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Digital health companies seeking FDA approval must weigh access versus price

Jul 19, 2021   |   Modern Healthcare

Companies in the growing digital health space increasingly are weighing Food and Drug Administration approval for their products, a strategy intended to differentiate them from competitors as they try to persuade insurers and employers to cover their offerings.

Companies like Biofourmis, Akili Interactive and Pear Therapeutics offer software systems for specific diseases. Patients need prescriptions from providers to use the products. Insurance coverage of these products and services could enable these companies to reach more patients—and get paid more for them.

As this $9 billion industry matures, payers should look beyond FDA approval when assessing the efficacy of these tools, and digital health companies should make decisions about whether to submit products to the FDA based on what’s best for their own business models, said Dr. John Torous, director of the digital psychology division at Harvard University’s Beth Israel Deaconess Medical Center. Read more…


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