FEB. 2, 2023

MEET THE SCIENTISTS WHO WANT TO MAKE MEDICAL DEVICES WORK FOR EVERYONE, FINALLY In the early months of the pandemic, Ashraf Fawzy, then a pulmonary fellow at Johns Hopkins University, noticed something strange. Black patients he was treating, all hospitalized with Covid-19, had oxygen levels scattered all over the place, often not in sync with their dire respiratory symptoms. “I remember one particular encounter…an African American woman, relatively young with asthma, came in with Covid [and] we were weaning her off supplemental oxygen,” Fawzy, now an assistant professor of medicine at Johns Hopkins, tells Inverse. But the patient’s pulse oximeter — a non-invasive medical device to rapidly measure blood oxygen levels — were giving readings higher than what her actual oxygen levels were on blood tests. “We realized we were under-treating her with oxygen because we were relying on these inaccurate pulse oximeters,” he says. One inaccurate machine could have been an isolated case, but Fawzy wasn’t the only one noticing something off with pulse oximeters. As the Covid-19 pandemic raged on and the simple fingertip device became an increasingly recommended way to monitor drops in oxygen, a December 2020 study in the New England Journal of Medicine captured national attention: Black patients were nearly three times more likely than white patients to have hidden hypoxemia, or dangerously low oxygen levels missed entirely by pulse oximeters.

"WE REALIZED WE WERE UNDER-TREATING HER WITH OXYGEN BECAUSE WE WERE RELYING ON THESE INACCURATE PULSE OXIMETERS."

The study spurred considerable alarm within the medical community, as pulse oximeters are a heavily relied-on medical device. In 2021, patients and lawmakers sent a letter to the Food and Drug Administration (FDA) expressing concerns about potential racial disparities, noting the pulse oximeter disparity as “a matter of life or death.” “The pulse [oximeter] has become the poster child of [health inequity], in part because of the pandemic. It really highlights the need for diversity at all stages of technology development, from the nascent stages of coming up with a design to how these things are tested, vetted, and distributed,” Kimani Toussaint, a professor of engineering at Brown University, tells Inverse. Pulse oximeters are just one example of a persistent, prevalent, and overlooked problem that the Covid-19 pandemic brought to light: Medicine and healthcare have harbored racial bias since their inception. But this long-known problem finally reached the federal level. In November 2022, the FDA discussed plans to both improve pulse oximeter regulation and provide clearer labeling and more testing of these devices. Now, the question becomes, can scientists fix these biases, starting with the ubiquitous pulse oximeter, and prevent them from happening in the future?

THE HISTORY OF THE PULSE OXIMETER

Long before it made its way to hospitals and consumer markets, the pulse oximeter was originally developed for the military by American and German scientists during World War II, according to a 1986 article in the Journal of Clinical Monitoring. The aim was to prevent fighter pilots from losing consciousness due to oxygen deprivation as they flew at high altitudes. The first iteration of the device, according to the report, was more of a clip-on earring pilots wore that warned them to take supplemental oxygen when their oxygen levels dipped below a critical level, making them more likely to lose consciousness.

PULSE OXIMETERS ARE JUST ONE EXAMPLE OF A PERSISTENT, PREVALENT, AND OVERLOOKED PROBLEM THAT THE COVID-19 PANDEMIC BROUGHT TO LIGHT: MEDICINE AND HEALTHCARE HAVE HARBORED RACIAL BIAS SINCE THEIR INCEPTION.

