The healthcare and medical-scientific research legal advisory service offered by PANETTA Consulting Group is designed to assist clients in the definition, adoption, and secure management of technologies (e.g. digital pre-screening and patient enrollment tools for clinical trials) and artificial intelligence applications (such as Virtual Human Twins and risk prediction algorithms) in the healthcare domain, ensuring full compliance with applicable laws and regulations. With the growing digitalization of the healthcare sector, expert legal counsel is essential to navigate its complex ethical and regulatory landscape and to seize the opportunities of e-Health, AI in medicine, and the European Health Data Space (EHDS).

With a specialized team, PANETTA Consulting Group provides tailored legal support in several key areas:

• Regulatory compliance: We ensure that e-Health solutions, such as telemedicine platforms, health monitoring applications, and electronic clinical data management systems, comply with European and national regulations. This includes adherence to the General Data Protection Regulation (GDPR), the Medical Devices Regulation, the In Vitro Diagnostic Regulation, the Clinical Trials Regulation, and the evolving EHDS framework.
• Reuse of health data: Since 2016, our professionals have been pioneers in analyzing and applying technological (e.g. synthetic data), organizational (e.g. Federated Learning), and legal (e.g., smart contracts) measures to support the reuse and sharing of personal and health data. We have been acting as legal partners and coordinators in some of the EU’s most ambitious projects in health technologies and AI for medical research (e.g., MyHealthMyData, DataTools4Heart, EDITH-CSA).
• Contracting and partnership agreements: Our experts assist in drafting and reviewing legal agreements in the health sector, including contracts with healthcare technology providers, software licensing agreements, and data-sharing partnerships. We also provide legal guidance on liability allocation and intellectual property protection.
• Data Protection Impact Assessments (DPIAs): Our dedicated team supports stakeholders in the healthcare ecosystem—including large hospitals, clinical institutions, public and private companies, innovative startups, and Big Pharma—in conducting DPIAs for innovative projects, helping them identify and mitigate risks associated with the use of digital technologies in healthcare.
• Innovation and governance: Our legal advisory extends to the governance of emerging medical technologies. We assist clients in developing internal policies and frameworks for the ethical and secure use of digital innovations, including AI in patient care and personalized medicine.
• Training and continuing professional development: PANETTA Consulting Group delivers targeted training programs to raise awareness about data protection and to promote best practices in the use of e-Health and AI within the healthcare sector.

Choosing PANETTA Consulting Group for legal advice in these areas means gaining access to a team of experts capable of guiding your organization through digital transformation and the implementation of cutting-edge technologies, ensuring the secure and compliant handling of sensitive data while fostering responsible innovation in healthcare.