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How to make the AI Act protect patient’s rights
The AI Act is an important piece of legislation being proposed by the European Commission in 2021. Since then, a lengthy process of negotiation has been ongoing, which is now approaching its end. While the EU recognises the many applications of artificial intelligence in healthcare, and has an ambition to promote the digitalisation of health systems, it does not take adequate provisions to regulate health AI in the AI Act. Currently, only the following health AI is regulated under the AI Act:
- Medical devices
- Systems to evaluate eligibility for public assistance benefits and services, including healthcare services
- Systems which assess the eligibility of natural persons for health and life insurance
- Systems to evaluate and classify emergency calls or to dispatch or establish priority in the dispatching of emergency first response services, including medical aid
- Emergency healthcare patient triage systems
In addition, there are problems around liability and redress, limitations in capacities of notified bodies who will need to assess the AI systems, and a need for greater transparency on the deployment and use of health AI systems.
For more information, read our report on the AI Act here.
Our voting advice on the AI Act for MEPs
The voting on the AI Act, scheduled for the 14th of June is of major importance, as at this point, the text of the act will be largely settled. This is the chance for MEPs to show they care about the protection of the rights of everyone in the EU.
New amendments proposed:
We ask MEPs to include the following AI systems as high-risk in Annex III
- AI systems which process sensitive health data, as defined by Article 9 of the General Data Protection Regulation (2016/679), irrespective of their intended use.
- AI systems intended to be used for monitoring or tracking of movement and activity for purposes of surveillance in home care and long-term care.
Voting advice on proposed amendments:
The compromise amendments contain important changes that will promote protection of people’s fundamental rights in the use of health AI. We therefore advise MEPs to in particular support CA1, CA3, CA5, CA9, CA10 and CA11. For an explanation of the implications of these compromises for the health sector, please consult our voting advice HERE.