Between the 1960s and 1970s, while collaborating with NASA to develop health devices for astronauts, computer company Hewlett-Packard (HP) took a stab at expanding the ear pulse oximeter for the hospital market. Interestingly enough, this would be the first attempt at an equitable device, although this probably wasn’t purely for the sake of equity. At the time, and still today, pulse oximeters worked like this: A light source shines two wavelengths of light — red light at 600 nanometers and infrared light at 940 nanometers — into a finger, passing through fingernail, skin, tissue, and blood. Hemoglobin, the molecule that carries oxygen throughout the body, absorbs either wavelength depending on whether it’s oxygenated (absorbing more infrared light) or not (absorbing more red light). How much of either wavelength is relayed back to the pulse oximetry is used to provide a blood oxygen level percentage. HP said it wanted something that would work for all skin types; in the October 1976 issue of their journal, called The Hewlett-Packard Journal, the company acknowledged how oxygen level readings were impacted by “skin and blood pigments, and the surface characteristics of the skin.” HP engineers borrowed the ear clip-on design and wired it with fiber optic cables that transmitted eight different wavelengths of light onto the skin — different brightness settings for different skin types. This build allowed the oxygen reader to be specifically adjusted and calibrated to one’s skin color. Indeed, this appeared to work in experimental trials HP conducted involving Black patients. Later studies of HP’s device show that this early pulse oximeter more closely matched the invasive arterial blood gas tests, which takes a blood sample to measure oxygen levels along with carbon dioxide and pH. Despite its early promise, HP’s pulse oximeter didn’t take off and had quite a number of limitations, Philip Bickler, director of the University of California, San Francisco’s Hypoxia Lab, tells Inverse. “It was a clumsy clamp that you put on the ears that didn’t really account for differences in the size and shape of [someone’s] ears,” says Bickler. On top of that, it was quite pricey at $13,000 a pop in 1970 and found mostly in a select few research labs. With the boom of the personal computing market of the 1980s, HP shifted its focus and abandoned plans to miniaturize its pulse oximeter.

LAYERS ON LAYERS OF BIAS Subsequent devices would continue to use light as a means of measuring oxygen levels. Given how versatile light is with its spectrum of wavelengths and intensities, it wouldn’t have been hard for pulse oximeter manufacturers to calibrate their devices for darker skin tones, as HP had done. But at the time, the nascent market was largely dominated by those of lighter skin, such as in Europe, the U.S., and Japan, says Bickler. The bias persisted simply because differences in skin color weren’t considered at all important. “Any additional complexity [like skin color] was met with resistance and a lack of interest,” says Bickler, who in 2005 co-authored one of several other early studies investigating how skin color affected pulse oximeter readings. “[Our study] was largely ignored. It was inconvenient for pulse oximeter manufacturers to accept that the way they had been testing and calibrating their devices [with lighter skin tones] had a flaw.” The indifference speaks to a wider, persisting crisis of bias within medicine, health care, and pharmaceutical or medical device development, Achuta Kadambi, an engineering professor at the University of California, Los Angeles, tells Inverse. “There’s essentially three types of bias: The bias of the physical layer, which is what we’re talking about often with pulse oximeters,” he says. “Then there’s bias at the [artificial intelligence], or computational, layer, and a third layer is interpretation bias, which means that even if the rest of the system is equitable, you might have a human factor adjust the output accordingly.” A prime example of interpretation bias, says Kadambi, is pulmonary function testing, where the results are filtered through equations that compare, or correct, the data against healthy values based on sex, height, age, as well as race. For Blacks and other ethnic minorities, these adjustments tend to assume a lower lung function. That doesn’t necessarily reflect on someone’s actual innate biology. Instead, it normalizes disparities that lead to poor lung health and exacerbate chronic disease, as studies have found.

THE BIAS EXTENDS EVEN BEYOND WHAT’S TYPICALLY USED IN A CLINICAL SETTING TO OUR EVERYDAY WEARABLES RELAYING A CONSTANT STREAM OF DATA WE USE TO MONITOR AND GUIDE OUR OWN HEALTH.

Other medical-grade devices harboring bias include the ubiquitous infrared thermometers, which are as much relied upon as pulse oximeters to make clinical decisions. A 2022 study out of Emory University found these forehead thermometers, which infer body temperature through infrared radiation produced by the body, were as much as 26 percent less accurate at detecting fever in Black patients compared to oral thermometers. The bias extends even beyond what’s typically used in a clinical setting to our everyday wearables relaying a constant stream of data we use to monitor and guide our own health. Devices like Fitbits and Apple Watches operate in a similar fashion to pulse oximeters, using light sensors to capture information such as oxygen levels and heart rate. Most of these wearables use green light (a cheaper option than red and infrared light used in a hospital-grade device), which a number of studies over the years have found may give inaccurate results for those of darker skin and people with obesity. This bias hasn’t gone unnoticed, judging from online complaints and the fact that last month, Apple was hit with a class-action lawsuit for allegedly not warning consumers that its Watch couldn’t accurately gauge blood oxygen levels for those of darker skin. In the case of pulse oximeters, subsequent studies since the December 2020 report in the New England Journal of Medicine have found inaccurate pulse oximeters readings delayed timely Covid-19 treatments for patients with darker skin or not getting appropriate treatment at all, according to Fawzy, in a study he co-authored in 2022, which was published in JAMA. (Important to note pulse oximeters are not solely to blame for the high Covid-19 mortality rate in Black and other ethnic minorities.) And this is problematic not just for anyone of darker skin hospitalized with Covid-19 but for anyone of darker skin with respiratory issues managed by pulse oximeters. “As a pulmonologist, my main research interest is COPD [chronic obstructive pulmonary disease], and in COPD, we prescribe oxygen to patients based on their pulse oximeter readings,” says Fawzy. “We’ve been depending on [pulse oximeters] to say whether someone has sleep apnea for decades. So it’s really problematic that there’s a potential underdiagnosis in lung diseases for prescribing oxygen [and] a potential for under-diagnosing sleep apnea using these devices.”

