The legal consulting service in the healthcare, medical and scientific research sectors offered by PANETTA Consulting Group is designed to support clients in the definition, adoption and secure management of technologies — such as digital pre-screening and patient enrolment for clinical trials — and artificial intelligence solutions, including Virtual Human Twins and risk prediction algorithms, applied to the healthcare field, ensuring full compliance with applicable regulations. With the increasing digitalisation of the healthcare sector, the support of expert advisors is essential to navigate the complex regulatory and ethical framework and to fully leverage the opportunities offered by e-Health, artificial intelligence and the European Health Data Space.

PANETTA Consulting Group, through a team of professionals specialised in these matters, is able to provide tailored advice across 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 compliance, among others, with the General Data Protection Regulation (GDPR), the Medical Devices Regulation, the In Vitro Diagnostic Medical Devices Regulation, the Clinical Trials Regulation and the European Health Data Space framework.

Reuse of health data: since 2016, our professionals have been pioneers in the study and analysis of technological measures, such as synthetic data; organisational measures, such as federated learning; and legal measures, such as the use of smart contracts, to support the reuse and sharing of personal data, including health data. We have been, and continue to be, partners and legal coordinators of some of the most challenging and cutting-edge European projects in healthcare technologies and the use of artificial intelligence for medical research purposes, such as MyHealthMyData, DataTools4Heart and EDITH-CSA.

Contracts and partnership agreements: PANETTA Consulting Group’s experts provide assistance in drafting and reviewing contracts and partnership agreements in the health sector, such as agreements with health technology providers, software licence agreements and partnerships for the sharing of health data. The service includes the management of legal liabilities and the protection of intellectual property.

Data Protection Impact Assessments: our dedicated team supports healthcare-sector players, major hospitals, clinical facilities, private and public companies, innovative start-ups and Big Pharma companies in carrying out Data Protection Impact Assessments on innovative projects, in order to identify and mitigate the risks associated with the use of digital technologies in healthcare.

Innovation and governance: our legal advice extends to the governance of medical technologies, helping clients develop internal policies and rules for the ethical and secure use of digital innovations, such as artificial intelligence applied to patient care and personalised medicine.

Training and updates: PANETTA Consulting Group offers targeted training programmes to raise awareness of the importance of data protection and to ensure the adoption of best practices in e-Health and AI in the healthcare sector.

Relying on PANETTA Consulting Group for legal advice on these matters means having access to a team of experts capable of guiding your organisation through digital transformation and the implementation of cutting-edge technologies, ensuring the secure and compliant management of sensitive data and promoting responsible innovation in the healthcare sector.