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  1. Article ; Online: European patent protection for medical uses of known products and drug repurposing.

    Aboy, Mateo / Liddell, Kathleen / Jordan, Matthew / Crespo, Cristina / Liddicoat, Johnathon

    Nature biotechnology

    2022  Volume 40, Issue 4, Page(s) 465–471

    MeSH term(s) Drug Repositioning
    Language English
    Publishing date 2022-04-13
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1311932-1
    ISSN 1546-1696 ; 1087-0156
    ISSN (online) 1546-1696
    ISSN 1087-0156
    DOI 10.1038/s41587-022-01269-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Standard contractual clauses for cross-border transfers of health data after

    Bradford, Laura / Aboy, Mateo / Liddell, Kathleen

    Journal of law and the biosciences

    2021  Volume 8, Issue 1, Page(s) lsab007

    Abstract: Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) ... ...

    Abstract Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in
    Language English
    Publishing date 2021-06-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsab007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Human embryo models: the importance of national policy and governance review.

    Foreman, Amy L / Liddell, Kathleen / Franklin, Sarah / Jackson, Emily / Rozeik, Christina / Niakan, Kathy K

    Current opinion in genetics & development

    2023  Volume 82, Page(s) 102103

    Abstract: Integrated and non-integrated stem cell-based embryo models are becoming widely adopted tools in biomedical research with distinct advantages over animal models for studying human development. Although SCB-EMs have tremendous benefits for research, they ... ...

    Abstract Integrated and non-integrated stem cell-based embryo models are becoming widely adopted tools in biomedical research with distinct advantages over animal models for studying human development. Although SCB-EMs have tremendous benefits for research, they raise a number of social, ethical and legal questions that affect future research and widespread adoption in industry and clinical settings. The 2021 International Society for Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation provide helpful guidance on many of these issues but do not have force in domestic law. Careful appraisal and development of national legal and ethical frameworks is crucial. Paving the way to better regulation provides an ethical and social foundation to continue using human embryo models and to fully realise their potential benefits for reproductive medicine.
    MeSH term(s) Animals ; Humans ; Biomedical Research ; Embryo, Mammalian ; Policy ; Stem Cells
    Language English
    Publishing date 2023-08-22
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 1077312-5
    ISSN 1879-0380 ; 0959-437X
    ISSN (online) 1879-0380
    ISSN 0959-437X
    DOI 10.1016/j.gde.2023.102103
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Differentiating Negligent Standards of Care in Diagnosis.

    Liddell, Kathleen / Skopek, Jeffrey M / Le Gallez, Isabelle / Fritz, Zoë

    Medical law review

    2022  Volume 30, Issue 1, Page(s) 33–59

    Abstract: Diagnosis lies at the heart of the medical encounter, yet it has received much less attention than treatment. It is widely assumed that negligent diagnosis claims should be governed by the Bolam test, but we demonstrate that this is not always the case. ... ...

    Abstract Diagnosis lies at the heart of the medical encounter, yet it has received much less attention than treatment. It is widely assumed that negligent diagnosis claims should be governed by the Bolam test, but we demonstrate that this is not always the case. First, we disaggregate the diagnostic process into three different acts: forming the diagnosis, communicating it to the patient, and recording it. Second, we consider alternatives to Bolam for defining negligence, including less deferential profession-led standards, patient-led standards, and even a reasonable person standard. Third, bringing together these distinctions-within the diagnostic process, and between standards of care-we reveal the unappreciated complexity of negligent diagnosis. Analysing the standard of care that might apply to the three different acts in the diagnostic process, we identify reasons to think that Montgomery should apply to the communication of a diagnosis. We also argue that even in areas where the law is well-established, such as the application of Bolam to the formation of a diagnosis, challenging questions arise that require further attention. Throughout, the framework and analysis that we develop have significant implications for a set of negligence cases, as well as for medical education, clinical guidelines, and patient care.
    MeSH term(s) Humans ; Malpractice ; Standard of Care
    Language English
    Publishing date 2022-01-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 1197078-9
    ISSN 1464-3790 ; 0967-0742
    ISSN (online) 1464-3790
    ISSN 0967-0742
    DOI 10.1093/medlaw/fwab046
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The frontiers of medical negligence and diagnosis: an interview-based analysis.

    Mackley, Annie / Liddell, Kathleen / Skopek, Jeffrey M / Le Gallez, Isabelle / Fritz, Zoë

    Medical law review

    2023  Volume 31, Issue 4, Page(s) 485–500

    Abstract: While errors in medical diagnosis are common and often litigated, the different dimensions of diagnosis-formation, communication, recording-have received much less legal attention. When the process of diagnosis is differentiated in this way, new and ... ...

