Below are four digital health rule changes that will bring opportunity to pharma, according to a PwC Health Research Institute analysis.
1. Digital health precertification: Pharma companies with high marks on regulatory quality are now eligible for shorter reviews and ONC approval.
2. Companion applications: Digital health apps that are intended to supplement prescription drugs will now be regulated as labeling, meaning they will not require FDA approval.
3. Multiple-function devices: The FDA will treat each function of a digital health device as a separate entity, making it easier to have full-function products.
4. Over the counter drug digital labeling: These drugs can be approved if evidence shows the consumer can use digital labeling to select a drug for treatment.
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