Digital healthcare: regulating the revolution

The digital health revolution has arrived. In 2017 the digital health industry was already worth $25bn (£19bn; €21bn) globally, with the potential to cut healthcare costs by an estimated $7bn a year in the US alone.1 Digital health, or e-health, encompasses several distinct technologies including but not limited to: decisional support systems that use algorithms derived through mining clinical datasets, such as the work carried out by Google DeepMind; mobile health apps, or m-health, which can support and monitor healthy behaviours; connected biometric sensors, such as continuous glucose monitoring; consultations via video link (“telemedicine”); and electronic personal health records.

New products come to market quickly—153 000 mobile health apps have been released since 2015, bringing the worldwide total to 320 000.3 The sudden influx of technology, combined with a lack of robust governance, has led to distrust among some clinicians, patients, and healthcare providers. Technologies are consequently ignored or abandoned.45 Regulating digital health, while trying to create an environment promoting innovation, is challenging.