There was one item I’d like to comment on:

The challenge is, of course, regarding regulatory management of open source frameworks. To a large degree open source software is anathema to the FDA regulatory process–and it relates to control and management of access.

OSS detested or loathed by the FDA? I don’t think so. The open source framework itself would not be subject to regulatory control.  The FDA does not really care where any specific software component comes from.  Also, security and  access management are certainly important, but I’m not sure of their applicability at the device connectivity level.

The FDA cares about intended use, efficacy, and safety of medical devices. All FDA regulated software is subject to the same design controls (§820.30) — design, risk analysis, verification, validation, etc. I.e. any company that included these open source software components would ultimately be responsible for proving these processes are followed.

Shahid N Shah’s OSCon 2011 Talk: The implications of open source technologies in safety critical medical device platforms does a good job of detailing these points (Will the FDA accept open source in safety-critical system? Yes!) as well as presenting an OSS connectivity software architecture.

The objective of the S&I framework is to create a robust, repeatable process based on federal best practices that will enable ONC to execute on initiatives that will help improve interoperability and adoption of standards and health information technology.

The question is where is this new effort going to squeeze itself into the bigger picture of Healthcare Un-Interoperability?

It’s been close to four years and nothing has really changed.

A lot of effort was put into HITSP, but “the S&I Framework is not envisioned to be the “sequel” to HITSP, but a new evolution in standards harmonization.”  Your have to wonder how YASC (Yet Another Standards Committee) initiated by the government is going to add clarity to an already confused standards landscape — again.

Technically, you have to love a standard that fully embraces acronyms:

• Computational Independent Model (MDA-CIM)
• Platform Independent Model (PIM)
• Platform Specific Model (PSM)
• Information Exchange Package Documentation (IEPD)
• National Information Exchange Model (NIEM)
• NIEM Health IEPD

Together, the CIM, PIM and PSM will be compiled to generate the NIEM Health IEPD.

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.

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.

Keely Wray advocates that PCHR data should be “Hackable” (my highlight):

I mean “hackable” in the sense of the word that is quickly growing in popularity: allow owners of a product to manipulate, re-purpose or add to the functionality of a product to serve their own personal needs.

Ms. Wray asks:

Doesn’t it make sense to allow patients to put the technologies together in a way that meets their needs?

Their own needs? Maybe yes, but probably not.

The biggest incentive for innovation will be where someone sees an opportunity to meet a lot of other people’s needs. This may well be for group that shares a common problem or aliment with the technologist(s).  The initial intent may be altruistic, but real growth will only take place when a market emerges.  This is the reality that could lead to significant new health data management solutions.

For example, PatientsLikeMe started off this way (from the About Us page):

Our personal experiences with ALS (Lou Gehrig’s disease) inspired us to create a community of patients, doctors, and organizations that inspires, informs, and empowers individuals.

There’s nothing wrong with that.

One of the most over-used buzz words in healthcare IT is “interoperability,” a is really a big word that self-important people use to describe data transfer.

OMG, I’ve been using that word for a long time…

All joking aside, for the most part Mr Olsen’s advise to get more out of existing IT tools is a reasonable suggestion. Unfortunately, interoperability means a lot more than just “data transfer” (see Healthcare IT Interoperability Defined), and is where the advise breaks down.

Scripting tools can manipulate those files, turning them into almost any format imaginable. With the correct format, data can be transferred to disparate systems, individually or concurrently, via a data stream.

The fundamental flaw in this statement is the oversimplification (sorry, another big word) of the problem. Simple scripts are good for simple tasks. Communicating medical data reliably and securely between disparate systems is not a simple task.

I would also encourage all HIT professionals to fully understand the tools at their disposal in order to improve the efficiency and effectiveness of their organizations.  There may be a few nuggets, I’m not so sure that there will be a whole lot of gold to be found when it comes to  interoperability.

Since I’m not going to HIMSS in Atlanta this year (starts Mar. 1) I thought now would be a good time to do some venting.

I’ve talked about HIT problems before, e.g. Healthcare Un-Interoperability and The EMR-Medical Devices Mess. With all of the ARRA/HITECH talk along with the National Healthcare debate raging it made me wonder how the issues facing device interoperability, wireless Healthcare, and HIT in general really fit in to the bigger picture.

After sitting though multiple sessions on a wide variety of topics presented by smart people the obvious hit me in the face:  The complexity of the issues are mind numbing. Everybody has good (and even great) ideas, but nobody has real solutions. Why is it that all this good HIT hasn’t translated into meaningful improvements in Healthcare?

For example. At first I thought the talk by Dr. Patrick Soon-Shiong might be heading somewhere interesting.  He presented a well structured view of the current Healthcare landscape that seemed to make a lot of sense. Then he plunged into the abyss with an in-depth discussion of transformational technologies (molecular data mining, Visual Evoked Potentials, etc.).  These developments could potentially lead to improvements in people’s health, but we never got to hear how any of the complex Healthcare delivery issues were going to be addressed.

Among his many endeavors Dr. Soon-Shiong is Chairman of  the National Coalition for Health Integration (NCHI). I think the “Zone of Complexity” point of view (see here — warning PDF) is a good starting point for understanding the position that Healthcare IT is in:

Also, following the diagram above is this statement:

However, currently, even when information is in digital formats, data are not accessible because they reside in different “silos” within and between organizations. In turn, the U.S. health system is hampered by inefficient virtual organizations that lack the mechanisms needed to engage in coordinated action.

