EU’s new AI Act must ensure regulatory safety while ‘helping and not hampering’ innovation
The European Union agreeing a landmark deal on regulation of artificial intelligence (AI) is a welcome development – but it must also remain open to change while ensuring global competitiveness, says InnoScot Health
While the proposed AI Act is yet to be ratified by member states and will not come into force until at least next year, it is set to be the world’s first comprehensive laws regulating artificial intelligence, governing the use of technologies such as facial recognition and ChatGPT.
EU Commissioner Thierry Breton has stated that the Act – agreed in December – will set “clear rules for the use of AI” while European Commission President Ursula von der Leyen insisted it is a "unique legal framework for the development of AI you can trust".
The Act will apply to EU AI providers and developers as well as those located in other territories – including the UK – if their AI systems affect individuals residing in the EU.
InnoScot Health’s Head of Regulatory Affairs, Elaine Gemmell nevertheless believes that the Act, which has been dubbed ‘Europe fit for the digital age’, must “primarily help, not hamper the development of key technologies while ensuring safety and rights for the end user”.
She said: “It’s good to see the EU stealing a march in this important, often contentious area, and the Act should serve to promote trust and investment thanks to greater clarity on how potential risks to health, safety and fundamental rights will be addressed.
“That means the banning of single-purpose AI systems that pose unacceptable risks to individuals' fundamental rights, health, or safety, or to society. At the same time, so-called ‘high-risk AI systems’ will be scrutinised but can be permitted if their operators adhere to strict requirements before placement on the market or use.
“However, with AI being a rapidly evolving area – including its role in the growth of important and innovative applications for healthcare – I believe that the new legislation has to retain an element of fluidity and be ready to adapt to fresh developments as they arise.
“The Act also has to ensure the EU remains competitive and that AI companies aren’t discouraged from operating and innovating within it.”
Elaine added: “At this juncture, I would say it is vital for individuals and organisations that are likely to be affected by the AI Act to start looking at it in closer detail.
“While the finer points of the Act, which organisations will need to fully assess for their potential strategic and operational impact, remain unknown for the time being, seeking appropriate advice now in order to prepare properly for it coming into force may well be prudent.”
The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive and Medical Device Regulation.
With more than 20 years’ experience in medical device development, Elaine Gemmell – recently awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University – is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.
Complying with medical device regulation
InnoScot Health offers a skilled team of regulatory experts. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.
Consultancy, training and advice is available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices. We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.