On 27 April 2016, after a troubled gestation,, Regulation 2016/6791 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was finally published. The Regulation is to have a two-year transitional period, meaning it will actually enter into force in the first half of 2018.
The assessment of data quality and suitability plays an important role in improving the validity and generalisability of the results of studies based on secondary use of health databases. The availability of more and more updated and valid information on data quality and suitability provides data users and researchers an useful tool to optimize their activities. In this paper, we have summarized and synthesized the main aspects of Data Quality Assessment (DQA) applied in the field of secondary use of healthcare databases, with the aim of drawing attention to the critical aspects having to be considered and developed for improving the correct and effective use of secondary sources. Four developing features are identified: standardizing DQA methods, reporting DQA methods and results, synergy between data managers and data users, role of Institutions. Interdisciplinarity, multi-professionality and connection between government institutions, regulatory bodies, universities and the scientific community will provide the "toolbox" for i) developing standardized and shared DQA methods for health databases, ii) defining the best strategies for disseminating DQA information and results.
The "Observational Studies" working group of the Italian Association of Medical Statistics and Clinical Epidemiology (SISMEC) has undertaken to study the impact of recent healthcare sector regulations on the legal and organisational aspects of managing all EMR databases with emphasis on Legislative Decree No. 196/2003 (the Italian Personal Data Protection Law). This paper examines six issues relating to theirs legal implications. The first section, "Confidentiality", provides definitions and the regulatory context for the terms "confidentiality" and "personal data". In the second, "Nature of data held in electronic medical record archives", we discuss the problem of sensitive data and procedures to make the identification code anonymous. In "Data ownership" we highlight the difference between the data controller and the database controller. The fourth section, "Conditions for processing", discusses problems associated with using research data from one study in other investigations. In the fifth, "Patient consent", we address the problems related to patient consent. Finally in "Penalties" we outline the main civil and criminal liability issues applied in case of non-compliance with the provisions of the Personal Data Protection Code. Where possible, we provide suggestions on how to comply with the legal requirements of managing medical record archives in order to make it easier for researchers to remain in compliance with the relevant provisions.
BACKGROUND: Research networks offer multidisciplinary expertise and promote information exchange between researchers across Europe. They are essential for the European Union's (EU) health information system as providers of health information and data. The aim of this mapping exercise was to identify and analyze EU research networks in terms of health data collection methods, quality assessment, availability and accessibility procedures. METHODS: A web-based search was performed to identify EU research networks that are not part of international organizations (e.g., WHO-Europe, OECD) and are involved in collection of data for health monitoring or health system performance assessment. General characteristics of the research networks (e.g., data sources, representativeness), quality assessment procedures, availability and accessibility of health data were collected through an ad hoc extraction form. RESULTS: Fifty-seven research networks, representative at national, international or regional level, were identified. In these networks, data are mainly collected through administrative sources, health surveys and cohort studies. Over 70% of networks provide information on quality assessment of their data collection procedures. Most networks share macrodata through articles and reports, while microdata are available from ten networks. A request for data access is required by 14 networks, of which three apply a financial charge. Few networks share data with other research networks (8/49) or specify the metadata-reporting standards used for data description (9/49). CONCLUSIONS: Improving health information and availability of high quality data is a priority in Europe. Research networks could play a major role in tackling health data and information inequalities by enhancing quality, availability, and accessibility of health data and data sharing across European networks. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13690-021-00766-2.
