This paper argues that assessing personal responsibility in healthcare settings for the allocation of medical resources would be too privacy-invasive to be morally justifiable. In addition to being an inappropriate and moralizing intrusion into the private lives of patients, it would put patients’ sensitive data at risk, making data subjects vulnerable to a variety of privacy-related harms. Even though we allow privacy-invasive investigations to take place in legal trials, the justice and healthcare systems are not analogous. The duty (...) of doctors and healthcare professionals is to help patients as best they can—not to judge them. Patients should not be forced into giving up any more personal information than what is strictly necessary to receive an adequate treatment, and their medical data should only be used for appropriate purposes. Medical ethics codes should reflect these data rights. When a doctor asks personal questions that are irrelevant to diagnose or treat a patient, the appropriate response from the patient is: ‘none of your business’. (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood (...) data collection technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

Property rights of personal data have been advocated for some time. From the perspective of economics of law some argued that they could lower transaction costs for contracts involving personal data. This may be the case, but new transaction costs are introduced by propertization and the issue has not been settled. In this paper, I focus on a different and potentially more important aspect. In the actual situation, data collectors externalize costs and internalize benefits. An ownership (...) regime that enables every citizen to hold a personal data account, like a bank account, and that gives people ownership rights over secondary use of personal data could correct these misallocations. I hope to shed new light on the normative implications of the issue by offering normative justifications for property rights of personal data (Sections 2–4). Secondly, I present fundamental goals and building blocks of a property regime of personal data (Section 5) and, thirdly, I illustrate how income from personal data ownership could for instance contribute to financing pensions under proper regulation (Section 6). (shrink)

Property rights of personal data have been advocated for some time. From the perspective of economics of law some argued that they could lower transaction costs for contracts involving personal data. This may be the case, but new transaction costs are introduced by propertization and the issue has not been settled. In this paper, I focus on a different and potentially more important aspect. In the actual situation, data collectors externalize costs and internalize benefits. An ownership (...) regime that enables every citizen to hold a personal data account, like a bank account, and that gives people ownership rights over secondary use of personal data could correct these misallocations. I hope to shed new light on the normative implications of the issue by offering normative justifications for property rights of personal data (Sections 2–4). Secondly, I present fundamental goals and building blocks of a property regime of personal data (Section 5) and, thirdly, I illustrate how income from personal data ownership could for instance contribute to financing pensions under proper regulation (Section 6). (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood (...) data collection technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

Data-driven technologies have come to pervade almost every aspect of business life, extending to employee monitoring and algorithmic management. How can employee privacy be protected in the age of datafication? This article surveys the potential and shortcomings of a number of legal and technical solutions to show the advantages of human rights-based approaches in addressing corporate responsibility to respect privacy and strengthen human agency. Based on this notion, we develop a process-oriented model of Privacy Due Diligence to complement (...) existing frameworks for safeguarding employee privacy in an era of Big Data surveillance. (shrink)

Data subject rights provide data controllers with obligations that can help with transparency, giving data subjects some control over their personal data. To date, a growing number of researchers have used these data subject rights as a methodology for data collection in research studies. No one, however, has gathered and analysed different academic research studies that use data subject rights as a methodology for data collection. To this end, we (...) conducted a systematic literature review that searched, compiled, and analysed 32 academic studies that use data subject rights as a data collection method. We find that the right of access is the most commonly-used data subject right by researchers, most studies are interested in measuring data subject rights compliance, and that a variety of difficulties exist in conducting research studies with data subject rights. We conclude that researchers should explore other data subject rights for alternative purposes, ease the process of exercising data subject rights, and improve the scalability of these studies. (shrink)

Social media data hold considerable potential for predicting health-related conditions. Recent studies suggest that machine-learning models may accurately predict depression and other mental health-related conditions based on Instagram photos and Tweets. In this article, it is argued that individuals should have a sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. The article (1) develops three basic arguments for a right to protection of personal data trading (...) on the notions of social control and stigmatization, (2) argues that a number of features of AI profiling make individuals more exposed to social control and stigmatization than other types of data processing (the exceptionalism of AI profiling), (3) considers a series of other reasons for and against protecting individuals against AI profiling based on publicly available data, and finally (4) argues that the EU General Data Protection Regulation does not ensure that individuals have a right not to be AI profiled based on publicly available data. (shrink)

The properties of DNA -- DNA as universal property -- DNA as intellectual property -- DNA as national property -- DNA as personal property -- DNA as academic property -- DNA as taxable propety.

