FDA clearances for digital health devices are on track to triple by 2018, according to new research from Accenture, as digital health offerings drive more than $100 billion in savings over that same time period.
Thirty-three digital health devices were cleared by the FDA in 2014, according to Accenture, and they predict 100 will be cleared in 2018.
The research group estimates that FDA-cleared digital health devices -- defined as "an internet-connected device or software created for detection or treatment of a medical indication" -- saved the US healthcare system $6 billion last year in the form of improved medication adherence, behavior modifications and fewer emergency room visits. They predict that savings will grow to $10 billion in 2015, $18 billion in 2016, $30 billion in 2017 and $50 billion in 2018.
"A digital disruption is playing out in healthcare, as witnessed by the emergence of new business models and technology that will change the nature of patient interactions, alter consumer expectations and ultimately improve health outcomes,” Rick Ratliff, managing director of digital health solutions at Accenture, said in a statement.
Accenture credits a number of different factors with helping along this trend, including growing demand on both the consumer and clinical sides. Accenture surveys show that the number of US consumers who own a wearable fitness device will double in the next five years, from 22 percent this year to 43 percent by 2020. Another shows that 57 percent of US consumers self-track their health information online, including medical history, physical activity, and symptoms.
Meanwhile, on the clinical side, meaningful use is guiding increased clinical interest in digital health tools. Additional factors include increased regulatory clarity from the FDA and the ongoing shift to value-based care, which is also driving venture fund investing in digital health.
Overall, Accenture predicts that consumer and clinical solutions will converge over the next four years, as consumer devices and software seek FDA clearance to enter regulated health markets and clinical offerings take lessons on usability and patient engagement from the consumer health sphere.
”The proliferation of internet-connected solutions and evolving regulatory guidelines are blurring the lines between clinical and consumer health solutions,” Ratliff said. “As consumer health platforms support more ‘medical’ devices, rather than just today’s wellness trackers, they’ll create a viable self-care model in a segment that today is occupied by chronic-disease monitoring companies.”
