Comments on: News 10/30/09

By: Lisa Bromley

Lisa Bromley — Tue, 03 Nov 2009 18:24:18 +0000

I agree, “software that displays or manipulates lab results, provides diagnostic suggestions, or manages drug therapy,” falls under the FDA’s definition of a medical device. Furthermore, the sophisticated ways in which labs now use middleware and LIS functionality will likely encourage more regulation. For example, the increased amount of automated functions being performed by clinical laboratory data management software, such as auto verification, illustrate how both laboratory middleware and laboratory information systems impact patient safety every bit as much as an FDA-regulated laboratory instrument that is used to initially produce a result.

Given that poorly designed and supported software has the potential to harm a patient, steps must be taken to ensure manufacturers develop and service these applications with quality patient care and safety if mind. Vendors must to adhere to best practices including strict design control, process evaluation, risk management, hazard analysis, and continuous quality improvement. These manufacturing and support systems are exactly what the FDA seeks to regulate, and such regulation is in the best interest of the consumer. In fact, our company believes this so strongly we became the first and only middleware device company to receive both a 510(k) clearance from the FDA and a Class II Medical Device Licensure from Health Canada.
http://www.datainnovations.com/

By: John@chilmark

John@chilmark — Tue, 03 Nov 2009 15:42:26 +0000

First, thanks Mr HIS talk to the post I wrote on Dossia. Agree, by and large PHRs are not exactly lighting up the HIT space. Main reason is that most consumers want to conduct transactions and not just have a digital, typically bolted to the floor (non-portable) PHR, consumers want transactions, thus the success of KP’s MyChart and Group Health’s as well. I inferred such in the post on Dossia.

Second, the folks at Accenture here in Boston have told me there has been some major realignment to build-out their HC services grp so doubt anything is shutting down.

By: S Silvesrtein

S Silvesrtein — Fri, 30 Oct 2009 16:47:58 +0000

“The government is making a large investment in healthcare information technology so it kind of makes sense for them to fully understand what that investment is going to be related to.”

excuse me.

Kind of?

By: Suzie, RN

Suzie, RN — Fri, 30 Oct 2009 15:07:14 +0000

“We view the committees interest and HIT is becoming embedded kind of in the dialogue around healthcare policy and reform so we look forward to working with the committee and providing requested information and working with them as needed, so we don’t see it impacting our near term business and I think that it’s something that the government is doing their job and we fully look forward to complying with any requests.” Marc Naughton, as reported above.

Does any one understand one word of what he is saying?
Does anyone understand one word of what Neal said on his “chime”?

The problems that have been reported with HIT systems in the UK and Australia may be due to the same cognitive capacity witnessed in these statements to shareholders and analysts.

By: AmmanForAllSeasons

AmmanForAllSeasons — Fri, 30 Oct 2009 13:36:43 +0000

Hi, Matt… how you been? Bet you didn’t know I read this rag, did you?
الملك عبد الله الثاني بن الحسين