Hardback
HealthTech
Law and Regulation
9781839104893 Edward Elgar Publishing
This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech.
Key features include:
• Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers
• Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges
• Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market
• Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
Key features include:
• Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers
• Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges
• Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market
• Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
More Information
Critical Acclaim
Contributors
Contents
More Information
This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Combining the insights of leading healthcare experts from around the world, chapters first examine the key characteristics, use cases and regulation in the field, before turning to the development and potential applications of cutting-edge technologies in healthcare. The book also addresses the main issues involved in setting up and running a HealthTech business, highlighting the vital role this will play in developing the technologies and skill sets required for the future of the sector.
Key features include:
• analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers
• examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges
• guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market
• discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
HealthTech: Law and Regulation will be an invaluable resource for both in-house lawyers in the healthcare and pharmaceutical sectors, as well as those working for law firms practising in these areas. It will also be of interest to academics and students teaching or researching in healthcare law.
Key features include:
• analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers
• examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges
• guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market
• discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
HealthTech: Law and Regulation will be an invaluable resource for both in-house lawyers in the healthcare and pharmaceutical sectors, as well as those working for law firms practising in these areas. It will also be of interest to academics and students teaching or researching in healthcare law.
Critical Acclaim
‘Healthtech: Law and Regulation makes an important contribution in the field of medical technology industry. It will be an invaluable resource for regulators and researchers looking to address the challenges produced by the technological advancement.’
– Fatima Kanij, Law in Context
‘The act of providing health-related care is experiencing a technology-enabled consumer revolution that has only compounded in the time of this rarely experienced pandemic. In order to understand and thrive in these changing yet exciting digital times, you need knowledge, a reference, a guide and a plan for excelling. This collection of all-encompassing topics around digital health technology is a must read and can assist in creating a True North for those bold passionate individuals and businesses that will change the world and spark innovation in how we deliver and receive health-related care.’
– Samir Batra, BAHA Enterprises, US
‘A valuable and timely addition to the literature, this book considers some of the most pressing issues facing those who practise, or are generally interested in, this rapidly developing field of law. Emerging technology offers unprecedented opportunities to transform the way healthcare is delivered, saving time, money and resources while also improving healthcare and wellness outcomes. But new healthtech also raises novel legal and regulatory challenges that we must grapple with if we are to assuage fundamental societal concerns around data privacy and ownership; avoiding designed-in biases; equitable access to healthcare; and how to innovate at pace without compromising end-user safety. Dr. Madir and her respected team of contributors traverse both the UK and international landscape with authority and insight.’
– Daniel Morris, Bevan Brittan LLP, UK
‘HealthTech provides a comprehensive accounting of the myriad legal issues that might affect health technology in practice, from medical devices to patient care, clinical trials and patient rights. The authors do an exceptional job explaining the future of healthcare for artificial intelligence and telehealth. If you are interested in the technology of healthcare, this book provides an excellent primer on the key issues that might affect your organization.’
– Charlotte Tschider, Loyola University School of Law, US
‘As data-driven and innovative health technologies will increasingly determine the nature of integrated health services while necessarily demanding transnational cooperation, this book is on the spot: a profound cross-border analysis of key use cases in healthcare technology and regulatory frameworks covering current and future core issues. A must read for all forward-looking minds in the healthcare sector.’
– Fabian Raddatz, Labor Berlin, Germany
‘This is a book which covers a wide range of topics relevant to HealthTech – from AI to data protection and from blockchain to medical devices regulation. It is ambitious in its vision, not shying away from covering areas which are still in a state of change and assessing the opportunities of HealthTech whilst also taking a cool eyed view of challenges such as slow procurement processes and the interoperability with legacy systems, which will meet with recognition by anyone who has spent time working in this sector. Its breadth and up-to-date content will make it a book to be kept at hand by lawyers, academics, investors, strategists, healthcare providers and suppliers alike. The book uses the example of Fintech as a thread running throughout – as a recent disruptor technology in a highly regulated sector this is a very valuable comparator. Lastly, the chapter on emerging markets strikes a particular chord in these times of global pandemic, where the interconnectedness of global healthcare systems has never been more apparent and the value of HealthTech tools (for example in track and trace apps) have shown themselves to be of huge significance in management of disease at a local and global scale.’
– Louise Fullwood, Pinsent Masons LLP, UK
– Fatima Kanij, Law in Context
‘The act of providing health-related care is experiencing a technology-enabled consumer revolution that has only compounded in the time of this rarely experienced pandemic. In order to understand and thrive in these changing yet exciting digital times, you need knowledge, a reference, a guide and a plan for excelling. This collection of all-encompassing topics around digital health technology is a must read and can assist in creating a True North for those bold passionate individuals and businesses that will change the world and spark innovation in how we deliver and receive health-related care.’
– Samir Batra, BAHA Enterprises, US
‘A valuable and timely addition to the literature, this book considers some of the most pressing issues facing those who practise, or are generally interested in, this rapidly developing field of law. Emerging technology offers unprecedented opportunities to transform the way healthcare is delivered, saving time, money and resources while also improving healthcare and wellness outcomes. But new healthtech also raises novel legal and regulatory challenges that we must grapple with if we are to assuage fundamental societal concerns around data privacy and ownership; avoiding designed-in biases; equitable access to healthcare; and how to innovate at pace without compromising end-user safety. Dr. Madir and her respected team of contributors traverse both the UK and international landscape with authority and insight.’
