The Ethical Challenges of Emerging Medical Technologies (The Library of Essays on the Ethics of Emerging Technologies)

This collection of essays emphasizes society's increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology's strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare. Cover Half Title Title Page Copyright Page Table of Contents About the Editors Acknowledgments Series Preface Introduction Part I: Ethics and Oversight Chapter 1: F. Lucivero, T. Swierstra and M. Boenink, Assessing Expectations: Towards a Toolbox for an Ethics of Emerging Technologies, Nanoethics, 5:2, 129–41 (2011) Chapter 2: B. Hofmann, Why Ethics Should Be Part of Health Technology Assessment, International Journal of Technology Assessment in Health Care, 24:4, 423–9 (2008) Chapter 3: D.B. Kramer, Shuai Xu and Aaron S. Kesselheim, Regulation of Medical Devices in the United States and European Union, New England Journal of Medicine, 366:9, 848–55 (2012) Chapter 4: G.D. Curfman and R.F. Redberg, Medical Devices: Balancing Regulation and Innovation, New England Journal of Medicine, 365:11, 975–7 (2011) Chapter 5: Emily C. Feinstein, Arthur Caplan, Jonathan D. Moreno and Ilene Albala-Reicher, The Ethics of Off-Label Use of FDA-Approved Products, in Mark Levy, ed., Off-Label Communications: A Guide to Sales and Marketing Compliance (4th edition). Washington, DC: Food and Drug Law Institute, 2014, pp.49–77 Part II: Preventive Chapter 6: M.J. Young, D.A. Sisti, H Rimon-Greenspan, J.L. Schwartz and A.L. Caplan, Immune to Addiction: The Ethical Dimensions of Vaccines against Substance Abuse, Nature Immunology, 13:6, 521–4 (2012) Chapter 7: A.L. Bredenoord, G. Pennings and G. de Wert, Ooplasmic and Nuclear Transfer to Prevent Mitochondrial DNA Disorders: Conceptual and Normative Issues, Human Reproduction Update, 14:6, 669–78 (2008) Chapter 8: R Sparrow and L Sparrow, In the Hands of Machines? The Future of Aged Care, Minds and Machines, 16:2, 141–61 (2006) Chapter 9: S.S. Bull, L.T. Breslin, E.E. Wright, S.R. Black, D. Levine and J.S. Santelli, Case Study: An Ethics Case Study of HIV Prevention Research on Facebook: The Just/Us Study, Journal of Pediatric Psychology, 36:10, 1082–92 (2011) Chapter 10: J. Timmermans, Y. Zhao and J. van den Hoven, Ethics and Nanopharmacy: Value Sensitive Design of New Drugs, Nanoethics, 5:3, 269–83 (2011) Part III: Diagnostic Chapter 11: B.J. Healey, D. Kopen and J Smith, Physicians, Defensive Medicine, and Ethics, Academy of Health Care Management Journal, 7:1, 59–78 (2011) Chapter 12: Eric T. Juengst, Michael A. Flatt and Richard A. Settersten Jr, Personalized Genomic Medicine and the Rhetoric of Empowerment., Hastings Center Report, 42:5, 34–40 (2012) Chapter 13: Holly K. Tabor, Jeffrey C. Murray, Hilary S. Gammill, Jacob O. Kitzman, Matthew W. Snyder, Mario Ventura, Alexandra P. Lewis, Ruolan Qiu, LaVone E. Simmons, Craig E. Rubens, Mark K. Santillan, Evan E. Eichler, Edith Y. Cheng, Michael J. Bamshad and Jay Shendure, Non-Invasive Fetal Genome Sequencing: Opportunities and Challenges, American Journal of Medical Genetics. Part A, 158:10, 2382–4 (2012) Chapter 14: Ralf J. Jox, James L. Bernat, Steven Laureys and Eric Racine, Disorders of Consciousness: Responding to Requests for Novel Diagnostic and Therapeutic Interventions, The Lancet Neurology, 11:8, 732–8 (2012) Part IV: Treatment Monitoring and Medical Information Chapter 15: R. Steinbrook, Personally Controlled Online Health Data: The Next Big Thing in Medical Care?, New England Journal of Medicine, 358:16, 1653–6 (2008) Chapter 16: Pilar N. Ossorio, The Ethics of Translating High-Throughput Science into Clinical Practice, Hastings Center Report, 44:5, 8–9 (2014) Chapter 17: E. Palm, Who Cares? Moral Obligations in Formal and Informal Care Provision in the Light of ICT-Based Home Care, Health Care Analysis, 21:2, 171–88 (2013) Chapter 18: E.