Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.

Following US FDA's final guidance on Medical Device Development Tools last year, the agency announced the first such tool has been qualified and that stakeholders should expect a slew of MDDTs to be approved in the next few months, including ones that apply to wearable medical monitoring devices.