Research legislation, health data protection and technology regulation

Our expertise

At RITTERSHAUS we take pride in the collaborative efforts shown by our lawyers specialising in research and universities, health data protection and technology regulation who offer clients convincing solutions for ever more complex problems.

We do, for example, possess specific expertise in issues relating to health data protection, regulatory assistance with large research projects, legislation concerning stem cell research, nanotechnology, the development and operation of biobanks, research-related animal rights legislation as well as within the application area of the Nagoya Protocol on Access and Benefit Sharing.

Having been involved, for decades, in the practical implementation of statutory requirements and having, on a regular basis, been able to broaden our horizon in the field, we are in a position to develop viable solutions to target specific problems.

We assist companies that work together with universities, be it in the field of research and development projects, be it via joint ventures, spin-offs, or longer-term cooperation projects outside company law. We also offer help with research collaboration undertaken between various scientific institutions.

Proactive advice on the ethical and legal aspects of research topics

The legal questions that typically arise in connection with IP, university funding and EU state aid law are covered by experienced teams that bring together the respective required perspectives. We put a particular focus on questions concerning the ethical/legal advice required for complex research topics that range from the development of viable, informed consent template that may, for example, be used for clinical trials, to the implementation of the 3R principle and the development of fiduciary health data management.

Companies engaged in the private education sector receive advice on all regulatory topics, in particular on state recognition, accreditations and the establishment and operation of subsidiaries.

  • Advice on legislation concerning health data protection in the field of research
  • Development of structures in line with data protection law suitable for multilateral and international exchange
  • Communication with ethics committees, licensing, and regulatory authorities
  • Proactive assistance with ongoing regulatory processes
  • Implementation of legal animal rights requirements in the field of research
  • Entrepreneurial obligations concerning the use of genetic resources in line with the Nagoya Protocol
  • Legal requirements concerning the development and operation of biobanks
  • Practical implementation of patients’ and trial subjects’ rights
  • State recognition of educational facilities
  • Accreditation
  • Research cooperation
  • Joint ventures
  • Spin-offs
  • Ethical-legal assistance with research projects and licensing procedures
  • Animal rights law in the field of research
  • Informed consent
  • Correct handling of research data