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Foreword
Over the last decade we have seen a transformation in the delivery of healthcare with telemedicine, virtual consultations, virtual wards, use of artificial intelligence, wearables, genomic medicine. All transforming the way healthcare practitioners make a diagnosis and the delivery of healthcare.
These technological advances will no doubt continue bringing opportunities and benefits. The challenge for healthcare providers globally is to ensure that the legal and regulatory framework is fit for purpose and appropriate indemnity is in place should there be any claims as a consequence of the transformation of healthcare services.
A panel of our global healthcare lawyers in Australia and Hong Kong, Canada and Chile, and England, France, Ireland, and Spain, recently explored healthtech in these jurisdictions through the lens of medical malpractice claims.
In this series of articles, we provide an overview of key areas of discussion. We recently held our annual 2024 global healthcare conference programme, which has been recorded for you to watch.
Christopher Malla, Global Head of Healthcare
Canada
Canada remains at a nascent stage in terms of dealing with medico-legal issues associated with healthtech. To date, the key issues relate to privacy and ethics. Essentially, as a consequence of a number of data breach incidents within the health sector.
To the extent that there is jurisprudence relating to healthtech issues, that which exists primarily arises from complaints made to provincial regulators following a virtual interaction with a healthcare provider. These have included:
- Providing prescriptions in a jurisdiction where the practitioner is not licensed;
- Improper supervision of the healthcare provider; and
- Improper diagnoses.
Artificial intelligence
Questions abound on how medical devices using artificial intelligence (AI) should be approved and regulated. Those questions in part derive from the division of authority over healthcare in Canada, which pose unique challenges for the regulation of AI in the health sector.
Healthcare primarily falls under the jurisdiction of individual provinces in Canada. Although similar, each province has its own set of regulatory frameworks addressing the safety and quality of healthcare. In relation to the use of AI, provincial legislation and regulations primarily govern the end-users of AI technology and its application to patients. However, it is important to note that the federal government also plays a significant role.
Health Canada is the federal regulatory authority which oversees drugs and medical devices. One of its primary responsibilities is to provide the licensing and approval of all medical devices. In recent years, Health Canada had begun to adapt its regulatory approach to support the development of digital health technologies, including AI in medical devices and telemedicine. The regulatory body has published guidance documents for manufacturers and software developers, however there are currently no definitive regulations for these products.
In addition to Provincial and Federal government bodies, there are also various professional bodies that provide oversight and self-regulation over healthcare professionals
Given all of the invested parties, there is the potential for a complex framework of oversight for the use of AI technology. As yet there is no real body of jurisprudence on this in Canada.
Currently, barring any specific regulations that may be implemented, the expectation is that any potential liability issues will derive from regulations themselves, negligence and/or contractual duties.
From a regulatory perspective, it remains to be seen whether potential issues will be addressed in new regulations or subject to existing legislation.
Contact: Jason Arcuri
Chile
The application of healthtech in the delivery of healthcare is in the early stages in Latin America. The discussion on liability at this point is therefore largely theoretical, and is anticipated to develop as the application of healthtech and in particular, artificial intelligence, increases.
Bill of law – in discussion
In Chile, a Bill of law - with a focus on new technology in healthcare (such as the use of robotic-assisted surgery, which is being used in Chile) - has been in discussion since 2022. The initial intention of the bill being to create mandatory liability insurance for practitioners when using healthtech. However, subsequent amendments made to the proposed bill would necessitate the healthcare provider to have its own insurance to cover the doctors that provide the healthcare. The bill of law is still in discussion and in the second stage the Health Authority will determine which level of insurance cover will be mandatory.
Big data and patient privacy
There is also an important discussion taking place in Chile regarding artificial intelligence in terms of big data and patient privacy. It is likely that Chile will closely follow European legislation on this issue.
Telemedicine
Chile has an extensive telemedicine practice, especially for consultations. A recent development has seen both the Court of Appeal and Supreme Court holding that patients have the right to a face to face consultation with a practitioner in the public sector.
Contact: Gian Carlo Lorenzini
Healthcare
Australia
Hong Kong