Law, Technology and Humans最新文献

{"title":"Vulnerability, Digital Technologies and International Law: Reflections on Contemporary Migration Flows","authors":"M. Bartolomei, Antonia Cava","doi":"10.5204/lthj.3310","DOIUrl":"https://doi.org/10.5204/lthj.3310","url":null,"abstract":"Migration, considered a ‘total social fact’, remains one of the most debated topics in contemporary society. Unfortunately, migration is not always a positive experience for everyone. Certain categories of people, such as women, children, persecuted ethnic minorities, and those fleeing conflict zones, widespread violence and natural disasters, are undoubtedly more exposed to its adverse effects. The socially disadvantaged conditions of migrants can also overlap with the risk of exclusion from digital literacy. ‘Digital availability’ is an essential asset for networking through the entire period of migration, which varies according to the departure and destination contexts and skills of use. Vulnerability can be a key concept when it comes to exploring the connection between migration processes and increasing digitisation, with both positive and negative consequences. Despite the frequent use of the term ‘vulnerability’ in political and legal discourse, its normative content is neither always clear nor universally accepted. Often treated as a self-explanatory condition, it is habitually used to distinguish migrants according to specific groups based on precise characteristics – especially refugees or asylum seekers – without specifying how the notion is conceptually understood or defined. The aim of our work is to provide some suggestions about three different concepts of vulnerability (subjective, situational and structural), the impact of the legal concept of vulnerability on migration processes and how situations of vulnerability are sometimes accentuated by the spread of media and social media.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"46 19","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141121877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Why Are There So Many Digital Identities?","authors":"Mitchell Landrigan, Stephen Wilson, Hamish Fraser","doi":"10.5204/lthj.3096","DOIUrl":"https://doi.org/10.5204/lthj.3096","url":null,"abstract":"This article analyses why people have so many digital identities and offers suggestions to reduce the numbers to more reasonable levels.  Digital identity thinking has been dominated by the objective of general-purpose reusable identity as a response to the unwieldy profusion of identifiers that came with expanding ecommerce. The notion of reusable digital identity is somewhat intuitive, energised by the mental model of humans exercising a virtual self in cyberspace. Many user interfaces are constructed to exhibit an intentional stance suggestive of humans having a digital counterpart making our digital actions more lifelike and comprehensible. \u0000In some nations, there is a precedent for national identity, which makes general-purpose digital identity culturally more logical, even appealing. In common law countries, however, the market for reusable digital identity is still not mature. To date, there is no solid business case for general purpose reusable identity - largely because it proves costlier than expected to reengineer transactional identifiers to align (or federate) with an intuitive singular digital identity. Thus, individuals must manage many siloed, special purpose identifiers, account names, passwords, and piecemeal authenticators. \u0000If transactional identifiers go hand in hand with transaction systems, then there will likely remain a need for about as many identifiers as there are transactional services. Recent technology developments, especially in cryptographic verifiable credentials and mobile digital wallets, may provide ways to automate the management of multiple identifiers and achieve the desired usability anticipated from singular identity without disrupting the forces that have led to transaction specific identification.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"6 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138584344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulating Artificial Intelligence and Machine Learning-Enabled Medical Devices in Europe and the United Kingdom","authors":"Phoebe Li, Robin Williams, S. Gilbert, Stuart Anderson","doi":"10.5204/lthj.3073","DOIUrl":"https://doi.org/10.5204/lthj.3073","url":null,"abstract":"Recent achievements in respect of Artificial Intelligence (AI) open up opportunities for new tools to assist medical diagnosis and care delivery. However, the typical process for the development of AI is through repeated cycles of learning and implementation, something that poses challenges to our existing system of regulating medical devices. Product developers face tensions between the benefits of continuous improvement/deployment of algorithms and keeping products unchanged. The latter more easily facilitates collecting evidence for safety assurance processes but sacrifices optimisation of performance and adaptation to user needs gained through learning-implementation cycles. The challenge is how to balance potential benefits with the need to assure their safety. Governance and assurance processes are needed that can accommodate real-time or near-real-time machine learning. Such an approach is of great importance in healthcare and other fields of application. AI has stimulated an intense process of learning as this new technology embeds in application contexts. The process is not only about the application of AI in the real world but also about the institutional arrangements for its safe and dependable deployment, including regulatory experimentation involving new market pathways, monitoring and surveillance, and sandbox schemes. We review the key themes, challenges and potential solutions raised at two stakeholder workshops