Archive for the 'EMR' Category

Americans Killed by Medical Errors Today

Current events have sparked popular tweets like this:

deaths-today

As referenced by the West Health To Err is Human: Interoperability is Divine article, based on a 300,000 annual death rate, the following could be added to the list:

Americans killed by medical errors today: 822

This shocking statistic positions medical errors as the third leading cause of death in the United States, behind heart disease and cancer.

Also see Deaths by medical mistakes hit records. Pretty depressing.

This is a complex problem to solve, but reducing preventable deaths with improved patient safety technology should be a priority. No duh!

Interoperability: Arrested Progress

When it comes to the state of interoperability in the medical device industry there couldn’t be a better metaphor than Arrested Development*.  A dysfunctional family made up of eccentric well-meaning personalities each doing their own thing, oblivious to each other and the rest of the world.

Healthcare Un-Interoperability has long been one of my favorite subjects. Let’s review where things are these days.

The article Health IT Interoperability: How Far Along Are We? provides a nice summary of the current state of HIT interoperability. This is particularly important because:

hospitals using basic EHR systems tripled from 12.2 percent in 2009 to 44.4 percent in 2012

For better or worse, it’s the monetary incentives of the Affordable Care Act that push doctors to electronic medical records and is the primary reason for the accelerated rate of EHR adoption. The goal of having more electronic health records is to improve the quality of patient care. Reduction of medication-related errors is a great example: Lack of Interoperability has Ownership for Medication ErrorsThe rapid uptake of these systems can also present problems. For example, in Emergency Departments: EHR systems pose serious concerns, report says.

Nevertheless, it’s clear that electronic medical records is the future in healthcare data management. The down-side of this growth from an interoperability point of view is that there are that many more systems out there that don’t talk to each other!

Initiatives like CommonWell and Healtheway are moving in the right direction but are just getting off the ground. Also, these types of efforts are often far removed from the medical device industry and have little impact on software development and interface decision making.

Let’s step back and look at the HIMSS definition of Interoperability:

  1. Foundational: Data exchange with no interpretation.
  2. Structural:  Allows identification of data structure (fields) but not necessarily data content.
  3. Semantic: Data structuring and codification (interpretation) of the data.

For all practical purposes only #3 (semantic) has value when in comes to the exchange of data with a medical device. As noted in Interoperability: Not a non-issue:

Semantic interoperability continues to be a major challenge and, if not addressed, will have a serious impact on the quality of care.

The same point is made here: Interoperability vs Health Information Exchange: Setting the Record Straight.  Just because you can send it (exchange) doesn’t mean the recipient can understand it (interoperability).

One area that is always part of this discussion are standards. It’s unfortunate that due to technical and (mostly) non-technical reasons the following is often true:

standards-vs-interoperability

Even more disheartening is when you read that a standards-based organization (OpenStack in this case) can’t necessarily make interoperability magically happen:

… success depends upon a single large vendor assuming leadership. Interoperability will follow, but it won’t be designed by committee.

The distress of a well-focused cloud computing API involving a hand-full of vendors makes the outlook for HIT interoperability look particularly bleak.  To make matters worse, the use of OSS in FDA regulated products face additional challenges that are not even seen in most other industries (see Open Source Medical Device Connectivity)

This is all good news for businesses that provide products and services that fill the connectivity gap. Companies like CapsuleiSirona, and Nuvon are many times the only effective way to provide an integration solution to a large number of customers.

I should note that there are some bright spots in the interoperability landscape. For example, the Continua Health Alliance has successfully pulled together over 200 companies to create a vision for inter-operable personal connected health solutions.  Also, the West Health Institute is building standardized communication protocols into their embedded software for medical devices. These and numerous other successes provide hope, but are still just the tip of a very large iceberg.

Dr. Julian Goldman sums up the current situation in Medical Device Interoperability: A ‘Wicked Problem’ of Our Time:

Our years of work on medical device interoperability have led us to see the barriers (including technical, business, liability, standards, and regulatory factors) as “wicked problems,” in which there is little agreement about “the problem,” no agreement on a solution, and problem solving is complex because of external constraints.

Others (Is HIT interoperability in the nature of healthcare?) see the proprietary business model of major HIT companies as the primary culprit.

So what are some possible scenarios for the future?

  1. Same old, same old.  This is essentially Einstein’s definition of insanity: doing the same thing over and over again and expecting different results.
  2. Federally enforced standards and regulations.  Dr. Goldman’s suggestion to require manufacturers to fully disclosure their communication interfaces?   Given the current anti-regulatory environment and budget restrictions, this seems unlikely to happen.
  3. A hegemon, like OpenStack above?  The healthcare industry is too diverse and complex. There is no single player that could even begin to tip the scales.

At least for the foreseeable future it looks like #1 (insanity) is going to prevail. If I’m missing some huge game-changer, please let me know.

In the mean time, let another episode begin!

                                             
*No deep meaning here. Certainly not like Arrested Criticism.  I’m just comparing the medical device industry to a bunch of fictional crazy people.

Design Patterns for EMR/EHR Performance

Healthy Architectures – Using CQRS and Event Sourcing for Electronic Medical Records presents a couple of interesting patterns for the management of healthcare data. The two patterns are:

  • Command Query Responsibility Segregation (CQRS)
  • Event Sourcing (ES)

Here’s another article that provides further clarification on the CQRS pattern and how it compares to ES and Task-Based UIs: CQRS, Task Based UIs, Event Sourcing agh!

These are high level design patterns that result in non-traditional and more complex system architectures when implemented.  The healthcare domain is complex and alternate approaches for providing robust solutions are worth consideration.

Open Source Medical Device Connectivity

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.

Standards & Interoperability (S&I) Framework

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

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

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.

Hacking Your Own Health Data

The MassDevice article Doctors to patients: Track your own health data has an interesting take on the  personally controlled healthcare record (PCHR).

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.

Interoperability is a Big Word!

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

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.

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