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and current regulations are outdated.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?
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