29.10.2013

Regulation of mHealth apps is on its way

Regulation of mHealth apps is on its way

We reached a point where very few people doubt about the importance of mobile technologies in the health ecosystem, a sector also known as mHealth. As we already mentioned in earlier articles, this field has seen many important developments over the last few years from apps that help us overcome bad feelings to mobile devices substituting expensive medical appliances. However, a question many people are concerned about is whether or not these applications and systems are safe to use for patients and doctors.

Until now, there was no regulatory framework for this type of apps that provide us with information about our health status and take decisions accordingly in order to improve it. And it is not surprising that doubts about their trustworthiness and safety are brought up. In order to dissipate these doubts about their usefulness, a few weeks ago, the American Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) presented guidelines to determine which kinds of apps need to be regulated and which do not.

FDA and TGA Establish two Categories of Apps

These institution have established two categories of mHealth apps:

  • On the one hand apps merely providing information to the users are considered low risk and therefore do not require any type of regulation; mobile applications that inform users about their health condition or those that allow you to keep a record of this kind of data would be included in this category.

  • On the other hand, there are apps that “participate in the diagnosis, prevention, monitoring and treatment of illnesses”. These applications have to be regulated by a competent authority; apps which give advice on medication or its dose would be included in this category.

So they distinguish between apps that have a risk associated and others that do not . But the type of application is not the only factor contributing to the risk assessment. Both the FDA and TGA claim that the risk level also depends on whether it is used directly by the user to try and diagnose any kind of health issue or if it is used and handled by health professionals as a diagnostics tool.

Even though these first steps in this direction are being taken in the United States and Australia, similar initiatives exist in Europe as well. The Directorate-General for Communications Networks, Content and Technology of the European Commission publishes an annual list of applications available to patients and provides information about their characteristics, creators, country of origin and the opinion of the patients’ associations. You can find here the reports for the years 2012 and 2013 on pdf. it should be noticed though, that the European Commission is not going as far as to prohibit certain types of apps and that the purpose of their report is merely to provide information.

Challenges and Problems in Regulation

As Life Hacker indicates, this kind of regulation will be a challenge for the organizations behind these initiatives. We have to be aware that the great majority of health apps are located in a grey area; for example, there is a software which is used on a daily basis by doctors to have an organized registry of their patients’ conditions. But this software is normally connected to complex algorithms that indicate the adequate medication and dose to doctors and patients according to the collected data. According to the rules established by the FDA and the TGA this would mean that these apps or software would have to be regulated, because a mistake in diagnostics could cause the wrong kind of medication.

Another challenge these organizations are facing is the regulation of apps in general. thousands of mHealth apps are released every year to online stores like Apple’s App Store or Google Play, how can they make sure that each and every one of them is being examined? This is really a major challenge if we take into account that until now, the FDA examined 20 programs per year.

Excellent News for Users, Developers and Investors

Despite the challenges institutions are facing, these kinds of initiatives are very good news for the ecosystem of users, developers and investors in this sector.

For users it is important, because they can find out about the risks that come with certain apps and rest assured when relying on them; developers and investors of these kinds of applications are also strengthened, because they can be that the app they are currently developing will not be stopped later on for not complying with certain prerequisites. Or they can at least know how cases of earlier releases of similar apps went.

At the end of the day, it is about certifying that apps work the way they are supposed to work. The FDA and the TGA have laid the foundation. Let us hope that the rest of public organizations will follow. After all, users and technology are many times ahead of bureaucratic administrations and when dealing with health issues, safety is of utmost importance.