On July 31, 2026, Montana signed a new right to try law allowing patients with severe conditions to access treatments not yet approved by the FDA, as MIT Technology Review reports. The human story is Brody DeVault, a two-year-old with developmental delays and a rare genetic mutation. His father Kris says they cannot wait. The law is imperfect, controversial — and still more honest than the European silence.
Why does this matter in Europe? In the US, right to try is a policy bet: give patients a legal lane, even when evidence is thin. In Europe we prefer compassionate use programs. Formal, regulated, safe on paper. In practice, as anyone inside the Italian health system knows, compassionate use is a maze of ethics committees, paperwork, and months of waiting. For a child with a neurodevelopmental disease, months are a lifetime. The deeper problem is structural: health systems still treat data as a byproduct, not as the core asset of medical decisions.
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The real gap is not the law. It is infrastructure. If patients can access an experimental therapy, someone has to track dosages, outcomes, side effects, consent. That requires modern platforms — interoperable records, APIs, real-time registries, misuse protection. This is where European digital companies could lead. Instead, public tenders ignore data standards, and procurement excludes small innovative firms. The result is no evidence, no speed, no trust.
We are a digital agency. We build platforms, manage infrastructure, optimize processes for businesses. We know that if data is not structured, the process is not safe. Period. The same applies to experimental medicine. Without a data-driven system, right to try is just a slogan with legal cover. With it, compassionate care becomes a learning system: faster, safer, scalable.
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Our position is clear. Europe needs a right to try built on open data and accountability
We do not support a blind copy of the American model, where companies can refuse access and outcomes often vanish in private notes. But keeping the current bureaucracy is not a moral victory. It is a political choice with real victims. We need a European framework for right to try with mandatory outcome reporting, digital informed consent, and public registries. Not as an extra bureaucratic layer, but as a technological backbone. Italy has the skills and the small innovative companies to build it. The opportunity belongs to those who move now.
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What to do? If you are a developer or an entrepreneur in digital health, stop waiting for public tenders. Build open standards, design privacy-first tools, sell to hospitals and biotech startups. If you are a business leader, push your associations to demand data infrastructure, not more paper. And every politician who claims to care about patients should answer one question: where is the platform that tracks compassionate use in real time? If there is no platform, there is no true right to try. There is only hope, outsourced.
