The facts. In July 2026, Montana signed a new right-to-try law aimed at individualized treatments: drugs built for a single patient, often a child with a rare disease. Brody DeVault, born in March 2023, is the face of that law. By age two and a half he had missed key speech, movement and coordination milestones; genetic testing confirmed the worst. His father Kris is desperate, and the law can't come soon enough. As MIT Technology Review reports, the American logic is simple: when a patient has no alternatives and gives informed consent, bureaucracy should not be a wall.
Why it matters. In Europe, the same story stalls. Compassionate use exists, but it runs through ethics committees, opinions and national authorizations. Every week of waiting is a week of disease progression. Meanwhile, precision medicine is producing n-of-1 therapies: a drug designed for a single mutation, for a single child. This is not a mass market. That is exactly why it is the perfect test of whether our regulations are alive or just an email circus. For Italian families, this means asking for permission instead of asking for a protocol.
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The technological layer matters even more. An individualized therapy is an experiment that produces data: what happened to the patient, which dose, what side effects. If those data remain in a PDF, in a doctor's drawer or in a mailbox, they do not generate knowledge. AI can learn from rare diseases only if datasets are structured, interoperable and pseudonymized. Without digital infrastructure, right to try is a lottery: a few survive, but medicine does not advance. For SMEs this is a huge opportunity. Real-world evidence platforms, remote monitoring, electronic informed consent, longitudinal registries: Europe has the data, the doctors and the companies. What is missing is an ecosystem that connects the dots.
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Our position
We, Meteora Web, come from accounting and code. So here is what we think: the right to try is right, but experimentation alone is not enough. Every experimental treatment must have a registry, a measurement protocol and an obligation to publish results, even negative ones. That is the double-entry bookkeeping of medicine: if you do not measure, you cannot claim it worked. Europe must accelerate access, but not with wild deregulation. It must do it with a serious technological infrastructure. GDPR does not forbid saving lives. The problem is that we use it as an excuse to build nothing. We are against bureaucracy as a wall, but also against access without data, because it turns hope into a blind bet. The answer is neither Montana's approach nor the old European one. It is a new European model based on registries, open standards and clinical accountability.
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What to do. If you are an Italian software company, move into health tech now: FHIR standards, interoperability, consent and data collection platforms are the work of the next decade. If you are an entrepreneur or a public administrator, demand clear timelines and digital procedures for compassionate use from your region and from AIFA. We do not need another app. We need a clear protocol and the technology stack to support it. And if you are a parent fighting a rare disease, remember: your case is a data point. Demand that it be recorded in a standard way, so the next family does not have to start from zero. A patient in Sicily should have the same chance as one in Montana.
