CeBIL NNF Collaborative Research Programme Publications
The list covers publications from 1 January 2018 to 31 December 2023.
9th Nordic Social Pharmacy Conference 2019. Conference abstracts. (2019). Research in Social and Administrative Pharmacy, (12), doi: 10.1016/j.sapharm.2019.09.006
Aboy M, Crespo C, Liddell K, Minssen T, Liddicoat J. (2019). Mayo's impact on patent applications related to biotechnology, diagnostics and personalized medicine. Nature biotechnology, 37(5), pp. 513-518. doi: 10.1038/s41587-019-0111-5
Aboy M, Liddell K, Crespo C, Cohen IG, Liddicoat J, Gerke S, ... Minssen T. (2019). How does emerging patent case law in the US and Europe affect precision medicine?. Nature biotechnology, 37(10), pp. 1118-1125. doi: 10.1038/s41587-019-0265-1
Aboy M, Crespo C, Liddell K, Davey N, Liddicoat J, Minssen T. (2020). One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections?. Nature biotechnology, 38(3), pp. 279-283. doi: 10.1038/s41587-020-0440-4
Aboy M, Liddell K, Liddicoat J, Crespo C, Jordan M. (2021). Mapping the European patent landscape for medical uses of known products. Nature biotechnology, 39(11), pp. 1336-1343. doi: 10.1038/s41587-021-01104-1
Aboy M, Liddell K, Crespo C, Liddicoat J, Jordan M. (2021). Response to USPTO’s Patent Eligibility Jurisprudence Study (Docket No.: PTO–P–2021–0032). SSRN Electronic Journal, doi: 10.2139/ssrn.3938183
Aboy M, Minssen T, Kop M. (2022). Mapping the Patent Landscape of Quantum Technologies: Patenting Trends, Innovation and Policy Implications. IIC - International Review of Intellectual Property and Competition Law, (6), doi: 10.1007/s40319-022-01209-3
Aboy M, Liddell K, Jordan M, Crespo C, Liddicoat J. (2022). European patent protection for medical uses of known products and drug repurposing. Nature biotechnology, 40(4), pp. 465-471. doi: 10.1038/s41587-022-01269-3
Aboy M, Price WN, Raker S. (2023). Mapping the patent landscape of medical machine learning. Nature biotechnology, 41(4), pp. 461-468. doi: 10.1038/s41587-023-01735-6
Aboy M., Druedahl L.C.; Minssen T. (2023). Evidence-based IP research. Research Handbook on Empirical Studies in Intellectual Property Law (pp. 120-136). Cheltenham, UK: Edward Elgar Publishing.
Angelis A, Darrow J. (2021). Safeguarding evidence-based decision making in the FDA for COVID-19 vaccines. Vaccine, 39(17), pp. 2328-2330. doi: 10.1016/j.vaccine.2021.03.053
Babic B, Gerke S, Evgeniou T, Cohen IG. (2019). Algorithms on regulatory lockdown in medicine. Science (New York, N.Y.), 366(6470), pp. 1202-1204. doi: 10.1126/science.aay9547
Babic B, Gerke S, Evgeniou T, Cohen IG. (2021). Beware explanations from AI in health care. Science (New York, N.Y.), 373(6552), pp. 284-286. doi: 10.1126/science.abg1834
Babic B, Gerke S, Evgeniou T, Cohen I. (2021). Direct-to-consumer medical machine learning and artificial intelligence applications. Nature Machine Intelligence, (4), doi: 10.1038/s42256-021-00331-0
Beall RF, Darrow JJ, Kesselheim AS. (2018). A Method for Approximating Future Entry of Generic Drugs. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 21(12), pp. 1382-1389. doi: 10.1016/j.jval.2018.04.1827
Beall RF, Darrow JJ, Kesselheim AS. (2019). Approximating Future Generic Entry for New Drugs. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 47(1), pp. 177-182. doi: 10.1177/1073110519840499
Beall RF, Ronksley PE, Wick J, Darrow JJ, Sarpatwari A, Kesselheim AS. (2020). Comparing Onset of Biosimilar Versus Generic Competition in the United States. Clinical pharmacology and therapeutics, 108(6), pp. 1308-1314. doi: 10.1002/cpt.1981
Beall RF, Hollis A, Kesselheim AS, Spackman E. (2021). Reimagining Pharmaceutical Market Exclusivities: Should the Duration of Guaranteed Monopoly Periods Be Value Based?. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 24(9), pp. 1328-1334. doi: 10.1016/j.jval.2021.04.1277
Beall RF, Kesselheim AS, Hollis A. (2022). Premarket Development Times for Innovative Vaccines--To What Extent Are the Coronavirus Disease 2019 (COVID-19) Vaccines Outliers?. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 74(2), pp. 347-351. doi: 10.1093/cid/ciab389
Beck S, Bergenholtz C, Bogers M, Brasseur T, Conradsen M, Di Marco D, ... Xu S. (2020). The Open Innovation in Science research field: a collaborative conceptualisation approach. Industry and Innovation, (2), doi: 10.1080/13662716.2020.1792274
Becker J, Gerke S, Cohen I. (2023). The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues. Handbook of Bioethical Decisions. Volume I - Decisions at the Bench (pp. 441-456). Springer International Publishing.
