The first anonymously stored patient information is based on the Next Generation Medical Infrastructure Rule, NTT Records, etc.

In order to facilitate studies using medical big data, Pfizer, Life Data Initiative, and NTT DATA have announced that they have signed a contract to provide anonymously stored medical information based on the Next Generation Medical Infrastructure Legislation for the first time in Japan.

A methodology for assessing health effects of medication effectiveness and safety based on real-world evidence (RWD) would be given under this deal, such as patient evaluation reports of regular medical care doctors collected on the basis of the Next Generation Medical Infrastructure Regulation. Uh, analysis. The implementation of this approach would enable the development of evidence for the advancement of personalized medicine and early access to medications.

Specifically, from anonymously processed medical details based on the Next Generation Medical Infrastructure Rule, we will perform research on methodologies for assessing clinical effects in cancer patients. The three sample materials below are shown.

(1) RWD has electronic medical records that contain a lot of text material, such as doctor’s medical records, and we will understand how to access them as information that leads to clinical results assessment.
(2) Examination findings Establish techniques and algorithms for generating clinical results from electronic medical record information based on
(3) Validate how much information can be accessed from a database that contains hospitals worldwide and is necessary for research. ..

The use of RWD is now advancing overseas, and there are several medications whose labels have been extended based on electronic medical record evidence based on clinical outcome assessment. The Next Generation Medical Infrastructure Bill was also implemented in Japan in 2018 with the goal of using medical knowledge. Obtained the first “handling contractor” certification from the national government.

In addition to receipt data and DPC (Diagnosis Protocol Combination) survey data, the anonymously processed patient records provision sector managed by the Life Data Initiative and NTT Data is distinguished by the right to link to electronic medical record data. However, for electronic medical reports, there is no specific definition form, and depending on the medical personnel, they are represented in various expressions. The development of new algorithms was then needed for use.

Pfizer claims that by using RWD, it is necessary to include suitable drugs and disseminate knowledge. We would use medical information such as electronic medical record details to target the provision of new drugs and the effective use of medicines, using the methods tested and implemented this period.