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The White House’s push to make it easier for patients to access and share their electronic health data could spur medical research—if critical challenges can be resolved.
Medical and scientific leaders who work at the intersection of health technology and medical research identified these challenges and opportunities to Bloomberg Law. Their comments build on the recent announcement from Seema Verma, administrator of the Centers for Medicare & Medicaid Services, that she wants to overhaul the regulation of digital health records. Jared Kushner, President Donald Trump’s son-in-law and White House adviser, is helping steer these changes.
The White House announcement—which doesn’t identify specific steps—focuses on patient care, not research. But it comes at a time when there’s movement in big-ticket research programs such as real-world data and a million-person study to advance personalized treatments, both of which might transform drug approval decisions and patient treatment options with the help of big data sets.
“If you give patients easier access to their data, they will donate it for research purposes,” Deven McGraw, a national leader in health data and privacy issues, told Bloomberg Law in a March 9 interview.
Delivered at a 40,000-person health IT conference, Verma’s announcement “hit all the right rhetorical points” that created an “energy level that was off the charts,” McGraw said March 8.
Verma wants to overhaul quality measures for the meaningful use program, which focuses on getting electronic health records into the provider setting. Since 2011, the CMS has paid out nearly $38 billion to more than 543,400 health-care providers to adopt EHRs. More than 95 percent of of hospitals eligible for the program have achieved meaningful use of certified health IT, according to CMS data.
“The availability of electronic records now is quite high in those settings,” Mark McClellan, director of the Duke University’s health policy center, told Bloomberg Law.
Verma’s announcement recognizes the need to spur the next phase of EHRs integration. “We need to do more on getting that information shared so that when patients go to different health-care providers—or when they just want to keep their own data to improve their health—they have an easier way to do that.” McClellan served as CMS administrator and commissioner of the Food and Drug Administration under President George W. Bush.
Despite an HHS guidance document that delineates patients’ rights to their health information under the Health Insurance Portability and Accountability Act, accessing patient data is still really difficult, McGraw said. She oversaw health privacy for the HHS agency that administers HIPAA before leaving last year for Silicon Valley startup Ciitizen.
Patients are still being charged thousands of dollars, or are being told they can’t get an electronic copy of their records when the office has EHRs.
“That should be unacceptable in this day and age, when we have so many digital tools and options available at our disposable,” McGraw said.
“To the extent that Medicare has some policy levers that it can pull to provide some incentives or requirements along those lines, I think it can be enormously helpful,” McGraw said.
Rebecca D. Kush, scientific innovation officer for Elligo Health Research, an Austin, Texas-based group that aims to use electronic health records to improve clinical trials participation, said the initial set up of meaningful use should have included a set of data standards for research.
“They didn’t, and I knew it was heading for a train wreck,” she said in a March 12 interview. “That’s what we’re looking at right now.”
Kush, who founded a standards consortium for medical research data, said there’s a critical need to develop EHR data standards that can be used for research, but the focus has been on billing codes.The FDA has actually forged ahead with programs like Sentinel, Kush said, referring to the agency’s database for tracking medical product safety through EHR, claims data, and other sources. But different HHS agencies are working on different standards. “At some point, you have to put a stake in the ground and say, ‘This is what we’re all going to use.’”
Clinical researchers need to be able to take advantage of the information donated by research participants, Kush said. “If only half of it is understandable and meaningful when it’s received, then you’ve wasted their time and their participation.”
Ideally, an administrationwide focus to improve data exchange would exist, so patients can have easy and cheap, if not for free, access their health information, McGraw said. A key to this would be interoperability, which is the ability of different health IT systems and software applications to communicate, exchange data, and use shared data.
Amy Abernethy, chief medical officer for Flatiron Health, said the push to improve interoperability is fundamental for better care for individuals, “but it will actually not solve getting data research-ready.” Flatiron develops cloud-based data tools to advance cancer research through better patient data collection, and pharmaceutical company Roche acquired the New York-based company for $1.9 billion in an agreement reached last month.
Much of the valuable information in health records rests in medical case notes or nursing notes which are in PDF formats and difficult to use in research. Supporting interoperability in research will require three fundamental steps, she said.
First, there needs to be a way to aggregate data across tens of thousands—and even millions—of patients quickly, as opposed to moving the data as single records. Secondly, when those data are downloaded, they must be input using a common format that’s analyzable.
Laboratory data, like hemoglobin levels, can be easily mapped into a common format to get research rapidly.
“The stuff that’s really hard to get research ready is the stuff that lives in PDFs and unstructured documents,” she said. “They’re stuck on a server over in the corner and hard to get at. We spend a lot of time at Flatiron just figuring out where they reside.”
Third, researchers need to have the right patient permissions to use their information, or remove any identifying information before they use it and then link that aggregated data, which she said is a complicated process that requires third-party linking applications.
It’s feasible to overcome these three challenges, Abernethy said. it’s just going to take a lot of work. “I think we’re in inning two,” she said.
McClellan said the CMS announcements mark an important step in expanding available data in general, as well as putting more data under the control of participants. “That is creating some new opportunities, but also challenges, that we have to work through in how we conduct research studies.”
“We’re going to see a lot more research projects that focus on recruiting patients, and then going through patients, through mechanisms like this to get historical data on the patient, the ongoing data on how the patients are doing, compared to what’s happened in the past,” he said.
The National Institutes of Health’s All of Us research project also can advance this research interoperability effort, both McGraw and McClellan said. Participants will securely share their EHRs in an effort to advance targeted treatments known as precision medicine.
“That’s a data donation initiative,” McGraw said, adding if the process for donating those data remains difficult, “You’re starving that as a potential vehicle for rapid learning.”
Scientists working in the traditional research model determine at the front end who is eligible for the study, how many of them are actually enrolling, and how to handle any missing data, McClellan said. All of Us creates a different environment in which patients who decide to share their information may be different from those that don’t “in ways that we don’t yet fully understand,” he said. That may make it hard to compare research results done the traditional way versus research data that come from patients.
“But that is the future, and it’s a set of new techniques and new understanding about how to do research that needs to happen within an era of big data,” McClellan said.
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
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Verma’s remarks to HIMSS https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06-2.html.The HITECH Act is available at https://www.hhs.gov/hipaa/for-professionals/special-topics/hitech-act-enforcement-interim-final-rule/index.html.
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