Medical Care Act
2023-06-28
手機睡眠
語音選擇
Chapter I General Principles
Article 1
The Medical Care Act (hereinafter referred to as—the Act“) is enacted for the purpose of advancing the comprehensive development of the medical care industry, reasonably distributing medical care resources, improving the quality of medical care, to protect the rights of the patient, and to promote national health. Any matter not provided for in the Act shall be governed by the provisions of other relevant laws.
Article 2
The term —medical care institutions“ as used in the Act shall refer to any institution in which physicians conduct the practice of medicine.
Article 3
The term —public medical care institutions“ as used in the Act shall refer to any medical care institution established by government authority, government-owned enterprises, or public schools.
Article 4
The term —private medical care institutions“ as used in the Act shall refer to any medical care institution established by physician(s).
Article 5
The term — juridical persons in medical care“ as used in the Act shall include corporate care and medical corporations.
The term —medical care corporate“ as used in the Act shall refer to corporate in which the founder endows a certain number of assets for the purpose of conducting medical practices or running a medical care institution, which has been approved by the central competent authority and registered at court.
The term —medical care corporations“ as used in the Act shall refer to registered corporations approved by the central competent authority for the purpose of conducting medical affairs and medical care institutions.
The term —medical care corporate“ as used in the Act shall refer to corporate in which the founder endows a certain number of assets for the purpose of conducting medical practices or running a medical care institution, which has been approved by the central competent authority and registered at court.
The term —medical care corporations“ as used in the Act shall refer to registered corporations approved by the central competent authority for the purpose of conducting medical affairs and medical care institutions.
Article 6
The term —subsidiary medical institutions of a juridical person“ as used in the Act shall refer to the following medical care institutions:
1. Subsidiary hospitals established by private medical colleges and universities for the purpose of clinical education.
2. Medical care institutions established to conduct medical practices by public-interest juridical persons in accordance with related laws.
3. Subsidiary infirmaries of businesses, schools, or institutions set up in accordance with the law for the purpose of providing medical and health care services or emergency medical care for employees or members.
1. Subsidiary hospitals established by private medical colleges and universities for the purpose of clinical education.
2. Medical care institutions established to conduct medical practices by public-interest juridical persons in accordance with related laws.
3. Subsidiary infirmaries of businesses, schools, or institutions set up in accordance with the law for the purpose of providing medical and health care services or emergency medical care for employees or members.
Article 7
The term —teaching hospital“ as used in the Act shall refer to medical care institutions whose education, research, and training facilities have been accredited in accordance with the Act as being able to provide training for physicians and other medical personnel, and clinical internship and practical training for students of medical colleges and universities.
Article 8
The term “human trial” as used in the Act shall refer to experimental research of new medical technology, new medicament, new medical implement, or the bioavailability and bioequivalence of generic drugs conducted by medical care institutions on humans based on medical theory.
In conducting a human trial, the medical care institution shall respect the voluntary intent of the trial subjects and protect their right to health and privacy.
In conducting a human trial, the medical care institution shall respect the voluntary intent of the trial subjects and protect their right to health and privacy.
Article 9
The term —advertisement of medical treatment“ as used in the Act shall refer to the act of advertising medical practices by means of propagation for the purpose of soliciting patients.
Article 10
The term “medical personnel” as used in the Act shall refer to physicians, pharmacists, professional registered nurses, physical therapists, occupational therapists, medical technologists, medical radiation technologists, dietitians, registered professional midwives, clinical psychologists, counseling psychologists, respiratory therapists, speech therapists, hearing specialists, dental technicians, opticians, assistant pharmacists, registered nurses, midwives, physical therapy assistants, occupational therapy assistants, medical technicians, medical radiological technicians, assistant dental technicians, optical technicians, and other persons with professional medical certificates issued by the central competent authority.
The term “physician” as used in the Act shall refer to physicians, Chinese medicine doctors, and dentists as referred to in the Physicians Act.
The term “physician” as used in the Act shall refer to physicians, Chinese medicine doctors, and dentists as referred to in the Physicians Act.
Article 11
The term “competent authority” as used in the Act shall refer to the Ministry of Health and Welfare in the case of the central government, the municipal government in the case of a municipality, and the county (city) government in the case of a county (city).
Chapter II Medical Care Institutions
Article 12
Medical care institutions with wards for the inpatient care of patients shall be referred to as hospitals; those with only out-patient facilities shall be referred to as clinics; and those which conduct medical care practices not for the purpose of directly treating patients shall be referred to as other medical care institutions.
Clinics referred to in the preceding Paragraph may set up no more than nine beds for observation. Gynecology clinics shall set up no more than ten obstetric beds, according to medical practice necessity.
The classification of medical care institutions, as well as the service facilities, personnel, and establishment standards of each type of medical care institutions shall be determined by the central competent authority.
Clinics referred to in the preceding Paragraph may set up no more than nine beds for observation. Gynecology clinics shall set up no more than ten obstetric beds, according to medical practice necessity.
The classification of medical care institutions, as well as the service facilities, personnel, and establishment standards of each type of medical care institutions shall be determined by the central competent authority.
Article 13
Two or more clinics may establish a joint clinic at the same location, and shall conduct respective clinical practices with the use of common facilities. The regulations regarding the management of joint clinics shall be established by the central competent health authority.
Article 14
The establishment or expansion of hospitals may apply for building license in accordance with related regulations under the Building Code after approval from the competent authority; the same applies to the establishment of a branch of a hospital.With respect to the approval of the establishment or expansion of hospitals, the applicant’s qualifications, review procedure and criteria, restrictions, revocation, repeal and other matters of compliance shall be set forth by the central competent authority.
Article 15
To commence practice, medical institutions shall apply to the municipal or county(city) competent authority of the locality for approval and registration, and commence practice only after a practice is issued.
The applicant qualifications, application procedures, documents, and other observances for the opening practice application referred to in the preceding Paragraph shall be determined by the central competent authority.
The applicant qualifications, application procedures, documents, and other observances for the opening practice application referred to in the preceding Paragraph shall be determined by the central competent authority.
Article 16
Where the private medical care institutions are above a certain scale announced By the central competent authority, said private medical care institutions shall be re-established as a medical juridical person.
Article 17
The use and change of the names of medical care institutions shall be restricted to those approved by the respective municipal or county(city) competent authority. The principles regarding the use and change of said names shall be determined by the central competent authority.
Non-medical care institutions may not use names of, or similar to, medical care institutions.
Non-medical care institutions may not use names of, or similar to, medical care institutions.
Article 18
One supervising physician shall be established at each medical care institution, and shall be responsible for the practice of medicine at said medical care institution. The applicant shall be the supervising physician of a private medical care institution.
The supervising physician referred to in the preceding Paragraph shall be limited to those who has received at least two years of medical training at hospitals or clinics designated by the central competent authority, and have received documents of certification.
The supervising physician referred to in the preceding Paragraph shall be limited to those who has received at least two years of medical training at hospitals or clinics designated by the central competent authority, and have received documents of certification.
Article 19
The supervising physician shall appoint a physician with supervising physician qualifications to act for, in the case that he/she is not able to conduct practice. In the case that the activity period exceeds 45days, the original supervising physician shall notify the original license issuing authority.
The acting period referred to in the preceding Paragraph shall not exceed one year.
The acting period referred to in the preceding Paragraph shall not exceed one year.
Article 20
Medical care institutions shall display the practice license, clinic hours, and other clinic items in a conspicuous place.
Article 21
Standards for medical fees charged by the medical care institution shall be determined by the municipal or county(city)competent authority.
Article 22
Receipts shall be made by medical care institutions for medical fees charged, which shall clearly state the item(s)and fee(s).
Medical fees charged by medical care institutions shall not violate or exceed the standard for the fees, nor shall medical institutions charge for items without authorization.
Medical fees charged by medical care institutions shall not violate or exceed the standard for the fees, nor shall medical institutions charge for items without authorization.
Article 23
When the practice is suspended or terminated, the medical care institution shall notify the original license issuing authority for record purposes within 30 days.
Duration of the suspension mentioned in the preceding paragraph shall be limited to one year; for suspension over one year, termination of practice shall be filed within 30 days from the date when the one-year deadline is over.
If a medical care institution fails to file for termination of practice as provided in the preceding paragraph, the competent authority may terminate its practice at its own discretion.
Provisions regarding the establishment and commencement of practice shall apply mutatis mutandis to the relocation of medical care institutions.
Provisions regarding the commencement of practice shall apply mutatis mutandis to the resumption of practice for medical care institutions.
