Bye bye innovation and medical app developers

As I mentioned in my earlier blog I am going to Canada. The subject of my placement in Canada is mHealth apps and their quality. mHealth apps? Yes mHealth apps, the abbreviation of mobile Health apps. mHealth is constantly growing business within the field of e-Health (electronic? enhanced? enabled? who knows?). And more and more mobile health applications are available in the different app stores. But the quality of most of these apps is not guaranteed and current regulations are outdated.

Legal and regulatory issues

The other day I was at a Seminar held by Axon lawyers in Amsterdam about Medical software and mHealth apps and their current legal and regulatory issues (Seminar brochure). The European Union decided that the current regulations need to change:

• For medicinal products and medical devices
• For collection and processing of health data

For every medical device (and yes medical software and apps are seen as a medical device) a CE marking needs to be obtained first before companies can sell their app on the market. In June 2013 the Dutch Inspectorate for Health care announced that it will enforce medical device legislation against companies with non-compliant software. And that’s what I found striking…

In order to obtain the CE marking you have to meet certain requirements, which cost both money and time, with the result that innovation will disappear. What is so beautiful about the app-building world is that everybody can do it! Every company or person with a great idea, can develop an application and sell it in one or multiple app store(s). But, smaller (1-person) companies will not have time nor the money to meet these requirements. Less companies or individuals will start building medical apps, innovation will decline and in the end only larger companies will be able to afford to go through the whole process of obtaining a CE marking. 

Develop elsewhere

It is on the other hand hard to say how the IGZ will control all the apps that are available in the app stores. Officially when someone wants to sell their app in the appstore and make it available in a certain country, they have to meet the local requirements. But what if that app is made available from outside the Netherlands/Europe? Can they still force companies to obtain a CE marking? Or will they force Apple and Google to refuse selling those applications on the Dutch/European market? If not, we can always start a company outside The Netherlands and still sell our apps here ;-)

Public pressure

Patients have the right to choose their own care and decline if they not want to use it, but not the right to choose between different apps? It's like the IGZ is forcing doctors to force care on patients, even though the patients don't want to receive that specific care. Only in this case the IGZ is forcing developers to obtain a CE market, destroy the market and leave patients with no choice than to choose for apps developed by big companies. 

I think it would be better if the CE marking for apps would be promoted more instead of enforcing it. And users do have a responsibility on their own too. If they are not sure, they can always go to their doctor to verify if they can use a certain app or look if their intended app to use is on one of the white lists with – by doctors – reviewed and rated apps. In this way there will remain space for innovation, while quality is covered more and more. People love their health, so they also want quality for their applications and go through those lists themselves. Other developers will then automatically follow due to public pressure. 

What do you think?