Smartphones Case Study

Smartphones have revolutionised the communication landscape. Carried by their users everywhere they go, smartphones provide communication, while their rich multimedia touch-displays operate with increasing speeds, delivering data services and computing power to document and improve the networked lives of their owners. With time going by, wireless data service: App, short for ‘application (program), are usually optimised to run on a mobile device.
What are Mobile Apps?
A mobile application or “mobile app” is defined as a software application that can be executed on a mobile platform (i.e., a handheld commercial off-the shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a

Help patients document, show, or communicate potential medical conditions to healthcare providers
5. Automate simple tasks for healthcare providers
6. Enable patients or providers to interact with personal health records or electronic health record systems
What Are the Current Regulatory Requirements for These Products?
First, the following are how medical devices are regulated. In the US, medical devices are classified according to risk under three device classes.
• Class I: Generally low risk (think dental floss) and subject to minimal regulatory oversight. This class is available for most devices
• Class II: Moderate-risk devices subject to both general controls and "special controls" which are meant to recognize the special risks associated with a device. Some Class II devices are exempt from premarket requirements, but many are subject to premarket notification (510(k)) which requires FDA to review a device.
• Class III: The riskiest devices, these devices almost always must be approved by FDA before they are allowed on the market, and typically rely on evidence obtained through clinical testing (i.e. on humans) to prove that they are safe and effective. For this class, the device needs PMA to be legal into the