Since approval of the EU General Data Protection Regulation (GDPR) in 2016, it has been widely and repeatedly claimed that the GDPR will legally mandate a ‘right to explanation’ of all decisions made by automated or artificially intelligent algorithmic systems. This right to explanation is viewed as an ideal mechanism to enhance the accountability and transparency of automated decision-making. However, there are several reasons to doubt both the legal existence and the feasibility of such a right. In contrast to (...) the right to explanation of specific automated decisions claimed elsewhere, the GDPR only mandates that data subjects receive meaningful, but properly limited, information (Articles 13-15) about the logic involved, as well as the significance and the envisaged consequences of automated decision-making systems, what we term a ‘right to be informed’. Further, the ambiguity and limited scope of the ‘right not to be subject to automated decision-making’ contained in Article 22 (from which the alleged ‘right to explanation’ stems) raises questions over the protection actually afforded to data subjects. These problems show that the GDPR lacks precise language as well as explicit and well-defined rights and safeguards against automated decision-making, and therefore runs the risk of being toothless. We propose a number of legislative and policy steps that, if taken, may improve the transparency and accountability of automated decision-making when the GDPR comes into force in 2018. (shrink)

Governments around the world collect huge amounts of personal data from their citizens for counterterrorist purposes. While mining this data has arguably increased the security of populations, the practices through which these data are currently collected in many countries have been criticised for violating individuals’ rights to privacy. Yet it is not clear what a permissible data collection regime would look like and thus also how we could reform existing regimes to make them morally acceptable. (...) This article explores a number of ways in which we might justify a data collection regime to those affected in spite of the setbacks to their privacy. In contrast to existing justifications, I argue that individuals can be asked to surrender their personal data as a requirement of reciprocity in a cooperative system in which they gain security from others doing likewise. Relying on this justification, though, has significant implications for how we should reform existing data collection regimes. In particular, more stringent limits will need to be placed on the forms which these regimes can legitimately take. (shrink)

Approximately twenty years after it was necessary to fight for human rights, the time came when it was necessary to do it again. Or to begin at the very least to protect them very strongly and thoroughly in a preventive manner. Other methods and means will revert to time when human rights were formally anchored but their material establishment is not yet realized, or not at least to the extent expected corresponding to their real substance. The beginning of (...) the 90’s in Central and Eastern Europe was a success in that human rights began to be looked on as natural, forming the basis of democratic State respecting the rule of law. Today we are increasingly more often encountering the reality that human rights, on the contrary, to the same extent that they have been able to be established, they are losing in value. The biggest danger consists in the fact that limiting of human rights often is attended by silence, without wider public discussion or deliberations. The lack of qualified discussion during the limiting of human rights by way of laws and implementing regulations is however a systemic problem. Correction of its results can be often very complex and doing away with the causes a long term effort. It is dependent on the quality of representative democracy and of the civil society as well. This article is devoted to problem of implementation of evidence of data accompanying telecommunications traffic, the so-called data retention, and in its development from lack of legal regulation to roughly unconstitutional legal regulation and finally to hope for a reasonably constitutional solution. (shrink)

There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient’s rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare (...) professionals, regulators and policy makers. We used a qualitative design to examine Swiss healthcare stakeholders’ experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries’ patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients’ rights and citizens’ involvement on the other. The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

The article analyzes ethnic data collection pertaining to criminal justice in Hungary. With such a sensitive and delicate issue at hand, Hungary has decided on an evasive approach, resisting ethnic data collection by law enforcement authorities. The author argues that this approach has become one of the obstacles in fighting discrimination and ethnic profiling. Moreover, Hungary’s restrictive approach to ethno-national data classification also causes severe constitutional problems in other, noncriminal legal circumstances, where ethnic data is used (...) in the context of additional rights and affirmative protection provided for ethno-national minorities. The first part of the article describes general problems relating to ethnic data collection and analyses of the Hungarian minority protection framework, in particular, the minority self-government structure (a unique constitutional institution). The second part focuses on the criminal justice system; the author’s aim is to show that prohibiting the official recognition and collection of data on ethnicity by criminal justice authorities has potentially ethnically discriminatory consequences. (shrink)

