HHS, under Secretary Robert F. Kennedy Jr., has sought access to detailed patient records held by state health information exchange systems as part of an effort to research a potential link between vaccines and autism, KFF Health News reported June 4.
Federal officials met with leaders of state-run health information exchanges several times over the past year, asking how the medical records they maintain from hospitals and health systems could be used for vaccine research, according to seven people familiar with the meetings.
Craig Behm, who runs the Maryland health information exchange, said Mr. Kennedy’s team asked directly whether the data the exchange stores could support vaccine research.
“If this administration wants to conduct research on the effectiveness of vaccines, are you saying you all can help us conduct that research?” Mr. Behm recalled being asked by a top official at HHS’ Health IT office.
Mr. Behm said Maryland declined. Sharing identifiable medical records for that purpose, he said, would require approvals from hospitals, state political leaders and research boards, none of which had been obtained. Most health information exchanges have contractual restrictions on who can access clinical data.
“A number of us said, ‘We can’t do anything our agreements don’t allow us to do, so no,'” Mr. Behm said.
John Kansky, CEO of the Indiana Health Information Exchange, confirmed that vaccine safety came up consistently throughout the discussions. Indiana is still weighing whether to share additional data with Mr. Kennedy’s project and nothing has been provided yet.
“Vaccine safety, or whatever words you want to use, has come up pretty consistently in those conversations,” Mr. Kansky said. “It’s like, oh man, I wish you would have picked something that pushed fewer buttons for people.”
Mr. Kennedy told KFF Health News in May that medical records are central to his effort to investigate autism, vaccine safety and chronic disease and that he has been frustrated by limited federal access to patient data.
“We need a good health record system, and one of the things that really surprised me most when I came into office is that there is — that the systems are broken,” Mr. Kennedy said. “We’ve had to go to the states and, luckily, we’ve got a lot of cooperation from the states, but we now have databases together that we can actually do the studies on. Those studies are in motion.”
HHS has not publicly announced any new projects involving medical records and vaccine or autism research. A department spokesperson did not answer questions about how many states are participating, what data is being collected, how it is protected or who has access to it, according to the news outlet.
Mr. Kennedy has asserted, without evidence, that vaccines can cause chronic illness. Decades of research have shown immunizations are safe and effective for most people.
Nearly every state has at least one health information exchange, often regulated by state laws and run by private companies or nonprofits, that enables hospitals and health systems to share patients’ medical records with one another. Under certain circumstances, most often involving infectious disease outbreaks, the exchanges notify public health authorities. Using the exchanges for broader research purposes is not unprecedented, but it presents privacy, legal and ethical complications, health officials said.
Daniel Jernigan, MD, a former top CDC official who left the agency last year after 31 years, said the federal government has limited legal authority to access records from state health information exchanges. He also raised doubts about whether those records would answer Mr. Kennedy’s questions.
“If they’re just using the electronic health record data, there are limits to that,” Dr. Jernigan said. “If they’re only looking at electronic health record data, all you’re going to get is what was captured in the encounter. It’s not going to be very satisfying.”
Dr. Jernigan said he tried to point Mr. Kennedy toward existing deidentified databases pulled from health systems nationwide and maintained by major EHR companies. Mr. Kennedy, he said, did not appear interested in that alternative.
At least one state has moved forward with cooperation. Jaime Bland, DNP, RN, former CEO of CyncHealth, Nebraska’s state health information exchange, helped lead the effort to share data with the federal government. In October, she presented a proposal to federal officials outlining how CyncHealth and other state exchanges would collect data from hospitals, clinics, laboratories, pharmacies, payers and social services agencies and link claims and clinical records. The proposal called for HHS to receive data from 90% of the population’s medical records by 2028, with the federal government paying exchanges $3 per person annually.
The slide presentation said data from the exchanges “will be deidentified where appropriate.”
Weeks after that meeting, the CDC awarded Nebraska’s state health department $18.7 million under its Epidemiology and Laboratory Capacity program, the largest award to any state last year, despite Nebraska being the 38th most populous state. By comparison, Texas received $9.2 million and California received $10.8 million. CyncHealth was then awarded three contracts from the state health department totaling $13.6 million in January.
A CyncHealth spokesperson told the news outlet that the organization retained $2.4 million of the funding for Mr. Kennedy’s project and distributed the rest to other participating states and vendors. The spokesperson added the work “is focused on improving outcomes related to acute and chronic illnesses” and characterized it as “a proof-of-concept project on how health information exchange and public health can work together,” not autism research specifically.
Dr. Bland left CyncHealth in December and was named in April as chief data strategist for the MAHA Institute, a think tank aligned with Mr. Kennedy’s Make America Healthy Again agenda.
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