Question 1

What kind of system is the Next Generation Medical Infrastructure Law?

Accepted Answer

This law stipulates the government's responsibilities, the formulation of basic policies, the certification of businesses that create anonymous and pseudonymous processed medical information, and the handling of anonymous and pseudonymous processed medical information, etc., regarding anonymous and pseudonymous processed medical information to be used for research and development in the medical field. Certified creators certified by the government will collect medical information on citizens and patients from medical institutions and other organizations that cooperate with the system. When providing medical information, the individual will be notified in advance.

Question 2

What kind of business is a certified business that conducts anonymous processing medical information creation business?

Accepted Answer

It is a reliable business that is certified by the government based on the law. We are familiar with research and development in the medical field, anonymous processing of medical information, and information security.

Question 3

Can anyone receive and use anonymously processed medical information provided by a certified information creator?

Accepted Answer

There are no restrictions on the businesses that can receive anonymously processed medical information. Pseudonymized medical information can only be provided to businesses that have been certified by the government. For details on certification of businesses that use pseudonymized medical information, please see the Cabinet Office website (https://www8.cao.go.jp/iryou/nintei/nintei/acceptance.html.). Utilization is possible for any organization, including industry, academia, and government.

Question 4

What kind of anonymously processed medical information can be provided and utilized by certified businesses?

Accepted Answer

A wide variety of information including inspection results such as images and numerical values can be used on a large scale. It is also possible to use the same patient's information that spans multiple medical institutions by collating the information collected by the certified business operator from multiple medical institutions in advance and then performing anonymous processing.

Question 5

Is there any cost to receive and utilize anonymously processed medical information from an authorized business operator?

Accepted Answer

Anonymous processing You will be charged for receiving medical information. For details, please consult with a certified business operator.

Question 6

Is it possible to provide anonymously processed medical information provided by an authorized business operator to a third party?

Accepted Answer

It is necessary to obtain the permission of the certified business operator in advance based on the contract between the certified business operator and the user.

Question 7

Do I need approval from the Institutional Review Board, etc. to utilize anonymously processed medical information?

Accepted Answer

There is no need for the approval procedure of the Institutional Review Board, which is required by the users in the "Ethical Guidelines for Medical Research for Humans". In addition, when deciding whether or not to provide anonymously processed medical information, the certified business operator must examine the purpose of use of anonymously processed medical information by the committee it establishes.

Question 8

Do I need to be certified if I am in the business of handling personal information and anonymously processed information?

Accepted Answer

What has been done properly under the existing system does not prevent it. You don't necessarily have to be certified.

Next-generation medical infrastructure law certified business operator

FAQ

T-19-01

JQA-IM1582