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.
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.
