- The FDA on Wednesday added a new description for a type of mobile medical app that it will not regulate as a medical device, the fourth description of this type that the organization has added this year.
- The FDA will not regulate mobile apps that allow users to "collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record.”
- The description matches HealthKit, Apple's new health data tracking platform, as well as similar recently-announced products from competitor Google.
How to regulate consumer mobile health apps continues to plague healthcare. More striking than the FDA's decision to decline to regulate these kinds of information-tracking apps is that, currently, they are not subject to HIPAA, either. Given that market experts estimate that by 2015, over half a billion people will be using mobile health apps, that creates a pretty big patient privacy risk — especially if, like HealthKit, some of these apps are going to be integrating with EMRs. Hospitals will have to tread carefully as this could create legitimate compliance issues.
The first three additions of apps the FDA will not regulate were made on March 12 and are as follows:
- Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number.
- Mobile apps that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications.
- Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform.