Is my mHealth app a medical device, an electronic medical record, or a wellness tracker?

If you are creating any mHealth app today, you need to classify your app so you that you can answer the following questions:

  • Do I need FDA approval?
  • Do I need Office of the National Coordinator (ONC) certification?
  • What Federal and state privacy and security regulations apply to my app?
  • Who's paying or reimbursing when the medical community uses my app? 


To determine the answers to these questions, you need to know two things:

  1. What is the intention of use for this app?
  2. To whom are you selling this app? 


As the oldest US consumer protection agency, it is in the best interest of consumers to have FDA enforce safe and effective medical devices, regardless of the technical platform.  FDA medical device definition has not changed, even with the advances in science and technology - it is still based on the "intent of use."  If the mHealth app (or any 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," then it is a medical device and requires FDA approval.   

Bottom line:  Ask yourself, "If my mHealth app fails to function as intended, is it placing a consumer's life or health at risk?"  If the answer to this question is "Yes," you are a medical device and must get FDA approval.

What is different about mHealth apps from most other medical devices?  It is the mobility, and hence the lower security, of data.  This aspect of the mobile app brings additional considerations and regulations of patient privacy and security standards.   mHealth apps which collect, store or exchange patients' health information (including EMR's and even some wellness trackers) are affected by Federal and state privacy and security regulations, and potentially by licensure requirements and unique provisions. 


mHealth pushes medical device manufactures and software developers into a joint product development cycle.   Manufactures and investors of medical devices are accustomed to longer approval times and longer sales cycle, while IT developers and investors are accustomed to agile and rapid development cycles and short sales cycles.  It will be interesting to see how the marriage of the two plays out in the market.

he business case for mHealth apps drives the question, "Who is your customer and how much will they pay?"   Moving towards a value-based health care system opens up opportunities for those mHealth apps that can prove higher health care outcomes, increased cost savings, necessity and reasonability.

-- Vizma Carver, Founder and CEO, Carver Global Health Group