Wave breaks on GOP House control

With help from Arthur Allen (@arthurallen202) and Mohana Ravindranath (@ravindranize)

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WAVE BREAKS ON REPUBLICAN HOUSE CONTROL: Democrats have — by all indications — taken the House Tuesday night, while the GOP tightened their grip on the Senate. The result likely rules out another GOP-led attempt to repeal and replace Obamacare, and sets House Democrats up to police the Trump administration’s management of health care policy.

We might also see bipartisan national privacy legislation, which, depending on how it’s handled, might jostle regulation of the health sector. (We discussed the possibility here.)

The changeover, of course, means a new cast of characters chairing the important committees. In the House, we’re likely to see Rep. Frank Pallone chairing the Energy and Commerce Committee and Rep. Mark Takano (likely) leading the Veterans’ Affairs Committee. Both chairs will play a role in monitoring the Trump administration’s activities — in particular the VA’s implementation of the Cerner EHR.

eHealth tweet of the day: Paul Kedrosky @pkedrosky “Machine learning, but for making US healthcare plan choices during annual open enrollment: I hate the endless options, & the general feeling you’re missing a crucial footnote that will cause a guy in camo scrubs to break in and remove your liver as partial payment for something.”

WEDNESDAY: Your correspondent hopes everyone had a nice, non-stressful voting experience — your correspondent waited about a half-hour to cast his ballot in D.C., which is altogether not so bad. What issues are you hoping a new Congress will address in 2019? Drop your correspondent a line at [email protected]. Discuss issues at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

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AI — SMART IN ALL SETTINGS?: Deep learning tools that were trained to detect pneumonia on chest X-rays in one hospital system were much less effective at detecting the disease on scans from two other systems, according to a study published Tuesday in PLOS Medicine.

Researchers at the Icahn School of Medicine at Mount Sinai in New York City compared the ability of their algorithm combinations — called convolutional neural networks — to detect disease on images from Mount Sinai Hospital with images from NIH and Indiana University hospitals. In three out of five comparisons on a total of 158,000 X-rays, performance on the outside hospitals’ X-rays was significantly lower than on X-rays from Mount Sinai.

“Our findings should give pause to those considering rapid deployment of artificial intelligence platforms without rigorously assessing their performance in real-world clinical settings,” said senior author Eric Oermann in a news release. “Patient populations and imaging techniques differ significantly across institutions.”

The findings point to fundamental difficulties in using AI in health care, Parsa Mirhaji, director of clinical research informatics at Montefiore Medical Center in New York, told POLITICO.

AI learns from the particular relationships of data, and not the clinical phenomena they represent, he said. “That makes it susceptible to variations and heterogeneity in data” resulting from differences in how the data is represented and in the different health systems’ clinical processes.

HHS GEARS GRIND ON: Meanwhile, HHS continued to keep active Tuesday. Here are the latest updates:

— FDA: FDA released a new, open-source app Tuesday intended to help researchers collect real-world data.

The app, called “MyStudies,” is intended to ease the gathering of reliable real-world data, including from EHRs and patients.

“Our hope is that the collection of more real world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring,” FDA Commissioner Scott Gottlieb said in a news release.

The app was tested in partnership with Kaiser Permanente, which deployed it to interact with pregnant women in a study dealing with sleep patterns and medication use. FDA is now releasing the app as open-source code for researchers to use.

The agency also released guidance on unique device identifier compliance for Class I and unclassified devices (i.e. the very least risky medical devices out there). Depending on when the device is labeled, manufacturers will have to submit identifiers in September 2020 or 2021.

— CDC RFI: The Centers for Disease Control and Prevention is in the middle of a request for information process on the creation of a national testbed to assess how health IT can deliver best evidence to providers while they’re using care. Final responses are due Dec. 20, and the webpage for the RFI is here.

— ASPE RFI: HHS’ Assistant Secretary for Planning and Evaluation also has an RFI, and the commentary period is concluding soon. ASPE wants to know how plans and providers are addressing Medicare patients’ social risks to health — including whether social risk data is being used to target services — and is asking for commentary. That’s due Nov. 16, and the RFI page is here.

SAMSUNG SMARTPHONE-CONTROLLED INSULIN PUMP PROJECT: Insulet Corporation, an insulin pump manufacturer, has a new collaboration with Samsung Electronics America, the firms are announcing today. The idea is for Insulet’s insulin pump to be managed by a Samsung Galaxy smartphone — a new advance for the field.

Some glucose monitors beam their data to phones, and some hackers have rigged together monitors, pumps and computers to adjust insulin doses automatically. This is a more formal approach to adjusting insulin dosage by mobile device. “It’s groundbreaking,” Dave Rhew, Samsung Electronics America’s chief medical officer, told Morning eHealth, though the combination hasn’t been approved by the FDA.

Rhew said that the collaboration wasn’t delivered through FDA’s pre-certificaton pilot process (which Samsung is part of), but touted the security of the smartphone, its software and the hook-up with Insulet’s device. “We have to be able to ensure this solution has the highest level of security,” he said.

While the fruits of the collaboration haven’t fully materialized, Rhew anticipates extending smartphones to help consumers manage more of their health. “As you think about the possibility of your smartphone being able to do everything with your health care, managing your devices, communicating with your physician, capturing data … the possibilities are tremendous,” he said, citing wellness data and EHR data as examples.

“We’ve got a single device people can use to manage their lifestyle and manage their medical condition,” he said.

— Other biz/tech notes: Alphabet’s holding a two-day conference for employees from its various health-related initiatives … startup Collective Health is adding a board member with experience taking companies public. … An interesting reaction from a Kaiser Permanente doc on Atul Gawande’s EHR article

USDA RURAL TELEMEDICINE REPORT: Telehealth advocates often tout the benefits of the technology for rural patients, but those patients may not be as receptive to it as their urban counterparts, a new study from USDA suggests.

About 17 percent of rural residents surveyed did health research online, 7 percent did health maintenance activities like checking records or paying bills online and 1.3 percent participated in remote monitoring — compared to 20 percent, 11 percent, and 2.5 percent in urban areas, respectively.

The analysis was conducted using the Census Bureau’s 2015 Current Population Survey data, so trends may have changed since then.

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Allscripts plans on making PDMP data available on its EHRs.

Ciitizen — a startup helping patients control their data — details some of the spurious reasons providers use to restrict access to patient data.