FDA: We Can't Scale To Regulate Mobile Health Apps

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.

Comments

Charge what it costs to certify

[Anonymous Coward]

Just charge what it costs to certify that an application/ device does what it claims to do. I know it is a novel concept of fee for service, but things are far more transparent that way. If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Re:Charge what it costs to certify

[Bing Tsher E]

That is completely garbage. The Underwriter's Laboratory is a private for-profit organization and does a very good job of assuring fire and electrical safety for a huge sector of industry. When something is UL listed you can be certain it meets stringent safety standards.