Pub Date : 2024-02-01eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsae001
Regina Becker, Davit Chokoshvili, Adrian Thorogood, Edward S Dove, Fruzsina Molnár-Gábor, Alexandra Ziaka, Olga Tzortzatou-Nanopoulou, Giovanni Comandè
The General Data Protection Regulation (GDPR) of the European Union, which became applicable in 2018, contains a new accountability principle. Under this principle, controllers (ie parties determining the purposes and the means of the processing of personal data) are responsible for ensuring and demonstrating the overall compliance with the GDPR. However, interpretive uncertainties of the GDPR mean that controllers must exercise considerable judgement in designing and implementing an appropriate compliance strategy, making GDPR compliance both complex and resource-intensive. In this article, we provide conceptual clarity around GDPR compliance with respect to one core aspect of the law: the determination and relevance of the purpose of personal data processing. We derive from the GDPR's text concrete requirements for purpose specification, which we subsequently apply to the area of secondary use of personal data for scientific research. We offer guidance for correctly specifying purposes of data processing under different research scenarios. To illustrate the practical necessity of purpose specification for GDPR compliance, we then show how our proposed approach can enable controllers to meet their compliance obligations, using the example of the overarching GDPR principle of lawfulness to highlight the relevance of purpose specification for the identification of a suitable legal basis.
{"title":"Purpose definition as a crucial step for determining the legal basis under the GDPR: implications for scientific research.","authors":"Regina Becker, Davit Chokoshvili, Adrian Thorogood, Edward S Dove, Fruzsina Molnár-Gábor, Alexandra Ziaka, Olga Tzortzatou-Nanopoulou, Giovanni Comandè","doi":"10.1093/jlb/lsae001","DOIUrl":"https://doi.org/10.1093/jlb/lsae001","url":null,"abstract":"<p><p>The General Data Protection Regulation (GDPR) of the European Union, which became applicable in 2018, contains a new accountability principle. Under this principle, controllers (ie parties determining the purposes and the means of the processing of personal data) are responsible for ensuring and demonstrating the overall compliance with the GDPR. However, interpretive uncertainties of the GDPR mean that controllers must exercise considerable judgement in designing and implementing an appropriate compliance strategy, making GDPR compliance both complex and resource-intensive. In this article, we provide conceptual clarity around GDPR compliance with respect to one core aspect of the law: the determination and relevance of the purpose of personal data processing. We derive from the GDPR's text concrete requirements for purpose specification, which we subsequently apply to the area of secondary use of personal data for scientific research. We offer guidance for correctly specifying purposes of data processing under different research scenarios. To illustrate the practical necessity of purpose specification for GDPR compliance, we then show how our proposed approach can enable controllers to meet their compliance obligations, using the example of the overarching GDPR principle of lawfulness to highlight the relevance of purpose specification for the identification of a suitable legal basis.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10834358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139681961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-26eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsad030
Danielle M Pacia, Beatrice L Brown, Timo Minssen, Jonathan J Darrow
{"title":"CRISPR-phage antibacterials to address the antibiotic resistance crisis: scientific, economic, and regulatory considerations.","authors":"Danielle M Pacia, Beatrice L Brown, Timo Minssen, Jonathan J Darrow","doi":"10.1093/jlb/lsad030","DOIUrl":"https://doi.org/10.1093/jlb/lsad030","url":null,"abstract":"","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10817822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139572094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-18eCollection Date: 2024-01-01DOI: 10.1093/jlb/lsad032
Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany
As we approach an era of potentially widespread consumer neurotechnology, scholars and organizations worldwide have started to raise concerns about the data privacy issues these devices will present. Notably absent in these discussions is empirical evidence about how the public perceives that same information. This article presents the results of a nationwide survey on public perceptions of brain data, to inform discussions of law and policy regarding brain data governance. The survey reveals that the public may perceive certain brain data as less sensitive than other 'private' information, like social security numbers, but more sensitive than some 'public' information, like media preferences. The findings also reveal that not all inferences about mental experiences may be perceived as equally sensitive, and perhaps not all data should be treated alike in ethical and policy discussions. An enhanced understanding of public perceptions of brain data could advance the development of ethical and legal norms concerning consumer neurotechnology.
