Congress is considering legislation to place more oversight on diagnostic lab tests currently not regulated by the Food and Drug Administration.
Advocates and medical experts argued the legislation is needed to reduce false positives which can delay critical treatment for cancer patients.
Mark Fleury, policy principal of emerging science for the American Center Action Network, said cancer patients in particular rely on molecular diagnostic tests. He noted the pandemic has given most people the experience of relying on a lab test for accurate information about their health.
"I certainly think over the past few years, people have made very significant decisions based on diagnostic tests in the form of COVID tests," Fleury observed. "Anybody who's gone through that experience wants to know: if they get a positive that it truly means a positive, and if they get a negative, it really is a negative."
In the FDA Safety and Landmark Advancements Act, co-sponsored by Sen. Richard Burr, R-N.C., companies would have to register their tests with the FDA, provide performance information, and report any cases of harm. Senate lawmakers approved the bill in June, and Congress is negotiating a final version.
Shannon Routh, an ovarian cancer survivor and advocate for the Ovarian Cancer Research Alliance and founder of TEAL Diva, explained her physician used a diagnostic blood test measuring levels of a protein called CA 125 to detect ovarian cancer. Routh acknowledged the CA 125 test is important, but does not always detect elevated levels, making the results less certain than a Pap smear for cervical cancer, or mammograms for breast cancer.
"Both screenings have saved lives," Routh stated. "But ovarian doesn't have one. And so, I think there is an extreme need for accurate screening tests, whether it be a blood test or whatever we have. It saves lives."
Fleury emphasized laboratory-developed tests are mostly accurate and of high quality. But he pointed to cases like the company Theranos and its founder, Elizabeth Holmes, who claimed to develop rapid diagnostic blood testing, which was revealed to be a scam. He contended without third-party review of such tests, there's a lack of certainty for patients, and he believes the legislation is needed.
"Bring up the oversight system to the modern era," Fleury urged. "Treat it as a diagnostic test rather than as an artificial hip, and ensure that if two tests perform the exact same function, that they've been looked at in the exact same way."
A Pew poll released last year finds one in 10 Americans who've received a clinical lab test report inaccuracy, and most said they support policies to improve oversight.
Support for this reporting was provided by The Pew Charitable Trusts.
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People who are part of the Deferred Action for Childhood Arrivals program, known as DACA, will be dropped from their CoveredCA health plans at the end of August.
The move comes after the Trump administration changed a Biden-era definition of "lawfully present" to revoke health care eligibility for thousands of immigrants.
Christine Smith, policy and legislative advocate for the nonprofit Health Access California, said people only have a few weeks to get medical appointments in before their coverage ends.
"If you're enrolled in Covered California and you're a DACA recipient, the Trump administration just ended your coverage," Smith emphasized. "People should use as much of your health care as you can before the August 31st deadline."
The Centers for Medicare and Medicaid Services defended the move, saying it will save taxpayers money. CoveredCA estimated the change affects about 2,400 DACA recipients in the state who make too much to qualify for Medi-Cal and have jobs not providing health insurance. They can still buy private insurance but it is much more expensive. People who prepaid for their coverage can seek a refund.
Smith predicted it will be a blow not just to those who lose coverage but to the state's health care system as a whole.
"The lines in the ERs are going to be longer because people are not going to be able to get affordable preventive care," Smith projected. "They're just going to get sicker and then end up in the ERs. People will overall incur more medical debt. Hospitals will have more uncompensated care."
The change is nationwide. As of mid-July, about 538,000 people in the DACA program across the U.S. are ineligible to enroll in any state-based insurance marketplace and are unable to access premium subsidies or cost-sharing assistance.
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Artificial intelligence is appearing more prominently in many aspects of life and research suggests older populations are curious, yet remain wary of using the technology in their everyday lives.
According to Stats Indiana, there are more than 1.5 million Hoosiers aged 65 and older, or 18% of the state's population. Experts said it is likely the demographic will use AI in some form in the next few years, either by choice or necessity.
Dr. Shaun Grannis, vice president of data and analytics for the Regenstrief Institute on Aging, said AI offers real benefits.
"It can reduce loneliness through conversation, provide reminders for medications and appointments," Grannis outlined. "It can support cognitive stimulation via games, storytelling, news updates."
The technology can also offer a low-pressure way to access information on public services, he added, which is valuable for those with mobility issues or those who feel intimidated by technology.
Grannis cautioned any tool which can be used for good can also lead to problems. He noted AI can create a false sense of companionship and mask social isolation. Overdependence is a legitimate concern, he argued, if the technology becomes a "crutch" for all forms of interaction.
"All cognitive activities or decision-making, it can actually lead to and create a negative feedback loop, lead to a decline in engagement and even basic self-management skills," Grannis explained. "This is risky."
Grannis believes one solution is designing AI systems to complement, not replace, human interaction. He stressed it can be done though building broader support ecosystems including family, friends, caregivers and community services. Grannis emphasized it would encourage real-world activity, prompting the user to go for a walk, call a grandchild or attend a local senior event.
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If you have an extra five minutes, you can save a life because you can learn cardiopulmonary resuscitation at no cost from a new mobile, hands-only CPR kiosk.
The new kiosk is in the lobby of Saint John's Health Center in Santa Monica. The machine's touch screen gives a brief overview of hands-only CPR and you can practice right there, on a mannequin.
Dr. Rigved Tadwalkar, cardiologist at St. John's, said it is an easy way for people to get more comfortable giving chest compressions in an emergency.
"It's a lot like a video game but of course, a lot more important than a video game," Tadwalkar pointed out. "It gives real-time feedback about the depth and rate of compressions, proper hand placement, which are all factors that influence the effectiveness of CPR."
The American Heart Association operates the St. John's mobile kiosk and a stationary model at L-A-X with support from the hospital. Santiago Canyon College in Orange County also has a mobile hands-only C-P-R kiosk now through September, sponsored by Edwards Lifesciences.
Steven Munatones, an Orange County business owner, said he survived what's known as a "widowmaker" heart attack which led to cardiac arrest nine years ago, thanks to his 17-year-old son, who gave him immediate CPR with instructions from a 911 operator.
"You don't have to put your mouth to anybody's mouth," Munatones explained. "You just put your hand on their chest and pump. He saved me, and others can do the same, anywhere. So, it's absolutely a lifesaving, heroic act that anybody can do."
Statistics show 350,000 Americans suffer from cardiac arrest outside a hospital each year and about 90% die, in part because they do not receive CPR. About 70% of those cardiac arrests happen at home, so people often depend on family or friends to give CPR before an ambulance arrives.
Disclosure: The American Heart Association Western States Region contributes to our fund for reporting on Health Issues. If you would like to help support news in the public interest,
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