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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/05/21 22:18
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Chapter Law Content

Title: Medical Care Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter IV Medical Practices
Article 56
Medical care institutions shall have appropriate locations for medical care and safety facilities in accordance with the nature of the services provided.
Medical care institutions shall ensure comprehensive provision of aseptic needles on progressive percentages within five years, starting from 2012, for their medical personnel who are working on care and treatment that require direct contact with a patient’s body fluids or blood.
Article 57
Medical care institutions shall supervise their medical personnel to conduct practices in accordance with the related provisions of each professional medical practice law.
Medical care institutions shall not employ or keep someone without proper medical personnel qualification for execution of duties that should be carried out solely by specialized medical personnel.
Article 58
Medical care institutions shall not establish clinical assistants to conduct medical practices.
Article 59
Hospitals shall appoint an appropriate number of physicians in accordance with the scope and practical needs of the hospital, to treat hospitalized and emergency patients during non-clinic hours.
Article 60
Hospitals and clinics shall first provide emergency patients with proper emergency treatment and offer remedies or undertake necessary measures within the capability of their personnel and facilities, and shall not delay without cause.
In the case that the emergency patients referred to in the preceding paragraph are low- or middle-income patients or were found to have collapsed on streets, and they or their supporters are unable to afford the medical costs, the social administrative competent authority at the municipal or county (city) level shall provide subsidies in accordance with the law.
Article 61
Medical care institutions shall not solicit patients through improper manners proclaimed and prohibited by the central competent authority.
Medical care institutions and its staff shall not take advantage of opportunities resulting from medical practice to gain improper interests.
Article 62
Hospitals shall establish medical care treatment quality control systems, and review and assess the quality.
For the purpose of improving medical care service quality, the central competent authority shall establish regulations regarding the applicable symptoms, qualification of technical personnel, conditions, and other observances for medical technology, examination, laboratory testing, medical devices.
Article 63
Medical care institutions shall explain the reasons for surgical operation, success rate, possible side-effects and risks to the patient or his/her legal agent, spouse, kin, or interested party, and must obtain his/her consent and signature on letter of consent for surgery and anesthesia before commencing with surgical procedure. However, in case of emergency, the provisions above shall not apply.
The legal agent, spouse, kin, or interested party may sign the letter of consent referred to in the preceding Paragraph in the case that the patient is a minor or unable to affix the signature personally.
The format of the letter of consent for surgery and anesthesia referred to in the first Paragraph shall be determined by the central competent authority.
Article 64
Medical care institutions shall explain the invasive examination or treatment regulated by the central competent authority to the patient or his/her legal agent, spouse, kin, or interested party, and must obtain his/her consent and signature on the letter of consent before commencing with the procedure. However, in case of emergency, the provisions above shall not apply.
The legal agent, spouse, kin, or interested party may sign the letter of consent referred to in the preceding Paragraph in the case that the patient is a minor or unable to affix the signature personally.
Article 65
The tissue specimens collected or organs taken in operations by the medical care institutions shall be sent in pathological examinations, and shall notify the patient or his/her legal agent, spouse, kin, or interested party of the examination result.
Medical care institutions shall analyze, review, and assess the clinical or pathological examination result of the tissue specimens or organs from operations mentioned in the preceding Paragraph.
Article 66
When dispensing medicaments to the patients, a hospital or clinic shall clearly indicate the patient’s name and sex, the name, dosage, quantity, method of administration, actions or indications, warnings or side effects of the medicament, the name and location of the medical institution, the name of dispenser and the date of dispensation on the container or package.
Article 67
Medical care institutions shall establish clear, accurate, and complete medical records.
The medical records referred to in the preceding Paragraph shall include the following information:
1. Medical records produced by the physician in accordance with the Physicians Act;
2. Each examination and inspection report;
3. Other records made by medical personnel during practice.
Hospitals shall make an index and statistical analysis of medical records for the purpose of research and reference.
Article 68
Medical care institutions shall instruct its medical personnel to personally make documentation of medical record, affix signature or seal, and add the year, month and date of inspection when conducting medical practices.
