NR 599 Final Exam - Questions and with Detailed Answers Regression Modeling a data mining technique - Modeling data for prediction or explaining some phen... [Show More] omenon with the least amount of error as possible - often used for predictive analytics such as predicting factors that are associated with mortality or 30-day readmission. Summarization a data mining technique - business intelligence (BI) tools that aggregate cubic views of data or report certain outcomes. - tools allow an end user to drag and drop and quickly identify patterns and trends in the data based on the summarization of tables. Mobile health (mHealth) - the use of wireless communication to support efficiency in public health and clinical practice. - generation, aggregation, and dissemination of health information via mobile or wireless device. - examples of areas of growth are: 1. prevention medicine and health promotion can be leveraged through education and awareness applications. 2. portable diagnostic devices that allow monitoring of human conditions in clinical settings or offsite locations. 3. applications for data management, training medical personnel and mobile payments. Mobile applications to facilitate mHealth; -can be executed on either a mobile platform( i.e. a handheld commercial off the shelf computing platform, with or without wireless connection) or on a web-based software application that is tailored to a mobile platform but is executed on a server Mobile medical applications - incorporates device software functionality that meets the definition of devices intended to be used as an accessory to a regulated medical device or are software that transforms a mobile platform into a regulated medical device. - these mobile devices may include mobile phones, smartphones, tablet computers, smartwatches and point of care testing (POC). Medical Applications 1. Apps providing access to electronic copies. 2. Apps for general patient education. 3. Generic aids or general purpose apps. 4. Apps as educational tools. 5. Apps automating office operations. Medical device "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component, part or accessory that is intended for use in performing a function for diagnosis of disease or other conditions or the cure, mitigation, treatment of prevention of disease" FDA regulated devices An intended use of a mobile app determines whether it meets the definition of a "device" - "intended" use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of the mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or any function of the body of man, the mobile app is a device under section 201h of the FD&C act ; - if a software function is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it runs. ex: mobile apps intended to run on smartphones to analyze and interpret EKG waveforms to detect heart function irregularities would be considered similar to software running on a desktop computer that serves the same function, which is regulated by the FDA. -FDA applies oversight and regulation only to those software applications whose functionality could pose a risk to a patient's safety if the software application were to no function as intended. Examples of regulated medical devices glucose test system, calculator processing module for clinical use, monitoring spirometer, esophageal stethoscope with electrical conductors, apnea monitor, blood pressure computer, etc. Apps providing access to electronic copies mobile apps that are intended to provide access to electronic "copies" (e.g. e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities. NOT considered medical devices because they are intended to be used as reference materials and not for diagnosis, tx, mitigation, cure, prevention of disease or to replace clinical judgment. Examples of apps providing access to electronic copies. ex: Medical dictionaries, medical textbooks and literature articles such as the physician's desk reference or diagnostic and statistical Manual of Mental Disorders; library of clinical descriptions for disease and conditions, encyclopedia for first-aid and emergency care information; medical abbreviations and definitions; translations of medical terms across multiple languages. [Show Less]
