The article addresses the regulatory framework of plant-based food in Brazil, considering the existence of more than one responsible authority for the regulation of food products and the current nonexistence of specific rules for plant-based food. Despite the lack of specific regulation there have been some initiatives to regulate plant-based products. This is mainly due to innovations in the food market arising from new technologies, and the need to provide clear and adequate information in order to reduce the asymmetry of information in the plant-based food market.
Released on Nov 2, 2023
Assistance should be provided to supply chain challenges in the Healthcare & Life Science Sector through the use of new technologies, and to make the supply chain more effective and fail-safe through the use of Artificial Intelligence (AI). The European Union wants to ensure that AI systems are safe, transparent, traceable, non-discriminatory and environmentally friendly. Therefore, the existing legal issues shall be embedded in a new legal framework to ensure legal certainty. The institutions of the European Union aim at adopting a common AI law by the end of this year.
Released on Nov 2, 2023
Telemedicine, despite being used in practice, was not explicitly and specifically addressed in Czech law. However, new legislation to introduce the concept of telemedicine into the Czech legal framework is now on the horizon.
Released on Nov 2, 2023
The impact of artificial intelligence (AI) in the healthcare market are becoming increasingly more pronounced, indicating a turning point in modern medical practice. For example, in areas such as diagnosis, some machine learning tools have been shown to be more accurate in identifying pancreatic cysts harbouring cancer or at risk of cancer, than conventional clinical and imaging criteria alone, demonstrating the potential for AI to reduce costs and current rates of morbidity.
Released on Nov 2, 2023
Telemedicine is viewed as a means of improving patients’ access to healthcare, allowing doctors both to work more effectively and reduce costs. This is achieved by cutting the number of unnecessary hospital admissions and facilitating doctor contact from as patient’s home in urgent cases. Such a way of working is possible, but requires a well-designed and predictable regulatory framework of standards for providing telehealth services.
Released on Nov 2, 2023
The integration of telemedicine has accelerated an innovative process within the healthcare sector, reshaping the ways in which medical services are provided. Consequently, the most competitive medical institutions have embraced continuous innovation as a fundamental strategic course. This approach has proved to be a distinguishing factor between healthcare provider organisations, solidly establishing and positioning themselves in relation to their competitors. In this context, the present article aims to outline certain considerations which require contemplation for achieving suitable implementation of telemedicine services in developing countries.
Released on Nov 2, 2023
This article gives an overview of the regulatory landscape for clinical trials in Peru. It discusses the key stakeholders involved, including the National Institute of Health (INS) and the General Directorate of Medicines, Supplies, and Drugs (DIGEMID), highlighting their roles in trial authorisation and product safety evaluation. It emphasises the regulatory framework, outlined in Decree No 021-2017-SA. The roles of various entities, such as sponsors, Contract Research Organisations (CROs), monitors, Principal Investigators, research centres, and Institutional Review Boards (IRBs), are also described.
Released on Nov 2, 2023
Incorporating new pharmaceutical technologies is one of the main challenges facing Brazil’s Unified Health System (SUS). Inspired by the United Kingdom model, Brazil’s National Commission for the Incorporation of Technology in the SUS (CONITEC) has based the analysis of incorporation on a combination of cost and effectiveness. However, in many cases, uncertainty remains about the advantage of replacing technologies due to the need for more sufficient data, which delays public access to these treatments through the regular channels.
Released on Nov 2, 2023
Striking a balance between the intellectual property rights of and access to affordable medication in developing countries has long been a debated issue in the healthcare sector and legal community. It is now more important than ever to strike a balance between the two perspectives, particularly in developing countries. This article explores the legal landscape surrounding patented medication and compulsory manufacturing licences in Pakistan.
Released on Nov 2, 2023
This article examines data protection and document management in Brazil’s health insurance sector. It discusses the implications of the Brazilian General Data Protection Law, emphasising patients’ rights over their personal data and the obligations with which health insurance providers need to comply. The article concludes by stressing the crucial balance between data use and patient protection, advocating robust data protection measures and responsible management for health insurance carriers’ integrity and innovation.
Released on Nov 2, 2023
Advances in AI have ushered in a new era of innovation across sectors, with the healthcare sector being at the forefront of this transformative wave. With the increasing use of AI across various segments of the healthcare sector, challenges and ethical considerations arise, along with the need for human intervention. There remains a need for collaboration between industry experts and policy makers across jurisdictions such that the AI tools can be deployed responsibly and effectively.
Released on Nov 2, 2023
Immediately before the global focus shifted to battling the Covid-19 pandemic in March 2020, India’s regulator for medical devices, the Central Drugs Standard Control Organisation (CDSCO), issued two notifications which brought about sweeping changes to the regulatory framework for medical devices.
Released on Nov 2, 2023
In 2021, Mark Zuckerberg's ambition was to bring internet users into the metaverse. Web giants and major brands have mobilised to develop their projects there. Although there is currently a period of less enthusiasm for the metaverse, it presents real opportunities for a variety of sectors, from gaming to sports, real estate to leisure, retail to education and many others.
