Integrating electronic dental records into research systems complicated

Dental records not easily adapted to medical data standards, Association says

While medicine has made significant progress in using structured data from electronic health records, dentistry has unique challenges that make this more complicated, according to ADA leaders. 

The American Dental Association filed comments June 10 in response to the Food and Drug Administration notice on how future research that uses real world data, like electronic dental records, can be standardized and better integrated into national research systems.  

ADA leaders emphasized in the letter that this includes differences in how records are kept, what data is collected, and technology used across private practices and public clinics. 

“While the ADA recognizes the potential for [real-world data] to validate research, there are significant logistical, technological, privacy and ethical concerns involved in the collection, use, and sharing of real-world dental data,” said the letter, signed by ADA President Brett Kessler, D.D.S., and Interim Executive Director Elizabeth Shapiro, D.D.S. “Dental practice and dental health information technology differ significantly at times from medical practice and technology.” 

Specifically, the letter includes suggestions for how the FDA can modernize clinical study data from real-world data sources in alignment with the assistant secretary for technology policy’s goals for the fast healthcare interoperability resources, which is a standard used by electronic health records. Drs. Kessler and Shapiro emphasized that dental records are not easily adapted to current medical data standards, as they may not include the necessary granular information in structured formats that can be easily extracted for research purposes.  

The letter also discusses whether the United States Core Data for Interoperability data components required for federal certification of health IT products include enough information to collect useful real-world data. It encouraged the adoption of Version 5 for federal certification of health IT products “to ensure that it meets the needs of the dental industry and is particularly ready to address interoperability using [the fast healthcare interoperability resources].” 

Drs. Kessler and Shapiro addressed whether adding a “research” exchange purpose to the Trusted Exchange Framework and Common Agreement — a nationwide floor for interoperability led by the assistant secretary for technology policy — would support the collection and exchange of real-world data for clinical research purposes.  

The ADA encouraged adding its national clinical data registry for oral health that already aggregates dental data, known as the dental experience and research exchange, to the Trusted Exchange Framework and Common Agreement’s research use case. This would ensure dentistry is included in federal efforts to move the fast healthcare interoperability resources adoption for seamless data exchange and interoperability, Drs. Kessler and Shapiro said.  

“Thank you for considering our comments on this critical issue. We welcome the opportunity to discuss these concerns and recommendations with you or your staff in more detail,” the letter concluded.