AI promised to revolutionize healthcare, but is currently rock-bottomed by rigid regulations. Europe is currently introducing the AI Act, the strictest AI legislation in the world. On paper, it sounds logical for healthcare: patient safety first. But these strict rules are already creating a rapidly growing gray market of AI applications and use within healthcare.
Let's be clear: There is currently an active gray market of AI applications within the healthcare industry. Individual healthcare providers deploy AI tools on a daily basis that are not officially certified, simply because the alternative - endless waiting for official approval - is not acceptable to them.
Consider AI algorithms for rapid diagnosis of critical illnesses. These systems often work fine, but are formally illegal under the AI Act. This leaves healthcare providers with an absurd choice: follow rules strictly and provide patients with less effective care, or provide better care outside the rules and face legal and disciplinary risks. A growing portion, the pirates of digital care, choose the latter. This results in uncontrolled and informal use of AI.
Gray market out of necessity
This gray market does not arise out of malice, but out of necessity. Healthcare providers want to offer patients the best, but rigid rules force them to color outside the lines. Precisely this uncontrolled situation can lead to unsafe scenarios: after all, supervision, validation and quality control are now lacking. In short, the very rigidity of the AI Act is currently causing a situation that achieves the opposite of what was intended.
We have seen this before. With the introduction of the European Medical Device Regulation (MDR), innovators also saw their projects founder on bureaucratic obstacles and opted for launches outside Europe. This history now threatens to repeat itself, but even more seriously. Like the innovators who previously sought refuge outside Europe, healthcare providers are now increasingly looking for alternative routes to still gain access to the latest AI technologies.
By installing apps and using VPNs, they manage to exploit algorithms that are officially illegal within Europe. With these applications, they can detect diseases early, personalize treatments and alleviate some of the enormous administrative burden and dire shortage of physical health care providers. While this forces healthcare providers to operate outside the rules, Europe remains stuck in a reality of stifling regulations, endless forms and unworkable protocols.
From cradle to museum
Europe, once the cradle of medical innovation, now threatens to be left behind as a museum full of beautiful stories about the old days when innovation was still possible. European regulatory pressure, however well-intentioned, threatens to reduce Europe to a location where innovative ideas stagnate, investment dries up and talent migrates away to places where they are given room to grow and flourish.
When regulations are stifling, people, businesses, and thus healthcare providers, start looking for other ways to still achieve their goals. Europe has created a framework with the AI Act that guarantees safety on paper, but in practice blocks use of the latest AI applications. This explains the rapid rise of the informal gray AI market and the use of unapproved applications within the healthcare sector.
Distress signal
In conclusion, this phenomenon is not a sign of unwillingness or recklessness, but an emergency signal: healthcare providers want to move forward, want to help patients with modern tools, but are not given enough space to do so. Healthcare in Europe risks losing its position as a leader and guide in innovation forever and ending up as a museum looking back nostalgically to a past of innovation and progress. Europe: the museum of stagnant innovation.