Released on Sep 12, 2023
Though silent, the bodies of those killed in war still have stories to tell. Customary and statutory international humanitarian law are dedicated to these stories, protecting the rights of the persons who used to inhabit these bodies. Despite the ongoing nature of the war in Ukraine and the dearth of reliable information, some reports set out facts which are likely to implicate these IHL principles both during and after the conflict. In looking to the dead for evidence, and acting to honor their memory, IHL reaffirms their dignity and humanity.
Released on Apr 21, 2023
The fear of being deprived of access to healthcare during the Covid-19 pandemic was clear. In Brazil, people have access to healthcare through the Unified Health System or through private healthcare plans, which generally tends to offer a better quality of healthcare services.
Released on Feb 13, 2023
Transactions related to the healthcare industry have been in the spotlight in the last few years. This sector has been responsible for the development of relevant technologies and for boosting the economy in different countries. This article aims to summarise the trends, advantages and legal challenges related to transactions in the healthcare ecosystem.
Released on Nov 14, 2022
The outbreak of the Covid-19 pandemic generated extensive debate regarding equitable access to vaccines and medical treatments. In this framework, discussion of the role of patents in health care came to the fore: Are patents a resource, or are they instead an obstacle to the widespread protection of public health during a pandemic emergency?
Released on Oct 21, 2022
This article introduces the principles China adopts to address ethical issues in ‘AI+life science’ applications and how China regulates certain specific ethical issues.
Released on Oct 21, 2022
The development and use of artificial intelligence (AI) in health and biotechnology is creating opportunities and benefits for healthcare providers and consumers. Presently, AI is being used in medical fields such as diagnostics, e-health and evidenced based medicine. A prime example has been the use of AI in the detection and management of diagnostic imaging such as thoracic imaging, mammography and colorectal polyps.
Released on Oct 21, 2022
It is clear that the Covid-19 pandemic has produced challenges for the global community and important lessons can be learnt to ensure that the international community is better prepared to ideally avert and, if not, identify, contain, and manage pandemics and reduce associated loss of life and social and economic damage.
Released on Oct 21, 2022
Telemedicine has always been a limited activity in Brazil that could be performed under very specific circumstances. The public health emergency of national interest declared in response to the Covid-19 pandemic, however, caused exceptional and temporary flexibility in the Brazilian telemedicine regulation.
Released on Oct 21, 2022
Uruguay was probably one of the first countries in the world to regulate cannabis production for recreational, medical and industrial use (Law No. 19.172, 20 December 2013 (the ‘Law’). The Law established the legal framework for state-control and regulation of the import, export, planting, growing, harvesting, production, acquisition, storage, marketing, distribution and use of cannabis and its derivatives.
Released on Oct 21, 2022
After two years of validity, the Brazilian Public Health Emergency of National Importance was revoked, taking away the validity of some important rules, such as telemedicine. In this article, we provide a legal and regulatory framework on telemedicine before the pandemic, the impact of it, and the current status in Brazil.
Released on Oct 21, 2022
Bill of Law No. 7,082/2017 promises to change the regulatory framework for clinical research in Brazil, if approved under the proposed terms by the Congress. Many changes relate to a potential decrease in bureaucracy in the ethical and regulatory approval procedures, as a way to stimulate more interest from the industry to sponsor studies.
Released on Oct 21, 2022
Nanotechnologies present a major innovation opportunity for the healthcare sector. Their use is increasing in drug and medical device development, as was reinforced by the deployment of messenger RNA vaccines against Covid-19. However, their medical applications are still underdeveloped globally and prompt concern about their safety. This article shares some insights into the evolving legal framework governing the use of nanotechnologies in healthcare at a European and French level.
Released on Sep 27, 2022
Aboard the International Space Station, scientific research is led by astronauts of different nationalities. This research prepares for space exploration missions but also brings benefits for humanity on Earth. It raises the question of which law applies to these kinds of experiments in general and clinical trials in particular, as well as the extent of intellectual property in space.
Released on Oct 7, 2021
Allowing high-reliability and low latency, 5G wireless technology is said to be a critical new generation network that will support the economy’s digital transformation and drive innovation. Healthcare is one of the key sectors targeted by 5G and may benefit from its deployment throughout the patient’s pathway, with enhanced remote health services.
Released on Oct 7, 2021
In Brazil, the National Regulatory Agency for Private Health Insurance and Plans (ANS) defines the scope of coverage offered in private healthcare plans and sets the guidelines for determining coverage. According to current regulations, the List of Healthcare Procedures and Events (the ANS List) is revised and updated every two years. Then all procedures and treatments qualifying for compulsory coverage under private healthcare plans are made public, without prejudice to any additional coverage stipulated in private healthcare contracts.
Released on Oct 1, 2021
Despite the worldwide acclaim that Brazil’s national immunisation programme receives, it has struggled to overcome inequality problems, legal and regulatory pitfalls, infrastructure shortfalls and distribution and logistics problems, in the context of Covid-19 vaccination. Besides, Brazil has been mired in intense internal political debates that stood in the way of science-based decision making in terms of vaccination plans and effective responses.
Released on Oct 1, 2021
Brazil, like other countries, has faced several challenges since the beginning of the global health crisis due to the spread of Covid-19. Throughout the pandemic, Brazilian authorities have engaged in an extensive legal and normative production seeking to regulate various issues, especially in dealing with health and technology.
Released on Oct 1, 2021