Five Regulatory Myths Keeping Bio/Pharma Out of Digital Health


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in MobiHealthNews, titled “Five Regulatory Myths Keeping Bio/Pharma Out of Digital Health.”

Following is an excerpt:

Digital tools offer an opportunity to revolutionize bio/pharma care, so why isn’t more being done faster?

Bio/pharma is desperate to offer new value to patients, providers and payers, and digital can unlock both clinical and economic outcomes.

That’s why we are heartbroken when these companies barely dip their toe in the digital waters. They want to move faster, but fear of regulatory consequences is creating significant friction and even paralysis.

No doubt there are valid issues to manage and unknowns to navigate. At the same time, at least some regulatory fears are rooted in myths rather than facts. By busting these myths, bio/pharma can more confidently enter the digital health market.


5. FDA wants to tightly regulate bio/pharma software.

4. Companion digital health developers always create regulatory risk for bio/pharma.

3. Any clinical trial software will be regulated as a medical device.

2. Any bio/pharma software must be approved via a supplemental NDA.

1. Bio/pharma companies must report adverse events in any databases they touch.