Nikolaus Forgo

University of Vienna | UniWien · Innovation and Digitalisation in Law

Solidarity-based data governance (in short: data solidarity) seeks to increase collective control, oversight and ownership over digital data and resources. Its core premise is that the benefits and risks of digital practices need to be borne fairly and collectively. In this manner, data solidarity helps to realise justice, but it also complements i...

Machine Learning may push research in precision medicine to unprecedented heights. To succeed, machine learning needs a large amount of data, often including personal data. Therefore, machine learning applied to precision medicine is on a cliff edge: if it does not learn to fly, it will deeply fall down. In this paper, we present Active Informed Co...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

Paying individual people for their health data will widen inequalities and reduce altruism, luring people to sell their privacy. Health data should instead be treated as collective property, and commercial profits should be shared with the public.

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

The emergence of digital platforms and the new application economy are transforming healthcare and creating new opportunities and risks for all stakeholders in the medical ecosystem. Many of these developments rely heavily on data and AI algorithms to prevent, diagnose, treat, and monitor diseases and other health conditions. A broad range of medic...

A correction to this paper has been published: https://doi.org/10.1007/s41060-021-00261-5

This paper presents a framework for research infrastructures enabling ethically sensitive and legally compliant data science in Europe. Our goal is to describe how to design and implement an open platform for big data social science, including, in particular, personal data. To this end, we discuss a number of infrastructural, organizational and met...

Full text: https://zenodo.org/record/6411788 This chapter focuses on social media data which is publically available and the data collection of which is regulated by the General Data Protection Regulation (GDPR). This chapter will describe the different categories of personal data available on social media platforms and broadly outline the techniq...

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for...

The exponential growth of disruptive technology is changing our world. The development of cloud computing, big data, the internet of things, artificial intelligence, machine learning, deep learning, and other related autonomous systems, such as self-driving vehicles, have triggered the emergence of new products and services. These significant techn...

Introduction: Multiple immunity biomarkers have been suggested as tracers of neuroinflammation in neurodegeneration. This study aimed to verify findings in cerebrospinal fluid (CSF) samples of Alzheimer's disease (AD) and Parkinson's disease (PD) subjects from the network of the European, Innovative Medicines Initiative-funded project AETIONOMY....

This chapter provides an overview of the legal framework addressing the exchange of electronic evidence and the implications related to privacy and data protection. While in Chap. 11 of this Volume, the current legal situation in general is reviewed, this chapter focuses specifically on privacy and data protection. Whereas many sources of law are s...

Big-Data-Technologien und -Prozesse versprechen große Potenziale für die gesellschaftliche Entwicklung, bergen jedoch auch Risiken, was einen verantwortungsvollen Umgang mit den Möglichkeiten, die Big Data eröffnet, erforderlich macht. Big Data wirft diverse Rechtsfragen auf, die in diesem Gutachten dargestellt und diskutiert werden. Einen Schwerpu...

Computer science, robotics and AI have all developed rapidly in recent years, bringing profound changes to all aspects of human life. However, the emergence and proliferation of these new technologies has not occurred within the bounds of traditional organizational, ethical and regulatory systems. We have reached an inflection point, where we need...

Artificial intelligence and related technologies are changing both the law and the legal profession. In particular, technological advances in fields ranging from machine learning to more advanced robots, including sensors, virtual realities, algorithms, bots, drones, self-driving cars, and more sophisticated “human-like” robots are creating new and...

In recent years, Big Data has become a dominating trend in information technology. As a buzzword, Big Data refers to the analysis of large data sets in order to find new correlations—for example, to find business or political trends or to prevent crime—and to extract valuable information from large quantities of data. As much as Big Data may be use...

The radical change in telecommunications technologies over the last fifteen years has enabled new techniques to lawfully intercept telecommunications and to gather digital evidence. These include covert remote access to data storages and lawful interception prior to communication encryption by hidden software tools. The specific intrusiveness of th...

Technology is transforming our lives and the way we perceive reality so quickly that we are often unaware of its effects on the relationship between law and society. As an emerging field, a key aim of IT Law is finding the best way of harnessing different cutting-edge technologies and at the same time reducing the ever-growing gap between new techn...

Analyses of biobank informed consent forms show that most of them do not include provisions for post-mortem use of biomaterial and data obtained from a donor who later dies. When these biobanks are confronted with issues of secondary use of these bioresources for research, especially when not completely anonymised, or when genetic research is invol...

Electronic Health Records (EHRs) contain an increasing wealth of medical information. When combined with molecular level data, they enhance the understanding of the underlying biological mechanisms of diseases, enabling the identification of key prognostic biomarkers to disease and treatment outcomes. However, the European healthcare information sp...

This edited collection brings together a series of interdisciplinary contributions in the field of Information Technology Law. The topics addressed in this book cover a wide range of theoretical and practical legal issues that have been created by cutting-edge Internet technologies, primarily Big Data, the Internet of Things, and Cloud computing. C...

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. Th...

