Ethics in Biomedical and Health

Informatics

Dr. Manal
Alothman
Dr. Sarah Allabun
 Ethical Issues in Biomedical
and Health Informatics

• Human values should govern research and practice in the health professions.
Health care informatics, like other health professions, encompasses issues of
appropriate and inappropriate behavior, of honorable and disreputable actions,
and of right and wrong.

• Students and practitioners of the health sciences, including informatics, share an

important obligation to explore the moral underpinnings and ethical challenges
related to their research and practice.
 Health Informatics
Applications
Application of computer-based technologies in the health professions can
build on previous experience in adopting other devices, tools, and methods

1. The Standard View of Appropriate Use: Ethical software use should be

evaluated against a broad background of evidence for actions that
produce favorable outcomes. As electronic laboratory information
systems improve access to clinical data when compared with manual,
paper-based test- result distribution methods.

2. Appropriate Users and Educational Standards: Efficient and effective

use of health care informatics systems requires prior system
“Veterans Health Information Systems
evaluations demonstrating utility, then education and training of new and Technology Architecture” (VistA),
the largest electronic health record
users, monitoring of experience, and appropriate, timely updating. system in the United States.
 Health-Informatics
Applications (cont’d)
3- Obligations and Standards for System Developers and Maintainers:

• Ethics, Standards, and Scientific Progress: Quality standards should stimulate scientific progress and
innovation while safeguarding against system error and abuse.

• System Evaluation as an Ethical Imperative: Evaluation of health information systems in their contexts of use
should be taken as a moral imperative. Such evaluations require consideration of a broader
conceptualization of “what works best” and must look toward improving the overall health care delivery
system rather than only that system’s technologically based components.
 Privacy, Confidentiality, and
Data Sharing
One challenge involves balancing two competing values: (1) free access to information, and (2) protection of patients’

privacy and confidentiality.

1. Foundations of Health Privacy and Confidentiality:

• Privacy and confidentiality are necessary for people to evolve and mature as individuals, to form relationships, and to

serve as functioning members of society.

2. Electronic Clinical and Research Data:

• Access to electronic patient records holds extraordinary promise for clinicians and for other people who need timely,

accurate patient data.

• Failure to use such systems may also dis- qualify institutions for reimbursements from public and private insurance,
 2- Electronic Clinical and
Research Data
a) Technological Methods: Computers can provide the means for maximizing their own security, including

authenticating system users with passwords, tokens or biometrics, to make sure that they are who they say they are;

using access controls to prohibit people without a professional need from accessing particular health information

within a system .

b) Policy Approaches: Create security and confidentiality committees and establish education and training programs, as

the Health Insurance Portability and Accountability Act (HIPAA).

c) Electronic Data and Human Subjects Research: The use of patient information for clinical research and for quality

assessment raises interesting ethical challenges.

d) Challenges in Bioinformatics: Safeguards are increasingly likely to be challenged as genetic information makes its way

into the health care record. How, to what extent, and by whom should genomic databases be used for clinical or

public health decision support?

 Social Challenges and Ethical
Obligations
Health informatics helps clinicians, administrators, third-party payers, governments, researchers, and other
parties to collect, store, retrieve, analyze, and scrutinize vast amounts of data.

1. Vendor Interactions: The transition from a paper patient record to an electronic one have—or should have—
begun. The need to make such a transition is not in dispute: paper (and handwriting) are hard to store, find,
read and analyze.

2. Informatics and Managed Care: Prognostic scoring systems that use physiologic and mortality data to
compare new critical-care patients with thousands of previous patients. Such systems allow hospitals to
track the performance of their critical-care units by comparing the previous year’s outcomes to this year’s or
by comparing one hospital to another.

3. Effects of Informatics on Traditional Relationships:

 3- Effects of Informatics on
Traditional Relationships

a) Professional–Patient Relationships: Computers, databases, and

networks can improve physician–patient or nurse–patient
relationships, perhaps by establish trust and improving
communication.

b) Consumer Health Informatics: This system focused on patients as

the primary users—makes vast amounts of information available to
patients

c) Personal Health Records: PHRs provide a storage base for data

once kept on paper (or in the patient’s head) and repeatedly
extracted with each institutional encounter for inclusion in that
entity’s records system, as, allergies, current medications,
Barcode scanner that recognizes medication labels.
vaccinations, surgeries and other treatments. allows elderly users to track prescriptions with
such scanners and portable touch-screen tablets.
 Legal and Regulatory
Matters
1. Difference Between Law and Ethics:

• Ethical considerations apply in attempts to determine what is good or meritorious and which behaviors are desirable or
correct in accordance with higher principles.

• Legal principles are generally derived from ethical ones but deal with the practical regulation of morality or behaviors and
activities

2. Regulation and Monitoring of Computer Applications in Health Care: Food and Drug Administration (FDA) control any
new methods and approaches to regulating clinical software systems as medical devices.

3. Software Certification and Accreditation: To make any system of regulation, review or certification ethically credible,
government and industry leaders must eventually make explicit that attention to ethics is a core component of their
efforts.

4. Legal Issues in Biomedical Informatics:

 4- Legal Issues in Biomedical
Informatics

a) Liability Under Tort Law: The principles of tort law govern situations in which harm or injuries

by intention from the manufacture and sale of goods and services, or by the negligence theory,

and strict product liability.

b) Privacy and Confidentiality: Health Insurance Portability and Accountability Act (HIPAA).

c) Copyright, Patents, and Intellectual Property: Intellectual property protection afforded to

developers of software programs, biomedical knowledge bases, and World Wide Web pages

remains an underdeveloped area of law. Copyright law protects intellectual property from being

copied verbatim, and patents protect specific methods of implementing or instantiating ideas.
 Summary

• Ethical issues are important in biomedical informatics, and especially so in the clinical arena.

• Computer software should not be allowed to overrule a human decision.

• Practitioners who use informatics tools should be clinically qualified and adequately trained in using the software
products.

• The tools themselves should be carefully evaluated and validated.

• Ethical obligations should extend to system developers, maintainers, and supervisors as well as to clinician users.

• Education programs and security measures should be considered essential for protecting confidentiality and privacy.

• Adequate oversight should be maintained to optimize ethical use of electronic patient information for scientific and
institutional research.
Dr. Manal Alothman
[email protected]

Dr. Sarah Allabun

[email protected]