RETHINKING THE DIGITAL MARKETPLACE: A new nonprofit started by three health systems is joining the push to improve information-sharing in health care by creating an app store where patients and providers can buy tools to manage their needs, all using a common data language.

Graphite Health’s arrival is the latest development stemming from a 2020 plan to free up digital records that patients have long complained are difficult to access from hospitals and doctors.

The new venture aims to create a standardized platform to sell apps that store patient data, coordinate care and help hospitals with tasks like tracking available beds and operating rooms. Graphite’s big test will be persuading enough health systems, software developers and doctors that its approach is the right one.

Health systems can take years to adopt and integrate new apps and test if they’re secure. Graphite envisions having a central governing body review applications for new digital tools so providers and patients don’t have to.

“There’s no reason to do independent security reviews,” Graphite CEO Ries Robinson said in an interview. “As a health care system, we don’t go through and say, ‘Medication X, we’re going to re-review it.’ We assume a central body, the FDA, can do it.”

Graphite is building off a common data standard known as FHIR that can make it easier for patients to export their data into other apps. Its member-led business approach is modeled on the nonprofit generic drug firm Civica Rx that one of Graphite’s backers, Intermountain Healthcare, helped launch. Graphite’s apps will be publicly available once it has commitments from health systems and other providers who serve 30 million patients.

The company is trying to assuage privacy concerns by pledging to maintain a “trusted” ecosystem, in which app developers won’t sell patient data. An Accenture study this year found that consumer concern about safeguarding health information has been an obstacle to digital health adoption, with a third of respondents saying they'd be more likely to use tech if their doctors and other providers recommended them.

Graphite is hoping its model offers a low-cost alternative to big electronic health competitors like Cerner, which has a platform touting digital health tools, and Epic, with its App Orchard.

The challenge will be getting enough software developers and health providers on board early, said Joe Turk, an associate principal at the Chartis Group, a health care advisory company.

Dean Sittig, a professor at the University of Texas Health School of Biomedical Informatics, said some apps could end up hurting providers, by reducing visits. Some virtual care apps that manage medication dosages and lab orders have reduced the frequency of trips to general practitioners.

“Right now, the apps are still ... a novelty,” Sittig said. “We’re very early.”

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_.

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Genevieve Morris @HITpolicywonk “My mom experienced her 1st false positive match in healthcare (she's had them in banking) there's someone w/ same name, bday, and zip. Her doc merged the records. Thankfully no safety issues for my mom, but since the other woman has had cancer not sure of the effect. 1/2

Interestingly, only reason it was caught is b/c cancer diagnosis would mean something very different w/ mom's recent CAT scans. When doc told her that she freaked out a bit since she hasn't had cancer. Not sure the merge would've been caught otherwise. 2/2”

Health data breaches were a growing concern in health care even before Covid-19. Data from HHS' Office of Civil Rights shows how cyberattacks on hospitals and other players have escalated during the pandemic. Health data breaches were a growing concern in health care even before Covid-19. Data from HHS' Office of Civil Rights shows how cyberattacks on hospitals and other players have escalated during the pandemic.

A GENERIC HUMIRA: The FDA crossed a key threshold this week, announcing the approval of the first interchangeable biologic drug to AbbVie’s blockbuster Humira, in a move that could eventually deliver savings to patients and insurers.

Cyltezo, made by Boehringer Ingelheim, is made from living cells like Humira and can treat most of the same conditions, including various forms of arthritis, psoriasis and Crohn’s disease. The FDA first approved it in 2017 but held back allowing it to be substituted without a change in the prescription until studies confirmed patients experienced similar clinical outcomes and the copycat treatment was safe and effective. The FDA’s blessing means pharmacists can make the switch without doctors, lowering patients' costs.

It is the second so-called biosimilar and the first monoclonal antibody to earn interchangeable status in the U.S. but won’t be available until the middle of 2023 because of an agreement the manufacturer signed with AbbVie in 2019.

Humira, which brought in sales of more than $20 billion last year, is still approved for more uses than Cyltezo, including eye and skin conditions and pediatric Crohn’s disease. A second biosimilar for Humira — Amjevita, manufactured by Alvotech — is off the market because of ongoing litigation between its maker and AbbVie.

NEW DAY FOR HEARING AIDS: More than four years after Congress authorized the sale of over-the-counter hearing aids, the FDA Tuesday began outlining technical requirements that could allow consumer electronics manufacturers to enter a market that’s increasingly driven by smart technologies.

FDA medical device chief Jeff Shuren said the agency took so long because it wanted to get feedback on the “appropriate performance criteria” for OTC hearing aids, POLITICO’s David Lim writes. Some of the FDA’s criteria track with recommendations made by four hearing care associations, but the maximum output level is higher than the peak level suggested by the hearing industry.

