USA builds autism registry through access to health databases

The National Institutes of Health (NIH) in the USA is currently building a national autism registry that will be populated with data from various sources such as patient records. The aim is to accelerate and improve research on autism through a centralized, large database.

According to recent reports, the NIH plans to bring together confidential medical data from numerous federal and commercial databases to create a platform with “broad coverage of the US population” for the first time.

Making autism research centrally accessible

The aim is to make this data centrally accessible for autism research. The data includes medication prescriptions, laboratory and genomic data, insurance data and information from fitness trackers and smartwatches, as reported by CBS News and others. An autism registry will be set up for this purpose. External research groups will be provided access to this data for autism studies funded by the US government. The initiative is described as a “transformative real-world data initiative” that aims to create a comprehensive and secure platform for research into chronic diseases and autism.

The NIH promises “state-of-the-art data protection measures”. Researchers are allowed to view the data, but not download it – how exactly this is to be ensured is unclear. The National Database for Autism Research (NDAR), a large, controlled, accessible research database for autism that has been continuously expanded since 2008 and brings together data from various sources, already existed. This includes information on medications from pharmacy chains, laboratory tests and genome data and more.

The initiative is being spearheaded by Secretary of Health and Human Services Robert F. Kennedy Jr. and aims to provide researchers with comprehensive patient data covering the entire U.S. population. “The idea of the platform is that existing data resources are often fragmented and difficult to access. The NIH itself often pays multiple times for the same data resource,” explained NIH Director Jay Bhattacharya. It is unclear why autism research is currently the political focus, even though there have been cuts in the area of medical research.

The NIH is also negotiating with the Centers for Medicare and Medicaid Services, a US federal agency that is also responsible for the State Children's Health Insurance Program, to expand access to their data. A new disease registry to track Americans with autism will also be integrated into this initiative. Kennedy views autism as a “preventable disease” – a statement that has been criticized as stigmatizing. The centralized collection of data could also lead to exclusion and discrimination in everyday life.

In the US, the attack on insurer Change Healthcare was a recent setback for the digitalization of the healthcare system. At the beginning of the year, the number of people whose data was affected by the ransomware attack on Change Healthcare was revised upwards from 100 to 190 million people.

Health Research Data Center and EU Health Data Space

There are similar plans for centralized access to research data at EU level and in Germany. The European Health Data Space, which came into force a few weeks ago, will in future make the data of all EU citizens available for research purposes. The decisive factor here is the purpose of the research. In Germany, the Health Research Data Center is currently being set up for this purpose, through which pseudonymized data from around 400 medical registers, electronic patient records and health insurance companies will be available in the future. Politicians are also promising that the data will not leave the secure environment at national level.

At EU level, there are already initiatives such as DARWIN (Data Analysis and Real-World Interrogation Network), in which the European Medicines Agency analyzes real-world data for drug therapy safety together with the Federal Institute for Drugs and Medical Devices, among others. The data sources include hospitals, insurance companies, biobanks, etc. A model project on genome sequencing was also launched in Germany last year.

(mack)