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 (mobile health) 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:

• Applications must be user friendly, with a simple and navigable Graphical User Interface (GUI)
• Infallible privacy settings, particularly with applications that communicate data between user and provider, that also adhere to the strict guidelines for HL7, HIE, and HIPAA messaging standards
• Seamless integration with wearable technology and other wearable medical hardware that allows the application to interpret data then display the information in an easy to understand format
• A monetization and Point-of-Sale (POS) strategy that allows for either paid downloads, in-app purchases, premium usage options, or a combination of the three strategies
• Cross platform functionality that allows users to access the same application from multiple devices
• mHealth apps need to be properly tested to ensure the application is fully functional and poses no risk of malfunction

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:

• Help users self-manage a condition without implying specific treatment regimens – These are apps that allow its users to track weight, exercise routines, diabetes readings, and sleep patterns, plus give users general helpful health tips
• Provide simple tools to organize and track health information – These allow users to record underlying symptoms so they may be able to report accurately to healthcare providers
• Help patients document and show potential medical problems to healthcare providers – apps that take advantage of a device’s camera and video capabilities to document, plus enhance communications between doctors and patients
• Automate simple tasks for providers for functions that include general calculations and showing certain rate scales
• Enable patients to access Personal Health Records (PHR) and Electronic Health Records (EHR), plus other electronic access to records

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:

• Any application that controls specific medical device hardware, such as those that pair with implanted medical devices or wearable medical devices like blood pressure sensors and glucose monitors
• Any application that aggregates specific medical device data including drug interaction databases and remote patient monitoring data
• Any software that transforms a mobile platform into a medical device that performs the same or similar functions as existing regulated devices
• Applications that can be used to diagnose and/or recommend treatment for medical conditions including those used to assist in surgical procedures by providing step-by-step tutorials

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.