STAT NEWS recently published an op-ed with a provocative question: How do we tell the difference between legitimate mental health tech and snake oil?
Looking back to the early 20th century, there were no regulations for medications or even for food additives. Babies were given morphine as “soothing syrups” and formaldehyde was used to preserve meat.
The first protection law for consumers, the Pure Food and Drug Act, was passed in 1906. The Act set standards for effective and safe medications as well as food additives.
About Digital Mental Health
Now that advances have been made in pharmacology, a new agency is needed to advise the public about digital mental health.
Several groups released digital mental health standards with each providing evidence of the need to review digital products and practices. However, there have been no rules established for either telehealth practice or mental health apps. Nor is there a review process.
There are, however, common themes presented suggesting:
- Safety and efficacy
- Product design
- Clinical Impact
- Privacy Protection
- Data Management
- Integration of Electronic Healthcare Records
- Expansion of Health Care
Note that national credentialing of therapists is also a consideration.
There are significant differences from all sides as to the definition of each issue. Therefore, a common standard is vital to this field. These new standards can support innovation as opposed to the approval process that is used for drugs (pass-fail).
One approach may be to create a new federal agency. However, such agencies are not efficient in their review of digital products and take years to launch.
A more efficient approach might be to create an industry group to review products. Due diligence is currently performed on many start-up companies and their digital solutions. These efforts can be integrated with an oversight board.
The type of cooperation needed for an integrated approach has not been evident in our competitive industry. One exception is The Digital Medicine Society. The society has created this type of consortium through its Digital Health Regulatory Pathways, although it has not focused on mental health.
Consumers are now inundated with digital therapeutics and diagnostics. Evidenced-based psychotherapies, which are the integration of clinical expertise, research, and patients’ values, may also be included.
About Digital Mental Health
Consider the number of mental health apps. They range from self-management to tools that connect coaches with users. The apps are mostly directed at consumers and therefore may not be covered by insurance.
Some new products have proven their value such as diagnostics and therapeutics which include virtual reality products. Therapeutics use hardware and software focused mainly on anxiety and mood disorders.
Another area in need of establishing standards is the host of companies that have come onto the scene due to the pandemic. These companies have improved access to psychotherapy and medication. Providers for these companies number in the thousands and interface with hundreds of thousands of patients. The ‘members’ are promised the ‘best therapist’ to satisfy their needs.
In truth, coaching services and meditation apps have helped millions of people suffering from anxiety and insomnia. Improved access through on-demand services has helped many people on waiting lists receive in-person therapy. In some instances, these virtual reality-based therapies have received approval from the FDA.
But one of the many questions remains: how will these products that do have value be evaluated without privacy protections?