Belay D, Abate T, Jensen J. (2020). A Montero Auction Mechanism to Regulate Antimicrobial Consumption in Agriculture. American Journal of Agricultural Economics, (5), doi: 10.1002/ajae.12079
Belay D, Jensen J. (2020). ‘The scarlet letters’: Information disclosure and self-regulation: Evidence from antibiotic use in Denmark. Journal of Environmental Economics and Management, doi: 10.1016/j.jeem.2020.102385
Belay D, Jensen J. (2021). Quantitative input restriction and farmers’ economic performance: Evidence from Denmark's yellow card initiative on antibiotics. Journal of Agricultural Economics, (1), doi: 10.1111/1477-9552.12439
Beukel K. (2018). How patent experts create patent breadth. International Journal of Intellectual Property Rights,
Bhaskar S, Tan J, Bogers MLAM, Minssen T, Badaruddin H, Israeli-Korn S, ... Chesbrough H. (2020). At the Epicenter of COVID-19-the Tragic Failure of the Global Supply Chain for Medical Supplies. Frontiers in public health, 8, pp. 562882. doi: 10.3389/fpubh.2020.562882
Boris Babic, I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke. (2020). When Machine Learning Goes Off the Rails. HARVARD BUSINESS REVIEW,
Bostyn S, De Jong T, Poort J, Radauer A. (2018). "Effects of Supplementary Protection Mechanisms for Pharmaceutical Products", Technopolis Group, Report commissioned by the Netherlands Ministries of Health and Economic Affairs and Climate,.
Bostyn S. (2020). Plant Variety Rights Protection and Essentially Derived Varieties: A Fresh Proposal to Untie the Gordian Knot. GRUR International, (8), doi: 10.1093/grurint/ikaa094
Bostyn S. (2020). Personalized Medicine, Intellectual Property Rights and Human Rights. In Torremans P. (Ed.), Intellectual Property and Human Rights (pp. 907-986). Kluwer Law International.
Bostyn S. (2020). Access to Therapeutics and Vaccines in Times of Health Pandemics: How Exclusivity Rights Can Affect Such Access and What We Can Do About It. Intellectual Property Quarterly, pp. 227-270.
Bostyn S. (2021). Why a COVID IP Waiver Is not a Good Strategy. SSRN Electronic Journal, doi: 10.2139/ssrn.3843327
Bostyn S. (2022). Sub-setting and indication stacking in orphan drugs: a recipe for the future of exclusive rights. Stockholm Intellectual Property Law Review, (1), doi: 10.53292/2d3a6004.61d4cd94
Bostyn S. (2022). Is the European Patent System for (Bio)Pharmaceuticals in Need of Change?. IIC - International Review of Intellectual Property and Competition Law, (2), doi: 10.1007/s40319-022-01259-7
Bostyn, S.J.R. (2021). Incentivising innovation in life sciences from the 1970s to the present: how complex exclusivity strategies became the standard and what it means for us. In COSTA, C, AURELIO MIRONE, ROBERTO PENNISI, PIERPAOLO M. SANFILIPPO, RUGGERO VIGO. (Ed.), Studi di diritto commerciale per Vincenzo Di Cataldo (pp. 71-116). Torino: G. Giappichelli Editore.
