Bob on Medical Device Software

Tim Gee’s EMR Connectivity for Medical Devices Is a Mess post is right on target. I’ve also expressed my opinion (”total chaos”) on this, but as you’ll see I’m coming from a different perspective.

The HealthLeaders Technology article primarily focuses on the challenges of interfacing medical devices in the hospital environment. I think the situation in a physician’s private practice or small group office is even worse.

The needs for medical device connectivity in both environments are essentially the same:

• Reduction in medical errors.
• Decrease in paperwork.
• Increased staff productivity.
• Timely delivery of clinical results.

Hospitals have the advantage of working with big EMR vendors who in turn can provide connectivity solutions for a larger variety of medical devices. Also, large hospital chains have enough clout to be able to mandate performance criteria from their vendors that include interoperability.

The typical physician’s office uses a smaller EMR provider (or even worse, a ‘home brew’ system) where in many cases connectivity with external devices is an afterthought, if it exists at all. Even when you work with mid-sized EMR companies, each has their own proprietary external data interface. Very few of these smaller stand-alone EMR management systems provide standard interfaces (e.g. HL7) for external device data capture.

The interoperability problem is not a technical one. The issue is the time and resources it takes to implement and validate a given medical device interface. The real hope of a MD PnP-like solution is that the cost of that interface can be significantly reduced.

So, here’s my perspective. As a medical device manufacturer, when we take our device into a private practice physician that has an existing (or planned) EMR system the first requirement is pretty much always the same. It’s simply that the diagnostic results from our device automatically appear in a patient’s record in their EMR system. To make this happen, they have to choose between three possibilities:

1. Pay the medical device manufacturer (us) to interface with their EMR system.
2. Pay their EMR vendor to do the interface.
3. Find a third party vendor or contractor that will provide or build the custom interface.

The problem with #1 is that we don’t have the resources to build each unique interface required to satisfy all of our customers. Plus that, our business is building medical devices, not EMR solutions.

#2 might not work out because unless the EMR company has a lot of customers with our devices they will either charge a large custom engineering fee or may just say they won’t do it at all. The third option is doable, but is also potentially costly.

Notice that all of the choices require additional investment by the physician. I wonder if these types of issues may be one of the contributing factors for the low adoption rate of EMR for office-based physicians.

Not being able to provide cost-effective EMR integration is bad for everyone involved. It’s bad for a medical device manufacturer (like us) because it makes it that much harder to sell systems. It’s bad for the physician’s office because without EMR integration they’ll end up with a less effective paper-based solution. It’s also bad for the EMR companies because they won’t be able to take advantage of the future opportunities that a fully integrated medical office would provide.

The reasons may be different, but my conclusion about EMR connectivity with medical devices is the same as Tim’s: “It’s a mess.”

UPDATE (7/21/08): Ran across this MIT Technology Review post about the MD PnP program:
“Plug and Play” Hospitals (Medical devices that exchange data could make hospitals safer).

Following my EMR-Facebook brainstorming post I ran across the IndivoHealth project (via WSJ-Health Blog). The announcement is that a consortium of large companies, Dossia, would be extending the Indivo open source core. Indivo has implemented the paradigm shift that I discussed.

The Indivo system is essentially an inversion of the current approach to medical records, in that the record resides with the patients and the patients grant permissions to institutions, clinicians, researchers, and other users of medical information. Indivo is a distributed, web-based, personally controlled electronic medical record system that is ubiquitously accessible to the nomadic user, built to public standards, and available under an open-source license.

Very cool. I guess I wasn’t the first to think of this!

There’s an article in the October The Atlantic Monthly entitled About Facebook (subscription required) by Michael Hirschorn. His contention is that Facebook is currently the site that “comes closest to fulfilling the promise of social media.” As I read though the description of what that means — the way you qualify friends, the ability to track others and their interaction with others, and the restrictions you can put in place on what others can see about you, the groups you join, etc. — it made me think of the implementation of EMR systems. The primary components that Facebook has tackled are work flow and interoperability (I’ve touched a little on this before).

