Life sciences may see accelerated digital health pathway as soon as 2020

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US August 02, 2019


Makers of digital health products may soon have a new regulatory pathway. The FDA recently announced it’s completed preliminary testing of the Digital Health Precertification (Pre-Cert) Program, which would give companies with excellent regulatory and quality capabilities streamlined reviews of their products.

In testing the Pre-Cert program, the FDA found that information provided through its company appraisals was “generally” able to support review decisions. Still, the agency said the program still needs fine-tuning. The pilot testing phase will continue through this year with the program rolled out to all companies in 2020.

HRI impact analysis

The FDA has been busy modernizing its regulatory processes for digital health, according to a recent HRI analysis. The Pre-Cert program is one program that eventually will help speed digital health products to market. Other changes, such as transformations in the way FDA treats multiple-function devices, companion applications and over-the-counter drug labeling, could lower the barrier to entry for pharmaceutical companies in the digital health space.

In 2018, 53 percent of pharmaceutical executives surveyed by HRI said that they had not invested in digital therapeutics or connected devices, but at the time, 80 percent said they planned to in the near future. Those investments could be easier to make, cheaper to complete and more effective following the changes the FDA has already made or soon plans to make.

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Ingrid Stiver

Senior Manager, Health Research Institute, PwC US

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