Bostyn, S.J.R. (2021). Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives.
Bracic A, Callier SL, Price WN. (2022). Exclusion cycles: Reinforcing disparities in medicine. Science (New York, N.Y.), 377(6611), pp. 1158-1160. doi: 10.1126/science.abo2788
Bradford L, Aboy M, Liddell K. (2020). International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an 'adequate' level of protection. Journal of law and the biosciences, 7(1), pp. lsaa055. doi: 10.1093/jlb/lsaa055
Bradford L, Aboy M, Liddell K. (2020). COVID-19 Contact Tracing Apps: A Stress Test for Privacy, the GDPR and Data Protection Regimes. Journal of Law and the Biosciences, lsaa034, pp. 1-20.
Bradford L, Aboy M, Liddell K. (2021). Standard contractual clauses for cross-border transfers of health data after Schrems II. Journal of Law and the Biosciences, (1), doi: 10.1093/jlb/lsab007
Brown BL, Mitra-Majumdar M, Darrow JJ, Moneer O, Pham C, Avorn J, ... Kesselheim AS. (2022). Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. JAMA internal medicine, 182(11), pp. 1223-6. doi: 10.1001/jamainternmed.2022.4226
Brown BL, Mitra-Majumdar M, Joyce K, Ross M, Pham C, Darrow JJ, ... Kesselheim AS. (2022). Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review. Journal of health politics, policy and law, 47(6), pp. 649-672. doi: 10.1215/03616878-10041093
Caceres AM, Singh KK, Minssen T, Van Katwyk SR, Hoffman SJ. (2022). Using the International Pandemic Instrument to Revitalize the Innovation Ecosystem for Antimicrobial R&D. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 50(S2), pp. 47-54. doi: 10.1017/jme.2022.79
Cathaoir K, Gunnarsdóttir H, Hartlev M. (2021). The journey of research data: Accessing nordic health data for the purposes of developing an algorithm. Medical Law International, (1), doi: 10.1177/09685332211046179
Celedonia K, Valenti M, Corrales Compagnucci M, Lowery Wilson M. (2020). Community-based health care providers as research participant recruitment gatekeepers: ethical and legal issues in a real-world case example. Research Ethics, (2), doi: 10.1177/1747016120980560
Celedonia KL, Corrales Compagnucci M, Minssen T, Lowery Wilson M. (2021). Legal, ethical, and wider implications of suicide risk detection systems in social media platforms. Journal of law and the biosciences, 8(1), pp. lsab021. doi: 10.1093/jlb/lsab021
Cohen I, Graver H. (2019). A Doctor’s Touch: What Big Data in Health Care Can Teach Us About Predictive Policing. SSRN Electronic Journal, doi: 10.2139/ssrn.3432095
Cohen I, Evgeniou T, Gerke S, Minssen T. (2020). The European artificial intelligence strategy: implications and challenges for digital health. The Lancet Digital Health, (7), doi: 10.1016/s2589-7500(20)30112-6
Cohen I, Minssen T, Price II W, Robertson C, Shachar C. (2022). Volume Introduction. The Future of Medical Device Regulation - Innovation and Protection (pp. 1-10). Cambridge University Press.
Cohen I. (2020). Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?. SSRN Electronic Journal, doi: 10.2139/ssrn.3529576
Cohen IG, Mello MM. (2018). HIPAA and Protecting Health Information in the 21st Century. JAMA, 320(3), pp. 231-232. doi: 10.1001/jama.2018.5630
Cohen IG, Mello MM. (2019). Big Data, Big Tech, and Protecting Patient Privacy. JAMA, 322(12), pp. 1141-1142. doi: 10.1001/jama.2019.11365
Cohen IG, Adashi EY, Gerke S, Palacios-González C, Ravitsky V. (2020). The Regulation of Mitochondrial Replacement Techniques Around the World. Annual review of genomics and human genetics, 21, pp. 565-586. doi: 10.1146/annurev-genom-111119-101815
Cohen IG, Gerke S, Kramer DB. (2020). Ethical and Legal Implications of Remote Monitoring of Medical Devices. The Milbank quarterly, 98(4), pp. 1257-1289. doi: 10.1111/1468-0009.12481
Compagnucci M, Fenwick M, Haapio H, Minssen T, Vermeulen E. (2022). Technology-Driven Disruption of Healthcare and ‘UI Layer’ Privacy-by-Design. AI in eHealth - Human Autonomy, Data Governance and Privacy in Healthcare (pp. 19-67). Cambridge University Press.