This article focuses on the issue of data mining as it relates to the consumer and to the issue of whether the consumer's private information has any proprietary status. A brief review of data mining is provided as a background for a better understanding of the purposes and uses of data mining. Also examined are several issues of the ethics of data mining, including a review of stakeholders, who they are and which may be most seriously (...) affected by unethical data mining practices. Several suggestions for the improvement of data mining as it relates to the consumer are further presented: suggestions that would allow for data mining that would be beneficial to both the business community and the consumer. (shrink)

This article focuses on the issue of data mining as it relates to the consumer and to the issue of whether the consumer's private information has any proprietary status. A brief review of data mining is provided as a background for a better understanding of the purposes and uses of data mining. Also examined are several issues of the ethics of data mining, including a review of stakeholders, who they are and which may be most seriously (...) affected by unethical data mining practices. Several suggestions for the improvement of data mining as it relates to the consumer are further presented: suggestions that would allow for data mining that would be beneficial to both the business community and the consumer. (shrink)

Artificial Intelligence systems—and in particular various types of machine learning models—have significant potential for improving the performance and effectiveness of diagnostics and treatme...

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. (...) healthcare professionals, regulators and policy makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

This article introduces an important concept: Transparency by way of Humanistic Intelligence as a human right, and in particular, Big/little Data and Sur/sous Veillance, where “Little Data” is to sousveillance as “Big Data” is to surveillance. Veillance is a core concept not just in human–human interaction but also in terms of Human–Computer Interaction. In this sense, veillance is the core of Human-in-the-loop Intelligence, leading us to the concept of “Sousveillant Systems” which are forms of Human–Computer Interaction in (...) which internal computational states are made visible to end users, allowing users to “jump” into the computational feedback loop whenever or wherever they want. An important special case of Sousveillant Systems is that of scientific exploration: not only is data considered, but also due consideration must be given to how data is captured, understood, explored, and discovered, and in particular, to the use of scientific instruments to collect data and to make important new discoveries, and learn about the world. Science is a domain where bottom-up transparency is of the utmost importance, and scientists have the right and responsibility to be able to understand the instruments that they use to make their discoveries. Such instruments must be sousveillant systems! (shrink)

The increasing availability of digital data reflecting economic and human development, and in particular the availability of data emitted as a by-product of people’s use of technological devices and services, has both political and practical implications for the way people are seen and treated by the state and by the private sector. Yet the data revolution is so far primarily a technical one: the power of data to sort, categorise and intervene has not yet been explicitly (...) connected to a social justice agenda by the agencies and authorities involved. Meanwhile, although data-driven discrimination is advancing at a similar pace to data processing technologies, awareness and mechanisms for combating it are not. This paper posits that just as an idea of justice is needed in order to establish the rule of law, an idea of data justice – fairness in the way people are made visible, represented and treated as a result of their production of digital data – is necessary to determine ethical paths through a datafying world. Bringing together the emerging scholarly perspectives on this topic, I propose three pillars as the basis of a notion of international data justice: visibility, engagement with technology and antidiscrimination. These pillars integrate positive with negative rights and freedoms, and by doing so challenge both the basis of current data protection regulations and the growing assumption that being visible through the data we emit is part of the contemporary social contract. (shrink)

The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for ‘treatment refractory’ psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown‐status trials related (...) to psychiatric DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area. (shrink)

In this paper, we argue that there is at least a pro tanto reason to favor the control account of the right to privacy over the access account of the right to privacy. This conclusion is of interest due to its relevance for contemporary discussions related to surveillance policies. We discuss several ways in which the two accounts of the right to privacy can be improved significantly by making minor adjustments to their respective definitions. We then test the improved versions (...) of the two accounts on a test case, to see which account best explains the violation that occurs in the case. The test turns out in favor of the control account. (shrink)

In today’s digital societies, it has become very difficult for people to exercise meaningful control over what and how data is collected and used. McCoy and colleagues (2023) seek to address this p...

