New AI policy push

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

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It’s another buzzy day, with President Trump calling for $500 million in new funding for childhood cancer research over 10 years in the State of the Union. And then there’s yet more news to cover:

— New AI policy push: One trade group is trying to get a jump on defining the artificial intelligence policy agenda for health care early with a new set of principles, and will be hoping to persuade legislators and administration officials, our colleague Mohana reports.

— Cerner, VA and DOD rumbling along: Implementation questions continue to burble on Cerner’s implementations of its software with its two government partners, VA and DOD, with a Senate hearing probing officials on their plans.

— Amazon/Berkshire/JPM legal battle deepens: The legal battle between Optum and the former executive who jumped ship to the stealthy Amazon-Berkshire-JP Morgan health venture continued Tuesday, with a judge ruling on a pair of motions.

But first, the jump:

eHealth tweet of the day: Zackary Berger, MD, PhD @ZackBergerMDPhD

“My favorite faxes are Epic notes

printed out

faxed to me

then scanned

into Epic”

WEDNESDAY: There’s something a bit surreal about enjoying a day with temperatures in the 70s with road salt crunching beneath one’s feet. Talk weather anomalies at [email protected]. Discuss weather socially at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

AI PRINCIPLES RELEASED — FIRST IN MORNING eHEALTH: Trade group ACT | The App Association’s health coalition has published several broad recommendations for national policy addressing AI in health, serving as the basis of an ongoing educational campaign for lawmakers and White House officials.

The Connected Health Initiative’s AI principles note that a national policy framework would be “vital” to helping patients and the health sector benefit from AI. Morgan Reed, who leads the association and CHI, says the group isn’t calling for “any specific legislation,” but hopes to start concrete discussions about who should regulate AI and how.

Any federal policy should include robust privacy and security protections for patients, including the promise that their sensitive data can’t be used to discriminate against them, for instance.

The group has targeted Washington leaders with an educational campaign defining terms like “algorithm” and “artificial intelligence” and articulating some of the ethical and regulatory challenges in health technology, Reed said. Pros can read the rest here.

CERNER, VA AND DOD RUMBLE ON: In a Senate Appropriations military construction-VA subcommittee hearing Tuesday, legislators pressed administration officials on the latest from the Cerner implementations in the DOD and VA.

VA officials said both departments expect to name an “arbiter” to settle major disputes between the two in implementing the software. Major differences in the way Cerner software is deployed makes it difficult to share data between the two systems.

Meanwhile, Sen. Tammy Baldwin (D-Wis.), whose state counts Epic as a homegrown company, asked a series of sharp questions about the VA’s decision to opt for a Cerner scheduling system over Epic. While the VA’s John Windom defended the decision by pointing to the eased interoperability between two Cerner systems, Baldwin questioned whether there’s evidence to support the claim. “Since no VA medical center currently uses the Cerner module, I’m not sure how you can make such a statement,” she said.

— Earnings season for Cerner: The company will start paying a quarterly cash dividend of 15 cents a share starting in the third quarter of this year, the company announced in a fourth quarter earnings call Tuesday. Its bookings in the fourth quarter were nearly $2 billion, the second highest quarterly result after the fourth-quarter 2017 figure of $2.3 billion. Full-year 2018 bookings were a record $6.7 billion, up 6 percent compared to 2017. “Our confidence in Cerner’s growth outlook, combined with strong cash flow and balance sheet, put us in a position to return capital to shareholders,” said chairman and CEO Brent Shafer, who just finished his first year at Cerner.

Some outside observers weren’t quite as sunny. In a note, analysts from bank Evercore ISI called the dividend “immaterial” and the overall results “reasonably weak.”

FDA COMBO PRODUCTS GUIDANCE: In another move sold as a big win for digital health, FDA released a new draft guidance Tuesday aimed at boosting combination products. For a brief explainer: a combination product is one in which two different therapies straddling the different FDA taxonomies (drug, device, biologics) are melded into one product. One popular digital health example: putting a tracker on a pill to see whether the user actually ingests the therapy as directed.

The guidance says that, generally, companies only must submit one application even if it’s reviewed by multiple FDA branches.

Commissioner Scott Gottlieb, in a release, pointed to several potential digital devices as a rationale for the guidance, citing digital pills and mobile apps. If it’s true, digital developers will be pretty pleased; we wrote in 2016 that entrepreneurs were frustrated that the agency’s device division had different standards than its drug division, which was demanding voluminous extra data.

But some observers aren’t entirely convinced by the draft. Bradley Merrill Thompson, a digital health lawyer with Epstein Becker and Green, wrote to your correspondent noting that while Gottlieb’s statement mentions digital health, the guidance does not. “So it doesn’t really contribute clarity with regard to digital health in particular,” he said. Moreover, Thompson doesn’t believe a single application solves the over-review problem raised by entrepreneurs; nor does it address the reality that the drug maker and digital product developer might be separate entities.

“I really don’t see helpful improvements from the standpoint of software used in tandem with pharmaceutical products,” he concluded.

AMAZON-BERKSHIRE-JPM LEGAL BATTLE CONTINUES: The legal battle between Optum and its former employee, David Smith, now of the Amazon-Berkshire Hathaway-J.P. Morgan health care hydra, continued Tuesday as a district judge ruled on a pair of early motions.

First, the judge stayed a motion that would’ve kept Smith from working for his new employer during the legal fight. Optum had sought the injunction; the company has argued Smith is violating non-disclosure and non-compete agreements by moving to the new venture.

But the judge also denied a motion from Smith that would’ve moved the case immediately to arbitration. The case has attracted heightened speculation given the thus-far opaque intentions of the new venture; Optum thinks Smith will be taking some of its secret sauce to the new firm.

— New Oscar Health exec, plus court resolution: The New York health insurance firm will have a new CFO beginning March 1: Sid Sankaran, formerly a top executive at AIG.

But the company was dealt a major setback in its fight with Florida Blue Cross and Blue Shield. The startup has alleged Florida Blue is unfairly enforcing exclusivity agreements preventing brokers from selling their plans. A federal judge on Tuesday rejected Oscar’s bid for a temporary injunction. Florida Blue’s motion to dismiss the lawsuit yet to be decided.

— CommonWell adds new link: The CommonWell Health Alliance members can now link their own customers to the health data exchange network, potentially simplifying the process of connecting to CommonWell, the group said Tuesday.

The CommonWell network is designed to make the exchange of certain health data, such as enrollment or patient record location, easier for members. The new CommonWell Connector Program means members can offer the CommonWell certified interoperability services they use to other providers or EHRs. Health Gorilla and InterSystems are among the first group of Connectors.

TELEMED OVERHAUL PASSES VIRGINIA: Both chambers of Virginia’s legislature have passed companion bills to overhaul the commonwealth’s telemedicine laws. The bills would add remote patient monitoring to the list of covered services by commercial insurance plans. Nathaniel Lacktman, a digital health lawyer with Foley & Lardner, called the bill a “great revision to Virginia’s telehealth laws.”

Deven McGraw, former OCR official and currently with consumer data access startup Ciitizen, blogs on the importance of the designated record set.

Maternal mortality data is inadequate to confront the rising death rate, researchers argue in a Health Affairs blog post.