Duration of the suspension mentioned in the preceding paragraph shall be limited to one year; for suspension over one year, termination of practice shall be filed within 30 days from the date when the one-year deadline is over.
If a medical care institution fails to file for termination of practice as provided in the preceding paragraph, the competent authority may terminate its practice at its own discretion.
Provisions regarding the establishment and commencement of practice shall apply mutatis mutandis to the relocation of medical care institutions.
Provisions regarding the commencement of practice shall apply mutatis mutandis to the resumption of practice for medical care institutions.
Article 24
Medical care institutions shall be clean and orderly, and shall not impede public health and safety.
For the purpose of protecting patients’ safety when they seek medical care, no person shall hinder medical practices by means of violence, coercion, intimidation, public insults or other illegal methods.
Medical care institutions shall undertake necessary measures to ensure the safety of medical personnel when they practice medicine.
The police authority shall eliminate or restrain persons who violate the provisions of Paragraph 2. In case that criminal liabilities have arisen, such violations shall be referred to the competent juridical authority for investigation purposes.
The central competent authority shall establish a reporting mechanism, and shall announce, on a regular basis, the details of any events set forth in Paragraph 2 when they occur in a medical care institution as well as the final results.
For the purpose of protecting patients’ safety when they seek medical care, no person shall hinder medical practices by means of violence, coercion, intimidation, public insults or other illegal methods.
Medical care institutions shall undertake necessary measures to ensure the safety of medical personnel when they practice medicine.
The police authority shall eliminate or restrain persons who violate the provisions of Paragraph 2. In case that criminal liabilities have arisen, such violations shall be referred to the competent juridical authority for investigation purposes.
The central competent authority shall establish a reporting mechanism, and shall announce, on a regular basis, the details of any events set forth in Paragraph 2 when they occur in a medical care institution as well as the final results.
Article 25
The architectural structure and facilities of hospitals shall have fire prevention, escape routes, and other necessary precautions. In addition, hospitals shall also establish emergency response measures.
The emergency response measures referred to in the preceding Paragraph and the regulations regarding their inspection shall be determined by the central competent authority.
The emergency response measures referred to in the preceding Paragraph and the regulations regarding their inspection shall be determined by the central competent authority.
Article 26
Medical care institutions shall submit reports in accordance with the provisions of the law or with the notification of the competent authority, and shall accept inspections or data collections conducted by the competent authority regarding personnel, facilities, medical fees, medical practices, health and safety, and medical records.
Article 27
In case of serious disasters, medical care institutions shall obey the orders and directions of the competent authority in providing medical care services and assisting in public health, which shall not be avoided, obstructed, or refused.
The competent authority shall provide compensation after consideration for the fees or costs incurred by medical care institutions which provide services or assistance according to the preceding paragraph.
The competent authority shall provide compensation after consideration for the fees or costs incurred by medical care institutions which provide services or assistance according to the preceding paragraph.
Article 28
The central competent authority shall conduct accreditation of hospitals. The municipal or county(city)competent authority shall conduct periodical assessment of medical care institutions within the respective jurisdiction.
Article 29
Public hospitals may invite local social personages to establish an management advisory committee, for the purpose of providing suggestions to improve regional medical care services.
Public hospitals shall allot at least ten percent of the annual medical income after expenses to conduct research and development, professional training, health education, medical relief, community medical care services, and other community services.
Public hospitals shall allot at least ten percent of the annual medical income after expenses to conduct research and development, professional training, health education, medical relief, community medical care services, and other community services.
Chapter III Medical Juridical Persons in Medical Care
Section I General Provisions
Article 30
The establishment, organization, and management of medical care corporate shall be conducted in accordance with the provisions under the Act. Any matter not provided for in the Act shall be governed by the Civil Code.
Medical care corporations shall be established in accordance with the provisions under the Act. The organization, management, rights and obligations of the directors, bankruptcy, dissolution, and liquidation of medical corporations not provided for in the Act shall be governed by the Civil Code.
Medical care corporations shall be established in accordance with the provisions under the Act. The organization, management, rights and obligations of the directors, bankruptcy, dissolution, and liquidation of medical corporations not provided for in the Act shall be governed by the Civil Code.
Article 31
Juridical persons in medical care may establish hospitals, clinics, and other medical care institutions. The number and scale of said establishments may be restricted as necessary.
The restrictions of number and scale of establishments as referred to in the preceding paragraph shall be determined by the central competent authority.
Juridical persons in medical care may establish the following subsidiary institutions with the approval of the central competent authority and the competent authority governing the related practice:
1. Nursing institutions, psychiatric rehabilitation institutions;
2. Medical research institutions;
3. Welfare institutions stipulated in accordance with the Law Governing Benefits for Senior Citizens and other welfare related laws.
The establishment criteria, procedure, and other observances of subsidiary institutions referred to in the preceding Paragraph shall be conducted in accordance with the provisions in related laws.
The restrictions of number and scale of establishments as referred to in the preceding paragraph shall be determined by the central competent authority.
Juridical persons in medical care may establish the following subsidiary institutions with the approval of the central competent authority and the competent authority governing the related practice:
1. Nursing institutions, psychiatric rehabilitation institutions;
2. Medical research institutions;
3. Welfare institutions stipulated in accordance with the Law Governing Benefits for Senior Citizens and other welfare related laws.
The establishment criteria, procedure, and other observances of subsidiary institutions referred to in the preceding Paragraph shall be conducted in accordance with the provisions in related laws.
Article 32
Juridical persons in medical care shall have the necessary as sets to achieve the purpose of establishment.
The necessary assets referred to in the preceding Paragraph shall be determined by the central competent authority in accordance with the scope of establishment and conditions for operations.
The necessary assets referred to in the preceding Paragraph shall be determined by the central competent authority in accordance with the scope of establishment and conditions for operations.
Article 33
A juridical person in medical care shall establish a board of directors with one chairperson, who shall represent said juridical person.
A juridical person in medical care shall establish bylaws governing the organization and powers of the board of directors and supervisor, the qualification, selection and dismissal procedure for directors, chairperson, and supervisors, meeting and resolutions procedure, and other observances, which shall be submitted for approval to the central competent authority.
A juridical person in medical care shall establish bylaws governing the organization and powers of the board of directors and supervisor, the qualification, selection and dismissal procedure for directors, chairperson, and supervisors, meeting and resolutions procedure, and other observances, which shall be submitted for approval to the central competent authority.
Article 34
Juridical persons in medical care shall establish an accounting system, adopting a fiscal year system and accrual system. The legal certificates of financial income and expenses shall conform to publicly-acknowledged accounting standards, and shall be kept on record.
Juridical persons in medical care should submit the annual financial report approved and recognized by the board of directors and supervisors to the central competent authority within five months after the end of the fiscal year.
The principles regarding the compilation of the financial report referred to in the preceding paragraph shall be determined by the central competent authority.
In addition to compliance with provisions stated above, accounting systems of juridical persons in medical care shall be conducted in accordance with related provisions of the Company Law.
The competent authority may order juridical persons in medical care to submit financial and operations reports, or inspect financial or operation situations at any time.
Juridical persons in medical care shall not avoid, obstruct, or refuse the order or inspection referred to in the preceding paragraph.
Juridical persons in medical care should submit the annual financial report approved and recognized by the board of directors and supervisors to the central competent authority within five months after the end of the fiscal year.
The principles regarding the compilation of the financial report referred to in the preceding paragraph shall be determined by the central competent authority.
In addition to compliance with provisions stated above, accounting systems of juridical persons in medical care shall be conducted in accordance with related provisions of the Company Law.
The competent authority may order juridical persons in medical care to submit financial and operations reports, or inspect financial or operation situations at any time.
Juridical persons in medical care shall not avoid, obstruct, or refuse the order or inspection referred to in the preceding paragraph.
Article 35
Juridical persons in medical care shall not be unlimited liability shareholders of a company or a partner of a partnership enterprise. In the case that a juridical person in medical care is a limited liability shareholder of a company, the total investment and investment in a single company or the ratio of investment may not exceed a certain restriction.
The restrictions of investment referred to in the preceding Paragraph shall be determined by the central competent authority.
Surplus shares given to juridical persons in medical care by the invested company shall not be taken account into the total investment or investment amount referred to in the preceding Paragraph.
The restrictions of investment referred to in the preceding Paragraph shall be determined by the central competent authority.
Surplus shares given to juridical persons in medical care by the invested company shall not be taken account into the total investment or investment amount referred to in the preceding Paragraph.
Article 36
The assets of juridical persons in medical care shall be registered or saved in the name of juridical person, and the use of which shall be supervised by the central competent authority.
