While the medical community has made significant progress in leveraging structured data from electronic health records, the dental industry faces unique challenges that complicate the process, according to American Dental Association (ADA) leaders.
The American Dental Association (ADA) commented on a June 10 FDA notice regarding how future research using real-world data, such as electronic dental records, can be standardized and better integrated into the national research system.
In the letter, ADA leaders highlighted that this includes differences in how private and public practices keep records, how data is collected, and what technology is used.
“While the ADA recognizes the potential of real-world data in validation studies, there remain significant logistical, technical, privacy, and ethical issues surrounding the collection, use, and sharing of real-world dental data,” states the letter, signed by ADA President Dr. Brett Kessler and Interim Executive Director Dr. Elizabeth Shapiro. “Dental practice and dental health information technology are sometimes very different from medical practice and technology.”
Specifically, the letter includes recommendations on how the FDA can modernize clinical research data to align it with the Assistant Secretary for Technology Policy’s goals for Rapid Healthcare Interoperability Resources, a standard used by electronic health records.
Dr. Kessler and Dr. Shapiro emphasized that dental records are not easily adaptable to current medical data standards because they may not contain the necessary details in a structured format that is easily extracted for research purposes.
The letter also discusses whether the data components of the U.S. Interoperability Core Data required for federal certification of health IT products contain enough information to collect useful real-world data.
The letter encourages adoption of the fifth edition of the standard for federal certification of health IT products “to ensure they meet the needs of the dental industry and are specifically prepared to use [Rapid Healthcare Interoperability Resources] to address interoperability issues.”
Dr. Kessler and Dr. Shapiro discussed whether adding the “research” exchange use to the Trusted Exchange Framework and Common Protocols (the National Interoperability Foundation, led by the Assistant Secretary for Technology Policy) could help collect and exchange real-world data for clinical research.
The American Dental Association (ADA) encourages its national oral health clinical data registry, the Dental Experience and Research Exchange, which already aggregates dental data, to be included in the research use cases of the Trusted Exchange Framework and Common Protocol.
This will ensure that the dental industry is included in the federal government’s move to adopt rapid healthcare interoperability resources to enable seamless data exchange and interoperability, Dr. Kessler and Dr. Shapiro said.
“Thank you for considering our input on this critical issue. We welcome the opportunity to discuss these issues and recommendations in more detail with you or your staff,” the letter concluded.
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