Book contents
- AI in eHealth
- Cambridge Bioethics and Law
- AI in eHealth
- Copyright page
- Contents
- Contributors
- Preface
- Acronyms
- 1 Mapping the Digital Healthcare Revolution
- Part I Platforms, Apps and Digital Health
- Part II Trust and Design
- Part III Knowledge, Risk and Control
- Part IV Balancing Regulation, Innovation and Ethics
- 11 Doctors Without Borders? The Law Applicable to Cross-Border eHealth Services and AI-Based Medicine
- 12 Organisational Readiness for the Adoption of Artificial Intelligence in Hospitals
- 13 Regulating the ‘Benefits’ of eHealth
- 14 Data Protection Implications of Forensic Genealogy
- 15 Health Research, eHealth, and Learning Healthcare Systems
- Index
- Cambridge Bioethics and Law
- References
11 - Doctors Without Borders? The Law Applicable to Cross-Border eHealth Services and AI-Based Medicine
from Part IV - Balancing Regulation, Innovation and Ethics
Published online by Cambridge University Press: 08 September 2022
Book contents
- AI in eHealth
- Cambridge Bioethics and Law
- AI in eHealth
- Copyright page
- Contents
- Contributors
- Preface
- Acronyms
- 1 Mapping the Digital Healthcare Revolution
- Part I Platforms, Apps and Digital Health
- Part II Trust and Design
- Part III Knowledge, Risk and Control
- Part IV Balancing Regulation, Innovation and Ethics
- 11 Doctors Without Borders? The Law Applicable to Cross-Border eHealth Services and AI-Based Medicine
- 12 Organisational Readiness for the Adoption of Artificial Intelligence in Hospitals
- 13 Regulating the ‘Benefits’ of eHealth
- 14 Data Protection Implications of Forensic Genealogy
- 15 Health Research, eHealth, and Learning Healthcare Systems
- Index
- Cambridge Bioethics and Law
- References
Summary
By their very nature eHealth applications – including telemedicine, AI-based medicine and ‘smart’ medical devices – are ubiquitous: These tools may be used by the physician next door as well as in the most remote locations abroad. Moreover, highly sensitive medical data may flow around the world within a split second. Against this backdrop, eHealth and telemedicine services can be provided from – and the necessary data can be transferred to – virtually every corner of the world. By contrast, the scope of application of regulation relating to AI-driven medicine, as well as eHealth and telemedicine, is usually confined to the legislating state. Moreover, the number and complexity of rules and regulations in this field vary considerably from state to state. Does this mean that international MedTech businesses may simply set up camp in the jurisdiction most favourable to their business models? For practitioners in telemedicine, the MedTech industry providing AI applications or digital medical devices such as eHealth apps, as well as for patients, it is essential to know which laws govern activities undertaken in cross-border scenarios. This concerns licensing requirements and the level of data protection as well as contract and tort law applicable to eHealth, telemedicine and telesurgery services.
Keywords
- Type
- Chapter
- Information
- AI in eHealthHuman Autonomy, Data Governance and Privacy in Healthcare, pp. 311 - 333Publisher: Cambridge University PressPrint publication year: 2022
References
Abrams, C, ‘Google’s Effort to Prevent Blindness Shows AI Challenges’ Wall Street Journal, 26 January 2019, www.wsj.com/articles/googles-effort-to-prevent-blindness-hits-roadblock-11548504004, accessed 19 June 2020.Google Scholar
Ameringer, C, ‘State-Based Licensure of Telemedicine: The Need for Uniformity but Not a National Scheme’ (2011) 14(1) Journal of Health Care Law and Policy 55–85.Google Scholar
Barnes, JK, ‘Telemedicine A Conflict of Laws Problem Waiting to Happen – How Will Interstate and International Claims be Decided?’ (2006) 28(2) Houston Journal of International Law 491–529.Google Scholar
Bashshur, R and Shannon, G, History of Telemedicine: Evolution, Context, and Transformation (Liebert 2009).Google Scholar
Bourassa Forcier, M and others ‘Integrating Artificial Intelligence into Health Care Through Data Access: Can the GDPR Act as a Beacon for Policymakers?’ (2019) 6(1) Journal of Law and the Biosciences 317–35.Google Scholar
Brkan, M, ‘Data Protection and Conflict-of-Laws: A Challenging Relationship’ (2016) 2(3) European Data Protection Law Review 1–18.CrossRefGoogle Scholar
Cheshire, North and Fawcett, Private International Law 15th ed (Oxford University Press 2017).Google Scholar
Cloud, M, ‘Robots Are Coming: A Discussion of Choice-of-Law Issues and Outcomes in Telesurgical Malpractice’ (2019) 6(3) Texas A&M Law Review 707–30.Google Scholar
