Evaluating digital health solutions with clinical value

Companies need to cultivate innovative evidence generation culture in order to develop quality digital health solutions. Effective digital transformation in healthcare depends on the creation of solid evidence. All parties involved in digital health will profit from taking the necessary steps to enable and promote robust evidence, but patients who are directly or indirectly serviced by digital solutions will gain the most. This is especially true for the subset of digital health solutions known as digital therapies, Software as a Medical Device (SaMD) in the US, Medical Device Software (MDSW) in the EU, and/or Software as a Medical Device (SaMD) in the UK. Evaluations of clinical effectiveness and safety will be required for these kinds of digital health solutions in order to support any requisite regulatory certification. If this approval is granted, it is also likely that there will be data to substantiate the value that the digital health solution provides.