There are more than 43,000 health-related apps only in the App Store, and the problem for any potential user is to what extent these are worthwhile.
A recent study presented by the Transparency Market Research U.S., highlighted the expectation that the market related to the #mHealth will reach an estimated turnover of 10.2 billion dollars in 2018 .
An analysis of the industry, its size, growth, trends and forecasts indicates that this trend is related to the important and progressive introduction of Smartphones among the population, the increasing incidence of chronic diseases and the constant growth of the number of applications related to health.
At present the health-related market is segmented into different contexts, monitoring services, diagnostic services, health care and other services.
The mobile telephone operators, the creators of new assistance devices connected to Smartphone, content generators and healthcare providers are the actors in this new emerging market segment of #mHealth, all adding to the current state of things.
Right now, a large number of entrepreneurs are becoming interested in this market. The U.S. market, which has a larger number of projects aimed at responding to the needs of the population in order to consolidate into it, as shown in the above study, presents some very attractive numbers to bet on.
However these entrepreneurs find a market that is not well regulated and is still applying an outdated legislation to these new needs. Again, technology is ahead of reality and out of the comfort zone to legislators, who must, quickly, update again.
That’s the reason why the Food and Drug Administration (FDA) has long worked to validate Apps, so as to ensure that, when an application related health issues hits the market, it meets minimum quality, value, functionality, etc.
The problem is that it is too slow, in fact in some cases they compare with drug approval process, rather than with the speed of the digital world, which is unacceptable.
In fact, organizations such as the FDA, the Federal Communications Commission (FCC) and the National Coordinating Office for Health Technology (ONC) are trying to find the balance for regulating innovation through mobile health applications quickly, protecting patients to whom they are intended.
One of the main problems that entrepreneurs who want to launch a spin off based on #mHealth face, is the bureaucracy and the costs of overcoming the process of accreditation by the FDA.
- Firstly it is important to determine if we want our project to be regulated by the FDA
- Secondly, if so, start trying to understand the costs of the whole process and include them into the inversion strategy.
- And finally, think about your regulatory strategy right alongside your business strategy. Recognize the connection between a business strategy and the potential impact of regulations, and begin to plan how you will go about managing or mitigating those impacts.
Apparently in January of 2014, the American Congress will discuss the regulatory proposal text presented by the FDA, and aims to regulate this new emerging market that is expected to become a huge business (10.2 Billion $ by 2018). And even more important than that, they are to discuss a matter that can make a paradigm shift in health care worldwide, at least as far as chronic diseases and their management is concerned.
We must be aware of how they solve this issue in the continent across the Atlantic, to learn, and if possible improve their decision on the old continent. I personally took time reflecting and thinking about this issue that I will try to develop in a future post.