Juridical persons shall not loan, rent out, create a right in rent over, change to the use of its real estate, or create a right in rent over its facilities, without authorization from the central competent authority.
Juridical persons shall not loan, rent out, create a right in rent over, change to the use of its real estate, or create a right in rent over its facilities, without authorization from the central competent authority.
Article 37
Juridical persons in medical care shall not be guarantors. The capital of juridical persons in medical care shall not be loaned to directors, members, other persons, or non-financial institutions. The assets of juridical persons in medical care shall not be guarantee for directors, members, or other persons.
Article 38
Personal contributions or contributions by organizations to medical care corporate shall be tax-deductible in accordance with related tax laws.
The deduction or exemption of income tax, land tax, or house tax for medical care corporate shall be conducted in accordance with the provisions of tax related laws.
Private medical care institutions established prior to the implementation of the amendment of the Act, which change to juridical person in medical care within three Years of implementation, and transfer original medical lands to juridical person in medical care for continued use without cost, shall be exempt from added value land tax. However, in the case the land is transferred again to a third party, added value land tax shall be collected according to the total added value from the original land value of previous or current transfer.
The deduction or exemption of income tax, land tax, or house tax for medical care corporate shall be conducted in accordance with the provisions of tax related laws.
Private medical care institutions established prior to the implementation of the amendment of the Act, which change to juridical person in medical care within three Years of implementation, and transfer original medical lands to juridical person in medical care for continued use without cost, shall be exempt from added value land tax. However, in the case the land is transferred again to a third party, added value land tax shall be collected according to the total added value from the original land value of previous or current transfer.
Article 39
Juridical persons in medical care may merge with other similar juridical persons in medical care under the approval of the central competent authority.
Juridical persons in medical care shall produce a financial statement and balance sheet, and notify obliges within two weeks of merging with the approval of the central competent authority. The provisions of Paragraph 2 of Article 73 and Paragraph 1of Article 74 of the Company Law shall apply mutatis mutandis.
The rights and obligations of juridical persons in medical care eliminated due to mergers shall be accepted in its entirety by the remaining or new medical juridical person.
Juridical persons in medical care shall produce a financial statement and balance sheet, and notify obliges within two weeks of merging with the approval of the central competent authority. The provisions of Paragraph 2 of Article 73 and Paragraph 1of Article 74 of the Company Law shall apply mutatis mutandis.
The rights and obligations of juridical persons in medical care eliminated due to mergers shall be accepted in its entirety by the remaining or new medical juridical person.
Article 40
Non-medical care juridical persons may not use the names of, or similar to, medical juridical persons in medical care.
Article 41
The competent authority may reform, give a deadline to make improvements, cease all or part of clinical or hospital practices, order the suspension of practice, or revoke the license of juridical persons in medical care which are ill-conducted, or in violation of laws or original establishment criteria, in accordance with the seriousness of the situation.
In the case that juridical persons in medical care fail to conform to the provisions of Paragraph 2 of Article 32 due to decrease of assets, suspension or alteration of the established institution, or revocation of license, the central competent authority shall give a deadline to make improvements. Those who fail to comply shall be subject to revocation of license.
The central competent authority may annul the permit license of juridical persons in medical care which fall under the following conditions:
1. Those that have been approved for termination of practice, and fail to apply for resumption of practice within the given time limit.
2. Those that have been ordered to terminate all or part of clinical or hospitalization practices, and do not comply.
3. Those that have been ordered to terminate practice and do not comply, or fail to make improvements within the given time limit.
4. Those imposed with revocation of practice license.
In the case that juridical persons in medical care fail to conform to the provisions of Paragraph 2 of Article 32 due to decrease of assets, suspension or alteration of the established institution, or revocation of license, the central competent authority shall give a deadline to make improvements. Those who fail to comply shall be subject to revocation of license.
The central competent authority may annul the permit license of juridical persons in medical care which fall under the following conditions:
1. Those that have been approved for termination of practice, and fail to apply for resumption of practice within the given time limit.
2. Those that have been ordered to terminate all or part of clinical or hospitalization practices, and do not comply.
3. Those that have been ordered to terminate practice and do not comply, or fail to make improvements within the given time limit.
4. Those imposed with revocation of practice license.
Section II Medical Care Corporate
Article 42
Medical care corporate shall submit endowment charter, establishment plan, and related documents for approval by the central competent authority for establishment. After approval for the medical care corporate referred to in the preceding Paragraph, the founder or executor of will shall appoint directors and establish a board of directors within 30 days.
The founder or executor of the will shall submit the list of directors for authorization from the central competent authority within 30 days of establishment of the board of directors, which shall be submitted to the respective court for registration of juridical person within 30 days of authorization.
The founder or executor of the will shall transfer the endowment to the juridical person within three months of the date of registration completion for the medical care corporate, and shall notify the competent authority.
The founder or executor of the will shall be given a time limit within which to transfer the endowment to the juridical person; those who fail to comply shall be subject to revocation of license by the central competent authority.
The founder or executor of the will shall submit the list of directors for authorization from the central competent authority within 30 days of establishment of the board of directors, which shall be submitted to the respective court for registration of juridical person within 30 days of authorization.
The founder or executor of the will shall transfer the endowment to the juridical person within three months of the date of registration completion for the medical care corporate, and shall notify the competent authority.
The founder or executor of the will shall be given a time limit within which to transfer the endowment to the juridical person; those who fail to comply shall be subject to revocation of license by the central competent authority.
Article 43
There shall be nine to fifteen directors for a medical foundation.
The requirements for the composition of directors are as follows:
1. No less than one-third of the directors shall be qualified medical personnel, and there shall be at least one physician.
2. No more than one-third of the directors shall be foreigners.
3. No more than one-third of the directors shall be spouses or relatives within the third degree of kinship of other directors.
The term of office for a director shall not exceed four years, but may be renewed through re-election. However, no more than two-thirds of the directors shall have their term of office renewed for each re-election.
In the event where a medical foundation stipulated in the articles of association a term of office of directors more than the period of time specified in the preceding paragraph prior to the enforcement of the provisions amended on November 26, 2013, its directors may continue to hold office till expiration of the current term of office. This rule also applies to succeeding directors who are elected to fill a vacancy.
Directors shall personally attend board of directors meetings, and shall not authorize an agent to represent him/her.
The requirements for the composition of directors are as follows:
1. No less than one-third of the directors shall be qualified medical personnel, and there shall be at least one physician.
2. No more than one-third of the directors shall be foreigners.
3. No more than one-third of the directors shall be spouses or relatives within the third degree of kinship of other directors.
The term of office for a director shall not exceed four years, but may be renewed through re-election. However, no more than two-thirds of the directors shall have their term of office renewed for each re-election.
In the event where a medical foundation stipulated in the articles of association a term of office of directors more than the period of time specified in the preceding paragraph prior to the enforcement of the provisions amended on November 26, 2013, its directors may continue to hold office till expiration of the current term of office. This rule also applies to succeeding directors who are elected to fill a vacancy.
Directors shall personally attend board of directors meetings, and shall not authorize an agent to represent him/her.
Article 44
Changes to the endowment charter of medical care corporate shall be made with the approval of the central competent authority.
In the case that there are any changes made in chairman, directors, assets, or any other registered particulars, the medical care corporate shall apply for approval in accordance with provisions by the central competent authority.
The changes referred to in the preceding two Paragraphs shall be registered at court within 30 days of approval by the central competent authority.
In the case that there are any changes made in chairman, directors, assets, or any other registered particulars, the medical care corporate shall apply for approval in accordance with provisions by the central competent authority.
The changes referred to in the preceding two Paragraphs shall be registered at court within 30 days of approval by the central competent authority.
Article 45
In the case that a medical care corporate director is not elected or replaced after the previous one has fulfilled his/her term, which results in clear damage to the organization of the board of directors, the central competent authority shall appoint a replacement director according to the petition of other directors or interested parties.
The regulations regarding appointment shall be determined by the central competent authority.
In the case that a medical care corporate director is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, and causes an inability to operate normally, the central competent authority may order said director to temporarily cease from his/her duties or dismiss him/her according to the petition of other directors or interested parties.
The temporary cessation from duties referred to in the preceding Paragraph shall not exceed six months. In the case that the cessation from duties results in clear damage to the organization of the board of directors, the central competent authority shall appoint a temporary director in replacement. The appointment of the temporary director shall be exempt from registration, and shall be appointed in accordance with provisions provided for in the first Paragraph.
The regulations regarding appointment shall be determined by the central competent authority.
