Chapter 4 Medical Accident Prevention
Article 33
Hospitals shall establish the patient safety management system and the promotion plan to encourage their internal staff members to report patient safety events, and shall also analyze, prevent, and control medical accident risks to increase medical quality and ensure patient safety.
Medical care institutions shall maintain the confidentiality of the identity of the reporter of patient safety events and may not take action to punish or retaliate against the reporter, such as terminating their employment or declining to renew their contract.
The report, analysis, and other relevant prevention and control measures concerning patient safety events described in Paragraph 1 may neither be used as evidence or as the basis for associated litigation or relevant administrative sanctions.
For hospitals conducting patient safety management systems and promotion plans with outstanding results pursuant to Paragraph 1, competent authorities may reward them.
Article 34
For major medical accidents, medical care institutions shall analyze the fundamental causes, propose improvement plans, and report to competent authorities.
What qualifies as a major medical accident subject to reporting requirements in the preceding paragraph, reporting procedures, reporting content, and other matters to be followed are determined by the central competent authority.
The major medical accident reports, the analysis of fundamental causes, and the improvement plans described in Paragraph 1 may not be used as evidence or as the basis for associated litigation or relevant administrative sanctions.
Article 35
In the event of a medical accident at a medical institution and the occurrence of one of the following conditions, the task force shall established, by the competent central authority themselves or by commission a foundation established by government funding, to conduct an investigation, to make a report, and to release the report :
1. During a certain period, medical accidents repeatedly occur or are expected to occur.
2. Medical accidents occur or are expected to occur across medical institutions or across municipalities or counties (cities).
3. Public health and safety is endangered or at risk.
4. Other situations identified by the competent central authority.
To conduct the investigation described in the preceding paragraph, related personnel of medical accident may be asked to be explain and provide information. Medical institutions, juridical entities, groups, and relevant personnel under investigation may not evade, obstruct, or refuse to participate in an investigation.
The content of the investigation report in Paragraph 1 is for the purpose of discovering the truth and discerning facts, not for attributing individual responsibility. It shall not be used as the only basis for conviction.
The organization, operation, investigatory procedure, and report of the task force convened under Paragraph 1 and other matters to follow are determined by the competent central authority.
Article 36
The competent central authority shall establish or commission a foundation, established by government funding, to establish an autonomous medical accident reporting system to receive reports by the public. The reporter’s identity and the source of information shall be kept confidential.
The reporting conditions, methods, procedures, content, handling, and other related matters shall be established by the competent central authority.
Article 37
When individuals involved in a medical accident implicated in an acted in violation of administrative or criminal responsibilities prescribe by law, whether they actively reported the case and whether they proactively cooperated in the investigation or provided information shall be considered in determining penalties or sentencing.