Mobile Healthcare Apps and the FDA
photo credit: Ari Herzog via photopin cc
As with all health IT developments, government regulatory bodies like the FDA have been increasingly concerned about the potential of mHealth technologies to disrupt the normal privacy and security protections of health information that are so critical in the practice of medicine. Indeed, at the 4th Annual mHealth World Congress, two of the first day’s four panel discussions were focused exclusively on the topics of the regulation of privacy and security concerns in regards to mobile health technologies. Much of the confusion arises from the simple fact that the growth of mHealth technologies is, generally speaking, a fairly recent phenomenon, something that laws like HIPPA did not necessarily anticipate.
New FDA Guidelines for mHealth Technologies
The FDA is anticipated to release its guidelines on wireless health apps for devices such as the iPhone, Android smartphones, iPad, and Android tablets sometime this fall, having invited input on their proposed guidelines since July 19, 2011. Although it is projected that there will be half a billion smartphone users utilizing mobile healthcare medical apps by 2015, they are only interested in a small fraction of such applications. Some of this revolves around marketing claims made of mobile health apps: wellness applications that help individuals monitor or improve their conditions will not receive much of the focus of FDA regulations, whereas those that claim to diagnose conditions have crossed an important line and would be subject to scrutiny.
What Needs to Be Regulated?
One study of 100 mobile health apps found on iTunes discovered that 56% of these would not need to be regulated, while only 8% would. Unfortunately, a large percentage—36%—were difficult to classify, highlighting the tricky territory that regulators will need to negotiate when they look at mobile healthcare technologies. (“Mobile health: What should be regulated and what not?”)
The FDA will be paying particularly close attention to those wireless health technologies that coordinate with medical devices already regulated by the FDA. This includes those medical applications which are used as an accessory to a currently-regulated medical device, or alternatively those that facilitate the transformation of a smartphone or tablet into a regulated medical device through the use of attachments. One example of this may be an iPad app that utilizes an accessory to transform the device into an ECG machine for the detection of abnormal heart rhythms.
Clinical decision support (CDS) software will also receive scrutiny in this new wave of FDA regulation. CDS software takes electronic health records (EHR) to the next step by analyzing the pools of data to draw medical conclusions. For this reason, the FDA is also working on a guidance document on CDS systems, which will likely have big implications for the regulation of EHRs as well.
DDA Medical is uniquely positioned to deal with the challenges posed by new regulations of mHealth technologies going forward. With an extensive marketing background, DDA Medical can help your business make sure that the claims made about an mHealth application do not invite strict regulatory scrutiny. Also, DDA Medical has HIPAA-compliant servers in addition to non-internet facing database servers for the best possible protection of sensitive medical information. Additionally, DDA Medical is a universal developer, and has designed and developed programs for every mobile device imaginable, from the iPhone and iPad to Android smartphones and tablets and more. When you need an organization you can trust to develop a mobile medical application that is sure to protect your interests as well as those who use the application, contact DDA Medical.
