Keeping up with the rapid developments in mobile health technology

I had the opportunity to participate in a day-long meeting sponsored by the Heart Rhythm Society (HRS). The goal was to help HRS develop recommendations for physicians and industry on providing patients access to information generated by wearable and implantable cardiac electronic devices.  The organizers invited me to provide the viewpoint of an educated patient.

I can’t say how HRS will ultimately craft the guidance (and I am not involved in writing it), but the discussion was lively, and I came away with a number of impressions.

First, device manufacturers understand that they must move to afford patient access to the data their products are generating, but they are limited in how quickly they can do so by a number of factors, including the slow pace of technical iteration created by close regulatory oversight, the uncertainty of what data patients want and how to present it, and concerns about getting out ahead of electrophysiologists (their traditional customers) on this issue. Nevertheless, I was impressed that there seemed to be unanimity of opinion among the manufacturers that patients should have access to the same data that doctors see.

Second, I learned that defining which data patients – or their doctors – get to see is more complicated than I thought. For example, a pacemaker may have proprietary software for arrhythmia detection. Does the “device data” include the algorithm, the data-set of recorded R-R intervals and QRS morphologies, or just the output of heart rate and rhythm? While there is a need for more discussion, definition, and consensus around these issues, I was pleased again to see that most everybody agreed that patients should see whatever their doctors are seeing.

Last, the regulatory environment has not kept up with changes in technology and demands for more data transparency. A representative of a home monitoring technology pointed out that sharing “machine readings” of rhythm abnormalities with patients would subject his company to a much higher level of regulatory scrutiny than it now has to comply with as a purveyor of information to physicians, who are assumed capable of independently interpreting the findings.

All in all, I left encouraged that we are getting closer to the goal of “data about patients should be the patients’ data.”

Ira Nash is a cardiologist who blogs at Auscultation.

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