Two years ago, I wrote about the FDA's draft guidance concerning regulation of mobile medical applications. The medical apps community is still awaiting final guidance, and some are getting anxious. Last month, opposing coalitions petitioned the government, one urging it to take its time on regulation and the other calling for the prompt release of final guidance.
A recent report from medical software resource Software Advice takes a closer look at the two sides of the debate.
According to the report, stakeholders on both ends of the spectrum claim to have patients' interests in mind, but they are also looking out for their own business interests.
On the one hand, the report says, provider associations and large IT companies point out that FDA regulation could discourage new market entrants, delay apps getting to market for patient use, and cost app makers time and money.
On the other hand, according to the report, a group consisting largely of mobile companies and app developers are calling for decisive action quickly, pointing out that clear guidance from the FDA will encourage investment in the app space and give developers the confidence to continue developing apps. However, some larger and more experienced app developers and medical device makers feel they can gain an advantage from FDA regulation as many smaller developers lack the resources and experience to achieve compliance in a timely fashion.
Should the FDA regulate mobile medical apps? Read the report at Software Advice and vote in the poll.