Toccaceli Virgilia, Fagnani Corrado, Stazi Maria Antonietta
Genetic Epidemiology Unit, National Centre of Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health , Rome, Italy.
J Public Health Res. 2015 Feb 25;4(1):401. doi: 10.4081/jphr.2015.401. eCollection 2015 Feb 20.
In a time when Europe is preparing to introduce new regulations on privacy protection, we conducted a survey among 1700 twins enrolled in the Italian Twin Register about the access and use of their medical records for public health research without explicit informed consent. A great majority of respondents would refuse or are doubtful about the access and use of hospital discharge records or clinical data without their explicit consent. Young and female individuals represent the modal profile of these careful people. As information retrieved from medical records is crucial for progressing knowledge, it is important to promote a better understanding of the value of public health research activities among the general population. Furthermore, public opinions are relevant to policy making, and concerns and preferences about privacy and confidentiality in research can contribute to the design of procedures to exploit medical records effectively and customize the protection of individuals' medical data. Significance for public healthInformation retrieved from medical records is critical for public health research and policy. In particular, large amounts of individual health data are needed in an epidemiological setting, where methodological constraints (e.g. follow-up update) and quality control procedures very often require data to be re-identifiable. Concern about European regulation affecting access to medical records seems to be widespread in the scientific community. Highlighting individuals' concerns and preferences about privacy and informed consent regarding the use of health data can support policy making for public health research. It can contribute to the design of procedures aiming to extract the greatest value from medical records and, more importantly, to create a system for the protection of personal data tailored to the needs of different people.
在欧洲准备出台新的隐私保护法规之际,我们对意大利双胞胎登记处登记的1700对双胞胎进行了一项调查,内容是关于在未获得明确知情同意的情况下,其医疗记录用于公共卫生研究的获取和使用情况。绝大多数受访者会拒绝或对未经其明确同意获取和使用医院出院记录或临床数据表示怀疑。年轻人和女性是这些谨慎人群的典型代表。由于从医疗记录中检索到的信息对于知识进步至关重要,因此促进普通民众更好地理解公共卫生研究活动的价值非常重要。此外,公众意见与政策制定相关,对研究中隐私和保密的关注及偏好有助于设计有效利用医疗记录的程序,并定制对个人医疗数据的保护。对公共卫生的意义从医疗记录中检索到的信息对公共卫生研究和政策至关重要。特别是在流行病学环境中,需要大量的个人健康数据,而方法学限制(如随访更新)和质量控制程序常常要求数据能够重新识别身份。科学界似乎普遍担心欧洲法规会影响医疗记录的获取。突出个人对健康数据使用的隐私和知情同意方面的关注及偏好,可为公共卫生研究的政策制定提供支持。这有助于设计旨在从医疗记录中获取最大价值的程序,更重要的是,有助于创建一个根据不同人群需求定制的个人数据保护系统。