In the case that a medical care corporate director is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, and causes an inability to operate normally, the central competent authority may order said director to temporarily cease from his/her duties or dismiss him/her according to the petition of other directors or interested parties.
The temporary cessation from duties referred to in the preceding Paragraph shall not exceed six months. In the case that the cessation from duties results in clear damage to the organization of the board of directors, the central competent authority shall appoint a temporary director in replacement. The appointment of the temporary director shall be exempt from registration, and shall be appointed in accordance with provisions provided for in the first Paragraph.
Article 45-1
Any person with any of the following conditions must not serve as a director or supervisor:
1. The person has violated Articles 121 to 123 and Article 131 of the Criminal Code or Articles 4 to 6-1 or Article 11 of the Anti-Corruption Act and has been convicted of the offense or issued a wanted circular for an unclosed case. However, this rule does not apply to the cases where probation is pronounced or the punishment has been commuted to a fine and the fine has been paid in full.
2. The person has been charged with misappropriation, fraud, or breach of trust and has been convicted of the aforesaid offenses or issued a wanted circular for an unclosed case. However, this rule does not apply to the cases where probation is pronounced or the punishment has been commuted to a fine and the fine has been paid in full.
3. The person is faced with the pronouncement of custodial protection or aid that has not been revoked yet.
4. The person has been appraised by physicians to be suffering from mental illness or any other physical or mental impairment that prevents him/her from engaging in professional practice.
5. The person had assumed the post of chairman of the board, director or supervisor and was dismissed pursuant to Paragraph 2 of the preceding article or Subparagraph 3, Paragraph 1 of Article 45-2.
6. The person has been adjudicated bankrupt or subject to the commencement of the liquidation process as ruled, and has not been reinstated to his/her rights and privileges.
1. The person has violated Articles 121 to 123 and Article 131 of the Criminal Code or Articles 4 to 6-1 or Article 11 of the Anti-Corruption Act and has been convicted of the offense or issued a wanted circular for an unclosed case. However, this rule does not apply to the cases where probation is pronounced or the punishment has been commuted to a fine and the fine has been paid in full.
2. The person has been charged with misappropriation, fraud, or breach of trust and has been convicted of the aforesaid offenses or issued a wanted circular for an unclosed case. However, this rule does not apply to the cases where probation is pronounced or the punishment has been commuted to a fine and the fine has been paid in full.
3. The person is faced with the pronouncement of custodial protection or aid that has not been revoked yet.
4. The person has been appraised by physicians to be suffering from mental illness or any other physical or mental impairment that prevents him/her from engaging in professional practice.
5. The person had assumed the post of chairman of the board, director or supervisor and was dismissed pursuant to Paragraph 2 of the preceding article or Subparagraph 3, Paragraph 1 of Article 45-2.
6. The person has been adjudicated bankrupt or subject to the commencement of the liquidation process as ruled, and has not been reinstated to his/her rights and privileges.
Article 45-2
The chairman of the board, a director or a supervisor shall be dismissed if any of the following circumstances occurs during his/her term of office:
1. Having a letter of resignation presented to a board of directors meeting and included in the meeting’s minutes.
2. Meeting one of the conditions as set forth in the preceding article.
3. Having abused the power gained from his/her position or status to commit crimes and been convicted.
4. The chairman of the board convening no board of directors meetings within one year without reason.
In the event where the chairman of the board, a director or a supervisor abused the power gained from his/her position or status to commit crimes and a prosecutor files a public prosecution, his/her duties shall be suspended.
The chairman of the board, a director or a supervisor who represents a government agency or was recommended by other corporations or organizations shall hold or be removed from office when his/her original position changes. Recommended successors shall be elected and engaged by the board of directors, and their term of office expires on the day when the original term of office expires.
1. Having a letter of resignation presented to a board of directors meeting and included in the meeting’s minutes.
2. Meeting one of the conditions as set forth in the preceding article.
3. Having abused the power gained from his/her position or status to commit crimes and been convicted.
4. The chairman of the board convening no board of directors meetings within one year without reason.
In the event where the chairman of the board, a director or a supervisor abused the power gained from his/her position or status to commit crimes and a prosecutor files a public prosecution, his/her duties shall be suspended.
The chairman of the board, a director or a supervisor who represents a government agency or was recommended by other corporations or organizations shall hold or be removed from office when his/her original position changes. Recommended successors shall be elected and engaged by the board of directors, and their term of office expires on the day when the original term of office expires.
Article 46
Medical care corporate shall allot at least ten percent of the annual medical care income to conduct related research and development, professional training, and health education. Medical care corporate shall allot at least ten percent of the annual medical care income to conduct medical relief, community medical care services, and other community services. Those without standing achievements shall be rewarded by the central competent authority.
Section III Medical Care Corporations
Article 47
Medical care corporations shall submit organization bylaws, establishment plan, and related documents for approval by the central competent authority for establishment.
After approval from the central competent authority referred to in the preceding Paragraph, said medical care corporation shall establish aboard of directors in accordance with its bylaws within 30 days. Within 30 days of establishment of board of directors, the medical care corporation shall report to the central competent authority for registration and issuance of juridical person registration license.
After approval from the central competent authority referred to in the preceding Paragraph, said medical care corporation shall establish aboard of directors in accordance with its bylaws within 30 days. Within 30 days of establishment of board of directors, the medical care corporation shall report to the central competent authority for registration and issuance of juridical person registration license.
Article 48
When a medical corporation is established, the following entries shall be registered:
1. Purpose and name of juridical person;
2. The principal and branch of ices;
3. Name and domicile of directors, chairperson, and supervisors;
4. Classification and number of assets;
5. Location, classification, and scope of established institution;
6. Total number of assets and contributions from each member;
7. Year, month, and date of permit license.
1. Purpose and name of juridical person;
2. The principal and branch of ices;
3. Name and domicile of directors, chairperson, and supervisors;
4. Classification and number of assets;
5. Location, classification, and scope of established institution;
6. Total number of assets and contributions from each member;
7. Year, month, and date of permit license.
Article 49
The juridical person may not be a member of the medical care corporation.
All members of medical care corporations have aright to vote, regardless of the amount of contribution. However, the right to vote shall be distributed in proportion to the contribution in accordance with the bylaws of said medical care corporation.
The bylaws of medical care corporations shall clearly state that members shall retain rights to the assets of the juridical person in relation to their contributions, which may be transferred, in part or in whole, to third persons.
In the case that members who jointly serve as directors or supervisors transfer their rights to third persons in the situation referred to in the preceding Paragraph, said persons shall notify the central competent authority. Those who transfer all of their rights to the assets shall be dismissed from their duties automatically.
All members of medical care corporations have aright to vote, regardless of the amount of contribution. However, the right to vote shall be distributed in proportion to the contribution in accordance with the bylaws of said medical care corporation.
The bylaws of medical care corporations shall clearly state that members shall retain rights to the assets of the juridical person in relation to their contributions, which may be transferred, in part or in whole, to third persons.
In the case that members who jointly serve as directors or supervisors transfer their rights to third persons in the situation referred to in the preceding Paragraph, said persons shall notify the central competent authority. Those who transfer all of their rights to the assets shall be dismissed from their duties automatically.
Article 50
The directors of medical care corporations shall be limited to three to nine persons, in which no less than two-thirds shall be physicians or other medical personnel.
No more than one-third of the total number of directors shall be foreigners. Furthermore, foreigners shall not be the chairperson.
Medical care corporations shall establish supervisors, the number of which shall not exceed one-third of the number of directors.
Supervisors shall not serve concurrently as a director or employee.
Directors shall personally attend the board of directors meeting, and shall not authorize an agent to represent him/her.
No more than one-third of the total number of directors shall be foreigners. Furthermore, foreigners shall not be the chairperson.
Medical care corporations shall establish supervisors, the number of which shall not exceed one-third of the number of directors.
Supervisors shall not serve concurrently as a director or employee.
Directors shall personally attend the board of directors meeting, and shall not authorize an agent to represent him/her.
Article 51
The alteration of the bylaw of a medical care corporation shall be reported to the central competent authority for approval.
In the case that there is a change in chairperson, directors, or alteration in assets or other registered particulars, the medical care corporation shall register the alteration in accordance with regulations by the central competent authority.
In the case of dissolution, the medical care corporation shall register the dissolution.
In the case that there is a change in chairperson, directors, or alteration in assets or other registered particulars, the medical care corporation shall register the alteration in accordance with regulations by the central competent authority.
In the case of dissolution, the medical care corporation shall register the dissolution.
