Digital Health Tools Need a New Benchmark

Digital health technologies made it possible for many of us to receive health care in a different way. Digital health technology is still in its infancy in national health systems around the world. A critical reason is that they often lack the necessary scientific evidence to back the range of benefits that its manufacturers claim they can deliver.

The extent of the problem was demonstrated in a recent study. The researchers looked at clinical trials, regulatory claims, and outcomes. Only 20 percent of solutions met the threshold considered acceptable. This situation makes it difficult for new innovations in health care to be taken up.

Increased scrutiny will be given to the evidence needed for digital health technologies. Regulators and payors will need more clarity on evidence for reimbursement. This is happening in several countries. A consensus is developed between leading bodies and experts.

New drugs and medical devices are tested in controlled trials. It's not always appropriate for digital health devices to use this methodology. We will see more acceptance of different ways of generating evidence, from clinical simulation trials to the use of real-world evidence in hospitals and medical centers.

A new tool that automated the search for suitable clinical trials for cancer patients was tested in a simulation by the pharmaceutical company. Synthetic patient data is mock data that is based on real-patient data, but with altered names, dates, clinical history, and patient outcomes. The clinical trial search tool continued to be iterated despite the fact that it was conducted remotely.

Clinical simulations offer a number of advantages, including being able to replicate real-world health care scenarios and be conducted remotely on multiple locations at a low cost, as well as allowing for the inclusion of high-risk patient cases, which are usually excluded on standard trials. Clinical simulations and synthetic data will become the new gold standard in the trial of new digital health tools.

Regulators favor a more pragmatic approach to evidence generation, and will accept novel methodologies as validation. The Early Value Assessment Program for Digital Tools will help select promising technologies and conduct a rapid assessment of their clinical effectiveness before embarking on more robust trials. In 2023, pilots will be conducted for digital apps for anxiety and depression in children, and it is hoped this will be rolled out for early cancer diagnoses, adult mental health, and cardiovascular disease. Clinics will be able to evaluate bold claims made by digital health companies in the near future, thanks to programs like these. We will see a better range of digital health technologies once we crack this.