FDA plans to link claims data to EHRs in its Sentinel safety database

With help from Darius Tahir and Mohana Ravindranath

Editor’s Note: This edition of Morning eHealth is published weekdays at 10 a.m. POLITICO Pro eHealth subscribers hold exclusive early access to the newsletter each morning at 6 a.m. To learn more about POLITICO Pro’s comprehensive policy intelligence coverage, policy tools and services, click here.

— FDA’s Scott Gottlieb announces a plan to link claims data to EHRs to bolster the agency’s Sentinel product safety data base

— Social media are helping to further measles outbreaks, CDC and NIH officials tell a House committee. Turns out that memes can spread germs.

— Dems and GOP senators show deep disagreement over preemption of state laws in any new privacy legislation. At a Commerce Committee hearing, it was revealed that 94 privacy bills are now circulating in the states.

But first let’s go public ...

Tweet of the Day Steph Guerra @Steph_Guerra Darrell Kirch, President and CEO of @AAMCtoday, sees reason for hope in health care: the vast majority of today’s medical students are team players learning how a patient’s zipcode is often more important than their genetics in determining health outcomes #Atlantichealthcare

Welcome to Thursday morning eHealth, filling in for the under-the-weather Darius Tahir. Parlor game of the week: Who plays Michael Cohen in the movie version of the Trump saga? What about Jim Jordan? Elijah Cummings? Send tips to [email protected]. Alert the team to vital news @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

FDA SEEKS A WIDER-ANGLE VIEW OF PATIENT SAFETY: The FDA plans to modernize its drug safety reporting systems this year so it can get the “big picture” on potential hazards faster and give the public more information, Commissioner Scott Gottlieb told House appropriators on Wednesday.

... The agency will launch a “safety signal tracker” that consolidates safety information about a drug from its time in early development through FDA review and once it is cleared for sale.

… FDA also plans to link claims data in its nationwide Sentinel safety database to EHRs in order to actively monitor therapies and pull in real-world evidence.

‘PREEMPTION’ DEBATE DRIVES PRIVACY TALKS: Members of the Senate Commerce Committee pushed tech leaders to defend the merits of national privacy legislation during a hearing Wednesday.

Jon Leibowitz, a former FTC chairman who leads a lobbying group for telecommunications companies, argued that a patchwork of state privacy policies “balkanizes commerce,” pointing to at least 94 state-level proposals. Woodrow Hartzog, a law and computer science professor at Northeastern, argued that a federal law preempting states could dilute privacy protections. Privacy is complex, and Congress might not get it right the first time, he said.

... As our POLITICO colleague Cristiano Lima reports, the committee’s top Democrat, Maria Cantwell (D-Wash.), called efforts to override state privacy laws “disturbing”; ChairmanRoger Wicker had called for a “preemptive framework” in his opening remarks, arguing that “a national framework does not mean a weaker framework.”

“I find this effort somewhat disturbing that with all the litany of things, the privacy violations [we] just went through and as countries are grappling with this, that ... the first thing that people want to organize in D.C. is a preemption effort,” Cantwell said.

Cantwell suggested that lawmakers in California will likely resist any federal measure that nullifies the sweeping privacy law they passed last year.

“The reason all the states are doing all of this is that we have done nothing here, and part of that is because the companies that you represent have been lobbying against legislation like this for years,” said Sen.Amy Klobuchar (D-Minn.), in a comment directed at Republicans. More for Pros here.

VA 2030? VA 2045?: Veterans Affairs Secretary Robert Wilkie appeared Wednesday at a House committee hearing on the VA of 2030, and interoperability was high on the docket. Former House Vets Chair Phil Roe (R-Tenn.) said the agency should focus on solving the problem now rather than waiting for the Cerner implementation to conclude. “Eleven years is a lifetime and the Cerner EHR is just one element,” he said. “We need to remain focused ... on things that will work just as well today with VistA as they will with Cerner in the future.”

Richard Stone, the Veterans Health Administration chief, said he found it “troubling” to hear people claim the VA was privatizing. “The Veterans health system is healthy and growing,” he insisted. As the number of veterans shrinks in coming years, he said, an integrated IT system will facilitate the VA’s survival.

... Meanwhile, MITRE and VA panelists outlined a future of VA innovation at an event led by former AHRQ director Carolyn Clancy, whose current title at the VA is “deputy undersecretary for discovery, education, and affiliate networks.” She talked about making sure all veterans, including the third living in rural areas. have equal access to health care. Some ideas: virtual tumor boards, remote monitoring and other home technology.

IS SOCIAL MEDIA SPREADING DISEASE?: House Energy and Commerce lawmakers asked public health officials Wednesday what they can do to fight vaccine disinformation that is contributing to a resurgence of measles.

Chairman Frank Pallone (D-NJ) said he was troubled by the role of digital media in “perpetuating myths and fears” about vaccines, particularly the measles-mumps-rubella vaccine. Anti-vaccine advocates enjoy a large, vocal presence online.

… The CDC has confirmed 159 confirmed cases of measles in 10 states this year. Measles vaccination rates for 13- to 17-year-olds in 2017 dipped below 78 percent in some states, a level that can lead to rapid spread of the highly contagious disease. The NIH’s Anthony Fauci said health officials need to keep educating people about the measles vaccine, perhaps the safest and most efficacious shot given to small kids.

The 2020 Election. The new Congress. The Mueller investigation. … Keep up with POLITICO Playbook. Be in the know. Sign up todayhere.

Speaking of social media, a Hastings Center Report argues that bioethicists need to take on their public health effects. Facebook, Twitter and the rest are promising tools to develop new diagnostics and therapies — and are catalysts of potentially negative social change. Bioethicists need to understand both trends and to develop codes of responsibility so social media companies don’t inadvertently sicken us all. … A study by startup Cricket and researchers from UC-San Francisco and the San Francisco VA shows that kidney dialysis patients remained engaged with an educational program to choose the best treatment for themselves. … A Nature review examines the promise of mobile apps in tracking infectious disease. … AnAvalere report looks at CMS’s decision to start reimbursing providers for certain virtual services this year.

MEDSPHERE BUYS EMERGENCY DEPARTMENT IT PROVIDER: Open source EHR maker Medsphere Systems said Wednesday it was buying Wellsoft, which makes ED software. Medsphere, which has a few big hospital clients but mainly provides IT for smaller and rural settings, says the Wellsoft purchase will enable it to provide a comprehensive solution for urgent care centers.

Physician-informaticist Mark Roche, a former Northwestern University adjunct professor and ONC subject matter expert, has been named CMS’s first chief health informatics officer, per his LinkedIn page. In this job he’ll be responsible for CMS’s clinical, technical and interoperability strategy. Read more on Roche here. ... Privacy attorney Kirk Nahra as of Wednesday ended his 31-year run at Wylie Rein Llp, switching to WilmerHale in the D of C. Nahra will co-chair WilmerHale’s privacy and cybersecurity practice, working for old clients and some new ones in health care and tech.

CNBC: Amazon chooses former Kindle leader to head its pharmacy biz

Undark: The psychology and allure of conspiracy theories

Health Affairs: The oversell and undersell of digital health

Daily Mail: An NHS-backed chatbot has some technical issue