Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "How the FDA Regulates Pharmaceutical Apps."
Following is an excerpt:
Mobile apps seem all the rage in the pharmaceutical industry. According to the website InPharm, there are presently over 100 of them publicly available. Based on what I'm hearing from pharmaceutical companies directly, that's only a small number compared to the apps in development.
Recently there's been a debate going on in the UK about whether pharmaceutical apps are medical devices under EU law. Consulting firms Bluelight & d4 suggested in a January report that many health-related apps are indeed medical devices in the UK. Specific to pharmaceutical apps, the report suggests that at least in the UK "if your app will be associated with, contributes to or makes a clinical decision, assume that it will be classified as a medical device?...." The report stirred quite a controversy among champions of innovation and free speech.