Compagnucci M, Nilsson N, Wagner P, Olsson C, Fenwick M, Minssen T, ... Szkalej K. (2023). Non-fungible tokens as a framework for sustainable innovation in pharmaceutical R&D: a smart contract-based platform for data sharing and rightsholder protection. International Review of Law, Computers & Technology, doi: 10.1080/13600869.2023.2233803
Corrales Compagnucci M, Meszaros J, Minssen T, Arasilango A, Ous T, Rajarajan M. (2019). Homomorphic Encryption: The ‘Holy Grail’ for Big Data Analytics and Legal Compliance in the Pharmaceutical and Healthcare Sector?. European Pharmaceutical Law Review, (4), doi: 10.21552/eplr/2019/4/5
Corrales Compagnucci M, Forgó N, Kono T, Teramoto S, Vermeulen E. (Ed.), (2019). Legal Tech and the New Sharing Economy. Singapore: Springer Nature.
Corrales Compagnucci M, Minssen T, Seitz C, Aboy M. (2020). Lost on the High Seas without a Safe Harbor or a Shield? Navigating Cross-Border Transfers in the Pharmaceutical Sector After Schrems II Invalidation of the EU-US Privacy Shield. European Pharmaceutical Law Review, (3), doi: 10.21552/eplr/2020/3/5
Corrales Compagnucci M, Gerke S, Minssen T. (2021). Informed consent during clinical care: A case study for the WHO.
Corrales Compagnucci M, Aboy M, Minssen T. (2021). Cross-Border Transfers of Personal Data after Schrems II: Supplementary Measures and New Standard Contractual Clauses (SCCs). Nordic Journal of European Law, 4(2), pp. 37-47.
Corrales Compagnucci M, Gerke S, Minssen T. (2021). Discrimination and racial bias in AI technology: A case study for the WHO.
Corrales Compagnucci M, Gerke S, Minnsen T. (2021). Ethics and Governance of Artificial Intelligence for Health : WHO Guidance.
Corrales Compagnucci M, Aboy M, Minssen T. (2021). Cross-Border Transfers of Personal Data After Schrems II: Supplementary Measures and new Standard Contractual Clauses (SCCs). Nordic Journal of European Law, (2), doi: 10.36969/njel.v4i2.23780
Corrales Compagnucci M, Fenwick M, Aboy M, Minssen T. (2022). Supplementary Measures and Appropriate Safeguards for International Transfers of Personal Data after Schrems II. SSRN Electronic Journal, doi: 10.2139/ssrn.4042000
Corrales Compagnucci M, Dahi A, Alexander Earls Davis P. (2023). Conducting a Data Protection Impact Assessment in Health Science: A Comprehensive Guide. European Health & Pharmaceutical Law Review, (3), doi: 10.21552/ehpl/2023/3/5
Corrales Compagnucci M. (2019). Big Data, Databases and "Ownership" Rights in the Cloud. Singapore: Springer Nature.
Corrales Compagnucci M., Meszaros J, Minssen T, Arasilango A, Ous T, Rajarajan M. (2019). Homomorphic Encryption: the ‘Holy Grail’ for Big Data Analytics & Legal Compliance in the Pharmaceutical and Healthcare Sector?. European Pharmaceutical Law Review, 3(4), pp. 144-155.
Corrales Compagnucci M; Fenwick M; Haapio H; Minssen T; Vermeulen E.P.M. (2022). Technology-Driven Disruption of Healthcare & "UI Layer" Privacy-by-Design. In Corrales Compagnucci M, L. Wilson M, Fenwick M, Forgó N, Bärnighausen T. (Ed.), AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare (pp. 19-67). Cambridge University Press.
Corrales Compagnucci Marcelo, Haapio Helena, Fenwick Mark. (2022). Research Handbook on Contract Design. United Kingdom: Edward Elgar Publishing Ltd.
