Privacy Policy

With respect to the protection of personal information including the registration records of the Shinanokai Affiliated Clinical Study Volunteer Association and the health examination records and medical records of clinics operated by said Association, Medical Corporation Shinanokai complies with confidentiality obligations and other norms under the Personal Information Protection Act, guidelines for the handling of personal information in medical- and nursing care-related businesses, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GPC-related laws, and certification laws. Medical Corporation Shinanokai has established, and implements and maintains, the following Policy for the Protection of Personal Information.

Overview of the Privacy Policy

1. We will establish rules for handling personal data and implement them after ensuring that the Company employees and other relevant parties are fully aware of them, and we will improve and maintain them.
2. Appropriate data security safeguards, such as measures against unauthorized access and computer viruses, shall be put in place to prevent the leakage, destruction, alteration, or loss of personal data.
3. We will not only ensure that personal data is obtained through lawful and fair means, but also obtain consent from the data subject regarding the purpose of use.
4. We recognize that the data subject has the right to request disclosure, correction, or suspension of the use of personal data and will respond to such requests from data subjects in accordance with our regulations.
5. Personal data will not be disclosed or provided to a third party without the consent of the data subject unless required under the law. When providing personal data to business consignees, we will obligate them to protect personal data through confidentiality agreements and ensure that they handle it properly.
6. The specific principles for collecting and handling personal data are defined below.
   Principle of Personal Data Usage
   
   • Personal data shall only be used by authorized personnel within the scope of the purpose of collection as needed for the performance of specific duties.
   Prohibited Acts
   
   • We will not use personal data beyond the scope of its intended purpose, remove it from its usual place of use, or leak personal data by sending it to external parties, etc.
   • We will not disclose personal data obtained through business to a third party without just cause, nor shall we use it for unfair purposes. The same shall apply even after an employee has retired from the job in question, and we will take the measures necessary to ensure this.
7. About the Handling of Anonymized Processed Information
   We create "anonymized processed information" as stipulated in Article 2, Paragraph 9 of the Act on the Protection of Personal Information, and provide this information to third parties. We expect to continue the creation of similar anonymized processed information and its provision to third parties.
   
   Items of information concerning individuals in anonymized processed information are as follows.
   • Age, date of birth, gender, height, weight, and other physical data and information related to medical treatment (information on infirmities, therapies, treatments, tests, medication, clinic visits, clinic admission/discharge, etc.)
   *The above items are subjected to necessary and sufficient processing to disallow the identification of specific individuals or restoration of the personal information used in the creation, in accordance with the standards established by the Personal Information Protection Commission.
   
   Methods by which anonymized processed information is provided to third parties are as follows.
   • Sending via email
   • Sending via CD-ROM or other external storage media
   • Upload to servers
   Safety management measures, etc., for anonymized personal information
   Shinanokai enacts necessary and appropriate measures for the prevention of leakage, loss, or damage of anonymized processed information and for other management of the safety of anonymized processed information.

Purposes of the use of personal information of Medical Corporation Shinanokai Clinical Trial Volunteer Association registrants and clinical study participants

* Information is provided anonymized.

Personal information	Purpose of use by the Shinanokai Affiliated Clinical Study Volunteer Association, Shinanozaka Clinic, and Samoncho Clinic	Provision of information to other business operators, etc.
Volunteer registration records	Searching and selection of clinical study participant candidates Guidance concerning recruitment of participants for clinical studies, etc. (DM, telephone, email) Contact regarding scheduling of clinical studies, etc.(telephone, email) Contact regarding reexaminations(telephone, email) Contact in emergencies(telephone, email) Questionnaire surveys Information on events, seminars, campaigns, etc., organized by or related to Shinanokai	Confirmation of study participation intervals and provision of study participation information to prevent duplicate registration (Japan Association of Contract Institutes for Clinical Pharmacology) Outsourcing of Clinical Trial Volunteer Association work (Tokyo Research Center of Clinical Pharmacology)
Treatment records, etc. (health examinations, clinical study records, etc.)	Searching and selection of clinical study participant candidates Reporting of health examination results (sealed and mailed to individuals' homes) Health consultations, specialist referrals Preparation of materials related to clinical studies, etc. Recording of examination data in clinical studies, etc. Preparation of case reports based on clinical study records	Outsourcing of study subject recruitment work(Tokyo Research Center of Clinical Pharmacology) Outsourcing of assistance works for physicians in searching and selecting clinical study participation candidates(Tokyo Research Center of Clinical Pharmacology, etc.) Outsourcing of support work for physicians in charge of clinical studies (Tokyo Research Center of Clinical Pharmacology, etc.) Outsourcing of clinical examinations (SRL, etc.)* Outsourcing of medical examinations (other medical institutions, etc.)* Notification to attending physicians of participation in clinical studies (in cases of visits to other clinics) Submission of case reports to clinical study clients (pharmaceutical companies) (separate obtaining of consent)* Direct viewing of health examination records, study records, etc., by pharmaceutical companies, clinical study review committees, regulatory authorities, etc. Provision of treatment information to other clinics (referrals to other clinics) Presentations to academic societies, medical journals, etc. *
Other	Accounting administrative work involving cooperation expenses, reimbursement expenses, and awareness-building expenses	Outsourcing of accounting administrative work(Tokyo Research Center of Clinical Pharmacology)

Purpose of use of personal information related to users of the Clinical Trial Volunteer Support Desk

• Examination and investigation of, and response to, the content of consultation, contact, etc.
• Confirmation of identity

Purpose of use necessary for providing medical care to patients, etc.

Purpose of use within Samoncho Clinic

Use for information provision outside the clinic

Provision of medical services Medical insurance administrative work Accounting Analysis of and reporting on quality enhancements, safety assurance, medical errors and prevention thereof, etc. Enhancement of medical services for patients, etc. Other management and operation work involving patients

Collaboration with other clinical study specialist medical institutions, hospitals, clinics, etc. Response to inquiries from other medical institutions, etc. For seeking opinions and advice from outside physicians, etc., for health examinations, treatments, etc., of patients, etc. Outsourcing of sample testing work, etc. Explanation of medical conditions to family members, etc. Provision of receipts to examination and payment agencies or insurers Response to inquiries from examination and payment agencies or insurers Cross-sectional sharing data, notification, etc., involving medical professional liability insurance, etc., with medical-related professional organizations, insurance companies, etc. Provision of information to external auditors Other uses related to medical insurance administrative work for patients

Purpose of personal data use pertaining to job applicants

• To screen candidates and determine hires
• To make contact regarding company information, recruitment information, recruitment results, and more
• Reporting and notification to government agencies based on laws and regulations
• To verify identity

Purpose of personal data use regarding Company officers, full-time employees, part-time employees, temporary employees, retirees, and their families

• For employment management such as human resources, welfare benefits, and skill development
• For administrative procedures such as general affairs, accounting, and systems
• To notify, provide information, and report to mutual aid associations, health insurance associations, welfare pensions, participating organizations, consolidated subsidiaries, partner companies, etc.
• To contact and provide information related to employee stock ownership associations, etc.
• Business-related communications or information exchanges
• Reporting and notification to government agencies based on laws and regulations
• To verify identity

2018.11.15
MEDICAL CORPORATION SHINANOKAI
Masami FUJITA, Chief Director

See here for inquiries regarding personal data