Article 52
In the case that a medical care corporation director is not elected or replaced after the previous one has fulfilled his/her term, which results in clear damage to the organization of the board of directors, the central competent authority shall order an immediate general meeting for the appointment of a replacement director according to the petition of other directors or interested parties. In the case that the general meeting cannot be called, the replacement director shall be appointed by the central competent authority. Regulations regarding appointment shall be determined by the central competent authority.
In the case that a medical care corporation director is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, and causes an inability to operate normally, the central competent authority may dismiss said director according to the petition of other directors or interested parties.
In the case that the resolution of board of directors of a medical care corporation is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, or causes an inability to operate normally, the central competent authority shall dismiss the board of directors and call for a general meeting in which to appoint new directors.
In the case that a medical care corporation director is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, and causes an inability to operate normally, the central competent authority may dismiss said director according to the petition of other directors or interested parties.
In the case that the resolution of board of directors of a medical care corporation is in violation of the law or bylaws, resulting in harm done to the juridical person, is harmful to the interests of the established institution, or causes an inability to operate normally, the central competent authority shall dismiss the board of directors and call for a general meeting in which to appoint new directors.
Article 53
Medical care corporations shall allot at least ten percent of the income to conduct research and development, professional training, and health education, medical relief, community medical care services, and other community services. Medical care corporations shall allot at least twenty percent of the income as the operation fund.
Article 54
Medical care corporations shall be dissolved under any of the following circumstances:
1. Occurrences calling for dissolution under the bylaw;
2. In the case that the established purpose can not be fulfilled;
3. Consolidation with other juridical persons in medical care;
4. Bankruptcy;
5. Revocation of license or order for dissolution by the central competent authority;
6. General resolution;
7. Lack of members.
Dissolution in accordance with Subparagraph1of the preceding Paragraph shall be reported to the central competent authority. Dissolution in accordance with Subparagraphs2 through7ofthe preceding Paragraph shall meet with the approval of the central competent authority.
1. Occurrences calling for dissolution under the bylaw;
2. In the case that the established purpose can not be fulfilled;
3. Consolidation with other juridical persons in medical care;
4. Bankruptcy;
5. Revocation of license or order for dissolution by the central competent authority;
6. General resolution;
7. Lack of members.
Dissolution in accordance with Subparagraph1of the preceding Paragraph shall be reported to the central competent authority. Dissolution in accordance with Subparagraphs2 through7ofthe preceding Paragraph shall meet with the approval of the central competent authority.
Article 55
The remaining assets shall be dispersed in accordance with provisions under the organization bylaw after the dissolution of the medical corporation, with exception of consolidations and bankruptcies.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Chapter V Advertisements for Medical Care
Article 84
Non-medical care institutions shall not make advertisements for medical care.
Article 85
The content of advertisements for medical care shall be restricted to the following:
1. The name, practice license number, address, and telephone number of, and directions to, the medical care institution;
2. The name, sex, academic background, professional experience, and physician or specialist physician certificate number of the physician;
3. Hospitals or clinics contracted or associated with the National Health Insurance or other non-commercial insurances;
4. Clinic practices and clinic hours;
5. The year, month, and date of the opening, suspension, close, resumption, or relocation of practice;
6. Other items approved and announced by the central competent authority for publication or broadcast.
Advertisements for medical care may orally present the content referred to in the preceding Paragraph through broadcast or television media with the approval of the respective municipal or county(city) competent authority.
Information provided by medical care institutions through the internet shall not be restricted by content limitations provided for in the preceding Paragraph, with exception to the conditions provided for in Paragraph 2 of Article 103. The regulations regarding management of advertisements for medical care on the internet shall be determined by the central competent authority.
1. The name, practice license number, address, and telephone number of, and directions to, the medical care institution;
2. The name, sex, academic background, professional experience, and physician or specialist physician certificate number of the physician;
3. Hospitals or clinics contracted or associated with the National Health Insurance or other non-commercial insurances;
4. Clinic practices and clinic hours;
5. The year, month, and date of the opening, suspension, close, resumption, or relocation of practice;
6. Other items approved and announced by the central competent authority for publication or broadcast.
Advertisements for medical care may orally present the content referred to in the preceding Paragraph through broadcast or television media with the approval of the respective municipal or county(city) competent authority.
Information provided by medical care institutions through the internet shall not be restricted by content limitations provided for in the preceding Paragraph, with exception to the conditions provided for in Paragraph 2 of Article 103. The regulations regarding management of advertisements for medical care on the internet shall be determined by the central competent authority.
Article 86
Advertisements for medical care shall not be made in any of the following manners:
1. To publicize by making use of the name of other person(s);
2. To publicize by sale or gift of medical publications;
3. To publicize by making known family trade secrets or by public question and response;
4. To publicize by making use of content contained in medical publications;
5. To publicize by means of releasing an interview or news report;
6. To publicize in association or side-by-side with advertisements in violation of the preceding Paragraph;
7. To publicize by any other improper means.
1. To publicize by making use of the name of other person(s);
2. To publicize by sale or gift of medical publications;
3. To publicize by making known family trade secrets or by public question and response;
4. To publicize by making use of content contained in medical publications;
5. To publicize by means of releasing an interview or news report;
6. To publicize in association or side-by-side with advertisements in violation of the preceding Paragraph;
7. To publicize by any other improper means.
Article 87
Advertisements containing content which implies or suggests medical practices shall be regarded as advertisements for medical care.
Publications of new medical knowledge or research results, health education for patients, or academic publications which do not involve solicitation for medical practices shall not be regarded as advertisements for medical care.
Publications of new medical knowledge or research results, health education for patients, or academic publications which do not involve solicitation for medical practices shall not be regarded as advertisements for medical care.
Chapter VI Distribution of Medical Manpower and Facilities
Article 88
For the purposes of promoting the balanced development of medical care resources, overall planning of existing public and private medical care institutions, and the reasonable distribution of manpower, the central competent authority shall divide medical regions, establish medical level system, and create a plan for medical care network.
The competent authority may provide incentives for the establishment of non-governmental medical care institutions and nursing homes in areas lacking medical care resources in accordance with the plan for medical care network referred to in the preceding Paragraph. When necessary, the government shall establish said medical care institutions.
The competent authority may provide incentives for the establishment of non-governmental medical care institutions and nursing homes in areas lacking medical care resources in accordance with the plan for medical care network referred to in the preceding Paragraph. When necessary, the government shall establish said medical care institutions.
Article 89
The division of medical regions shall take into account the medical care resources and distribution of population within the region, and may exceed the boundaries of municipalities or counties (cities).
Article 90
The municipal or county (city) competent authority shall examine the establishment or expansion of medical care institutions within the respective jurisdictions in accordance with the plan for medical care network established by the central competent authority. However, the establishment or expansion of large-scale hospitals of a certain scope shall be reported to the central competent authority for approval.
The competent authority shall restrict the establishment or expansion of medical care or nursing institutions in areas with surplus of medical facilities.
The competent authority shall restrict the establishment or expansion of medical care or nursing institutions in areas with surplus of medical facilities.
Article 91
For the purposes of promoting the development of the medical industry, improving the quality and efficiency of medical care, and balancing the distribution of medical care resources, the central competent authority shall adopt incentive measures.
The regulations regarding the items, methods, and other coordinative measures of the incentive measures referred to in the preceding Paragraph shall be determined by the central competent authority.
The regulations regarding the items, methods, and other coordinative measures of the incentive measures referred to in the preceding Paragraph shall be determined by the central competent authority.
Article 92
The central competent authority shall establish a medical development fund for the purpose of providing the incentives referred to in the preceding Article. The regulations regarding the revenues and expenditures, safekeeping, and use of the fund shall be determined by the Executive Yuan.
Article 93
When necessary, the central competent authority may review and assess the dangerous medical instruments that are to be purchased and used by medical care institutions.
Corporate or foundations for public interests purpose, within the scopes of purposes of their constitutions, in order to promote research and development plans to upgrade medical care techniques, and their capital investments exceed a certain level, may, upon permission of the central competent authority, in accordance with regulations of Article 30 and Article 31, establish corporate medical care institutions and purchase and use dangerous medical care instruments.
Regulations governing the review and assessment of the dangerous medical instruments referred to in Paragraph 1 shall be determined by the central competent authority.
Corporate or foundations for public interests purpose, within the scopes of purposes of their constitutions, in order to promote research and development plans to upgrade medical care techniques, and their capital investments exceed a certain level, may, upon permission of the central competent authority, in accordance with regulations of Article 30 and Article 31, establish corporate medical care institutions and purchase and use dangerous medical care instruments.
