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 (

RSS From Medical Design & Outsourcing

  • Vicon captures a new development in motion capture (mocap)
    Vicon announced the launch of its new flagship camera platform, the Vicon Vantage. Drawing on over 30 years’ of motion capture (mocap) experience, the Vantage platform combines innovative technology with accessible design to open up motion capture to a broader audience. Vicon is a motion capture technology specialist company for science and life industries. Advances in […]
  • Satel’s latest product sets a new milestone in radio manufacturing
    The new Satelline TR4, from the Finnish manufacturer of radio data transmission systems, Satel sets a new milestone. The compact UHF transceiver with transmitting power of 1,000 mW is compatible with the protocols of Pacific Crest, Trimble and Satel. The type certifications in all important regions of the world make the TR4 ideal for integration […]
  • SCHURTER announces retirement of founder and management changes
    SCHURTER announced the retirement of founder Bruno H. Schurter on June 29, 2015. The company, founded in 1982 in Petaluma, California, will change management effective July 1, 2015. Bruno H. Schurter, president and CEO will retire after 33 years of heading up the privately held company, which is a subsidiary of SCHURTER Holding AG, founded in […]
  • Silicone: Expanding the horizon for modern medical devices
    Editor’s note: This article comes from Albright Technologies a manufacturer of custom silicone prototypes and provides volume production for medical, pharmaceutical, industrial, and other applications. Silicone materials have been around for more than 70 years. Beginning in the 1960s, silicones have played an important and evolving part in products designed for the medical field. Since that time, […]
  • DeNovo Sciences appoints a molecular diagnostics veteran as new CSO
    DeNovo Sciences, a producer of  liquid biopsy products, announced the appointment of Dr. Yixin Wang as Chief Scientific Officer (CSO). Dr. Wang is a veteran in molecular diagnostics where he has played significant R&D roles at large, multi-national companies including Parke-Davis/Pfizer, Veridex/Johnson & Johnson and Ventana/Roche. He will lead strategic initiatives for clinical development of DeNovo’s […]
  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]
  • GDS security protects medical devices from hackers
    As data breaches become more commonplace with serious consequences to personal, corporate and national security, it is clear that there is no shortage of accomplished and effective hackers ready to steal data and trade it on the open market. Global Data Sentinel (GDS) has the ability to provide retroactive security to remove access to email […]
  • BRAEBON and SomnoMed combine products to combat sleep apnea
    BRAEBON Medical Corporation announces that the DentiTrac oral appliance compliance system has passed a regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device. BRAEBON congratulates SomnoMed for being the first company to achieve this milestone. “We are pleased DentiTrac is launching in the US market. Accurate oral appliance […]
  • For advanced shielded plastic connector solution, ODU delivers with latest product
    ODU, a company which designs and manufactures connector solutions and cable assemblies, is announcing ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions, to the US market. ODU MEDI-SNAP EMC is the latest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable […]

Leave a Reply