Several studies have documented that when presented with data from social media platforms machine learning (ML) models can make accurate predictions about users, e.g., about whether they are likely to suffer health-related conditions such as depression, mental disorders, and risk of suicide. In a recent article, Ploug (Philos Technol 36:14, 2023) defends a right not to be subjected to AI profiling based on publicly available data. In this comment, I raise some questions in relation to Ploug’s argument that (...) I think deserves further discussion. (shrink)

This paper investigates the conceptual possibility for, and the institutions relating to a positive right of private property to data. To do so, it distinguishes between structured data, as a designator, and datapoints, which are data embedded in the timeline. The reasoning being explored here is: the agents generating datapoints – he source of the data – have a right to private property to the datapoints they generate. The agents, then, can choose to retain the datapoints (...) or to sell them to data-users, aggregators, etc. Once these data-users render property of data themselves, they can further market it. There are, however, challenges to this view. One is the relative high cost of managing private property to data versus the relative low cost of misappropriating data and datapoints. The other is network effects: more precisely, data created or enriched in networks. (shrink)

In 2009, with the enactment of the Lisbon Treaty, the Charter of Fundamental Rights of the European Union entered into force. Under Article 8 of the Charter, for the first time, a stand-alone fundamental right to data protection was declared. The creation of this right, standing as a distinct right to the right to privacy, is undoubtedly significant, and it is unique to the European legal order, being absent from other international human rights instruments. This commentary examines (...) the parameters of this new right to data protection, asking what are the principles underpinning the right. It argues that the right reflects some key values inherent in the European legal order, namely: privacy, transparency, autonomy and nondiscrimination. It also analyses some of the challenges in implementing this right in an era of ubiquitous veillance practices and Big Data. (shrink)

This paper presents the results of an empirical study that reflects monitoring and evaluation of the implementation of some legal acts on the labour of the Republic of Lithuania. The analysis of legal documents at the national and international level is provided. A review of cognate studies conducted by foreign and Lithuanian researchers is presented and the professional situation of a Lithuanian teacher from the employee rights perspective is highlighted. The professional activities contexts and sectors, wherein systematic violations of (...) teachers’ rights to a healthy and safe working environment are possible, are distinguished. A lack of generalized scientific data of employee (especially teacher) working conditions, the actual security of relevant rights and its monitoring and evaluation is still felt both in the country and abroad. A contradiction between: a) insufficient research of the issue and b) its importance to science and practice, exactly presupposes the scientific problems of the empirical study presented in the given paper. The subject of the study: teachers’ rights to a healthy and safe working environment and a fair remuneration for their work. The objective of the study: to conduct monitoring and evaluation of the effective implementation of relevant legal norms and legal acts applying a written sociological survey. The study is based on the results of a mass country-wide written survey of teachers. (shrink)

Susser and Cabrera (2024) assess the role of bespoke neuro-privacy regulations including the creation of a novel right to mental privacy. They argue that focusing on what distinguishes mental priva...

Studies suggest that machine learning models may accurately predict depression and other mental health-related conditions based on social media data. I have recently argued that individuals should have sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. In a comment, Holm claims that there are scenarios in which individuals have a reason to prefer attempts of social control exercised on the basis of accurate AI predictions and that (...) the suggested right burdens individuals unfairly by allowing for those individuals to consent to AI profiling. In this reply, I address both of these alleged problems and their underlying assumptions and show why they fail to provide any reasons not to introduce the suggested right. (shrink)

Life on earth is bound together by a common heritage, centered around a molecule that is present in almost every living cell of every living creature. Deoxyribonucleic acid (DNA), composed of four base pairs, the nucleic acids thymine, adenine, cytosine, and guanine, encodes the data that directs, in conjunction with the environment, the development and metabolism of all nondependent living creatures. Except for some viruses that rely only on ribonucleic acid (RNA), all living things are built by the interaction (...) of DNA and RNA within cells and their environments. There is no worldwide consensus yet as to whether portions of the human genome should be granted intellectual property protection, as indeed they are in the United States and a number of other nations. DNA posed numerous challenges to the legal framework for patent protection and may suggest developing an entirely new social and legal category recognizing its uniqueness. (shrink)