Regulations governing the review and assessment of the dangerous medical instruments referred to in Paragraph 1 shall be determined by the central competent authority.
Chapter VII Teaching Hospitals
Article 94
For the purpose of improving medical standards, hospitals may apply for accreditation to become teaching hospitals.
Article 95
The accreditation of teaching hospitals shall be regularly conducted by the central competent authority in conjunction with the central competent education authority.
The central competent authority shall notify in writing the teaching hospital which applied for accreditation of the accreditation result, and shall release a bulletin of the list of qualified teaching hospitals, terms of validity, and other particulars.
The central competent authority shall notify in writing the teaching hospital which applied for accreditation of the accreditation result, and shall release a bulletin of the list of qualified teaching hospitals, terms of validity, and other particulars.
Article 96
Teaching hospitals shall draft a training plan, to conduct the training and continuing education of physicians and other medical personnel, and shall accept students of medical universities and colleges for practical clinical training and internship.
The number of physicians, medical personnel, and students of medical universities and colleges referred to in the preceding Paragraph shall be in accordance with the approved training capacity.
The number of physicians, medical personnel, and students of medical universities and colleges referred to in the preceding Paragraph shall be in accordance with the approved training capacity.
Article 97
Teaching hospitals shall prepare an annual budget for research and development and professional training, which shall account for at least three percent (3%) of the total annual medical revenue of said teaching hospital..
Chapter VIII Medical Review Committee
Article 98
The central competent authority shall establish a medical review committee, which shall set up different working groups in accordance with the different missions, which are as follows:
1. Improvement of the medical care system;
2. Review of medical technologies;
3. Review of human trials;
4. Assessment commissioned by the judiciary or procuratorial authority;
5. Improvement of the specialist system;
6. Promotion of medical ethics;
7. Review of establishment or expansion of large hospitals exceeding a certain scale;
8. Review of other medical affairs.
The organization, meeting, and other regulations of the medical care committee referred to in the preceding Paragraph shall be established by the central competent authority.
1. Improvement of the medical care system;
2. Review of medical technologies;
3. Review of human trials;
4. Assessment commissioned by the judiciary or procuratorial authority;
5. Improvement of the specialist system;
6. Promotion of medical ethics;
7. Review of establishment or expansion of large hospitals exceeding a certain scale;
8. Review of other medical affairs.
The organization, meeting, and other regulations of the medical care committee referred to in the preceding Paragraph shall be established by the central competent authority.
Article 99
Municipal and county (city) competent authorities shall establish medical care committees, which shall fulfill the following missions:
1. Review of establishment or expansion of medical care institutions;
2. Review of medical fee standards;
3. Mediation of medical disputes;
4. Promotion of medical ethics;
5. Review of other medical affairs.
The organization, meeting, and other regulations of the medical review committee referred to in the preceding Paragraph shall be established by the municipal or county(city)competent authority.
1. Review of establishment or expansion of medical care institutions;
2. Review of medical fee standards;
3. Mediation of medical disputes;
4. Promotion of medical ethics;
5. Review of other medical affairs.
The organization, meeting, and other regulations of the medical review committee referred to in the preceding Paragraph shall be established by the municipal or county(city)competent authority.
Article 100
Members of the medical review committee referred to in the preceding two Articles shall include medical experts, legal experts, scholars, and social personages, excluding legislators/councilors and representatives of medical juridical persons, of which legal experts and social personages shall account for at least one-third of the number of members.
Chapter IX Penal Provisions
Article 101
Any person who violates any of the provisions of Paragraph 1 of Article 17, Paragraph 1 of Article 19, Article 20, Paragraph 1 of Article 22, Paragraph 1 of Article 23, Paragraph 1 of Article 24 or Paragraph 2 of Article 56, and does not cease the law-violating act within the given time limit after receiving a warning, shall be subject to a fine of no less than NT$10,000 but no more than NT$50,000.
The fine may be imposed consecutively for repeated violations.
The fine may be imposed consecutively for repeated violations.
Article 102
Persons under the following conditions shall be subject to a fine of no less than NT$10,000 but no more than NT$50,000 and given a time limit to cease the law-violating act; persons who do not comply shall be subject to a successive fine:
1. Violation of any of the provisionsofParagraph1ofArticle 25, Article 26, Paragraph1ofArticle 27, Article 59, Paragraphs1ofArticle 60, Article 65, Article 66, Paragraph1and 3 of Article 67, Article 68, Article 70, Article 71, Article 73, Article 74, Article 76, or Paragraph2 of Article 80.
2. Violation of the establishment standards determined by the central competent authority in accordance withParagraph3 of Article 12.
3. Violation of management regulations determined by the central competent authority in accordance with Article 13.
4. Violation of regulations determined by the central competent authority in accordance with Article 69.
Persons under the following conditions shall be subject to the fine referred to in the preceding Paragraph, and given a time limit to cease the law-violating act; persons who do not comply shall be subject to suspension of practice for no less than one month but no more than one year:
1. Violations of the provisionsofParagraph1ofArticle 25or Article 66.
2. Violation of the establishment standards determined by the central competent authority in accordance with Paragraph3 of Article 12.
3. Violation of management regulations determined by the central competent authority in accordance with Article 13.
4. Violation of regulations determined by the central competent authority in accordance with Article 69.
1. Violation of any of the provisionsofParagraph1ofArticle 25, Article 26, Paragraph1ofArticle 27, Article 59, Paragraphs1ofArticle 60, Article 65, Article 66, Paragraph1and 3 of Article 67, Article 68, Article 70, Article 71, Article 73, Article 74, Article 76, or Paragraph2 of Article 80.
2. Violation of the establishment standards determined by the central competent authority in accordance withParagraph3 of Article 12.
3. Violation of management regulations determined by the central competent authority in accordance with Article 13.
4. Violation of regulations determined by the central competent authority in accordance with Article 69.
Persons under the following conditions shall be subject to the fine referred to in the preceding Paragraph, and given a time limit to cease the law-violating act; persons who do not comply shall be subject to suspension of practice for no less than one month but no more than one year:
1. Violations of the provisionsofParagraph1ofArticle 25or Article 66.
2. Violation of the establishment standards determined by the central competent authority in accordance with Paragraph3 of Article 12.
3. Violation of management regulations determined by the central competent authority in accordance with Article 13.
4. Violation of regulations determined by the central competent authority in accordance with Article 69.
Article 103
Persons under any of the following conditions shall be subject to a fine of no less than NT$50,000 but no more than NT$250,000:
1. Violation of any of the provisions of Paragraph 1 of Article 15, Paragraph 2 of Article 17, Paragraph 2 of Article 22, Paragraphs 4 and 5 of Article 23, Paragraph 1 of Article 57, Article 61, Paragraph 1 of Article 63, Article 64, Article 72, Article 85, or Article 86, or those who alter approved advertisement content without authorization.
2. Violation of regulations determined by the central competent authority in accordance with Paragraph 2 of Article 62 or Paragraph 2 of Article 93.
3. Medical care institutions employing or keeping unqualified medical personnel other than physicians for execution of duties that should be carried out by specialized medical personnel.
Persons who violate any provisions of Article 85 or Article 86 or revise the content of the previously approved medical advertisements without authorization, and fall under any of the following conditions, shall be subject to suspension of practice for no less than one month but no more than one year or revocation of practice license, in addition to the penal provisions provided in the preceding paragraph, and the central competent authority shall revoke the physician certificate of the supervising physician for one year:
1. Content contains false, exaggerated, or distorted facts, or is indecent;
2. Promotes illegal abortion;
3. Has already been penalized three times within one year.
1. Violation of any of the provisions of Paragraph 1 of Article 15, Paragraph 2 of Article 17, Paragraph 2 of Article 22, Paragraphs 4 and 5 of Article 23, Paragraph 1 of Article 57, Article 61, Paragraph 1 of Article 63, Article 64, Article 72, Article 85, or Article 86, or those who alter approved advertisement content without authorization.
2. Violation of regulations determined by the central competent authority in accordance with Paragraph 2 of Article 62 or Paragraph 2 of Article 93.
3. Medical care institutions employing or keeping unqualified medical personnel other than physicians for execution of duties that should be carried out by specialized medical personnel.
Persons who violate any provisions of Article 85 or Article 86 or revise the content of the previously approved medical advertisements without authorization, and fall under any of the following conditions, shall be subject to suspension of practice for no less than one month but no more than one year or revocation of practice license, in addition to the penal provisions provided in the preceding paragraph, and the central competent authority shall revoke the physician certificate of the supervising physician for one year:
1. Content contains false, exaggerated, or distorted facts, or is indecent;
2. Promotes illegal abortion;
3. Has already been penalized three times within one year.
Article 104
Persons who violate Article 84to make medical advertisements shall be subject to a fine of no less than NT$50,000 but no more than NT$250,000.
