DOI: 10.38023/e479f9fb-60a1-4012-9a43-2334e8edb22a

Ambient assisted living technologies – regulatory framework and safety and security concerns

Michal Koscik

Citation: Michal Koscik, Ambient assisted living technologies – regulatory framework and safety and security concerns, in: Jusletter IT 15 February 2024

The paper provides an overview of the prevailing regulatory framework and highlights challenges concerning the safety, security, and protection of rights related to Ambient Assisted Living platforms. These platforms are intricate ecosystems comprising information technology, consumer products, medical devices, and quasi-medical devices. The paper argues that the current regulatory framework is insufficient to regulate larger environments composed of mixed hardware and software elements. It tends to focus on the functioning of individual pieces of technology, leaving AAL platforms vulnerable from an information safety and security perspective. The expansion of language models and the growth of AI technologies bring new capabilities, but also risks of potential exploitation or misleading of the end user.

Table of contents

1. Introduction
2. Is AAL technology a medical device or consumer product?
3. European regulatory framework
- 3.1. Medical devices regulation
  - 3.1.1. The definition of a medical device
  - 3.1.2. The information security standards of MDR
- 3.2. General Data Protection Regulation
- 3.3. The Network and Information Security Directive
  - 3.3.1. AI Act – projected impact
- 3.4. National rules
4. Liability issues
- 4.1. Liability for product malfunction
- 4.2. Liability for breach information safety or security
5. Conclusion
6. Funding