How the FDA Could Impact Machine Learning, IoT in Healthcare

Health Data Management, Information Management

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Health Data Management, titled “How the FDA Could Impact Machine Learning, IoT in Healthcare.” (Read the full version - subscription required.)

Following is an excerpt:

The Federal Food Drug and Cosmetic Act gives the FDA oversight of both drugs and medical devices. Broadly speaking, regulated medical devices include those items, such as software, that are intended for use in the cure, mitigation, treatment or prevention of disease. In this example, software that directs the patient on when to take specific medicines in the management of asthma would seem to fit that definition. Indeed, FDA has regulated various types of software for decades.

Because of the 21st Century Cures Act passed last December, software that advises healthcare professionals is no longer regulated by the FDA, as long as the professional has the ability to independently review the basis for the recommendation. However, much of the intelligent software used in connection with the Internet of Things will target consumers to change behaviors. One study, for example, has shown that average adherence among children using inhaled corticosteroids for asthma improved from 30 percent to 84 percent with the introduction of smart inhalers that produce audiovisual reminders. The opportunity to impact patient behavior is too alluring not to nudge the patients directly. So it is likely that much of the machine learning-based software used in connection with the Internet of Things will not qualify for this exclusion from FDA oversight.

Related reading:

Information Management, “How the FDA Could Impact Machine Learning, IoT in Healthcare.”