{"title":"U.S. public perceptions of the sensitivity of brain data.","authors":"Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany","doi":"10.1093/jlb/lsad032","DOIUrl":"10.1093/jlb/lsad032","url":null,"abstract":"<p><p>As we approach an era of potentially widespread consumer neurotechnology, scholars and organizations worldwide have started to raise concerns about the data privacy issues these devices will present. Notably absent in these discussions is empirical evidence about how the public perceives that same information. This article presents the results of a nationwide survey on public perceptions of brain data, to inform discussions of law and policy regarding brain data governance. The survey reveals that the public may perceive certain brain data as less sensitive than other 'private' information, like social security numbers, but more sensitive than some 'public' information, like media preferences. The findings also reveal that not all inferences about mental experiences may be perceived as equally sensitive, and perhaps not all data should be treated alike in ethical and policy discussions. An enhanced understanding of public perceptions of brain data could advance the development of ethical and legal norms concerning consumer neurotechnology.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10800024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The sharing of health data is an essential component in the provision of healthcare, in medical research, and disease surveillance. Health data sharing is subject to regulatory frameworks that vary across jurisdictions. In Africa, numerous factors complicate the regulation of health data sharing, including technological, motivational, economic, and political barriers, as well as ethical and legal challenges. This comparative study examines the regulation of health data sharing in Africa by comparing and contrasting the legal and policy frameworks of five African countries. The study identifies gaps and inconsistencies in the current regulatory regimes and provides recommendations for improving the regulation of health data sharing in Africa.
{"title":"The regulation of health data sharing in Africa: a comparative study.","authors":"Annelize G Nienaber McKay, Dirk Brand, Marietjie Botes, Nezerith Cengiz, Marno Swart","doi":"10.1093/jlb/lsad035","DOIUrl":"10.1093/jlb/lsad035","url":null,"abstract":"<p><p>The sharing of health data is an essential component in the provision of healthcare, in medical research, and disease surveillance. Health data sharing is subject to regulatory frameworks that vary across jurisdictions. In Africa, numerous factors complicate the regulation of health data sharing, including technological, motivational, economic, and political barriers, as well as ethical and legal challenges. This comparative study examines the regulation of health data sharing in Africa by comparing and contrasting the legal and policy frameworks of five African countries. The study identifies gaps and inconsistencies in the current regulatory regimes and provides recommendations for improving the regulation of health data sharing in Africa.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10800019/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-13eCollection Date: 2023-07-01DOI: 10.1093/jlb/lsad034
Gratien Dalpé, Katherine Huerne, Charles Dupras, Katherine Cheung, Nicole Palmour, Eva Winkler, Karla Alex, Maxwell Mehlman, John W Holloway, Eline Bunnik, Harald König, Isabelle M Mansuy, Marianne G Rots, Cheryl Erwin, Alexandre Erler, Emanuele Libertini, Yann Joly
Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers' health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers' minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and societal issues surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers' rights and ethical questions about using epigenetic engineering for soldiers' enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts.
{"title":"Defusing the legal and ethical minefield of epigenetic applications in the military, defense, and security context.","authors":"Gratien Dalpé, Katherine Huerne, Charles Dupras, Katherine Cheung, Nicole Palmour, Eva Winkler, Karla Alex, Maxwell Mehlman, John W Holloway, Eline Bunnik, Harald König, Isabelle M Mansuy, Marianne G Rots, Cheryl Erwin, Alexandre Erler, Emanuele Libertini, Yann Joly","doi":"10.1093/jlb/lsad034","DOIUrl":"https://doi.org/10.1093/jlb/lsad034","url":null,"abstract":"<p><p>Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers' health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers' minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and societal issues surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers' rights and ethical questions about using epigenetic engineering for soldiers' enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10719446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138813228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract The use of Artificial Intelligence (AI) medical devices is rapidly growing. Although AI may benefit the quality and safety of healthcare for older adults, it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explains how ‘digital ageism’ is produced throughout the entire lifecycle of medical AI and may lead to health inequity for older people: systemic, avoidable differences in the health status of different population groups. This paper takes digital ageism as a use case to show the potential inequitable effects of AI, conceptualized as the ‘AI cycle of health inequity’. The second part of this paper explores how the European Union (EU) regulatory framework addresses the issue of digital ageism. It argues that the negative effects of age-related bias in AI medical devices are insufficiently recognized within the regulatory framework of the EU Medical Devices Regulation and the new AI Act. It concludes that while the EU framework does address some of the key issues related to technical biases in AI medical devices by stipulating rules for performance and data quality, it does not account for contextual biases, therefore neglecting part of the AI cycle of health inequity.
