It's not uncommon for doctors to tell patients that they need to relax, but now one company is aiming to develop a digital meditation product that can be prescribed by physicians. Headspace, maker of a mindfulness and meditation app, announced that it is a digital health subsidiary called Headspace Health. The goal of the subsidiary is to create a new prescription meditation app by 2020. 

“The creation of Headspace Health is the most significant step ever taken to introduce meditation into medicine at scale,” Rich Pierson, founder and CEO of Headspace, said in a statement. “Health professionals have long recommended Headspace as an effective tool in treating a wide variety of health problems, and now we’re leading the effort to validate and deliver prescription meditation solutions to doctors and their patients for physical conditions. By standardizing meditation into health care, we’re bringing Headspace even closer to realizing our mission of improving health and happiness around the world.”

Right now the company is planning for the meditation app to be part of a portfolio of products that will be FDA-cleared and clinically validated. These products will be released later on down the road, according to the company, and will be designed to help treat a range of chronic diseases. 

Headspace Health is set to begin its randomized control trials on its first targeted disease state this summer. After the clinical trials are completed the company plans to submit to the FDA in 2019, and hopes to have its first product ready for business by 2020.

While this summer’s trials will be the first for Headspace Health, the parent company has been involved with studies in the past. A recent study published in BMC Psychology, found no significant difference in mindfulness, dispositions, or critical thinking scores when comparing a group of participants that received mindfulness meditation training through Headspace’s meditation app to a group that went through a “sham” version of the mediation training delivered by the same app. 

However, the company said it has completed or is currently conducting over 65 evidence-based research studies on the implications of the mediation app on chronic conditions. The Santa Monica, California-based startup reports that overall, the results have come back positive. 

Meditation apps have a long history in the digital health space — in fact, as far back as 2010, the Mayo Clinic was partnering with startup mRemedy to create one. Still,  most of these offerings purport to improve users' wellness, as opposed to clear medical outcomes. 

As for digital FDA-clearance, the process for software and devices is beginning to evolve. Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway. Among these is Pear Therapeutics, which has designed an FDA-cleared app to treat addiction and dependency on stimulants cannabis, cocaine, and alcohol.  

The FDA's pilot program is ongoing and drafts of new guidances are continuing to emerge at this time.