智慧医疗的伦理和法律问题及其应对策略

人工智能于医疗领域的广泛应用在造福人类的同时，也不可避免地产生一些伦理和法律问题。智慧医疗对医生的主体性地位带来挑战；解构传统的医患关系；对社会的公平、正义带来挑战；算法歧视带来安全性挑战；对患者的隐私权带来挑战；智慧医疗还会带来医疗损害的责任承担问题。为了推动智慧医疗的健康发展，应该从以下几个方面做出努力：坚持以人为本的原则；确保医生的主体地位，注重对患者的人文关怀；加大对智慧医疗领域的投入，解决公平受益问题；采取有效措施解决算法歧视；加强医疗大数据管理，保护患者隐私；明确智慧医疗损害的责任认定。     

医疗技术发展的伦理监督和法律调控——兼对《医疗技术临床应用管理办法》的解读

医疗技术的违规使用问题日趋严重,对医疗技术的发展进行监管有其必要性;通过医疗技术发展实现目的·陛与规律性的统一、动机与效果的统一,达到技术发展与社会的协调。主张对医疗技术的发展、使用、推广进行监管：对医疗技术的发展进行伦理监督和法律监管;对医疗技术及其使用主体即医生、医疗机构实行准入制度。     

人工智能技术对医生工作量的影响研究

目的 基于2012—2021年我国31个省份的面板数据,分析人工智能技术发展水平对医生工作量的影响。方法 采用MATLAB R2022b软件对医生工作量进行Kernel核密度估计,分析10年来医生工作量的变化情况;选择固定效应模型,借助Stata MP 17.0软件对人工智能技术和医生工作量进行面板回归分析。结果 当前,我国医生工作量存在严重的区域多级分化现象;人工智能辅助诊断、治疗和管理等技术均明显降低了医生工作量,但人工智能技术的负向影响存在区域性差异,在东部地区影响最明显,而在西部地区影响不明显;老龄化程度和个人健康投资均负向调节了人工智能辅助诊断技术与医生工作量的关系。结论 人工智能尤其是人工智能辅助诊断技术对降低医生工作量具有重要作用,能够缓解我国老龄化背景下医疗资源不足以及分配不均等问题带来的压力,应给予高度重视。     

医疗人工智能技术评估与监管的国际经验及启示

人工智能技术在生物技术、医学影像识别、药物研发、辅助诊断等领域发挥了重要作用。介绍了国际上关于医疗人工智能技术的评估与监管框架，包括英国的《数字卫生技术的证据标准框架》、美国的医疗器械独立软件预认证试点项目、欧盟的《可信赖人工智能道德准则》等，指出有效性与安全性是医疗人工智能技术评估与监管的前提，需制订符合我国国情的医疗人工智能设备分类标准，注重医疗人工智能产品的持续监管与风险控制。     

公立医院临床医生对医疗监管认知的调查与分析

目的了解临床医生对公立医院医疗监管的认知情况。方法对新疆医科大学附属医院202名在职临床医生随机进行问卷调查,采用卡方检验处理数据。结果不同年龄的临床医生对完善医院监管体制是否有助于加强医师职业管理、提高专业技术能力的看法有差异(P<0.05);不同年龄、职称、工龄的医生对医院监管制度的认识、对现有监管制度是否得到严格执行的认识和对管理人员的监管意识认识没有差别(P>0.05);不同年龄、职称、工龄的医生对于普通员工监管意识的认识有差别(P<0.05);对于医院医疗监管存在的问题及原因,大部分医生认识比较清楚,存在的问题符合社会普遍现象。结论建立完善的医院医疗监管机制,积极探索科学的、系统的监管模式,内部监管与外部监管相结合。     

医疗健康人工智能应用评估研讨会在京召开

正2018年9月6日,国家卫生计生委统计信息中心在北京组织召开了医疗健康人工智能应用评估研讨会。医院信息化、科研院所及高校专家30余人参加了会议。会议指出,目前人工智能已经逐步应用于包括院前、院中和院后在内的医疗全过程,伴随着医疗人工智能产业的发展,医疗风险、隐私安全和医学伦理等问题也引起了社会的广泛关注。信息技术部门应尽可能全面地把握医疗人工智能     

人工智能在医疗领域的应用与存在的问题

在概述人工智能相关概念的基础上,介绍了人工智能(简称AI)在医疗领域的主要应用,包括AI虚拟助理、智能辅助诊疗、智能医学影像、医疗机器人、智能健康管理、智能药物研发等,分析了人工智能应用于我国医疗领域面临的数据利用、算法"黑箱"、标准缺乏、人才短缺、法律伦理等方面的问题。     

急诊医疗中的伦理问题及对策

目的 探讨急诊医疗中的伦理问题及解决策略.方法 总结其他医院急诊科室的问题和经验,并融合华山医院急诊的特点,以及根据华山医院急诊接诊医生小范围调查结果和深入访谈所反映的问题进行分析和提出相应对策.结果 急诊科是抢救急危重病人的第一线,急诊科因其特殊性,会产生与其他科室所不同的伦理问题,要重视急诊医疗的特点,重视急诊医疗中的伦理问题及产生的背景原因,采取相应的对策,以进一步完善急诊医疗工作.结论 要完善急诊医疗中相应的政策和急诊流程问题;重视病人权益,加强医患沟通,保障病人返家后的安全;同时也要减轻急诊医生工作压力,加强急诊医生可持续性培训及团队合作精神.     

“健康中国”战略下医疗人工智能诊断产品技术风险及主体责任探讨

目的为精准高效监管医疗人工智能产业提供参考。方法通过总结医疗人工智能诊断产品主体责任困境,梳理国内外相关研究,构建医疗人工智能诊断产品主体责任体系。结果构建以医疗人工智能上市许可持有人为“第一责任人”的主体责任体系,提出算法透明和可解释,分类分级监管模式、社会共治监管模式三大保障措施。结论医疗人工智能诊断产品主体责任体系有助于落实主体责任,打造“负责任的、有益的”人工智能,实现“自律”“善治”“有序”。     

落实医疗卫生机构伦理审查主体责任

<正>近日,中共中央办公厅、国务院办公厅印发了《关于加强科技伦理治理的意见》,要求明确科技伦理原则、健全科技伦理治理体制、加强科技伦理治理制度保障、强化科技伦理审查和监管并深入开展科技伦理教育和宣传。《意见》提到,“十四五”期间,重点加强生命科学、医学、人工智能等领域的科技伦理立法研究。科技伦理是开展科学研究、技术开发等科技活动需要遵循的价值理念和行为规范,     

The role of attorneys on Hospital Ethics Committees: potential influence on committee decisionmaking

Conclusion The most important issue remains: Whether attorneys should serve on HECs? Will they tend to inhibit the development of other discussions, ethical discussions, regarding the issues brought before the HEC? D. Niemira (17, p. 982) suggests that what a hospital needs is not necessarily an attorney to help in their ethical deliberations, but an ethicist. This suggestion should receive further analysis. What types of ethical deliberations to which attorneys have not been exposed in their legal training are important given the broader attorney-role (beyond giving legal opinion) in HEC discussions?The pro-active attorney faces many challenges, both in the current setting (as cases are brought to the HEC) and as future questions are raised (due to innovations in medical technology). These questions remain unclarified by the courts. The nature of the attorney's role is ever challenging; he or she remains in a key position that is currently needed (regarding the uncharted areas of HEC decisionmaking) and important for the future (as new cases emerge and require extensive deliberations).     

Position of the American Dietetic Association: Ethical and Legal Issues in Nutrition, Hydration, and Feeding

It is the position of the American Dietetic Association that individuals have the right to request or refuse nutrition and hydration as medical treatment. Registered dietitians (RDs) should work collaboratively to make recommendations on providing, withdrawing, or withholding nutrition and hydration in individual cases and serve as active members of institutional ethics committees. RDs have an active role in determining the nutrition and hydration requirements for individuals throughout the lifespan. When patients choose to forgo any type of nutrition and hydration (natural or artificial) or when patients lack decision-making capacity and others must decide whether or not to provide artificial nutrition and hydration, the RD has an active and responsible professional role in the ethical deliberation around that decision. Across the lifespan, there are multiple instances when providing, withdrawing, or withholding nutrition and hydration creates ethical dilemmas. There is strong clinical, ethical, and legal support both for and against administration of food and water when issues arise regarding what is or is not wanted by the patient and what is or is not warranted by empirical clinical evidence. When a conflict arises, the decision to administer or withhold nutrition and hydration requires ethical deliberation. The RD's understanding of nutrition and hydration within the context of nutritional requirements and cultural, social, psychological, and spiritual needs provides an essential basis for ethical deliberation on issues of nutrition and hydration. The RD, as a member of the health care team, has a responsibility to promote use of advanced directives and to identify the nutritional and hydration needs of each individual patient. The RD promotes the rights of the individual patient and helps the health care team implement appropriate therapy.     

Paradigm shift, metamorphosis of medical ethics, and the rise of bioethics

Both the increasing incorporation of medical technology and new social demands (including those for health care) beginning in the 1960s have brought about significant changes in medical practice. This situation has in turn sparked a growth in the philosophical debate over problems pertaining to ethical practice. These issues no longer find answers in the Hippocratic ethical model. The authors believe that the crisis in Hippocratic ethics could be described as a period of paradigm shift in which a new set of values appears to be emerging. Beginning with the bioethics movement, the authors expound on the different ethical theories applied to medical practice and conclude that principlism is the most appropriate approach for solving the new moral dilemma imposed on clinical practice.     

