Should medical apps be regulated?
The issue is the topic of debate in the most recent BMJ with two US experts going head to head on the need for oversight of what is a fast growing industry.
Bradley Merrill Thompson – an attorney from the firm Epstein Becker & Green – argues in the BMJ that while regulation by the US Food and Drug Administration (FDA) need not extend to health and wellness apps, so called ‘mobile medical apps’ provided sufficient risk to warrant tight monitoring.
Mr Thompson wrote that “under the existing regulatory scheme, software used to program pacemakers and defibrillators and to view and analyse medical images has long been regulated”.
“Such software carries significant patient risk, so why would we stop regulating it just because we can now do those things on a cell phone?” he reasoned.
He added that “in a world where, unfortunately, some people are willing to hurt other people