-H.W. Kluge, Ethical and Legal Challenges for Health Telematics in a Global World: Telehealth and the Technological Imperative, International Journal of Medical Informatics, 80:2, e1–e5 (2011) Chapter 19: Sharona Hoffman and Andy Podgurski, Big Bad Data: Law, Public Health, and Biomedical Databases, Journal of Law, Medicine and Ethics, 41:Suppl 1, 56–60 (2013) Part V: Therapeutic Chapter 20: M. Miyasaka, S.Sasaki, M. Tanaka and J. Kikunaga, Use of Brain-Machine Interfaces as Prosthetic Devices: An Ethical Analysis, Journal of Philosophy and Ethics in Health Care and Medicine, 6, 29–38 (2012) Chapter 21: R. Grant, C. Halpern, G. Baltuch, J. O’Reardon and A. Caplan, Ethical Considerations in Deep Brain Stimulation for Psychiatric Illness, Journal of Clinical Neuroscience, 21:1, 1–5 (2014) Chapter 22: J. Dixon, J. Logue and P. Komesaroff, Promises and Ethical Pitfalls of Surgical Innovation: The Case of Bariatric Surgery, Obesity Surgery, 23:10, 1698–1702 (2013) Chapter 23: P. McCormack, S. Woods, A. Aartsma-Rus, L. Hagger, A. Herczegfalvi, E. Heslop, J. Irwin, J. Kirschner, P. Moeschen, F. Muntoni, M. Ouillade, J. Rahbek, C. Rehmann-Sutter, F. Rouault, T. Sejersen, E. Vroom, V. Straub, K. Bushby and A. Ferlini, Guidance in Social and Ethical Issues Related to Clinical, Diagnostic Care and Novel Therapies for Hereditary Neuromuscular Rare Diseases: “Translating” the Translational, PLOS Currents Muscular Dystrophy, 1 (January 2013). doi: 10.1371/currents.md.f90b49429fa814bd26c5b22b 13d773ec Chapter 24: Jeremy Sugarman, Questions Concerning the Clinical Translation of Cell-Based Interventions under an Innovation Pathway, Journal of Law, Medicine and Ethics, 40:4, 945–50 (2012) Chapter 25: Fa-Ming Chen, Yi-Min Zhao, Yan Jin and Songtao Shi, Prospects for Translational Regenerative Medicine, Biotechnology Advances, 30:3, 658–72 (2012) Chapter 26: K.I. Reid and C.S. Greene, Diagnosis and treatment of Temporomandibular Disorders: An Ethical Analysis of Current Practices, Journal of Oral Rehabilitation, 40:7, 546–61 (2013) Part VI: Rescue and End of Life Chapter 27: S. Badylak, D. Weiss, A. Caplan and P. Macchiarini, Engineered Whole Organs and Complex Tissues, The Lancet, 379:9819, 1–10 (2012) Chapter 28: D. Abrams, K. Prager, C. Blinderman, K. Burkart and D. Brodie, Ethical Dilemmas Encountered with the Use of Extracorporeal Membrane Oxygenation in Adults, Chest, 145:4, 876–82 (2014) Chapter 29: M. Gysels, N. Evans, A. Meñaca, E. Andrew, F. Toscani, S. Finetti, H. Roeline Pasman, I. Higginson, R. Harding and R. Pool, Culture and End of Life Care: A Scoping Exercise in Seven European Countries, PLoS ONE, 7:4, 1–16 (2012) Chapter 30: D. Sulmasy. Within You/Without You: Biotechnology, Ontology, and Ethics, Journal of General Internal Medicine, 23:Suppl 1, 69–72 (2007) Chapter 31: J. Guerra González, Ethical and Regulatory Issues for Clinical Trials in Xenotransplantation, Humana Press, 281–305 (2012) Chapter 32: K. Swetz and J. Keith Mansel, Ethical Issues and Palliative Care in the Cardiovascular Intensive Care Unit, Cardiology Clinics, 31:4, 657–68 (2013) Part VII: Normalization and Enhancement Chapter 33: Silvia Camporesi and Michael J. McNamee, Gene Transfer for Pain: A Tool To Cope With The Intractable, Or An Unethical Endurance Enhancing Technology?, Life Sciences Society and Policy, 8:1, 20–31 (2012) Chapter 34: A. Frank, Emily’s Scars: Surgical Shapings, Technoluxe, and Bioethics in Erik Parens, ed., Surgically Shaping Children. Baltimore, MD: Johns Hopkins University Press, pp. 68–89 Chapter 35: Tom Humphries, Poorna Kushalnagar, Gaurav Mathur, Donna Jo Napoli, Carol Padden, Christian Rathmann and Scott Smith, Cochlear Implants and the Right to Language: Ethical Considerations, the Ideal