NIH unveils data sharing strategy

With help from Arthur Allen (@arthurallen202), Darius Tahir (@dariustahir) and Rachel Roubein (@rachel_roubein)

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Quick Fix

— NIH takes a stab at data sharing strategy: The agency’s slated to publish a draft policy proposal today that would require research grant applicants to submit their plans for sharing and managing the information they gather.

— Texas health agency dinged for HIPAA violations: Among the missteps: allowing sensitive information belonging to more than 6,000 patients to remain online and visible to outsiders.

— Abortion roundup: Acting FDA commissioner Brett Giroir has riled abortion rights advocates, and Rep. Ron Wright introduces a bill banning telemedicine prescription of abortion medication.

eHealth Tweet thread of the day: Christina Farr @chrissyfarr “Can’t tell what’s a bigger challenge: Being a medical person at a digital health/ tech company or a tech/innovation person at a pharma/ health plan/ health system?”

Ben Miller @miller7 “Being a patient in the health care ‘system’”

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Driving the Day

NO MONEY TILL YOU TELL US WHERE THE DATA’S GOING — NIH plans to officially publish a draft data sharing policy today, part of a broader push by scientists, patients and government officials to speed up scientific and medical research by making studies widely accessible.

... The draft, which proposes requiring grant applicants to submit data sharing and management plans, is a “very good start,” said Sage Bionetworks’ John Wilbanks. But as with all such policies, he adds, “the enforcement is going to be the key.”

According to an unpublished version of the draft posted earlier this week, only the applicants who are likely to be funded would need to submit these plans, which also would outline efforts to protect research subjects’ privacy and sensitive data. Failure to comply with those plans could affect future funding. Comments are due Jan. 10, 2020.

SOFTWARE FLAW LEADS TO $1.6M OCR PENALTY — A Texas government health agency was dinged for HIPAA violations between 2013 and 2017, and will have to pony up $1.6 million for the civil penalty, according to an HHS release.

... The Texas Health and Human Services Commission, which now contains the Department of Aging and Disability Services, runs various health programs offering mental health and substance use treatment, child care and nutrition assistance, among others.

Back in 2015 the Department of Aging and Disability Services reported to OCR that health data belonging to 6,617 patients — names, addresses, Social Security numbers and treatment information — was accessible to users online without credentials. (The department was later added to the Texas Health and Human Services Commission.)

... The breach occurred when an internal application was moved from a private to a public server, propagating a flaw in the software code that made the health data viewable, according to OCR.

GIROIR’S TENURE PROVOKES CONCERN AMONG WOMEN’S, ABORTION RIGHTS GROUPS — Brett Giroir’s appointment as acting FDA commissioner is prompting some concerns given his track record in the Trump administration, eHealth’s Darius Tahir reports. Giroir, who has served as assistant secretary for health, was reportedly instrumental in banning fetal tissue research and the so-called gag rule in Title X funding targeting abortion.

... That’s led to concerns among Democrats and women’s groups. Patty Murray, the top Democrat on the Senate HELP Committee, said last Friday that she was “alarmed” by his record of “letting ideology drive decisions and the expense of women and families.”

“He clearly doesn’t prioritize either science/evidence based policies or ensuring the best public health outcomes for women,” said Susan Wood, a George Washington professor who previously served as director of the Office of Women’s Health at FDA. “He may not be there long enough to engage in direct decision making at FDA, but he may well allow for the injection of politics in what should be science based decisions that fulfill the public health mission of the FDA.”

Also on abortion, freshman Rep. Ron Wright‘s new Telebortion Prevention Act (H.R. 4935 (116)) would make virtually prescribing abortion medication — without physically examining the patient, being present while the patient ingests the medication, and scheduling a follow up visit — a federal offense. In a release, the Texas Republican cited concerns about the safety of medication abortions administered without a physician present.

This is the second abortion-related bill Wright has sponsored; back in May he filed a measure, H.R. 2817 (116), that would make it a federal offense to transport a minor across state lines to circumvent state laws that require parental involvement in abortion decisions.

... As POLITICO has reported, research suggests that abortion medication prescribed virtually is about as safe as that prescribed in-person. In one suchFDA-reviewed trial, research group Gynuity and partnering clinics prescribed medication when appropriate over video chat, once clinicians reviewed ultrasounds and medical history. Patients could then take the medication at home.

Another study, conducted in Iowa, found that adverse medical events are rare in medication abortions, and that telemedicine abortions are no less safe. Abortion rights groups have said telemedicine could save patients a several hours-long trip to the dwindling number of abortion providers in some states.

FALLOUT FROM ETHYLENE OXIDE SCARE — Some companies that use a toxic gas to sterilize medical devices have jacked up prices amid fears that state environmental regulators might force more facilities to close, eHealth’s Arthur Allen reports.

Sterilization plants using ethylene oxide in Georgia, Illinois and Michigan have closed in response to fears of high levels of the cancer-causing gas in neighboring communities. That’s forced the 100 or so remaining sterilizing plants to run at maximum capacity, Steven Elliott from the FDA’s Center for Devices and Radiological Health said at an FDA advisory committee meeting this week.

About a dozen manufacturers that depended on shuttered sterilization factories have approached FDA for help but “it’s becoming less and less possible to find alternative sites” for them, Elliott said.

“Inadequate sterilization would threaten modern medicine as we know it,” said Kara Mascitti, an infectious disease specialist at St. Luke’s University Health Network.

APPLE TAKES HOLD AT VA — The health record app that lets patients download their medical data on their phones is now live for VA patients, just in time for Veteran’s Day. The VA and Apple initially announced their partnership in February.

... It’s not clear when Android users will get the same capability. The agency said it will make health records accessible on other devices and software but mentioned no specifics.

UPCOMING KIDNEY CARE MOVES — HHS Secretary Alex Azar detailed Thursday a few next steps on Trump’s executive order to shake up the kidney care market, where the federal government spends over $100 billion per year, our colleague Rachel Roubein writes.

Collecting data: HRSA will issue a request for information this month on ways to modernize IT systems to better manage the allocation of organs and handle both patient and donor data on a national scale, Azar said at the American Society of Nephrology’s annual meeting.

— HHS will also issue an RFI on advancing human trials of wearable or implantable artificial kidneys, and NIH is opening up applications to develop technologies to help create an artificial kidney.

T-MSIS DATA NOW AVAILABLE TO RESEARCHERS — Researchers are about to get a lot more access to data about Medicaid patients, although questions remain about the quality of the data.

In an announcement Wednesday, CMS Administrator Seema Verma touted the release of data through the T-MSIS program, a long-delayed effort to collect comprehensive information about the administration of Medicaid across the country.

If it works, it’ll provide researchers with a much more granular view of what’s going on in the program. “TMSIS has been a long time coming, and while there may be some data issues still to work through, having access to timely data for analysis will be extremely valuable to understanding post-ACA coverage and spending patterns in Medicaid,” Rachel Garfield, co-director of the Kaiser Family Foundation’s program on Medicaid and the uninsured, told us.

... But there’s a hitch: how good the data actually is. Watchdogs and observers (like the Government Accountability Office, HHS’ Office of Inspector General, and MACPAC analysts) have raised questions about the quality of the data, which could distort findings derived from the database.

What We're Reading

— Reddit is perhaps not the best platform for diagnosing STDs, Bruce Y. Lee writes in Forbes, citing a research letter in JAMA.

— Bloomberg’s Kristen V. Brown reports on a data breach at DNA testing company Veritas.