FDA’s $100M Proposal Could Set E-Health Data Standards

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By Jeannie Baumann

The FDA’s push to use real-time data for evaluating drugs and devices could bring about more useful electronic medical records that improve patient care, current and former commissioners said May 4.

The Food and Drug Administration is asking Congress for $100 million in its 2019 budget to build a database of 10 million individual electronic health records across a range of health-care settings that could help guide how it evaluates medical products.

The agency has a unique opportunity to develop a repository that establishes standards for these electronic health records (EHRs), FDA Commissioner Scott Gottlieb said. A lack of EHR standards and the need to foster data sharing have been two big setbacks in building an interoperable system, in which data can move seamlessly across different health systems effectively, according to a government watchdog report in 2015.

“The risk that I see is that data has become so cheap—and there are so many players in the space—that everyone’s now throwing out their own databases,” Gottlieb said. “So instead of moving towards a system where we have more interoperable data, we have more silos being created.”

If every health entity creates its own data warehouse that’s targeted for its own purposes, it’ll become increasingly more difficult to harness the potential of that data to inform decisions that could improve the health-care system. “FDA has a unique opportunity to be able to become the repository and establish the standards,” he said.

Builds on Existing Programs

The EHR database proposal builds on FDA existing databases, such as the Sentinel Initiative, which monitors medical product safety, and the National Evaluation System for Health Technology (NEST), which aims to generate better evidence to evaluate medical devices. While they are transformative in their ability to create true consolidated databases for postmarket assessments, Gottlieb said, these systems have limitations because they look at retrospective payer claims data. “The next inflection point,” he said, “has been to start to look at EHR data in more of a real-time fashion or near a real-time fashion.”

The agency proposes that academic partners and perhaps even the medical products industry would have access to the database to conduct postmarket research to expand allowed uses of their products and to answer important safety questions. “If we can get some component of what we put forward in a budget, I think that could form the basis for a really transformative opportunity for FDA,” he said.

Gottlieb made his remarks during the May 4 annual public meeting of the Reagan-Udall Foundation, a nonprofit established by Congress to advance the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products, which is known as regulatory science. Ellen Sigal, chairwoman of the foundation and founder of Friends of Cancer Research, said the foundation also aims to help the FDA work on collaborations.

The meeting included a panel with Gottlieb and three former FDA commissioners: Robert M. Califf, who splits his time between Duke University and Verily, the life sciences arm of Google’s holding company, Alphabet Inc.; Mark B. McClellan, the director of Duke’s health policy center; and Andrew C. Von Eschenbach, president of Samaritan Health Initiatives in Houston.Both McClellan and Von Eschenbach supported a trusted, two-way portal for information and calls for collaboration flowing to and from the FDA. But Von Eschenbach noted any outreach from industry must be done so that it can’t be perceived as influencing the agency’s decisions. “A trusted, reliable two-way portal is a great vision for the future of FDA,” McClellan said.

But the biggest impact on a person’s health status is everyday life, Califf said.

Califf mentioned data from the internet and cell phones. “The science of EHR analysis and claims data analysis is moving very quickly, but it’s through the integration of this other information that’s really going to allow things to move.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bloomberglaw.com

For More Information

More information on the FDA’s $100 million request to build an EHR database is available at https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm.

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