Situation, and Practical Measures Toward Reaching the Ideal, in Cila Umat and Rinze Anthony Tange, eds, Cochlear Implant Research Updates. Rijeka, Croatia: InTech, 2012, pp. 193–212 Chapter 36: Ruby Catsanos, Wendy Rogers and Mianna Lotz, The Ethics of Uterus Transplantation, Bioethics, 27:2, 65–73 (2013) Chapter 37: F. Coeytaux, M. Darnovsky and S.B. Fogel, Assisted Reproduction and Choice in the Biotech Age: Recommendations for a Way Forward, Contraception, 83:1, 1–4 (2011) Chapter 38: David Gems, Tragedy and Delight: The Ethics of Decelerated Ageing, Philosophical Transactions of the Royal Society B: Biological Sciences, 366:1561, 108–12 (2011) Chapter 39: Barbro Elisabeth Esmeralda Froding, Cognitive enhancement, virtue ethics and the good life, Neuroethics, 4:3, 223–34 (2011) Index Machine Generated Contents Note: Pt. I Ethics And Oversight -- 1. F. Lucivero, T. Swierstra And M. Boenink, Assessing Expectations: Towards A Toolbox For An Ethics Of Emerging Technologies, Nanoethics, 5:2, 129 -- 41 (2011) / M. Boenink -- 2. Why Ethics Should Be Part Of Health Technology Assessment, International Journal Of Technology Assessment In Health Care, 24:4, 423 -- 9 (2008) / B. Hofmann -- 3. D.b. Kramer, Shuai Xu And Aaron S. Kesselheim, Regulation Of Medical Devices In The United States And European Union, New England Journal Of Medicine, 366:9, 848 -- 55 (2012) / Aaron S. Kesselheim -- 4. G.d. Curfman And R.f. Redberg, Medical Devices: Balancing Regulation And Innovation, New England Journal Of Medicine, 365:11, 975 -- 7 (2011) / R.f. Redberg -- 5. Emily C. Feinstein, Arthur Caplan, Jonathan D. Moreno And Ilene Albala-reicher, The Ethics Of Off-label Use Of Fda-approved Products, In Mark Levy, Ed., Off-label Communications: A Guide To Sales And Marketing Compliance (4th Edition). Washington, Dc: Food And Drug Law Institute, 2014, Pp. 49 -- 77 / Ilene Albala-reicher -- Pt. Ii Preventive -- 6. Immune To Addiction: The Ethical Dimensions Of Vaccines Against Substance Abuse, Nature Immunology, 13:6, 521 -- 4 (2012) / A.l. Caplan -- 7. Ooplasmic And Nuclear Transfer To Prevent Mitochondrial Dna Disorders: Conceptual And Normative Issues, Human Reproduction Update, 14:6, 669 -- 78 (2008) / G. De Wert -- 8. In The Hands Of Machines? The Future Of Aged Care, Minds And Machines, 16:2, 141 -- 61 (2006) / L. Sparrow -- 9. Case Study: An Ethics Case Study Of Hiv Prevention Research On Facebook: The Just/us Study, Journal Of Pediatric Psychology, 36:10, 1082 -- 92 (2011) / J.s. Santelli -- 10. Ethics And Nanopharmacy: Value Sensitive Design Of New Drugs, Nanoethics, 5:3, 269 -- 83 (2011) / J. Van Den Hoven -- Pt. Iii Diagnostic -- 11. Physicians, Defensive Medicine, And Ethics, Academy Of Health Care Management Journal, 7:1, 59 -- 78 (2011) / J. Smith -- 12. Personalized Genomic Medicine And The Rhetoric Of Empowerment., Hastings Center Report, 42:5, 34 -- 40 (2012) / Richard A. Settersten Jr -- 13. Non-invasive Fetal Genome Sequencing: Opportunities And Challenges, American Journal Of Medical Genetics. Part A, 158:10, 2382 -- 4 (2012) / Jay Shendure -- 14. Disorders Of Consciousness: Responding To Requests For Novel Diagnostic And Therapeutic Interventions, The Lancet Neurology, 11:8, 732 -- 8 (2012) / Eric Racine -- Pt. Iv Treatment Monitoring And Medical Information -- 15. Personally Controlled Online Health Data: The Next Big Thing In Medical Care?, New England Journal Of Medicine, 358:16, 1653 -- 6 (2008) / R. Steinbrook -- 16. Pilar N. Ossorio, The Ethics Of Translating High-throughput Science Into Clinical Practice, Hastings Center Report, 44:5, 8 -- 9 (2014) / Pilar N. Ossorio -- 17. Who Cares? Moral Obligations In Formal And Informal Care Provision In The Light Of Ict-based Home Care, Health Care Analysis, 21:2, 1-71-88(2013) / E. Palm -- 18. Ethical And Legal Challenges For Health Telematics In A Global World: Telehealth And The Technological Imperative, International Journal Of Medical Informatics, 80:2, El-e5 (2011) / E.