Article 105
Persons who violate any of the provisions of Paragraph 1 or 2 of Article 78 herein by administering human research without the approval, entrustment or consent of the central competent authority, shall be subject to a fine of no less than NT$200,000 but no more than NT$1,000,000, and be ordered to suspend or terminate the human research by the central competent authority. Violations of a serious nature shall also be subject to suspension of practice for no less than one month but no more than one year or revocation of practice license.
Persons who violate any of the provisions of Paragraph 3 of Article 78 herein or any regulations about the review benchmark stipulated by the central competent authority in accordance with Article 79-1 shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and be ordered to discontinue the human research or the review set forth in Paragraph 3 of Article 78.
Persons who violate any of the provisions of Article 79, Article 79-2, Paragraph 1 of Article 80 herein or the regulations governing the supervision and management or review criteria set forth by the central competent authority pursuant to Article 79-1 herein shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and in addition, be ordered to discontinue the human research if the safety of the research or damage to the interests of the research subjects is a concern. Violations of a serious nature shall also be subject to cessation of practice for whole or part of relevant business or for departments and services that violate the provisions for no less than one month but no more than one year.
Persons who violate any of the provisions of Paragraph 4 of Article 78 herein shall be subject to a fine of no less than NT$50,000 but no more than NT$250,000 by the central competent authority, and in addition, be ordered to discontinue the human research. Violations of a serious nature shall also be ordered to terminate the human research.
Persons who violate any of the provisions of Paragraph 3 of Article 78 herein or any regulations about the review benchmark stipulated by the central competent authority in accordance with Article 79-1 shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and be ordered to discontinue the human research or the review set forth in Paragraph 3 of Article 78.
Persons who violate any of the provisions of Article 79, Article 79-2, Paragraph 1 of Article 80 herein or the regulations governing the supervision and management or review criteria set forth by the central competent authority pursuant to Article 79-1 herein shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and in addition, be ordered to discontinue the human research if the safety of the research or damage to the interests of the research subjects is a concern. Violations of a serious nature shall also be subject to cessation of practice for whole or part of relevant business or for departments and services that violate the provisions for no less than one month but no more than one year.
Persons who violate any of the provisions of Paragraph 4 of Article 78 herein shall be subject to a fine of no less than NT$50,000 but no more than NT$250,000 by the central competent authority, and in addition, be ordered to discontinue the human research. Violations of a serious nature shall also be ordered to terminate the human research.
Article 105-1
Persons who cause the disruption of a blood center’s or emergency responsibility hospital’s water supply, power supply, medical gas supply, electronic medical records system, or the operation of other facilities or equipment through theft, destruction, or other illegal means shall be subject to a term of imprisonment of no more than seven years or, in addition thereto, a fine of no more than NT$10,000,000.
Persons who commit any of the offenses described in the preceding paragraph with intent to threaten national security or societal stability shall be subject to a term of imprisonment of no less than three years and no more than ten years or, in addition thereto, a fine of no more than NT$50,000,000.
If during the commission of any of the offenses described in the preceding two paragraphs severe damage is incurred, the sentence shall be increased by 50%. If the offense results in one or more deaths, the violator shall be subject to life imprisonment or a term of imprisonment of no less than seven years or, in addition thereto, a fine of no more than NT$100,000,000. If the offense results in severe injury, the violator shall be subject to a term of imprisonment of no less than five years and no more than twelve years or, in addition thereto, a fine of no more than NT$80,000,000.
Any attempt to commit an offense described in Paragraphs 1 and 2 above shall be punishable by law.
Persons who commit any of the offenses described in the preceding paragraph with intent to threaten national security or societal stability shall be subject to a term of imprisonment of no less than three years and no more than ten years or, in addition thereto, a fine of no more than NT$50,000,000.
If during the commission of any of the offenses described in the preceding two paragraphs severe damage is incurred, the sentence shall be increased by 50%. If the offense results in one or more deaths, the violator shall be subject to life imprisonment or a term of imprisonment of no less than seven years or, in addition thereto, a fine of no more than NT$100,000,000. If the offense results in severe injury, the violator shall be subject to a term of imprisonment of no less than five years and no more than twelve years or, in addition thereto, a fine of no more than NT$80,000,000.
Any attempt to commit an offense described in Paragraphs 1 and 2 above shall be punishable by law.
Article 105-2
Persons who disrupt the operation of a major blood center’s or emergency responsibility hospital’s water, power, or medical gas supply system or electronic medical records system through any of the following means shall be subject to a term of imprisonment of no less than one year and no more than seven years or, in addition thereto, a fine of no more than NT$10,000,000:
1. Gaining access to a major blood center’s or designated first-aid hospital’s computer system or related equipment by entering the password of another person’s computer account, compromising the protective measures for using the computer system, or exploiting loopholes in the system without just cause
2. Employing a computer program or other electromagnetic means to interfere with the computer system or related equipment of a major blood center or designated first-aid hospital without just cause
3. Obtaining, deleting, or altering the magnetic record of a major blood center or designated first-aid hospital’s computer system or related equipment without just cause
The same legal sanctions shall apply to persons who produce or induce others to produce a computer program for the purpose of committing any of the offenses described in the preceding paragraph.
Persons who commit any of the offenses described in the preceding two paragraphs with intent to threaten national security or societal stability shall be subject to a term of imprisonment of no less than three years and no more than ten years or, in addition thereto, a fine of no more than NT$50,000,000.
If during the commission of any of the offenses described in the preceding three paragraphs severe damage is incurred, the sentence shall be increased by half. If the offense results in one or more deaths, the violator shall be subject to life imprisonment or a term of imprisonment of no less than seven years or, in addition thereto, a fine of no more than NT$100,000,000. If the offense results in severe injury, the violator shall be subject to a term of imprisonment of no less than five years and no more than twelve years or, in addition thereto, a fine of no more than NT$80,000,000.
Any attempt to commit an offense described in Paragraphs 1 through 3 above shall be punishable by law.
The designation of the major blood centers and emergency responsibility hospitals described in Paragraph 1 of this article and the preceding article shall be determined and announced by the central competent authority.
1. Gaining access to a major blood center’s or designated first-aid hospital’s computer system or related equipment by entering the password of another person’s computer account, compromising the protective measures for using the computer system, or exploiting loopholes in the system without just cause
2. Employing a computer program or other electromagnetic means to interfere with the computer system or related equipment of a major blood center or designated first-aid hospital without just cause
3. Obtaining, deleting, or altering the magnetic record of a major blood center or designated first-aid hospital’s computer system or related equipment without just cause
The same legal sanctions shall apply to persons who produce or induce others to produce a computer program for the purpose of committing any of the offenses described in the preceding paragraph.
Persons who commit any of the offenses described in the preceding two paragraphs with intent to threaten national security or societal stability shall be subject to a term of imprisonment of no less than three years and no more than ten years or, in addition thereto, a fine of no more than NT$50,000,000.
If during the commission of any of the offenses described in the preceding three paragraphs severe damage is incurred, the sentence shall be increased by half. If the offense results in one or more deaths, the violator shall be subject to life imprisonment or a term of imprisonment of no less than seven years or, in addition thereto, a fine of no more than NT$100,000,000. If the offense results in severe injury, the violator shall be subject to a term of imprisonment of no less than five years and no more than twelve years or, in addition thereto, a fine of no more than NT$80,000,000.
Any attempt to commit an offense described in Paragraphs 1 through 3 above shall be punishable by law.
The designation of the major blood centers and emergency responsibility hospitals described in Paragraph 1 of this article and the preceding article shall be determined and announced by the central competent authority.
Article 106
Persons who violate the provisions of Paragraph 2 of Article 24 shall be subject to a fine between NT$30,000 and NT$50,000. Violations that involve criminal liabilities shall be referred to the juridical authority.
Persons who damage the life saving equipment in medical care institutions or other similar places and consequently endanger the life, body or health of others are subject to imprisonment for no more than three years, detention or a fine of no more than NT$300,000.
Persons who hinder medical personnel or emergency medical services personnel from carrying out medical practices or emergency medical services by means of violence, coercion, intimidation or other illegal methods are subject to imprisonment for no more than three years, or in addition thereto, a fine of no more than NT$300,000.
Those who commit the offense set forth in the preceding paragraph are subject to imprisonment for life or no less than seven years if their offense causes the death of medical personnel or emergency medical services personnel, and imprisonment for no less than three years but no more than ten years if their offense causes serious injury to medical personnel or emergency medical services personnel.
