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How Biden’s tech trustbuster could change health care – Politico

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Lina Khan’s Federal Trade Commission has its eyes on health care.

The agency known for efforts to rein in Big Tech companies like Facebook and Amazon is also enmeshed in high-stakes health care and health tech battles that extend well beyond Silicon Valley.

Case in point: The FTC trial that kicked off yesterday examining monopoly concerns in the market for cancer screening technology. (More on that below.)

That closely watched antitrust case — involving the giant Illumina and startup Grail — predates Khan’s confirmation as FTC chair. But it underscores how health issues are looming over the agenda, particularly heading into the pandemic’s second year.

The way health care companies and consumer health apps handle sensitive data “is an area that I’m sure [Khan’s] very, very interested in,” said Jessica Rich, former director of the FTC’s consumer protection bureau, adding that the Biden administration’s FTC will also be closely scrutinizing hospital mergers.

“I expect her and the commission to take a very bold approach to what constitutes harm for both,” Rich said. “I expect her to pay close attention to algorithms and potential discrimination in health care, both denials and pricing issues which the FTC’s laws can address.”

The FTC’s jurisdiction touches nearly the entire health economy. While its competition bureau looks at health care mergers like the Illumina-Grail deal, its consumer protection side is focused on health privacy and data security issues, as well as fighting bogus medical claims on everything from weight loss to Covid cures. When Congress passed the Covid-19 Consumer Protection Act last year, the agency was granted new authority to police Covid scams.

Although Khan hasn’t spoken publicly about her health care agenda, she’s likely to take issue with health apps and companies whose business models maximize, incentivize and monetize data collection. Of particular concern is how firms disclose what they’re doing with consumers’ data — and whether it may still be deceptive or unfair.

“We are at a point where there is more of a robust conversation about whether that notice and consent framework is outdated,” Khan said recently, “especially in a world where people sometimes don’t have a choice about whether they are using these technologies.”

But the agency is taking on a booming industry with its enforcement power curtailed. An April Supreme Court ruling took away one of the agency’s most potent tools — its so-called 13(b) authority. which empowered the FTC to recover monetary restitution from companies that break consumer protection or antitrust laws.

“I think the FTC will continue to bring health cases, but the hope was that the FTC would get more authority that would enable it to get money in these cases,” said Rich, who described the ruling as a major setback.

The FTC’s ability to protect privacy also has significant gaps, which is why Rich and other agency leaders have long called for a national privacy law. But those prospects continue to go from bad to worse this Congress.

That’s precisely why consumer advocates are waiting to see how Khan plans to tackle health data.

Her background as a Big Tech trustbuster has made her approach to antitrust clear. “But right now,” Rich said, “she’s a pretty blank slate on privacy.”

Leah Nylen contributed to this report.

Welcome back to Future Pulse, where we explore the convergence of health care and technology. Share your news and feedback: @dariustahir, @ali_lev, @abettel, @samsabin923, @_BenLeonard_.

Krutika Kuppalli, MD FIDSA @KrutikaKuppalli “I am concerned about the state of healthcare. I have had so many discussions with friends and colleagues over the past few months where many have told me they are exhausted – this has increased recently with many considering leaving the field.

What are we doing to help?”

SEPSIS ALGORITHM STIRS CONTROVERSY: Sepsis is a leading killer, with complications from infections said to cause one in five deaths worldwide. But it can be tricky to detect the condition early and reliably enough to make a difference, leading technologists to look to predictive algorithms that scan a variety of clinical data and medical records.

One leading player in the detection field, the electronic health record giant Epic, has been under the spotlight since a June study in JAMA Internal Medicine found the company’s algorithm performed poorly in some 38,455 hospitalizations, raising “fundamental concerns about sepsis management on a national level.” Now, dueling research in Critical Care Medicine suggests Epic’s algorithm works well, in certain circumstances.

A randomized controlled trial at MetroHealth Medical Center in Cleveland found the algorithm could prompt a team of pharmacists and other providers to administer antibiotics early enough to see “modest improvements” in clinical outcomes.

