HHS plan to create autism database using Medicare, Medicaid data sparks privacy concerns

The U.S. Department of Health and Human Services (HHS) on Wednesday announced a new pilot initiative allowing the National Institutes of Health (NIH) to utilize Medicare and Medicaid data in a bid to uncover the underlying causes of autism.

The proposed database — which would compile insurance claims, medical records, and data from wearable devices like smartwatches — marks an early move in HHS Secretary Robert F. Kennedy Jr.’s ambitious effort to identify autism’s root causes “by September.”

However, the plan has already sparked backlash from doctors and advocacy groups. Concerns were heightened last month when NIH Director Dr. Jay Bhattacharya referred to the effort as a “new autism registry” offering “broad coverage” of the U.S. population — a description that quickly drew criticism.

The Autism Science Foundation flagged the announcement as a potential privacy risk, while the Autism Self Advocacy Network condemned the initiative as emblematic of an administration that has “completely frozen out autistic people” from key decisions.

HHS acknowledged the privacy concerns in its announcement Wednesday, stating that the NIH and the Centers for Medicare & Medicaid Services will begin the initiative with a data use agreement specifically targeting Medicare and Medicaid enrollees diagnosed with autism spectrum disorder. The agencies plan to develop a “secure, tech-enabled mechanism” to facilitate data sharing that complies with privacy and security standards. Over time, the pilot database will be expanded to include information on chronic illnesses and their associated economic impact, according to HHS.

“From the moment the registry was announced, it sparked deep concern within the autism community,” Helen Tager-Flusberg, director of Boston University’s Center for Autism Research and head of the Coalition of Autism Scientists, told CNN. “People are worried — who will access this data, and how will it be used?”

Tager-Flusberg also noted the inherent limitations of using CMS data. “Focusing on Medicare and Medicaid only captures specific segments of the population,” she said. Medicaid primarily covers low-income individuals and families, while Medicare mainly serves those 65 and older, along with some younger people with disabilities.

While CMS data can be used for medical research, it’s governed by strict privacy laws, said Jeff Wurzburg, a former HHS general counsel and current health care regulatory attorney at Norton Rose Fulbright. “CMS’s top priority is protecting beneficiaries,” he explained. “So it’s entirely valid to question how this data will be gathered and safeguarded.”

An HHS spokesperson emphasized Wednesday that “any data containing personal identifiers will be governed by federal privacy laws and regulations. The platform will be fully compliant to ensure the protection of Americans’ sensitive health information.”

Despite these assurances, autism advocates and researchers have cast doubt on Secretary Kennedy’s claim that the government will identify the causes of autism by September—a timeline that NIH Director Dr. Jay Bhattacharya has already appeared to temper.

“Scientific discovery takes time,” Bhattacharya said on April 22. “We are moving quickly and cutting through red tape to launch a program of this scale. By September, I hope we’ll have a system in place that allows scientists to compete for grant funding.”

Still, the rollout has sparked anxiety. Advocates report a “flood” of concerned calls, fueled by ongoing uncertainty over how the autism data would be used, who would access it, and whether patients would have a say in its collection and application.

Following Dr. Bhattacharya’s initial remarks about an autism registry, the Autism Science Foundation was inundated with calls, emails, and texts, according to co-founder and President Alison Singer. The latest announcement from HHS has done little to ease those worries.

“What troubles me most,” Singer said, “is hearing from autistic individuals who now fear going to the doctor, and from families who suspect developmental concerns in their toddlers but are hesitant to seek a diagnosis.” She added that the uncertainty surrounding the registry is already creating a chilling effect on access to medical care.

Singer stated that the foundation is in favor of registries, recognizing their potential value in tracking care and outcomes over time. However, the absence of clear privacy details and the lack of communication with the autism community before launching the project has made it challenging to address the growing concerns.

“We’ve been trying to alleviate the fear surrounding registries, but it’s difficult to do so until more details are shared from the administration about how this will be implemented,” Singer said.

An HHS spokesperson responded, emphasizing the initiative’s focus on advancing science, improving care, and supporting families. “Understanding the scope and impact of a condition is standard in public health and essential for driving funding, improving services, and informing policy decisions.”

However, other autism advocates strongly oppose the registry, citing concerns over HHS Secretary Robert F. Kennedy Jr.'s recent statements about autism. Kennedy referred to autism as part of a “chronic disease epidemic” that “destroys” families and children, and made controversial comments suggesting that people with autism would never achieve certain milestones, such as holding a job or using a toilet without assistance. He later clarified that he was referring to individuals with “severe” autism.

Nicole Clark, a nurse and co-founder of the Adult and Pediatric Institute for Health and Wellness in Florida, voiced her concern: “This sets a dangerous precedent, implying it’s acceptable to weaponize someone’s medical diagnosis for political purposes.”

"Why would someone’s medical diagnosis be placed in a registry to demonstrate financial burden? What is the ultimate goal here?" asked Clark, who has two young children with autism.

She shared concerns from other healthcare providers about the growing anxiety among individuals with autism and their families. Some patients have even inquired whether it's possible to have their autism diagnosis removed from medical records.

"Are we using this data to create fear among providers, causing them to hesitate in making diagnoses?" Clark asked. "It feels like we’re feeding into the fear surrounding something we don’t fully understand."