WHAT’S THE SOLUTION? In February 2021, the FDA issued a warning that skin pigmentation and other factors could impact pulse oximeter readings. And this past November, a Medical Devices Advisory committee convened to review the current clinical data on pulse oximeters, recommending the agency update its regulation and put labels that warn of potentially inaccurate readings. The FDA has requested new studies to assess pulse oximeter accuracy in hospital settings for both adults and children. For Black engineers like Valencia Koomson, an associate professor of electrical and computer engineering at Tufts University, the challenge to offsetting the racial bias is not so much overhauling the pulse oximeter entirely but finding ways to improve how it functions. “We’re dealing with very weak optical signals that have to transverse through tissues with lots of [other] elements that absorb and scatter light,” she tells Inverse. “It’s very similar to when you’re riding a car, and you go through a tunnel. You lose signal because of the absorption of the materials in the tunnel, such that the signal being transmitted from the cell phone tower is too weak to be processed by your phone. To remedy this, Koomson and her fellow scientists are working on a pulse oximeter that uses the same light as devices currently on the market but includes a technology that measures a person’s skin tone. So if you’ve got darker skin (i.e., more melanin), the pulse oximeter will emit more light. Skin color, though, isn’t the factor that can give rise to inaccurate pulse oximeter readings. At the Hypoxia Lab, Bickler and his colleagues are seeking to comprehensively understand how these other factors like blood flow and body temperature stacked on top of skin color impact a pulse oximeter reading. In a recent study that’s currently in pre-print, the researchers found that poor perfusion, or blood flow through vessels and body tissues, exacerbated inaccurate pulse oximeter oxygen readings alongside skin color. “Poor perfusion is super common in sick people,” says Bickler, due to a combination of problems such as low blood oxygen levels, being dehydrated, or being on medications that cause blood vessels to constrict. Koomson says while further research and innovation are all great and good, it doesn’t change the fact that devising with equity in mind needs to happen at the federal regulatory level, with how the FDA sets guidelines for pulse oximetry approval, which on the whole are relatively lax. “We know that if you have a [federal] guideline that says that a device has to be tested on a minimum of 10 people and at least 15 percent have to be [of] dark skin pigmentation, that opens the door for a lot of loopholes because ‘dark’ is very subjective,” says Koomson. “That subjectivity is going to affect the kind of product that you put out.” Other Black engineers, like Brown’s Kimani Toussaint, are taking a slightly offbeat tack by investigating how light’s electromagnetic waves interact and behave with matter such as body tissues, the skin pigment melanin, and blood.

“We’re trying to exploit [these] properties to see if we can use that to differentiate between the response from oxygenated hemoglobin versus deoxygenated hemoglobin,” says Toussaint. “Although we strive to get rid of the bias completely, it’s still an open question how effective our approach is… and how reduced is the effect of having the melanin contribution.” Toussaint’s lab also has a prototype that’s undergone some initial trials in healthy volunteers. An upcoming clinical study started earlier this year at the intensive care unit at The Miriam Hospital in Providence, Rhode Island. “We’re trying to vet this [device] right now, compare it to [the] gold standard arterial blood draw that physicians normally use,” he says. Bickler, Fawzy, and Toussaint are optimistic that shining a spotlight on the pulse oximeter will be the clarion call to action within the health community, rousing physicians and other healthcare workers to advocate for a better understanding of the inequities inherent in this devices as well as a hunt for solutions — especially as we don’t have more equitable, non-invasive technologies or alternatives on the foreseeable horizon. “The FDA is working very hard towards improving [pulse oximeters]. We’ve had funding from the FDA to study pulse oximeters in patients in the hospital and in real-world clinic conditions in a very carefully controlled way,” says Bickler. “It’s been almost 20 years since this was really defined as a problem, and here we are 20 years later. Yes, it’s way too late, but at least it’s on the radar.” It may also encourage discourse around bias beyond the borders of the pulse oximeter, firmly entrenched in other medical devices and in health care at large. Part of that need for diversity is essential within a workforce that can inform and guide equity during a technology’s development. According to a 2021 Pew Research Center study, while jobs in science, technology, engineering, and math (STEM) have seen considerable growth in years, Black and Hispanic workers still remain underrepresented. “These are things now where we have to think about how technologies aren’t as agnostic as we may have thought in terms of their impact on communities,” says Toussaint, “It’s part of the human condition to think about how bias can creep in and be perpetuated, whether deliberately or not.”

