Patients deserve their data | Guest Editorial by Joe Kiani, Masimo CEO

Joe Kiani

By Joe Kiani

It’s astonishing there is even a debate whether patients should have access to their own health information from medical devices being used to physically monitor their wellbeing.

Keeping patients in the dark is not a prescription for patient safety and better patient outcomes. Indeed, access to information critical to the health of an individual is at the heart of improving patient safety.

The tragedy reported in the New York Times of 12-year-old Rory Staunton from Queens, N.Y., who died this year from sepsis just a few days after being released from a hospital, stands as a stark reminder of how communication silos in healthcare contribute to sometimes avoidable adverse events. Other recent stories of patients with heart defibrillators underscore the frustration many patients experience in trying to obtain their own health information, even from devices that are implanted inside their own bodies.

I recently met with the mother of an 11-year-old girl who died of preventable respiratory depression that went undetected. I believe that avoiding the death of one child and all the destruction it can bring to families is enough reason to do everything reasonable to ensure these types of preventable tragedies never occur. Part of that is ensuring patients have access to their own health information, regardless of where it resides or who perceives ownership of it.

The number of preventable deaths at U.S. hospitals – just among Medicare patients – is estimated to be as high as 180,000 a year, according to the Department of Health and Human Services, Office of the Inspector General. We know that a lack of meaningful communication and information sharing among medical technologies, clinicians and patients contributes to poor patient outcomes.

Patient advocates, healthcare leaders and government officials tell us we should empower patients and families with better information so they can make better healthcare decisions. Yet when it comes to obtaining medical information from medical devices, patients are told either they need their doctor’s permission first, or the device maker that “controls the data” cannot release it to the patient.

In what other aspect of society do keepers of our own information decide when and what we can see about ourselves? We’re not required to get approval from a financial advisor before we can see our bank account balances. We don’t need approval from a professor before we can see our own college transcripts. Patients should not be required to seek doctor or device maker approval to see their own medical information housed in medical devices.

There is no doubt that medical device makers have made incredible advances in helping to diagnose, treat and monitor patients with advanced medical, technologies. However, data ownership, information sharing, device integration and interoperability issues are hindering our healthcare system’s ability to stem the tide of preventable patient deaths. As I see it, today’s advances in medical technology should include ways to make patient data more accessible to patients.

Clearly, the 1996 Health Insurance Portability and Accountability Act (HIPAA) – the law governing patient access to their health files held by doctors and hospitals – needs updating to include medical devices. And the Food and Drug Administration needs to better accommodate device-data transparency so that the regulatory process isn’t burdensome to patients, industry and innovation.

Yet at this crucial intersection of technological innovation and patient rights, medical device manufacturers owe it to clinicians and patients to make their data more accessible and consumer-friendly.

At the upcoming Patient Safety, Science & Technology Summit, Jan. 13-14, 2013, I hope to create a movement of industry collaboration and ‘coopetition’ that will remove the device and information barriers that are plaguing patient safety. As a first step, I am signing what I call a pledge to patients. And I am challenging my device-maker counterparts and others in the healthcare industry to make similar pledges to improve patient safety.

As leaders of our respective industries/professions, I believe that we are collectively committed to improving patient safety. 

I invite us to consider that the data we produce be the patient’s data, to be used for the empowerment of those patients and on their behalf by clinicians and manufacturers, regardless of where or when their care is being provided

Toward that end, I pledge to make the data that my company’s products produce, subject to HIPAA, available to anyone who wants to use it for the betterment of patient care.

This is my pledge to making a better healthcare system, so that there will be no more stories like Rory’s.

Will you join me in making a pledge for patient safety?

Mr. Kiani is a medical technology innovator, corporate patient advocate, founder and CEO of Masimo Corporation, founder and Chairman of the Masimo Foundation for Ethics, Innovation & Competition in Healthcare, and the visionary responsible for creating the Patient Safety Science & Technology Summit (www.patientsafetysummit.org).

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