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An mHealth Company Wants FDA Approval for a Prescription Meditation App


Headspace, a mindfulness and meditation app maker, hopes to use new scientific research to support its prescription program by 2020.

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The maker of a leading meditation app is jumping squarely into the mobile health (mHealth) arena, announcing a new subsidiary to market what would be the first-ever clinically validated prescription meditation product.

Headspace, the 8-year-old organization that offers guided meditation and mindfulness sessions to nearly 30 million users, said it has launched a subsidiary called Headspace Health. The new subsidiary plans to begin randomized controlled trials this summer of meditation as a treatment for chronic diseases, with an eye toward achieving clearance from the FDA by 2020. Since 2015, the company has already completed or is currently conducting 65 research studies looking into the health effects of meditation.

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Headspace has not yet said which specific diseases it intends to target first. However, Headspace’s chief scientific officer, Megan Jones Bell, MS, PsyD, told Healthcare Analytics News that the company is evaluating several conditions as possible targets for meditation therapy.

“We have about a dozen disease areas we are exploring,” she said. “What I can say at this point is that we are exploring both mental and physical health conditions.”

In attempting to create a prescription meditation app, Headspace Health will be merging the very old practice of meditation with a relatively new technology, the smartphone app. At the same time, the body of research suggesting that meditation can have health benefits has been increasing. For instance, the National Center for Complementary and Integrative Health, part of the National Institutes of Health, published a digest in 2014 noting research related to meditation for the treatment of a number of conditions, from menopausal symptoms and anxiety disorders to cancer.

Jones Bell said the time is right for a product like Headspace Health’s prescription meditation programs.

“A number of things have come together to make this possible today: a long legacy of research supporting the impact of meditation on health outcomes, increased awareness of this practice and its benefits in popular culture, the FDA's interest in creating a more appropriate path for software as a medical device, and the groundbreaking work of those who have come before us in paving a way for lifestyle medicine such as Dean Ornish and Jon Kabat-Zinn,” she said.

Ornish, MD, is founder of the Preventative Medicine Research Institute and Kabat-Zinn, PhD, is the founding executive director of the Center for Mindfulness at the University of Massachusetts Medical School. Both have studied extensively the health benefits of mindfulness and meditation.

The FDA has been looking at the concept of software as a medical device for several years. In 2013, the agency joined with other regulators from around the world to form a working group aimed at coming up with definitions and a risk categorization framework for evaluating software-based medical products.

Headspace’s prescription meditation app will be a standalone product, separate from the existing Headspace meditation app. Jones Bell said stakeholders are still discussing the potential for features such as electronic health records interoperability and direct physician access to data.

“We are working with physicians, physician organization, patients, patient advocacy organizations, and payers to determine what product features will be serve the needs of our target patient populations and the physicians from whom they seek care,” Jones Bell said.

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