The Laszlo Letter

Operational excellence through IT enablement in the Life Sciences industry

My Photo

About

Favorite ePubs

  • Bio-IT World
  • ClinPage
  • Health-IT World
  • Pharmaceutical Executive Europe
  • Wikipedia

Favorite Blogs

  • Coolerheads - Kevin O'Donnell
  • Eye on FDA - Mark Senak
  • In the Pipeline - Derek Lowe
  • Medrants - Robert Centor
  • MedTech Sentinel - Sara Calabro
  • Pharmaceutical Executive Europe
  • Regulatory Affairs - Joe Schwoebel
  • The Business Insider
Add me to your TypePad People list
Subscribe to this blog's feed

Mistake Riddled EHRs - The Elephant Revealed

An articleby Lisa Wangsness in the April 13, 2009 issue of the Boston Globe shows that the time has come to reveal an era of misdeeds by the healthcare community (i.e. doctors and hospitals).

The misdeeds are partly revealed by a seemingly innocent attempt by Google to import medical billing data into their electronic health records (EHR) database.

In this case, a cancer patient, Dave deBronkart, transferred his medical records from Beth Israel Deaconess Medical Center to Google Health. He then found out that the medical codes entered by the hospital for insurance purposes decoded to a list of conditions that he did not really have. So much for accurate health records!

The article in the Boston Globe does not, however, point out that there is deliberate miscoding of health conditions going on. Rather, it describes how the real conditions that deBronkart had were fitted to the codes that seemed closest to them in the coding manual. An exercise of trying to put round pegs into a square hole.

The elephant in the closet, however, is the fact that it is common practice in the United States for physicians and hospitals to deliberately miscode claims to assure that they will get the highest reimbursement and the fewest questions from insurers. This alone should disqualify claims data from entry into any personal health record or EHR. The practice should simply be banned!

This incident should also be seen as a warning to consumers that using EHR systems like those from Google or Microsoft does not come without risk. These are large companies that think they are doing good while growing their business. In this case they are exhibiting poor judgment and no viable method for fixing the problem.

Hospital systems, like Beth Israel Deaconess, that provide the data for transfer to EHR systems like those at Google and Microsoft deserve even greater blame for allowing claims data to be transferred in this manner. Unlike Google and Microsoft, it should be obvious to them that these data are simply inappropriate for such use.

As to the deliberate miscoding of medical conditions, it is time to recognize that this common practice is simply wrong. It is fraud, pure and simple. Yes, there will be lawsuits and public outrage. Penalties will be paid by the hospital systems without admitting guilt. Fortunately, we will have a somewhat better healthcare system when we emerge on the other side.

Tuesday, 14 April 2009 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: Beth Israel Deaconess, EHR, electronic health record, fraud, Google, insurance claims, John Halamka, Laszlo Letter, medical claims, Microsoft

Electronic Health Records (EHR) coverage at HIMSS

The annual meeting of the Healthcare Information and Management Systems Society (HIMSS) took place last week in Chicago. While there are many publications out there covering this meeting, ChannelWeb had an especially good series of articles on it.

Those of you who are not yet familiar with ChannelWeb, it is a web site focusing on companies that sell computer and communication based solutions (i.e. hardware and software.) In other words, the sellers ARE the channel.

As you will see from these articles, the most popular topic at HIMSS was the Obama stimulus package and its implications for health care. As you can imagine, vendors had a Pavlovian reaction about the potential to make a lot of money.

How well the money will be spent remains an open item. Once thing is certain. A lot of it will be wasted.

Read on...


