HHS Announces Major Data Initiative
The Department of Health and Human Services (HHS) announced Wednesday that the National Institutes of Health (NIH) will build a comprehensive real-world data platform utilizing Medicare and Medicaid data. This announcement comes just two weeks after HHS walked back earlier claims about creating an autism database, clarifying the department’s intentions with this new initiative. The platform aims to enable advanced research by integrating claims data, electronic medical records, and consumer wearables information in a secure environment.
“We’re using this partnership to uncover the root causes of autism and other chronic diseases,” said HHS Secretary Robert F. Kennedy Jr. 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.”
Platform to Focus Initially on Autism Research
The partnership between the Centers for Medicare and Medicaid Services (CMS) and NIH will begin by establishing a data use agreement under CMS’ Research Data Disclosure Program. This initial phase will specifically focus on Medicare and Medicaid enrollees with autism spectrum disorder (ASD) diagnoses, using this as a pilot research program to develop the larger platform infrastructure.
NIH Director Dr. Jay Bhattacharya emphasized the importance of this initiative, stating, “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. 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.”
Data Sources and Implementation Timeline
According to presentations made by Bhattacharya to NIH advisors, the data sources for the platform will be diverse and comprehensive. These will include pharmacy chains, health organizations, clinical data, insurance claims and billing information, environmental data, and information from sensors and wearable devices. The NIH hopes to pilot the platform within six months of the project launch.
The initiative aims to represent broad coverage of the U.S. population by leveraging existing NIH programs to accelerate progress. Teams at CMS and NIH will work to “establish a secure tech-enabled mechanism to enhance this data sharing with timely, privacy and security compliant data exchange,” according to HHS statements.
Potential Broader Applications for Chronic Disease Research
While the initial focus is on autism research, HHS indicated that the platform has much broader potential applications. “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 stated.
The opportunities for the NIH’s real-world evidence platform include real-time health monitoring, national disease registries, drug development, creation of longitudinal datasets, regulatory approvals, and research competitions. Industry experts have responded positively to the multi-modal approach with hopes that it can rapidly extend beyond autism research.
Rising Autism Rates Drive Research Push
A recent report by the Centers for Disease Control and Prevention (CDC) found that in 2022, 1 in 31 eight-year-old children had autism, an increase from 1 in 36 in 2020. These rising rates have intensified calls for comprehensive research into potential causes.
Kennedy has previously advanced theories about environmental factors contributing to increasing autism rates. During a press event last week, he stated that HHS would use electronic health records and artificial intelligence to more quickly find root causes of autism than researchers have been able to do in the past. He also told reporters that he will accept research findings regardless of whether they support his theories.
Privacy Concerns Emerge from Advocacy Groups
Despite the potential research benefits, the initiative has sparked significant privacy concerns from various advocacy and 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,” said Ariana Aboulafia from the Center for Democracy and Technology.
Critics have raised questions about data anonymization, protection from breaches, and the broader implications of creating what some consider a registry of people with disabilities. HHS has attempted to address these concerns by emphasizing that all data linking will be done “in a manner consistent with applicable privacy laws to protect Americans’ sensitive health information.”
Industry experts familiar with health data platforms note the significant challenges involved. “Real-world data has incredible potential to transform our approach to understanding and treating diagnoses like Autism,” said Mitesh Rao, founder of data platform OMNY. “However, getting access to that data on a national level and making it usable have always been enormous hurdles.”
The HHS spokesperson clarified that they are not creating an “autism registry” but rather a real-world data platform that will “link existing datasets” to support research into the causes of autism and potential treatments.
Discover the latest payers’ news updates with a single click. Follow DistilINFO HealthPlan and stay ahead with updates. Join our community today!
