Montana has passed a new right-to-try law in 2026, expanding access to experimental treatments that have not yet received FDA approval. The story of Brody DeVault, a two-year-old child with developmental delays and a genetic test that gave no answers, became the symbol of a demand coming from thousands of families. Supporters say the law will let patients bypass bureaucratic timelines and access therapies that already showed promise in trials. Critics call it a dangerous leap in the dark. Unlike the federal right-to-try law, Montana's new measure was designed to speed up access even further.
For people working in digital, this is not just healthcare news. It is the symptom of an imbalance that affects tech companies. The United States is shortening the distance between lab and patient, while Europe keeps debating AI Act, GDPR and clinical trial regulations. The result is concrete: companies building telemedicine platforms, genetic diagnostics and predictive algorithms find more fertile ground where data flows and protocols move fast. For Italian digital health SMEs, this is a wake-up call.
Sponsored Protocol
There is also a technological issue. A law like Montana's, without digital infrastructure, is just paper. Deciding who can access an experimental treatment requires interoperable medical records, genetic tests, safely managed informed consent. This is exactly where small Italian companies could excel. But today the regulatory environment punishes them: anyone building health software in Italy knows validation takes forever and compliance costs are huge. A digital health system that does not speak the same language slows everyone down.
Our position
We, at Meteora Web, see companies giving up on innovation every day because the regulatory framework is a swamp. Our position is clear: the right to try is not built with a single law, but with serious data infrastructure. Health software today must deal with rules written before AI, designed for a world that no longer exists. Europe must decide whether to be a museum of regulations or a laboratory for the future. The Wild West without control is not the answer, but inertia is worse. If an Italian company cannot test an early diagnosis algorithm, it will do it in the US or Asia. European patient data will travel anyway — without our added value.
Sponsored Protocol
What to do? If you are in health-tech, get ready. Invest in interoperability, privacy by design and certifications that work beyond national borders. And push your industry associations: this issue must enter the political agenda. The technology is already there. What is missing are rules that let it run. If the US is accelerating in 2026, Italy cannot afford to stay on the bench.