and highlight recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"51 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139250906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biometric Harm","authors":"Sara Migliorini","doi":"10.5204/lthj.2830","DOIUrl":"https://doi.org/10.5204/lthj.2830","url":null,"abstract":"This article argues in favour of the recognition of biometric harm, which is a specific type of harm arising from the use of biometrics to identify and classify people without a valid legal justification. The importance and pervasiveness of biometric technologies have increased. The development of biometric systems is rapidly advancing; however, their potential negative implications for individuals and society are routinely dismissed or willingly ignored. Biometrics deeply affects some of the basic needs of humans, including the need to step out of one’s social identities to enjoy unobserved time and the need to self-represent oneself in all social relationships. Such necessities are preserved by the legal system via high-ranked provisions that protect personhood, dignity, the right to private life and the right to express one’s personality. Because of these negative effects on core human necessities and legal values, this paper submits that biometric identification should be considered harmful, unless justified by another equally fundamental legal value. In line with other restrictions of the involved fundamental values, necessity and law enforcement purposes may justify biometric identification. Conversely, it is submitted that consent, while essential, does not fulfil the requirements of a stand-alone justification for biometric harm.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"45 S1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139252470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas","authors":"Antonia J Cronin, Rebecca Thom, Vanguard","doi":"10.5204/lthj.3118","DOIUrl":"https://doi.org/10.5204/lthj.3118","url":null,"abstract":"Regenerative medicine solutions for type 1 diabetes are a rapidly developing field of medical technology. So far, these solutions have been principally cell-based treatments and, at present, in Europe, are regulated under the European Union regulations for Advanced Therapy Medicinal Products (ATMPs). But now, new, emerging technology combining cellular therapy with medical devices is under development. The potential of this novel hybrid model to create a bioartificial pancreas is tantalising. However, incorporating medical devices creates a further layer of complexity to an already challenging product development process. Moreover, it raises important questions about how bioartificial organs should be regulated. This article seeks to expose the complexity of the legal and regulatory landscape relating to such products, focusing on the laws of the European Union and, where appropriate, bringing in examples from other jurisdictions. We set out the role of the European Medicines Agency (EMA) and review the classification of existing ATMPs and those proposed for type 1 diabetes to highlight the potential consequences and effects of nomenclature and classifications. We argue that emerging hybrid regenerative medicine solutions at the intersection of cellular and medical device therapies, in which medical devices are integral to and facilitate the cell therapy mechanism of action, are not satisfactorily accounted for in the existing legal paradigm regulating regenerative medical therapies. We suggest that these functional hybrid products, currently in their infancy, may yet have far-reaching implications for the interface of law, regulation and technology. For example, they are likely to challenge the conventional discourse related to a market in (bioartificial) organs. We recommend that the EMA, national competent authorities for medical devices, national transplantation authorities and those responsible for overseeing translational clinical research respond to this by developing the existing regulatory framework in such a way that captures the essence of these hybrid products as a single entity. Issuing guidance on updated regulations to researchers engaged in this emerging technology will be key to the success of its translation into human therapies.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139253831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contraception, Fertility Tracking, and the Limits of Medical Devices Regulation","authors":"C. McMillan","doi":"10.5204/lthj.3047","DOIUrl":"https://doi.org/10.5204/lthj.3047","url":null,"abstract":"Many technologies in mobile health (mHealth) available for private purchase and use are becoming available in smartphone app stores worldwide. Of key concern is the proliferation of fertility-related ‘femtech’ (FRF), a category of software that is increasingly being used by women, girls and people with wombs as their main contraceptive method. Contraceptives are an important part of women’s health, and like any other medicine, they are stringently regulated in the United Kingdom (UK). ‘Digital contraceptive’ software, when marketed as such, normally falls within the definition of a ‘medical device’ and is regulated by the UK’s medical devices regime. However, some apps that may be used as digital contraceptives through tracking users’ ‘fertile windows’ sit outwith this framework and thus leave their users at risk of unplanned pregnancy. Software as a medical device (SaMD) is rapidly growing beyond the vision of the current medical devices regime, even within the past few years. This paper explores, in depth, the urgent issue of regulatory inadequacy when it comes to femtech software that may be used for contraceptive purposes. Law and regulation in this field, as they are currently constituted, are ill equipped to capture the types of mHealth and personal health tracking technologies that, normatively speaking, ought to be caught by the medical devices regime. Therefore, it is posited that while FRF poses a distinct challenge for law and regulation in that FRF may cause unwanted pregnancies, the specific issue of regulatory inadequacy posed is symptomatic of a broader problem faced by the medical devices regime.