We can help our clients act in conformity with the law when developing and using artificial intelligence. The legal standard to be applied to artificial intelligence is anything but clear. New provisions and regulations are currently being drafted and issued at all levels. In particular the European Commission’s draft for a so-called AI Regulation will bring far-reaching provisions in this regard. We are in contact with the national and European legislative bodies on various issues in this context and actively contribute to the academic and public discussion.

From a legal perspective, AI-based products and applications naturally first of all give rise to questions about data protection. Compliance with the requirements for the secure handling of personal data, which result mainly from the European General Data Protection Regulation (GDPR), is imperative, as this is the only way how warnings and sometimes very high administrative fines can be avoided, for example.

​​​​​​In order for a company to be able to use the necessary data generated by the application for its own purposes, it is absolutely necessary, due to the as yet unclear allocation of the data to one of the actors involved, that contractual allocations be made. This is because statutory rules on who owns the data do not yet exist. A contractual agreement is currently the only way to ensure that the data can be used for further solutions and business projects in compliance with data protection law.

Another aspect that should be considered when using AI is liability and product liability issues in the event that malfunctions occur and cause damage. We can, for example, observe in this respect that the high level of integration of AI-based solutions results in the product monitoring obligation shifting to manufacturers and programmers.

In addition, when companies use AI solutions, it is of crucial importance that they take timely precautions to protect the work results generated by the AI. In this regard, too, contractual arrangements should be made as early as possible and with all the actors concerned.

We can only provide a brief overview of the relevant topics here. However, our lawyers deal with these topics in depth, as is shown by the large number of publications, amongst other things.

• Providing advice and assistance with regard to the legal requirements (EU General Data Protection Regulation (GDPR), German Federal Data Protection Act (BDSG), sector-specific requirements for the protection of sensitive health data)
• Quality management and supplementing the "Internal Audit" guidelines
• Advising on the German E-health Act
• Advising on using Big Data in clinical trials
• Advising on using and developing e-health apps and e-health platforms
• Subsidy programmes, innovation funds
• Providing assistance and advice when selecting specialised IT providers and negotiating the agreements
• Providing advice and assistance regarding the creation of competence centres "Medicine 4.0", incubators and accelerators
• Conception and implementation of partnerships ("joint ventures") with other medical service providers and IT providers
• Advising on the innovative structuring of investment financing
• Advising on public procurement law for the integration of digital processes and products in clinics and surgeries; innovative contract design

Go to Practice Area Digital Health