Many of the game-changing innovations the Internet brought and continues to bring to all of our daily professional and private lifes come with privacy-related costs. The more day-to-day activities are based on the Internet, the more personal data are generated, collected, stored and used. Big Data, Internet of Things, cyber-physical-systems and sim...

The potential of ICT to address problems in modern healthcare is considerable, and an ICT-driven revolution in healthcare appears imminent. Such developments may be 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 outsid...

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/).

The following paper considers some of the novel ethical and legal issues that may arise in the context of in silico-based medicine, with particular reference to the development of hypermodels to optimize treatment decisions for specific diseases.

One area where the application of data protection law has proven complex is in relation to the secondary usage of health data in EHRs for medical research. Here the tension between the privacy interests of patients and the risk of harm if such sensitive data are compromised, and on the other side, the potential societal value of utilizing the data...

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 comm...

Keypoints ICT is a key driver of medical research today. ICT-driven medical research often deals with better accessability and connectivity of existing (personal) medical data which brings data protection rules into play. It is of utmost importance to distinguish anonymous from personal data here. The upcoming reform of European Data Protection...

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 representati...

Background / Purpose: Advancing clinical practice and accelerate medical research, by providing pharmaceutical companies, healthcare professionals and patients with an innovative semantic interoperability framework facilitating the efficient and homogenized access to anonymized aggregated distributed Electronic Health Records (EHRs), while confor...

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 -...

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...

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 exp...

Anlässlich der immer größer werdenden Relevanz von Mobile Learning, gerade unter Berücksichtigung der ansteigenden Tendenzen der Nutzung von Smartphones und Tablets im privaten und universitären Umfeld darf eine Reihe von rechtlichen Fragen nicht außer Acht gelassen werden. Dieser Beitrag soll aufzeigen, mit welchen wichtigen rechtlichen Fragestell...

Electronic Health Records (EHRs) contain an increasing wealth of medical information. They have the potential to help significantly in advancing medical research, as well as improve health policies, providing society with additional benefits. However, the European healthcare information space is fragmented due to the lack of legal and technical sta...

The article presents the possible security issues in a European research project concerning medical data with reference to the specific project Linked2Safety. A distinction is made between legal and ethical requirements for such a research project.

A general overview of the legal requirements for consent in health in European Union is presented and a comparison between three different usage of consent is being offered: consent for care; consent for clinical trial participation and consent for data processing. On a second stage a practical example of the strengths and weaknesses of the Europea...

Apart from technical challenges, legal and ethical issues form part of the considerations when pooling together and sharing databases for translational medical research. Questions referring to data protection, data security and intellectual property rights, which are even made more complex because of the transnational aspect of such research, have...

Cloud transformations require dynamic redistribution of resources across cloud infrastructure. From a legal perspective this movement of data from one data processor to another without the explicit consent of the data subject is a threat to data privacy. Levels of assurance and accountability have to be provided from the cloud infrastructure provid...

Eine aktuelle Online-Recherche fördert wenige frühe Beiträge mit Nikolaus Forgó zutage. Die Berliner Zeitung berichtete 2000 über einen Rechtsstreit zwischen der Neuen Kronen Zeitung und einem Domain-Inhaber, der die Zeitung auf seiner Website offenbar durch den Kakao zog. Die Zeitung zitiert Forgó dreimal als IT-Experten; er bewertet die Chancen d...

We demonstrate the OPTIMIS toolkit for scalable and dependable service platforms and architectures that enable flexible and dynamic provisioning of Cloud services. The innovations demonstrated are aimed at optimizing Cloud services and infrastructures based on aspects such as trust, risk, eco-efficiency, cost, performance and legal constraints. Ada...

This article contains an analysis of the relevant intellectual property rights concerning e-health projects using grid computing infrastructure within a clinical trial environment. There are two important issues at stake: which (intellectual) property rights arise during the course of such a project and which patient rights have to be regarded? Thi...

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...

A comparative study on the transpositions of the EC data retention directive in EC member states, focused on progress, intensity and form of transposition.

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...

During the last few years, the ‘omics’ revolution has dramatically increased the amount of data available for characterizing intracellular events. As a result, a lot of patterns of gene expression were found that could be used to classify molecular subtypes of tumours and predict the outcome and response to treatment. Currently, the main focus is o...

Zusammenfassung Zur Verarbeitung personenbezogener Bildungsdaten am Beispiel des österreichischen Bildungsdokumentationsgesetzes

Die Verfasser setzen sich mit der Frage auseinander, unter welchen Voraussetzungen sich eine für eine Verarbeitung personenbezogener Daten verantwortliche Stelle das für eine Deanonymisierung erforderliche Zusatzwissen zurechnen lassen muss und unterbreiten hierzu einen Defintionsvorschlag.

Rezensiertes Werk:Vanessa Géczy-Sparwasser, Die Gesetzgebungsgeschichte des Internet. Die Reaktion des Gesetzgebers auf das Internet unter Berücksichtigung der Entwicklung in den USA und unter Einbeziehung gemeinschaftsrechtlicher Vorgaben (Beiträge zum Informationsrecht, Bd. 3), Berlin: Duncker & Humblot 2003, 290 S., ISBN 3-428-10853-1