Should clinical software be regulated?

substitution study that should have been excluded, the odds ratio for mortality in HITH becomes a near-statistically significant 0.76 (95% CI 0.57–1.01; P=0.0599)! The fact that it is not significant is probably a type II error. Interestingly, both groups in the Cochrane analysis, after removing the failed HITH trial, show an odds ratio of about 0.76 for mortality, indicating homogeneity. Even with borderline statistical significance, a one-quarter reduction in mortality from 17.8% to 13.4%, with a number needed to treat in HITH to prevent one death in 25, is clinically significant. Assessment for function in HITH studies shows two patterns. Studies where HITH substituted for hospital admission found that physical and cognitive function were improved. In studies in which patients are discharged early to HITH, the general focus on rehabilitation means that both groups attain comparable function. There are insufficient data on nursing home placement to draw conclusions. The problems with the financial analyses are similar, but simpler. Services where HITH is not a substitute for in-hospital care, but merely add-on care, are bound to be more expensive, no matter how sophisticated the economic analysis. Where HITH substitutes for inhospital care, and the service works at reasonable capacity, HITH is cheaper than hospital. All the pieces are in place, though more evidence is needed to achieve statistical significance. The evidence clearly leads towards a conclusion that HITH offers better health outcomes and a reduction in costs.