A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, "Forschungsorganisationsgesetz"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies.

Donor's support tool: Enabling informed secondary use of patient's biomaterial and personal data.

PURPOSE: Biomedical research is being catalyzed by the vast amount of data rapidly collected through the application of information technologies (IT). Despite IT advances, the methods for involving patients and citizens in biomedical research remain static, paper-based and organized around national boundaries and anachronistic legal frameworks. The purpose of this paper is to study the current practices for obtaining consent for biobanking and the legal requirements for reusing the available biomaterial and data in EU and finally to present a novel tool to this direction enabling the secondary use of data and biomaterial. METHOD: We review existing European legislation for secondary use of patient's biomaterial and data for research, identify types and scopes of consent, formal requirements for consent, and consider their implications for implementing electronic consent tools. To this direction, we proceed further to develop a modular tool, named Donor's Support Tool (DST), designed to connect researchers with participants, and to promote engagement, informed participation and individual decision making. RESULTS: To identify the advantages of our solution we compare our tool with six other relevant approaches. The results show that our tool scores higher than the other tools in functionality, security and intelligence whereas it is the only one free and open-source. In addition, the potential of our solution is shown by a proof of concept deployment in an existing clinical setting, where it was really appreciated, as streamlining the relevant workflow.

Using Patient Avatars to Promote Health Data Sharing Applications: Perspectives and Regulatory Challenges.

The potential of ICT to address problems in modern healthcare is considerable, and an ICT-driven revolution in healthcare appears imminent. Such developments maybe viewed largely in positive terms. Thus they should result in enhanced treatment and care options, empowering patients--including by permitting greater self-management of illness outside hospital, while offering economic benefits and costs savings over traditional healthcare provision. However, the new possibilities also present manifold risks, such as of data breaches, encroachments on subject autonomy, as well as of other harms. This article considers some of the key regulatory challenges against the background of the progress of the current EU Commission-sponsored 'MyHealthAvatar' project.

p-BioSPRE-an information and communication technology framework for transnational biomaterial sharing and access.

Biobanks represent key resources for clinico-genomic research and are needed to pave the way to personalised medicine. To achieve this goal, it is crucial that scientists can securely access and share high-quality biomaterial and related data. Therefore, there is a growing interest in integrating biobanks into larger biomedical information and communication technology (ICT) infrastructures. The European project p-medicine is currently building an innovative ICT infrastructure to meet this need. This platform provides tools and services for conducting research and clinical trials in personalised medicine. In this paper, we describe one of its main components, the biobank access framework p-BioSPRE (p-medicine Biospecimen Search and Project Request Engine). This generic framework enables and simplifies access to existing biobanks, but also to offer own biomaterial collections to research communities, and to manage biobank specimens and related clinical data over the ObTiMA Trial Biomaterial Manager. p-BioSPRE takes into consideration all relevant ethical and legal standards, e.g., safeguarding donors' personal rights and enabling biobanks to keep control over the donated material and related data. The framework thus enables secure sharing of biomaterial within open and closed research communities, while flexibly integrating related clinical and omics data. Although the development of the framework is mainly driven by user scenarios from the cancer domain, in this case, acute lymphoblastic leukaemia and Wilms tumour, it can be extended to further disease entities.

Computational Horizons In Cancer (CHIC): Developing Meta- and Hyper-Multiscale Models and Repositories for In Silico Oncology - a Brief Technical Outline of the Project.

This paper briefly outlines the aim, the objectives, the architecture and the main building blocks of the ongoing large scale integrating transatlantic research project CHIC (http://chic-vph.eu/).

Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms.

Patient empowerment is acclaimed as one of the major trends in the health care area bringing forward new conceptions how to involve patients in clinical research in a more (inter)active way. Patients and clinicians could benefit from more flexible consent-management and improved communication processes. This is where technology comes as an asset - the novel technological approaches promise to give more control to the patient, lessen the burdens on the researchers and all that in compliance with the legal and ethical requirements (e.g. data protection). The views of the European projects EURECA and p-medicine serve as examples for European approaches to patient empowerment.

Joint conference on the impact of EU legislation on therapeutic advance.

On October 11, 2012, two FP7-funded Research Consortia, CONTRACT (Consent in a Trial and Care Environment) and Academic GMP, held a Joint Conference in Brussels entitled "The Impact of EU Legislation on Therapeutic Advance." Academic researchers including stem cell transplant physicians and cell therapy specialists, legal advocates and representatives from industry, regulatory authorities and patient advocacy groups met with members of the European Parliament and the European Commission. This article summarizes important points of discussion and detailed proposals for improvement.

Navigating legal constraints in clinical data warehousing: a case study in personalized medicine.

Personalized medicine relies in part upon comprehensive data on patient treatment and outcomes, both for analysis leading to improved models that provide the basis for enhanced treatment, and for direct use in clinical decision-making. A data warehouse is an information technology for combining and standardizing multiple databases. Data warehousing of clinical data is constrained by many legal and ethical considerations, owing to the sensitive nature of the data being stored. We describe an unconstrained clinical data warehousing architecture, some of the legal constraints that have led us to reconsider this architecture, and the legal and technical solutions to these constraints developed for the clinical data warehouse in the personalized medicine project p-medicine. We also propose some changes to the legal constraints that will further enable clinical research.

Legal issues in clouds: towards a risk inventory.

Cloud computing technologies have reached a high level of development, yet a number of obstacles still exist that must be overcome before widespread commercial adoption can become a reality. In a cloud environment, end users requesting services and cloud providers negotiate service-level agreements (SLAs) that provide explicit statements of all expectations and obligations of the participants. If cloud computing is to experience widespread commercial adoption, then incorporating risk assessment techniques is essential during SLA negotiation and service operation. This article focuses on the legal issues surrounding risk assessment in cloud computing. Specifically, it analyses risk regarding data protection and security, and presents the requirements of an inherent risk inventory. The usefulness of such a risk inventory is described in the context of the OPTIMIS project.

Data protection in grid-based multicentric clinical trials: killjoy or confidence-building measure?

In order to protect the privacy of participating patients in multicentric genetic research projects and to improve the working conditions for researchers in such projects a data protection framework needs to be installed. In the first place, all genetic data processed in the project has to be pseudonymized. In addition to that, contracts have to be concluded between the project and each project partner to guarantee that genetic data are used only within the project and that each partner complies with data security standards. Furthermore, a central data protection authority has to be installed in the project to control the partners' compliance with these contracts and to serve as a central contact point for participants. If these conditions are fulfilled, only (de facto) anonymous data are used in the project, so that data protection legislation is not directly applicable. Second, each participant has to sign a special consent form for ethical reasons and as a fallback solution if the pseudonymization of the genetic data fails. With this safety net it is possible to protect the participants' privacy and to improve the working conditions for researchers.

A data protection framework for trans-European genetic research projects.

The paper proposes a data protection framework for trans-European medical research projects, which is based on a technical security infrastructure as well as on organizational measures and contractual obligations. It mainly relies on pseudonymization, an internal Data Protection Authority and on a Trusted Third Party. The outcome is an environment that combines both good research conditions and an extensive protection of patients' privacy.