Opinion of the Japan Academy of Nursing Science on the Enforcement of the Act on the Protection of Personal Information

Japan Academy of Nursing Science
September 26, 2006

1. nursing and personal information

Nursing is an activity that aims to promote the physical, mental, social, and spiritual health of individuals, families, groups, and communities through practice activities in diverse areas. In every aspect of nursing practice, there is a target population. Nursing activities, which pursue what should be done and what should not be done, always have an ethical dimension, considering the best actions for the health of these people and society.

Because of the nature of nursing, those involved in nursing have been instilling an attitude of self-discipline by clearly stating their ethical responsibilities through the "Code of Ethics for Nurses" (Japan Nurses Association, 2003). Since access to people's "personal information" is an essential part of nursing activities, Article 5 of the above Code of Ethics clearly states that "Nurses shall observe confidentiality and endeavor to protect personal information, and shall exercise appropriate judgment when sharing such information with others.

Nursing science aims to develop, disseminate, and further improve the knowledge and skills of nursing practice on an academic foundation. The Japan Academy of Nursing Science is aware that nursing is premised on access to personal information, and has worked to develop academic activities in an ethical manner as it contributes to the development of nursing science. To cite a few examples, he reported "The Actual State of Ethical Recognition and Response of Nursing Professionals to the Drug-induced AIDS Problem" (1997) and "Views on Transplantation Medicine and Nursing under the Organ Transplantation Law" (2001). The 21st Annual Meeting of the Japanese Society of Nursing Science (President: Noriko Katada) also provides an opportunity to actively discuss ethical issues related to genetic diagnosis and treatment and research methodology, with the main theme of "Ethics in Nursing in the 21st Century. In addition, the Nursing Ethics Review Committee has continued its activities since 1990, during which time it has made various recommendations and reported on actual conditions from the perspective of protecting people who are the subjects of nursing research. In 1995, the committee published "Study on Ethical Considerations in Nursing Research," and in 1997, "Survey on the System of Ethical Review of Research in Nursing Colleges" in the Journal of the Society, and in the last fiscal year, the committee presented "Guidelines for Ethical Review in Nursing Research" to promote ethical review of research.

Thus, in a series of attempts to refine the state of research ethics, the Society has always emphasized and examined perspectives on the handling of personal information. In addition to the perspective of research ethics, the Society has always questioned ethics in the expansion and development of nursing science.

2. background of the "Act on the Protection of Personal Information" and current status after its enforcement

The "Act on the Protection of Personal Information" (hereinafter referred to as the "Personal Information Protection Act") was enacted in 2003 to protect the rights and interests of individuals while taking into consideration the usefulness of personal information, in response to the significant expansion of the use of personal information with the development of the advanced information communications society, and came into full force as of April 2005. The basis of this concept is the eight principles (1. Principle of collection limitation, 2. Principle of data content, 3. Principle of data content, 3. Principle of clarity of purpose, 4. Principle of limitation of use, 5. Principle of security protection, 6. Principle of disclosure, 7. Principle of individual participation, and 8. Principle of responsibility). However, Article 50, Paragraph 1 states that the application of this law is exempted in the following cases: when the press conducts news reporting; when authors conduct writing; when universities, institutions and organizations for academic research purposes and persons belonging to them conduct academic research; when religious organizations conduct religious activities; and when political organizations conduct political activities. The "personal information protection law" is not applicable to the following cases. In addition, "personal information" under the Personal Information Protection Law is defined as information about a living individual, and refers to information that can identify a specific individual by name, date of birth, or other description.

It is undeniable that there have been aspects of medical care in which personal information has been handled too easily. For example, there have been situations such as "a questionnaire collection box for a research survey left in a conspicuous place forever," "a visitation book left carelessly," or "the name of a disease or treatment method being heard by a patient in the next bed. The enactment of the law was an opportunity for the health, medical, and welfare sectors to review such current conditions and consider appropriate handling of personal information. At the same time, however, there have been some reactions that could be considered excessive, such as "all research involving patients is now rejected," "students can no longer accept patients," and "patients can no longer be called by their personal names," which has caused no small amount of confusion in the fields of nursing research, education, and practice. In particular, the previously mentioned Article 50, which exempts "universities and other institutions or organizations for the purpose of academic research, or persons belonging to such institutions or organizations, for the purpose of academic research," has not been well known.

By the way, information disclosure should be considered together with personal information protection in the fields of research, education, and practice. The appropriate disclosure of information on medical care has already been pointed out in the 1995 White Paper on Health and Welfare, and both medical institutions and patients/families have become more aware of the need for disclosure. For example, movements toward receipt disclosure and medical record disclosure have accelerated over the past several years. From the perspective of research ethics as well, an increasing number of institutions are establishing information disclosure policies, mainly from the perspective of ensuring transparency in the research process.

