Smartphones and tablets are a common accessory for nearly two billion people globally. These devices provide easy access to a plethora of applications and services that were traditionally reserved for face-to-face settings including shopping, education, banking, travel, and even healthcare services. It is no surprise that the healthcare industry has embraced the trend of providing easy access to healthcare services from mobile devices. The healthcare industry has often been highly enthusiastic about adopting new technologies that can help improve patient care. mHealth applications are increasingly popular with consumers, with some estimates predicting that the mHealth sub-industry will reach more than $26 billion in total revenue by 2017. However, this burgeoning market represents unique opportunities and challenges for software providers seeking to create applications for the healthcare industry.
mHealth applications cover a wide range of potential uses including health & fitness tracking, medication interactions, and mobile access to patient medical health records. These apps can be integrated with wearable technology, medical records, cloud databases, or other hardware to track and record data to better serve patients and providers.
To penetrate the current mobile healthcare application market, it is critical that software providers include the following core attributes:
Although most mHealth applications are unregulated, there are certain types of apps that will fall under the scrutiny of the Food and Drug Administration. For applications that do require regulation, the FDA uses a risk-based assessment to determine if an application is safe and effective for use with other medical devices. This assessment classifies each application as either Class I, Class II, or Class III based on the intended use, functionality, and the potential risk to public health of the application. Class I applications are not usually regulated by the FDA because they pose little to no risk to public health.
Examples of Class I applications include:
If an application meets any of the following criteria, it will be considered a Class II or Class III device that will need to be monitored, approved, and regulated by the FDA:
Regardless of the classification applied by the FDA, it is vital to keep in mind that the end consumers are highly selective and far more likely to scrutinize mHealth applications. Mobile medical applications that do not function flawlessly while providing accurate data to the consumer will not last long in the market. Even if you do not intend to develop a mHealth application that requires strict oversight by the FDA, it is important that you ensure the application would qualify for approval in terms of functionality, security, and accuracy because the end-user will tolerate no less than perfection when dealing with something as important as personal health.
Chetu does not affect the opinion of this article. Any mention of a specific software, company or individual does not constitute an endorsement from either party unless otherwise specified. This blog should not be construed as legal advice.
Founded in 2000, Chetu is a global provider of healthcare app development solutions and support services. Chetu's specialized technology and industry experts serve startups, SMBs, and Fortune 500 companies with an unparalleled software delivery model suited to the needs of the client. Chetu's one-stop-shop model spans the entire software technology spectrum. Headquartered in Plantation, Florida, Chetu has fourteen locations throughout the U.S. and abroad.