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Regulation is needed as AI paves the way for precision medicine

It’s up to healthcare organizations using artificial intelligence to help get regulations in place.

Regulation is needed as AI paves the way for precision medicine
[Source photo: Andriy Onufriyenko/Getty Images]

Artificial intelligence (AI) quickly evolved from a plotline in science fiction novels to something that touches our lives every day. Its virtually endless applications come with nearly equal risks and rewards and a plethora of public debate. But the fact remains that AI in healthcare is life-changing—literally. So while it may feel impossible to garner universal acceptance and adoption of AI in healthcare, it’s paramount we do so, and that starts with regulating the industry.

That’s why I was glad to see that after years of debate, the European Union (EU) finally reached an agreement on the AI Act proposal. At the heart of these regulations is a recognition of the fundamental rights that European citizens possess.

A few years ago, Europe successfully passed the General Data Protection Regulation (GDPR), setting a global landmark for the protection of personal data. GDPR proved to be a timely and needed act to safeguard the privacy of individuals in a rapidly evolving online world. This legislation created a precedent of trust allowing individuals to share their personal data safely.

The new AI laws signal a continued commitment by lawmakers to upholding basic rights like nondiscrimination, equal access, and freedom of expression, which can be challenging with new technologies. And while these regulations are an excellent step in the right direction, the technology is fast-moving. That means that in practice, it is up to us, the leaders of AI healthcare companies, to propel regulation forward to continue moving forward the implementation of precision medicine around the world. So, what’s next?

Building trust hinges on ensuring data safety

It is almost impossible to trust what you don’t understand and for most of us, artificial intelligence is still very new. One hallmark of the AI Act and other AI laws that will inspire public confidence is the new transparency requirements regarding how the systems work. This includes explaining how AI systems arrived at their decisions, and which data was used to train the system.

Having analyzed over 1.5 million patients’ genomic profiles globally since 2015, we are keenly aware of the challenges of keeping that data safe. Our company protects data through a meticulous combination of data architecture, pseudonymization, anonymization, minimization, and segregation. In light of these new regulations, healthcare companies must continue to refine their protection frameworks to ensure data safety for millions of patients worldwide.

In addition to new transparency requirements, we expect that AI healthcare companies will be required to maintain risk mitigation systems, keep better documentation, and provide human oversight. We can help build public trust when we comply with existing regulations, embrace new rules, and demonstrate a track record of data safety. The standardization of regulations surrounding AI in healthcare will only serve to expedite its adoption.

ACCELERATE PROGRESS WITH DEEPER PROVIDER UNDERSTANDING

The ability for AI to translate someone’s entire genome into actionable insights that can inform a diagnosis and treatment plan will one day be the standard. AI is just starting to revolutionize the healthcare industry because it can synthesize, analyze, and utilize on a grand scale. The simple fact is that the more data companies are entrusted with, the more medical breakthroughs that are possible. AI is the catalyst that transforms this abundance of data into invaluable insights.

Earning the trust of doctors and researchers is crucial to gaining access to this valuable data. Companies need to explain how they apply algorithms to massive data sets to gain profound insights into how patients respond to diseases and treatments. AI is not meant as a replacement for healthcare providers. Rather, its role in the industry is to complement providers’ training and intuition to make it faster and easier for them to make data-driven decisions for their patients.

WHERE DO WE GO?

It remains unclear how the EU will enforce this new regulation, and many components of it won’t go into effect for almost two years. Global cooperation is paramount to safely using AI for healthcare innovation. Companies pioneering this technology must work together and in tandem with regulators. While regulators will ultimately help unite all parties, companies currently using AI must continue an open dialogue with each other to facilitate the safe adoption of AI in healthcare and propel data-driven medicine forward.

We must also acknowledge that AI technology will always outpace regulations. Neither of these things makes regulations futile, but they place the responsibility of AI’s careful and safe use squarely on the shoulders of the companies pioneering medical advancements with it. The world is watching and waiting for us to do great things with this technology. It’s up to us to keep our shared fundamental rights as cornerstones of these new developments.

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ABOUT THE AUTHOR

Jurgi Camblong is CEO and cofounder of SOPHiA GENETICS. More

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