Final Exam Study Guide
• Ethical decision making
o refers to the process of making informed choices about ethical
dilemmas based on a set of standards differentiating right from wrong.
This type of decision making reflects an understanding of the principles
and standards of ethical decision making, as well as the philosophic
approaches to ethical decision making, and it requires a systematic
framework for addressing the complex and often controversial moral
questions.
• Examine the ethical dilemma (conflicting values exist).
• Thoroughly comprehend the possible alternatives available.
• Hypothesize ethical arguments.
• Investigate, compare, and evaluate the arguments for each
alternative.
• Choose the alternative you would recommend.
• Act on your chosen alternative.
• Look at the ethical dilemma and examine the outcomes while
reflecting on the ethical decision
• Bioethical standards
o six contemporary bioethical standards:
▪ (1) autonomy, refers to the individual’s freedom from controlling
interferences by others and from personal limitations that
prevent meaningful choices, such as adequate understanding.
Two conditions are essential for autonomy: liberty, meaning the
independence from controlling influences, and the individual’s
capacity for intentional action.
▪ (2) freedom,
▪ (3) veracity, The right to truth
▪ (4) privacy,
▪ (5) beneficence, refers to actions performed that contribute to
the welfare of others. Two principles underlie beneficence:
Positive beneficence requires the provision of benefits, and
utility requires that benefits and drawbacks be balanced. One
must avoid negative beneficence, which occurs when constraints
are placed on activities that, even though they might not be
unjust, could in some situations cause detriment or harm to
others.
▪ (6) fidelity, The extent to which a simulation mimics the
processes of a real environment; in the context of ethics, the
right to what has been promised.
• Telehealth
o Telecommunication technologies used to deliver health-related services
or to connect patients and healthcare providers to maximize patients’
health status. A relatively new term in the medical/nursing vocabulary,
referring to a wide range of health services that are delivered by
telecommunications-ready tools such as the telephone, videophone,
and computer.
• Medical Applications
, • An app is defined as a medical device and may be subject to regulation by the FDA if
“the intended use of a mobile app is for the diagnosis of a disease or other conditions, or
the cure, mitigation, treatment, or prevention of disease, or if it is intended to affect the
structure or function of the body of man”
o Provides a list of examples of apps that are not currently viewed as medical
devices, such as apps that help users organize personal medical data, track fitness,
or self-manage a disease.
• however, the mobile app is an accessory to a regulated medical device, then it is also
considered a medical device and is subject to FDA oversight.
•
• Medical Devices
o medical device and may be subject to regulation by the FDA if “the
intended use of a mobile app is for the diagnosis of a disease or other
conditions, or the cure, mitigation, treatment, or prevention of disease,
or if it is intended to affect the structure or function of the body of
man”
• FDA Oversight for Medical Devices
o
• Privacy
o An important issue related to personal information, about the owner or
about other individuals, that focuses on sharing this information with
others electronically and the mechanisms that restrict access to this
personal information.
• Confidentiality
o The mandate that all personal information be safeguarded by ensuring
that access is limited to only those who are authorized to view that
information.
• Cybersecurity
o the state of being protected against the criminal or unauthorized use of
electronic data, or the measures taken to achieve this.
o The FDA oversees the safety of medical devices, which includes addressing the
management of cybersecurity risks and hospital network security.
• Computer-aided translators
o Human translation is the only validated method for translation in a medical
setting.
o from case study- google translate has 57.7% accuracy compared to human
translator for medical phrase translations for English
• HIPPA
o Health Insurance Portability and Accountability Act -passed 1996
o establishes national standards for the protection of certain health information
o providers and organizations participating in the government HIT related payment
program are required to attest that they meet certain privacy and security measures.
o The HIPAA Privacy Rule establishes national standards to protect individuals’ medical
records and other personal health information and applies to health plans, health care
clearinghouses, and those health care providers that conduct certain health care
transactions electronically. The Rule requires appropriate safeguards to protect the
privacy of personal health information, and sets limits and conditions on the uses and
• Ethical decision making
o refers to the process of making informed choices about ethical
dilemmas based on a set of standards differentiating right from wrong.
This type of decision making reflects an understanding of the principles
and standards of ethical decision making, as well as the philosophic
approaches to ethical decision making, and it requires a systematic
framework for addressing the complex and often controversial moral
questions.
• Examine the ethical dilemma (conflicting values exist).
• Thoroughly comprehend the possible alternatives available.
• Hypothesize ethical arguments.
• Investigate, compare, and evaluate the arguments for each
alternative.
• Choose the alternative you would recommend.
• Act on your chosen alternative.
• Look at the ethical dilemma and examine the outcomes while
reflecting on the ethical decision
• Bioethical standards
o six contemporary bioethical standards:
▪ (1) autonomy, refers to the individual’s freedom from controlling
interferences by others and from personal limitations that
prevent meaningful choices, such as adequate understanding.
Two conditions are essential for autonomy: liberty, meaning the
independence from controlling influences, and the individual’s
capacity for intentional action.
▪ (2) freedom,
▪ (3) veracity, The right to truth
▪ (4) privacy,
▪ (5) beneficence, refers to actions performed that contribute to
the welfare of others. Two principles underlie beneficence:
Positive beneficence requires the provision of benefits, and
utility requires that benefits and drawbacks be balanced. One
must avoid negative beneficence, which occurs when constraints
are placed on activities that, even though they might not be
unjust, could in some situations cause detriment or harm to
others.
▪ (6) fidelity, The extent to which a simulation mimics the
processes of a real environment; in the context of ethics, the
right to what has been promised.
• Telehealth
o Telecommunication technologies used to deliver health-related services
or to connect patients and healthcare providers to maximize patients’
health status. A relatively new term in the medical/nursing vocabulary,
referring to a wide range of health services that are delivered by
telecommunications-ready tools such as the telephone, videophone,
and computer.
• Medical Applications
, • An app is defined as a medical device and may be subject to regulation by the FDA if
“the intended use of a mobile app is for the diagnosis of a disease or other conditions, or
the cure, mitigation, treatment, or prevention of disease, or if it is intended to affect the
structure or function of the body of man”
o Provides a list of examples of apps that are not currently viewed as medical
devices, such as apps that help users organize personal medical data, track fitness,
or self-manage a disease.
• however, the mobile app is an accessory to a regulated medical device, then it is also
considered a medical device and is subject to FDA oversight.
•
• Medical Devices
o medical device and may be subject to regulation by the FDA if “the
intended use of a mobile app is for the diagnosis of a disease or other
conditions, or the cure, mitigation, treatment, or prevention of disease,
or if it is intended to affect the structure or function of the body of
man”
• FDA Oversight for Medical Devices
o
• Privacy
o An important issue related to personal information, about the owner or
about other individuals, that focuses on sharing this information with
others electronically and the mechanisms that restrict access to this
personal information.
• Confidentiality
o The mandate that all personal information be safeguarded by ensuring
that access is limited to only those who are authorized to view that
information.
• Cybersecurity
o the state of being protected against the criminal or unauthorized use of
electronic data, or the measures taken to achieve this.
o The FDA oversees the safety of medical devices, which includes addressing the
management of cybersecurity risks and hospital network security.
• Computer-aided translators
o Human translation is the only validated method for translation in a medical
setting.
o from case study- google translate has 57.7% accuracy compared to human
translator for medical phrase translations for English
• HIPPA
o Health Insurance Portability and Accountability Act -passed 1996
o establishes national standards for the protection of certain health information
o providers and organizations participating in the government HIT related payment
program are required to attest that they meet certain privacy and security measures.
o The HIPAA Privacy Rule establishes national standards to protect individuals’ medical
records and other personal health information and applies to health plans, health care
clearinghouses, and those health care providers that conduct certain health care
transactions electronically. The Rule requires appropriate safeguards to protect the
privacy of personal health information, and sets limits and conditions on the uses and