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"29 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139253226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Yeslam Al-Saggaf (2022) The Psychology of Phubbing. Springer Singapore","authors":"Katherine Herbert","doi":"10.5204/lthj.3103","DOIUrl":"https://doi.org/10.5204/lthj.3103","url":null,"abstract":"Katherine Herbert reviews The Psychology of Phubbing by Yeslam Al-Saggaf","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"84-86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139250960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Cybersecurity in Medical Devices Regulation: Future Considerations and Solutions","authors":"K. Ludvigsen","doi":"10.5204/lthj.3080","DOIUrl":"https://doi.org/10.5204/lthj.3080","url":null,"abstract":"The cybersecurity of medical devices is paramount in a world where everything is increasingly digitised. Attention to how this important defence against malicious actors is regulated must, therefore, also increase. This paper uncovers how the cybersecurity of medical devices is currently regulated and how it can be improved going forward. First, the paper compares the regulation of medical device cybersecurity in the European Union, the United States and the United Kingdom (UK)—differentiating between Great Britain and Northern Ireland as per the current state of the law in the UK. Second, the paper develops a model of how cybersecurity shapes three key areas in the ecosystem of medical devices. These areas are the medical device itself; the structure between the surrounding institutional systems (such as manufacturers and healthcare providers); and the security of the data, the surrounding institutional system and the medical device. Third, based on a comparative analysis and a view of the system from above, the paper puts forward four recommendations on what future regulation should contain to properly regulate the cybersecurity of medical devices: technology specificity, circumvention protection, genuine privacy and security by design. The paper recommends that these four principles be followed. Technology specificity because it guarantees legislation that understands the necessary technical aspects to promote security and safety. Circumvention protection because preventing manufacturers and others from circumventing these requirements decreases risks to the health and wellbeing of patients. Finally, genuine privacy and security by design should be followed to align cybersecurity and privacy with current and future technical capacities.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"132 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139251923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Futures and Medical Devices: Where Next for Europe and the United Kingdom?","authors":"Muireann Quigley, Laura Downey, Joseph T. F. Roberts","doi":"10.5204/lthj.3174","DOIUrl":"https://doi.org/10.5204/lthj.3174","url":null,"abstract":"The symposium in this issue of Law, Technology and Humans brings together a range of scholars looking at the broad question of where next for medical devices regulation in the European Union (EU) and the United Kingdom (UK). Initially arising out of a workshop held in September 2022,[1] our motivation for the symposium is rooted in the challenges raised by what has been a significant period of change in both the EU and the UK when it comes to medical devices regulation.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"35 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139251989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Independent Medicines and Medical Devices Safety Review: Regulatory Reform and Remedies","authors":"Sonia Macleod","doi":"10.5204/lthj.3083","DOIUrl":"https://doi.org/10.5204/lthj.3083","url":null,"abstract":"For years, groups of patients and their families in the United Kingdom raised their concerns about three medical interventions. The first was a possible link between hormone pregnancy tests and fetal malformations and deaths; the second was the physical and neurodevelopmental impacts of in utero valproate exposure; and the third was life-changing adverse events caused by pelvic mesh implants for pelvic organ prolapse repair and stress urinary incontinence management. In response to their tireless campaigning, the Independent Medicines and Medical Devices Safety (IMMDS) Review was commissioned by the Secretary of State for Health and Social Care in 2018. The review, chaired by Baroness Cumberlege, found a catalogue of institutional, systems and structural failures within both the medical establishment and healthcare system more broadly. Drawing on the IMMDS Review findings on pelvic mesh, in this article, I consider the dire consequences when medical devices go wrong. Drawing on firsthand experience as lead researcher for the IMMDS Review, I examine some of the background, outline some key findings and reflect on the strategic changes recommended to medical device regulation and the redress prompted by the pelvic mesh scandal. In so doing, I contextualise and consider the relevant regulatory frameworks, the fundamental systems failures and the other issues identified. Three years on, this article also provides an opportunity to assess the extent to which the IMMDS Review recommendations have been successfully operationalised, as well as to take stock of the improvements that still need to be made.","PeriodicalId":397638,"journal":{"name":"Law, Technology and Humans","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139251604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}