FDA re-kindles debate over regulation of mHealth apps

By June 08, 2013
doctor with a computer

The debate on how far mobile eHealth apps need to be regulated has been re-kindled as a result of the United States FDA calling the uChek app providers into line.

There has recently been a sharp increase in the number of mobile apps relating to health, fitness and well-being – apps that test your pulse rate, glucose levels, sleep quality, and so on.  According to a report published by Transparency Market Research, an Albany, New York State-based market intelligence company, the global mHealth market is set to reach $10.2 billion in 2018, up from $1.3 billion in 2012. This burgeoning market would appear to require some form of regulation, especially where people’s health could be at risk. However, the increasing number of mobile health apps appearing every day at the Apple Store do not systematically come under United States Food and Drug Administration (FDA) regulations, and there are so many of them that it would be hard to keep track of all that should be applying for official clearance. A recent study by Brad Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, which is the voice of the mHealth technology stakeholders in Washington DC and Brussels, reveals that out of 100 apps chosen arbitrarily from the Apple Store, only 8% “definitely needed regulation” by the FDA. Recently however the FDA highlighted the issue when it pointed the finger at the uChek urine test mobile app, which FDA officials claim does not have the required FDA clearance. This imbroglio is a ‘first’ in the short history of mHealth.

 uChek case re-opens the debate

The uChek iPhone app enables the user to analyze the chemical contents of his/her urine. It drew the attention of the FDA, which sent a letter to the developer Biosense, based in Thane in India, challenging the company to explain why it has not sought authorization to market the uChek urine analyzer. The way the uChek system works is that first of all you dip a urinalysis reagent strip, a ‘dipstick’, into a urine sample and it will change color according to the chemical substances present. You then use your mobile phone, armed with the app, to analyze the result. The FDA has reminded the company that the dipstick results are supposed to be interpreted by direct visual reading rather than electronically, and argued that since the app enables a mobile phone to perform the analysis, the phone and device as a whole is now functioning as an automated strip reader. The dipsticks will therefore require new FDA clearance as part of an integral test system. Following publication of the FDA letter, debate over the regulation of mobile apps relating to health, fitness and well-being has re-surfaced. Firstly, there are questions regarding any necessary pre-authorization before the app is published; and secondly on the details of each regulatory category. For example, the line which is drawn between health apps and fitness apps is sometimes open to question. The FDA has three regulatory classes. Apps related to well-being and fitness are excluded from Classes II and III but may require a label or registration under Class I.

A check or a boost to the development of health apps?

Stricter regulation could have an impact on development in this sector, which has seen an increasing number of start-ups designing eHealth apps for smartphones and tablets. In the three classes of products which are currently identified by the FDA, we see for example mobile apps linked to the use and monitoring of medical devices such as an electrocardiogram. Then there are software programs which transform a mobile platform into a medical device through the use of sensors, for example a glucometer. Lastly, there are mobile apps which are used to help make clinical decisions, such as those which help doctors make a diagnosis. While stricter regulation might be seen as a limiting factor, it may well be that some investors would be keener to invest in mHealth apps if they could obtain more formal reassurance on the performance of the product in question.



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