Cultivation and medicinal use of Cannabis sativa L in Brazil
By Camila Martino Parise and Júlia de Castro Kesselring
In Brazil, Cannabis sativa L is included in the list of plants that, as a general rule, cannot be cultivated, harvested, exploited, imported, exported, traded, extracted, handled or used. These activities are typified as criminal conduct. An exception is made for the cultivation and harvest of the plant for scientific or medicinal purposes, under certain restrictions and upon authorisation of the Ministry of Health.
The use of artificial intelligence in the healthcare sector in India
By Sameer Sah and Avantika Govil
The rapid evolution in the spheres of technology and healthcare in India has given an impetus to the use of artificial intelligence in the healthcare sector. This article focuses on some of the challenges, along with recognising the advancements made, limitations to be resolved and incentives to be introduced.
Healthcare and Life Sciences Law Committee update, September 2018
This issue contains a diverse range of articles from global jurisdictions. Get the latest on data protection law; telemedicine; advertising and social networks; privacy and blockchain; AI, machine learning and the Internet of Things; and international trade law and local health law.
From the Co-Chairs
By Patricia Barclay and Stephen Rau
The Committee Co-Chairs greet Committee members, thank those involved in submitting, reviewing and publishing the below articles, and invite members to share their thoughts and ideas on the Committee’s discussion forum, and at the 2018 Annual Conference.
From the Website Officer
By Cécile Théard-Jallu
The Committee's Website Officer Cécile Théard-Jallu introduces this committee update, covering important topics for the life sciences and healthcare industry from all over the world.
How to process health personal data under French law after 25 May 2018
By Cécile Théard-Jallu and Nina Gosse
Following the arrival of the GDPR, France has modified its legislation regarding the protection of personal data, using some of the subsidiarity zones left by the GDPR to maintain existing or add new conditions to the latter’s provisions.
Processing health personal data for scientific research: the specific regime under Belgian law
By Herman Croux and Jari Vrebos
Following the arrival of the GDPR, Belgium is modifying its legislation regarding the protection of personal data, using some of the subsidiarity zones left by the GDPR.
Data Protection Act 2018: special category data and health provisions
By Beverly Flynn
While the GDPR was implemented on 25 May 2018, it also gave EU Member State bodies the ability to both restrict and impose further conditions on the processing of personal data under the GDPR. This article examines some examples of these in the UK in the context of the DPA.
GDPR and health data in Germany – special data needs special protection
By Thomas Jansen
This articles provides an overview of the German data protection regime, which the author argues provides a good example of what ‘further conditions’ Member States would be likely to adopt in relation to health data and its interplay with the GDPR.
Personal data in healthcare in Sweden – an overview
By Odd Swarting, Camilla Appelgren and Peter Nilsson
This article aims to provide a high-level overview of the Swedish legislation governing health data in healthcare, as adapted to the GDPR. The article also provides a glance at current news and trends in health data in Sweden.
The impact of the GDPR from a Spanish perspective
Manual Alonso and Paula Regueira Leal
Although months have passed since the entry into force of the GDPR, there is still a considerable confusion within the Spanish life sciences world regarding its interpretation, impact on local legislation and, as a result, its implications on standard practices in biomedical research.
Enforcing the GDPR in the healthcare sector: a blended approach between European and national laws
By Cécile Théard-Jallu and Nina Gosse
In certain subsidiary zones, EU Member States have been left with the possibility to derogate from GDPR rules. This article aims to help life sciences actors prepare and implement their processing activities in this framework.
Proposed data privacy regime for the healthcare sector in India
By Supratim Chakraborty, Shweta Dwidedi and Shayak Sircar
On 21 March 2018, the Indian Ministry of Health and Family Welfare released the draft of the Digital Information Security in Healthcare Act (DISHA) and invited public comments. This article provides an overview of key changes sought to be introduced through the DISHA.
Israeli health data privacy rules
By Sharon Gazit and Yael Edell Rosenmann
Israeli health data privacy rules and regulations seem to still be a work in progress and health data privacy rules are far from being concluded. This article reviews the current legal state of health data privacy rules in Israel.
Health data protection in Nigeria
By Cheluchi Onyemelukwe
With the advent and growth of e-health in Nigeria, described broadly here as the intervention of information and communication technology, the generation of data has become much easier, more ubiquitous and arguably easier to share, duplicate and access.
International trade law and local health law: regulatory harmonisation and regulatory convergence
By Christian Lopez-Silva
For the first time in international law, provisions directly disciplining aspects of human health regulation have been directly incorporated in free trade agreements. Latin America, where harmonisation is desperately needed, could be one of the regions to benefit most.
US and EU health information privacy – different laws, similar complexity
By Dianne L Bourque
This article provides an overview of the different sources of US health information privacy law and an approach for analysing applicability. Note that the focus will be on privacy law, even though some of these laws, including the HIPAA, include security and breach notification requirements as well.
Technology in healthcare: changes in Singapore’s regulatory landscape
By Benjamin Gaw
The increasing confluence between technology and medicine has transformed Singapore’s healthcare landscape. This article focuses on the recent or proposed legislative and regulatory changes in relation to both telemedicine and the National Electronic Health Record.
Telemedicine in Germany – past, present, future
By Stephen Rau and Lucia Reuter
This article aims to clarify the legal and regulatory landscape of telemedical services in Germany. It will discuss the current situation of admissibility of teleconsultation, as well as recent and forthcoming regulatory amendments with regard to telemedicine.
Advertising medical devices through social networks and use of testimonials: new Guidelines in Italy
By Elisa Stefanini and Lydia Mendola
This article looks at the advertising of medical devices in Italy, assessing the recent Guidelines published by the Ministry of Health. The article also reports on a recent judgment on the liability of the entity responsible for the communication channel for unlawful advertising of medical devices.
Blockchain technology: a privacy tool for the healthcare sector
By Ioanna Michalopoulou, Tryfon Memos and Vassilis Argentinis
This article explains the structure and potential of blockchain technology, the solutions it could provide for healthcare privacy and the legal issues that are raised by its implementation in the European and Greek legal environment, also in view of the recent entry into force of the GDPR.
A primer on law, risk and AI in healthcare
By Domenic Crolla and Martin Lapner
The adoption of AI by the Canadian healthcare sector has largely occurred in a piecemeal manner in an uncertain regulatory environment, and without other authoritative guidance to clarify the legal and policy context in which AI in healthcare will be implemented and governed.
Product liability of digital health technologies: a Canadian perspective on regulatory and litigation developments
By Glenn Zakaib and Edona Vila
The expansion and adoption of the Internet of Things has caused a transformational eruption across all industries. Healthcare is no exception. This article seeks to provide an overview of the regulatory and products litigation risks associated with the adoption of digital health technologies in Canada.
Mexican privacy health-related framework: a regime in good shape that is likely to become more fit for healthcare companies
By Carlos Vela-Treviño and Christian Lopez-Silva
The GDPR is causing a revolution in many countries, but Mexico is not quite one of them. Rather than disrupting the local system, the GDPR could represent a synergetic step forward into maturity for the Mexican legal framework, particularly as it relates to healthcare.