Data from Implantable Defibrillators and Pacemakers: The World’s Best Kept Secret


 

     The HITECH (Health Information Technology for Economic and Clinical Health Act, part of the American Recovery and Reinvestment Act of 2009, states that patients have a right to their electronic health record including test results.  Implantable defibrillators and pacemakers contain a significant amount of data which reflects the function of the implanted device system as well as information reflective of a patient’s heart status. The data are derived from a computerized device interrogation which may occur during an office visit or remotely wirelessly.  It is rare for any patient (personal experience) to know that they have a right to the data, and rarer that they ask for it.  If they didn’t know before, then publicity informing patient of their rights to digital health records (I’m still waiting to see this) might change this.

There are over 5,000 medical apps available to consumers, ranging in scope from patient and provider educational tools, to those providing guidance and monitoring of chronic disease.  There is an app at least from one company, for the cardiologist to view a patient’s implantable device data; however, this is not accessible by the patient.  Why is this type of data different from other digital health data?  For one, this technology has been available for over 11 years.  Remote monitoring of implantable cardiac rhythm devices was designed as a service to physicians with a for-profit business model.  It soon evolved into a necessary best-practice free service adopted by all cardiac rhythm device companies because of the beneficial clinical and technical information it provided, recommended by the Heart Rhythm Society.  Some of the information provided is life-saving.  Data containing information regarding a rhythm called atrial fibrillation might identify patients at high risk of stroke, which could prompt preventative treatment.  Other data might contain crucial information signaling malfunction of a device or component under an advisory watch by the FDA. This type of data is very different from other available digital health tools which are not as critically important.  One might make an argument that very high or low blood sugar detected with digital technology is just as critical.  I wouldn’t argue with that, however the patient has ready access to the data.  Cardiac rhythm device patients have no such direct access. There is much more data furnished by these devices than could be digested or needed by the average patient.  However, a patient portal with fundamental information (heart rate settings of the device coupled with  a green light/red light indicator of device system function and rhythm status would be a welcomed and in most cases adequate provision) is sorely needed for patients and caregivers to increase their engagement.  I feel that an educated patient is the best kind.  Let’s get patients with implantable cardiac devices out of the dark, decreasing ignorance, anxiety, and fostering better adherence and doctor-patient relationships.  Help in accomplishing this will involve multiple stakeholders (professional groups, patient advocates, and industry), but it can and will happen.  This author will make sure of that.

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About davidleescher

David Lee Scher, MD is Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in helping digital health technology companies, their partners and clients. As a former cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he is uniquely qualified to address both clinical and operational concerns of clients. Scher was Chair of Happtique's Blue Ribbon Panel which established standards for certification of medical apps in the categories of safety, operability, privacy, and content. He is a well-respected expert in mobile and other digital health technologies and lectures worldwide on technology and its impact on patients and healthcare systems.
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One Response to Data from Implantable Defibrillators and Pacemakers: The World’s Best Kept Secret

  1. Pingback: Your Essential Medical Device News Resource » Blog Archive » Would You Want To See Real-Time Data from Your Implantable Pacemaker?

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