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Sunday, August 7, 2022

Flawed devices and Covid-19 diagnoses- POLITICO

WHEN PULSE OXIMETERS FAIL — Inaccuracies in pulse oximeter readings for people of color may have contributed to the pandemic’s toll, and advocates say the government is struggling to respond.

Studies have shown pulse oximeters often can overestimate blood oxygen levels in people with dark skin. Such inaccuracies led doctors to underestimate their disease severity and delay treatment, recent research showed.

The devices, typically placed on a patient’s fingertip, use light beams to estimate oxygen saturation levels. The Covid-19 pandemic brought pulse oximeters greater public attention because many people used them at home.

The FDA warned doctors about the problem last year and is bringing together experts to discuss it later this year. An agency spokesperson said it has prioritized assuring that pulse oximeters are “sufficiently safe and accurate for all people,” but some public health advocates say the FDA is moving too slowly. A string of studies finding misreadings dates back decades, though many were small.

“It’s really shocking that it was only until 2021 for the FDA to actually issue an alert,” said Uché Blackstock, an emergency medicine physician and CEO of Advancing Health Equity. “And even in that alert last year, they didn’t even mention racial bias or race or racism in it.”

In a December 2020 study, researchers from the University of Michigan found that Black patients were roughly three times more likely than white patients to have low oxygen levels go undetected. More than 1 in 10 Black patients had dangerously low oxygen levels that pulse oximeters missed.

Experts say the errant readings are due to the way light is absorbed differently by different skin tones.

The flaws magnify concerns about bias in technology as tech becomes omnipresent in health care, as well as regulators’ ability to stop it. Experts say racial disparities could deepen if technology doesn’t work the same for everyone and warn that bias can creep into technology in a number of different ways.

“Biases can really occur anywhere in the chain, from the laws of physics to sensors to data that gets stored to algorithms that process the data and even finally, humans that interpret the algorithms,” said Achuta Kadambi, an engineering professor at UCLA. “There are definitely steps being taken. But there’s still a long way to go.”

Solutions: Clinical trials have long underrepresented people of color. Experts say that diversifying them is part of the solution.

It’s important for researchers to be intentional about increasing trials’ diversity, said Adrian Aguilera, the head of the Digital Health Equity and Access Lab at UC Berkeley, because they often don’t represent the broader population.

The FDA spokesperson said it seeks to broaden the available data on the problem by funding a prospective clinical trial to inform any recommendation changes.

But some advocates say the agency now knows enough about the flaws in readings to take more action.

Welcome back to Future Pulse, where we explore the convergence of health care and technology. You may not be able to live forever, but it turns out your tattoos can. What other fascinating things are evading death these days? Tell us what you’re seeing.  

Share your news, tips and feedback with Ben at [email protected] or Ruth at [email protected] and follow us on Twitter for the latest @_BenLeonard_ and @RuthReader. Send tips securely through SecureDrop, Signal, Telegram or Whatsapp here

Tony Romm @TonyRomm: “just got a covid exposure notification on my smartphone during the week i had covid and was confined to bed, just in case anyone’s curious how this system is working in the omicron age.”

POST-ROE BIDEN ADMIN PRIVACY GUIDANCE — The Biden administration issued privacy guidance last week for data covered by landmark health privacy law HIPAA and the plethora of data that falls outside of it, Ben reports. 

The guidance from HHS’ Office for Civil Rights aimed to shed light on what data privacy rights individuals and health care organizations have in the new post-Roe v. Wade America.

The new legal landscape, with many states moving to restrict abortion, has left abortion advocates fearful that prosecutors will use digital data, including health records, internet search history and location data to bring charges against those who end their pregnancies and/or the providers who helped them.

The new guidance didn’t create new rules — which would require a formal rule-making process — but clarified that without a court order, abortion clinics cannot disclose abortion records to law enforcement. If a court issued an order, the clinics would be allowed, but not mandated, to hand over the records.

The administration’s guidance for non-HIPAA covered data offered suggestions to protect privacy online, including disabling location services, but emphasized the tips wouldn’t protect all data.

GOOGLE MAKES DATA MOVE — Google said Friday it will delete location data for people visiting abortion clinics “soon after” they travel to them, POLITICO’s Olivia Olander reports. 

The company and other big tech firms had come under fire from abortion-rights advocates for their data practices since prosecutors potentially could use the information to bring cases against people receiving abortions, or their providers.

Yes, but: That still leaves a whole host of data vulnerable, and the company’s policy change didn’t provide much clarity on how it would answer law enforcement data requests. The company said only that it would “oppose demands that are overly broad or otherwise legally objectionable.”

MEDICATION ABORTION SEARCH SPIKE — Google searches for medication abortion have soared since POLITICO published the Supreme Court’s draft opinion overturning Roe v. Wade, according to a new study in JAMA Internal Medicine, Ruth reports.

In the three days following the news, searches for abortion medications jumped 162 percent. The week of the POLITICO report, Americans conducted 350,000 searches for abortion pills, the highest level recorded in any equivalent time span, the researchers said.

The states that saw the largest rise in searches for medication abortion have some of the toughest restrictions on abortion.

Medication is already the most utilized method for ending a pregnancy, accounting for over half of all abortions, according to the Guttmacher Institute, a reproductive health and policy non-profit that supports abortion rights.

BUILDING ON THE ELECTRONIC HEALTH RECORD — Shafiq Rab, chief digital officer at Tufts Medicine, tells POLITICO that building a technology platform in the cloud is helping his health system use various data sources beyond the electronic health record to make predictions about patient health.

Rab says Tufts is seeking to bring together information culled from electronic health records, medical devices, and other places where Tufts doctors are monitoring patients.

“What are the variables you need to understand sepsis? You want to understand age, date, sex, temperature, condition, diagnosis — all those things,” he says. “Creating that one ecosystem and standard, allows us not to be dependent on the EHR itself for our machine learning and for all other things, because all the data is in one place.”

TELEHEALTH’S ‘PARADOX’ — Telehealth has potential to address health disparities among racial groups, Harvard researchers wrote in a commentary in Lancet Digital Health. But a lack of trust in technology could undermine its promise, they argue.

Vivian Yee, Simar Bajaj and Fatima Cody Stanford point to studies showing Black patients were more than four times more likely than white patients to go to the emergency room instead of using telemedicine. A patient’s satisfaction with virtual care was “primarily influenced” by how much they trusted their doctor, the researchers found.

“The lack of pre-established relationships with physicians, as well as mistrust of digital platforms, could drive this reluctance to pursue telemedicine,” they wrote.

PROMOTING GOOD HEALTH TO FIGHT CANCER — Pharmaceutical company Eli Lilly, in collaboration with Sidekick Health, is launching an online platform for breast cancer patients in Germany. The app will give patients specific diet plans, physical activity regimens and tools for sticking to their medication as well as suggestions for sleep and stress management. The goal is to see whether behavioral changes in tandem with medication can improve outcomes.

Meanwhile, Faeth, a startup developing new cancer drugs in tandem with meal plans designed to starve tumors, has raised $47 million to fund clinical trials.

A new dawn for psychedelics? — Helen Collis, POLITICO Europe

VC deals and valuations begin falling apart amid biotech’s stock shock — Allison DeAngelis, STAT

Highway to health: Unlocking whole patient care through data interoperability — Julia Klein and Adriana Krasniansky, Rock Health

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