Expertise

Legal Pathways’ areas of expertise include all aspects of the control, procurement, protection, processing, linking, accessing and transfer of health data for health and medical research, innovations and applications. Our scope of work includes compliancy, contracts, cases and courses.  For data controllers and processors established outside the EEA Legal Pathways serves as their legal representative under the GDPR.

Legal Pathways provides solutions and counselling on the legal and regulatory aspects of the development (training, validation, surveillance) and marketing approval of AI applications in healthcare.

Legal Pathways deals with a variety of health law issues covering the entire research, healthcare, pharmaceutical and medical devices continuum: basic research, (population) screening programmes, clinical trials, marketing authorisations, pricing, reimbursement, advertisement, pharmacy and post-marketing surveillance.

Specifically, Legal Pathways is subject matter expert on medical innovations, clinical trials, personalised medicine, regenerative medicine, tissue-engineering and biobanking. Training medical students and professionals and serving on institutional review boards, secures us first hand experience with both the basics and the latest developments in these areas.

Legal Pathways deals with bio-technology transfer and academic consortium agreements, and has in-depth knowledge of both the key elements and the fine print that go into designing and negotiating successful university-industry collaboration agreements, material transfer agreements, and data access agreements.