Apple Watch study finally out

With help from Darius Tahir (@dariustahir)

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OMB is expected to release agency-level appendices and further details for the Trump administration’s fiscal 2020 budget request today. Here’s what else we’re tracking:

—Apple Watch study finally out: A new Apple-funded study found that 84 percent of wearers who got irregular heartbeat notifications were in atrial fibrillation.

—The EU’s plan to lead in “trustworthy AI”: Next month, a high-level expert group plans to release guidance on ethical AI.

—FCC roundup: The agency approved a proposal to locate 911 calls in multistory buildings, and an interagency dispute on 5G continued.

eHealth Tweet thread of the day: Fulvio Capitanio @FulvioCapitanio Replying to @ePatientDave @blestab and 4 others Starting from the baseline that people needs to be empowered, there’s another question we need to answer: [do] people want to be empowered?

Enlightening Results @GraceCordovano Replying to @FulvioCapitanio @ePatientDave and 4 others Perhaps not every person proclaims they want to be empowered. Does not mean they do not have a right to accessing the information & tools they need to make an informed decision about their care.#HITsm

It’s MONDAY at Morning eHealth where your author is eager to see the new Theranos documentary on HBO. Anyone hosting a watch party? Thoughts and news tips go to [email protected]. Reach the rest of the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

RESULTS ARE OUT: Stanford researchers presented the long-awaited results of a massive, Apple-funded study on the Apple Watch’s ability to detect atrial fibrillation over the weekend at the American College of Cardiology conference in New Orleans.

The virtual study enrolled more than 400,000 people; just about 0.5 percent got an irregular pulse notification, and 84 percent of the time they were found to be experiencing atrial fibrillation.

About a third of the participants who got the notification and then used an ECG patch for the next week were found to have an atrial fibrillation later, researchers found. And about 57 percent of patients who received the notification sought medical attention afterwards.

The findings might help clinicians better understand how devices like the Apple Watch can fit into the detection of cardiac problems, principal investigator Mintu Turakhia said in a release.

...The results come during an ongoing debate about the value of such devices and the research surrounding them. In a piece for Stat, CardioBrief’s Larry Husten pointed out that study was purely observational and lacked a control group, so there’s no information on how people who don’t wear Apple Watches behave. And as Darius reported earlier this month, Apple has been encouraging wearers to share anecdotes with news media about how the device pushed them to seek medical attention; many cardiologists feel the company is exaggerating the Apple Watch’s value.

...In other Apple Watch news, the University of Michigan is launching its own Apple Watch study examining how data generated by those devices can be combined with information from EHRs and other sources. The study will last three years; about 1,000 people are enrolled already.

EUROPE’S PLAN FOR COMPETING ON ETHICAL AI: The European Union hopes to be a world leader in “trustworthy” artificial intelligence, our POLITICO EU colleague Janosch Delcker reports -- and next month, a group of experts plans to publish guidelines for the ethical use of the technology.

“Ethics and competitiveness are intertwined, they’re dovetailed,” Pekka Ala-Pietilä, who chairs the EU’s high-level expert group on AI, said. “If that kind of sustainably leveled playing field is established, that gives a great incentive for companies to create products or services where ethics is part of their competitive advantage.”

Once the guidelines are released, the group plans to publish recommendations for increasing Europe’s investment in artificial intelligence. The two documents are meant to serve as a road map for lawmakers. Pros can read the rest of the story here.

FCC ROUNDUP: Last week the FCC voted 4-1 to approve a proposal that would help first responders locate 911 callers in multistory buildings — Democrat Jessica Rosenworcel said the system wouldn’t provide enough accuracy, our POLITICO colleague Margaret Harding McGill reports.

“We should choose standards that without fail provide floor-level accuracy,” Rosenworcel said. “When police or firefighters show up in an emergency, the last thing they need to do is break out a measuring tape. They need a standard that tells them precisely where you are.”

FCC Chairman Ajit Pai has said the proposal is more accurate than what was proposed by the wireless industry. “I have every expectation that our proposal ... will give our nation’s first responders useful information, perhaps life-saving information,” Pai said.

...Also at the FCC, commissioners complained about an interagency feud about 5G airwaves, Margaret reports. Pai has been engaged in a spat with with Commerce Department Secretary Wilbur Ross and NASA Administrator Jim Bridenstine about whether the FCC’s efforts to free up spectrum for 5G could interfere with weather observation satellites.

“This is embarrassing,” Rosenworcel said last week. “In this administration, the right hand is not talking to the left.”

“This is clearly not the best way to do things,” she continued. “And I think we’ll have to figure out how to do better going forward as a matter of spectrum policy and as a simple matter of governance.”

COMMENTS TO THE FDA: Medical technology trade group AdvaMed (which, as we noted last week, is launching its own internal cyber threat sharing effort) has some thoughts for the FDA on the content of premarket submissions related to cybersecurity. Draft guidance proposed creating two risk tiers with different submission requirements; Advamed suggested a “single risk-based approach” that would take into account how easy it is to exploit a device and the “severity of patient harm.” Read the full comments here.

Streaming platform GIBLIB plans to upload Mayo Clinic’s medical conference lectures online, and then work together on new videos including virtual-reality footage of the hospital, those groups announced today.

The Consumer Technology Association hired West Front Strategies to lobby on privacy, our colleagues at POLITICO Influence report.

—ICYMI: Cleveland Clinic opens an AI center, Healthcare Dive reports
—Commonwealth Fund’s David Blumenthal writes about the interoperability and information blocking rules in the Harvard Business Review
—Zach Whittaker writes for TechCrunch on Meditab’s security lapse exposing thousands of health records

CLARIFICATION: The White House event mentioned in the March 1 edition of Morning eHealth was hosted by the Presidential Innovation Fellows, in addition to HHS officials.