Drug Evaluation Committee 2022-56 Are tumor specimens and blood samples included in medical information?
Related classification: Obtaining consent
First published: Apr 2023
Question
Are tumor specimens and blood samples collected from patients included in medical information?
We asked this question when we were preparing the consent explanation document for our facility.
We would also appreciate it if you could tell us the definition of medical information.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
I will answer on the assumption that the specimens to be collected will be used within the scope stipulated in the relevant study protocol.
The term "medical information" is used in the "Guidelines for the Safety Management of Medical Information Systems Version 5.2" (March 2022, Ministry of Health, Labor and Welfare) to mean "information including patient information (personal identification information) related to medical care.
In addition, Article 2, Paragraph 1 of the "Act on Anonymously Processed Medical Information to Contribute to Research and Development in the Medical Field" (Act No. 28 of 2009) defines "medical information" as follows
Medical history of a specific individual and other information concerning the mental or physical condition of said individual, including descriptions, etc. (documents, drawings, or electromagnetic records (electromagnetic), which are specified by a Cabinet Order as requiring special consideration in their handling to prevent unjust discrimination, prejudice, or other disadvantages to said individual or his/her descendants on the basis of said mental or physical condition. (means a record made in the form of a document, drawing, or electromagnetic record (meaning a record made by an electronic method, a magnetic method, or any other method that cannot be recognized by human senses). The same shall apply hereinafter. The same shall apply hereinafter). (i) All matters described or recorded in a document (including personal identification code (meaning personal identification code prescribed in Article 2, paragraph 2 of the Act on the Protection of Personal Information (Act No. 57 of 2003); the same shall apply hereinafter) or expressed by means of voice, motion, or other methods (meaning personal identification code prescribed in Article 2, paragraph 2 of the Act on the Protection of Personal Information (Act No. 57 of 2003); the same shall apply hereinafter). The same shall apply hereinafter) (excluding personal identification code (meaning the personal identification code prescribed in Article 2, paragraph 2 of the Act on the Protection of Personal Information (Act No. 57 of 2003). (meaning the personal identification code (meaning the personal identification code prescribed in Article 2, paragraph 2 of the Act on the Protection of Personal Information (Act No. 57 of 2003). The same shall apply hereinafter). (i) Information that falls under any of the following items, among information concerning an individual that includes a name, a name of the person whose name is a personal identification code (meaning a personal identification code prescribed in Article 2, paragraph 2 of the Personal Information Protection Act (Act No. 57 of 2003); the same shall apply hereinafter)
(i) Information that can identify a specific individual by name, date of birth, or other description, etc., contained in said information (including information that can be easily cross-checked with other information, thereby making it possible to identify a specific individual)
(ii) Items that contain personal identification codes.
Tumor specimens and blood samples are not considered to fall under the category of medical information because they are not information in themselves. However, various data obtained from them and information such as patient background accompanying the specimens fall under the category of medical information.