Archive for the 'Interoperability' Category

Open Source Medical Device Connectivity

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

In The Case for Open Source Healthcare IT John Zaleski uses the VistA open source software as a model for improving the medical device data gathering in order to produce a “more robust end product”.  On the whole, I could not agree more. Achieving this in such a diverse and fragmented community would be a real challenge, but it may indeed be a worthwhile path to pursue.

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.

Third Annual Medical Device Connectivity Conference

Published on August 14, 2011 by Bob in FDA, Interoperability and Medical Devices. 0 Comments Tags: , .

This year’s Medical Device Connectivity Conference is less than a month away. It’s being held Sept. 8-9, 2010 in Boston.


In addition to the post-conference workshops, there is also a special preconference event: an open house at the Medical Device Plug and Play Interoperability program’s lab. September 7, from 4pm to 6pm attendees can tour the lab, interact with various demonstrations and chat with program staff.

Tim has put together another great conference.

Standards & Interoperability (S&I) Framework

Published on July 4, 2011 by Bob in EMR and Interoperability. 0 Comments Tags: , .

There’s a new standards organization in town: Standards & Interoperability (S&I) Framework.

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.

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.

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.

Second Annual Medical Device Connectivity Conference

Published on September 2, 2010 by Bob in Interoperability and Medical Devices. 0 Comments Tags: , .

This year’s Medical Device Connectivity Conference is being held Sept. 28-29, 2010 in San Diego.

From the press release Tim Gee says:

The only conference devoted to the topic of medical device connectivity, the program will offer a unique opportunity to get immersed into every aspect of connectivity, workflow automation and enabling technologies. The keynotes and panel discussions on the first day frame the conference’s focus on connectivity and tackle two of the biggest issues facing health care: industry standards and regulatory issues. Program tracks on the second day provide a survey of connectivity applications, clinical capabilities and outcomes, and explore the gap between regulated vendor-managed systems and the customer-managed and controlled environments in which these systems are used.

Here are just a few of the topics I’m particularly interested in:

  • EMERGING PROBLEMS AND RISING AWARENESS OF MEDICAL DEVICE SYSTEMS ON ENTERPRISE NETWORKS
  • LOOKING BEYOND CONNECTIVITY IN HOSPITALS TO HOME HEALTH AND MOBILITY
  • OPEN EHR MANIFESTSO: OPPORTUNITIES FOR MEDICAL DEVICE COMPANIES
  • INTEROPERABLE MEDICAL DEVICE SYSTEM ARCHITECTURES

Looks like another great conference!

Interoperability is a Big Word!

Published on May 13, 2010 by Bob in EMR and Interoperability. 1 Comment Tags: , .

There was a statement in one of the HIStalk Readers Write 5/10/10 articles in that I haven’t been able to get out of my mind. In Digging for Gold in your HIT Applications, Ron Olsen writes:

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.

Why Healthcare IT is Not a Game Changer

Published on February 15, 2010 by Bob in EMR, FDA and Interoperability. 1 Comment Tags: , , , , , .

Last week I attended the WLSA/Continua Mobile Healthcare Symposium and the opening day of the Continua Health Alliance Winter Summit 2010.  Also, a couple of weeks ago I attended a few of the FDA Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness sessions via a Webcast*.

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.

A Medical Device Gateway Data Standard?

Published on November 18, 2009 by Bob in Google, Interoperability, Medical Devices, Microsoft and PHR. 1 Comment Tags: .

The Wipro OEM medical device gateway press release makes it all seem so easy (my highlight):

The device, consisting of interfaces that can feed-in data such as blood pressure, pulse rate, ECG reading and weight from the respective devices, is connected to the gateway that would format it into standard patient information and transmit it to either public health data platform such as Google Health or to private platforms like Microsoft Health Vault.

What exactly is “standard patient information”?  Maybe they’ve finally developed the magic interoperability bullet.  Yeah, right!  I’m sure companies like Capsule see these kind of claims all the time.  Statements like these are unfortunate because they give the impression that health data interoperability is a given. Of course we know that is not the case.

Also, since when is Google Health a public health data platform?

Hat tip: Avantrasara

UPDATE (11/19/09):  Wipro ties up with Intel for rural medical solutions

Standards should be as Simple and Stupid as Possible

Published on October 31, 2009 by Bob in Interoperability. 1 Comment Tags: .

Great post by Adam Bosworth:

Talking to DC

Hat Tip: Joel on Software

Also see Dreaming of Flexible, Simple, Sloppy, Tolerant in Healthcare IT and Liberate the Data!

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