Medical Records Confidentiality and Public Health Research: Two Values at Stake? An Italian Survey Focus on Individual Preferences

Abstract

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.

A review of attitudes towards the reuse of health data among people in the European Union: The primacy of purpose and the common good

“…The majority of studies explored attitudes towards the use of health data for research [17,18,[27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44]]. Most studies asked for views regarding research in general [17,18,[27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38],44], while six studies focused on specific registries [[39], [40], [41], [42], [43],45]. Eight studies explored views on the use of data for purposes other than treatment and research, namely the evaluation of a screening programme [46], planning and polic y purposes [32,34,35,44], the production of performance reports [47] and quality assurance (clinical audit ) [48].…”

“…The vast majority of studies were conducted in the UK [17,18,27,31,[33], [34], [35], [36], [37],[39], [40], [41], [42], [43], [44], [45],47,48,[51], [52], [53]]. Six studies from other countries were identified, including Italy, Germany, Finland, Netherlands and Ireland [[28], [29], [30],38,46,49] and one study was a pan-European survey [50].…”

“…The majority of studies explored attitudes towards informed consent [[27], [28], [29], [30], [31],33,35,37,38,39,[41], [42], [43],45,46,52,53]. Some studies sought to reveal preferences for different consent models [28,30,37,39,[41], [42], [43],45,52].…”

“…Some studies sought to reveal preferences for different consent models [28,30,37,39,[41], [42], [43],45,52]. Others explored whether people wanted informed consent [27,33,38] and whether the anonymization of data affected the preference for this [29,31,35,37,46,53]. Table 4 presents an overview of different consent models presented in the studies, along with stated attitudes towards the models.…”

The Italian Twin Registry: An Update at 18 Years From Its Inception

“…Finally, we consider worth addressing a few results of research conducted by the ITR on this topic during the last few years. When Europe was just preparing to introduce the new regulation on privacy, we conducted a survey among 1700 twins regarding preferences about the access and use of their medical records for public health research without explicit informed consent (Toccaceli et al, 2015). A great majority of respondents refused or was doubtful about the access and use of hospital discharge records or clinical data without their explicit consent.…”