Both privacy protection and information disclosure are intended to ensure the proper handling of information. However, the former is the right to have personally identifiable information protected, while the latter is the right to obtain (know) information. Since both movements occurred at about the same time, it is predicted that they have created a contradiction of two contradictions and have made it difficult to sort out the various phenomena. As a society that has always emphasized ethics as an intrinsic part of nursing science and nursing inquiry, we would like to clarify the situation in which the members of the Society find themselves and present the Society's views on the matter.

3. results of the survey conducted in accordance with the enforcement of the "Act on the Protection of Personal Information

The survey, which was conducted in conjunction with the enforcement of the "Act on the Protection of Personal Information," was conducted from March to April 2006, primarily by the Nursing Ethics Review Committee of the Japanese Society of Nursing Science. The survey was sent to all 4407 members, and the data consisted of 641 (14.51 TP3T) questionnaires that could be collected by the end of April. It was found that 638 (99.51 TP3T) respondents were aware of the Personal Information Protection Law, and 518 (80.81 TP3T) perceived that the enforcement of the law had changed their awareness of the handling of personal information. The following is a summary of the survey results in the respective areas of nursing research, nursing education, and nursing practice.

For details of the survey results, please refer to the "Report: Survey on the Enforcement of the Personal Information Protection Law" on the website of the Society and in the Journal of the Japanese Society of Nursing Science, Vol. 26, No. 3 (2006).

(1) Findings in the area of nursing research

In terms of how research protocols have been prepared since the law went into effect, 181 members (28.21 TP3T) indicated that they have not changed, while 390 members (60.81 TP3T) indicated that they have become more detailed.

Regarding access to research collaborators, about half of the respondents indicated that it had remained the same, while 214 (33.41 TP3T) indicated that it had become more difficult to obtain their cooperation. The same ratio was true for access to research subjects, with 360 respondents (56.21 TP3T) saying it had remained the same, while 177 (27.61 TP3T) felt it had become more difficult to obtain their cooperation. Only a few respondents indicated that the research has become more acceptable, although it takes more time to explain, and the actual situation of access difficulties were raised, such as not even being given the opportunity to explain the research, not being allowed to make recordings, and not being allowed to take patient information.

The number of respondents who answered that they did not know (378, 59.01 TP3T) exceeded those who answered that they knew (253, 39.51 TP3T) about Article 50's exemption from the Personal Information Protection Law. This suggests that the lack of widespread understanding regarding Article 50 may be one reason for the difficulty in gaining cooperation for the study.

Regarding the disclosure of information about research, most respondents (39.01 TP3T) indicated that it was not maintained, and 32.81 TP3T were considering it. However, not many actual disclosure requests were made.

(2) Survey results in the area of nursing education

With regard to the acceptance of practical training, there were indications of stricter conditions from the accepting side. Many reported situations in which they had difficulty in deciding which patients to accept, or were turned down because of conditions attached. In some cases, it was reported that it took time to obtain the consent of all patients, which interfered with the start of the practice. Access to medical records was reported to be restricted by 248 (38.71 TP3T). In particular, a large number of respondents reported that they were no longer able to access their records prior to the start of their practice.

It can be seen that various restrictions have also been placed on the transcription of medical and practice records to the practice record form. Regarding the management of practice records, 368 respondents (57.41 TP3T) indicated that they have changed. A number of respondents indicated a shift to management methods such as not taking the records off campus, shredding them when no longer needed, not returning them to students but destroying them after graduation, collecting or burning the records and notes, etc.

When providing patient care, changes were observed such as not being able to approach patients who did not give consent, not being able to observe patients other than those in their care, and having to obtain consent for each act of care.

In the free-response section, the participants described how nursing education was not smooth, including overreacting, lack of access to a variety of patients, and students being inhibited in their learning.

3) Results of survey in nursing practice areas

With regard to access to patient and resident records, 33 respondents (36.71 TP3T) indicated that there has been a change, indicating that there are stricter controls for access to electronic medical records and other records. Regarding the handling of patients' and residents' names, 28 respondents (31.11 TP3T) indicated that there has been a change.

With regard to the relationship between disclosure and protection of information, the free-text sections included cases in which family members (patients) demanded disclosure but patients (family members) demanded protection of information, and the current situation in which negative assessments and intuitive things could no longer be written because records were written based on disclosure.

4. views of the Japan Academy of Nursing Science

It is natural for nursing professionals to pay sufficient attention to the handling of personal medical and life history data to ensure that it is not handled inappropriately. Therefore, the enactment of the Personal Information Protection Law does not change the existing approach to the handling of personal information in nursing research, practice, and education. The enforcement of the Personal Information Protection Law is not simply a matter of creating rules and manuals on how to handle personal information, but rather an opportunity for nursing professionals to reconfirm and implement the methods they have been using autonomously up until now.

