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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.