HIMSS: Moving From Stimulus Hope To Real Health-Care IT Projects
ChannelWeb , April 10, 2009
At HIMSS, VARs, CIOs and vendors look past the initial round of stimulus excitement to gauge what's coming next.
spacer
20 Scenes From HIMSS 2009
ChannelWeb , April 09, 2009
The annual HIMSS conference brought more than 27,000 attendees to McCormick Place in Chicago, to hear from each other and from the likes of Dennis Quaid and Alan Greenspan as they place their bets on the future of health care IT. A strong pulse? You bet--and Channelweb was there to check it.
spacer
HIMSS: Greenspan Says Economy 'Will Turn, But Not Yet'
ChannelWeb , April 08, 2009
At HIMSS, Alan Greenspan addresses technology's role in health care and the broader economy.
spacer
HIMSS: Dell, Perot Systems Unleash Health Care IT Salvo
ChannelWeb , April 06, 2009
Dell announces partnerships with Perot Systems and others and virtualization and social networking solutions for health care
spacer
HIMSS: Dennis Quaid Calls On Health-Care Modernization To Eliminate Errors
ChannelWeb , April 05, 2009
Actor Dennis Quaid said at HIMSS keynote that health-care IT technology is the only way to reduce medical errors.
spacer
HIMSS Preview: Health Care Tech Revs Up As Stimulus Begins
ChannelWeb , April 03, 2009
Electronic medical records and health care IT funding from the federal stimulus package are on everyone's minds as HIMSS gets under way in Chicago.
spacer
Health Care IT: 25 Solutions To Check Out At HIMSS
ChannelWeb , April 02, 2009
A sampling of products and solutions to see at the 2009 HIMSS Conference in Chicago.

Monday, 13 April 2009 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: ChannelWeb, EHR, electronic health records, EMR, HIMSS, Laszlo Letter

Software for Clinical Development - 2009 Edition

Many of you have written to me over the past year that the MS Excel spreadsheet I created last year that listed software for clinical development was very useful.

Some people also wrote in that the list was by no means complete. Of course, they also told me which software packages were missing.

So, without further ado, here is an up-to-date list for 2009. Of course, I expect that several readers will again let me know that it's still not complete!

Download ClinDevSoftwareVendors-2009

Wednesday, 11 February 2009 | Permalink | Comments (2) | TrackBack (0)

Technorati Tags: adverse events, AE, biostatistics, CDM, CDR, clinical development, clinical trials, CTMS, Drug Safety, eCTD, EDC, ePRO, labeling, R&D, regulatory affairs, SCE, Software, SPL

Obama, Healthcare IT and the FDA

Today is day 2 of Obama's presidency.

While I do not expect him to even think about the FDA just yet, his inauguration led me to speculate about the possible changes that may come about for Healthcare IT in general and the FDA in particular. Somewhat coincidentally, these thoughts came out on inauguration day in the now weekly magazine Pharmaceutical Executive Europe. If you don't yet subscribe to this wholly electronic publication, consider doing so.

Click here to read the article which begins on Page 8. Your own thoughts on these topics are welcome.

Wednesday, 21 January 2009 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: EHR, EMR, FDA, healthcare, Information Technology, Laszlo Letter, Obama

Obama's Healthcare Team

Next week the USA gets a new President!

Anyone who is interested in what Obama will do with Healthcare should be interested in the colorful cast of characters that he has (and will) assembled to tackle this monster. One of them is Peter Orszag who will now be his budget director.

An Economist by training, Mr. Orszag already knows a thing or two about healthcare. He's got the facts on the spending front and has a few ideas about putting healthcare on a diet.

If you want to know more, there is plenty of that on the Internet. Here is one pretty good review (The Number Cruncher in Chief) about Mr. Orszag. Skim it first and then decide what parts you want to read.

Tuesday, 13 January 2009 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: CBO, Healthcare, Obama, OMB, Peter Orszag

The High Cost of Swimming Upstream with IT Projects

PharmexecSetting the scope of an IT project is possibly the most important factor affecting it's chance for success or failure. While most project do end up delivering some benefits, they rarely deliver everything that was hoped for.

Even when projects succeed, we may still be left clueless about unintended consequences. This is the main point of an article I recently wrote in the June issue of Pharmaceutical Executive Europe called "The High Cost of Swimming Upstream."

Just click on the title to see the article.

Monday, 23 June 2008 | Permalink | Comments (2) | TrackBack (0)

Technorati Tags: Clinical Research, EDC, ePublishing, IT Projects, Laszlo Letter, Pharmaceutical Executive

Is Biopharma ready for open source software

In the future, 2008 may be looked at as the year when open source software finally became viable in the biopharmaceutical industry. To be clear, I don't mean software that can be used across industries but only those designed for operations specifically and uniquely performed in our industry.

A second caveat is that the term "viable" may only apply to the software products themselves (i.e. the vendors) but not necessarily the companies that would use or benefit from them. In other words, the technology is ready while the industry may not be!

We'll dive into the relevance of and issues surrounding open source software by answering a few questions.