The NCHI Integrated Health Platform (grid computing) is a good idea, but does it really even begin to provide the solution to these complex problems?

1. They are taking a “bottom-up” approach to interoperability (system, data , and process) and trying to leverage existing technologies (like DICOM and HL7).  Makes sense. But other than academic or government institutions what’s the incentive for private  companies (like EMRs) to participate?
2. How is an improved underlying infrastructure going to reduce the chaotic nature of the health delivery system (hospitals, insurance companies, Medicare, etc.)? It’s like putting the cart before the horse.

This is the dilemma. We can come up with clever and even ingenious technical solutions in our little IT world, but none of them are going to be game changers.   The availability of a great technologies are not enough to change the institutional processes that make an organization inefficient or communication ineffective.

The solution is in the people and the processes they follow. The best example I can think of is EMR adoption. Everybody knows why the rate of conversion from a paper to a paperless office is so low.  It’s mostly because of people’s resistance to change the way they’ve “always done it.”  Change is hard, and in this case HIT is the barrier to adoption, no mater how good the EMR solution is.

At the national level Healthcare IT only enables interoperability and improved data management.  The chaos can only be solved by first changing U.S. Healthcare delivery policies.  Whatever the changes are, they will then determine the incentives and processes that actually drive the system and put HIT to use.

For Healthcare IT, the NCHI is just one example. There are a whole bunch of other technology-driven initiatives that also have high hopes.  I’m not saying we should stop developing great technologies.  We just shouldn’t be surprised when they don’t change the world.

Happy Presidents Day!

UPDATE (8/4/10): Martin Fowler’s UtilityVsStrategicDichotomy post is another perspective on “IT Doesn’t Matter”.

*I thought the Webcast was very well done.  It had split screen (speaker and slides) along with multiple camera views that included the audience. The video quality wasn’t great (it really didn’t need to be) but the streaming was reliable.  Also, the web participants could chat among themselves and the on-site staff and ask the speaker questions.

But by 2020, when a vast majority of American health providers are expected to have electronic health systems, the data mining component alone could generate sales of up to $5 billion…

The magnitude of data needed to generate that kind a revenue is significant.  The likelihood that “de-identification” of someone’s health information will occur is very high.  “Anonymized” Data Really Isn’t points out the same thing that the NYT article does:

Computer scientists over the past fifteen years show that it is quite straightforward to extract personal information by analyzing seemingly unrelated, “anonymized” data sets.

The demand for the secondary use of health data (and here) is high because it is believed it will

Significantly improve the quality of patient care and offers the promise of even greater benefits in the future.

Many feel that use of secondary health information should be regulated by the government.

Here’s a good overview that covers many health data secondary use issues: Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper.

UPDATE (10/20/09): Also see the Wired article Medical Records: Stored in the Cloud, Sold on the Open Market.

Medical Data in the Internet “cloud”:

• (part 1) – Data Safety
• (part 2) – Data Security
• (part 3) – Data Privacy

Being an EMR in the cloud requires Practice Fusion to address these issues in depth. If you’re thinking about putting health information in the cloud like I’ve previously discussed, these articles are worth a careful read.

Hat Tip:  Healthcare IT News

UPDATE (10/1/2009):

Some commentary on the Practice Fusion EHR:  Cloud based EHRs – a response to PracticeFusion.

UPDATE (10/5/2009): EMR Vendor Practice Fusion’s CEO Interview

I’ll get back to his central points in a minute. One thing I find fascinating is the knee-jerk reaction in the comments to even a hint of government control.  How on earth can someone jump from “industry standard” to a “march towards socialism”? We saw the same thing at this summer’s town hall meetings and in Washington a couple of weeks ago.  The whole health care debate is just mind boggling!

Anyway, let’s focus on the major points of the article. First:

Every industry, as its use of computing matures, eventually moves toward industry standards. It happened in law, it happened in manufacturing, it happened in publishing.

It has not happened, yet, in medicine.

Very true.  In the medical device world, connectivity and interoperability are hot topics. A couple of recent posts — Plug-and-Play Medicine and Medical Device Software on Shared Computers — point out the significant challenges in this area.  In particular, the development and adoption of standards is a very intensive and political process. But where’s the incentive for the industry to go through this? Dana’s comment addresses this (my emphasis):

The role I like best for government is in directing market incentives toward solutions, and not just to monopolies or bigger problems.

The reason health care costs jump every year is because market incentives cause them to. Those incentives must be changed, but the market won’t by itself because the market profits from them.

Only government can transform incentives. …

Like it or not, this may to the only way to push the medical industry to do the right thing.  But those other industries didn’t need government intervention in order to create their standards.  Using PC (or other industry) standards as a model for facilitating medical data access just doesn’t work.  The health industry will have to dragged to the table kicking and screaming, and the carrot (or stick) will have to be large in order for them to come to a consensus.

Second, I don’t see the relationship between the use of PHRs and the promotion of standards.

By supporting PHRs, you support your right to your own data. You support liberating data from proprietary systems and placing it under industry standards.  You support integrating your health with the world of the Web, and the benefits such industry standards can deliver to you.

Taking responsibility for your own health data is great, but both Microsoft HealthVault and Google Health are proprietary systems.  Just because your data is on the Web doesn’t make it any more accessible.  And even if one of these PHRs did became an industry standard, it would have very little impact on how EMRs communicate with each other or medical devices in general.

There are no easy answers.