- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Medical Safety
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
Key Highlights
of the Regulation:
- Details on the do 2019s and don'ts of AI utilization,
including facial recognition and emotion detection technologies based on biometric
data.
- Certain uses, such as in workplaces, schools, or retail
environments will be strictly prohibited, with exceptions for state counter
terrorism or criminal investigation needs.
- A ban on 'social scoring'
by companies 2013 the practice of evaluating individuals based on collected
data.
- Clearly labeling of AI-generated content to avoid the spread
of misinformation.
Potential impacts on pharmacovigilance:
·
The act follows a risk-based approach for the AI application using four
categories: unacceptable, high, limited and minimal/none.
· The
act will impact pharmacovigilance because even where activities "self-categorise"
their risk by their nature, pharmacovigilance is expected to be at least in
the "high" category.
· Pharma companies, as well as vendors and
integrators, may have additional constraints like readiness certifications,
pre- and post-implementation obligations like reporting AI usage, and more.
· More control should have a positive effect on AI adoption as
it should increase trust and confidence in PV AI Solutions where up to now,
compared to other regulated domains like finance, pharmacovigilance has been
more conservative.
The EU AI Act is a monumental step towards balancing
AI technology innovation with ethical considerations and the protection of societal
values, and this can only be a good thing for an area like pharmacovigilance
which relies on confidence and trust to maintain patient safety.
iVigee will monitor the EU AI act rollout as we do with all the latest developments
in AI and incorporate this in our AI in PV Masterclass, a comprehensive blend of theoretical knowledge, practical
application, and latest innovation, tailored to corporate teams.
And
we are experts on Generative AI implementations too! We can build PV AI Co-Pilots,
AI-first processes / products, or update your existing predictive ML-based stack
with the power of Large Language Models in a controlled and compliant way.
Connect
with us today at iVigee AI Services.
Or contact Kane Smith or Robert Scheiner directly to talk about any of our other products and services.
#pvtechnology #pharmacovigilance #generativeai #ai #pvai #euaiact