Health 2.0

Posted on October 22, 2007 by Bob

The Health 2.0 movement (also see here) is a comprehensive approach to many of the EMR/PHR topics I've discussed in the past. Scott Shreeve, MD (there are many good posts on his blog) proposes what he calls the "Triple-A of Health 2.0" approach (also see the overviews here and here):

Aggregate, Analyze, and Advise

I like Dr. Shreeve's Health 2.0 Business Model analysis in that it clearly defines corporate motivations in this marketplace. It's hard not to like the Aggregate concepts of Prostitution, Voyeurism, and Fetishes.

How is value going to be derived and payed for? Put into this Health 2.0 business model context at least you can begin to ask the right questions.

What Health 2.0 makes clear is the complexity of the issues that need to be resolved and that there's a long road ahead.

UPDATE (15-Nov-2007) :

A new Health 2.0 site: Health 2.0 Blog

Posted in EMR, Health 2.0, PHR | 3 Comments

Off Topic: Pandora Radio

Posted on October 18, 2007 by Bob

One of the main reasons I don't listen to a lot of music is that I tend to get stuck in a rut. I'll listen to the same thing over and over again until I'm sick of it. Then I'll just stop all together. I don't own a music player, but I do have headphones on my office computer. I've tried Internet radio stations, but just like regular radio, I end up in switching-channels mode. Then I'll just stop all together.

If you're a music connoisseur you probably already know about Pandora Radio. The whole concept of creating stations based on your selection of an artist or song seems strange at first. Once you understand how the station music is selected, it makes a lot of sense. This is especially true when the resulting play-list matches the attributes of the original so well. As you rate the tracks (thumbs up, thumbs down) the selections get even better. It's pretty amazing actually.

Pandora is a great way to discover new artists that match your tastes. Give it a try.

Posted in General | Leave a comment

Medical Device Software Forensics

Posted on October 17, 2007 by Bob

"The Gray Sheet" has an article called CDRH Software Forensics Lab: Applying Rocket Science To Device Analysis. Can it really be true that CDRH is doing static code analysis for detecting software defects in recall investigations?

Static code analysis has been around for a long time. I remember using Lint back in the old days. Nowadays all commonly used computer languages (like C and C++) have fairly advanced analysis tools. For Microsoft .NET languages there are tools like FxCop and ReShaper. These tools are great for spotting trouble areas and maintaining code conventions during the development process.

I just have a hard time imagining a process using these tools that would successfully detect real defects in complex medical device software. Especially software that's controlling hardware devices, doing communications tasks, and recording sensor data. Also, what about all of the assembly language code for embedded processors and DSPs?

Anyway, from the article:

A recent review in the forensics lab found 180 "questionable constructs" in 100,000 lines of code, but only two turned out to be real design issues, Taylor said.

He also pointed to two other cases where static analysis of the software did not find any bugs, thus clearing software as a root cause candidate in the recall investigations.

These statements beg the following questions:

  1. Were the two "real design issues" related at all to the device failures?
  2. Just because no static analysis "bugs" were found, why does that exonerate the software from being the cause of the failure?

I'm not impressed that static analysis has "been embraced by the aeronautical and automotive sectors". IMHO this approach just seems like it would create a lot of work for very little return. The manufacturer that produced the device should be responsible for tracking down and fixing the software (and/or hardware) defects.

I'll stop now.

UPDATE (25-Oct-07):

Check out Tim's post on this subject: FDA Raises Bar on Medical Device Software Testing.

Posted in FDA, Medical Devices, Software Quality | 4 Comments

Medical Device Software Development – Going Agile

Posted on October 14, 2007 by Bob

I've been involved in some informal discussions regarding the use of Agile methodologies for medical device software. The Medical Device and Diagnostic Industry (MD&DI) October 2007 article by Tim Bosch entitled Medical Device Software Development—Going Agile provides a good overview of the challenges that face medical device design and development organizations that want to embrace Agile. Here's Figure 2 from the article:

A typical agile development process

I liked the organization 'rejection, force fitting, or abandonment' analysis. Changing organizational behavior is a difficult thing to do. Add in the documentation requirements and you can see why adopting Agile is an uphill battle. This is especially true for an organization that already has a history of doing software development the old fashioned way.

On the regulatory side, Tim references General Principles of Software Validation; Final Guidance for Industry and FDA Staff and claims that:

An agile development approach aligns well with this guidance.

I'm not so sure about that. As I've pointed out before, because of the validation requirements those guidelines are much better suited for the Waterfall development approach. That's why most people do it that way. Agile can be applied, but it comes with increased cost and potential regulatory risk.

I think the advantages of Agile methodologies are real and application of them does have the potential to improve the functionality, cost effectiveness, and quality of medical device software. It's good to see articles that detail the issues and provide a realistic strategy for achieving those goals.

Posted in Agile, FDA | 2 Comments

Little Bobby Tables

Posted on October 10, 2007 by Bob

I'm a Bob and this one is just too funny. Too bad my mother wouldn't get it -- or my wife, or my kids, anyway:

Little Bobby Tables

Original link: http://xkcd.com/327/ (hat tip Peter).

Posted in General | Tagged , | 1 Comment

Scoble interview: The Stanford IT doctor is in.

Posted on October 9, 2007 by Bob

Here's an interesting interview with Dr. Christopher Longhurst from The Stanford IT doctor is in.

The discussion of standards and interoperability is very good.

Posted in EMR | 1 Comment

Microsoft HealthVault

Posted on October 4, 2007 by Bob

Everybody is talking (WSJ-Health Blog, MedGadget, Health IT Guy, and many more) about the introduction of Microsoft HealthVault.

This seems to be a step in the right direction for personally controller health records. The direct device interfaces are particularly interesting.

Update:

There's more discussion about this on the HISTalk blog. People certainly have strong feelings about whether PHR has a future, and even stronger ones about Microsoft. From here:

Last on HealthVault: lots of people hate Microsoft. Blue screen of death. Microsoft Bob. Forced upgrades. Browser security holes. Antitrust issues. Internet tollgate. Assume people buy into PHRs on a big scale. Of all the companies offering PHRs, which one would they trust least with their most personal information? Some Ukrainain hater will have it hacked by this time next week, I suspect.

Even if this was a real concern, I'm not so sure the general public has this level of technical knowledge that would lead them to distrust Microsoft.

In any case, I think a bigger concern about companies like Microsoft and Google getting into PHR is their bottom line motive: advertising. You can be sure that everything they do is driven by a business model -- i.e to make money. This makes their shareholders happy, but what will it ultimately mean for PHR?

Posted in EMR, Microsoft, PHR | 2 Comments

Microsoft and the Health Care IT Market

Posted on October 1, 2007 by Bob

Here's a good read about Microsoft and the health care IT market: Vertical Markets: Prescription for Profit. Redmond Channel Partner Online is a magazine for the Microsoft partner community so the article is geared more towards third party opportunities. It talks a little about Microsoft's marketing efforts (or lack thereof), but nothing about their technology strategy. The discussion about the Azyxxi purchase in 2006 and how it's perceived by some as a competitive threat is interesting.

The overall take-away is that the health care industry has a lot of potential for Microsoft. What you don't get from the article is where the competitive threats are in this market.

Here's a quote I like:

Doctors can be tough customers too. "They're notoriously cheap,"....

Posted in EMR, Microsoft | 1 Comment

CardioDynamics Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility

Posted on September 30, 2007 by Bob

CardioDynamics International Corporation (CDIC) Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility.

WooHoo! Congratulations to all of the CDIC R&D (including yours truly) and Quality teams for getting this done. Great job everyone!

Posted in EMR, FDA, ICG | Leave a comment

Language Integrated Query (LINQ)

Posted on September 26, 2007 by Bob

Last night I attended a San Diego .NET Users Group meeting where the topic was LINQ. The presentation was done by Julie Lerman (http://www.thedatafarm.com/blog and http://blogs.devsource.com/devlife).

Since I have an interest in ORM (see here) I've done some reading on LINQ in the past. It's always amazing to me how much more you seem to learn from a presentation. Especially when the speaker is well organized and knowledgeable and provides an engaging delivery. Great job Julie!

LINQ is very impressive. The new .NET Framework Orcas (VS 2008) language features include:

  • Automatic Properties
  • Extension Methods
  • Lambda Expressions
  • Query Syntax
  • Anonymous Types

These not only provide a foundation for ORM work, but are also powerful .NET language and tool additions for just about any programming task.

Posted in .NET, LINQ, ORM | Leave a comment