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Chamberlain College of Nursing: NR 599 Final Exam study Guide (Version-2, Latest-2022)/ NR599 Week 8 Final Exam study Guide (Latest-2022): Nursing Informatics for Advanced Practice | Complete and Latest Guide | R286,71   Add to cart

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Chamberlain College of Nursing: NR 599 Final Exam study Guide (Version-2, Latest-2022)/ NR599 Week 8 Final Exam study Guide (Latest-2022): Nursing Informatics for Advanced Practice | Complete and Latest Guide |

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Chamberlain College of Nursing: NR 599 Final Exam study Guide (Version-2, Latest-2022)/ NR599 Week 8 Final Exam study Guide (Latest-2022): Nursing Informatics for Advanced Practice | Complete and Latest Guide |

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  • February 14, 2022
  • 79
  • 2021/2022
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By: kiddylane18 • 1 year ago

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,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.

, Privacy


According to Healthit.gov (2014) Protecting Your Health Information, the privacy and security

of patient health information is a top priority for patients and their families, health care providers

and professionals, and the government. This was also previously discussed under HIPAA. It also

requires that "key persons and organizations that handle health information to have policies and

security safeguards in place to protect your health information whether it is stored on paper or

electronically."


Confidentiality


Hard to maintain due to social media and use of mobile devices such as smartphones, they are

being utilized in treatment rooms around the globe, Providers need to be aware of institutional

policies regarding audio/video recordings by patient and families, requires two-party consent,

sometimes enthusiasm for patient care and learning can lead to ethics violations.


Cybersecurity


Another federal regulatory agency with a role in the privacy and security of health care data is

the Food and Drug Administration (FDA). The FDA oversees the safety of medical devices,

which includes addressing the management of cybersecurity risks and hospital network security.

Recent guidelines issued (FDA, 2013) recommend that medical device manufacturers and health

care facilities take steps to ensure that appropriate safeguards are in place to reduce the risk of

failure caused by cyberattack. This could be initiated by the introduction of malware into the

medical equipment or unauthorized access to configuration settings in medical devices and

hospital networks. The consequences of not adequately addressing these risks could be dire. As

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