NR 599 week 8 FINAL EXAM_Study Guide latest 2022

nr 599 study guide to help you in tackling your revision for your exams. wishing you all the best. 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 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. 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 medical devices are increasingly integrated within health care environments, there will be a need for vigilance toward cybersecurity practices to ensure all systems are adequately protected and patients remain safe from harm. Nurse Informaticists are frequently called on to evaluate safety and effectiveness of new devices and software. Considerations of cybersecurity must be included in any evaluation process.