

• Privacy, Confidentiality, and Data Sharing  • Social Challenges and Ethical Obligations • Legal and Regulatory Matters

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Appropriate Use Appropriate Use • A computer program should be used in clinical practice only after – appropriate appropriate evaluation of its efficacy evaluation of its efficacy – documentation that it performs its intended tasks at an acceptable  cost 

• Clinical software systems should be used – by health professionals qualified to address any issues that come up • qualification determined by licensure, clinical training, and experience

– to augment or supplement (not to replace or supplant) these  individuals in making decisions – only after adequate training and instruction • review of all available forms of previous product evaluations review of all available forms of previous product evaluations • understanding of how to troubleshoot technology • ability to recognize errors and read multiple outputs

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Obligations and Standards for System Developers  and Maintainers d i i • Users of clinical programs must rely on the work of other people  who are often far removed from the context of use, i.e. people who  h f f df h f i l h develop, maintain, and sell health care computing systems and  components  • Patient care as the leading value • Developer‐user relationship  Develop quality standards to stimulate scientific progress and  quality standards to stimulate scientific progress and • Develop innovation while safe‐ guarding against system errors and abuse.

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System Evaluation is an Ethical Imperative in HIT  ( (arguably in any computing endeavor) bl i i d ) 1. Does the system work as designed? 2 Is it used as anticipated? 2. Is it used as anticipated? 3. Does it produce the desired results? 4. Does it work better than the procedures it replaced? 5 Is it cost effective? 5. Is it cost effective? 6. How well have individuals been trained to use it? 7. What are the anticipated long‐term effects on how departments  interact? 8. What are the long‐term effects on the delivery of medical care? 9. Will the system have an impact on control in the organization? 10. To what extent do effects depend on practice setting? 

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Privacy, Confidentiality, and Data Sharing Privacy, Confidentiality, and Data Sharing  Two major goals for health information systems: (1) free access to information, and (2) protection of patients’ privacy and confidentiality

Discussion:  Are these two necessarily in conflict? Why or  h l fl ? h why not?

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Privacy, Confidentiality, and Data Sharing Privacy, Confidentiality, and Data Sharing  • What is the difference between privacy and confidentiality? • Why do we need to protect privacy and confidentiality?

• How do considerations for public health impact considerations for  individual privacy and confidentiality considerations?

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Privacy and Confidentiality for EMR and  Clinical Research Databases li i l h b • What What are some potential threats? How do these differ when  are some potential threats? How do these differ when considering digital systems instead of paper?

• How can access to these records be protected?

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What are the implications of electronic data and  systems on managed care? d ? • Example One: Prognostic scoring systems • Example Two: Decision support system by insurance companies  • Some challenges in clinical systems Some challenges in clinical systems – Human cognition vs. machine intelligence – Value laden decisions – Aggregate vs. individual patients A t i di id l ti t

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Impact of Informatics on Traditional  Relationships l i hi

• Professional–Patient Relationships

• Consumer Health Informatics (Patient‐other people relationships)

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Legal and Regulatory Matters • Liability Under Tort Law

• Privacy and Confidentiality 

• Copyright, Patents, and Intellectual  Property

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Case discussion: PatientsLikeMe Case discussion: PatientsLikeMe  Break into groups of 3 or 4 people Break into groups of 3 or 4 people

Discuss: Discuss:  – What are the ethical issues at stake here? – How might you address them if you were PatientsLikeMe? What if you  p yg p y p y were a patient advocacy group? What if you were an ALS physician? – Prepare to report back

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Outline • Key issues in BMI ethics • Training and Standards • Discussion Recommended Reading • Recommended Reading

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Training and Standards Training and Standards

Why are training and standards in informatics ethical issues?

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Standard of Care Standard of Care • idea of keeping to procedures that have been shown (or are generally  believed) to be better than other options believed) to be better than other options • How are these determined? • How does the preference in medicine for randomized clinical  controlled trials interface with software design and informatics  evaluation techniques?

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Standards in  BMI • What is a standard? • Why do they matter?

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Standards Development Methods Standards Development Methods • Ad hoc

• De facto

• Government‐mandated Government mandated

• Consensus C

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Standards Development Stages Standards Development Stages • Identification • Conceptualization C t li ti • Discussion  – Writing of a draft standard – Reviewing and refining of the standard

• Early implementation • Conformance  • Certification see 7 3 2 in the blue book for details of some specific standards agencies see 7.3.2 in the blue book for details of some specific standards agencies

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Codes • Medical data coding is all about controlling the terminology and  standardizing the data standardizing the data • Abstraction vs. Representation

• see 7.4.2 in the blue book for some specific examples of  terminologies

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Data‐Interchange Data Interchange Standards Standards • Computing applications need to be able to exchange data uniformly  (e g HTTP and HTML) – WHY? (e.g., HTTP and HTML) – • In the 1980s, people began to recognize this need in healthcare – AAMSI task force – later two bodies: HL7 and IEEE Medical Data Interchange Standard – then… many more smaller bodies for niche interests

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The 7 levels of communication exchange The 7 levels of communication exchange

image courtesy of catalyst.washington.edu

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Recommended Reading Recommended Reading ETHICS • • • • •

Chapter 10 in blue book Ch t 10 i bl b k National Research Council (1997). For the Record: Protecting Electronic Health Information HIPPA James G. Anderson ‐ The role of ethics in information technology decisions: a case‐based  approach to biomedical informatics education IJMI 73(2): 145‐150. approach to biomedical informatics education. IJMI 73(2): 145‐150 Amitai Etzioni – The limits of privacy

STANDARDS • Chapter 7 in blue book • Chute, C.G. (2000) Clinical classification and terminology: some history and current  Chute C G (2000) Clinical classification and terminology: some history and current observations JAMIA, 7(3):298‐303 • Institute of Medicine report from 2003 on Patient Safety: Achieving a New Standard of Care

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