Acting FDA Commissioner Janet Woodcock said about 38 million American adults report issues with their hearing, and only one in five people who may benefit from a hearing aid are currently using one.

“The new regulatory category will provide the public with greater control over their hearing-aid purchasing decisions at stores nationwide or online without the need for a professional hearing exam, fitting adjustment or a prescription,” Woodcock said.

Cowen analyst Eric Assaraf wrote in a note to clients the move allows electronics makers to compete in a market that’s now dominated by companies like ReSound, Sonova and William Demant. Demand could grow if congressional Democrats make good on plans to use a sweeping social spending package to create a new Medicare benefit for hearing services, along with vision and dental, by year’s end.

VA's EXECUTIVE SEARCH: The Department of Veterans Affairs has established an expert commission to find a new leader for the Veterans Health Administration who’ll help oversee its troubled electronic health records modernization.

Acting Under Secretary Richard Stone resigned in July after learning he wouldn’t be nominated to serve as the permanent leader of the agency, which is the biggest integrated medical care system in the country, serving some 9 million veterans.

Toward the end of his tenure, Stone warned of problems with the department’s multibillion dollar, decadelong overhaul of digital health records, which had been pushed by former President Donald Trump’s senior adviser Jared Kushner. In the beginning of the year, he called for the department to pause deployments of the record while it sorted out the problems. The department later launched a strategic review to address some concerns.

The VA last month gave Congress a new rollout schedule that calls for the deployment of software in 22 VA centers by the end of fiscal 2023—a slowdown from pre-pandemic plans. While ultimate responsibility for the system is further up the department's hierarchy, the next leader of VHA will have to make health providers comfortable with the new system. The VA’s incumbent records system, while outdated, still has many advocates.

SENATE SCRAPS PATIENT ID BAN: Senate appropriators cut a provision banning funding for a national patient identifier from a fiscal 2022 health care spending bill, a win for patient ID advocates after House appropriators made a similar move earlier this year.

Advocates have said the lack of a unique identifier to match and manage patient information has stifled information sharing. It could in theory reduce medication errors and other mix-ups stemming from patients having the same names. Senate appropriators, who struck the provision from the Labor, HHS and Education appropriations bill, said the ban has also gotten in the way of contact tracing and vaccination data efforts during the pandemic.

The federal government has been blocked from taking action on the issue for decades over privacy fears, led by Sen. Rand Paul (R-Ky.). Paul’s father, former Rep. Ron Paul, was behind the original ban.

EMERGENCY GUARANTEED?: Though no one really knows when the pandemic will end, telehealth advocates want assurances from the Biden administration that it will officially remain a public health emergency through next year.

The designation isn’t just some exercise in semantics. The Trump administration’s original emergency declaration included temporary flexibilities encouraging rapid telehealth adoption, including a Medicare waiver to pay for more virtual services for more patients. Those policies will disappear when the emergency is lifted, unless Congress permanently extends them.

With lawmakers otherwise occupied, the College of Healthcare Information Management Executives and the American Telemedicine Association each wrote to HHS Secretary Xavier Becerra this week, calling for assurance of an extension through “at least” 2022.

“We implore Secretary Becerra to provide as much predictability and certainty as possible to ensure adequate warning before patients are pushed over this looming cliff,” ATA CEO Ann Mond Johnson wrote.

So far, the administration is staying tight-lipped. Public health emergencies must be renewed by HHS every 90 days, and an HHS official said Tuesday the administration will give states 60 days notice of any change.

TRUSTED TRAVELERS: Nearly 600 million EU digital Covid-19 travel certificates have been issued since they were authorized in June, amounting to nearly one per person, according to a European Commission report to the European Parliament and Council.

The overwhelming response — the population of the EU and 16 non-EU states adopting the credentials sits around 650 million, according to EU and U.N. estimates — is in stark contrast with the U.S., which has a patchwork of vaccine verification systems and no single standard endorsed by the Biden administration.

The EU credentials — with scannable QR codes showing bearers have been tested for Covid, vaccinated or have had the disease — were seen as essential to reopening the continent and helping summertime travelers navigate around sometimes arduous testing and quarantine requirements. They now connect 43 countries or territories without requiring the exchange of personal data or the need for an EU database.

Some 437 million certificates were used for proving vaccination status, while 144 million displayed test results and 10 million more certified users’ recoveries, according to the report. The certificates are in effect until the end of June, unless authorities grant an extension.

NPR reveals patients’ attitudes to telehealth through their poll, and interviews.

The Financial Times considers the future of medical research in the pandemic’s wake.

The Wall Street Journal looks at the competitive market … for pet prescriptions.