Thanks to a Biotronik Eluna 8 DR-T pacemaker that sits below my clavicle, I’m now a thing on the internet of things. What my new gizmo does, other than keeping me ticking, is collect data and send it to a cell device sitting on my nightstand.
Once a day, the cell uploads my data to Biotronik’s Home Monitoring website, where my cardiologist can see what’s going on. If something needs prompt attention, the system sends alerts. Now, this is a one way system. My cardiologist can’t program my pacemaker via the net. To do that requires being near Biotronik’s Renamic inductive system. That means I can’t be hacked like Yahoo email.
The pacemaker collects and sends two kinds of data. The first set shows the unit’s functioning and tells a cardiologist how the unit is programmed and predicts its battery life, etc. The second set measures heart functioning. For example, the system generates a continuous EKG. Here’s the heart related set:
- Atrial Burden per day
- Atrial Paced Rhythm (ApVs)
- Atrial Tachy Episodes (36 out of 48 criteria)
- Complete Paced Rhythm (ApVp)
- Conducted Rhythm (AsVp)
- Counter on AT/AF detections per day
- Duration of Mode Switches
- High Ventricular Rate Counters
- Intrinsic Rhythm (AsVs)
- Mode Switching
- Number of Mode Switches
- Ongoing Atrial Episode Time
- Ventricular Arrhythmia
Considering the pacemaker’s small size, the amount of information it produces is remarkable. What’s good about this system is that its data are available 24/7 on the web.
The bad news is Biotronik systems don’t directly talk to EHRs. Rather, Renamic uses EHR DataSynch, a batch system that complies with IEEE 11073-10103, a standard for implantable devices. EHR DataSynch creates an XML file and ships it along with PDFs to an EHR via a USB key or Bluetooth. However, Renamic doesn’t support LANs. When the EHR receives the file, it places the data in their requisite locations. The company also offers customized interfaces through third party vendors.
For a clinician using the website or Renamic, data access isn’t an issue. However, access can be problematic in an EHR. In that case, the Biotronik data may or may not be kept in the same place or in the same format as other cardiology data. Also, batch files may not be transferred in a timely fashion.
Biotronik’s pacemaker, by all accounts, is an excellent unit and I certainly am glad to have it. However, within the EHR universe, it’s one more non-interoperable device. It takes good advantage of the internet for its patients and their specialists, but stops short of making its critical data readily available. In Biotronik’s defense, their XML system is agnostic, that is, it’s one that almost any EHR vendor can use. Also, the lack of a widely accepted electronic protocol for interfacing EHRs is hardly Biotronik’s fault. However, it is surprising that Biotronik does not market specific, real time interfaces for the products major EHRs.