Four Major Regulatory Changes to Digital Health Driving New Opportunities for Pharma

1. Digital Health Precertification: companies with high degrees of regulatory quality are eligible for shorter reviews and ONC certification
2. Multiple Function Devices: The FDA will treat as separate the various functions of a digital health device, making it easier to have full-function products
3. Companion Applications: The FDA will allow digital apps intended to supplement prescription drugs to be regulated as labeling and not require approval
4. OTC Drug Digital Labeling: OTC drugs drugs may be approved based on evidence that consumers can use digital labeling to select a drug for treatment

Source: PWC
Source URL: https://www.pwc.com/us/acceleration-by-regulation?WT.mc_id=C...

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