Maybe the Facebook model could point the way to better EMR solutions. As I started to look around I found that others are thinking the same way.

The first question is how are the requirements for an EMR system solved though the functionality provided by a social network?

1. Patient-centric: I think a huge missing piece in today’s EMR systems is patient interaction. Most are only concerned with data presentation, record management, and billing functions for the physician. Except for a few limited read-only web portals, the patient does not have the ability to add content or even interact with their own medical record. An important paradigm shift would be that the physician would seek out and gain permission to access the patients private medical account, not the other way around.
2. Patient-Doctor interaction: By not allowing the patient to have interactive control over their health information you are also limiting their ability to interact with their physician(s). Also, if multiple physicians were able to have a common platform for patient consultations it would save time, confusion, and duplication. Patients and their doctors can be thought of as a group of friends that need to interact in a unique way.
3. Multi-media: If teenagers can share music and video, why can’t patients and doctors share symptoms and test results just as easily? Also, the improved Web 2.0 interactivity holds a lot of promise for innovations in the presentation of medical data (e.g. Silverlight comes to mind).
4. Security: Nothing is perfect, but I think the Web has already proven itself secure. Think about the number of Web sites where you’ve left your credit card number, let alone if you’re like me you do all of your banking on-line. HIPAA standards can most certainly be met with current Web technology.

As the article points out:

In Facebook’s vision of the Web, you, the user, are in control of your persona.

The same should be said for your personal health information.

In addition to providing work flow restrictions, Facebook also allows developers to create custom applications though the use of the Facebook Platform. By doing so, it has created a well-defined sandbox in which to create user defined content. MySpace will also be following suite in this regard.

It’s the “walled garden” that opens the door to interoperability. This strategy is considered flawed by some (quoted in the article), but is perfect for EMR purposes. Within the confines of these APIs any medical record content provider would be able to share their data inside the sandbox. The real value is the content of the data, not the mechanism that allows access into the environment.

I know there are many other issues that need to be dealt with when considering EMR functionality. However, when thinking about the popularity and ease-of-use of these social networking sites it’s hard not to see them as a possible model for improving health information flow.

I think the recent New York Time’s article entitled Google and Microsoft Look to Change Health Care missed the bigger picture. The article talks about other Internet companies (like WebMD), but it does not make any mention of the Federal Government’s involvement in this arena.

In particular is the Nationwide Health Information Network (NHIN) which was initiated by an executive order in April 2004:

The Nationwide Health Information Network (NHIN) is the critical portion of the health IT agenda intended to provide a secure, nationwide, interoperable health information infrastructure that will connect providers, consumers, and others involved in supporting health and healthcare. The NHIN will enable health information to follow the consumer, be available for clinical decision making, and support appropriate use of healthcare information beyond direct patient care so as to improve health.

At the end of May NHIN published four prototype architectures. The proposals are standards-based, use decentralized databases and services (’network of networks’), and try to incorporate existing healthcare information systems. The companies involved were Accenture, CSC/Connecting for Health, IBM, and Northrop Grumman.

It seems to me that Google and Microsoft are using their proprietary technologies to try to achieve the same goals as NHIN. One of the major differences of course is transparency. Everything that NHIN does is open to public scrutiny whereas GOOG/MSFT have their own market research programs and keep their strategies (for making money) close to the vest.

Besides ensuring privacy, I would argue that one of the key components for creating a successful NHIN is interoperability. Even with “standards” like HL7 and DICOM being available, IMHO the current state of the Electronic Health/Medical Records industry is total chaos. Just like GOOG/MSFT are creating their own islands of knowledge, there are a lot of other vendors (84 listed on Yahoo! Directory) doing the same. As a medical device developer trying to interface with customer EMR systems, we’re faced with having to provide essentially unique solutions to (what seems like) just about every customer. If that’s the reality down here in the trenches, a NHIN is most likely a very long way off.

In a related item, there are some screen shoots from the future Google Health service (codenamed “Weaver”) here.

Update: Dr. Bill Crounse at the HealthBlog also has some thoughts about the NYT article: Doctor Google and Doctor Microsoft; if not them, who?