Overview
In August 2024, the European Union (EU) approved the Artificial Intelligence (AI) Act, the first legislation aimed at regulating AI applications whilst protecting EU citizens from the potential harms of AI. The regulation will take effect on 2nd August 2026 and will have a significant impact on the healthcare sector.
Legislative changes are also afoot across the globe. In the US, the FDA continues to update its guidance on AI-enabled device software. For example, in December 2024, the FDA published new guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for AI-Enabled Device Software Functions to provide a reasonable assurance of device safety and effectiveness Conversely, Asia-Pacific has adopted a light touch and voluntary approach to AI regulation, some jurisdictions like China have taken a more prescriptive approach.
According to a recent survey from Norstella, 66% of biopharma organisations say the skills required for their employees have changed due to the introduction of AI. Over 70% of industry leaders confirmed the main reason behind its limited adoption is a lack of expertise, followed by 43% having a lack of knowledge/awareness of AI and what it can do to improve pharmaceutical R&D processes. This session will summarise the European AI Act and its implications on the healthcare sector and what provisions and assessments organisations may need to put in place to be compliant with the new regulatory framework.
Key topics covered in this exciting talk include:
- An overview of the AI Act, the EU’s Coordinated Plan on Artificial Intelligence, and its potential impact on the healthcare sector
- A look at what constitutes a high-risk AI system and provide examples of where this might impact the pharmaceutical drug development and medical device commercialisation strategy
- Discuss the minimum information regulators will require for Fundamental Rights Impact Assessments (FRIAs) and Data Protection Impact Assessments (DPIAs) and what measures organisations need to put in place to ensure they are fully compliant with the protection of personal data
CPD Hours: 1
Speakers
Cheryl Barton
Dr Cheryl L Barton is an independent consultant with over 35 years' research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for a variety of CNS research projects. Dr Barton joined Dutch investment bank ABN Amro NV as a senior equity analyst to provide coverage on pan-European companies and assessed the potential impact of new drug development on European Stocks. In 2002, Dr Barton founded PharmaVision to provide independent, tailor-made, life science and consumer health research to pharmaceutical companies, competitive intelligence specialists, investment institutions, and healthcare communication agencies. Dr. Barton regularly writes articles for Pharmtech regarding the latest advances in scientific technologies and regulatory issues that impact the Biopharma and MedTech industries.
