NR 599 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.
FDA Oversight for Medical Devices
The Food and Drug Administration (FDA) (2013) recognizes the extensive
variety of actual and potential functions of mobile apps, the rapid pace of
innovation in mobile apps, and the potential benefits and risks to public
health represented by these apps. The FDA intends to apply its regulatory
authorities to select software applications intended for use on mobile
platforms. Given the rapid expansion and broad applicability of mobile apps,
the FDA is issuing this guidance document to clarify the subset of mobile
apps to which the FDA intends to apply its authority.
Many mobile apps are not medical devices, meaning such mobile apps do
not meet the definition of a device by the Federal Food, Drug, and Cosmetic
Act (FD&C Act); therefore, the FDA does not regulate them.
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.
FDA Oversight for Medical Devices
The Food and Drug Administration (FDA) (2013) recognizes the extensive
variety of actual and potential functions of mobile apps, the rapid pace of
innovation in mobile apps, and the potential benefits and risks to public
health represented by these apps. The FDA intends to apply its regulatory
authorities to select software applications intended for use on mobile
platforms. Given the rapid expansion and broad applicability of mobile apps,
the FDA is issuing this guidance document to clarify the subset of mobile
apps to which the FDA intends to apply its authority.
Many mobile apps are not medical devices, meaning such mobile apps do
not meet the definition of a device by the Federal Food, Drug, and Cosmetic
Act (FD&C Act); therefore, the FDA does not regulate them.
