Consulting on AI in healthcare

Artificial Intelligence

Artificial intelligence in healthcare: innovative yet legally compliant

We provide advice on data protection, the AI Act and liability issues for AI systems that are both medically effective and compliant with regulations.

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What are the use cases for AI in healthcare?

Artificial intelligence has a wide range of innovative applications in healthcare, from accurate diagnosis to personalised patient care. For example, AI algorithms are used in radiological image analysis to detect abnormalities such as tumours more quickly and accurately than conventional methods.

In personalised medicine, AI systems analyse large amounts of data to develop tailor-made therapies for each patient. AI is also improving administrative efficiency by automating administrative processes and optimising the allocation of resources.

These technologies not only optimise medical decisions, but also help to reduce costs and improve processes in the healthcare system.

What are the challenges for users, developers and providers of AI systems in healthcare?

The development or use of AI systems poses some legal challenges for many reasons - but in particular, because of the new AI Regulation. For example:

AI inventory: Companies and organisations need an overview of all AI systems in use and their characteristics.
AI literacy: The AI Act requires managers and AI managers to have sufficient competence in the field of artificial intelligence.
AI governance: Companies and organisations need efficient structures to meet the requirements of AI compliance.
Classification: It must be determined whether the system is an AI solution and which risk class it belongs to.
Role determination: For each AI system, it must be determined whether the company or organisation is acting as a provider or operator. Individual modifications can make this classification difficult, and compliance requirements also change depending on the role.
Contract management: For both providers and operators of AI systems, legally compliant contract design with service providers or customers is essential.
Data use & Data protection: AI systems must always take into account the processing of (personal) data and the corresponding legal regulations in the areas of data protection, trade secrets and database law. The requirements for health data are particularly high.

How we support you as a user, developer or provider of AI systems

Regulatory mapping:
Identification of relevant regulatory requirements through detailed mapping according to various national requirements and EU data regulations.
Data & AI governance:
Development and adaptation of governance structures, identification of requirements and preparation for AI regulation.
Training:
Workshops on the scope and implementation of the AI Act, AI competence according to Art. 4 of the AI Act for managers, product teams and developers.
AI inventory:
Support in creating an overview of all AI systems in the company, including determining whether a system should be defined as an AI system or not.
Contract design:
Drafting contracts related to AI projects, such as development contracts, KIaaS contracts and others.
Advice on external AI applications:
Advice and guidance on the use of third-party AI applications and testing of third-party applications.
Anonymisation & pseudonymisation:
Design and advice on anonymisation and pseudonymisation policies
Risk assessments:
Advice on risk assessments in the context of data protection and fundamental rights impact assessments in relation to AI systems.
Copyright advice:
Advice on copyright implications in the context of GenAl (e.g. rights to data input, protectability of prompts and output).
Legally compliant data use:
Advice on legally compliant data use of big data, machine learning and generative AI in the context of data protection law, trade secrets and database rights.
AI development advice:
Holistic advice on contract management, compliance and other legal aspects of AI development projects.

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Intro

Our motto: secure, radical, digital.

SRD is the boutique law firm for digital projects, supporting you from kick-off to go-live. We combine technical innovation with compliance. We create radically clear legal scope for this.