This has been HORIZONS, a newsletter that explores the innovations of today shaping the world of tomorrow. Do you think it can be improved? Have a story idea? Send your tips and all other musings to horizons@inverse.com

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Research Kit Demo by Jeff Williams at Apple Special Event, March 2015

Eric Topol - Twitter Feed

There is so much information related to health informatics these days. One authoritative source to tap into is the twitter feed of Eric Topol. Many insightful links to articles and information. Who is Eric Topol? His twitter account says "Cardiologist, geneticist, digital medicine aficionado, Editor-in-Chief, Medscape, author of The Creative Destruction of Medicine". He is famous for using an AliveCor Monitor on his smartphone to diagnosis and save the lives of people on airplanes who were having heart distress .< Here >is  a link to an article about that. His twitter feed recently posted an interesting article about a brain stimulation technology that I have been learning more about from researchers, on tDCS.

Awesome Wearable Intelligence Google Glass in the ER Video

http://geekdoctor.blogspot.ca/2014/04/google-glass-details.html

John Halamka posted this video on his blog about the Wearable Intelligence software using Google Glass technology for healthcare (ER). It is awesome to see this from a Health Informatics perspective. They are experimenting with Google Glass in their ER. I like that he said:

"After several months of testing, we have deployed the product to clinical providers in the ED and are completing the first IRB approved study (to our knowledge) of the technology’s impact on clinical medicine."

The devices using the Wearable Intelligence software are medical devices and need to be tested clinical and cleared by the IRB. Evaluating the efficacy and patient safety over a longer term will also be interesting. I wonder how how they designed the clinical trial methodologically.

One commenter on the blog post on their experience with the efficacy of Google Glass over EHR/EMR has an excellent article:
http://www.acutecarecontinuum.com/Home/tabid/84/entryid/245/Slow-Death-by-EMR-or-How-I-Learned-to-Stop-Clicking-and-Love-Google-Glass.aspx


There are other stories on Google Glass I have picked up recently:

http://www.theverge.com/2014/4/7/5589940/google-glass-and-the-specter-of-instant-facial-recognition

http://www.prweb.com/releases/2014/04/prweb11740581.htm

The International Association for Privacy Professionals had this news item posted:
https://www.privacyassociation.org/publications/google_glass_surgeon_saves_lives_with_it_bar_bans_it

FACIAL RECOGNITION

Google Glass: Surgeon Saves Lives with It, Bar Bans It

Livestream has released its first piece of Glass software, PC Magazine reports, which allows users to tap the headset and say, “Okay Glass, Livestream,” and then livestream the event to viewers. Meanwhile, The Verge reports on the multitude of facial recognition apps on the market today, including “NameTag,” which links a user’s face to “a single, unified online presence.” And The New York Times reports on both the opportunities and the challenges inherent in Google Glass, with some welcoming the technology enthusiastically—such as one lung surgeon who recently used Glass to help perform a procedure—and others banning it entirely, such as one California nightclub.
Full Story

Surgery transmitted by Google glass

Google glass apparently wasn't used here first, according to a poster at the Kurzweil site:

Great accomplishment BUT not the 1st time! It was a FutureMed/Singularity grad who performed the first Surgery s GoogleGlass! See:
Google Glass In The Operating Room! http://t.co/bMR64jVCTQ
&in Med Ed”OK Glass:Teach me Medicine!” http://t.co/0vYPZcrzKk

The spanish Clinica Cemtro looks like an interesting organization with eHealth applications like this, even though I am not sure how this can be applied in the future.

The Nano Revolution: More than Human

CBC -The Nature of Things with David Suzuki - - The Nano Revolution: More than Human

This video apparently is only viewable in Canada. It is an excellent view of the future of nano technology at the "point of care" in medicine. It also has an excellent scenario of "post humans". It is worth watching just for the computer graphics effects on nanotechnology models.

