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Compliance requirements for companies are growing, especially in the fields of ESG (Environmental, Social, and Corporate Governance) and data privacy. The phenomenon can be observed not only within the EU, but also many other areas of the world. Within the regulatory environment, fostering ESG practices has long since developed from a voluntary commitment to a “real” compliance issue which lawmakers are driving forward with serious sanctions and which courts are also shaping within the framework of the evolving laws. These laws are very complex, often unclear, and intrude deeply into the areas of risk analysis and risk management, which traditionally represent a core responsibility of companies. Many regulations emphasize development and implementation of internal processes within companies. This greatly reduces companies’ discretionary powers, since responsible use of leeway is a core area of entrepreneurial decision-making governed by the business judgment rule. Structurally, we are seeing increased legalization of risks, through which the legislator de facto takes away companies' leeway to make entrepreneurial decisions. Also, the threat of severe fines and uncertainty about the interpretation of legal terms makes it difficult for companies to decide what needs to be done to meet the laws’ requirements and to avoid risk. Looking at the char acter of the regulations, we see value-driven and symbolically-charged laws. However, these laws are anything but “dead letters” - they intervene deeply in companies’ risk management, aim at changing behavior, and have sharp “teeth” in the form of sanctions. The EU may be a particularly fertile source of symbolic legislation, which can serve to create political identity. Companies can, however, choose different ways to deal with these challenges, and they are free to find the right path. Even if lawmakers are increasingly intervening in the way companies carry out risk analyses and the priorities they set in that context, companies should defend their leeway and use it wisely. It is of utmost importance to know the real risks well and to use leeway responsibly. A diligent risk analysis, carefully aligned to a company’s circumstances and needs, is always a good starting point. Perfect knowledge of applicable laws and the company’s operations is a prerequisite for a professional risk assessment and building an effective Compliance Management System (CMS). There is always room for balanced decision-making regarding risk assessment and prioritization in accordance with the business judgment rule and entrepreneurial responsibility.

In the situation where the environmental issue is becoming an increasingly addressed issue, and the legislator in various legislative acts imposes new and new regulations with a nature of environmental protection, it becomes difficult to identify whether, being incorporated in the text of a certain law, a certain legal norm, belongs to environmental law or is a norm that belongs to the field which in substance represents the regulatory object of this law. In other words, it is often quite complicated to identify the boundary of environmental law regulations, especially since the norms of this branch are not always compactly found in environmental legislative acts. It must be recognized that the legal mechanisms for environmental protection change their appearance over time, becoming much more aggressive and relentless. They are often applied without taking into account certain traditional rules and presumptions that often do not ensure effective protection of the environment. In such cases, it is necessary to understand that the regulatory mechanisms for environmental protection are a component of environmental law, even if they are based in other legislative acts and even if they are very similar to the mechanisms used in the regulation of other categories of legal relations.

The text discusses the concept of 'internal investigations' in legal contexts, emphasizing the lack of a specific legal definition in the USA, Germany, and Austria. It explains that internal investigations, often triggered by suspicions of legal violations by company employees, aim to systematically process and resolve such cases. The distinction between compliance (prevention) and internal investigations (response to suspected violations) is highlighted. The article explores the role of external investigators, often lawyers or auditors, in conducting internal investigations, emphasizing the need for coordination between auditing and legal aspects. It discusses the historical development of internal investigations in the German-speaking countries and their increasing importance in recent years. The second part of the text delves into the importance of company behavior in response to suspected violations. If the offense benefits the company, the focus is on exoneration, with potential benefits such as penalty suspension through active repentance or self-disclosure. The article also discusses legal conditions for penalty annulment, emphasizing timely actions in internal investigations. The text addresses the role of the public prosecutor's office and legal considerations in refraining from prosecuting a company based on its behavior during internal investigations. It stresses that a positive impression, compliance measures, and transparent cooperation can influence the decision to refrain from prosecution. The final section outlines criminal liability risks for internal investigators, citing potential offenses such as coercion, violation of correspondence secrecy, unlawful use of a computer system, violation of telecommunications secrecy, and abuse of audio recording or listening devices. The discussion includes legal considerations and justifications for certain actions, emphasizing the importance of balancing interests and goods, especially in legal proceedings.

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.