Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Politico Morning eHealth, in “FDA Releases Draft Patient-Experience Data Guidance,” by Darius Tahir.

Following is an excerpt:

The new agency guidance regarding patient-experience data in drug development includes few details about using digital health tools as a means for collecting that information. The agency says that companies interested in using digital apps or gadgets to gather the data should consult with the agency.

Conceptually, patient-experience data is information regarding how patients react to drugs beyond traditional metrics, like mortality and morbidity, that seeks to capture other important factors how patients feel about therapies they’re taking. For example, a patient might become more active when taking a drug.

Digital health enthusiasts have long felt their gizmos could play a role here; for example, a smartphone might be able to measure the increase in steps taken during a study period. But the guidance simply says that groups interested in using those technologies for gathering the data should consult with the agency first.

Some industry observers we chatted with were puzzled by the scanty detail — described over two sentences — in the guidance. “FDA really doesn't explain what [its] concerns might be with digital health technologies,” said Epstein, Becker and Green lawyer Bradley Merrill Thompson. “It would have been much more useful if FDA articulated what [their] concerns were, rather than just saying, hey come talk to us.”

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.