(1) Nursing Research and Personal Information

In nursing research, the protection of personal information of research participants leads to the ethical conduct of research. Therefore, it is commendable that sufficient consideration has been given to the protection of personal information at the research planning stage since the enforcement of the law. However, there have been cases where research implementation has been restricted or denied due to a lack of widespread understanding of the exemptions to Article 50 of the Personal Information Protection Law. It is undeniable that unnecessary restrictions may be imposed on the quality and quantity of research due to the lack of understanding of Article 50 among academic society members. We would like to take the stance that the academic societies should make themselves known to the public, based on an understanding of the purpose of the law. In addition, we believe that researchers should make efforts to inform cooperating institutions and research participants and seek their understanding by acknowledging the purpose of Article 50 in research request letters and by other means.

2) Nursing Education and Information Management

In education, familiarizing students with the Personal Information Protection Law provides an opportunity to instill in them a professional awareness that nursing is a profession that handles personal information. The current trend toward the protection of personal information and information disclosure also reveals the increasing number of opportunities for lectures and explanations on ethics.

The major changes in the educational setting can be broadly categorized into the method of determining the patient to be assigned, the method of accessing records, and the method of storing student records. The process of obtaining patient consent in determining the patient to be assigned has generally been in writing rather than verbally. The survey revealed that it has become more difficult to obtain consent, but this should not be taken negatively, but rather should be taken seriously by those who may have been unable to refuse even if they had wanted to. However, with the trend toward shorter average hospital stays, we cannot overlook the fact that students are so busy obtaining consent forms that they have less time for teaching, or that they cannot even approach patients without obtaining a consent form. The situation in which students are unable to talk to or help a patient when he or she is nearby may be more of an ethical challenge. If educational opportunities continue to be severely curtailed, it will be necessary to reconsider, together with educational institutions, medical institutions, and relevant academic societies, what consent is required for.

Students are not fully equipped to sort out information that is necessary for patient care from information that is not. Therefore, placing restrictions on access to records is considered a necessity for information management. However, if students are given only the information they need from the outset, or if access is overly restricted, their own ability to sort information may deteriorate further. Rather than setting uniform restrictions on information access, we believe that flexible measures should be discussed in accordance with the objectives of practical training and educational needs.

With regard to the management of student records, the most common response was that an agreement was made not to take them out, while other notable responses included collecting them without returning them to the students or destroying them. From the standpoint of the host institution and patients/families, it is natural that students would be reluctant to keep records forever, even if anonymity is ensured, and educational institutions should take responsibility for record management. However, it must be remembered that records are a form of the student learning process. Situations that would extremely inhibit student learning should be avoided, and the way information is managed should be in line with learning and educational needs.

(3) Nursing Practice and Information Management

In practice, appropriate information collection and information management will lead to a reaffirmation of the role of the patient advocate. In clinical practice, this survey reveals a situation in which ID management has become stricter with the introduction of electronic medical records and efforts have been devised to keep patients' individual names out of the public domain, and it is commendable that various institutions are making efforts to respond to the need for appropriate information management.

One area of confusion that stands out in clinical practice is related to information disclosure. Some respondents commented that they could only write records that anticipated information disclosure, while others were confused between patients (family members) who wanted to protect their personal information and family members (patients) who wanted to disclose information, according to their free comments. Since retaining necessary information is essential for medical and nursing activities, the scope and quality of information to be recorded must be considered. In addition, since cases in which the protection of personal information conflicts with the disclosure of information can be expected to occur in the future, it is desirable to establish a system in which such conflicts are promptly discussed not only at departmental conferences but also at the institution concerned and at the facility as a whole through clinical ethics committees.

Selecting essential information based on appropriate objectives and sharing it among the nursing population and health care providers will improve the quality of nursing care. There is still some confusion as to how to apply the Personal Information Protection Law in each of these settings, and there remains much to be discussed on an ongoing basis.

The enforcement of the Personal Information Protection Law is an opportunity to review past practices regarding information management and to increase ethical sensitivity. In this survey, it became clear that nursing practices in research, education, and practice are actively engaged in reviewing and taking measures to manage information. Through these efforts, we must refine the way nursing has handled information in the past and raise the awareness of those involved in nursing. We believe that the functions and roles of nursing, which are predicated on the handling of personal information, should be promoted to society, and that this should lead to the development of nursing itself.

5. future activities

Although the number of respondents to this survey was 14.51 TP3T (641) of all Society members (4407 as of March 17, 2006), we were able to obtain a general understanding of the current status of the nursing field as a result of the implementation of the Personal Information Protection Law. Based on the results of this survey, we believe that the Society must continue to educate the public so that nursing research, education, and practice can be improved.

The Society will continue to focus its future activities on the following points
(1) To ensure that the quality and quantity of research by JSPS members is not compromised, we will ensure that all JSPS members are aware of the exemption from the application of the Personal Information Protection Law (Article 50).
(2) To ensure that the quality of nursing education does not deteriorate, consult on the appropriateness of educational opportunities in cooperation with related academic societies and organizations.
(3) To avoid confusion between privacy protection and information disclosure in the field of nursing, we will organize the interpretation of each from the perspective of nursing science.

... and upwards