Updated May 7, 12 p.m.
Two weeks after it walked back claims that it was creating an autism database, the Department of Health and Human Services on Wednesday announced that the National Institutes of Health would build a real-world data platform pulling Medicare and Medicaid data.
The goal is to enable advanced research across claims data, electronic medical records and consumer wearables, according to HHS in a press release.
This partnership will focus first on enabling research around the root causes of autism spectrum disorder (ASD). In the long term, the partnership will link real-world data, in a manner consistent with applicable privacy laws to protect Americans’ sensitive health information, for research on chronic conditions, HHS said.
“We’re using this partnership to uncover the root causes of autism and other chronic diseases,” said HHS Secretary Robert F. Kennedy, Jr. said in a statement. “We’re pulling back the curtain—with full transparency and accountability—to deliver the honest answers families have waited far too long to hear.”
The Centers for Medicare and Medicaid Services (CMS) and NIH will start this partnership by establishing a data use agreement under CMS’ Research Data Disclosure Program focused on Medicare and Medicaid enrollees with a diagnosis of ASD.
Using ASD as the pilot research program, teams at CMS and NIH will "establish a secure tech-enabled mechanism to enhance this data sharing with timely, privacy and security compliant data exchange," HHS said.
"This pilot research program will inform continued development of a landmark NIH platform to ultimately be used by researchers in understanding healthcare utilization, chronic disease etiology and treatment, and the economic burden of chronic conditions," the agency said.
“This partnership is an important step in our commitment to unlocking the power of real-world data to inform public health decisions and improve lives,” said NIH Director Dr. Jay Bhattacharya in a statement. “Linking CMS claims data with a secure real-world NIH data platform, fully compliant with privacy and security laws, will unlock landmark research into the complex factors that drive autism and chronic disease – ultimately delivering superior health outcomes to the Americans we serve.”
HHS walks back NIH Director's claim of new autism database
Updated April 25, 3:32 p.m.
The Trump administration walked back a claim by the National Institutes of Health that it would create a central data repository of patient health records to study autism.
“We are not creating an autism registry,” a spokesperson for the Department of Health and Human Services said in an email to Fierce Healthcare.
The spokesperson clarified the department will create a real-world data platform that will “link existing datasets” to support research into the causes of autism and treatments.
The NIH is exploring opportunities to work with other government agencies, such as the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, the Department of Veterans Affairs and the Department of Defense to put together a dataset, the email said.
The report comes days after NIH Director Jay Bhattacharya presented the idea of a data repository consisting of electronic medical records, pharmacy data and smart watch health data to a meeting of NIH advisers.
HHS told STAT it is launching a $50 million research effort to study the disease and improve treatments.
Health Secretary Robert F. Kennedy Jr. also told reporters last week that HHS would use electronic health records and artificial intelligence to more quickly find the root cause of autism than researchers have been able to do in the past.
The National Institutes of Health (NIH) will begin work on a comprehensive federal database of patient records to study autism and chronic disease, Director Jay Bhattacharya, M.D., Ph.D., announced Monday.
The commitment gives legs to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s calls to find the root cause of childhood autism, which he calls an epidemic. The NIH appears poised to put federal resources to work to create a central, shareable resource for the researchers that undertake RFK Jr.’s call to action.
Last week at an event with reporters, Secretary RFK Jr. announced that HHS will soon be offering research grants for identifying the cause of autism, including exploring causes that were formerly considered taboo by the research community. “People will know they can research and follow the science no matter what it says, without any kind of fear that can be censored ... gaslighted ... silenced," he told reporters April 16.
The NIH will now work to build out a data resource (PDF) consisting of medical records, insurance claims and data from wearable devices to aid autism researchers in their quest to find the root cause of the disease. Bhattacharya explained the initiative to a meeting of NIH advisors on Monday.
The NIH will partner across the HHS and with external stakeholders, the presentation says. He said the data sources for the real-world data platform will be pharmacy chains, health organizations, clinical data, claims and billing, environmental, sensors and wearables. He said the NIH hopes to pilot the platform within six months of the project launch.
The NIH’s goal is for the platform to represent broad coverage of the U.S. population. Bhattacharya wants to leverage existing NIH programs to fast-track progress.
The initiative has sparked some privacy concerns from industry groups.
"Compiling health and disability-related data from both federal and commercial sources to create a federal registry of people with autism, without individuals’ consent, is the latest dangerous effort by this Administration to repurpose Americans’ sensitive information for unchecked government use," Ariana Aboulafia, project lead of disability rights in technology policy at the Center for Democracy and Technology, said in a statement. "This plan crosses a line in the sand, particularly given longstanding and historical concerns surrounding the creation of registries of people with disabilities.
"The data that would be used to create this registry and inform governmental studies on autism was originally shared with government agencies and private companies, like insurers and wearable technology companies, for a wide range of purposes," Aboulafia said. "It’s unclear exactly who the federal government plans to share this data with, or how they’ll eventually use it. And, while NIH has claimed that the confidentiality of this information will be safeguarded using 'state of the art protections,' it’s also unclear if it’ll be anonymized or disaggregated, or how it will be protected from a hack or breach."
RFK Jr. teased the creation of a real-world data platform to understand the prevalence of chronic disease in the country. He said last week that the HHS’ new department, the Administration for a Healthy America (AHA), would make data on autism and diabetes prevalence available in real time.
“Because of AI and because of the digitalization of health records and the mass health records that are now available to us, we can do this much more quickly than it’s been done in the past,” he said.
He also told reporters that the department would find the cause of autism faster through the use of electronic health records and artificial intelligence. Collecting that data, though, has been historically difficult. Companies that specialize in coalescing data for the use of researchers and to train novel AI models have spent years building up their data resources.
Real-world data platform OMNY is one such company. OMNY cleans and structures clinical data to make it research-grade and compliant with regulations, founder Mitesh Rao previously told Fierce Healthcare. The data are being used to answer novel research questions and to train AI models on real patient data.
"Real-world data has incredible potential to transform our approach to understanding and treating diagnoses like Autism,” founder of data platform OMNY, Mitesh Rao, M.D., said in a statement to Fierce Healthcare on Tuesday. “However, getting access to that data on a national level and making it usable have always been enormous hurdles. For the NIH to accomplish this, they'll want to partner with data platforms designed to enable secure and compliant access to patient data at scale. They'll also want to ensure both compliance and traceability to the source data if this data is going to form a foundation for regulatory work going forward."
Bhattacharya’s presentation also says that NIH must invest in innovation and new technologies with the goal of making discoveries that enhance health and lengthen life.
The opportunities for the NIH’s real-world evidence platform include real-time health monitoring, national disease registries, drug development, longitudinal datasets, regulatory approvals and research competitions, the presentation said.
“We think this is a great step forward, the NIH can act as a catalyst to unify what is already a robust and vibrant public and private data ecosystem,” Brigham Hyde, CEO of Atropos, said in a statement to Fierce Healthcare. “We applaud the multi-modal approach, and hope this type of approach can rapidly extend beyond just the important needs around ASD."
A report by the Centers for Disease Control and Prevention (CDC) last week found that in 2022, 1 in 31 eight-year-old children had autism, up from 1 in 36 in 2020. Kennedy advanced a theory that environmental toxins are causing the rise in childhood autism rates.
Kennedy told reporters that he will accept the outcomes of the research findings on autism, regardless of whether they adhere to his theory.
HHS did not respond to a request for comment by the time of publication.