Singularity University Future Med 2013 Autodesk Innovation Lab & Demos

I am just copying and pasting the whole page - endlessly interesting:

FutureMed has an Innovation Lab and Demonstration Room for participants and faculty speakers to use during the entire FutureMed program.

FutureMed 2013 Demos

Make rounds with the latest mobile telepresence robots from 9th Sense and AnyBots
Visualize realistic 3D anatomy with Anatomage’s amazingly interactive Virtual Dissection Table
Achieve better understanding of oral care behavior with BeamBrush, the world’s first app-connected toothbrush.
Experience the latest in high tech robotic surgery using the da Vinci Surgical System by Intuitive Surgical
Learn how Bespoke Innovations 3D Scanning Technology is changing the world of custom tailored prosthetics.

From Star Trek to Future Med, check out the new “tricorder” prototypes by MedSensation and Scanadu  – futuristic  devices that accurately measure body metrics and allow data to be transferred wirelessly.
Make DNA analysis and interpretation more accessible and less expensive by using the new DNA Guide Genome Browser for iPAD.
Turn your smartphone into a digital first aid kit with CellScope.
Learn how Ekso Bionics Exoskeletons can be used to augment human mobility and capability.
Check out Esteem, the world’s first and only fully implantable hearing restoration device that doesn’t rely on a microphone or speaker.

Take a look at GE Healthcare’s amazing Vscan, a pocket-sized visualization tool with ultrasound technology.
Check out the technology behind the Genome Compiler, the next generation of computer-aided design tools for synthetic biology.
Meet the folks at Health Tech Hatch, a company providing platforms for start-up fundraising, and usability feedback on healthcare concepts and prototypes.
Use Intellisense’s innovative new technology to measure data, to video-document research, or to measure soft touch, pulse, and pressure metrics.Learn about the latest in Deep Infrared Thermography and its current use in the early diagnosis of breast cancer.
Try out “m3d”, an intuitive clinical and biomedical search engine, now being billed as the new “Google for Healthcare”
Monitor your fitness with Lark, Larklife, & Lark-Pro, three cutting edge wearable health and wellness tracking devices.
Be the first to view the next generation of Ultra-Thin Flexible Endoscopes created by Lightscan Technologies.
Sit up and take notice with LUMOback, the smart, wearable sensor and a mobile app that provides feedback on posture and movement.
Take a close look at CATRA, a low-cost, snap-on, mobile phone eyepiece that provides precise maps of cataracts in the eye. 

Make first response safer, more efficient, and cost-effective using the MEDIVIEW cloud-and-client platform
Use the BrainBot brainwave headset to literally read someone’s mind.Capture, compare, and share medical images for easy analysis using CaptureProof
Learn how CliniCast’s ARTO enables providers to improve outcomes and reduce costs through predictive analytics.
Manage your HR benefits more strategically using Benefitter Exchange 

Improve your health with Prevent  – an online program that uses digital tracking, personalized coaching, and social support to promote healthy behaviors.
Learn the many ways that Moxe Health aims to improve access to care for the underserved.
Learn how Neural ID’s Intelligent Waveform Service uses data pattern recognition to streamline and improve research.
Use OncoSec’s Medical Electroporation Device to specifically target cancer cells during chemo and immunotherapy
Size yourself up with Poikos, a smart-device technology that can quickly and accurately measure your body habitus. 

Think you have an idea that can change healthcare?  Meet the team of Rock Health, a business incubator company with a long, successful track record in nurturing Start-Up’s
Not sure that rash is serious?  Take a moment to consult Virtual Nurse, an interactive new age application that helps triage your need to see a doctor.
Check out the latest in remote vital signs monitoring using the  ViSi Mobile® System
Learn how researchers, providers, and payers use genomics to improve medical outcomes using the Discovery Biomedical Data Platform
Use Inside Tracker to identify the nutritional, supplemental, lifestyle, and exercise interventions most needed to improve your health
Give your patients a personalized medical video using Telesofia Medical, a platform aimed at increasing patient compliance and reducing health care costs
Sequence your microbiome using citizen science with uBiome.
Get the benefits of a two-hour workout in only 20 minutes with Vasper System’s SA-1Learn how the Due Date Plus mobile health platform is making pregnancy healthier, safer, and cheaper.