    Abstract While errors in medical diagnosis are common and often litigated, the different dimensions of diagnosis-formation, communication, recording-have received much less legal attention. When the process of diagnosis is differentiated in this way, new and contentious legal questions emerge that challenge the appropriateness of the Bolam/Bolitho standard. To explore these challenges, we interviewed 31 solicitors and barristers and asked them: (i) whether Montgomery should apply to information about alternative diagnoses; and (ii) whether the Bolam/Bolitho standard should be rejected in 'pure diagnosis' cases. Our qualitative analysis of the interviews sheds light not only on the two questions posed, but also on three cross-cutting themes. First, Bolam/Bolitho is criticised on two grounds that are often conflated: its paternalism for patients and its deference to medical professionals. Second, adopting different standards for different aspects of treatment and diagnosis may be justified in principle, but it can sometimes be difficult or not make sense in practice. Third, new conceptions of patients, doctors, and courts are being articulated in terms of rights or responsibilities over risks. In mapping these issues at the frontiers of medical negligence, this empirical study identifies potential pressure points for future legal developments.
    MeSH term(s) Humans ; Malpractice ; Physicians ; Communication
    Language English
    Publishing date 2023-05-28
    Publishing country England
    Document type Journal Article
    ZDB-ID 1197078-9
    ISSN 1464-3790 ; 0967-0742
    ISSN (online) 1464-3790
    ISSN 0967-0742
    DOI 10.1093/medlaw/fwad009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: An empirical study of large, human biobanks: intellectual property policies and financial conditions for access.

    Jordan, Matthew / Liddicoat, Johnathon / Liddell, Kathleen

    Journal of law and the biosciences

    2021  Volume 8, Issue 1, Page(s) lsab018

    Abstract: Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar ... ...

    Abstract Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks
    Language English
    Publishing date 2021-07-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsab018
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Patient data ownership: who owns your health?

    Liddell, Kathleen / Simon, David A / Lucassen, Anneke

    Journal of law and the biosciences

    2021  Volume 8, Issue 2, Page(s) lsab023

    Abstract: This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of health information make it unsuitable for conferral of property rights ... ...

    Abstract This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of health information make it unsuitable for conferral of property rights without an extensive system of data-specific rules, like those that govern intellectual property. Additionally, we argue that even if an extensive set of rules were developed, the advantages of a property framework to govern health information would be slight: propertization is unlikely to enhance patient self-determination, increase market efficiency, provide patients a foothold in the data economy, clarify legal uses of information, or encourage data-driven innovation. The better approach is to rely less, not more, on property. We recommend a regulatory model with four signature features: (i) substantial protection for personal health data similar to the GDPR with transparent limits on how, when, and by whom patient data can be accessed, used, and transmitted; (ii) input from relevant stakeholders; (iii) interoperability; and (iv) greater research into a health-data service, rather than goods, model.
    Language English
    Publishing date 2021-10-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsab023
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Mapping the European patent landscape for medical uses of known products.

    Aboy, Mateo / Liddell, Kathleen / Liddicoat, Johnathon / Crespo, Cristina / Jordan, Matthew

    Nature biotechnology

    2021  Volume 39, Issue 11, Page(s) 1336–1343

    Language English
    Publishing date 2021-11-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1311932-1
    ISSN 1546-1696 ; 1087-0156
    ISSN (online) 1546-1696
    ISSN 1087-0156
    DOI 10.1038/s41587-021-01104-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Allocating Medical Resources in the Time of Covid-19.

    Liddell, Kathleen / Martin, Stevie / Palmer, Stephanie

    The New England journal of medicine

    2020  Volume 382, Issue 22, Page(s) e79

    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Health Care Rationing ; Health Resources ; Pandemics ; Pneumonia, Viral ; SARS-CoV-2 ; Triage
    Keywords covid19
    Language English
    Publishing date 2020-04-28
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2009666
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: COVID-19 contact tracing apps: a stress test for privacy, the GDPR, and data protection regimes.

    Bradford, Laura / Aboy, Mateo / Liddell, Kathleen

    Journal of law and the biosciences

    2020  Volume 7, Issue 1, Page(s) lsaa034

    Abstract: Digital surveillance has played a key role in containing the COVID-19 outbreak in China, Singapore, Israel, and South Korea. Google and Apple recently announced the intention to build interfaces to allow Bluetooth contact tracking using Android and ... ...

    Abstract Digital surveillance has played a key role in containing the COVID-19 outbreak in China, Singapore, Israel, and South Korea. Google and Apple recently announced the intention to build interfaces to allow Bluetooth contact tracking using Android and iPhone devices. In this article, we look at the compatibility of the proposed Apple/Google Bluetooth exposure notification system with Western privacy and data protection regimes and principles, including the General Data Protection Regulation (GDPR). Somewhat counter-intuitively, the GDPR's expansive scope is not a hindrance, but rather an advantage in conditions of uncertainty such as a pandemic. Its principle-based approach offers a functional blueprint for system design that is compatible with fundamental rights. By contrast, narrower, sector-specific rules such as the US Health Insurance Portability and Accountability Act (HIPAA), and even the new California Consumer Privacy Act (CCPA), leave gaps that may prove difficult to bridge in the middle of an emergency.
    Keywords covid19
    Language English
    Publishing date 2020-05-28
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsaa034
    Database MEDical Literature Analysis and Retrieval System OnLINE

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