{"title":"The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices","authors":"Hannah van Kolfschooten","doi":"10.1093/jlb/lsad031","DOIUrl":"https://doi.org/10.1093/jlb/lsad031","url":null,"abstract":"Abstract The use of Artificial Intelligence (AI) medical devices is rapidly growing. Although AI may benefit the quality and safety of healthcare for older adults, it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explains how ‘digital ageism’ is produced throughout the entire lifecycle of medical AI and may lead to health inequity for older people: systemic, avoidable differences in the health status of different population groups. This paper takes digital ageism as a use case to show the potential inequitable effects of AI, conceptualized as the ‘AI cycle of health inequity’. The second part of this paper explores how the European Union (EU) regulatory framework addresses the issue of digital ageism. It argues that the negative effects of age-related bias in AI medical devices are insufficiently recognized within the regulatory framework of the EU Medical Devices Regulation and the new AI Act. It concludes that while the EU framework does address some of the key issues related to technical biases in AI medical devices by stipulating rules for performance and data quality, it does not account for contextual biases, therefore neglecting part of the AI cycle of health inequity.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138593818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-09eCollection Date: 2023-07-01DOI: 10.1093/jlb/lsad028
Alexandra Mullock, Elizabeth Chloe Romanis
Cryonics, the 'freezing' of the human body after death in the hope of reanimation in the future, remains a remote possibility, and yet it is becoming a more popular choice. There has been much academic discussion of the ethics of cryopreservation; however, the legal problems have received little attention. There are, however, several potential current conflicts that might arise, as was illustrated by the case of JS in England, in which a 14-year-old girl who sought cryopreservation against her father's wishes. In the USA, there have been disputes within families about cryonic preservation, and between cryonics organizations and loved ones of the deceased when there is negligent preservation. Cryopreservation raises questions concerning the law on death and posthumous interests, property in the body, contract law, and (potentially) negligence. We argue that, in the absence of proper regulation, cryonics organizations may be able to exploit the dying and dead. The potential legal problems that we have identified in relation to the law in England and Wales demonstrate that the law is ill-equipped to protect the interests of the dead and their next of kin.
{"title":"Cryopreservation and current legal problems: seeking and selling immortality.","authors":"Alexandra Mullock, Elizabeth Chloe Romanis","doi":"10.1093/jlb/lsad028","DOIUrl":"https://doi.org/10.1093/jlb/lsad028","url":null,"abstract":"<p><p>Cryonics, the 'freezing' of the human body after death in the hope of reanimation in the future, remains a remote possibility, and yet it is becoming a more popular choice. There has been much academic discussion of the ethics of cryopreservation; however, the legal problems have received little attention. There are, however, several potential current conflicts that might arise, as was illustrated by the case of <i>JS</i> in England, in which a 14-year-old girl who sought cryopreservation against her father's wishes. In the USA, there have been disputes within families about cryonic preservation, and between cryonics organizations and loved ones of the deceased when there is negligent preservation. Cryopreservation raises questions concerning the law on death and posthumous interests, property in the body, contract law, and (potentially) negligence. We argue that, in the absence of proper regulation, cryonics organizations may be able to exploit the dying and dead. The potential legal problems that we have identified in relation to the law in England and Wales demonstrate that the law is ill-equipped to protect the interests of the dead and their next of kin.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10639002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89720819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-01eCollection Date: 2023-07-01DOI: 10.1093/jlb/lsad027
Elizabeth Chloe Romanis
A growing body of literature examines the ethico-legal challenges resulting from novel forms of assisted gestation like uterus transplantation and artificial placentas (also known as 'artificial wombs'). However, there has not yet been consideration of reproductive rights organizations/advocates' understandings of novel forms of assisted gestation and their challenges. These perspectives provide critical insight into how novel procreative practices are understood and the problems and pressures that might arise from their use. This is the first legal article to engage with reproductive rights organizations/advocates and thus it provides important contextual grounding to existing scholarship about assisted gestation. Focus group discussion epitomized the need for legal reform in key areas surrounding reproduction. Themes were constructed that exemplify what participants highlighted as critical: the need to re-evaluate the fundamentals of legal parenthood, consideration of how novel technologies could further enable the policing of gestation, and the space and time needed for law-making.
{"title":"<i>'The law is very, very outdated and not keeping up with the technology':</i> novel forms of assisted gestation, legal challenges, and perspectives of reproductive rights advocates in England and Wales.","authors":"Elizabeth Chloe Romanis","doi":"10.1093/jlb/lsad027","DOIUrl":"https://doi.org/10.1093/jlb/lsad027","url":null,"abstract":"<p><p>A growing body of literature examines the ethico-legal challenges resulting from novel forms of assisted gestation like uterus transplantation and artificial placentas (also known as 'artificial wombs'). However, there has not yet been consideration of reproductive rights organizations/advocates' understandings of novel forms of assisted gestation and their challenges. These perspectives provide critical insight into how novel procreative practices are understood and the problems and pressures that might arise from their use. This is the first legal article to engage with reproductive rights organizations/advocates and thus it provides important contextual grounding to existing scholarship about assisted gestation. Focus group discussion epitomized the need for legal reform in key areas surrounding reproduction. Themes were constructed that exemplify what participants highlighted as critical: the need to re-evaluate the fundamentals of legal parenthood, consideration of how novel technologies could further enable the policing of gestation, and the space and time needed for law-making.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71523522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-26eCollection Date: 2023-07-01DOI: 10.1093/jlb/lsad025
Matthew R O'Shaughnessy, Walter G Johnson, Lucille Nalbach Tournas, Christopher J Rozell, Karen S Rommelfanger
Innovations in neurotechnologies have ignited conversations about ethics around the world, with implications for researchers, policymakers, and the private sector. The human rights impacts of neurotechnologies have drawn the attention of United Nations bodies; nearly 40 states are tasked with implementing the Organization for Economic Co-operation and Development's principles for responsible innovation in neurotechnology; and the United States is considering placing export controls on brain-computer interfaces. Against this backdrop, we offer the first review and analysis of neuroethics guidance documents recently issued by prominent government, private, and academic groups, focusing on commonalities and divergences in articulated goals; envisioned roles and responsibilities of different stakeholder groups; and the suggested role of the public. Drawing on lessons from the governance of other emerging technologies, we suggest implementation and evaluation strategies to guide practitioners and policymakers in operationalizing these ethical norms in research, business, and policy settings.
{"title":"Neuroethics guidance documents: principles, analysis, and implementation strategies.","authors":"Matthew R O'Shaughnessy, Walter G Johnson, Lucille Nalbach Tournas, Christopher J Rozell, Karen S Rommelfanger","doi":"10.1093/jlb/lsad025","DOIUrl":"10.1093/jlb/lsad025","url":null,"abstract":"<p><p>Innovations in neurotechnologies have ignited conversations about ethics around the world, with implications for researchers, policymakers, and the private sector. The human rights impacts of neurotechnologies have drawn the attention of United Nations bodies; nearly 40 states are tasked with implementing the Organization for Economic Co-operation and Development's principles for responsible innovation in neurotechnology; and the United States is considering placing export controls on brain-computer interfaces. Against this backdrop, we offer the first review and analysis of neuroethics guidance documents recently issued by prominent government, private, and academic groups, focusing on commonalities and divergences in articulated goals; envisioned roles and responsibilities of different stakeholder groups; and the suggested role of the public. Drawing on lessons from the governance of other emerging technologies, we suggest implementation and evaluation strategies to guide practitioners and policymakers in operationalizing these ethical norms in research, business, and policy settings.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10602660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71415406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-14eCollection Date: 2023-07-01DOI: 10.1093/jlb/lsad026
Calvin W L Ho
Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively to its data environment through ML, the current risk-based regulatory approaches are inadequate in facilitating this technological progression. Recent and innovative regulatory changes introduced to regulate AIMDs as a software, or 'software as a medical device' (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time) reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. These features are better explained by a rights-based approach and consistent with the human right to science (HRS). With reference to the recent explication of the normative content of HRS by the Committee on Economic, Social and Cultural Rights of the United Nations, this paper explains why a rights-based approach that is centred on HRS could be a more effective response to the regulatory challenges posed by AIMDs. The paper also considers how such a rights-based approach could be implemented in the form of a regulatory network that draws on a 'common fund of knowledges' to formulate anticipatory responses to adaptive AIMDs. In essence, the HRS provides both the mandate and the obligation for states to ensure that regulatory governance of high connectivity AIMDs become increasingly collaborative and participatory in approach and pluralistic in substance.
{"title":"Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare.","authors":"Calvin W L Ho","doi":"10.1093/jlb/lsad026","DOIUrl":"https://doi.org/10.1093/jlb/lsad026","url":null,"abstract":"<p><p>Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively to its data environment through ML, the current risk-based regulatory approaches are inadequate in facilitating this technological progression. Recent and innovative regulatory changes introduced to regulate AIMDs as a software, or 'software as a medical device' (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time) reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. These features are better explained by a rights-based approach and consistent with the human right to science (HRS). With reference to the recent explication of the normative content of HRS by the Committee on Economic, Social and Cultural Rights of the United Nations, this paper explains why a rights-based approach that is centred on HRS could be a more effective response to the regulatory challenges posed by AIMDs. The paper also considers how such a rights-based approach could be implemented in the form of a regulatory network that draws on a 'common fund of knowledges' to formulate anticipatory responses to adaptive AIMDs. In essence, the HRS provides both the mandate and the obligation for states to ensure that regulatory governance of high connectivity AIMDs become increasingly collaborative and participatory in approach and pluralistic in substance.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2023-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49685506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}