Vediamo come tre innovazioni in ambito medico sono state possibili negli Usa, grazie a un nuovo approccio della FDA basato sulla “real world evidence”, tentando dunque soluzioni senza evidenze di base. Una prospettiva interessante per la telemedicina ancora frenata dall’assenza di studi che ne provino efficacia e sicurezza.
L’impatto più importante delle soluzioni di telemedicina riguarda l’accessibilità dei pazienti ai servizi sanitari. Ma come spesso accade in diversi ambiti innovativi legati alla medicina, questo aspetto viene messo in secondo piano in attesa degli esiti di studi lunghi e costosi atti a dimostrare l’efficacia e la sicurezza degli interventi.
C’è, evidentemente, la necessità di tentare soluzioni senza evidenze di base. La Food and Drug Administration, che negli Usa regolamenta i prodotti farmaceutici ha deciso ad esempio di sdoganare la real world evidence come possibilità di generare prove di efficacia utili alla registrazione dei dispositivi medici. E i risultati si vedono.
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