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The Washington Senator, the FDA Head, the Data Silo and the Heartbeat Wristwatch

August 25, 2016

By Mendy Hecht, Hamaspik Gazette

High-profile Public Officials Address Intersection of Personal Data, Modern Medicine

Besides being influential public servants in positions of power over American health policy, Sen. Elizabeth Warren (D-Mass.) and FDA leader Robert M. Califf, M.D. have another thing in common: They both recently took to respected publications to independently call for modern medicine to harness the enormous and still-growing power of personal health data.

In an August 4 editorial in the leading New England Journal of Medicine, Sen. Warren, long a proponent of healthcare improvement, dwells on data sharing—specifically, free trade of and access to the raw and nameless banks of numbers that result from clinical trials.

The Massachusetts Senator argues that data from clinical trials and other medical studies should be shared with researchers across the industry, with an eye toward facilitating more independent research. 

Sen. Warren even opines that medical publications should require researchers to agree to share their data with industry peers before even considering their research for publication.  “This requirement would be a significant step forward in improving the transparency of clinical trials for consumers and the academic medical community,” she writes.

The general non-accessibility of research data between research entities is the “silo effect” whose eventual elimination is the goal of Vice President Joe Biden’s current cancer “moon shot” effort.  

The Vice President’s initiative aims to foster universal access to cancer research data across the field of independent researchers.  Sen. Warren’s editorial applies that concept to all of medical research.

“Data sharing has incredible potential to strengthen academic research, the practice of medicine, and the integrity of the clinical trial system,” Sen. Warren posits.  “I look forward to following these proposals as they continue to develop and urging their implementation.”

Pressing for progress in another corner of the vast intersecting vistas of public health and data is the Food and Drug Administration’s Dr. Robert M. Califf.

“We are now entering a new era in medicine that is characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices,” Dr. Califf recently editorialized in the Journal of the American College of Cardiology.

The FDA head invoke today’s world, in which more and more people are surrounded by all sorts of personal electronic gadgets, and not just cell phones, that can record every bit of personal vital health data, including heart health.

As far as Dr. Callif sees it, that disconnected jumble of heart health data can—and should—be fused into one seamless system that allows today’s cardiology to take a bold leap into a high-tech future.

According to Califf, a flood of quality patient heart data is waiting for the tapping.

“Dramatic improvements in the rate, quantity, and quality of evidence generation are within reach,” he wrote.  “Almost all Americans now have electronic health records, and social media combined with wearable devices are opening new frontiers in patient- and population-level data.  When combined with modern informatics and computing resources, this rich tapestry of information will enable a true paradigm shift.”

The two editorials come against the background of a public health policy study written by the highest-ranking public official in the country, and world, for that matter, U.S. President Barack Obama, who took to the prestigious pages of the Journal of the American Medical Association (JAMA) on Aug. 2 to make a compelling case for the efficacy of his Affordable Care Act.

But personal health data finds itself increasingly at loggerheads with personal privacy—with the powerful provisions of the landmark HIPAA patient-privacy law long since outmoded by the advent of personal health-data technology.

Those newfangled wristwatches that count your every footfall and take your pulse, ever-efficient and increasingly-shrinking blood glucose monitors, and smartphone apps that keep an eagle eye on your diet and exercise habits (if you’re honest, that is) are all an infinite treasure trove of data just waiting to be mined.

But who gets their hands on that data, and what they do with it, remains to be seen.