**3.2 The relationship between the disclosure of the "Synthesized edition" of the investigative report and the latest revision of the Personal Information Protection Law and relevant administrative guidelines**

The "Synthesized edition" of the investigative report has been published and posted on the website as one of the products of the system [11]. They have been referred by parents, patient groups, and medical professionals for various purposes such as confirming transparency and improving quality of perinatal care through scientific research. The revised Act on the Protection of Personal Information was enacted and promulgated in 2015 and fully enforced on May 30, 2017, which unprecedentedly forced the "Donor rule" applicable when we consider if the data we disclose on the web is "Personal information." "Personal information" shall be provided to third parties through the prior consent of an individual to which the data belong with some exceptions such as the data provision for promoting public health. The "Donor rule" states that the data is defined as "Personal information" when the

*The Japan Obstetric Compensation System for Cerebral Palsy: Novel System to Improve Quality… DOI: http://dx.doi.org/10.5772/intechopen.106760*

#### **Figure 3.**

*Production of standardized investigative report.*

donor of the data, i.e., the JQ can identify an individual from whom the data derive even if recipient of the data, i.e., the general public does not know whose data it is. Accordingly, the "Synthesized edition" that had been available on the website turned out to be "Personal information" that could be transferred to third parties principally through prior consent procedure. Therefore, the "Synthesized edition" posted on the website, for which consent of family and childbirth facility for the disclosure had not been obtained, had to be temporarily withdrawn from the website, and the Steering Committee took deeper dive into the issue from a broad perspectives such as purpose and impact of the disclosure and procedures required for the disclosure in consistent with the revised Personal Information Protection Act [12].

In January 2019, the JQ consulted with legal experts and the government officials again on this issue. In light of their comments and guidance, the JQ decided to make efforts in obtaining the consent of the guardians, the childbirth institutions, and the relevant medical institutions on all the "Synthesized editions" in response to the public concern on the system and the changing public view with regard to the handling of personal information, although the JQ believed that it fell under the exceptions for obtaining prior consent to the provision of personal information to third parties in the revised Personal Information Protection Act (**Table 4**). Later, when the JQ's policy on disclosure of the "Synthesized edition" was proposed at the 40th Steering Committee meeting held in January 2019, comments such as "all synthesized editions should be disclosed on the web as they were" and "The JQ should clarify the reasons for no-consent by guardians and/or childbirth facilities in detail" were raised from many of committee members.

#### **Table 4.**

*Article 23, paragraph 1, item 3 of the Personal Information Protection Act.*

Article 23

A business operator handling personal information shall not provide personal data to a third party without obtaining the prior consent of the individual, except in the following cases

<sup>(</sup>i)-(ii) Omitted. (iii) When it is particularly necessary for the improvement of public health or the promotion of the sound growth of children, and it is difficult to obtain the consent of the person concerned.

In February 2019, the JQ conducted a questionnaire survey targeting guardians and childbirth facilities to get hold of the reasons why they answered "agree" or "disagree" on the disclosure of the "Synthesized edition." At the 41st Steering Committee meeting held in August 2019, the JQ reviewed the aim and value of this system to consider if we should disclose all the "Synthesized edition" that achieves public good such as quality improvement in perinatal care as only about 3/4 of the "Synthesized edition" is agreed on the disclosure [13]. The JQ concluded at that time that it continued its efforts to improve the rate of consent on disclosure and consulted with the relevant ministries and the government to explore measures to disclose more "Synthesized editions" on the web.

In December 2019, the Personal Information Protection Committee in the government published the "Outline of the Amendment of the System for the So-called Triennial Review of the Personal Information Protection Act" (**Table 5**), and in January 2020, the Ministry of Health, Labor and Welfare (MHLW) presented a new commentary (**Table 6**). At the 42nd Steering Committee held in February 2020 and the 43rd Steering Committee meeting held on July 3, this issue was discussed to eventually compile an audacious policy on releasing all the "Synthesized editions" on the web. In the meantime, at the 94th meeting of the Investigation Committee

With regard to this point, the current Personal Information Protection Act has exceptions to the limitation of the purpose of use and provision to third parties, such as "when it is necessary for the protection of the life, body, or property of an individual and it is difficult to obtain the consent of the individual" and "when it is particularly necessary for the improvement of public health or the promotion of the sound growth of children and it is difficult to obtain the consent of the individual." The use of personal information for public benefit is also considered acceptable in certain cases. However, since there is a tendency that these exceptions have been strictly applied so far, it is necessary to provide specific examples in guidelines and Q&As according to the expected needs. Therefore, we will promote the utilization of personal information that benefits the entire nation, such as the resolution of social issues, by providing specific examples in the guidelines and Q&As according to the expected needs.

For example, a case in which a medical institution or a pharmaceutical manufacturer uses the information for the purpose of contributing to the development of medical research in order to realize healthcare services, drugs, and medical devices of high quality in terms of safety and effectiveness.

#### **Table 5.**

*The Personal Information Protection Law, dubbed as Triennial Review, Outline of System Revisions (December 13, 2019) (excerpt).*

In December 2019, the Personal Information Protection Committee released the "Personal Information Protection Act: dubbed as Triennial Review: Outline of Revisions," which also states that "the handling of personal information in the private sector is a matter for each business operator to decide. Therefore, it would be desirable for the JQ to consider the policy again, taking into account the balance between the promotion of public health and the protection of personal information. In addition, the MHLW has no objection if it is widely accepted by the society to disclose the summarized edition of all investigative reports as they were."

#### **Table 6.**

<sup>3.</sup> Clarification of the exception defined in the law pertaining to the handling of personal information for the purpose of public interest

With the rapid progress of information and communication technology, it has become possible to collect and analyze big data such as customer information. In this context, Japan is aiming to realize Society 5.0, which is a new society in which advanced technologies such as big data analysis are incorporated into all industries and social life to achieve both economic development and solutions to social issues. As social issues become more diverse, it is desirable to support an environment in which businesses can make use of data in order to efficiently and effectively solve these issues.

*Commentary issued to the JQ by the Ministry of Health, Labor and Welfare.*

*The Japan Obstetric Compensation System for Cerebral Palsy: Novel System to Improve Quality… DOI: http://dx.doi.org/10.5772/intechopen.106760*

held on June 10, the following comments to support the full disclosure were proposed: "In the Investigative Report, the causes of cerebral palsy are analyzed in detail and carefully for each case. So, they are worthwhile to disclose, and "All the "Synthesized editions" need to be disclosed on the web as they were. Accordingly, it was unanimously agreed that the "Synthesized edition" is published for all the Investigation Reports. From the viewpoint of improving public health, the publication of the "Synthesized edition" falls under the exceptions of Article 23, Paragraph 1, Item 3 of the Personal Information Protection Act as described above (**Table 4**). In addition, in order to prevent the recurrence of CPs, which is the purpose of the system, and to widely commit to quality improvement in perinatal care, the JQ believed that it was incredibly important to disclose all "Synthesized edition" on the web after a year-long argument over the disclosure under the revised Personal Information Protection Act. As there were some opinions that a certain level of agreement has been formed between the JQ and the family and childbirth facility who had disagreed on the disclosure, the JQ needed to make efforts to carefully convince families and childbirth facilities to agree on the new policy on disclosure. After all those discussions, the new disclosure policy was agreed in the Steering Committee [14].