The United Nations deemed internet access to be of critical importance for human rights in 2016. In 2020, schools around the world closed during the COVID-19 pandemic. As schools were closed, inequities in internet access gained widespread public attention as many educational opportunities shifted online. Amidst this shift, this paper analyzes an Ontario provincial announcement to provide 21,000 iPads and free data for young people, during the pandemic. The closure of schools in Ontario, Canada, meant that young people (...) and families who faced technological challenges, such as a lack of devices, stable and affordable internet connections, or sufficient data allowances, could experience barriers to their right to an education. This paper revisits a community informatics model of internet access, the Access Rainbow, to analyze attempts to operationalize the right to an education through technology in Ontario. In parallel to rights, however, the field of CI faces the ongoing presence of profit-oriented corporations within universal access efforts. This paper argues that socio-technical infrastructural elements of access to the internet became visible through the breakdown of the pandemic. Furthermore, it considers the multi-stakeholder efforts required to implement useful and effective access, where school boards responded in varied ways locally. The paper contributes the concept of refraction to offer continued theorization of a distributive paradigm and a rights-informed approach in community informatics against the backdrop of the pandemic, which could also act as an opening for privatization and disaster capitalism. (shrink)

Moving away from the strong body of critique of pervasive ‘bad data’ practices by both governments and private actors in the globalized digital economy, this book aims to paint an alternative, more optimistic but still pragmatic picture of the datafied future. The authors examine and propose ‘good data’ practices, values and principles from an interdisciplinary, international perspective. From ideas of data sovereignty and justice, to manifestos for change and calls for activism, this collection opens a multifaceted conversation (...) on the kinds of futures we want to see, and presents concrete steps on how we can start realizing good data in practice. (shrink)

After a brief overview of ethical issues in an Australian context catalyzed by the current pandemic, this article focuses on data protection in the light of recent debates about COVID-19 data tracking in Australia and globally. This article looks at the issue of trust as a fundamental principle of effective and ethical COVID-safe measures undertaken by the government. Key to ensuring such trust are Habermasian participatory dialogs, which assume trust as a condition of authentic illocution, and an emphasis (...) on short-term data capture. (shrink)

The World Bank estimates that over one billion people currently lack official identity documents. To tackle this crucial issue, the United Nations included the aim to provide legal identity for all by 2030 among the Sustainable Development Goals. Technology can be a powerful tool to reach this target. In the digital age, new technologies increasingly mediate identity verification and identification of individuals. Currently, State-led and public–private initiatives use technology to provide official identification, to control and secure external borders, and to (...) distribute humanitarian aid to populations in need. All of these initiatives have profound implications for the protection of human rights of those affected by them. Digital identity technologies may render individuals without legal documentation more visible and therefore less vulnerable to abuse and exploitation. However, they also present risks for the protection of individuals' human rights. As they build on personal data for identification and identity verification, data protection and privacy rights are most clearly affected. The prohibition of discrimination in the digital space is also of concern as these technological advances' societal impact is not yet fully understood. Accordingly, the article argues that emerging digital identity platforms will only contribute to the protection of human rights if the providers adequately mitigate any risks of potential discrimination and promote high standards of privacy and data protection. (shrink)

The technological solutions adopted during the current pandemic will have a lasting impact on our societies. Currently, COVID-19 health status certificates are being deployed around the world, including in Europe, the United States and China. When combined with identity verification, these digital and paper-based certificates allow individuals to prove their health status by showing recent COVID-19 tests results, full vaccination records or evidence of recovery from COVID-19. Most countries in the Global South, where vaccination rates are low, have not yet (...) fully implemented such certificates, although several initiatives are currently underway. That is, for instance, the case in the African Union. Yet, it is not sufficient to develop technical solutions for the verification of COVID-19 health status. Because technologies do not evolve in a legal vacuum, the existing laws and regulations must be respected. The risks of implementing such technologies must be anticipated and mitigated as much as possible before any large-scale deployment. Risk mitigation should also underpin strategies throughout the deployment of these certificates. This article evaluates the key legal implications of COVID-19 health status certificates for data privacy and human rights. In doing so, it contributes to the current debates, thus informing policymakers in this area of vital national and international interest. (shrink)

