Using embedded technology to improve patient outcomes
Artificial intelligence (AI) is already embedded in many aspects of our lives, from the use of voice recognition devices such as Alexa and Siri, personalized recommendations on streaming platforms and enhanced internet searches, through to higher end analytics and data management across a range of industries. Within healthcare, the development of AI-enabled solutions is a significant area of opportunity.
AI in healthcare
The use of AI, inclusive of Generative AI, in healthcare is evolving rapidly and has the ‘potential to enhance healthcare outcomes by improving clinical trials, medical diagnosis and treatment, self-management of care, and personalized care.1AI is already being used as a co-pilot in many aspects of healthcare, such as assisting healthcare professionals to review MRI and x-ray generated images, and helping them make informed decisions about patient treatment and care.
‘ML (machine learning) and AI is driving innovations at a rate we’ve never seen before...AI isn’t science fiction, it’s science fact.’ Alex Denoon, Partner and Head of Life Sciences and Regulatory Team, Bristows LLP
With the use of AI in everyday life, the impact is generally not that significant if something goes wrong. For example, it is highly unlikely anyone will be harmed if Alexa plays an unwanted song or can’t recall trivia correctly. However, with AI in healthcare, when it goes wrong, the impact can be significant. It’s imperative that devices and products which harness the power of AI, and the way the data is used to train them, are regulated and compliant, to protect privacy and data, ensure products are suitable for all users, and to keep everyone safe.
‘AI has a lot to offer the medical technology industry. At the moment, we’re only seeing the tip of the iceberg.’ Gabriel Adusei, Founder of Triune Technologies Limited
Regulation of AI in healthcare
With the rapid advancement of technology, regulations can lag behind the products and devices they need to regulate. There is a balance between holding back innovations of life sciences organizations to keep people safe and allowing devices and products to enter the market so they can benefit those who need them.
AI itself can be used to speed up this process, to ensure quality and compliance, help organizations analyze the large amounts of data needed for verification and validation, help them be ready for regulators and auditors, and assist in the delivery of their products to patients.
‘The regulator is the ultimate arbitrator of our safety.’ Phil Brown, Director, Regulatory and Compliance, ABHI
In October 2023, the World Health Organization (WHO) released a publication entitled Regulatory considerations on artificial intelligence for health, which emphasizes the ‘importance of establishing AI systems’ safety and effectiveness, rapidly making appropriate systems available to those who need them and fostering dialogue among stakeholders.1
IQVIA Technologies recently invited a panel of regulatory and quality experts to talk about the use of AI in healthcare. Focusing on the legal, regulatory, and quality sphere, they discuss taking a realistic, risk-based approach of AI in healthcare, looking at a blend of practical solutions for today and where AI could take us, and the regulators, tomorrow. This is of particular interest when the industry leverages intelligent driven solutions to empower AI augmented professionals who work with eQMSand RIM solutions to operate with higher levels of efficiency, effectiveness and compliance.
This lively and sometimes slightly controversial discussion debates the benefits and risks of AI, touches on whether AI could replace a human workforce – including regulators – in healthcare and looks at how regulators can be flexible and think innovatively about how they regulate AI products, to provide maximum benefit to patients while maintaining public safety.
‘I think AI gives us an awesome opportunity to improve the provision of healthcare.’ Mike King, Senior Director, Product and Strategy, Safety, Quality and Regulatory Solutions and Strategy, IQVIA
Find out more and discover which of our panellists you agree (or disagree) with by watching the fireside chat here.