Crootof R, Kaminski M, Price II W. (2022). Humans in the Loop. SSRN Electronic Journal, doi: 10.2139/ssrn.4066781
Darrow J, Kesselheim A. (2020). Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working?. Open Forum Infectious Diseases, (1), doi: 10.1093/ofid/ofaa001
Darrow JJ, Sinha MS, Kesselheim AS. (2018). When markets fail: patents and infectious disease products. Food & Drug Law J, Volume 73(3),
Darrow JJ, Beall RF, Kesselheim AS. (2019). The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Applied health economics and health policy, 17(1), pp. 47-54. doi: 10.1007/s40258-018-0420-8
Darrow JJ, Beall RF. (2020). Commentary: Expedited Regulatory Review of Low-Value Drugs. Healthcare policy = Politiques de sante, 15(4), pp. 35-40. doi: 10.12927/hcpol.2020.26226
Darrow JJ, Chong JE, Kesselheim AS. (2020). Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs. BMJ (Clinical research ed.), 369, pp. m2236. doi: 10.1136/bmj.m2236
Darrow JJ, Najafzadeh M, Stefanini K, Kesselheim AS. (2020). Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities. The Lancet. Infectious diseases, 20(7), pp. e159-e164. doi: 10.1016/s1473-3099(20)30197-3
Darrow JJ, Dhruva SS, Redberg RF. (2021). Changing FDA Approval Standards: Ethical Implications for Patient Consent. Journal of general internal medicine, 36(10), pp. 3212-3214. doi: 10.1007/s11606-021-06762-0
Darrow JJ, Light DW. (2021). Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding. Health affairs (Project Hope), 40(2), pp. 281-288. doi: 10.1377/hlthaff.2020.00328
Darrow JJ, Borisova E. (2022). Communication of Drug Efficacy Information via a Popular Online Platform. Journal of the American Board of Family Medicine : JABFM, 35(4), pp. 833-835. doi: 10.3122/jabfm.2022.04.210539
Darrow JJ, Mai D. (2022). An Orange Book Landscape: Drugs, Patents, and Generic Competition. Food and Drug Law Journal, 77, pp. 51.
Darrow JJ, Van de Wiele V, Beran D, Kesselheim AS. (2023). An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology, pp. 19322968231178016. doi: 10.1177/19322968231178016
Darrow JJ. (2021). Government Pharmaceutical Development to Address High Prices: Challenges Ahead. Therapeutic innovation & regulatory science, 55(5), pp. 1103-1105. doi: 10.1007/s43441-021-00324-6
Darrow JJ. (2021). Few new drugs deserve expedited regulatory treatment. Journal of managed care & specialty pharmacy, 27(5), pp. 685-688. doi: 10.18553/jmcp.2021.27.5.685
Darrow JJ. (2021). The Perils of Increasing Medicaid Rebates for Drugs With Accelerated Approval. JAMA health forum, 2(10), pp. e213184. doi: 10.1001/jamahealthforum.2021.3184
Darrow JJ. (2023). Two views of cancer medicines: Imagery versus evidence. Health marketing quarterly, 40(2), pp. 141-152. doi: 10.1080/07359683.2021.1997512
de Miguel Beriain I, Minssen T, Chortara T, Duardo Sánchez A, Feeney O, Felzmann H, ... Herrmann J R. (2019). An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. European Public Law,
Deb C, Moneer O, Price WN. (2020). Covid-19, single-sourced diagnostic tests, and innovation policy. Journal of law and the biosciences, 7(1), pp. lsaa053. doi: 10.1093/jlb/lsaa053
Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF. (2022). Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Journal of general internal medicine, 37(16), pp. 4176-4182. doi: 10.1007/s11606-021-07316-0
Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF. (2022). Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel. Clinical pharmacology and therapeutics, 111(6), pp. 1307-1314. doi: 10.1002/cpt.2583
Druedahl LC, Almarsdóttir AB, Kälvemark Sporrong S, De Bruin ML, Hoogland H, Minssen T, ... Sarpatwari A. (2020). A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nature biotechnology, 38(11), pp. 1253-1256. doi: 10.1038/s41587-020-0717-7
Druedahl LC, Lebret A, Minssen T. (2020). ELSI Implications of Prioritizing Biological Therapies in Times of COVID-19. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 48(3), pp. 579-582. doi: 10.1177/1073110520958884
Druedahl LC, Kälvemark Sporrong S, van de Weert M, De Bruin ML, Hoogland H, Minssen T, ... Almarsdóttir AB. (2021). Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators. BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 35(3), pp. 351-361. doi: 10.1007/s40259-021-00478-7
Druedahl LC, Minssen T, Price WN. (2021). Collaboration in times of crisis: A study on COVID-19 vaccine R&D partnerships. Vaccine, 39(42), pp. 6291-6295. doi: 10.1016/j.vaccine.2021.08.101
Druedahl LC, Kälvemark Sporrong S, Minssen T, Hoogland H, De Bruin ML, van de Weert M, ... Almarsdóttir AB. (2022). Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution. PloS one, 17(1), pp. e0262537. doi: 10.1371/journal.pone.0262537
Druedahl Louise C., De Bruin Marie L., Hoogland Hans, Minssen Timo, van de Weert Marco, Sporrong Sofia Kalvemark, ... Almarsdottir Anna Birna. (2019). MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY.