– Daniel Morris, Bevan Brittan LLP, UK
‘HealthTech provides a comprehensive accounting of the myriad legal issues that might affect health technology in practice, from medical devices to patient care, clinical trials and patient rights. The authors do an exceptional job explaining the future of healthcare for artificial intelligence and telehealth. If you are interested in the technology of healthcare, this book provides an excellent primer on the key issues that might affect your organization.’
– Charlotte Tschider, Loyola University School of Law, US
‘As data-driven and innovative health technologies will increasingly determine the nature of integrated health services while necessarily demanding transnational cooperation, this book is on the spot: a profound cross-border analysis of key use cases in healthcare technology and regulatory frameworks covering current and future core issues. A must read for all forward-looking minds in the healthcare sector.’
– Fabian Raddatz, Labor Berlin, Germany
‘This is a book which covers a wide range of topics relevant to HealthTech – from AI to data protection and from blockchain to medical devices regulation. It is ambitious in its vision, not shying away from covering areas which are still in a state of change and assessing the opportunities of HealthTech whilst also taking a cool eyed view of challenges such as slow procurement processes and the interoperability with legacy systems, which will meet with recognition by anyone who has spent time working in this sector. Its breadth and up-to-date content will make it a book to be kept at hand by lawyers, academics, investors, strategists, healthcare providers and suppliers alike. The book uses the example of Fintech as a thread running throughout – as a recent disruptor technology in a highly regulated sector this is a very valuable comparator. Lastly, the chapter on emerging markets strikes a particular chord in these times of global pandemic, where the interconnectedness of global healthcare systems has never been more apparent and the value of HealthTech tools (for example in track and trace apps) have shown themselves to be of huge significance in management of disease at a local and global scale.’
– Louise Fullwood, Pinsent Masons LLP, UK
Contributors
Contributors: A. Bruyndonckx, M. Bulckaert, T. Chakraborti, R. Cheng, E. Chukwu, S. Cohen, C.D. Combs, N. Cooper, A. Dennis, M. DeNoncour, S. Giordano, J. Madir, T. Mulder, V. Murovec, P. Parkin, F. Potin, B. Robin, S. Tainsh, J. Thomason, R. Wiring
Contents
Contents:
Preface xvii
1. Using technology to deliver health services 1
Jelena Madir
PART I REGULATION AND GOVERNANCE OF HEALTHTECH
2. Data protection, information security and international data transfers:
a practical guide through key provisions and compliance tools 24
Tom Chakraborti
3. Healthcare technology regulation in the EU and the UK: from medical devices
to intellectual property and advertising 53
Alison Dennis
4. Healthcare technology regulation in the US 80
Matthew DeNoncour
5. Product liability: compliance and safety issues 114
Annabelle Bruyndonckx, Vladimir Murovec and Michael Bulckaert
PART II FRONTIER TECHNOLOGIES AND MARKETS
6. Artificial intelligence in healthcare 14
Roland Wiring
7. The role of digital ID in healthcare 167
Emeka Chukwu
8. Blockchain opportunities in healthcare 193
Jelena Madir
9. Technology and healthcare opportunities in emerging markets 218
Jane Thomason and Nichola Cooper
PART III HEALTHTECH BUSINESSES
10. Financing healthcare start-ups 246
Stephen Tainsh
11. Collaboration and partnership structures in HealthTech 270
Simonetta Giordano, Frédérique Potin and Sharon Cohen
12. Procurement considerations for the acquisition of HealthTech products 303
Patrick Parkin
13. The impact of the European Medical Device Regulations on the development
and use of mHealth apps in Europe 329
Trix Mulder
14. Telemedicine: opportunities and challenges – a US perspective 354
Richard Cheng and Barrett Robin
15. What skills will be required of healthcare professionals in the future? 374
C. Donald Combs
Glossary of key terms 398
Index 403
Preface xvii
1. Using technology to deliver health services 1
Jelena Madir
PART I REGULATION AND GOVERNANCE OF HEALTHTECH
2. Data protection, information security and international data transfers:
a practical guide through key provisions and compliance tools 24
Tom Chakraborti
3. Healthcare technology regulation in the EU and the UK: from medical devices
to intellectual property and advertising 53
Alison Dennis
4. Healthcare technology regulation in the US 80
Matthew DeNoncour
5. Product liability: compliance and safety issues 114
Annabelle Bruyndonckx, Vladimir Murovec and Michael Bulckaert
PART II FRONTIER TECHNOLOGIES AND MARKETS
6. Artificial intelligence in healthcare 14
Roland Wiring
7. The role of digital ID in healthcare 167
Emeka Chukwu
8. Blockchain opportunities in healthcare 193
Jelena Madir
9. Technology and healthcare opportunities in emerging markets 218
Jane Thomason and Nichola Cooper
PART III HEALTHTECH BUSINESSES
10. Financing healthcare start-ups 246
Stephen Tainsh
11. Collaboration and partnership structures in HealthTech 270
Simonetta Giordano, Frédérique Potin and Sharon Cohen
12. Procurement considerations for the acquisition of HealthTech products 303
Patrick Parkin
13. The impact of the European Medical Device Regulations on the development
and use of mHealth apps in Europe 329
Trix Mulder
14. Telemedicine: opportunities and challenges – a US perspective 354
Richard Cheng and Barrett Robin
15. What skills will be required of healthcare professionals in the future? 374
C. Donald Combs
Glossary of key terms 398
Index 403
