SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Send us your Comments

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

Ohio medical board disciplines radiologist for HIPAA violation Incident not uncommon and underscores importance of compliance programs

Imagining a less-invasive surgery with MRI-powered millirobots Is injecting 'millirobots' into patient spinal canals the future?

Magnetic stimulation (nTMS) gives German brain surgeons new insight Pre-operative brain mapping may reduce brain surgery damage

Testing equipment: Still a challenge, but getting easier Testing equipment is getting easier but no less a challenge

GE Healthcare launches Vscan Access portable ultrasound for developing regions Aims to reduce pregnancy related deaths worldwide

Proton therapy's real-world benefits accrue at PTCOG Measuring appropriate use and untapped potential with two new studies

Study confirms patient preference for receiving imaging results The referring doctor is seen as best source of info, although a majority of patients also want to view their radiology report

Announcing the 'Rosetta Stone' of advanced prostate cancer Researchers say prostate cancer not a "single disease" but 90 percent of cases yield actionable mutations

Surgical robotic device market to grow over 600 percent by 2021 Will jump from $3.2 billion to $20 billion

New radiation blood test awaits human application Research funded by feds to save lives offers faster, cheaper testing

Calgary Scientific ResolutionMD Mobile

Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry?

by Brendon Nafziger , DOTmed News Associate Editor
This report originally ran in the June 2010 edition of DOTmed Business News.

About a year and a half ago, the U.S. Food and Drug Administration made a decision that many in the booming smartphone medical app industry regard as menacing.

Story Continues Below Advertisement

There's never been a better time - or an easier way to excel

Partner with Siemens to achieve success. At Siemens, service means more than fixing what breaks. It means providing you with the education, tools and support you need to work smarter. Click above to learn more



Shortly after the Apple Store launched, the agency told Apple to remove an image viewer produced by the Cleveland-based MIMVista from its virtual shelves. The viewer, Mobile MIM, earned the dubious distinction of being among the first radiology iPhone apps ever taken out of circulation by the agency.

In January, the FDA did something to disturb industry-watchers even more: it rejected the second of MIMVista's so-called fast-track, or 510 (k), applications, requiring the company to go through the lengthy, and expensive, premarket approval before the product could ever be sold by the Apple Store.

Of course, this was an isolated case. Mostly, smartphone users with a medical bent have been in clover. According to a recent MobiHealthNews industry survey, there are around 5,820 medical, health or fitness-themed apps for devices such as the iPhone, iPod Touch and the various Google-run Android platforms. These apps range from iTriage, which lets users check wait times at nearby hospital emergency rooms, to Epocrates, an incredibly popular guide for drug interactions for doctors, and the sundry "wellness" apps that help people schedule workouts and plan their diets. Surveys have shown between two-thirds to three-quarters of doctors own and use some sort of smartphone and often carry the device on rounds.

Yet the news of Mobile MIM's plight coupled with signs of a tougher FDA regulatory attitude compels many to wonder whether they face a brewing storm: will the FDA soon clamp down on the thousands of health care smartphone apps? Will the agency focus mostly on radiology viewers - where there is clear potential for dangerous misreadings by rushed radiologists on tiny screens - or is just the fear of coming regulations going to, in the end, do the most harm?

Light touch
After the initial pulling of the Mobile MIM, few app companies announced being contacted by the FDA, according to most reports. In fact, regulations have actually been fairly light, observed Bradley Merrill Thompson, partner at Epstein Becker and Green, P.C. in Washington D.C. and counsel for EBG Advisors.

"I think the FDA, to their credit, has been holding back to study what's going on, to try to understand the hardware and software and decide what they want to do based on risk," Thompson said.

Continue reading Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry? ...
  Pages: 1 - 2 - 3 - 4 - ... >>

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.
Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED