Author Archive for Bob

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Google Health: R.I.P.

Published on June 24, 2011 by Bob in Google and PHR. 2 Comments Tags: .

The announcement that Google Health was being discontinued shouldn’t be a surprise.  In March the Wall Street Journal reported that once Larry Page took over the CEO role at Google he would be looking to cut projects:

Some managers believe Mr. Page will eliminate or downgrade projects he doesn’t believe are worthwhile, freeing up employees to work on more important initiatives, these people said. One project expected to get less support is Google Health, which lets people store medical records and other health data on Google’s servers, said people familiar with the matter.

There have been a number of retrospectives written today already, most concerned with the future of PHRs. For example:

It just goes to show you that being a pioneer does not guarantee long-term success. Microsoft HealthVault has done a much better job with device integration than Google Health did. There are many other factors that will determine the viability of PHRs in general though.  Adoption by the general population and a revenue model to support growth are just a few.

UPDATE (6/25/11): Mr. HIStalk’s take is the lead in Monday Morning Update 6/27/11. Two quotable statements:

Why did Google Health fail? Simple and obvious: consumer demand for personal health records is close to zero, which has always been the case and probably always will be.

Probably true.

Google predictably did what its know-it-all technology company predecessors have done over the years: dipped an arrogant and half-assed toe into the health IT waters; roused a loud rabble of shrieking fanboy bloggers and reporters…

OK, but how do you really feel?

Seriously though, I think Google’s foray in the Healthcare space was no different then how they approach any other market: “If we build it, they will come.”  If they don’t come, we pull the plug. Google has a graveyard full of products that suffered the same fate.

UPDATE (6/26/11): Some more:

UPDATE (7/1/11):

ZDNet Healthcare: Gone forever?

Published on June 11, 2011 by Bob in General. 1 Comment Tags: , .

Wow! It took me 7 months to realize that I had not seen an update from the ZDNet Healthcare blog. The reason is that Dana Blankenhorn was fired around the end of November 2010.  Apparently it was his Free and Open Source (FOSS)  blogging that lead to his demise at ZDNet. Also see the comments section in this article.

I commented on his Healthcare blog several times and even took issue with him in Access to Medical Data: Are PC Standards and PHRs (You) the Answer?

It looks like ZDNet has not found a replacement for dedicated Healthcare coverage. This means I can remove ‘ZDNet Healthcare Blog RSS’ from my reader feed.

Final Plea to Launch: Healthcare IT Q&A

Published on May 9, 2011 by Bob in General. 0 Comments Tags: , , .

Closer to Launch: Healthcare IT Q&A didn’t get close to doing the job. Even after 8 months the commitment level is still at only 60%:

It doesn’t look like Area51 has a time limit on how long a proposal can languish in the Commitment phase, but we’re going to need a lot more support to get to Beta. So go over and sign up today!

Discomfort with Computerized Medical Devices

Published on April 11, 2011 by Bob in FDA, Medical Devices and Software Quality. 1 Comment Tags: .

Here are some thoughts regarding the article: I feel a little uncomfortable about computerized medical devices, and here’s why.

  • Just about all medical devices are computerized these days. Most will not harm or kill you if their software fails (Class I & II), but that’s no excuse for writing crappy code.
  • As pointed out, the mission critical nature of mass transit systems (airplanes, subways, etc.) affords those industries a much higher level of scrutiny then cars or medical devices ever will. But that’s still no excuse for writing crappy code.

Even through drugs and airplanes need advance approval from authorities before being brought to the market, medical devices and software do not, at least in the United States.

  • This statement is not correct. All medical devices, including diagnostic and therapeutic software-only products, require FDA clearance to be sold in the US market (see the Class I & II link above).  There are many exemptions, but a 510k pre-market approval is generally a minimum requirement. After you receive approval the FDA can pull your device off the market (the dreaded “recall”) at any time due to complaints or unsatisfactory audit results.
  • The FDA QSR Subpart C (§ 820.30) looks a lot like DO-178B as quality system design controls go, but I’m sure the aviation standard enforcement is far more rigorous (well, at least I hope it is). It’s true, there are no coding standards for medical device software.  Good companies set their own development standards and practices — some even use static analysis! It’s all the other companies that don’t bother to do anything that you have to worry about.

I’m certain that static analysis technology has improved vastly in the four years since some of the articles below were written.  The challenge is that the complexity of medical device software and the systems they run on has also increased tremendously during that time. In particular, the explosion of high bandwidth wireless networks along with advances in handheld computing power and graphics capability (think iPhone/iPad, of course) is fundamentally changing the way medical devices will be developed and delivered to the market in the future.

Static analysis will remain a valuable tool for identifying critical software defects, but new methods will have to be developed for rooting out risks in the new network-connected, multi-touch world.

It’s sad to say, but you should probably be more than “a little uncomfortable.”

Other static analysis articles:

A Few Billion Lines of Code Later: Using Static Analysis to Find Bugs in the Real World
More Software Forensics and Why Analogies Suck
Medical Device Software Forensics
Pascal’s 3 part static analysis series that starts here:
Guest Article: Static Analysis in Medical Device Software (Part 1) — The Traps of C

The Reality of EMR Integration for Medical Devices

Published on April 5, 2011 by Bob in EMR, Interoperability and Medical Devices. 1 Comment

Tim provides a good starting point for understanding this in EMR Integration for Medical Devices: The Basics.

What this highlights of course is that getting data from a medical device into an EMR is a lot harder than it should be. “It’s not pretty” is an understatement.  In the ideal world nobody should have to be connectologist to get medical data where it needs to be.  Unfortunately, we have a long way to go before that becomes a reality.

Binary Waveform Data in SQL Server 2008

Published on March 8, 2011 by Bob in .NET, Microsoft and Programming. 0 Comments Tags: .