Continue reading "Is Biopharma ready for open source software" »

Saturday, 17 May 2008 | Permalink | Comments (3) | TrackBack (0)

Technorati Tags: Alfresco, CRIX, Firebird, GNU, Laszlo Letter, MS Office, NCI, Open source software, OpenClinical, OpenOffice, PhOSCo, source code

The Changing Role of CIOs

If you are a regular reader of this blog, you have no doubt noticed that I have not posted anything since the 8th of April. Please accept my apologies for this with the explanation that both business and personal commitments have severly limited the time available for "extra-curricular" writing. This post will be no different since I'm not going to write an original post.

However, I am pleased to report that I was given a fair amount of space in the latest issue of Pharmaceutical Executive Europe. I took that opportunity to focus on two topics:

  1. the changing and ever more important role of the CIO in our industry, and
  2. three key challenges that CIOs must focus on over the next few years

So, if you click on the "space" hyperlink above, you will get a pretty large dose of my opinions. As always, I will welcome your comments on them either here or the Pharmaceutical Executive Europe web site.

Monday, 28 April 2008 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: CIO, information technology, Laszlo Letter, Pharmaceutical Executive, Pharmaceutical Industry

Software for Clinical Development

Having recently particiapted in two DIA meetings, I thought it would be useful to pull together a spreadsheet of vendors offering software used in clinical development. This can serve as the basis for a more comprehensive list built and maintained by reader input.

For now, the list is kept in an Excel spreadsheet:

Download ClinDevSoftwareVendors-April2008.xls

Please note that I consider this spreadsheet as the intellectual property of The Laszlo Letter. In other words, it is copyrighted. You may use it as a reference document but not benefit from it in any financial manner or reproduce it without my permission.

To contribute new items or update those that already exist, just use the comment function of the blog. I will take it from there and post new versions of the spreadsheet as necessary.

Thanks in advance for your help.

Tuesday, 08 April 2008 | Permalink | Comments (5) | TrackBack (0)

Technorati Tags: clinical development, clinical trials, Laszlo Letter, R&D, software

Lilly: Implementing SAS Drug Development

Notes from the 23rd DIA CDM Conference

Susan Duke of GSK chaired a session on Tuesday, March 18th, called "Statistical Computing Environments: Collaboration through Metadata, People, Process and Software." During this session, Christopher Colangelo, Associate Senior Statistician, presented Eli Lilly's effort to implement SAS Drug Development (SDD) as a centralized but globally available repository for clinical data.

But first, and for those unfamiliar with this relatively new concept, a Statistical Computing Environment (SCE) is a combination of hardware, software and processes, that enable the collection, management, analysis, and transparency of operational data within a life sciences environment performed in compliance with government regulations and operating best practices. From a technical perspective, it is also an extension of a relatively new software category called "Clinical Data Repository" or CDR.

You can learn more about both SCE and CDR via the following posts on this web site:

  • Clinical Data Repository (CDR) 101
  • Clinical Data Repository (CDR) Vendors
  • Of CDR, CDMS and EDC
  • The EDC, CTMS, CDM Confusion
  • DIA Reflections: The Importance of Semantics
  • Genzyme: Biostatistics with Waban SCE

At Lilly, the selection of SDD arose from the recognition that internal staff in Data Management, Data Delivery, Statistics, Medical Communications and external partners such as CROs needed an environment that would allow for greater collaboration within a secure environment.

Continue reading "Lilly: Implementing SAS Drug Development" »

Monday, 31 March 2008 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: biostatistics, CDR, clinical research, data management, DIA, Laszlo Letter, SAS, SCE, statistics

Next »

Categories

Recent Posts

  • Mistake Riddled EHRs - The Elephant Revealed
  • Electronic Health Records (EHR) coverage at HIMSS
  • Software for Clinical Development - 2009 Edition
  • Obama, Healthcare IT and the FDA
  • Obama's Healthcare Team
  • The High Cost of Swimming Upstream with IT Projects
  • Is Biopharma ready for open source software
  • The Changing Role of CIOs
  • Software for Clinical Development
  • Lilly: Implementing SAS Drug Development

Archives

  • April 2009
  • February 2009
  • January 2009
  • June 2008
  • May 2008
  • April 2008
  • March 2008
  • February 2008
  • January 2008
  • December 2007

More...