Dögg Gunnarsdóttir H. (2023). Transparent data use in biomedical research.
Foreman AL, Liddell K, Franklin S, Jackson E, Rozeik C, Niakan KK. (2023). Human embryo models: the importance of national policy and governance review. Current opinion in genetics & development, 82, pp. 102103. doi: 10.1016/j.gde.2023.102103
Gerke S, Minssen T, Yu H, Cohen I. (2019). Ethical and legal issues of ingestible electronic sensors. Nature Electronics, (8), doi: 10.1038/s41928-019-0290-6
Gerke S, Kramer DB, Cohen IG. (2019). Ethical and Legal Challenges of Artificial Intelligence in Cardiology. AIMed Magazine, 2(2), pp. 12–17.
Gerke S, Babic B, Evgeniou T, Cohen IG. (2020). The need for a system view to regulate artificial intelligence/machine learning-based software as medical device. NPJ digital medicine, 3, pp. 53. doi: 10.1038/s41746-020-0262-2
Gerke S, Stern AD, Minssen T. (2020). Germany's digital health reforms in the COVID-19 era: lessons and opportunities for other countries. NPJ digital medicine, 3, pp. 94. doi: 10.1038/s41746-020-0306-7
Gerke S, Yeung S, Cohen I. (2020). Ethical and Legal Aspects of Ambient Intelligence in Hospitals. JAMA, (7), doi: 10.1001/jama.2019.21699
Gerke S, Shachar C, Chai PR, Cohen IG. (2020). Regulatory, safety, and privacy concerns of home monitoring technologies during COVID-19. Nature medicine, 26(8), pp. 1176-1182. doi: 10.1038/s41591-020-0994-1
Gerke S, Minssen T & Cohen G. (2020). Ethical and Legal Challenges of Artificial Intelligence-Driven Health Care. In Bohr A, Memarzadeh K. (Ed.), Artificial Intelligence in Healthcare (pp. 295-336). Academic Press.
Gerke S, Katznelson G, Reiss D, Shachar C. (2021). COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 49(2), pp. 293-302. doi: 10.1017/jme.2021.42
Global Genes, Local Concerns - Legal, Ethical, and Scientific Challenges in International Biobanking. (2019). Edward Elgar Publishing.
Golbus JR, Price WN, Nallamothu BK. (2020). Privacy Gaps for Digital Cardiology Data: Big Problems With Big Data. Circulation, 141(8), pp. 613-615. doi: 10.1161/circulationaha.119.044966
Goodman GR, Kikut A, Bustamante MJ, Mendez L, Mohamed Y, Shachar C, ... Chai PR. (2022). "I'd feel like someone was watchin' me… watching for a good reason": perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use. AIDS and behavior, 26(9), pp. 2981-2993. doi: 10.1007/s10461-022-03614-8
Governing, Protecting, and Regulating the Future of Genome Editing - The Significance of ELSPI Perspectives. (2023). Brill | Nijhoff.
Graber-Soudry O, Minssen T, Nilsson D, Corrales Compagnucci M, Wested J, Illien B. (2021). Legal Interoperability and the FAIR Data Principles: An X-officio study commissioned by the EOSC FAIR Working Group. EOSC Secretariat & X-officio.
