Corporations around the globe are embracing Digital Transformation (“DT”) to enhance competitiveness i.e., streamline operations, strengthen relationships with customers, and increase revenue.1 In this dynamic digital world, where data and algorithms are increasingly leveraged both for decisionmaking and to achieve economic and social objectives, a relevant digital transformation requires corporations to, not only onboard new technologies and ways of working, but also to address how they will be using tech in a responsible, ethical, customer/consumer-centric, and sustainable way.2 Necessarily, functions that directly impact the bottom line (like Sales, R&D, Supply Chain) are deeply engaged in these DT efforts.3 The question is what role is and should Compliance be playing in these DT efforts. This thought piece focuses on the evolving role of the Compliance function in this rapidly developing ecosystem, analyzing what role does – and should – the Compliance function play in DT and how should the Compliance function future-proof itself to better manage the governance, risk, and compliance (GRC) aspects of their corporation’s DT initiatives and better leverage the environment, social, and governance (“ESG”) objectives of their company. To address these questions, the authors interviewed two heads of Compliance at larger multinational corporations and facilitated a Salon hosted by the Digital Legal Exchange, entitled 'The Role of Compliance In Digital Transformation: Old Habits Risk Harm”. This event was attended by 12 participants including several General Counsel and Compliance professionals. The Salon was conducted under the Chatham House rule. All participants consented to an anonymised write up for these purposes.4 The purpose of this piece is to provoke more international, cross border discussion around the role of Compliance in digital transformation.

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The pleasure of humans seems to be often found in crossing boundaries. However, crossing legal boundaries provides a compliance violation that can lead to serious consequences – especially in the highly regulated German healthcare system. Due to the large number of regulations, economic competition is strictly limited in the German healthcare sector creating a considerable conflict between economic pressure, entrepreneurial visions and legal requirements. The identification of clear boundaries, the exploration of creative leeway and the crossing of compliance-related prohibition zones is oftentimes difficult due to the considerable legal 'grey area' between black and white, which has not yet been fully clarified by case law. The use of these grey areas as well as the crossing of permissible boundaries takes place in various forms in reality. Cooperations in which a physician crosses the so-called sectoral boundary (Sektorengrenze) in his own person, for example as an affiliated or fee-based physician (Beleg- oder Honorararzt), and provides both inpatient (stationäre) and outpatient (ambulante) medical services, are of particular relevance. In this context, this article is intended to provide an overview of the most commonly used forms of combined outpatient and inpatient activities (intersectoral activities) by the same person and to highlight the associated compliance issues.

This article shall – after a quick introduction into the European Medial Device Regulation – examine the duties of the so called „person responsible for regulatory compliance“ of medical device manufacturers.

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In this article I have analyzed the world legislation that regulates the environmental impact assessment but also the attributions of the public authorities related to this topic. By researching the results obtained during the implementation of the legislation in this field, we can deduce that the existence of the legal framework does not fully guarantee the successful execution of a procedure, and in this case the implementation of environmental impact assessment. Environmental Impact Assessment (EIA) is a process that identifies, assesses and mitigates the environmental impacts of a proposed project. This article examines the challenges faced in carrying out EIAs, the similarities and differences between EIAs in different countries, and the evolution of EIA effectiveness over time. Although, the legislation of the Republic of Moldova regulates this process, in practice very few projects, whether public or private, are subject to environmental impact assessment. At the end of the article I have proposed some solutions to improve the performance of this large procedure.

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This article analyses compliance interfaces between the German Supply Chain Act (short: LkSG), Money Laundering Act (short: GwG) and German Criminal Code (short: StGB) in connection with human rights risks. The authors conclude that remedies taken only in accordance with the LkSG after a human rights risk has been identified may still constitute a compliance violation within the meaning of the GwG or even a criminal liability under Section 261 StGB.

The protection regime for products of human activity is a critical component of modern environmental and public health policy. This paper provides a broad overview of the general considerations surrounding the regime for pollutants and products, which aim to protect both human and environmental well-being. This paper gives a historical overview of the evolution of environmental policies concerning the management of waste and chemical substances. It discusses the growing recognition of the potential risks posed by various human-made substances and products, enumerating the provisions related to the regime of harmful products and substances This article underlines the need for a robust regulatory framework to address these concerns, outlining the primary objectives of the substances and products regime, including the protection of human health, the preservation of the environment and the promotion of sustainable production and consumption. It examines the key components of the regime, such as the identification and classification of harmful substances, the establishment of safety standards and exposure limits, and the implementation of control measures and enforcement mechanisms, by exploring the complexities and challenges associated with the effective implementation of the toxic substances and products regime, including scientific uncertainties, stakeholder interests and the need for international cooperation. In conclusions we summarize the key findings and highlight the importance of continued research, policy development and collaborative efforts to further strengthen the protection regime for products of human activity. This article provides a concise yet comprehensive overview of the key aspects covered and sets the stage for a detailed examination of the pollutant and product regime and its impact on the environment and public health.