When does a smartphone become a medical device?
Eileen OBrien on how the FDA might regulate apps and other mobile health solutions
Part of the transformation of health care is the new technology that allows smartphones to be used for diagnosis and tracking medical concerns.
These mobile apps do everything from monitoring heartbeats to managing glucose levels.
There were more than 7,000 health-related apps for the iPhone in September 2010, according to a MobiHealthNews study.
With the popularity of the iPad, these numbers are sure to grow.
However, its important to realize that any programmer can develop a health app.
Apple puts the responsibility for following regulatory guidance on developers.
So when do these apps (and the smartphone or tablet itself) become considered medical devices requiring monitoring by the US Food and Drug Administration (FDA)?
The FDA defines a medical device broadly on its website: Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.
As weve seen with pharmaceutical advertising and promotion, the existing FDA guidelines fail to address the unique issues that arise with new technology.
The issue of regulation has huge implications for innovation in this space.
To regulate or not to regulate
In December 2010, the mHealth Regulatory Coalition issued a whitepaper,which is essential reading for anyone interested in this topic.
The authors discuss what mobile health hardware and software the FDA might regulate and, if these areas are regulated, in which device classification the FDA might place them.
They dont come up with any answers, but they do illustrate the complexity of the questions.
The authors identify three areas for review:
Intended use To what extent can mHealth-related products be excluded from FDA regulation by focusing their marketing campaigns on general improvements to consumer wellness, as opposed to focusing on the management or treatment of diseases such as diabetes and hypertension?
Connected hardware To what extent do mobile phones and other generic communication hardware become FDA-regulated medical devices simply because they are promoted for connection to a medical device?
Software functionality To what extent does the FDA regulate software apps that are intended to reside on mobile phones, ordinary PCs, servers, or perhaps in the cloud if they function to provide connections between communication hardware and medical devices or as repositories for health data?
With the 54-page whitepaper, the Coalition has identified key topics for discussion and hopes to open a dialogue with the FDA.
With the volume of mobile health apps predicted to grow significantly, how would the FDA handle an increased regulatory workload?
And if a pharma brand wants to create an app for patients, will they need to get it approved as a device first and then get messaging reviewed by the Division of Drug Marketing, Advertising and Communications (DDMAC)?
It will be interesting to see how this all plays out in the years to come.
What do you think?
Eileen OBrien is director of search and innovation at Siren Interactive. She blogs at Sirensong.
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