Archive for the 'Interoperability' Category

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!

The Desperate Need for Simplicity

Published on October 13, 2009 by Bob in Agile, Interoperability and Programming. 0 Comments Tags: .

Ted Neward’s article “Agile is treating the symptoms, not the disease” touches on several important points about the software industry.

  • Modern software development tools and technologies require a significant learning curve.
  • Development methodologies (like Agile) exist for managing complexity, but do not reduce the load of these technologies.
  • In the last decade there has been no “Next Big Thing”, like Access was in the 90s.

What’s most interesting to me is:

We are in desperate need of simplicity in this industry. Whoever gets that, and gets it right, defines the “Next Big Thing”.

What’s true in the broader software world is also generally true in Healthcare IT.  In HIT there has never been an Access equivalent, just a lot of pieces and parts trying unsuccessfully to work together.

The need was touched on in Liberate the Data!.  Simplicity is desperately needed in order to create the “First Big Thing” for HIT interoperability.

UPDATE (10/14/09):  More commentary:

Access to Medical Data: Are PC Standards and PHRs (You) the Answer?

Published on September 22, 2009 by Bob in EMR, Google, Interoperability, Medical Devices and Microsoft. 0 Comments Tags: , , .

Dana Blankenhorn’s article Give medicine access to PC standards makes some good points about the medical device industry but (IMHO) misses the mark when trying to use PC standards and PHRs as models for working towards a solution.

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.

Plug-and-Play Medicine

Published on September 20, 2009 by Bob in HL7, Interoperability and Medical Devices. 1 Comment Tags: , , , .

The MIT Technology Review article Plug-and-Play Medicine claims that:

… a Boston research group has come up with a software platform for sharing information among gadgets …

Uh, what software platform? I discussed the MD PnP program a couple of years ago. Other than the Integrated Clinical Environment (ICE, ASTM F2761:2009) standards work I don’t see a lot of progress, let alone software to look at.  The draft ASTM standard (Dec-2008) is still just a shell. The overall model structure makes sense, but the models themselves are not described in any detail (that I could find anyway).

I have a lot of respect for academic endeavors, but creating a comprehensive standard for something as multidisciplinary and complicated as medical device connectivity will not be an easy task.   I once participated in an ASTM standard that was limited to a single communications protocol, and it took years to finalize.  Developing models for how systems behave and interact is at a level of complexity that I’m not sure can ever really be standardized (how do you nail down a moving target?).

A good example is HL7 V3 RIM (Reference Information Model).  RIM has been under development for more than 10 years and as HL7 RIM: An Incoherent Standard (warning: PDF) points out, many mistakes have been made.  These issues may partially explain the woeful rate of HL7 V3 adoption.

The other thing HL7 V3 shows is the magnitude of work required in these standards efforts. The MD PnP group understands this and that standards are just part of the solution. The slide from here (warning: PDF) summarizes this well:

PnP

Unfortunately, the devil is in all these messy details and is the reason why plug-and-play medicine is still a long way off.

Hat tip: Mike Attili

Medical Device Software on Shared Computers

Published on September 7, 2009 by Bob in FDA, Interoperability, Medical Devices and Networking. 6 Comments

ECG PCThe issues raised in Tim’s post Running Medical Device Software on Shared Computers literally opens Pandora’s box. Installation of medical device software on general purpose computers is an intractable problem.

It’s very similar to the complications associated with Networked Medical Devices, except worse.  An FDA approved device in a changing network environment is one thing.  Software that controls a medical device on a PC that is open for the user to install operating system upgrades, applications, and other device drivers is a recipe for disaster.

I don’t care how obsessed a vendor is, there is no way for a medical device manufacturer to verify proper operation for all possible hardware and software environments.

With today’s PC architectures, the highest risk area is at the device driver level. Running multiple devices that require even modest I/O bandwidth can cause interference that could result in lost or significantly delayed data. This is especially true with Windows XP or Vista that do not inherently provide any real-time data processing capabilities.

I think the best strategy is to provide stand-alone medical devices that have no dependencies on the PC hardware and software that may be available for down-stream data processing and display. This not only reduces compatibility risk, but it can also address mobility issues. With miniaturization and wireless capabilities, the medical device can now travel with the patient.

Also, with Pandora’s box safely closed, solving the networked medical device issues suddenly feels manageable.

UPDATE (9/15/09): Here’s an interesting take on this subject from the consumer perspective: Should Medical Devices Multitask?

