Is wireless health regulation just as grey in the UK and other parts of Europe as it is in the US?
"It's much easier to develop technology than it is to get permission to use it," Peter Bentley, the inventor of an iPhone app that supposedly turns the device into a stethoscope, told the UK's Guardian in a recent interview. Bentley, a researcher at the University College London, believes that innovation is being stifled by regulators in Europe: "I could create a mobile ultrasound scanner and an application to measure the oxygen content in blood, but the regulations stop me. We're not allowed to turn the phone itself into a medical device, and what that precisely means is currently a grey area in terms of regulation. That's the only reason we're not seeing a flood of these devices yet."
Bentley's perspective is shared by Professor Ian Wells, head of the scientific computing section in the department of medical physics at the Royal Surrey County hospital in Guildford: "The approach of the regulators is not well worked out yet. There's a wonderful new world out there but we need to find a way for regulators to protect patients and doctors, while not impeding innovation, research and development," he told The Guardian.
The Guardian reported that a consortium of regulators from a number of European countries: Austria, Belgium, Denmark, France, Ireland, Sweden and the UK convened late last year to develop guidance for software regulations under European Medical Device Regulations -- a report is expected by year-end.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) recently set up a Medical Device Technology Forum that is tasked with establishing regulatory best practices for new technologies.
"This is such a complex area that we are currently looking at every application on a case-by-case basis," an MHRA spokesperson told The Guardian. "We want to ensure that these new technologies are effectively regulated – thereby protecting health and avoiding unnecessary deterrents – while at the same time removing any unnecessary obstacles to manufacturers who wish to exploit new technologies for the benefit of patients."
More on regulations and Bentley's popular stethoscope app (3 million downloads to date for his paid app) over at The Guardian
For a comprehensive understanding of the regulatory environment for mobile health in the US, be sure to read our free report: FDA Regulation of Mobile Health (PDF)