The paper has three parts. First, a survey and analysis is given ofthe structure of individual rights in the recent EU Directive ondata protection. It is argued that at the core of this structure isan unexplicated notion of what the data subject can `reasonablyexpect' concerning the further processing of information about himor herself. In the second part of the paper it is argued thattheories of privacy popular among philosophers are not able to shed much light on the issues (...) treated in the Directive, whichare, arguably, among the central problems pertaining to theprotection of individual rights in the information society. Inthe third part of the paper, some suggestions are made for a richerphilosophical theory of data protection and privacy. It is arguedthat this account is better suited to the task of characterizingthe central issues raised by the Directive. (shrink)

The first few years of the 21st century were characterised by a progressive loss of privacy. Two phenomena converged to give rise to the data economy: the realisation that data trails from users interacting with technology could be used to develop personalised advertising, and a concern for security that led authorities to use such personal data for the purposes of intelligence and policing. In contrast to the early days of the data economy and internet surveillance, the (...) last few years have witnessed a rising concern for privacy. As bad data practices have come to light, citizens are starting to understand the real cost of using online digital technologies. Two events stamped 2018 as a landmark year for privacy: the Cambridge Analytica scandal, and the implementation of the European Union’s General Data Protection Regulation (GDPR). The former showed the extent to which personal data has been shared without data subjects’ knowledge and consent and many times for unacceptable purposes, such as swaying elections. The latter inaugurated the beginning of robust data protection regulation in the digital age. Getting privacy right is one of the biggest challenges of this new decade of the 21st century. The past year has shown that there is still much work to be done on privacy to tame the darkest aspects of the data economy. As data scandals continue to emerge, questions abound as to how to interpret and enforce regulation, how to design new and better laws, how to complement regulation with better ethics, and how to find technical solutions to data problems. The aim of the research project Data, Privacy, and the Individual is to contribute to a better understanding of the ethics of privacy and of differential privacy. The outcomes of the project are seven research papers on privacy, a survey, and this final report, which summarises each research paper, and goes on to offer a set of reflections and recommendations to implement best practices regarding privacy. (shrink)

This chapter contains sections titled: The Current Conundrum The Objects of Our Study The Legal Framework So Far Special Challenges of DNA Property and Parts Autonomy, Individuality, and Personhood Economics and the Marketplace for Genes Ethics and Method An Outline for the Investigation The Challenge Ahead.

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by (...) the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the (...) normative legitimacy of the industry’s demand to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; (...) in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

Recent algorithmic technologies have challenged law’s anthropocentric assumptions. In this article, we develop a set of theoretical tools drawn from new materialisms and the philosophy of information to unravel the complex intra-actions between law and computer code. Accordingly, we first propose a framework for understanding the enmeshing of law and code based on a diffractive reading of Barad’s agential realism and Simondon’s theory of information. We argue that once law and code are understood as material entities that intra-act through in-formation, (...) the concept of transduction allows us to trace how they push each other towards change. After developing the theoretical tools, we deploy them to make sense of how law and code have changed in response to increasing automation of decision-making and the appearance of unexplainable artificial intelligence (AI) code. Thus, we employ a case study to trace transformations of the right to explanation under the European data protection regulations. This provides the backdrop for our account of how law transduces into code (and vice versa) and a proving ground for our framework. (shrink)

ICTs, personal data, digital rights, the GDPR, data privacy, online security… these terms, and the concepts behind them, are increasingly common in our lives. Some of us may be familiar with them, but others are less aware of the growing role of ICTs and data in our lives - and the potential risks this creates. These risks are even more pronounced for vulnerable groups in society. People can be vulnerable in different, often overlapping, ways, which place (...) them at a disadvantage to the majority of citizens; Table 3 in this guide presents some of the many forms and causes of vulnerability. As a result, vulnerable people need greater support to navigate the digital world, and to ensure that they are able to exercise their rights. This guide explains where such support can be found, and also answers the following questions: - What are the main ethical and legal issues around ICTs for vulnerable citizens? - Who is vulnerable in Europe? - How do issues around ICTs affect vulnerable people in particular? This guide is a resource for members of vulnerable groups, people who work with vulnerable groups, and citizens more broadly. It is also useful for data controllers1 who collect data about vulnerable citizens. While focused on citizens in Europe, it may be of interest to people in other parts of the world. It forms part of the Citizens’ Information Pack produced by the PANELFIT project, and is available in English, French, German, Italian and Spanish. You are welcome to translate this guide into other languages. Please send us a link to online versions in other languages, so that we can add them to the project website. (shrink)