It’s a contentious finding. Andrew Wong, one of the University of Michigan researchers behind the JAMA paper, said in an email that the better outcome could be the result of care coordination in the hospital — not the algorithm — and that patients who weren’t monitored by the algorithm received similar antibiotic treatment.

It may all be apples to oranges, said Epic executive Emily Barey, who noted the dueling researchers used different definitions of sepsis, making it hard to compare results. Predicting sepsis is “a hard problem to solve,” she conceded, adding many of the company’s clients like the algorithm.

MINING EHRs FOR VAX OUTREACH: Health systems have used emails, patient portals and other online resources to advertise the availability of Covid-19 shots. Now, they’re mining their own electronic health records to hone in on underserved populations.

A new study in JAMA Oncology details how the North Carolina Cancer Hospital of the University of North Carolina Health System found through its health records 536 unvaccinated, at-risk patients with cancer who lacked an email or an online account or lived in a high poverty region. Nurses called the patients to provide “standardized education” about vaccines and discuss concerns about side effects. More than a quarter of the patients were confirmed to have been vaccinated as of April, a figure researchers said only covered people who got their shots within the UNC system.

“Feedback from patients suggests that the calls aided them in their decision to proceed with vaccination,” the authors wrote. Another 4 percent of people reached had a vaccination appointment scheduled.

FTC’s DAY IN COURT: The biotech firm Grail says a blood test it developed could revolutionize early cancer detection and save 10,000 lives a year. But standing in the way, the company argues, are antitrust prosecutors at the Federal Trade Commission, who have challenged the firm’s $7 billion merger with genetic sequencing giant Illumina.

The agency took its case to court on Tuesday, POLITICO’s Leah Nylen reports, arguing that Illumina’s control over the DNA sequencers that Grail and rivals need gives it an incentive to undermine development of other cancer tests.

Grail spun off from Illumina in 2015 to develop a blood test, called Galleri, to detect 50 types of early stage cancer using DNA sequencing. It debuted in June but the FDA hasn’t yet approved it. Illumina CEO Francis deSouza said the company is uniquely positioned to help bring Galleri to market because of its familiarity with the technology and history of gaining genetic disease testing approvals in 140 countries.

Illumina makes most of its money selling sequencers to competitors, which deSouza says undermine’s the FTC’s theory. But the company offered price cuts and a commitment to provide equal access to its technology. Obama-era and Trump antitrust enforcers accepted several deals with these types of promises, but today’s FTC has rejected all negotiations, he said.

FLYING BLIND?: The Centers for Disease Control and Prevention is using outdated, unreliable data on coronavirus breakthrough infections to help make major decisions, such as who gets booster shots, officials with direct knowledge tell POLITICO’s Erin Banco.

The agency originally tried to track all infections, from mild to severe, in vaccinated people. But in May it decided to focus on the most severe cases to better monitor overall conditions and make more informed, targeted policy decisions.

Forty-nine states are now regularly sending CDC information on hospitalized breakthrough patients. But more than a dozen state officials told POLITICO they don’t have the capacity to match patients’ hospital admission data with their immunization records. Instead, those states rely on hospital administrators to report breakthrough infections. The resulting data often omits critical details, such as which vaccine a person received and whether they got two doses, officials said.

The information gaps raise questions about how well the Biden administration can spot and respond to changes in the virus’s behavior — such as the spread of the Delta variant — or vaccines’ performance. It also underscores the extent to which the CDC and public health departments across the country are still struggling to collect and study critical Covid-19 information 18 months after the pandemic began.

“I think it would be really challenging [for the CDC] to interpret the results or to interpret the data when you have only some jurisdictions reporting,” said Theresa Sokol, lead epidemiologist for Louisiana’s public health department, which is working closely with the CDC on breakthrough infection studies. “I know that there are some jurisdictions that don’t even have access to their vaccination data.”

Google’s head of AI chats with physician Eric Topol on the future of tech in medicine.

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And Science Magazine describes the importance of AI-aided predictions of protein folding.