In the case that the medical records referred to in the preceding Paragraph is revised or amended, the signature or sign and date shall be affixed to the revised or amended portions. Amended records shall be drawn out with a line, and not deleted.
The physician‘s orders shall be clearly stated in the medical record or in written form. However, in case of emergency, the physician‘s orders may be given orally, and documented within 24hours.
Article 69
Medical care institutions which document and store medical records by means of electronic record shall be exempt from producing another written copy. The regulations regarding the criteria, production method, content, and other observances for electronic medical records shall be determined by the central competent authority.
Article 70
Medical care institutions shall designate appropriate location and appoint personnel for the storage of medical records, which shall be retained for at least seven years. However, medical records of minors shall be retained for at least seven years after their coming of age, and medical records for human trials shall be retained indefinitely.
Medical care institutions which cease practice due to certain reasons shall transfer the medical records to the successor for retentions in accordance with the law. In the absence of a successor, the patients or their agents may ask the medical care institution to turn over their medical records, while the rest of the records shall be retained for at least another six months before destruction.
Where a medical care institution becomes unable to keep the medical records with justified reasons, the local competent authority will keep those records.
Medical care institutions shall ensure that the destruction method of medical records which exceed retention period will not disclose the contents of the medical records.
Article 71
Medical care institutions shall provide a copy of the patient‘s medical records or Chinese summary of medical records when necessary in accordance with the patient‘s requests, and shall not delay or refuse without cause. The fee for the copy of medical records shall be paid by the patient.
Article 72
Medical care institutions and their staff shall not disclose without cause any information regarding patient’s illnesses or health, which are acquired by virtue of practice.
Article 73
Hospitals or clinics which are unable to ascertain the patient‘s illness or provide full treatment due to restrictions of personnel, facilities, or expertise, shall suggest the patient to transfer to another medical care institution. However, hospitals or clinics shall provide emergency medical care in accordance with Paragraph1of Article 60 in the case of emergency patients before transfer to another medical care institution.
A summary for transfer medical record shall be filled out and provided to the patient in the case of transfer referred to in the preceding Paragraph, which shall not be delayed or refused without cause.
Article 74
When treating a patient, the hospital or clinic may contact any previous hospitals or clinics where the patient was treated for copies of medical records, medical record summary, and other examination reports as necessary, but only after obtaining the consent of the patient or his/her legal agent, spouse, kin, or interested party. The previous hospital or clinic shall not refuse to provide said information. The cost shall be paid by the patient.
Article 75
Hospitals shall provide appropriate medical care facilities and personnel to provide continuing care for discharged patients per their requests.
Hospitals shall obtain a signed discharge form from the patient or his/her legal agent, spouse, kin, or related party in the case that the patient demands to be discharged prior to completion of his/her treatment.
Patients shall immediately process the discharge or transfer upon notification of discharge by diagnosis or physician order.
Article 76
Hospitals and clinics shall not refuse to provide the patient with birth certificate, certificate of diagnosis, death certificate, or stillbirth certificate without cause as stipulated in the laws or regulations. When issuing the various certificates, caution shall be exerted as much as possible, especially when related to the cause of death.
If the certificate of diagnosis mentioned in the preceding paragraph is issued for the patient’s insurance claim, it shall be written in Chinese. In the event that the name of disease indicated is different from the one that appears in the insurance policy, a remark shall be made.
Hospitals and clinics shall report cases of death not caused by illness, or suspected not to be caused by illness, to the procuratorial authority for investigation in accordance with the law.
Article 77
Medical care institutions shall accept entrustment by the government in medical care service related affairs, such as assisting in conducting public health, continuing education, on-the-job training, disaster relief, emergency relief, community welfare, and civil defense.
Article 78
For the purpose of improving the level of medical care or prevention of disease in the country, teaching hospitals may conduct human research after formulating a plan and obtaining approval from the central competent authority, or upon entrustment of the central competent authority. Notwithstanding the foregoing, the approval of the central competent authority is not required for human research with aim of evaluating the bioavailability and bioequivalence of generic drugs.