Grimpe C, Minssen T, Price II WN, Stern A. (2022). Will mRNA Technology Companies Spawn Innovation Ecosystems?. Harvard Business Review,
Gunnarsdóttir H, Cohen I, Minssen T, Gerke S. (2022). The Ethics and Laws of Medical Big Data. The Cambridge Handbook of Information Technology, Life Sciences and Human Rights (pp. 48-55). Cambridge University Press.
Gunnarsdóttir HD, Sinha MS, Gerke S, Minssen T. (2020). Applying the proportionality principle to COVID-19 antibody testing. Journal of law and the biosciences, 7(1), pp. lsaa058. doi: 10.1093/jlb/lsaa058
Gunnarsdóttir HD, Cohen G; Minssen T; Gerke S. (2022). The Ethics and Laws of Medical Big Data. In Marcello I, Pollicino O, Liguori L, Stefanini E, Andorno R. (Ed.), The Cambridge Handbook of Life Science, Information Technology and Human Rights (pp. 48-55). Cambridge University Press.
Gyawali B, Darrow JJ, Kesselheim AS. (2021). Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling. JAMA internal medicine, 181(7), pp. 897-898. doi: 10.1001/jamainternmed.2021.1994
Hamidzadeh A, Liddicoat J, Liddell K. (2023). Should Europe Adopt a Policy Like the US FDA’s Project Renewal?. European Health & Pharmaceutical Law Review, (3), doi: 10.21552/ehpl/2023/3/6
Hamidzadeh A, Liddicoat J, Liddell K. (2023). Should Europe Adopt a Policy Like the US MODERN Labeling Act?. European Health & Pharmaceutical Law Review, (1), doi: 10.21552/ehpl/2023/1/7
Harish KB, Price WN, Aphinyanaphongs Y. (2022). Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges. JMIR formative research, 6(4), pp. e33970. doi: 10.2196/33970
Hey SP, Kesselheim AS, Patel P, Mehrotra P, Powers JH. (2020). US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals. JAMA internal medicine, 180(1), pp. 131-138. doi: 10.1001/jamainternmed.2019.5451
Holman C, Minssen T, Solovy E. (2018). Patentability Standards for Follow-On Pharmaceutical Innovation. Biotechnology Law Report, (3), doi: 10.1089/blr.2018.29073.cmh
Ian T. Liu, Jonathan J. Darrow. (2021). Reconsidering Eradication to Address the Global Infectious Disease Burden. Quinnipiac Health Law Journal, 24(3), pp. 279-325.
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Nilsson N, Minssen T. (2018). Unlocking the full potential of open innovation in the life sciences through a classification system. Drug discovery today, 23(4), pp. 771-775. doi: 10.1016/j.drudis.2018.01.002
Nordberg A, Minssen T, de Miguel Beriain I, Wartiovaara K, Galvagni L, Feeney O. (2018). Response to Nuffield Council on Bioethics’ Genome Editing and Human Reproduction: Open Call for Evidence. Nuffield Council on Bioethics, 28 Bedford Square London WC1B 3JS: Nuffield Council on Bioethics (2018) (London: Nuffield Council on Bioethics).
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Nordberg A, Minssen T, Feeney O, de Miguel Beriain I, Galvagni L, Wartiovaara K. (2020). Regulating germline editing in assisted reproductive technology: An EU cross-disciplinary perspective. Bioethics, 34(1), pp. 16-32. doi: 10.1111/bioe.12705
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Patel NG, Kesselheim AS, Darrow JJ. (2023). Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process. Journal of health politics, policy and law, 48(5), pp. 799-820. doi: 10.1215/03616878-10637726
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Polak TB, Cucchi DGJ, van Rosmalen J, Uyl-de Groot CA, Darrow JJ. (2022). Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations. Frontiers in pharmacology, 13, pp. 913567. doi: 10.3389/fphar.2022.913567
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Schovsbo J, Minssen T, Riis T. (2020). An Appraisal of the EU Directive on Trade Secrets. The harmonization and protection of trade secrets in the EU : – An Appraisal of the EU Directive (pp. 1-7). Edward Elgar Publishing.
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Shachar C, Engel J, Elwyn G. (2020). Implications for Telehealth in a Postpandemic Future: Regulatory and Privacy Issues. JAMA, 323(23), pp. 2375-2376. doi: 10.1001/jama.2020.7943
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