Department of Health and Human Services, ‘Telemedicine Licensure Report’ Office for the Advancement of Telehealth, Centre for Telemedicine, 2003.Google Scholar
European Commission, ‘Staff Working Document on the Applicability of the Existing EU Legal Framework to Telemedicine Services’ SWD(2012) 414 final, 6 December 2012, https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0414:FIN:EN:PDFGoogle Scholar
European Commission, ‘Staff Working Document on Liability for Emerging Digital Technologies’, SWD(2018) 137 final, 25 April 2018, https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A52018SC0137Google Scholar
Fenton, J, Taplin, S, Carney, P and others, ‘Influence of Computer-Aided Detection on Performance of Screening Mammography’ (2007) 356(14) New England Journal of Medicine 1399–1409.Google Scholar
Ferrera, D and Woodward, M ‘Liability Issues Continue to Evolve in Computer-Assisted Surgery’ MDDI Online, 2020, www.mddionline.com/legal/liability-issues-continue-evolve-computer-assisted-surgery, accessed 9 June 2020.Google Scholar
Food and Drug Administration, ‘Computer-Assisted Surgical Systems’ 13 March 2019, www.fda.gov/medical-devices/surgery-devices/computer-assisted-surgical-systems, accessed 9 June 2020.Google Scholar
Food and Drug Administration, ‘Examples of Device Software Functions the FDA Regulates’ 26 September 2019, www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates, accessed 9 June 2020.Google Scholar
Health Resources & Services Administration, ‘Office for the Advancement of Telehealth’, www.hrsa.gov/rural-health/telehealth/, accessed 24 May 2021.Google Scholar
Heinze, C and Warmuth, C, ‘Das Sonderprozessrecht der Datenschutz-Grundverordnung’ (2016) 21 Zeitschrift für Zivilprozess International 175–98.Google Scholar
Jakobs, I and Huber, F ‘Software als Medizinprodukt: Haftungs-und versicherungsrechtliche Aspekte’ (2019) 1 Zeitschrift Medizin Produkte Recht 1–6.Google Scholar
Kadner, Graziano Th ‘Torts’ in Basedow, J and others (eds), Encyclopedia of Private International Law II (Edward Elgar 2017) 1709–17.Google Scholar
Keysers, D, ‘Implantate – (Produkt-)Haftungsrechtliche Fragestellungen unter Berücksichtigung der Medical Device Regulation (Teil 2)’ (2020) 2 Haftpflicht International 54–61.Google Scholar
Kohler, C, ‘Conflict of Law Issues in the 2016 Data Protection Regulation of the European Union’ (2019) 3 Rivista di diritto internazionale privato e processuale 653–75.Google Scholar
Kowalewski, K-F, Kriegmair, MC and Michel, M-C, ‘Kollaborative Automatisierung und Robotik’ (2019) 37(12) Reinprecht 925–27.Google Scholar
Lehman, C and others ‘Diagnostic Accuracy of Digital Screening Mammography With and Without Computer-Aided Detection’ (2015) 175(11) JAMA Internal Medicine 1828.Google Scholar
Lüttringhaus, J, ‘Art. 1 Rome I Regulation’ in Ferrari, F (ed), Concise Commentary on the Rome I Regulation, 2nd ed (Cambridge University Press 2020).Google Scholar
Lüttringhaus, J, ‘Das internationale Datenprivatrecht: Baustein des Wirtschaftskollisionsrechts des 21. Jahrhunderts – Das IPR der Haftung für Verstöße gegen die EU-Datenschutzgrundverordnung’ (2018) 117(1) Zeitschrift für Vergleichende Rechtswissenschaft 50–82.Google Scholar
Marescaux, J, ‘Nom de code: ‘Opération Lindbergh‘ (2002) 127(1) Annals of Surgery 2–4.Google Scholar
Metz, C ‘India Fights Diabetic Blindness With Help From A.I.’ New York Times, 10 March 2019, www.nytimes.com/2019/03/10/technology/artificial-intelligence-eye-hospital-india.html, accessed 17 June 2020.Google Scholar
Middendorf, M and Wever, C, ‘Telemedicine to the Rescue? Reviewing the Current Liability Picture in Germany’ (2020) 4(2) Haftpflicht International 1–4.Google Scholar
De Miguel Asensio, P, ‘Jurisdiction and Applicable Law in the New EU General Data Protection Regulation’ (2017) 69(1) Revista Española de Derecho Internacional 75–108.Google Scholar
Ortner, R and Daubenbüchel, F‚ ‘Medizinprodukte 4.0 – Haftung, Datenschutz, IT-Sicherheit’ (2016) 41 Neue Juristische Wochenschrift 2918–24.Google Scholar
Pfeiffer, M, ‘Europarechtliche Aspekte der Medizinprodukthaftung’ (2019) 3 Haftpflicht International 116.Google Scholar
Pormeister, K, ‘Genetic Research and Applicable Law: The Intra-EU Conflict of Laws as a Regulatory Challenge to Cross-Border Genetic Research’ (2018) 3 Journal of Law and the Biosciences 706–23.Google Scholar
Spickhoff, A, ‘Rechtsfragen der grenzüberschreitenden Telemedizin’ (2008) 36(8) Medizinrecht 535–43.Google Scholar
Wendelstein, C, Kollisionsrechtliche Probleme der Telemedizin (Mohr Siebeck 2012).CrossRefGoogle Scholar
Wilderspin, M, ‘Consumer Contracts’ in Basedow, J, Rühl, G, Ferrari, F and others (eds), Encyclopedia of Private International Law I(Edward Elgar 2017) 464–72.Google Scholar