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).

RSS From Medical Design & Outsourcing

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply