21世纪被誉为大数据时代，这是因为数据的增长和处理已经达到了前所未有的水平，尤其是“机器学习”、“算法”等技术的发展加速了对数据的处理和利用。在卫生健康领域，大数据的应用使得我们能够更好地理解生命的本质，并且能够促进医疗服务和公共卫生实践。虽然健康大数据在许多方面都大有可为，但数据的使用及其衍生的研究结果可能会引发一系列伦理问题，这些问题源于被操作数据的敏感性、无限的潜在用途和再利用，以及对个人、人群乃至人类福祉的影响。

关于健康大数据使用的隐私保护和知情同意等诸多伦理问题，多年来一直是基于个人权益的传统生物医学研究范式下开展讨论，仍存在伦理争议和监管困难，尚未形成最佳实践。因此，本文在大数据所带来的“数据密集型科学”这一新的研究范式下，关注公共利益和群体层面，基于生命伦理学视角重新审视上述伦理问题。为促进健康大数据使用的规范发展提出伦理学方面的建议。

本文系统性地回顾了国内外关于健康大数据使用所带来的伦理挑战的相关文献，对大数据的概念和特征、健康大数据的概念和范围进行了梳理，并对健康大数据使用的概念进行了重新界定。而后概述了健康大数据使用的发展和监管情况，并对所涉及的伦理问题和伦理学问题进行了归纳。基于当前健康大数据面临的伦理问题和新的研究范式，通过探讨生命伦理学的理论和原则，构建了一个用于评估健康大数据使用决策的伦理框架，而后对伦理问题进行论证。首先，健康大数据使用往往是对一定规模的数据集或数据集链接进行研究，因此在受益风险评估时探讨了新范式下的受益和风险发生的变化，并强调了公共利益和共济的重要性。其次，隐私和隐私权在伦理学研究和法律规范中被广泛关注，然而隐私保护和隐私披露之间存在张力，隐私保护技术至关重要但存在一定的局限性，个人隐私保护不足以防范群体隐私的侵犯，因此需要综合考虑道德、法律和技术因素。再次，基于新的研究范式对知情同意方式进行评估，一方面探讨研究参与者的信任以及尊重自主性的问题，以及巩固这种信任关系确保研究的持续性。另一方面，在新的研究范式下需要为公共利益限制个人自主性进行辩护。最后，讨论了大数据鸿沟问题，健康大数据具有公共品属性，但是数据鸿沟所带来的不公正问题存在两难，在健康大数据研究并应用于实践过程中，大数据鸿沟给数字弱势群体带来的伦理困境需要权衡。

最后结合前文分析，提出了我国在“数据密集型科学”研究范式下健康大数据使用的政策建议。这些建议旨在为我国健康大数据的使用决策和监管方面提供支撑，确保大数据在健康领域的应用既能促进公共利益，又能防范个人和群体面临的潜在风险，同时充分保护个人权益。

The 21st century is known as the era of big data, as the growth and processing of data have reached unprecedented levels, especially with the development of technologies such as "machine learning" and "algorithms" accelerating the processing and utilization of data. In the field of health, the application of big data enables us to better understand the essence of life and promote medical services and public health practices. Although health big data has great potential in many aspects, the use of data and its derived research results may raise a series of ethical issues, which stem from the sensitivity of manipulated data, unlimited potential uses and re-use, as well as the impact on individuals, populations, and even human welfare.

Under the traditional biomedical research paradigm, many ethical issues related to the use of health big data, such as privacy protection and informed consent, have received widespread attention for many years. However, there are still ethical disputes and regulatory difficulties, and best practices have yet to be established. Therefore, this article re-examines the above ethical issues from the perspective of bioethics under the new research paradigm of "data-intensive science" brought about by big data, and proposes ethical recommendations to promote the standardized development of the use of health big data.

This article systematically reviews relevant literature on the ethical challenges posed by the use of health big data at home and abroad, combs the concepts and characteristics of big data, and redefines the concept of the use of health big data. Then it summarizes the development and regulation of the use of health big data, and summarizes the ethical and ethical issues involved. Based on the ethical issues facing current health big data and new research paradigms, this article constructs an ethical framework for evaluating the decision-making process of using health big data by exploring the theories and principles of bioethics, and then demonstrates the ethical issues involved. Firstly, the use of health big data often involves conducting research on a certain scale of data sets or data set links. Therefore, when evaluating the risk-benefit balance, this article discusses the changes in benefits and risks under the new paradigm, and emphasizes the importance of public interest and mutual aid. Secondly, privacy and privacy rights have been widely concerned in ethical research and legal norms. However, there is tension between privacy protection and privacy disclosure, and privacy protection technology is crucial but has certain limitations. Individual privacy protection is not sufficient to prevent infringement of group privacy, so it is necessary to consider ethical, legal, and technological factors comprehensively. Thirdly, based on the new research paradigm, this article evaluates the informed consent approach. On the one hand, it discusses the issues of trust and respect for autonomy among research participants, as well as consolidating this trust relationship to ensure the continuity of research. On the other hand, under the new research paradigm, it is necessary to defend public interest by limiting individual autonomy. Finally, this article discusses the issue of big data divide. Health big data has public goods attributes, but there is a dilemma in terms of the injustice caused by data divide. In the process of researching and applying health big data in practice, it is necessary to weigh the ethical dilemma brought by big data divide to digital disadvantaged groups.

Finally, combined with the previous analysis, policy recommendations for the use of big data in health under the research paradigm of "data-intensive science" in China are proposed. These recommendations aim to provide support for decision-making and regulation in the use of big data in health in China, ensuring that the application of big data in the field of health can promote public interests while preventing potential risks faced by individuals and groups, and fully protecting individual rights and interests.