Non-teaching hospitals may not conduct human research. However, the preceding paragraph may apply mutatis mutandis to medical care institutions with specific expertise and having obtained the approval of the central competent authority.
The plan for human research by a medical care institution shall be first reviewed and approved jointly by a board consisting of medical technologists, legal experts and impartial citizens or representatives of civil groups; people of either gender shall constitute no less than one third of the board. Members of the review board shall abide by the principle of recusal due to conflicts of interest.
Subsequent changes of the human research plan shall be implemented only after being examined and verified or approved according to the preceding three provisions.
Article 79
When conducting human research, medical care institutions shall pay necessary attention to medical procedures, and first obtain a written consent from the research subjects. The subjects of human research must be adults with disposing capacity. The preceding provision however does not apply to human research that is apparently beneficial to the health of specific population or patients with a special disease.
Where a research subject in the proviso of the preceding paragraph is a person with limited disposing capacity, the consents of both the subject and his/her legal representative are required; where the research subject is a person with no disposing capacity, the consent of his/her legal representative is required.
The medical care institution shall clearly state the following on the written consent referred to in the preceding paragraph, and shall inform the subject or his/her legal representative in a manner comprehensible to him/her before obtaining his/her consent:
1. Purpose and method of research;
2. Possible risks and side effects;
3. Expected results;
4. Explanation of other possible treatment methods;
5. Subject’s right to withdrawal of consent at any time;
6. Research-related compensation for damages or insurance coverage;
7. Confidentiality of the subject’s personal information; and
8. The preservation and reutilization of the subject’s biological samples, personal data or derivatives thereof.
With respect to informing the subjects and obtaining written consent mentioned in the preceding paragraph, the medical care institution shall give the research subjects ample time to consider and shall not use coercion or other improper methods.
When a doctor carries out human research in accordance with the preceding four provisions, causing death or injury of a patient because of unforeseeable factors in the research, the provisions concerning intentional or negligent offence as set down in Article 13 or 14 of the Criminal Code shall not apply.
Article 79-1
Unless it is otherwise provided by the Act, the application procedure, review criteria and the principle of withdrawal in case of conflict of interest, disclosure of information, supervision and administration, examination, and other information to be disclosed relating to a human trial mentioned in the preceding two articles shall be set forth by the central competent authority.
Article 79-2
Medical care institutions shall continue to provide standard care to patients who decline to participate in the trial or who later withdraw their consent without impairing their legitimate right to medical care.
Article 80
Medical care institutions shall submit trial report in accordance with notification by the central competent authority during human trial period. If the central competent authority feels there is concern for safety, the medical care institutions shall cease trial immediately.
Medical care institutions shall submit trial report to the central competent authority at the completion of the human trial.
Article 81
When treating the patient, the medical care institution shall inform the patient or his/her legal agent, spouse, kin, or interested party of his/her condition, course of treatment, disposition, medication, expected condition, and possible ill effects.
Article 82
Those conducting medical practices shall exercise due care in carrying out a medical procedure.
Only in the event that medical personnel cause harm to patients in conducting medical practices intentionally or breach of medical due care, which goes beyond reasonable exercise of professional clinical discretion, the medical personnel shall be bound to compensate for such harm.
Only in the event that medical personnel negligently cause injury or death to patients in conducting medical practices due to a breach of medical due care, which goes beyond the reasonable exercise of professional clinical discretion, the medical personnel shall assume criminal responsibility.
The extent of the breach of the duty of due care and professional clinical discretion, as set forth in the preceding two paragraphs, shall be determined based on objective conditions such as the customary medical practice, medical level, medical facilities, working conditions, and level of emergency or urgency in the locality at the time of practice in the medical field concerned.
Medical care institutions shall be liable for compensation only for such harm that causes to patients in the course of medical practices, whether deliberately or negligently.
Article 83
The Judicial Yuan shall appoint courts to establish professional medical courts, in which a judge with related professional medical knowledge and trial experience shall handle medical disputes and litigation.
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