Position of the American Dietetic Association: ethical and legal issues in nutrition,hydration, and feeding

It is the position of the American Dietetic Association that the development of clinical and ethical criteria for the nutrition and hydration of persons through the life span should be established by members of the health care team. Registered dietitians should work collaboratively to make nutrition, hydration, and feeding recommendations in individual cases. Registered dietitians have an active role in determining the nutrition and hydration requirements for individuals throughout the life span. When patients choose to forgo artificial nutrition and hydration, or when patients lack decision-making capacity, and others must decide whether or not to provide artificial nutrition and hydration, the registered dietitian has an active and responsible professional role in the ethical deliberation around that decision. There is strong clinical, ethical, and legal support both for and against the administration of food and water when issues arise regarding what is or is not wanted by the patient and what is or is not warranted by empirical clinical evidence. When a conflict arises, the decision to administer or withhold nutrition and hydration requires ethical deliberation. The registered dietitian's understanding of nutrition and hydration within the context of nutritional requirements and cultural, social, psychological, and spiritual needs provides an essential basis for ethical deliberation on issues of nutrition and hydration.     

Position of the Academy of Nutrition and Dietetics: Ethical and Legal Issues in Feeding and Hydration

It is the position of the Academy of Nutrition and Dietetics that individuals have the right to request or refuse nutrition and hydration as medical treatment. Registered dietitians (RDs) should work collaboratively as part of the interprofessional team to make recommendations on providing, withdrawing, or withholding nutrition and hydration in individual cases and serve as active members of institutional ethics committees. RDs have an active role in determining the nutrition and hydration requirements for individuals throughout the life span. When individuals choose to forgo any type of nutrition and hydration (natural or artificial), or when individuals lack decision-making capacity and others must decide whether or not to provide artificial nutrition and hydration, RDs have a professional role in the ethical deliberation around those decisions. Across the life span, there are multiple instances when nutrition and hydration issues create ethical dilemmas. There is strong clinical, ethical, and legal support both for and against the administration of food and water when issues arise regarding what is or is not wanted by the individual and what is or is not warranted by empirical clinical evidence. When a conflict arises, the decision requires ethical deliberation. RDs' understanding of nutrition and hydration within the context of nutritional requirements and cultural, social, psychological, and spiritual needs provide an essential basis for ethical deliberation. RDs, as health care team members, have the responsibility to promote use of advanced directives. RDs promote the rights of the individual and help the health care team implement appropriate therapy. This paper supports the “Practice Paper of the Academy of Nutrition and Dietetics: Ethical and Legal Issues of Feeding and Hydration” published on the Academy website at: www.eatright.org/positions.     

人工智能在医学领域应用浅析

医疗与人工智能相结合,是医学发展的重要方向。作者综述了人工智能在诊断、治疗、预防、科研、教学等医学领域的应用情况,分析了人工智能发展面临的问题和挑战,对人工智能的应用前景进行了展望。     

人工智能技术应用于电子病历质控的研究与思考

针对电子病历质控存在的问题，阐述了机器学习、自然语言处理（NLP）、图像识别、专家系统等人工智能核心技术。论述了质控专家与人工智能质控的关系、人工智能质控目标、人工智能质控隐私保护等问题，以期为提高电子病历质控水平提供参考。     

Practice Paper of the Academy of Nutrition and Dietetics Abstract: Ethical and Legal Issues of Feeding and Hydration

It is the position of the Academy of Nutrition and Dietetics that individuals have the right to request or refuse nutrition and hydration as medical treatment. Registered dietitians should work collaboratively as part of an interprofessional team to make recommendations on providing, withdrawing, or withholding nutrition and hydration in individual cases and serve as active members of institutional ethics committees. This practice paper provides a proactive, integrated, systematic process to implement the Academy's position. The position and practice papers should be used together to address the history and supporting information of ethical and legal issues of feeding and hydration identified by the Academy. Elements of collaborative ethical deliberation are provided for pediatrics and adults and in different conditions. The process of ethical deliberation is presented with the roles and responsibilities of the registered dietitian and the dietetic technician, registered. Understanding the importance and applying concepts dealing with cultural values and religious diversity is necessary to integrate clinical ethics into nutrition care. Incorporating screening for quality-of-life goals is essential before implementing the Nutrition Care Process and improving health literacy with individual interactions. Developing institution-specific policies and procedures is necessary to accelerate the practice change with artificial nutrition, clinical ethics, and quality improvement projects to determine best practice. This paper supports the “Position of the Academy of Nutrition and Dietetics: Ethical and Legal Issues of Feeding and Hydration” published in the June 2013 issue of the Journal of the Academy of Nutrition and Dietetics.     

基于卫生技术评估构建医学人工智能技术临床应用评估路径的探讨

医学人工智能可以应用于疾病的预防、诊断和治疗等方面,以改善医疗服务的提供。卫生技术评估在国际上已广泛应用于新医药技术准入、医疗保险支付范围确定等方面。本文基于卫生技术评估,探讨构建我国医学人工智能临床应用评估路径,并提出了进一步发展的政策建议,为发展我国医学人工智能技术临床应用和卫生技术评估事业提供决策依据。