-h.w. Kluge -- 19. Big Bad Data: Law, Public Health, And Biomedical Databases, Journal Of Law, Medicine And Ethics, 41: Suppl 1, 56 -- 60 (2013) / Andy Podgurski -- Pt. V Therapeutic -- 20. Use Of Brain-machine Interfaces As Prosthetic Devices: An Ethical Analysis, Journal Of Philosophy And Ethics In Health Care And Medicine, 6, 29 -- 38 (2012) / J. Kikunaga -- 21. Ethical Considerations In Deep Brain Stimulation For Psychiatric Illness, Journal Of Clinical Neuroscience, 21:1, 1 -- 5 (2014) / A. Caplan -- 22. Promises And Ethical Pitfalls Of Surgical Innovation: The Case Of Bariatric Surgery, Obesity Surgery, 23:10, 1698 -- 1702 (2013) / P. Komesaroff -- 23. Guidance In Social And Ethical Issues Related To Clinical, Diagnostic Care And Novel Therapies For Hereditary Neuromuscular Rare Diseases: Translating The Translational, Plos Currents Muscular Dystrophy, 1 (january 2013). Doi: 10.1371/currents. Md. F90b49429fa814bd26c5b22b 13d773ec / A. Ferlini -- 24. Questions Concerning The Clinical Translation Of Cell-based Interventions Under An Innovation Pathway, Journal Of Law, Medicine And Ethics, 40:4, 945 -- 50 (2012) / Jeremy Sugarman -- 25. Prospects For Translational Regenerative Medicine, Biotechnology Advances, 30:3, 658 -- 72 (2012) / Songtao Shi -- 26. Diagnosis And Treatment Of Temporomandibular Disorders: An Ethical Analysis Of Current Practices, Journal Of Oral Rehabilitation, 40:7, 546 -- 61 (2013) / C.s. Greene -- Pt. Vi Rescue And End Of Life -- 27. Engineered Whole Organs And Complex Tissues, The Lancet, 379:9819, 1 -- 10 (2012) / P. Macchiarini -- 28. Ethical Dilemmas Encountered With The Use Of Extracorporeal Membrane Oxygenation In Adults, Chest, 145:4, 876 -- 82 (2014) / D. Brodie -- 29. Culture And End Of Life Care: A Scoping Exercise In Seven European Countries, Plos One, 7:4, 1 -- 16 (2012) / R. Pool -- 30. Within You/without You: Biotechnology, Ontology, And Ethics, Journal Of General Internal Medicine, 23: Suppl 1, 69 -- 72 (2007) / D. Sulmasy -- 31. Ethical And Regulatory Issues For Clinical Trials In Xenotransplantation, Humana Press, 281 -- 305 (2012) / J. Guerra Gonzalez -- 32. Ethical Issues And Palliative Care In The Cardiovascular Intensive Care Unit, Cardiology Clinics, 31:4, 657 -- 68 (2013) / J. Keith Mansel -- Pt. Vii Normalization And Enhancement -- 33. Gene Transfer For Pain: A Tool To Cope With The Intractable, Or An Unethical Endurance Enhancing Technology?, Life Sciences Society And Policy, 8:1, 20 -- 31 (2012) / Michael J. Mcnamee -- 34. Emily's Scars: Surgical Shapings, Technoluxe, And Bioethics In Erik Parens, Ed., Surgically Shaping Children. Baltimore, Md: Johns Hopkins University Press, Pp. 68 -- 89 / A. Frank -- 35. Cochlear Implants And The Right To Language: Ethical Considerations, The Ideal Situation, And Practical Measures Toward Reaching The Ideal, In Cila Umat And Rinze Anthony Tange, Eds, Cochlear Implant Research Updates. Rijeka, Croatia: In Tech, 2012, Pp. 193 -- 212 / Scott Smith -- 36. Ethics Of Uterus Transplantation, Bioethics, 27:2, 65 -- 73 (2013) / Mianna Lotz -- 37. Assisted Reproduction And Choice In The Biotech Age: Recommendations For A Way Forward, Contraception, 83:1, 1 -- 4 (2011) / S.b. Fogel -- 38. Tragedy And Delight: The Ethics Of Decelerated Ageing, Philosophical Transactions Of The Royal Society B: Biological Sciences, 366:1561, 108 -- 12 (2011) / David Gems -- 39. Cognitive Enhancement, Virtue Ethics And The Good Life, Neuroethics, 4:3, 223 -- 34 (2011) / Barbro Elisabeth Esmeralda Froding. [edited By] Arthur L. Caplan And Brendan Parent, New York University, School Of Medicine. Includes Bibliographical References And Index.