Science1 publisher3 min readPublished
Kennedy wants patient records pooled for researchers without data holders' permission
Robert F. Kennedy Jr. told a MAHA Institute event that researchers should not need a gatekeeper's permission to study patient health records. Allies offered Nebraska's exchange as the model, though state consent laws limit such access and the Nebraska deal appears never to have been announced.
The Scientist · Science desk
What happened
- Kennedy wants records linked from state health exchanges, EHRs, laboratories, Medicare, Medicaid and commercial platforms such as HealthVerity.
- KFF Health News reported earlier this year that Nebraska's exchange, CyncHealth, shares patient data with the CDC for studies of vaccines and autism.
- According to STAT, neither the CDC nor the NIH arrangement with Nebraska appears to have been publicly announced.
- Jamie Bland led CyncHealth until the end of last year and became the MAHA Institute's chief data strategist in April.
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Why it matters
- contradiction The two accounts of the Nebraska deal name different agencies and different research aims, so the model being offered to other states has no settled public description.
- constraint In a state with rules like Arizona's, consent requirements would block the Nebraska model for researcher grants even on de-identified records unless the law changed.
- cost By Gorton's own account, expanding the model means each state paying for Nebraska-style data governance, so the cost falls on state exchanges before any federal study runs.
- decision Every other state exchange now faces the choice Nebraska made and its peers declined: whether to send patient records to federal researchers at all.
Kennedy's stated aim is longitudinal. He wants to aggregate "immunization records, clinical data, laboratory results, pharmacy information, and claims to create a more complete picture of a patient's health over a long period of time" [4]. The event pitched that as a way to study the origins of chronic disease [1]. His complaint was about who decides access. User agreements, he said, give "institutions that control important health data the power to decide who can study it and what questions they're allowed to ask, and that creates protectionism in science and it leads to the politicization of science." [2] He singled out the need for permission from "an industry gatekeeper" [3], and said he wants the linked data available to all researchers [6].
Andrew Kress, CEO and founder of HealthVerity, one of the commercial platforms Kennedy named as a source [5], has also blamed governance. "The issue is not a technical limitation," Kress told STAT last year. "It's really been more around data governance, data ownership, data privacy." [15] Hospitals sometimes sell de-identified patient data, or grant access under data use agreements that spell out what the data may be used for. Patients normally have to consent to research use [14].
Nebraska was the working example. Mark Gorton, the MAHA Institute's president, said the state's partnership with the NIH "has successfully produced data for the study of chronic disease and serves as a proof of concept for the state-federal hybrid model." [8] Producing data shows that records moved from a state exchange to a federal agency. A proof of concept for research would be a published result, with a design and a comparison group that people outside the partnership could check.
Gorton attached a condition. The partnership worked, he said, "because of the investments that Nebraska has made in data governance." [16] He added: "If this model is going to expand, we will need to see other states make similar investments in the mundane yet crucial function of data governance." [16] So in Gorton's account, the model rests on the same kind of access controls that Kennedy called protectionism [2] [16].
State law is the harder limit. STAT reported that using exchange data for research is controversial because of privacy concerns [17]. Jonathan Ketcham, the White House's chief health care economist until earlier this year and now an economics professor at Arizona State University, said Arizona's exchange data "cannot be used, even de-identified, for researcher grants without individual consent" from providers [13].
The administration framed its earlier data efforts, such as the CMS Health Tech Ecosystem, as giving patients more control over their own records [18]. "Liberate patient records," top HHS official Chris Klomp said at a STAT event in March [19]. Monday's event was about access for researchers [1]. As reported, the speeches set out a goal. They did not attach a rule or program that would take access decisions away from data holders, or say what consent standard pooled records would carry. Separately, the NIH is already building its own Medicare and Medicaid databases to study autism [10].
What to watch
- Whether HHS, the CDC or the NIH publicly documents the Nebraska partnership, including which agency receives the data and under what use terms.
- Any HHS rule or funding program that would require or pay state health exchanges to share records with federal or outside researchers.
- Published results from the Nebraska data, which would show whether the linked records support the chronic disease studies Gorton described.