Ambient Assisted Living Technologies – Regulatory Framework and Safety and Security Concerns

EasyChair Preprint 11663

Abstract

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. Marketed primarily to the elderly and individuals with disabilities, the goal of these solutions is to support independent living and enhance the quality of life. They are crafted to assist with health-related tasks, such as rehabilitation, predicting deteriorating health conditions, and addressing communication challenges in daily activities. 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. The paper further aims to analyse and compare the legal responsibilities of manufacturers, vendors, and operators of registered medical devices with the legal duties of companies that market diagnostic devices as "hobby" devices, possibly extending to social networks. The paper posits that the information security standards for registered medical devices and "hobby" devices should not be different in principle. There's a need for robust regulatory frameworks that address both the unique challenges of AAL and the broader issues of digital health. These frameworks should encompass aspects like device certification as well as regulation that looks on broader picture of how the AAL ecosystem may impact the client’s life, privacy, but also personal autonomy.

Keyphrases: Ambient Assisted Living, Information Security, Medical Device Regulation, patient safety

@booklet{EasyChair:11663,
  author    = {Michal Koscik},
  title     = {Ambient Assisted Living Technologies – Regulatory Framework and Safety and Security Concerns},
  howpublished = {EasyChair Preprint 11663},
  year      = {EasyChair, 2024}}