New details on pre-cert

With help from Arthur Allen (@arthurallen202), Darius Tahir (@dariustahir), Sarah Karlin-Smith (@SarahKarlin) and Sarah Owermohle (@Owermohle)

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FDA head Scott Gottlieb canceled his trip to J.P. Morgan’s health conference because of the government shutdown, but he’s still scheduled to speak today via videoconference. We’ve got Pro’s Darius Tahir and Victoria Colliver on site in San Francisco. In the meantime, here’s what we’re tracking:

— NEW DETAILS ON PRE-CERT: If FDA’s pre-certification pilot approving digital health companies instead of their products proves successful, the agency will seek new congressional authority to implement it.

— APPLE’S PIVOT TO HEALTH: Some analysts predict that Apple, one of the companies in the pre-cert pilot, will double down on health products to offset stiff competition in the phone market.

— DEARTH OF PEER-REVIEWED RESEARCH ON COST, ACCESS: The digital health companies snapping up major private equity dollars aren’t routinely studying the impact they have on high-burden, high-risk patients, a new study suggests.

eHealth Tweet of the day: Harlan Krumholz @hmkyale Trying to get my mom’s med records…this seems to be an all day ordeal. We thought we had it solved — but just heard that she didn’t check the right box; now asking if she can drive 30 minutes to fill out another form. Not kidding. Then they can try again.

It’s TUESDAY at Morning eHealth where your author is thrilled about Olivia Colman’s Golden Globe win. Whose performances have you enjoyed this movie season? Names and tips go to [email protected]. Reach the rest of the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

The FDA plans to establish a new, 52-person Office of Drug Evaluation Science, which Gottlieb is slated to discuss today, Stat’s Matthew Herper reports.

The office would promote new drug development tools, research and biomedical informatics, an FDA spokesperson said.

Gottlieb is sketching out a futuristic vision in which drug companies could upload study results into the cloud so FDA could analyze raw data. “Eventually the drug review process will look a lot different,” he wrote to Stat.

...Other dispatches from JP Morgan: Here’s some of the essential news from Darius on the first official day.

— Teladoc: The leading telehealth firm’s CEO, Jason Gorevic, was relentlessly upbeat during his presentation. He said his company is seeing more and more patients, who are using the service the service more and more. The company estimates it provided a total of 2.5 million visits in 2018.

Gorevic also signaled his company plans to go deeper into the government market, citing initiatives with Medicaid and Medicare as CMS has been loosening the reins on telehealth reimbursement.

— Omada Health: The startup, as we originally hinted back in October, is expanding beyond its diabetes prevention program origins, with a suite of new services targeted for behavioral health. In an announcement Monday, Omada said it will offer services for patients suffering from depression and anxiety and using cognitive behavioral therapy software from Lantern. CEO Sean Duffy has also signaled interest in areas like hypertension.

— Funding still fizzing, but not yet bubbly: Digital health investors Rock Health say the sector is fizzing – but still not yet bubbly. Investors poured $8.1 billion into the sector in 2018, nearly $2.5 billion more than in 2017.

But for all the investor enthusiasm, Rock Health believes there’s no bubble being inflated. The report cites a number of factors that might lead one to believe there’s a bubble blowing up — fraud, limited opportunity for profit, too much hype — and says, at worst, the sector is “moderately bubbly” by their reckoning. Report here.

— Quick hits: At one lunch, HHS chief data officer Mona Siddiqui said the department had started up a data science training series to help teach employees new skills, and 500 applied.

...Former VA official Ashwini Zarooz, now of Salesforce, offered one interpretation for some of the EHR implementation turbulence. When asked about how to effect cultural transformation, she referenced the implementation by saying, “It was all about resistance … our providers and frontline staff really resisted the idea of this change coming forward,” she said, before stressing the need to engage providers when installing a new EHR.

NEW DETAILS ON PRE-CERT: Back in Washington, the FDA laid out a roadmap for its digital health pre-certification pilot program, which focuses scrutiny on developers’ practices, rather than their products, Darius reports. Such a system would allow companies to rapidly release new and presumably improved versions of their software, as is done in other industries.

The pilot has two phases this year. First, FDA will review previous software approvals to see whether its pre-approval process would have obtained enough information for the agency to have made a proper decision. In the next phase, the agency will test its pre-certification model on some new software submissions, applying the standards it uses for medical devices classed as medium-risk.

FDA also plans to test data-sharing between developers and reviewers to monitor the performance of approved software, and that a series of unsuccessful reviews might endanger a developer’s pre-certification status. Pros can read more from Darius here.

As other tech companies encroach on Apple’s phone, hardware and wearable offerings, the Cupertino giant is digging its heels into health. It’s been about a year since it launched a feature that can download patient records to phones; the newest Apple Watch, which can take ECG scans, is cleared by the FDA.

Research firm CBInsights says Apple’s strong brand and popularity with consumers makes it a formidable competitor to more established health IT companies, as does its ability to bundle hardware and software. And the company has enough money from other products to “weather the regulatory uncertainty” in health, CBInsights analysts write in a new report.

…. In other digital health news, the top-funded private digital health companies aren’t studying their impact on cost or access to care among high-risk patients and those with high-burden conditions, researchers find in a new Health Affairs study. And when these companies do get studies in peer-reviewed journals, they tend to focus on healthy patients, they said.

Researchers examined 104 studies covering the products sold by 20 digital health companies. Those companies, whose products ranged from biosensors to precision medicine software, had a combined $2.5 billion in private equity funding. Just about 28 percent of the studies demonstrated the products’ impact on disease burden or cost for patients with high-burden conditions.

It’s not that these companies don’t care about sick patients, researcher Adam Cohen, the health technologies program manager at the Johns Hopkins University, tells Morning eHealth. It’s possible that early-stage health companies do their first wave of clinical effectiveness or validation studies on healthy patients and progress to sicker patients later, he said. It’s also possible these companies don’t need to prove their efficacy in peer-reviewed journals when they can market directly to consumers.

The transition to value-based purchasing and value-based health care delivery could incentivize these companies to demonstrate their impact on cost, access and other factors, researcher and Harvard Medical School instructor Kyan Safavi said.

NEW OFFERING FROM PEAR: Novartis proprerty Sandoz and Pear Therapeutics have launched a 12-week cognitive behavioral therapy program for patients with opioid use disorder, designed to be used along with medication.

NIH’s mission to collect biospecimens and surveys from 1 million people may require rethinking the informed consent process, especially when a patchwork of state and territory laws might protect participants differently. That’s what Sage Bionetworks’ Megan Doerr discussed this weekend at the Pacific Symposium on Biocomputing; her team’s research concludes that sticking with one uniform consent process would be difficult. Breaking the consent process into smaller, distinct chunks for each action would give the NIH more flexibility, her team finds.

Anand Shah is joining CMS’ Office of the Administrator as the senior medical adviser for innovation...Solera Health, which integrates health services into one network, has hired Andrey Ostrovsky, formerly chief medical officer for Medicaid, as its chief medical offer.... Ed Kopetsky of Lucile Packard Children’s Hospital Stanford and Stanford Children’s Health is named CIO of the Year by the College of Healthcare Information Management Executives and the Healthcare Information and Management Systems Society. Kopetsky, who co-chairs the CHIME opioid task force, lost his son to an opioids overdose...AMGA’s board announced members of its 2019 Executive Committee and board.

—WSJ’s runs down some health tech companies at CES

—The New York Times reports on the Mavericks’ collection of players’ blood samples

—Researchers call in Nature for applying deep-learning to EHRs