image of meditation app

Meditation? There’s an (almost FDA-approved) app for that

Headspace is paving the way for the first FDA-approved prescription meditation app.

Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can help treat 12 mental and physical conditions.

Megan Jones Bell, the company’s chief science officer explained in a recent interview that the new app will be developed with input from patients, physicians, and advocacy groups.

“It will be designed as a prevention and treatment intervention,” said Bell. Because the app will be used to “treat” chronic diseases, using it “really should be done under the doctor’s supervision and that’s why FDA clearance is necessary.”

If Headspace receives FDA approval, this will be another significant step forward in guiding those trying to navigate the murky smartphone mental health arena.

I researched smartphone mental health apps for my Petrie-Flom Student Fellowship project by speaking to mental health care professionals, and during these conversations one thing was clear: when it comes to smartphone apps, there is little clarity for health care professionals.

Currently, the FDA’s regulatory stance on smartphone mental health apps is largely to take a “hands-off approach.” In its non-binding recommendations, The FDA categorizes some apps as “medical devices,” and warrants regulation only for those “whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” The FDA defines a “medical device” as a device “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”

The FDA says it would oversee an app that uses a patient’s parameters to calculate dosage for radiation therapy, for example. An app for which the FDA would exercise enforcement discretion is one that would “help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a “Skill of the Day” behavioural technique or audio messages that the user can access when experiencing increased anxiety.”

Somewhere in between these two poles fall the majority of smartphone mental health apps, which proliferate in the market, unregulated by the FDA. It’s the wild west. From the app “Relieve Depression Hypnosis,” which boasts 6 million downloads, to a depression-testing free app titled “Depression Screening / Evaluation / Test,” to an app called “Mental Health Recovery Guide” that claims to provide “17 essential skills you need to know to fast track your recovery,” a plethora of apps offer unwitting patients who genuinely suffer from mental health issues a cornucopia of untested and possibly harmful options.

The consequences can be severe. Several years ago, the app “iBipolar” recommended users who were experiencing a manic episode to drink alcohol before bed, a recommendation that is not based in evidence and could significantly harm users.

There are also risks to personal health information. A recent study investigating the privacy policies of apps for dementia found that only 46 percent of apps had an available privacy policy, of which most expressed that they share data with third parties. Consumers should be aware that any information they share with health apps may not at all be secure. Apps do not abide by the same ethics of confidentiality that health care professionals do.

Where the FDA has failed to ensure the safety of users for mental health apps, several efforts have arisen to address the issue.

The American Psychiatric Association has released a flow chart to help clinicians and patients evaluate an app before deciding to use it. Other platforms, such as PsyberGuide and Ranked go a step further by curating databases of apps evaluated by experts. These apps are scored on metrics such as usability, credibility and transparency.

Still, of the 22 clinicians I spoke to during my research, many did not know where to start when thinking about how to support their patients’ mental health with smartphone apps. Most of the participants in my study conceded that having a reputable source such as a professional organization endorse an app would make it much easier to recommend an app to a patient. Scientific validation was also an important factor that these clinicians valued in considering how apps could help their patients.

An FDA stamp of approval would ensure that an app has been scientifically validated to show evidence for treatment and would allow clinicians to confidently recommend apps to patients.

Furthermore, if a treatment app were to maintain identifiable health information, be administered by a health care provider, and/or require a prescription, it would also likely be subject to HIPAA. This is not the case for your typical smartphone mental health app that is more likely to sell your data rather than keep it secure.

The only other app to have received FDA approval in the mental health space is reSET® by Pear Therapeutics. It is a 12-week prescription for substance use disorder to be used as an adjunct to standard, outpatient care. In mental health, the company also plans to gain approval for apps addressing opioid use disorder, PTSD, general anxiety disorder, major depressive disorder, and insomnia.

The bar may have been set low by the FDA for smartphone mental health apps, but Pear Therapeutics, and now Headspace Health, are raising it by creating evidence-based, safe products, that will come with the FDA’s seal of approval.

App developers should take note and follow suit.

Gali Katznelson

Gali Katznelson

During her fellowship year, Gali Katznelson was an MBE candidate at the Center for Bioethics at Harvard Medical School. Before her master's degree, she completed a bachelor’s degree in Arts & Science at McMaster University in Canada. Her fellowship project focused on clinicians' perceptions of the uses and regulations of smartphone mental health apps.

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