The National Institutes of Health (NIH) and the Centers for Medicare and Medicaid Services (CMS) recently announced a partnership to develop a “real-world data platform” aimed at advancing the understanding of autism. This platform will integrate claims information, electronic medical records, and consumer wearable data to facilitate research on autism spectrum disorder and other chronic conditions.
While the initiative has been lauded for its potential to provide valuable insights into autism diagnosis trends, health outcomes, and care disparities, concerns about data privacy and security have been raised by public health researchers and privacy attorneys. Many are questioning how the collected data will be used, whether personally identifiable information will be protected, and whether patients will have the opportunity to consent to the use of their data.
The announcement of this data use agreement comes on the heels of previous reports suggesting the creation of a centralized autism registry, which HHS has since clarified is not the case. Instead, the focus will be on leveraging real-world data to explore the root causes of autism and other chronic diseases.
The partnership between CMS and NIH will initially concentrate on research related to autism spectrum disorder, with plans to expand to other chronic conditions in the future. The agencies have emphasized their commitment to complying with privacy laws to safeguard sensitive health information.
Despite the potential benefits of using real-world data for research, questions remain about the specifics of the data usage limitations and the nature of the data use agreement between CMS and NIH. Experts suggest that establishing clear guidelines for data use, ensuring patient consent, and implementing robust security measures are essential to protect privacy and maintain trust in the research process.
Moving forward, the pilot research program will focus on informing the development of a comprehensive NIH platform for researchers to study healthcare utilization, chronic disease etiology, treatment outcomes, and the economic impact of chronic conditions. As the initiative progresses, ongoing efforts to address data security and privacy concerns will be critical to ensuring the responsible and ethical use of real-world data in autism research.
Overall, the collaboration between NIH and CMS holds promise for advancing our understanding of autism and improving outcomes for individuals with autism spectrum disorder. By addressing concerns about data privacy, security, and consent, researchers can harness the power of real-world data to drive meaningful progress in autism research and care. Peter Hotez, a prominent public health professor and vaccine researcher at Texas Medical Center, recently expressed concern about the zeal to pursue a registry in a social media post on X. While acknowledging the importance of data insights in public health decision-making, Hotez raised questions about the potential implications of a registry, particularly in relation to privacy and consent for autism patients.
Healthcare IT News reached out to the Department of Health and Human Services (HHS) to seek clarification on key aspects of the proposed registry. These include the de-identification of data, the protection of personally identifiable information (PII), and the presence of a consent process for individuals with autism. Additionally, inquiries were made regarding compliance with upcoming HIPAA security rule updates.
The autism community and healthcare providers working with individuals on the autism spectrum have expressed anxiety about the registry. Dr. Clark emphasized the need for transparency and detailed information to address concerns within these communities. With autism prevalence affecting 1 in 31 children in the U.S., and a significant portion experiencing severe autism, the urgency for multi-source real-world data insights is evident.
Previous research has led to the development of advanced digital screening tools for autism, such as Duke University’s screening tool for toddlers. This tool has shown promise in accurately identifying children with ASD and connecting them to appropriate resources. The collaboration between CMS and NIH aims to leverage real-world data to inform public health decisions and improve outcomes for individuals with autism and other chronic diseases.
NIH Director Dr. Jay Bhattacharya highlighted the significance of linking CMS claims data with a secure NIH platform, emphasizing the potential for groundbreaking research into the factors influencing autism and chronic disease. CMS Administrator Dr. Mehmet Oz echoed this sentiment, emphasizing the importance of innovation while safeguarding patient privacy.
In conclusion, the partnership between CMS and NIH holds promise for advancing research and improving health outcomes for individuals with autism and other chronic conditions. However, transparency, privacy protection, and consent processes must be prioritized to address the concerns of the autism community and healthcare providers. Healthcare IT News will continue to monitor developments in this area and provide updates as necessary.
Andrea Fox, senior editor of Healthcare IT News, can be contacted at afox@himss.org. Healthcare IT News is a publication of HIMSS Media.