Inaugural Medical Device Connectivity Conference and Exhibition

Published on August 27, 2009 by Bob in Interoperability and Medical Devices. 0 Comments Tags: , .

meddeviceconn-conf

Tim Gee has put together an impressive conference. It’s happening Sept. 10-11, 2009 in Boston. Unfortunately, I will not be able to attend. Hopefully Tim and others will be able to provide highlights from the many interesting topics.

Here’s a condensed list of the agenda:

Day 1:

MEDICAL DEVICE  CONNECTIVITY IN HEALTH CARE: WHERE ARE  WE, WHERE ARE WE GOING, AND HOW DO WE  GET THERE?  Tim Gee, Connectologist & Principal, Medical  Connectivity Consulting

CONNECTING  OPERATIONAL AND STRATEGIC PERSPECTIVES  Julian M. Goldman, MD, Medical Director of Biomedical Engineering, Partners HealthCare System, Director,  CIMIT Program on Interoperability and Medical Device Plug-and-Play Interoperability Program, Massachusetts General Hospital

INDUSTRY STANDARDS  (FORMAL AND DE FACTO) IN CONNECTIVITY Charles (Chuck) Parker, Executive Director, Continua Health Alliance

PANEL DISCUSSION: INDUSTRY STANDARDS – WHICH STANDARDS WILL BE ADOPTED AND WHY?

IMPACT OF PROPOSED FDA RULE ON MEDICAL DEVICE DATA SYSTEMS William A. Hyman, ScD, PE, Professor, Department of Biomedical Engineering, Texas A&M University & President, ACCE Healthcare Technology Foundation

IEC 80001 AND PATIENT SAFETY Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, Vice
President, Technology in Medicine, Inc. & Immediate Past President, American College of Clinical Engineering (ACCE)

PANEL DISCUSSION: HOW WILL MDDS AND IEC 80001 IMPACT THE MARKET?

HOW CLINICIANS AND DEVICE MANUFACTURERS CAN COLLABORATE TO REDUCE RISK Steven R. Rakitin, President, Software Quality Consulting & AAMI member

THE BASIC COSTS OF CONNECTIVITY Bridget Moorman, CCE, President, BMoorman Consulting, LLC

Day 2:

TRACK A – INFRASTRUCTURE

CONVERGED MEDICAL DEVICE AND ENTERPRISE NETWORKS: CHALLENGES AND BEST PRACTICES

OPTIMIZING SUPPORT FOR POINT OF CARE AUTOMATION

DISTRIBUTED ANTENNA SYSTEMS: REALITY VERSUS HYPE

WIRELESS SENSORS: PERFORMANCE, COEXISTENCE & INTEROPERABILITY

TRACK B – CONNECTIVITY SOLUTIONS

INFUSION PUMP CONNECTIVITY FOR EMR DOCUMENTATION

ENABLING POINT OF CARE APPLICATIONS WITH DEVICE CONNECTIVITY

POSITIVE PATIENT ASSOCIATIONS IN CONNECTIVITY

OPERATING ROOM INTEGRATION: THE INFORMATION CROSSROADS IN SURGERY

TRACK C – CLINICAL & WORKFLOW IMPACTS

POST SURGICAL PATIENT-CENTRIC CENTRAL SURVEILLANCE: PREDICTORS OF CARDIORESPIRATORY MORBIDITY

THE LINK BETWEEN MEDICAL DEVICE CONNECTIVITY AND CLINICAL DECISION SUPPORT FOR INTERVENTIONAL GUIDANCE

CREATING A CONNECTIVITY STRATEGY FOR HEALTHCARE

OPTIONAL POST-CONFERENCE WORKSHOPS

ONE — DISTRIBUTED ANTENNA SYSTEMS IN HOSPITALS: BEST PRACTICES

TWO — IEC 80001-1: APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES

UPDATE (9/10/09): Tim is posting conference updates here: The Connectologist

UPDATE (9/16/09):

Review #1: Wireless connectivity and medical devices

Integrating wireless technology into medical devices presents the industry with both a carrot and a stick: Stimulus cash (carrot) versus increasing demand for connective devices from hospitals (stick).

Review #2:  Analyst: Healthcare’s wireless sensor opportunity

Gee broke down some of the drivers for the recent interest in medical sensors, outlined use cases and dissected the market for the more than 200 attendees at last week’s event.

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