Operational Regulations Governing the Reporting of Cancer Prevention and Control Information by Medical Care Institutions

Article 1. This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 11 of the Cancer Control Act (hereafter referred to as the Act).

Article 2. The central competent authority may, for the purpose of establishing a cancer-screening database, request medical care institutions to report the following information:

(1)Basic information: name, national ID card No. or passport No., sex, date of birth, permanent address, present address, telephone No., medical record No., relevant medical history and other basic information;
(2)Screening information: screening method, screening results and other screening information;
(3)Confirmation diagnosis information of positive cases: results of confirmation diagnosis, diagnosis method, cytology or histopathology results, postoperative pathology results, stage, lateralization and other confirmation diagnosis information;
(4)Other information necessary for the promotion of cancer prevention and control.

The information stipulated in Subparagraph 1 and Subparagraph 2 of the preceding Paragraph shall be reported to a research institution commissioned by the central competent authority within two weeks after a patient undergoes screening.

The information stipulated in Subparagraph 3 of Paragraph 1 shall be reported to a research institution commissioned by the central competent authority within two weeks after a patient with a positive screening result undergoes confirmation diagnosis.

Article 3. The central competent authority may, for the purpose of establishing a database of the newly diagnosed cancer cases, request medical care institutions to report the following information:

(1)Basic information: name, national ID card No. or passport No., sex, date of birth, permanent address, telephone No., medical record No. and other basic information;
(2)Diagnosis and treatment information: diagnosis results, diagnosis basis, date of initial diagnosis, hospital where initial diagnosis was performed, cancer site, cytology or histopathology results, postoperative pathology results, stage, lateralization, treatment method, treatment results, follow-up and other related diagnosis and treatment information;
(3)Other information necessary for the promotion of cancer prevention and control.

The information stipulated in the preceding Paragraph shall be reported to a research institution commissioned by the central competent authority within 12 months after a patient undergoes initial diagnosis.

Article 4. Where a medical care institution fails to report the required information by the specified deadline, and still has not reported said information within two months of subsequent notification by the competent authority, penalties shall be imposed in accordance with Article 17 of this Act.

Article 5. Medical care institutions shall provide the required cancer prevention and control information to a research institution commissioned by the central competent authority via e-mail attachment, floppy disk or in written form.

Article 6. Where the central competent authority commissions a research institution to establish cancer prevention and control database, fees paid to medical care institutions for the reporting of information related to cancer prevention and control shall be listed in the database plan or annual budget.

Article 7. Where a research institution is commissioned by the central competent authority to establish cancer prevention and control database, and learns or obtains confidential information about any third party, said institution shall comply with regulations of the Computer-processed Personal Data Protection Act.

Article 8. This set of Regulations shall come into force from the date of announcement.