As Shahid points out in Consider MySQL ‘Archive’ storage engine to store large amounts of med device structured or waveform data, saving physiologic waveform data from a medical device in a MySQL database for archive purposes is a reasonable alternative to using flat files.

In SQL Server 2008 you can have it both ways.  In addition to saving binary data directly in the database you have the option to have a varbinary column stored as a file stream. From the article How to store and fetch binary data into a file stream column:

File stream data can be used from the .NET Framework using the traditional SqlParameter, but there is also a specialized class called SqlFileStream which can be used with .NET Framework 3.5 SP1 or later. This class provides mechanisms, for example, for seeking a specific position from the data.

There are pros and cons to this approach. The backup and transactional issues, along with the performance considerations, all have to be evaluated against your specific system requirements.  Having the SQL Server engine manage the database relationship to the binary files seems like a big advantage over maintaining flat files yourself.

Read the MSDN article FILESTREAM Storage in SQL Server 2008 for all the gory details.

UPDATE (3/25/11): Who’s Got Access to your FileStream Directories?

Writers Writing about Writing

Published on February 4, 2011 by Bob in General. 1 Comment Tags: , .

Jeff Atwood is a great writer. All of his blog posts are informative and interesting.

How to Write Without Writing is a case in point.  It starts off with a clever hook (“trick my fellow programmers”), expounds the benefits of writing, particularly answering questions (“fun sized”) as a way to improve your communication skills.  All of this is true.

The worm in the apple of course is the blatant promotion for the Writers Stack Exchange site. You really can’t fault Jeff for doing this though. If you were running a venture funded business that depended on driving traffic, you’d make use of your celebrity in exactly the same way.

This will hopefully not diminish the message that writing can be used as an effective vehicle to gain technical knowledge as well as being a critical professional skill.

That wasn’t as insurmountable and impenetrable as I thought it was going to be.

Personal Healthcare Products: This is what the future looks like.

Published on January 4, 2011 by Bob in FDA and Medical Devices. 2 Comments Tags: .

I’m jealous of companies that get to produce diagnostic medical devices without having to go through the FDA 510(k) process. For example, the iHealth BP3 blood pressure monitor is a high-tech looking device with a  free Apple application:

Hopefully they’re using an approved non-invasive blood pressure (NIBP) device like the SunTech module.

The built-in ability to e-mail results to family or a physician seems useful, but posting your blood pressure on Facebook or Twitter?  I don’t know…

Hat Tip: medGadget

Medical Devices and the Cloud

Published on January 3, 2011 by Bob in Cloud Computing, EMR, Interoperability and Medical Devices. 2 Comments

The article Is Cloud the tomorrow of Medical Devices Industry? includes some of the challenges — regulatory, privacy, security etc. — faced by manufacturers trying to manage medical device data in the cloud. You can’t disagree with this statement:

The success of the vision of Smart Connected Health Grid is dependent on wide scale adoption of cloud computing in all areas of healthcare.

There’s no doubt that adoption of cloud-based technologies are starting to provide concrete market opportunities in the Healthcare space.

There are also two major market barriers that will have to addressed in order for the cloud’s full potential to be realized:

1. Who’s going to pay for it?

  • The Apple/Google/Facebook “created a marketplace around the end consumer” model will not work in the medical industry.  Consumers do not manage their own healthcare, and certainly not their medical data.
  • Glucose monitoring is also not a good model. Strips and meters are reimbursed by Medicare and most private insurers.
  • The “Service Delivery Platform” may be a great idea, but unless you can prove its effectiveness at saving money in the overall healthcare delivery system it has only limited value.
  • Proving this effectiveness is difficult to do, and the bar is very high on the expected returns for preventative care.  Maybe this is where the vertically integrated Accountable Care Organizations (ACO) could have an impact?
  • The end consumer (re: their willingness to spend money anyway) is not likely to be part of the revenue generation equation.

2. Interoperability.

  • You can’t overstate connected in “Connected Health Grid.”  This is where the real value is.
  • Data collected from a medical device must be put into context with all of the available health data in order to properly access a patient’s current state.
  • This means you have to make the device data that resides in your cloud available to be consumed by others, e.g. payers, PHRs, hospital EMR systems, etc.  Each of these interfaces is unique and costly. HIPAA is also key barrier here.
  • There are many technical issues surrounding medical device connectivity. I’ve written frequently about these interoperability topics in the past.

The potential is there, but IMO creating a value proposition that will result in a sustainable market based on a technology alone will probably not work. It’s the old “hammer looking for a nail” problem.

Medical device data combined with cloud-based technology will be part of many effective healthcare solutions. Some of these may actually make money, someday.

The Cardiocam: Physiological Monitoring via Webcam

Published on December 19, 2010 by Bob in Medical Devices and Technology. 0 Comments Tags: .

Today’s New York Times Magazine The Year in Ideas: 10th Anniversary Special features the MIT Cardiocam:

Cardiocam is a low-cost, non-contact technology for measurement of physiological signals using a basic digital imaging device such as a Webcam. The ability to perform remote measurements of vital signs is promising for enhancing the delivery of primary health care.

Medgadget covered this in October: MIT Student Uses Webcam to Measure Heart Rate From a Distance includes a video that shows how the Cardiocam is used to create a “medical mirror” for home health monitoring.

A link to a PDF (here) has a full description of the research, including their Cardiac pulse recovery methodology:

The method uses Blind Source (Signal) Separation (BSS) by Independent Component Analysis (ICA) of the changes in the video signal:

Volumetric changes in the facial blood vessels during the cardiac cycle modify the path length of the incident ambient light such that the subsequent changes in amount of reflected light indicate the timing of cardiovascular events.

Very cool.

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