Over-regulation 'stops app development'

Misguided regulatory regimes are making it difficult for the manufacturers of mobile medical apps to bring their products to market, an industry summit has been told.

The audience at the Mobile Healthcare Industry Summit 2011 in Brussels heard that there are now significant differences in the regulation of mobile medical software and applications in Europe and the United States.

In the US, the Food and Drug Administration is getting heavily involved in the regulation of mobile medical applications.

In July, the FDA issued guidance on how it plans to monitor apps, and it is now in the process of formulating regulatory guidelines in consultation with the industry.

In contrast, Brian Kelly, regulatory lawyer at Covington and Burling, said that in the European Union the Medical Devices Directive put the "onus on the manufacturer" to self-regulate applications.

He said there were significantly different views of what regulation should look like across the EU, which made standardisation difficult.

"You could sit down with all these 27 different countries, and they could all have different views and desires on how software should be regulated.

"Some of the concerns and differences on how to regulate even quite simple software, with very little potential to actually affect patient care, is largely driven by individual patient incidents."

Kelly used the UK as an example. He said it wanted to regulate electronic prescription systems as medical devices because of a one-off patient incident caused by a software malfunction.

Yet when prescribing systems were paper-based, there would not have been the inclination to regulate because of a single incident, he argued.

Placing the onus on the manufacturer also meant companies were producing 'wellness' apps instead of ‘health’ or ‘medical’ apps in order to avoid having to show that they were complying with the directive.

However, Bradley Merrill Thompson from law firm Epstein Becker & Green said the over-regulation of mobile medical apps was also making it difficult for companies to commercialise their products in the US.

"As soon as we mention a chronic disease it [the software] gets regulated." he said. "The FDA needs to allow the industry a little bit of guidance, and to mention chronic diseases without being regulated."

The FDA is working to separate applications into three levels of involvement with patient care, with connected levels of regulation being attached.

The lowest level, where the app aids another device, would receive the lowest regulation, while one that changed device so much that it acted as a new medical device would be more heavily regulated.

Merrill Thompson urged industry experts to push for lower levels of regulation before the consultation period closed in about three weeks’ time. "The FDA doesn't always get it right, so I would urge you to get involved and make comments."