Health Economics and Healthcare Management Division, Kozminski University, 57/59 Jagiellonska St., 03-301, Warsaw, Poland.
Global Market Access, Straub Medical, Switzerland Straub Medical AG, Wangs, Switzerland.
Pharmacoeconomics. 2020 Oct;38(10):1021-1029. doi: 10.1007/s40273-020-00927-1.
The development of evidence to demonstrate 'value for money' is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the other side, especially when it comes to "personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about his or her health status". At the forefront of these discussions are data protection issues as well as the population's trust in digital services. It seems that the new era has begun, where citizens and patients will have the ability to manage their personal or self-generated data. The European Commission has laid the groundwork for this paradigm shift that will steadily emerge in the coming years. To prepare for this change, we believe attention should be given to data security and other rules of data privacy. It has become increasingly important to ensure that individuals are properly introduced into complex environments with multiple sources of Big Data for clinical and behavioral purposes to provide an optimal balance between societal and individual benefits. In this article, a number of issues are considered and discussed, based upon the authors' experience, with the aim of helping the reader better understand the implications of the use of Big Data and the importance of data protection in the coming years.
证据的发展被认为是展示“物有所值”的重要步骤，有助于寻找有限资源的最佳分配，并已成为医疗保健决策的重要组成部分。从整个医疗保健连续体中匿名个体收集的真实世界证据是技术评估中最有价值的来源。然而，在欧盟，基于真实世界数据的价值评估变得具有挑战性，因为最近个人有权在撤回同意或数据被认为不再必要的情况下删除其个人数据。这一行为可能会限制数据在未来的有用性，因为它可能会引入信息偏差。在医疗保健利益相关者中，这已成为一个重要的讨论话题，因为它涉及到数据的重要性和个人数据保护的必要性，特别是在涉及“与自然人的身心健康有关的个人数据，包括提供医疗保健服务，这些服务揭示了有关其健康状况的信息”时。这些讨论的前沿是数据保护问题以及公众对数字服务的信任。看来，新时代已经开始，公民和患者将有能力管理自己的个人或自生成数据。欧盟委员会已经为这一范式转变奠定了基础，这种转变将在未来几年稳步出现。为了为这种变化做好准备，我们认为应该关注数据安全和其他数据隐私规则。确保个人在具有多个大数据源的复杂环境中正确引入，以实现社会效益和个人利益之间的最佳平衡，这一点变得越来越重要。在本文中，作者根据自己的经验考虑并讨论了一些问题，旨在帮助读者更好地理解大数据的使用所带来的影响以及数据保护在未来几年的重要性。
