The FDA has made it clear it plans on implement blockchain technology.
On August 22nd, 2019, Dr. Amy Abernethy gave a speech at the National Coordinator for Health IT Third Interoperability Forum. Dr. Abernethy serves as the Principal Deputy Commissioner and Acting CIO of the FDA. In the speech, Dr. Abernethy explained the FDA’s plans to implement additional modern technology. Specifically, this plan will include an update of infrastructure so the FDA can support artificial intelligence and blockchain.
Reasons for Change
This change comes after Dr. Abernethy’s experience as an M.D. in the healthcare field. She has worked as an oncologist, researcher, and has experience in the startup field. Consequently, Dr. Abernethy has extensive knowledge of the most prevalent healthcare issues.
During her career, Dr. Abernethy has worked frequently with data accessibility. Specifically, accessibility for both patients and researchers. Dr. Abernethy experienced many roadblocks and hopes to improve these pain points with the FDA’s new technology plan.
Specifically, she found issues when she ran the Center for Learning Healthcare at Duke. Here, she first experienced interoperability problems with her research. Unfortunately, medical information systems aren’t built to communicate with each other. As a result, data is inaccessible between systems. Fortunately, this is one of the most promising use cases of healthcare blockchain. Data stored in the immutable ledger is secure and easily accessible. After this experience, Dr. Abernethy entered the world of startups.
In the startup field, Dr. Abernethy worked on electronic health records and data models. Her team focused on improving the lives of doctors with electronic health records. In addition, her team worked to improve the quality of data acquired from these records. As previously mentioned, blockchain provides an easy solution for securing health records. Then, secure data can be run through artificial intelligence programs to generate results.
Unique Identifiers and Supply Chain Management
A unique device identification system for medical devices would give patients and doctors the information they need faster. Likewise, such a system would allow for immediate identification of FDA approved devices. Again, blockchain provides an easy solution. In addition to unique identification, blockchain can secure the entire medical device supply chain.
The FDA’s Role
Dr. Abernethy says this about the FDA:
“What I learned was that the FDA both set the direction and clarified how to get there—particularly for the development of medical products like drugs and devices including technology-based solutions like software as a medical device.”
As Dr. Abernethy stated, the FDA has an essential role in the innovation of new healthcare solutions. Consequently, the FDA must stay up to date with new technologies. If the FDA is to serve as an example of how new companies should create and secure their technologies, the FDA itself must support new technologies.
Fortunately, Dr. Aebernethy’s experiences have led her to the conclusion that the FDA needs to support technologies like blockchain. Many of the FDA’s existing regulatory problems can be solved with blockchain. In order to see companies implement these solutions, the FDA must update their infrastructure to accommodate these new technologies.