Persons who damage the life saving equipment in medical care institutions or other similar places and consequently endanger the life, body or health of others are subject to imprisonment for no more than three years, detention or a fine of no more than NT$300,000.
Persons who hinder medical personnel or emergency medical services personnel from carrying out medical practices or emergency medical services by means of violence, coercion, intimidation or other illegal methods are subject to imprisonment for no more than three years, or in addition thereto, a fine of no more than NT$300,000.
Those who commit the offense set forth in the preceding paragraph are subject to imprisonment for life or no less than seven years if their offense causes the death of medical personnel or emergency medical services personnel, and imprisonment for no less than three years but no more than ten years if their offense causes serious injury to medical personnel or emergency medical services personnel.
Article 107
Those who violate any of the provisionsofParagraph2 of Article 61, Paragraph2 of Article 62, Paragraph1ofArticle 63, Paragraph1ofArticle 64, Article 68, Article 72, Article 78, Article 79, or Paragraph 2 of Article 93 shall be penalized in accordance with the provisions of Article 102, Article 103, or Article 105. In addition, the offender shall also be penalized by said Articles. Persons whose violations involve criminal liability shall be transferred to the juridical authority for disposal.
In the event that the offender is a medical person, he/she shall be penalized in accordance with the respective specialty medical profession laws.
In the event that the offender is a medical person, he/she shall be penalized in accordance with the respective specialty medical profession laws.
Article 108
Medical care institutions which fall under the following conditions shall be subject to a fine of no less than NT$50,000 but no more than NT$500,000. In addition, the of ending clinic departments or service items, or all or part of the clinic departments and hospitalization practices shall be subject to suspension of practice for no less than one month but no more than one year, or revocation of practice license, in accordance with the seriousness of the violation:
1. Obvious negligence of medical practice management, resulting in injury or death to the patient;
2. Knowingly documents medical records or produces diagnosis, birth certificate, death certificate or still born certificate which are inconsistent with the facts;
3. Conduct medical practices forbidden by central competent authority regulations;
4. Use of drugs forbidden by central competent authority regulations;
5. Permits persons who violate Article 28 of the Physician‘s Act to conduct medical practices;
6. Conduct improper practices, including those which are indecent or harmful to human health;
7. Verification upon examination of collection of excess medical fees, or collecting fees for items created without authorization, and failure to return the excess amount to patients within the given time limit.
1. Obvious negligence of medical practice management, resulting in injury or death to the patient;
2. Knowingly documents medical records or produces diagnosis, birth certificate, death certificate or still born certificate which are inconsistent with the facts;
3. Conduct medical practices forbidden by central competent authority regulations;
4. Use of drugs forbidden by central competent authority regulations;
5. Permits persons who violate Article 28 of the Physician‘s Act to conduct medical practices;
6. Conduct improper practices, including those which are indecent or harmful to human health;
7. Verification upon examination of collection of excess medical fees, or collecting fees for items created without authorization, and failure to return the excess amount to patients within the given time limit.
Article 109
Medical care institutions which continue to operate after being imposed with suspension of practice shall have their practice license revoked.
Article 110
The supervising physician of medical care institutions imposed with revocation of practice license shall not apply to establish any medical care institution at the original or other locations for one year.
Article 111
The supervising physician of medical care institutions which continue to operate after being imposed with revocation of practice license shall have his/her physician revoked for two years by the central competent authority.
Article 112
Juridical persons in medical care who violate the provisions of Paragraph 5 of Article 34 or Paragraph1ofArticle 37 to become guarantors, shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority, and shall be given a time limit in which to make amendments. Those who fail to make amendments within the given time limit shall be fined successively. The offender shall be responsible for the guarantee.
The chairperson of juridical persons in medical care who violate the provisions Of Paragraph 2 of Article 37 shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority. In addition, in the case that violation by juridical persons in medical care result in damage or injury, the offender shall be responsible for compensation.
The chairperson of juridical persons in medical care who violate the provisions Of Paragraph 2 of Article 37 shall be subject to a fine of no less than NT$100,000 but no more than NT$500,000 by the central competent authority. In addition, in the case that violation by juridical persons in medical care result in damage or injury, the offender shall be responsible for compensation.
Article 113
Juridical persons in medical care which violate any of the provisions of Paragraph 2 of Article 34, Paragraph1ofArticle 35, or Article 40 shall be subject to a fine of no less than NT$10,000 but no more than NT$100,000 by the central competent authority, and given a time limit within which to make amendments. Those who fail to make amendments within the given time limit shall be fined successively.
In the case that juridical persons in medical care fail to register any of the stipulated particulars, the person responsible for registration shall be subject to a fine of no less than NT$10,000 but no more than NT$100,000 by the central competent authority, and shall be given a time limit within which to make corrections. Persons who fail to make corrections within the given time limit shall be fined successively.
In the case that there is more than one person responsible for registration in the situation referred to in the preceding Paragraph, all persons responsible for registration shall be jointly liable.
In the case that juridical persons in medical care fail to register any of the stipulated particulars, the person responsible for registration shall be subject to a fine of no less than NT$10,000 but no more than NT$100,000 by the central competent authority, and shall be given a time limit within which to make corrections. Persons who fail to make corrections within the given time limit shall be fined successively.
In the case that there is more than one person responsible for registration in the situation referred to in the preceding Paragraph, all persons responsible for registration shall be jointly liable.
Article 114
Directors or supervisors who fail to report in violation of Paragraph 4 of Article 49 shall be subject to a fine of no less than NT$50,000 but no more than NT$200,000 by the central competent authority.
In the case that juridical persons in medical care fail to establish medical care institution in accordance with the respective establishment plan, the central competent authority shall order the juridical person in medical care to make amendments within a given time limit. Those who fail to comply within the given time limit shall be subject to revocation of permit. This provision shall apply mutatis mutandis to juridical persons in medical care who revise their establishment plan.
In the case that juridical persons in medical care fail to establish medical care institution in accordance with the respective establishment plan, the central competent authority shall order the juridical person in medical care to make amendments within a given time limit. Those who fail to comply within the given time limit shall be subject to revocation of permit. This provision shall apply mutatis mutandis to juridical persons in medical care who revise their establishment plan.
Article 115
The supervising physician shall be subject to the fines specified in this Act when applied to private medical care institutions.
The medical corporate body shall be subject to the fines specified in this Act when applied to medical care institutions set up by a medical corporate body.
Regarding the first part of Paragraph 1 above, if the offender subject to punishment as laid down in Article 107 is the supervising physician, no additional punishment shall be given.
The medical corporate body shall be subject to the fines specified in this Act when applied to medical care institutions set up by a medical corporate body.
Regarding the first part of Paragraph 1 above, if the offender subject to punishment as laid down in Article 107 is the supervising physician, no additional punishment shall be given.
Article 116
Unless otherwise provided for in the Act, the fines, suspension of practice, and revocation of practice license specified in the Act shall be imposed by the municipal or county (city) competent health authority.
Article 117
Any person who fails to pay the fine imposed upon him/her under the Act within the time limit set in a notice given to him/her shall be turned over to the court for compulsory execution.
Chapter X Supplementary Provisions
Article 118
The establishment and management of subsidiary medical care institutions of military authority and other non-governmental subsidiary care institutions shall be governed by the provisions of the Act. However, the management of subsidiary medical care institutions which are involved in matters of national security shall be governed in accordance with the provisions established by the Ministry of National Defense.
Article 119
Medical care institutions established prior to the coming into effect of the amendment of the Act, which do not conform to the provisions provided under the Act, shall make the corrections within one year of the coming into effect of the amendment of the Act. Those which do not make the corrections within the given time period shall have their permits revoked by the original issuing authority. However, those with special circumstances and cannot make the corrections within one year may apply for an extension with the approval of the central competent authority.
Article 120
Bone setting technician licenses issued by the competent authority prior to the implementation of the Act shall continue to be valid, the regulations regarding the management of which shall be determined by the central competent authority.
Article 121
The central competent authority shall collect accreditation fee for the accreditation of hospitals. The municipal or county (city) competent authority shall collect license fee for the issuance of licenses in accordance with the Act.
The amount of accreditation fee and license fee referred to in the preceding Paragraph shall be determined by the central competent authority.
The amount of accreditation fee and license fee referred to in the preceding Paragraph shall be determined by the central competent authority.
Article 122
The Enforcement Rules of the Act shall be established by the central competent authority.
Article 123
The Act shall become effective on the date of promulgation.