Good morning. Today we have data liberation, splintering variants, and commercial determinants of health. Dive right in.

It's data liberation day for patients

Today’s the day: Under new federal rules, health care organizations must give patients unfettered access to their full health records in digital format. That means no more long delays, no more fax machines, no more exorbitant charges for printed pages. Until now, health systems and their medical records companies determined how much data patients can access, when, and under what circumstances, all while private data brokers mine de-identified medical records in order to sell insights to drug companies, device makers, and insurers without patients’ knowledge or consent.

For brain cancer patient Liz Salmi to read her records when her insurance changed in 2017, she had to buy an external hard drive to load DVD disks into her computer (rather than pay $723.45 to print 4,823 pages). “I had no idea there was a whole other narrative going on behind the scenes,” Salmi told STAT’s Casey Ross. Read more about what's in store.

As Omicron's many variants splinter, get ready for Covid’s next phase

Where are we now in the Covid pandemic? The U.S. seems to be in bit of a lull as cases and hospitalizations are falling, but Covid is on the rise in Europe, raising worries about a fall and winter wave. STAT’s Andrew Joseph spoke with Tom Peacock, a virologist at Imperial College London, to get his take on the evolution of the SARS-CoV-2 virus. Two points:

The virus’s evolution looks like “drift”: “It’s a little bit like what we would expect to see over a couple years of flu, but crammed into about three months with SARS-CoV-2.”
One year after Omicron’s emergence: “We should never forget that SARS-CoV-2 has done that once, and can absolutely do it again. Everyone’s looking at these minute changes in all these sublineages and suddenly Pi comes through and torpedoes the whole lot.”

The government wants to clean up insurance directories of doctors

This sounds familiar: You look on your insurers’ list of doctors, but many have moved, retired, or aren’t accepting new patients — so-called phantom networks. But here’s an idea: What if there were a national directory that listed accurate, up-to-date information for all doctors and providers across the country? That’s the thinking behind an ambitious federal attempt to fix the plethora of error-riddled directories maintained by health insurance companies.

As STAT’s Bob Herman explains, instead of loading telephone numbers, addresses, and insurance information into dozens of different systems for different insurers, as doctors currently do, providers would instead log into a “centralized data hub” and put in all of their information through there. That data then would be available to federal insurance programs and private insurers to craft their own directories. Read more — public comment period closes Dec. 6.

Closer look: The commercial determinants of health earn poor grades from experts

(hyacinth empinado/STAT)

You’ve heard of the social determinants of health, defined as factors in a person’s environment that affect health. Now the commercial determinants of health are drawing interest as a way to understand how businesses affect someone’s health. Or, as one researcher told STAT’s Nicholas Florko, “when companies profit from making us sick.” So Nick asked 10 global experts to grade the U.S. approach to grappling with all the ways that businesses can drive sickness and death in the country. No one gave the U.S. higher than a C+, and several gave the nation an F.

It’s not just the obvious industries, like tobacco, fast food, or alcohol, they told him. CUNY’s Nick Freudenberg pointed to the financial industry and its tendency to “sacrifice long-term investment or balancing public and private needs with an insistence on short-term profits.” Read more.

Less likely to have a gun at home, immigrants fear gun violence more

STAT's Usha Lee McFarling brings this report: Immigrants living in California are far less likely to keep a gun at home than non-immigrants and are far more concerned about gun violence, according to survey results released yesterday from UCLA’s California Health Interview Survey, the largest state health survey in the nation. The survey of more than 24,000 households found that 7.7% of immigrants had a firearm at home vs. 17.6% of all California adults, but that 24% of immigrants were “very worried” about being a victim of gun violence compared to 12.9% of California residents.

The groups most likely to have guns at home included military veterans (38.1%) and rural residents (31.9%). The survey indicates that California, which has some of the most restrictive gun laws in the nation, has 5.2 million residents with guns at home, with 7.7% of gun owners saying those guns are kept loaded and unlocked.

Researchers call for transparency from FDA on response to safety signals

Before a drug is approved by the FDA, clinical trials must demonstrate its safety and effectiveness. Because even large studies might not turn up rare problems, the agency monitors what happens when the drug is widely available through the FDA Adverse Event Reporting System. More than 2 million submissions are sent annually to FAERS, which the FDA reviews to decide if it should act.

A new analysis in BMJ found the agency took action on about 80% of 603 safety signals from 2008 to 2019, mostly with label changes. But the researchers question why only 30% of FDA’s regulatory actions were backed up by published research or other publicly available evidence. “Knowing what evidence was used to support regulatory actions to resolve safety signals, as well as what other evidence might have corroborated those actions, could inform and improve clinical decision making,” they write.

deaths

Correction: An item in yesterday’s newsletter about Covid vaccination rates misstated how many adults over 50 have received the new bivalent booster. About 36% of those older adults have gotten a second booster, but far fewer — only 7.6 million Americans of any age — have gotten the updated booster, CDC says.

What we're reading

Okla. GOP ties hospital’s Covid funds to end of gender-affirming care, Washington Post
‘The more dangerous the operation, the more I wanted to do it’: neurosurgeon Henry Marsh on mistakes and mortality, The Guardian
Medicare tasks a senior adviser with staffing its new drug pricing division, STAT
Lifesaving fund to fight AIDS, malaria and TB falls short of $18-billion target, Nature
Alzheimer’s clinical trials have a recruitment problem. Telehealth platform Ro thinks it can help, STAT