Mental health apps (MHAs) are increasingly popular in India due to rising mental health awareness and app accessibility. Despite their benefits, like mood tracking, sleep tools and virtual therapy, MHAs lack regulatory oversight. India's framework, including the Central Drugs Standard Control Organization (CDSCO) and Medical Device Rules 2017, does not cover standalone health apps, raising concerns about data privacy and accuracy. Establishing a centralised regulatory body with guidelines for MHAs is essential for user safety and efficacy. This paper examines the current regulatory landscape, compares international approaches and proposes a tiered regulatory framework to foster responsible innovation while safeguarding user interests in digital mental health services.

This study sought to establish the elements that constitute comprehensive legal and regulatory landscape for successful digital identity system establishment and implementation. Subsequently, the study sought to assess whether these elements were present in the establishment and implementation of the National Integrated Identity Management System (NIIMS) in Kenya. The study adopted a qualitative approach, data was obtained firstly, through literature review that provided background information to the study. Secondly, semi structured interviews were undertaken on purposively selected key informants. The study established that the elements that constitute a robust legal and regulatory framework for digital identity (ID) establishment and implementation include presence of a constitutional provision on the right to privacy; existence of a digital ID law governing the establishment of the system; amendment of laws relating to the registration of persons; existence of a data protection law; existence of an overarching law governing the digital economy among others. Largely, most of these elements were present in Kenya. However, the legislative approach adopted in crafting digital ID law in Kenya was wanting. This has undermined effective implementation of the NIIM system by among other things eroding public confidence in the system. The study concluded that effective operation of the system hinged on the existence of a robust and comprehensive legal and regulatory framework that will engender users’ trust in the system. In this regard, the study recommended review of the existing legal framework to ensure that it underpins both the foundational and functional aspects of the NIIM system.

Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

In light of the urgent need for coastal adaptation policies and the impediments to their implementation, this article examines the early experience with coastal adaptation policies in the EU (in particular the Netherlands and the UK) and Australia, with a view to identifying the important features of an effective regulatory framework for coastal adaptation. We conclude that an integrated approach to coastal adaptation law is currently needed to lay the foundations for the required long-term strategy. Such an approach would establish processes by which adaptation objectives are agreed for each part of the coast, ensure land use planning that can accommodate future change and does not expose new communities to risk, integrate coastal adaptation with biodiversity and coastal zone policy, allocate regulatory responsibility in a way that promotes subsidiarity and consistency, and ensure that funds are available for future measures.