mHealth Mobile Applications

iOS Android Smartphone Tablet & Cloud Based

Mobile apps are software programs that run on smartphones and or tablets either running on the mobile device or cloud based. They can also rely on hardware accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.

Mobile medical apps are medical devices that are mobile apps, which by the developer’s use intent meet the definition of a medical device, can be an accessory to a regulated medical device or transform a mobile device into a regulated medical device.

Consumers, caregivers, and health care professionals can use mobile medical apps and mobile apps to manage their own health and wellness, and or  monitor and oversee patient care.

It may be difficult to conclusively determine if your mobile or cloud based app falls under the FDA or EU oversight.  The CRO Group can determine if your app may need a 510(k) or Notified Body review, or if it may be eligible for other premarket regulatory pathways such as de Novo or PMA.  Careful planning of App functionality and submission label claims can make the difference between unregulated vs. 510(k) vs. de Novo vs. PMA, and between a Class IIA and IIB under the MDD, and between the new product classifications under MDR and IVDR, particularly for mHealth/SaMD involving new, unique diagnostic decision algorithms/AI.

In addition, for mHealth Apps with hardware accessories including body contact electrodes, CRO Group functions as the compliance engineer of your hardware design team, so that design requirements address the relevant IEC 60601 standards at the start vs. the end of project.

*mHealth (also written as m-health or mobile health) is a term used for the practice of medical and public health, supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as smartphones and tablets , for health services and information.  Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it, and, allow their health care providers and caregivers to participate as well. According to the FDA and research2guidance.com, “these tools are being adopted almost as quickly as they can be developed. According to industry estimates, by 2018, “50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.”