Undoubtedly, the innovation of medical personnel is the main source of new medical technology, medical personnel to create a variety of new procedures, new diagnostic and treatment methods, to improve the quality of medical care, to protect the patient's safety, and to reduce the risk of medical care are greatly beneficial. However, the legal risks involved should not be underestimated. Mainly embodied in:
1, the new technology caused by the long-term effect of time to test
Like any knowledge, technology, medical technology is the objective thing of knowledge and transformation of the "stage" results, is the truth of the relative cognition. Whether a new treatment is effective, especially in the long term, needs time to test, only theoretical basis or short-term observation often may have hidden dangers and risks, even including the Nobel Prize winners of the discovery or invention is also so. A typical example is the 1949 laureate A.E. Moniz, whose treatment of psychosis with frontal white matter amputation was considered at the time to be the most important discovery and contribution. However, several years later, this treatment developed serious complications. Therefore, it will take practice and time to determine whether our current new techniques have good long-term results for patients.
2, the promotion of new technologies needs a process
Technology is to be recognized and mastered by people, no matter how advanced and superb the technology, but the understanding of the bias, mastery of the improper, still can not reflect its advanced and superb, and even to the opposite. However, the promotion and mastery of any technology has its own process, especially China's large population, the number of medical personnel is also very large, the level of development of various medical institutions around the world varies, the learning ability of medical personnel and acceptance also varies from person to person, therefore, the promotion of new technologies in the process of the hidden risks and pitfalls should have a sobering understanding of.
(II) Damage to medical products
New medical products are an important source of new medical technologies, especially with the rapid development of related disciplines, such as biology, genetics, the Internet, and electronic technology, which have made great contributions to new medical technologies. Therefore, analyzing the legal risks of new medical technologies involved in new medical products should be an important part of the study of the legal risks of medical damages.
1, fully aware of the limitations of the new medical products
New products brought by the new technology, "new" word is good, fear that it is difficult to perfect. For example, a variety of endoscopes, well-crafted, multi-functional, it is the extension of the surgeon's arm, but has its own inherent defects, endoscopy, after all, not as flexible as our bare hands; it is the extension of the surgeon's vision, but there are limitations, after all, there is a blind spot rather than the "three-dimensional" even if it is the "da Vinci system" of robotics is not as good as a surgeon. Even the "da Vinci system" robot is not as good as the surgeon's field operation. Another example of telemedicine, although the terminal can be closer to the distance between the doctor and the patient, but after all, not face-to-face, only through observation and verbal communication, the traditional "palpation", "percussion" and other information can not be accessed in its entirety, therefore, it may lead to misdiagnosis and underdiagnosis! The legal risk is that it is embedded.
2, the new technology should be combined with traditional technology, its role in the objective evaluation
New technology often need to be combined with traditional technology in order to form a complete diagnosis and treatment process, do not blindly rely on the new technology, otherwise it is easy to lead to the occurrence of risks. For example, the HPVDNA hybridization capture (hC2) test introduced in recent years is important for cervical cancer screening and diagnosis and treatment of cervical intraepithelial neoplasia, and due to its high degree of automation and standardization, it has a high negative predictive value (NPV), which means that hC2 (-) can be considered to be free of HPV infection. However, even if HPV is positive, it can only prove that there is HPV infection, but also depends on the cytology and histology results, can not be diagnosed and treated with HPV results.
(C) medical ethical damage
The use of new technologies, on the one hand, is to correctly recognize the limitations of the technology itself legal risks, in addition, the new technology brought about by the medical ethical issues, should also be concerned.
1, the protection of patients' personality rights in clinical trials
Any new technology, before it is widely promoted in the clinic, it is necessary to carry out well-designed and operated clinical trials. In the process of clinical trials, full respect, protection of the subject's personality rights, to participate in the trial is a person, must respect his or her personality, to participate in the trial must be consistent with the interests of those who participate in the trial, under this premise, the trial can be done. Moreover, during the trial, the participant may not continue the trial without any reason, and his (or her) choice is one in which no one, including the doctor, has the right to interfere. These are the basic requirements of medical ethics.
All kinds of clinical trials at home and abroad have strict legal regulations, such as the Code for Quality Management of Drug Clinical Trials issued by China's State Food and Drug Administration. Any behavior that violates the personality of the subjects, or violates medical ethics, will be regarded as illegal, and will be subject to the corresponding legal responsibility.
2, the ethical issues involved in the application of new technologies
New technologies in addition to the ethical issues involved in the phase of clinical trials, there are ethical risks in the phase of clinical application, as well as the legal risks arising from it, such as organ transplantation, organ donation and transplantation involves the corresponding ethical issues in China's Human Organ Transplantation Regulations, requires that. medical institutions engaged in human organ transplantation, there should be a clinical application of human organ transplantation technology and ethics committee composed of experts in medicine, jurisprudence, ethics, etc., and the medical experts engaged in human organ transplantation in this committee shall not exceed 1/4 of the number of members.
(D) Medical Management Damage
There is still a certain amount of The controversy. However, the author believes that the act of diagnosis and treatment is not only the independent behavior of individual medical personnel or several people, but also closely related to the management system of the medical institution, including the process of setting up, personnel arrangements, facilities, emergency measures, etc. Therefore, the management of the medical institution should be an independent factor leading to medical damage.
In the process of applying new technologies, there is a greater need for scientific and perfect management procedures and high-quality management personnel in order to fully utilize and deploy the resources of medical institutions, improve management efficiency and ensure medical safety. Such as mobile medical care, which involves the relationship between clinical departments, equipment departments, testing departments, pharmacies, etc. within the medical institutions, but also involves the relationship between the medical institutions and mobile medical equipment providers, but also involves the coordination between the medical institutions and the administrative supervision department or other medical institutions, any one link of the failure, the legal risks arising from it may be more serious than the traditional medical behavior, more difficult to deal with
In the application of new technology, there is a greater need for scientific and perfect management procedures and quality management personnel to fully utilize and deploy the resources of medical institutions to improve management efficiency and ensure medical safety. p>