AI is transforming healthcare, driven by a rise in chronic illnesses, ageing population, and a shortage in medical personnel, a Philip Lee briefing note has explained.

Partners Sean McElligott and Anne Bateman have written that wearable heart monitors and live-in robots to answer medical questions are now a reality.

The health-technology industry has witnessed enormous growth over the past five years, from $8 billion in 2016 to $44 billion in 2022 in the United States.

Regulators must grapple with complex issues to ensure that AI-enabled devices, apps, and other digital healthcare tools are safe, effective, and abide by the General Data Protection Regulation (GDPR) and Medical Devices Regulation.  

Protection of data

Under the GDPR, health information is classified as a ‘special-category’ data requiring higher levels of protection.

The new European Health Data Space Regulation strengthens these protections with requirements for data storage of electronic-health-record systems and third-party use guidelines.

Providers of AI will also have to contend with proposed new legislation, the Artificial Intelligence Act (AIA), including providers selling into the EU, the lawyers point out.

Breaches fines

Breaches could result in a fine of up to €30 million, or 6% of turnover, exceeding the highest GDPR penalties.

The legislation is still in draft form, with many amendments proposed from each political group within the European Parliament. The parliament will debate amendments to the AIA in the coming months, but businesses should remain mindful of developments.

As with GDPR, the proposed legislative regime may have a ripple-effect across the Atlantic, the Philip Lee lawyers point out.