Part 2: What not to do.
In Part 1 of this series, we reviewed EHR systems and protocols of greatest concern to a telemedicine system seeking to pass clinical information to the EHR.
That revealed the confounding situation where the least rigorous (from an academic/theorist point of view) standard – HL7 v2.x – dominates and the newer rigorously structured standards have had a hard time gaining traction in actual usage.
Lessons learned from efforts to create standards
In Part 2, we’ll talk about the lessons learned from efforts to create standards and how telemedicine could benefit from them in going forward.
As important as rigorous structure might be in academic circles and with standards purists, what matters in a fast moving competitive environment is timely usefulness.
Communication today is built on the Internet. Up until recently, end points for telemedicine have been video conferencing set top platforms, PCs and tablets. Typically, the patient end station has the medical devices and needs to get that information to the clinician and into the EHR.
In many hospital telemedicine systems, both the clinician end and patient end stations are on the hospital network with access to the EHR.
Home telemedicine stations and Remote Patient Monitoring stations typically don’t have direct access to the system’s EHR. When the patient end point is a mobile device, access to the EHR is even more difficult.
In addition to the need to send medical device measurements into the EHR, it is becoming more important for the person at the patient end point to be able to view information from the EHR.
Telemedicine Driving Need for EHR Standards
Where there is a need, solutions quickly follow. The telemedicine market is driving this need and it is going to be fulfilled with or without standards.
There are precedents for this so we have some insight into how this might unfold. The challenge is to learn from those precedents so we could do a better job in dealing with the current situation.
We saw one precedent in Part 1 where a flawed standard (HL7 v2) was embraced on an ad hoc basis and held off other highly structured, more abstract later standards.
HL7 v2 took off precisely because it was allowed to be done ad hoc. HL7 v3 could not unseat it. FIHR has a lot of merit, but still isn’t complete enough or simple enough to have an impact.
What can we learn from the medical device market in creating useful standards?
At one extreme, look at the medical device market where governments specify standards to which everyone is forced to comply.
For example, the FDA requires compliance to its Quality System Regulations for medical devices used in the USA; in other parts of the world compliance to ISO 13485 is required.
As these standards demonstrate, creating a perfect standard that covers every medical device from high risk (e.g. implantables) to benign (e.g. stethoscopes) produces an unnecessarily high level of complexity for simple devices.
It doesn’t matter if a requirement is illogical, excessive or burdensome; it must be met. (If you have ever wondered why medical devices are so expensive, here is the starting point for understanding.)
At the other extreme is the Internet of Things (IoT). It is charging along driven by market acceptance. No matter how much the purists point out its flaws and vulnerabilities, IoT will keep advancing.
Looking at Protocols. What not to do.
Another precedent to look at is one that is pertinent to telemedicine – ISO/IEEE 11073 Personal Health Device Communications.
Prior to ISO 11073, there were many medical devices that sent device results over a cable or over Bluetooth to a telemedicine hub station. Each device had its own communications interface, so the telemedicine hub had to design its interface software to accommodate them. (Although this sounds very inefficient, the device interfaces were very simple and the individual integration effort small.)
With no device interface standard, the standards group had an open field and a receptive audience in the telemedicine industry. Hundreds of contributors participated and every kind of medical device was covered. And covered completely.
After about 10 years, it is estimated that there are only about 100 products in the field implementing the ISO 11073 protocol according to the Office of the National Coordinator for Health Information Technology (ONC). And most of those also have simplistic proprietary interface as integration alternatives, which continue to be used extensively.
While this is certainly not a failure, given such broad backing and having no competing standard to dislodge, ISO 11073 did not achieve the success initially hoped for. At risk of over simplifying, the problem was too much complexity.
To make all the participants happy (including those playing the role of “devil’s advocate”) completeness was required including unlikely or unusual scenarios.
The penalties for complexity are more difficult implementation, more difficult testing and more things to go wrong. Exactly what the KISS principle argues against.
The free market does not wait for completeness and has little tolerance for unnecessary complexity.
Coming back to EHRs, new standards like FHIR and openEHR have a double burden – creating a standard that meets every possible requirement and supplanting a widely installed base.
It’s no wonder that integrating telemedicine into the EHR world is so difficult.
But it doesn’t have to be. There is a middle ground between a free wheeling ad hoc approach and an excessively complex standard in a free market.
In Part 3 of this series, we’ll lay the groundwork for such a solution.
With over 20 years in telemedicine, C. R. (Rich) Abbruscato is one of the pioneers in the telemedicine market. He is founder of RNK Products (using the brand Telehealth Technologies) a company dedicated to the design, development and manufacture of telemedicine medical devices (most notably real-time stethoscopes) and telemedicine systems.
Rich is a Guest Contributor for EHRGuide.org.