The legislation in place today for regulating in silico products actually predates the existence of these technologies. In order for the in silco market to grow and for research in this field to be encouraged, a policy framework for in silico medicine needs to be developed. Just as the internet has created an urgent need to reform how we think about issues such as data security and IPR, in silico medicine requires we reevaluate our existing health policy structures.
Even the most advanced and predictive model has little value to industry if it cannot be submitted as evidence of the effectiveness or safety of their product:
- Manufacturers of medical devices who use in silico technologies must be provided with a framework for submitting this data to notified bodies, health authorities and evaluators of health technologies.
- Similarly for pharmaceuticals, a framework for admissibility of in silico clinical trial data needs to be developed so that we can move from exploratory clinical trials in humans, to a scenario where we seek to confirm what we know from in silico methods.
Incentives in policy need to be provided for industries that pioneer this research which has the potentially to drastically decrease overall research costs and greatly improve patient safety. Providing a system for assessing modelling and simulation data that supplement efficacy or safety data is required to bring healthcare into the digital era.
“If healthcare is to move into the digital era, we need new policies that will enable this transition”
