Comments on: Study: FDA Hampering Technology in Healthcare

By: Home Health Monitoring is Big Business: Mobile «

Home Health Monitoring is Big Business: Mobile « — Tue, 21 Dec 2010 15:55:51 +0000

[...] beginning to play a role in home healthcare, and such usage should continue to evolve as long as regulating authorities stay out of the way. The benefits gained by such apps are already coming to the attention of the healthcare industry, [...]

By: Quentin Dewolf

Quentin Dewolf — Fri, 19 Nov 2010 21:19:30 +0000

being the head of regulatory at a software company the quoted numbers are absurd. we integrate iso processes so the only pure FDA process is the 90 days you wait for the 510k approval and the every 2 year audit cycle.
A PMA might take 20 or 30 million and years but not a 510k.

By: Glenn Laffel, MD, PhD

Glenn Laffel, MD, PhD — Fri, 19 Nov 2010 13:22:01 +0000

There’s a similar problem with electronic health records, where the FDA has indicated it wants to become the arbitor the safety of these “devices.” This decision would not only cost vendors hundreds of millions of dollars, but it would threaten to block the initiatives of another federal agency, the Office of the National Coordinator for HIT, also known as the ONC (both agencies are part of HHS). This latter agency is determined to stimulate the adoption of EHRs on a national scale through the HITECH incentive program.

The issue of EHR safety is real. It should be the subject of regulatory scrutiny. But the locus of this scrutiny should be the ONC itself, not the FDA. Otherwise, we have a counterproductive situation in which one federal agency is interfering with the strategic objectives of another.

By: Kingsnarfer

Kingsnarfer — Fri, 19 Nov 2010 02:45:53 +0000

Don’t we want our medical devices to work flawlessly 100% of the time? To rigorously adhere to claimed functions and tight specifications of the device? I certainly would not trust my buggy Android phone to be monitoring vital functions, or regulating the frequency of delivery of medication. We want everything to be cheap and easy but people freak out when Toyota recalls millions of cars for a (potentially fatal) flaw that occurs in a TINY fraction of their cars. Should we expect less from medical devices? It’s a case of diminishing retunes when pursuing perfection but that’s what we expect when it comes to our well-being. Get used to it, we want the FDA to apply a high level of scrutiny.

By: ocos

ocos — Thu, 18 Nov 2010 20:48:37 +0000

I expect Obomacare to compound these problems…sorry.

By: Study: FDA Hampering Technology in Healthcare - Technotype

Study: FDA Hampering Technology in Healthcare - Technotype — Thu, 18 Nov 2010 19:47:44 +0000

[...] Read Full Story Mobile [...]

By: Bcreekski

Bcreekski — Thu, 18 Nov 2010 18:36:10 +0000

Do not be concerned. With Obamacare there will be such massive savings that the FDA will pass these on as incentives to the mobile technology researchers.