NR599 Week 8 Final Exam study Guide
Ethical decision making
This refers to the process of making informed choices about ethical dilemmas based on a set of
standards differentiating right from wrong.
Bioethical standards
1) autonomy-the right to choose for himself or herself
2) freedom-
3) veracity-right to truth
4) privacy-the right of privacy avoids conflict and promotes harmony
5) beneficence-actions performed that contribute to the welfare of
others
6) fidelity-right to what has been promised
Telehealth- 3 broad methods of digital care delivery that are "away" from the patient-
means "healing at a distance"
1) telemedicine (stationary scheduled remote diagnostics of health status)
2) remote management/monitory/coaching (stationary home or facility-based, with scheduled
and as-needed remote transmission of health status
3) Mobile health (mHealth) "community" groups/social media (wearable mobile patient-
generated health data with scheduled and asneeded remote transmission of health status
Clinical uses
a) transmitting clinical date for assessment, diagnoses, or disease
b) promoting disease prevention and good health
c) using telephone and videographic technologies to provide health advice in emergent cases
, d) using real time video i.e: exchanging health services or video conferencing
Medical Applications
Apps Providing Access to Electronic Copies
Apps for General Patient Education
Generic Aids or General Purpose Apps
Apps as Educational Tools
Apps Automating Office Operations
Medical Devices
Some mobile apps may meet the definition of a medical device but because they pose a lower
risk to the public, the FDA intends to exercise enforcement discretion over these devices
(meaning it will not enforce requirements under the FD&C Act). One example is a mobile app
that makes a light emitting diode (LED) operate. If the manufacturer intends the system to
illuminate objects generally (i.e., without a specific medical device intended use), the mobile app
would not be considered a medical device. If, however, through marketing, labeling, and the
circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for
use as a light source for providers to examine patients, then the intended use of the light source
would be similar to a conventional device such as an ophthalmoscope.
Ethical decision making
This refers to the process of making informed choices about ethical dilemmas based on a set of
standards differentiating right from wrong.
Bioethical standards
1) autonomy-the right to choose for himself or herself
2) freedom-
3) veracity-right to truth
4) privacy-the right of privacy avoids conflict and promotes harmony
5) beneficence-actions performed that contribute to the welfare of
others
6) fidelity-right to what has been promised
Telehealth- 3 broad methods of digital care delivery that are "away" from the patient-
means "healing at a distance"
1) telemedicine (stationary scheduled remote diagnostics of health status)
2) remote management/monitory/coaching (stationary home or facility-based, with scheduled
and as-needed remote transmission of health status
3) Mobile health (mHealth) "community" groups/social media (wearable mobile patient-
generated health data with scheduled and asneeded remote transmission of health status
Clinical uses
a) transmitting clinical date for assessment, diagnoses, or disease
b) promoting disease prevention and good health
c) using telephone and videographic technologies to provide health advice in emergent cases
, d) using real time video i.e: exchanging health services or video conferencing
Medical Applications
Apps Providing Access to Electronic Copies
Apps for General Patient Education
Generic Aids or General Purpose Apps
Apps as Educational Tools
Apps Automating Office Operations
Medical Devices
Some mobile apps may meet the definition of a medical device but because they pose a lower
risk to the public, the FDA intends to exercise enforcement discretion over these devices
(meaning it will not enforce requirements under the FD&C Act). One example is a mobile app
that makes a light emitting diode (LED) operate. If the manufacturer intends the system to
illuminate objects generally (i.e., without a specific medical device intended use), the mobile app
would not be considered a medical device. If, however, through marketing, labeling, and the
circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for
use as a light source for providers to examine patients, then the intended use of the light source
would be similar to a conventional device such as an ophthalmoscope.
