Can NIH help drive health data access?

The National Institutes of Health released a new data-management and data-sharing policy this year that seeks to address longstanding data interoperability and oversight issues that have plagued the federal government’s response to public health emergencies like the COVID-19 pandemic.

Its success will now depend on how effectively the policy can be implemented across the nation's medical research agency and its diverse network of complex IT systems that span hospitals, clinical centers, research institutions and external partners throughout the public health community. 

The policy was years in the making, and collaboration across those complex IT systems was a key component from the beginning, according to Cindy Danielson, associate director of systems integration for NIH's Office of Research Reporting and Analysis. 

“We are really looking to help enable a cultural shift in research, one in which data sharing is the norm,” Danielson said. “One lesson learned is that community engagement is really key, and NIH has focused on engaging the community while developing the policy, while implementing it and continuing now while it’s in effect.”

The agency has since taken a phased approach and recently launched a pilot project with the research community to assess its implementation. The pilot is spearheaded by the Federal Demonstration Partnership, a cooperative of 10 federal agencies and more than 200 institutions focused on reducing administrative burdens associated with research funding. 

The partnership will test different structured templates that entities in the community can use to develop and submit their data-management and data-sharing plans with NIH, Danielson said, adding that later phases of the pilot will focus on costs, administrative burden and other aspects of the implementation. 

“We want to make sure that we’re flexible and able to adapt as we move on,” Danielson said. 

Accessible research data 

The new policy — which comes 20 years after the agency published the Final NIH Statement on Sharing Research Data — applies to all research supported by NIH that generates scientific data. It aims to make research data more broadly accessible by expanding data-sharing processes and improving data interoperability across NIH. 

Taunton Paine, director of the scientific data sharing policy division of the NIH Office of Science Policy, said at a National Cancer Institute event last year that the new policy "will create a consistent minimum expectation for all research" supported by the agency. 

"Fundamentally, the goal of the policy is to increase the availability of data underlying NIH-supported research," he said. 

NIH consists of 27 various institutes and centers, including the National Institute of Mental Health, the National Human Genome Research Institute, the National Cancer Institute and more. Each component must adhere to unique privacy and security requirements depending on the data it oversees, which complicates the process of developing common standards across NIH. 

Some agency components have had major success in managing and leveraging their data sets, according to Mark Forman, vice president of digital government strategy for the nonprofit ACT-IAC. 

Forman heralded NIH's oversight of its human genome data as "a clear success story" that involved a "bipartisan understanding of the value in creating that data set and managing it so it can be effectively used." 

"But with public health data, it's 180 degrees different," Forman said. 

A Government Accountability Office report published last year identified a wide range of challenges associated with the federal government's management of public health data. Longstanding issues, like a lack of common data standards and interoperability, had hindered its response to emergencies like the COVID-19 pandemic and monkeypox, according to the report. 

As part of an effort to cope with various data elements and restrictions, NIH's Office of Extramural Research developed 13 sample data-management and data-sharing plans that could be used by the agency's various components to develop their own unique pathways to complying with the new policy. 

“The policy was set up to allow real diversity and recognize that — depending on the scientific goals, depending on the data types and scope of research projects and scientific design methods — that data management and sharing plans would look different,” said Julia Slutsman, director of NIH Genomic Data Sharing Policy Implementation. “There is no one-size-fits-all plan or approach to managing or sharing data.”

A broader push

The new NIH policy is part of a broader push across the public health community to expand accessible health data, improve information-sharing efforts between the public and private sectors and develop common standards around health data. The Office of the National Coordinator for Health Information Technology also recently launched a submission page on its HealthIT.gov website for public input on the U.S. Core Data for Interoperability, a standardized set of health data classes to promote interoperable health data exchanges nationwide. 

“A huge part of our work within ONC is to start expanding the areas and domain, and expand health care data,” said Avinash Shanbhag, executive director for ONC’s Office of Technology. He added that his office is working on developing standards to create consistent pathways to exchange data across the vast range of components under the Department of Health and Human Services.  

NIH's new data policy also impacts the research centers and external partners that receive grants to conduct their work. The Association of American Medical Colleges, a recipient of NIH grants, has been working closely with the agency to develop its own data-management and data-sharing plan as required by the policy. 

Heather Pierce, AAMC's senior director for science policy and regulatory counsel, said the association collaborated with NIH throughout the development of the data management and strategy policy "to help ensure that an initiative to facilitate meaningful data sharing is also feasible and readily integrated into established processes."

"More than half of the research that NIH supports occurs at AAMC member institutions, making this new policy particularly significant for the nation’s medical schools and teaching hospitals," Pierce said, adding that the release of the new policy has provided further opportunities "for us to communicate concerns and challenges to the NIH."

As NIH continues working to implement the new policy across its entire enterprise, data security and integrity have also been a central focus. Slutsman said the policy was developed with data privacy and strict regulations around sharing in mind to prevent sensitive information from research institutes from becoming compromised. 

“The policy is really explicit that the goal is to maximize appropriate data sharing — and that word ‘appropriate’ is very, very intentional, because it signals that data sharing must respect participant privacy and participant interest,” she said.