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Cyber Security & Data Protection

The dynamics of cyberspace are changing; new connected devices, networks, services and data emerge. After years of leadership in Cyber Security and Data Protection Law in the Health sector, our firm understands increased data complexity.
We focus on helping clients understand the risks associated with the processing of personal data, maintaining compliance of cross-border data transfers with global privacy laws and earn stakeholder trust in their use of personal data - while identifying opportunities to optimize compliance, risk and value creation. We conduct training and awareness programs on data privacy to improve data handling activities of organizations.
Our firm offers high quality legal advice building cyber resilience tailored privacy programs. We have successfully transformed internal business procedures by managing and implementing cyber compliance projects aiming to ensure a company’s full compliance with the GDPR and assisted in the management of incidents of improper disclosure and identity theft, breach notification, forensic investigation as well as negotiation and ongoing compliance.

Artificial Intelligence & Digital Health

A series of products is currently being developed by healthcare companies that may assist in tracking, diagnosing and treating illnesses. Machine Learning, mhealth apps, wearable technology in the form of medical devices, as well as narrow-AI device systems and conversational agents set significant legal challenges. We are here to help you solve them. Our firm provides assistance to healthcare companies in the following indicative fields: privacy and personal data compliance in digital health projects, cybersecurity, intellectual property, product liability, blockchain technology, big data analytics, smart contracts, AI and cloud computing as well as incorporation and funding support for start-up companies. We are proud to have worked and advised clients on narrow artificial technologies for personalized medicine and industry experts on “digital twin” MedTech.

Healthcare Compliance

In the last few years, substantial change in the Health sector has seen a wave of challenges driven by public policy, reduced funds and the need to comply to whole new sets of rules and conditions. Our firm has been successfully advised for Global Compliance Programs, effective reporting processes to relevant bodies, legal duties of management, as well as drafting standard operating procedures (SOPs). In this highly regulated environment, we have a long record of advising Life Sciences companies on their interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs) with a particular focus on Transparency requirements by implementing Anti-Bribery programs, drafting Ethics and Integrity Guides, designing of whistleblowing systems, operating efficiently compliance hotline systems and services. Moreover, our team is a key thought leader and often invited to give educational lectures, briefings and seminars to keep our clients informed and confident on recent developments and changes in healthcare compliance.

Corporate & Commercial

We provide commercially focused advice to protect and grow your business in a landscape of changing policy priorities and rolling regulation waves. We actively assist multinational and Greek companies in life sciences to form subsidiaries, branches or joint ventures in Greece. We advise clients on the optimal legal vehicles from a corporate and commercial point of view, we negotiate between shareholders and draft joint-venture agreements leading to M&As; we form Greek subsidiaries on behalf of foreign investors. We advise on all corporate matters from incorporation to liquidation. Agency, Distribution appointments, Terms and Conditions of Trade, collaborations and Joint Ventures, Grant agreements, Clinical Trial agreements, specializing in Intellectual Property and Mergers & Acquisitions, we undertake all formalities required for the successful completion of our clients’ objectives.

Competition & Antitrust

Our firm has a deep knowledge of competition law and offers its clients strategic advice; we have a clear market perception and work with precision for our clients’ needs and core business. We offer both consulting as well as litigation services regarding competition and antitrust law and have considerable experience in Parallel Trade issues within the life science sector. More specifically, we help our clients anticipate and confront potential competition and antitrust issues, navigate through the negotiation of core agreements and represent them before competent Courts and Competition Authorities.

Intellectual Property

We serve our clients’ interests in intellectual property (“IP”) across a wide spectrum of healthcare IP issues, spanning from Data Protection to Compliance for Life Sciences and Medical Technology companies. We provide clients with general and strategic legal advice regarding e-health projects, patents, trademarks and trade secrets. We regularly advise on the issues which arise from actual or potential breaches of licensing agreements. While electronically stored and transmitted information is inherently global, the laws and enforcement mechanisms still have their trace in EU and within national borders.

Litigation & Dispute Resolution

Our firm has significant experience on litigation, having dealt successfully with numerous complex and high-risk cases before the Greek Courts. By being proactive, we gain the time to explore all options and resolve a dispute before it escalates. We differentiate by offering strategic business thinking and a clear point of view, rooted in our legal knowledge. We defend our clients on civil, administrative, penal actions tackling their most complicated disputes. We furthermore have expert knowledge on nutrition, health and medical claims. We have successfully engaged our firm in product liability and safety, clinical negligence, agreements violations and terminations, financial claims, competition violations, as well as IP infringements, as well as healthcare compliance Anti-bribery (FCPA) cases including white-collar crimes and investigations, where we have had exceptional results. Our team prides itself for the in depth understanding of the particularities of each case and offers a clear horizon of client action on legal matters.

Clinical Negligence & Malpractice

First rate healthcare is the primary objective for all health practitioners. However, sometimes this objective is not met, leading to great stress for everyone involved. We will work tirelessly to gather the evidence needed to support your claim and proceed to analyze each of the three key elements of each claim – duty of care, breach of duty and causation of injury. Our research, enriched by our collaboration with important practicing experts, will leave no stone unturned and our skills in cross examination of even highly specialized clinical professionals will secure a fair result. Our health law team can deliver successful strategies and invent resources to keep the costs under control for all parties involved.

Start Up Consulting

Healthtech and Μedtech are on the rise: the advent of AI and technology is increasing start-ups ‘innovation’ potential by the hour. Innovation however, is followed by the need to protect your intellectual property, rights and patents. Developing a service or product, may also carry privacy and regulatory implications depending on the type of data used to build it, the countries it will be launched and deployed in etc. And certainly setting up a new company is a project with demanding requirements in sound legal advice, right from the onset. We are here to help you firmly establish your start up, advise you on corporate formation, corporate relations with employees, clients and suppliers, followed by drafting all necessary legal documents to set you up and running (e.g. agreements, regulatory framework of operations, GDPR, corporate governance). Our tailored approach includes tested partnerships with accounting and consulting firms, with in depth expertise in the start up ecosystem, allowing you to have all your business needs covered under one roof.

Regulatory Lobbying

We respond to our clients’ needs immediately and effectively, covering a wide range of life science products. Our focus includes product classification, market access, pricing and reimbursement, promotion and advertising, data exclusivity, product recalls, inspection and risk assessment, product classifications and CE marking, clinical trials, supply, manufacture and license agreements. Our global network enables us to deal with complex issues of cross-border scope, promptly and efficiently. Our daily involvement in law and policymaking ensures a predictive capacity in seeing regulatory changes brewing both nationally and internationally before they officially come into effect.

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CONTACT US

(+30) 210 33 05 230

info@lawgroup.gr

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